Legal Study on Pharmaceutical Patent Under TRIPs Agreement

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TOPIC:

A legal study on pharmaceutical patent under TRIPs Agreement. Current impressions of the practical implementation in some countries including Vietnam & Proposal.

 

Chapter I: GENERAL INTRODUCTION OF PHARMACEUTICAL PATENT

  1.                    Definition of patent and pharmaceutical patent.

1.1.1. Definition

Patent has been mentioned in agreements or conventions that related in Intellectual Property Rights, one of those shows as below:

“Patents shall be available for any inventions, whether products or process, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application…patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology or whether products are imported or locally produced”. [1]

To put it another way, Patents for inventions is a national diploma based on the application for protection, which describes an invention and a set of legal conditions for the owner of the patent.

There is the fact that pharmaceutical patent has not been defined in any agreement or convention that related in Intellectual Property Rights but the definition of pharmaceutical products can be found in FC&D Act which states that: The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”[2]. With this in mind, we can give a definition of pharmaceutical patent as follows: pharmaceutical patent is technical solution as an invention or process to serve people’s health through the application of the rules of nature.

Pharmaceutical patent protection means the state through the legal system in order to establish the rights of patent holders and protection of such rights, against any violation of third parties.

1.1.2. Typical types of pharmaceutical patent

There are three major types of pharmaceutical patents: drug-substance patents, which claim the active ingredients of drugs (also known as AI patents); drug-product patents, which claim either particular drug formulations or compositions; and finally, method-of-use patents, which claim various therapeutic indications of a specific drug.[3]

– Drug-substance patents: This claims the active chemical substance as a new chemical entity and is generally regarded as being superior claim. If there is a product claim on the drug then none but the patent holder or licensee can make, sell or import the chemical for any use without infringing the product patent.[4]

This type of patent claim is now allowed in most commercially important countries, although it is a fairly recent event in many others. For instance, Japan, Switzerland, Sweden and Italy introduced product patent for pharmaceuticals in the 1970’s, Austria in 1987, Portugal, Spain and Greece in 1992.[5]

The novel drug is claimed either by chemical name or by chemical structure, or both. The drug may be claimed within a Markush structure. This comprises a core chemical structure with several optional chemical groups that may be attached to the core structure. This is known as a generic claim to a compound. A drug will be covered by the generic claim and there may be a specific claim to the chemical as well. Some Markush structures are so general that they can cover millions of actual chemicals.

– Drug-product patents: This claims the pharmaceutical dosage form on the drug, commonly also known as a composition but not to be confused with ‘composition of matter’ (see previously). It may take the form of a formulation of a particular drug or class of drugs, or a general formulation applicable to many drugs with different actions, such as slow release technologies, transdermal patches, etc. There may also be formulation process patents covering the manufacturing processes used to make the formulation.[6]

– Method-of-use patents: This covers the use of the drug to treat a disease. This type of claim is originally allowed in the USA and Germany, but is now being accepted in other countries including the UK. However, a careful wording of the claim in European patent application allows this type of claim. The European claim usually goes ‘… use of drug x to manufacture a pharmaceutical dosage form to treat …’, thereby avoiding a direct method of treatment claim.[7]

  1.                      Benefits of pharmaceutical patent protection

The pharmaceutical patent protection brings tremendous benefits for creative and social development, as indicated in the following aspects:

 

Firstly, patent protection encourages pharmaceutical research and development of new products and processes, thus promoting innovation.

Under patent protection, patent owners are given the rights to their patent by law including including the right to use or permit others to use the invention; the right to prevent others from using the invention and right to dispose of a certain period of time[8]. These rights are legally recognized as exclusive rights and created for pharmaceutical patent owners opportunity to obtain economic benefits by commercial exploitation of inventions. Profits earned from the exploitation of pharmaceutical patents not only encourage innovators and investors on scientific research but will continue to be invested into research in the future to find out new patents, promote innovation cycle and develop society as well. Moreover, the inventor is assured that investors will be given the incentive to commit the financial resources necessary to support the inventor’s research and to develop it so that can be manufactured and made available to the market[9].

The race for patents would create a range of alternative products as diversified options for the society. Patent protection system brings benefits to society at both promoting discounts and creating continuously technology and new products.

 

Secondly, pharmaceutical patent protection encourages the disclosure of new technologies as well as the transfer of technology.

One of the mandatory requirements for the patent application is that it must be disclosed fully and clearly the nature of the invention to the extend that any person with average knowledge of the relevant technical field  can implement that solution[10]. To be granted and protected the legal rights to the invention by the State, patent owners must publicize their invention to society which play particularly important role for the following reasons:

  •     Contributing to enriching the treasure of human knowledge;
  •     The opportunity to exploit the patent for free to individuals and organizations after the expiration of patent protection;
  •     Avoiding waste in research to create new invention afterwards.
  •     Enabling the creation of new inventions on the basis of existing inventions.

Thirdly, pharmaceutical patent protection encourages investment in the industries, especially in pharmaceutical industry which products made by higher levels of intelligence.

 

  1.                      Basic international legal sources for the patent protection of pharmaceutical products.

International protection of Intellectual Property Rights in general and pharmaceutical patent protection in particular have a long history of development.

Multilateral treaties in industrial property were first signed in 1983. The majority of bilateral treaties signed earlier. Until now, there are more than thirty  important multilateral treaties have been signed in Intellectual Property creating an effective international legal system on Intellectual Property protection.

Patent protection is stipulated in the Paris Convention and TRIPS Agreement. Patent protection for pharmaceutical products is also adjusted in the Doha Declaration and TRIPS Agreement Protocol. Besides, patent protection is also specified in bilateral trade agreements, for instance trade agreements between the US – Vietnam (2000); United States – Jornon (2001); US-Singapore (2004), the US – Australia (2005) and in a number of regional agreements. However, under the research scope of the thesis, the author only limit analysis of the provisions of the multilateral treaties and especially in the TRIPS Agreement, the Doha Declaration and the TRIPS Agreement Protocol on the issue pharmaceutical patent protection.

Before TRIPS, many States did not issue patents for pharmaceuticals in their territory, which meant that the inventor had no particular right over his invention in that country, which led to the growth of copies of patented drugs in some countries. The lack of adequate protection was the driving force behind the establishment of TRIPS. [11]

 

CHAPTER II: GENERAL PROVISION OF PHARMACEUTICAL PATENT UNDER TRIPS AGREEMENT

 

The TRIPS Agreement defines the guidelines that Members must follow in setting up systems to protect intellectual property rights. If WTO allows countries cannot do the rules but TRIPS does not. TRIPS states what countries must do. Member States must grant patents for a minimum of twenty years to the invention of a pharmaceutical product or process that exhibits novelty, inventiveness, and usefulness. TRIPS also stipulated requirements which determine a product or process can be protected as a patent or not, accompany with provisons of protection, as follow:

 

2.1. Object of patent protection for pharmaceutical products.

TRIPS Agreement stipulate that patent protection is applied for any invention, whether product or process, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.[12]

Article 27.1 of the TRIPS Agreement resolving one of the main shortcomings of the Paris Convention, the first time prescribing general principles to be patented for both products and processes in all technological fields including the pharmaceutical sector. According to the Paris Convention, the countries are free to exclude the areas which not patented and prescribe special rules for certain types of patents, as well as identifying the requirements for patentability. 49 countries participate in the Paris Convention  excluded pharmaceutical products from the scope of the patent and 10 countries of the Paris Convention excludes pharmaceutical production processes also. The TRIPS Agreement has changed this situation by prohibiting discrimination between sectors and places of production of the invention, between domestic products and imported products. Thus, patent for pharmaceutical products  is adjusted by the TRIPS Agreement as the same as the invention in other fields.

2.2. Conditions on patent applicants.

Patent system imposed a number of conditions for the patent applicant and ensuring that inventors enjoy rights corresponding to their contribution. Like most of the legal system of the invention, the TRIPS Agreement uses three criteria to consider grant pharmaceutical patent protection, namely: novelty, creativity, and ability of industrial applications of pharmaceuticals or pharmaceutical processes.

First, Article 27.1 of the TRIPS allows WTO members the right to request proof of novelty as a condition for patented pharmaceuticals. However, the Agreement does not define novelty. Member States are free to set the criteria for determine the novelty of the invention in particular cases.

However, requirements for novelty is usually based on the evaluation and comparison with previous invention in the world. In general, a patent shall not be deemed to be new if it has been previously published in writing, has been used or disclosed in any form of public communications.

Secondly, Trips Agreement also have no definition of creativity of invention. Member States are free to set standards in this regard.

Creativity is explained by the term “non-obvious” in US Patent Act which means that an invention compared with existing knowledge is not obvious to the average person having ordinary skill in the relevant fields[13].

Last, The last requirement under the TRIPS Agreement is an invention must be capable of industrial application. This condition requires a pharmaceutical inventions must bring benefit to social community. The aim of this provision is to encourage the development of technology and practical solutions. However, The TRIPS Agreement has no specific definition of this condition. The concept of industrial applications are very different in countries. In general, any invention can be put into production or used in commercial operations, create industrial products are considered to meet this standard.

 

2.3. Duty to disclose information material to patent.

Article 29.1 of the TRIPS Agreement set out requirements for the Members that the applicant must provide technical information about the invention so that others can be applied to what the applicant claims in the application its patents.

“Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application”. [14]

Disclosure requirements are necessary to balance the interests of the parties and reduce the inefficiencies caused by monopolies abuse. The requirement of publicity can meet social objectives of sharing interest because the important and useful technicals are published within the duration of protection, also ensuring that patents actually serve community service after patent’s expiry.

Disclosure of information is one of the basic principles of patent law. This provisions of the TRIPS Agreement encompasses the obligation to provide information about patents, but empowers the Member States free to determine the application of this obligation. Article 29.1 of the Agreement set out two mandatory requirements. Firstly, this provision requires Member States to disclose information about the invention fully and clearly so that that invention can be carried out by persons who have experiences and skills in the relevant technical field. This requirement aims to ensure that inventions implemented its information function through the demanding specifications record of the invention that allows the expert skilled in the relevant technical field can produce and use the invention fully without trial.

Secondly, Article 29.1 requires the “optimal way” similar to the provisions of the US law on patents. This requirement aims to prevent the inventor from receiving the protection of the public while hiding specific information about your invention. Unlike the first request which requires an objective review, demand about “optimal way” is subjective assessment.

In addition, Article 29.2 allows Member States to request information relating to the application and the corresponding protection of the applicant abroad. This information can be very important, especially in the Patent Office in developing countries to improve and expedite the checkout process. However, this requirement does not affect the basic principle of the independence of the patent application, the Agreement does not mention the consequences of failure to fulfill this requirement. However, because this requirement may be imposed as a condition of license, a patent application may be rejected if the applicant fails to provide the information requested above.

Agreements spent considerable space for Member States to apply the criteria of Article 29, under which the country can apply towards tightening these standards to promote creativity and competition. In addition, Member States are allowed to determine the level of information provided by the applicant to where, if the invention include portions are applying with. Moreover, Member States may also require a description of the invention in the form of text, and determine how to assess the correlation between the description with licensing requirements as well as methods for the review of licensing requirements’ content.

2.4. Exception.

Article 5A of the Paris Convention, as a part of the TRIPS Agreement provides that each WTO member has the right to apply legal measures provide for compulsory licenses to prevent the abuses that can lead to forming exclusive implementation. [15] This is repeated in Article 30, 31 of the TRIPS Agreement that stipulate a specific number of situations in which a country has the right to grant compulsory licenses for the public interest. Specifically, Article 30 of the TRIPS Agreement allows using without the consent of the patent owner in the event of conditions:

Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.[16]

Additionally,Article 31(b) provides an exception to the general prohibition against the use of patentable subject matter without authorization of the patent holder. This “other use” exception applies only in certain circumstances. Specifically, Article 31(b) provides that such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the patent holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the patent holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the patent holder shall be informed promptly .

Thus, the “other use” exception can only be applied in circumstances of “national emergency or “extreme emergency.” The language of TRIPS is ambiguous in that it does not provide a definition of “national emergency” or “extreme urgency” and gives no other guidance for what circumstances would qualify as such. But this language was intentionally left vague, and has produced substantial discussion regarding the scope of these terms. [17] It is arguable whether these terms include HIV or AIDS, the bird flu, chronic conditions, or others medical scenarios.

Even after the Doha Declaration,[18] scholars are undecided as to whether the TRIPS ambiguities have been resolved. [19] Specifically, the argument is that the Declaration fell short of defining the language with any certainty and granted power to individual WTO members to define for themselves what constitutes a national emergency. It is not clear, for example, that the WTO requires that Brazil be steeped in disease before declaring the compulsory licensing a necessity. The licensing of a medication against the will of the patent holder may be a necessary means of averting such disaster. However, this would hold without some clear declaration from the WTO. As the Doha Declaration shows, the WTO has been hesitant to provide a concrete definition of “national emergency” on which an outcome could be easily predicted.

However, the lack of a definition may be necessary to give individual nation states the ability to respond rapidly to conditions that constitute a “national emergency” or “extreme urgency” relative to the circumstances that formulate the “norm” for that particular country.

 

2.5. Term of protection.

The term of a patent is the maximum period that a patent takes effect. This period usually begins from the date of filing the patent application or the date the patent has been granted.The term of patent protection in general and pharmaceuticals in particular is not shorter than 20 years from the filing date. [20] The result is that most of the legal system specified present invention patent term of protection is 20 years from the filing date. However, this provision does not prohibit WTO Members recognized in their domestic legislation the similar rights patents with shorter duration. An example of this right is the right kind of solution for utility models for the duration of protection is usually 6 or 10 years.

 2.6. Provisions on patent protection.

Related to the enforcement of intellectual property rights, beside to the measures provided for full and satisfactory that the members must have to protect the rights to the invention, the TRIPS Agreement has certain limitations in order to the balance of the interests of society. Specifically in the enforcement procedures, TRIPs Agreement clearly expressed the view of rights to the invention. According to that, pharmaceutical inventions are considered civil rights and civil procedures will be applied to infringements of patent rights.

2.7. Provision on enforcement of patent.

2.7.1. General provisions

TRIPS Agreement is the first multilateral international agreement adjusting legal mechanism and administrative affairs of the national about implementation of intellectual property rights, according to that, Part III of TRIPS Agreement requires the Member States to establish a mechanism for administrative and judicial for intellectual property rights in general, and the owners of pharmaceutical patents in particular so that they may seek to protection for their interests effectively. General obligations of the members is to establish enforcement procedures which is recognized in national laws to prevent any infringement of intellectual property rights including infringement of pharmaceutical patents. These procedures must be “fair and reasonable” and “not too complicated or costly, requiring unreasonable time limits or unwarranted delays[21]. In addition, paragraph 5 of Article 41 of the TRIPS Agreement established two important principles: the members do not need to establish a separate judicial system for the enforcement above, and there is no obligation to the distribution of resources between enforcement of intellectual property rights with enforcement of law in general.

 

2.7.2. The civil and administrative procedures.

From articles 42 to article 49 of the TRIPS Agreement establish the basic principles for the conduct of civil proceedings to enforce intellectual property rights, including patent ownership pharmaceuticals. These regulations are the same between the legal system, including the rights of the defendant and the plaintiff, the parties have the opportunity to give evidence, the precautionary measures … There is flexibility in these regulations eg in the calculation of damages for violations in a manner not usual in other fields.

A notable prescription is stipulated in Article 44.2 of the TRIPS Agreement which allows members to exclude the ban in cases involving compulsory license to transfer the patent rights of pharmaceutical products.

 

2.7.3. Temporary method

TRIPS Agreement obliges Members to establish temporary emergency measures to prevent the introduction of the patent-infringing goods into the channels of commerce pharmacy and to preserve evidence[22]. Article 50.2 requires that judicial authorities have the right to apply provisional measures unilaterally if the delay could cause irreparable damage. This means that pharmaceutical patent owners have the right to apply a this measure regardless of the defendant has been informed and have the opportunity to defend or not.

2.7.4. The controls measures at the border

Article 51 to Article 60 of the TRIPS Agreement recognized the measures that a Member shall apply to prevent the introduction of goods which infringe patents on pharmaceutical in circulation from entering a market. According to Article 51.1 of the TRIPS Agreement these procedures should only be applied to goods suspected of “counterfeit trademark or copyright infringement”, and particularly excluding parallel imports.

Thus, owners of pharmaceutical patents can apply to the authorities the full presentation of goods which infringe patents along with the relevant information. The plaintiff may have to take measures to ensure the compensation of damage can occur to the importer in the absence slithered violations of pharmaceutical patents. In addition, the Agreement includes the terms inform importers about the custody or return the goods in custody of the competent authority; pharmaceutical patent owners have the right to inspect infringing-goods.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CHAPTER III: CURRENT IMPRESSION OF THE PRACTICAL IMPLEMENTATION ON PHARMACEUTICAL UNDER TRIPS AGREEMENT IN SOME COUNTRIES

 

3.1. Canada

 

3.1.1. Overview of Canada’s Patent system

In Canada, the policies on pharmaceutical intellectual property has changed many times by the Government during the last four decades but the changes that most affected market exclusivity for brand drugs was occurred in 1969, 1987, 1993, 1995 and 2006. [23]

The change of law can be summarized briefly as following:

In 1969, the Canada’s Patent Act was modified to allow generic drug companies to import the active ingredients needed to produce and sell copies of brand drugs that were still under patent. The Commisioner of Patents granted a “compulsory license” granted to generic companies. Therefore, Generic drug companies were required to pay a royalty of 4% of their drug’s selling price to the innovator firm. [24] By this change, the new policy is admitted  with the expansion of Canada’s domestic generic drug sector.

Beginning in 1989, the duration of patents has changed from 17 years which was issued before to 20 years from the date on which the patent application was filed. [25]

In 1993, the compulsory licensing was rejected. Thus, brand drugs were able to protected by Patent Act.[26] At that time two additional sets of regulations were introduced.[27] First, the Patented Medicines (Notice of Compliance) regulations were introduced in 1993. The Notice of Compliance regulations govern the market entry of generic versions of brand drugs that are still under patent protection. Particularly,  generic firm must issue a Notice of Allegation to the manufacturer of the reference brand drug that the existing patents are either invalid or not infringed by the generic drug. The brand firm, should it disagree, can petition the federal court to prohibit the generic product from entering the market until after the matter is adjudicated or 30 months have elapsed, whichever comes first. (In 1998, the 30-month stay was reduced to 24 months.) The federal court can prohibit the sale of the generic drug by ordering the Minister of Health to refrain from issuing a Notice of Compliance to the generic drug firm. A Notice of Compliance is required for a prescription drug to be marketed in Canada.[28] The second set of regulations concerning pharmaceutical intellectual property are the “data protection regulations” found in the Food and Drugs Act. When introduced in 1995, these provisions guaranteed brand drugs five years of market exclusivity following regulatory approval. Data protection is a binding constraint on entry of generic drugs only if the market exclusivity offered by the patent system is less than five years.[29]

 

3.1.2. Overview of Canadian pharmaceutical industry

In Canada, the pharmaceutical industry is considered to be one of the most develope industry which have innovative pharmaceutical manufacturing companies. Canada has the fourth-fastest-growing pharmaceutical sector after China, the United States and Spain and has tended to grow steadily. The Canadian pharmaceutical industry is gradually becoming more favorable to generic drugs than branded drugs. [30]

Pharmaceutical sales in Canada have a 2.0% share of the global market, making Canada the 8th largest world market. Since 2010, compound annual growth has remained positive at 0.9%. [31]

Companies in Canada are constantly striving to find out and develop new therapies or patent innovations. In addition, the development of equivalent biological copies when the patent expires is also an interest. Moreover, Canada is also working to create a new field of biology. General, brand-name products account for 77% of Canadian sales and 34% of prescriptions. Generics occupy only 23% remains. [32]

Total revenue of Canadian pharmaceuticals is growing rapidly, for example, within 15 years (2001-2015), total pharmaceutical sales (including non-patented over the counter medicines) in Canada have doubled to $24.6 billion. [33] Annual domestic pharmaceutical manufacturing production is valued at $9 billion as of February 2016 with a compound annual growth rate of 0.28% since 2008.

3.1.3. Current impression of the practical implementation on pharmaceutical patent under TRIPS Agreement

 

3.1.3.1. Compulsory license

Approach to affordable medicines for treating serious diseases such as HIV / AIDS and other human diseases (cancer, cardiac disease) is a challenge in many countries. These challenges are part of result of patent law strengthen under the TRIPS Agreement. However, TRIPS allows its member states to use reasonable exceptions to minimize the adverse effects of patent protection and to provide generic medicines to potential patients. Issueing compulsory license is one of those measures that has been used by some countries for several years including Canada.

In Canada, compulsory licensing continues to be condoned by section 66(1)(a) of the Canadian Patent Act: [34]

 66. (1) On being satisfied that a case of abuse of the exclusive rights under a patent has been established, the Commissioner may exercise any of the following powers as he may deem expedient in the circumstances: (a) he may order the grant to the applicant of a licence on such terms as the Commissioner may think expedient, including a term precluding the licensee from importing into Canada any goods the importation of which, if made by persons other than the patentee or persons claiming under him, would be an infringement of the patent, and in that case the patentee and all licensees for the time being shall be deemed to have mutually covenanted against that importation.

The compulsory license has helped Canada get more benefit from the manufacturing industry. The widespread use of compulsory license terms in the years after 1969 led to a drop in drug prices. [35] However, between November 1993 and 2004, compulsory licensing was no longer allowed in Canada.

 

3.1.3.2. Price control

Price control is adjusted by establishing a “Patented Medicine Prices Review Board”. ThisBoard have broadly powers for the purpose of control the selling price of marketed drugs. [36] The Patented Medicines Prices Review Board consists of not more than 5 members, [37] appointed for a period of 5 years [38] at the suggestion of an advisory panel of persons chosen from consumer groups and the pharmaceutical industry. [39]

The first task of this Board is to prepare every year and submit to the Minister ofConsumer and Corporate Affairs, a report giving a summary of pricing trendsin the pharmaceutical industry and the names of the patentees about whomenquiries were made. [40] The second task of the Board is, to control prices of patented drugs and to deal severely with any abuse. To determine whether the price of the patented medicine is excessive or not, the Board must take into account the following factors:

– The price at which the patentee sold the medicine in Canada and abroad during the five years immediately preceeding the current determination;

– The price of other medicines in the same therapeutic class onthe market in Canada and abroad during the same 5 years; and

– The Consumer Price Index. [41]

Although there are mixed opinions surrounding this establishment, some arguments that the incorporation of such a price control system into the Patent Act is inconsistent with discriminatory provisions, but on the writer’s opinion, the establishment of Patented Medicine Prices Review Board has resolved an important issue that patent law brings, which answer for question “whether the price of a patented drug is excessive?!”.

 

3.1.2.3. Case study: DS114 Canada – Patent Protection of Pharmaceutical products

The TRIPs agreement allows its member states to self-regulate exceptions subject to certain conditions, however, the application of these national exceptions remains controversial, raise arguments among states. Case study below is a typical example:

3.1.2.3.1. Key Fact

The complainant is EU communities and the respondent is Canada.

On 19 December 1997, the European Community requested consultations with Canada regarding its alleged domestic legislation, in particular the Patent Act which lack of patent protection. The European Community accuses Canada’s legislations is unconsistent with its obligations under TRIPS Agreement because it does not adequately protect the patented drugs for the entire term of protection under Articles 27.1, 28 and 33 of the TRIPS Agreement. [42]

On 11 November 1998, the European Communities requested the establishment of a panel. At its meeting of 25 November 1998, the DSB postponed the establishment of a panel. [43]

On 1 February 1999, at the second request of the European Community, the DSB decided to establish a panel. Australia, Brazil, Colombia, Cuba, India, Israel, Japan, Poland, Switzerland, Thailand and the United States participate as third parties. [44]

On 15 March 1999, the European Communities and their member countries requested the Director-General to determine the panel structure. [45]

On March 25, 2000, a panel was established. [46]

 

3.1.2.3.2. Issue

Issue 1: Wherether “stockpiling exception” of Article 55.2(1) and Article 55.2(2) in Canada Patent Act violated its obligation under Article 28.1 & Article 30 of TRIPS Agreement?

Patent Act, Section 55.2(2) states that:

“It is not an infringement of a patent for any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1) to make, construct or use the invention, during the applicable period provided for by the regulations, for the manufacture and storage of articles intended for sale after the date on which the term of the patent expires.”

The provision allows competitors to manufacture and stockpile patented goods during a certain period before the patent expires, but the goods cannot be sold until the patent expires. Without this exception, the patent owner’s right to exclude any person from “making” or “using” the patented good would enable the patent owner to prevent all such stockpiling.

Canada argued that Section 55.2(2) complies with each of the three conditions of Article 30. The European Communities argued that Section 55.2(2) fails to comply with any of the three conditions. Both parties introduced their arguments with an analysis of the object and purpose of the TRIPS Agreement in this area, and then presented interpretations of the three Article 30 conditions in support of their positions.

Article 30 establishes three criteria that must be met in order to qualify for an exception: (1) the exception must be “limited”; (2) the exception must not “unreasonably conflict with normal exploitation of the patent”; (3) the exception must not “unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties”. The three conditions are cumulative, each being a separate and independent requirement that must be satisfied. Failure to comply with any one of the three conditions results in the Article 30 exception being disallowed.

a, the exception must be limited

Under Canada’s argument, section 55.2.(2) is restricted in scope because it has only a limited impact on a patent owner’s rights. The stockpiling exception, Canada noted, does not affect the patent owner’s right to an exclusive market for “commercial” sales during the patent term, since the product that is manufactured and stockpiled during the final six months of the term cannot be sold in competition with the patent owner until the patent expires.

Meanwhile, EC argued that the stockpiling exception is not “limited” because it takes away three of the five Article 28.1 rights – the rights to exclude “making”, “using” and “importing”.

The Panel agreed with the EC. In the Panel’s view, the question of whether the stockpiling exception is a “limited” exception turns on the extent to which the patent owner’s rights to exclude “making” and “using” the patented product have been curtailed. The right to exclude “making” and “using” provides protection, additional to that provided by the right to exclude sale, during the entire term of the patent by cutting off the supply of competing goods at the source and by preventing use of such products however obtained. With no limitations at all upon the quantity of production, the stockpiling exception removes that protection entirely during the last six months of the patent term, without regard to what other, subsequent, consequences it might have. By this effect alone, the stockpiling exception can be said to abrogate such rights entirely during the time it is in effect.

Having concluded that the exception in Section 55.2(2) of the Canadian Patent Act does not satisfy the first condition of Article 30 of the TRIPS Agreement, the Panel therefore concluded that Section 55.2(2) is inconsistent with Canada’s obligations under Article 28.1 of the Agreement. the Panel did not consider the claims of inconsistency under the second and third conditions of Article 30.

 

b, The exception must not “unreasonably conflict with normal exploitation of the patent”

For this issue, there are confliction between parties concern about interpreting the term of “normal exploitation”.

Canada considered that the regulatory review exception of Section 55.2(1) does not conflict with “normal exploitation” because it does not conflict at all with the patent owner’s exclusive marketing rights throughout the term of the patent.

Under Canada’s opinion, the exception in collecting information for the preparation of the licensing procedure did not affect the marketing of the product on the market and also did not affect third parties in the normal exploitation of the patent. In addition, Canada considers that extention the period of patent time rights after the expiry of the 20-year protection is unusual, thus collecting information to obtain permission to use, produce or sell products in the market when the patent expires does not fall into the case of affecting the normal exploitation of the invention.

The EC contends that Canada defines “normal exploitation” as the loss of a sum of money in the accounts of patent holders to exclude the use of inventions for the collection of information is not satisfactory. According to the EC, the normal exploitation of the patent owner is a comprehensive comply with the rights in Article 28.1, and as well as comply with monolopy rights in the extension after the patent’s expiry date.

The panel considered that the EC arguments contained no evidence of normal exploitation. the Panel found that the regulatory review exception of Section 55.2(1) does not conflict with a normal exploitation of patents, within the meaning of the second condition of Article 30 of the TRIPS Agreement.

 

c, The exception must not “unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties”.

The European Communities argued that the regulatory review exception in Section 55.2(1) fails to satisfy the third condition of Article 30. The EC asserted that the “legitimate interests” of the patent owner can only be the full enjoyment of his patent rights during the entire term of the patent. [47]

The EC argued that the only relevant “third parties” for the purpose of Article 30 are the patent owner’s competitors – in the case of pharmaceutical patents the generic drug producers, because they were the only parties with interests adverse to those of patent owners.  Then, following its position that “legitimate interests” are essentially legal interests, the EC went on to argue that the legitimate interests of competing producers are essentially the same as those of patent owners – that is, the full enjoyment of their legal rights. The legal rights of the patent owner’s competitors, the EC argues, are the rights to make, use or sell the patented product on the day after the patent expires. (414) Such competitors, therefore, could have no “legitimate” interest in the rights granted by the regulatory review exception of Section 55.2(1), because they could have no legal right to “make” or “use” (or “sell”) the patented product during the term of the patent.

Canada contested the two key parts of this EC argument – the EC’s interpretation of the term “legitimate interests”, and the EC’s interpretation of the term “third parties”. Canada asserted that legitimate interests are those that “relate to the rights and duties that the patent laws confer or impose”, and which “arise from the status of being a patent holder, not from the more general status of being a business person or manufacturer”.415  Under Canada’s view, the third party must have a link with those who have a conflict of interests with the patent holders.

In sum, the Panel was unable to accept the EC’s interpretation of that term as referring to legal interests pursuant to Article 28.1. Accordingly, the Panel was unable to accept the primary EC argument with regard to the third condition of Article 30.

Issue 2: : Wherether exception of Article 55.2(1) and Article 55.2(2) in Canada Patent Act violated its obligation under Article 27.1 of TRIPS Agreement?

Article 27.1 provides that:

“Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.”

The EC claimed that Section 55.2(1) of the Canada Patent Act is also in conflict with the obligations under Article 27.1 of the TRIPS Agreement. Under EC’s argument, the anti-discrimination rule stated in the italicized language in the text of Article 27.1 above not only requires that the core patent rights made available under Article 28 be non-discriminatory, but also requires that any exceptions to those basic rights made under Articles 30 and 31 must be non-discriminatory as well. Thus, the EC concluded, Article 27.1 requires that the exception made by Section 55.2(1) must be non-discriminatory. The EC contended that Section 55.2(1) does not comply with the obligations of Article 27.1, because it is limited, both de jure and de facto, to pharmaceutical products alone, and thus discriminates by field of technology.

On the other hand, Canada argued that the non-discrimination rule of Article 27.1 does not apply to exceptions taken under Article 30. Second, Canada argued that Section 55.2(1) does not discriminate against pharmaceutical products.

The Panel was unable to agree with Canada’s contention that Article 27.1 did not apply to exceptions granted under Article 30. The text of the TRIPS Agreement offers no support for such an interpretation. Article 27.1 prohibits discrimination as to enjoyment of “patent rights” without qualifying that term. Article 30 exceptions are explicitly described as “exceptions to the exclusive rights conferred by a patent” and contain no indication that any exemption from non-discrimination rules is intended. A discriminatory exception that takes away enjoyment of a patent right is discrimination as much as is discrimination in the basic rights themselves.

The Panel concluded, therefore, that the anti-discrimination rule of Article 27.1 does apply to exceptions of the kind authorized by Article 30.

There is one more confiction in opinion between parties is that The EC pointed out, however, that pharmaceuticals were the only products mentioned in Canada’s 1991 legislative debates on the enactment of Sections 55.2(1). [48] It also asserted that Section 55.2(1) was “in effect applied only to pharmaceuticals products”[49] while Canada denied that the de jure scope of Section 55.2(1) is limited to pharmaceuticals.[50] It pointed to the words of that provision making the exception available to “any product” for which marketing approval was needed.

The Panel found that Section 55.2(1) is not inconsistent with Canada’s obligations under Article 27.1 of the TRIPS Agreement. Because the record did not present issues requiring any more precise interpretation of the term “discrimination” in Article 27.1, none was made.[51]

 

c.  Conclusion

Under Panel’s decision, conclusion as follows:

(1)  Section 55.2(1) of Canada’s Patent Act is not inconsistent with Canada’s obligations under Article 27.1 and Article 28.1 of the TRIPS Agreement.

(2) Section 55.2(2) of Canada’s Patent Act is not consistent with the requirements of Article 28.1 of the TRIPS Agreement.

Accordingly, the Panel recommends that the Dispute Settlement Body request that Canada bring Section 55.2(2) into conformity with Canada’s obligations under the TRIPS Agreement.

d. Assessment

Vietnam has not yet established a private patent law, provisions on the protection of inventions are provided in the Law on Intellectual Property, adopted by the National Assembly on November 29, 2005 (the “Law on Intellectual Property”) and amended in 2009 [52]. However, Vietnam’s accession to the WTO and TRIPS Agreement have opened up both opportunities and challenges for Vietnam, one of those is Vietnam have to compliance with the obligations set out in the TRIPS agreement. Since TRIPS allows its member states the freedom to establish provisions of national law under certain circumstances provided it is not inconsistent with their obligations on TRIPS, this has led to disputes in the application of the law.

This case brings Vietnam a lesson in the process of creating its own legal system in the future, especially in the context that Vietnam has not built a independent patent law, that is when applying national law on the basis of compliance with the duty to a international agreement, it should be considered in comprehensive respects so that limit conflicts with the terms of the agreement and avoid falling into the litigation.

 

3.2. India

 

3.2.1.  Overview of  Patent Law in India

India is a country with exceptionally fast growing economy and a large technological workforce. Emerging markets are important to the pharmaceutical industry. With the advantage of the large population while the government does not meet the health needs combine with the growing of middle class creating huge potential for consumers for innovative medicines and medical treatments. Recently, pharmaceutical innovators have continued to grow in India despite a very “primitive”. [53]

At the same time, India’s patent law has grown exponentially, especially when India joined the TRIPS Agreement. Indian patent law has undergone many changes over the past decade in a bid to comply with TRIPS. [54]

The Indian Patent and Design Act were first issued in 1911 provides for a term of fourteen years from the filing date of the patent application, which made the basis of India’s patent law. After that, term of patent protection will last from fourteen years to sixteen years when the Act was  modified in 1930. [55] Under the system established under the 1911 Act, eighty to ninety percent of all Indian patents held by foreigners. [56] Moreover, In the early 1940s and 1950s, 90% of the drug market in India was under the control of foreign companies, and it was entirely dependent on imports of both drugs: bulk drugs (the active ingredients) and formulations (drugs that have been manufactured from bulk drugs). Hence, India’s drug prices are among the highest in the world. [57]

Subsequently, the Indian government established committees that were tasked to study India’s patent regime and proposed improvements to make India’s patent system more compatible with other countries [58] with the key rule that the Indian patent system allows foreigners to achieve market monopoly control in major industries such as food, chemicals and pharmaceuticals. [59] As a result of this work, in 1970, The Indian Patent Act of 1970 passed by the Indian Parliament. [60]

However, The Indian Patent Act of 1970 severely restricted the term of protection of patents for food products and medicines. Most inventions have obtained a patent term of fourteen, [61] except for methods or processes for the production of trace elements for use as a food or a drug, in this case. The patent term is limited to five years from the date of issue of the patent, or seven years from the filing date. Additionally, Lack of Product Patent Protection is the limitation of the law this period. The patent law of this period did not extend patent protection for pharmaceutical products. As a result, some Indian companies can quickly copy drugs without paying royalties to the patent owners. [62]

Joining the WTO in 1995 was a milestone in the history of India’s legal patent system. India is forced to revise its rules in compliance with TRIPS standards within the ten year grace period. From 1995 and earlier, India allowed the protection of inventions for only manufacturing processes and drug compounds were unprotected, [63] but the entry into WTO with the consequent signing of trip agreements had changed the landscape of preservation. If in the past, India could use a drug which protected in another country and apply a new manufactuaring  process to legalize and sell to market, but TRIPS Agreement requires India to take patent protection measures in line with international standards. [64]

In 2005, the 1970 Indian Patent Act was further amended to assume that it would fully comply with TRIPS before the deadline. [65]

Until 2005, The Patent Act extends the possibilities to acquire and use compulsory licenses, the Indian government allows third parties to use patents without the consent of the patent owner for domestic production. A compulsory license is granted for the purpose of giving priority to the Indian market and licensor may export the patentable product if necessary. [66] Also, it is possible to issue compulsory licenses for the export of a patented product to overcome anti-competitive behavior. These regulations benefit Indian pharmaceutical companies, encourage domestic production and protect the public health of citizens. [67]

There are two prominent features of India’s 2005 Patent Act compared with the 1970 Act: Firstly, the 1970 Law only protects inventions as processes, but the 2005 Act protects both Patent is a product and process; Secondly, the 1970 Act allowed the term of protection to be only seven years and was not renewed  while the 2005 Act allowed the term of protection to be 20 years.

The Indian Patent Act 2005 concerning pharmaceutical patents is considered to be consistent with TRIPS, as a significant positive step of India in implementation of new laws.

3.2.2. Situation of India’s Pharmaceutical industry

The pharmaceutical industry in India ranks third in volume and 14th in value in the world. [68] Also, India is the fourth largest pharmaceutical producer in the world with approximately 3,250 pharmaceutical manufacturers and 250 major research producers. [69]

Over the years, India has affirmed itself as one of major generics makers in the world. [70] In 2010, about 20% of the world’s generic drugs are produced by India. [71] With rapid growth speed, experts predict that India’s pharmaceutical industry will grow at a cost of $74 billion by 2020, [72] helping India maintain its position as a “global leader in the pharmaceutical industry.” [73]

The Indian pharmaceutical industry has been successful in creating millions of jobs as well as ensuring that the necessary medicines come up with majority of people at a reasonable price. [74]

Prior to 2005, India was the world’s fourth largest market in terms of volume – 8% of the world’s pharmaceutical industry and 13th in value – to reach 1% of the world’s pharmaceutical industry. Indian pharmaceutical products are exported to 200 countries around the world, 50% of export volume is to developing countries, the rest are exported to the big pharmaceutical markets of the world such as USA, Japan and the European Union. [75] Achieving such success is due to the low cost of drug production in India, the government’s price control policy, and in particular the absence of protected drugs there. However, this does not attract multinational drug companies – companies that produce drug based research. They found no guarantee of profit when investing in research, development and production of drugs in India  but everything changed completely after India had reforms in its legal system. With the advantage of local pharmaceutical companies and experienced workforce in the pharmaceutical industry, combine with the change in patent law, more and more foreign pharmaceutical company invest in India. This is evidenced by the impressive statistics, for instance, in 2006 and 2007, India had the highest growth rate in the world’s pharmaceutical industry, at 17.5% and 13%, respectively ($7.3 and $8.2 billion, respectively). [76]

After joining and adhering to the patent regulations in TRIPS Agreement, India has achieved tremendous growth. Over the past 10 years, India has refined its patent system to develop a pharmaceutical industry that can earn economic gains through intellectual property in country. Hence, recent strategies and legislation adopted and issued by India relating to TRIPS should be very useful for other developing countries.

 

3.2.3. Implementing of TRIPS Agreement for pharmaceutical patent in India

 

3.2.3.1. Compulsory license

Granting a compulsory license is a manifestation of exception under TRIPS Agreement. In India patent law, the provisions of Compulsory License are stipulated in Sections 84, 86,89, 93 and 93. [77] This regulation is used as a fighting tool of a government for a patent holder to improve the accessment to a particular invention. However, beside to the advantages, the use of compulsory licenses also has the reverse side, which lead the reduce of creation of new inventions, and reduce the value of a patent also if it to be used regularly. [78]

The problem is how the compulsory license can be used effectively? Although the TRIPS Agreement and the laws of developing countries provide for the compulsory licensing of inventions, especially in pharmaceutical field but the application of this provision in practice is not easy. The case study below is a typical example which shows the complication of licensing compulsory license of pharmaceuticals in India:

 

Case study: Natco Pharma Limited vs. Bayer Corporation

 

3.2.3.1.1 Fact

Bayer Corporation is the patentee which is an internationally renowned manufacturer of innovative drugs held the rights to a patent for a cancer drug,  named “Sorafenib Tosylate”, otherwise marketed as “Nexavar” (which is a cancer drug used to treat Hepatic Cell Carcinoma (HCC) and Renal Cell Carcinoma (RCC)). Bayer first applied for Patent in United States and later entered into international filing on 12th January, 2000. A Patent was granted to Bayer on the drug “Nexavar” by the Indian Patent Office on 3rd March, 2008.

Natco, Pharma Ltd is a well known generic Indian manufacturer. Natco approached Bayer for a voluntary license but it was denied, then Natco brought an application before the Controller of Patents Court, for a compulsory license. [79]

On March 9, 2012, the Controller granted the license to Natco, against which Bayer

appealed to the IPAB.

 

3.2.3.1.2. Issue

Article 84 in India Patent Law sets out the conditions which a compulsory license may be granted. According to this Article, the basis for a compulsory license is that the owner of a patent for invention can not do the following conditions:

– The reasonable requirements of the public with respect to the patented invention have not been satisfied;

– The patented invention is not available to the public at a reasonably affordable price;

–  The patented invention has not worked in the territory of India.

 

Issue 1:whether the reasonable requirements of the public with respect to the patented invention have not been satisfied?

Natco argues the figures on the use of Nexavar and the actual need to prove that Bayer did not meet the reasonable demands of the population.

The drug Nexavar by Bayer was available to only 2% of the eligible patients while the requirement for treatment come up to nearly 10,000 patients, thus reasonable requirements of the public are totally not satisfied.

In response, Bayer cited another lawsuit between Bayer and Cipla which is a another generic manufacturer for infringement of the same patent. Bayer’s argument is that the supply of generic drugs manufactured by Cipla must be taken into account in determining whether Bayer meets public demand or not. However, the authorities emphasized Bayer’s confliction , on the one hand, Bayer sue Cipla for infringment while on the other hand, Bayer use Cipla’s drug production to prevent compulsory licensing, thus disagreeing with the argument. [80]

Issue 2: Whether the patented invention is not available to the public at a reasonably affordable price?

Section 84(1)(b) of the Indian Patents Act requires that in order for a compulsory licence to be granted, the patented invention must not have been made available to the public at a “reasonably affordable price”. Natco argued that the drug was excessively priced and unaffordable to the public. [81]

Natco and Bayer disagree strongly on the issue of reasonable prices. Natco thinks that the term “fair price” is first applied to the general public. Bayer argues that the concept must apply equally to the manufacturer, which must cover both successful and failed research and development efforts until the drugs are actually marketed. Bayer also complained that forced compulsory license would damage them and the rich people would be bought the low-cost drugs which should offer for the poor people. [82]

Finally, the authorities find that “fair prices” should be interpreted in conjunction with reference to the general public. Bayer has not denied the evidence that Nexavar’s price has outweighed the reach of the vast majority of Indian cancer patients.

Issue 3: Whether the patented invention has not worked in the territory of India?

Indian Patents Act allows for a compulsory license if the patented invention is not worked in the territory of India. [83]

However, Article 84 does not define the term “worked in India”. Natco claims that “worked” means “produced”. Bayer opposed that the term could not be interpreted as being manufactured in India. [84]

In the interpretation of the language of Article 84, the competent authority has relied on many international treaties [85] before concluding that the term “worked in the territory of India” means “manufactured to a reasonable extent in India” [86],  then the authorities rejected Bayer’s argument.

 

3.2.3.1.3. Findings.

In dealing with the question of whether the reasonable requirements of the public were being met by Bayer, including whether the drug was publicly available at a reasonably affordable price, the IPAB once again chose to adopt the public interest lens. Dismissing Bayer’s contentions, it opined that the sole consideration in granting compulsory licenses was whether the patented product was available to the public at a price that was reasonably affordable for them. [87]

on the issue of the ‘working’ of the drug in Indian territory, the IPAB refused to accept Bayer’s plea that it was not feasible to manufacture the drug in India and that importation was the only option.

Overall therefore, the IPAB upheld Natco’s compulsory license, dismissing Bayer’s appeal. Controller of Patent decided to grant Compulsory License under Section 84 of the Patent Act 1970 as amended in the year 2005. However, certain terms and conditions of the License were laid down by the Controller as follows:

– The price of the drug “Sorafenib Tosylate” shall not exceed Rs. 8880 for a pack of

120 tablets required for one month’s treatment.

– The license is a non-exclusive and non-assignable license.

– The licensee shall pay royalty at a rate of 6% of the net sale of drug.

–  Right to license is only for making, using, offering to sell for the purpose of treating HCC and RCC within the territory of India.

– The licensee shall maintain accounts of sale etc.in a proper name and report it to the

Controller and the Licensor.

 

3.2.3.1.4. Assessment

There are several different opinions about the effect of compulsory lisence in Bayer & Natco case. The World Health Organization has welcomed the decision of the Indian authorities while pharmaceutical and biotech groups are concerned about the opposite effects that compulsory license may cause for research and development. [88]

In general, this case provides a lesson for pharmaceutical companies that they should pay more attention to the requirements of patent law and know how to do it flexibly instead of just trying. In this way, they may be able to get more benefit when they are not involved in litigation and suffer huge costs for such disputes. Manufacturers can sacrifice a small percentage of profits by lowering prices and increasing distribution to eliminate compulsory licenses. In addition, pharmaceutical companies should consider a voluntary license between the parties that can help them recover a higher profit based on negotiation before being subject to the imposition of Compulsory license.

3.3.3.4. Comparing on applied compulsory license between India and Canada.

In India, any person may apply for a compulsory license for a patent after three years from the grant date. [89] Also, section 92A allows the export of pharmaceutical products to any country with lack of production capacity in the pharmaceutical industry while Canada has no corresponding provision.

 

3.2.3.2. Price control

One of  experience was extracted from protection of pharmaceutical  patent in Indian is that this country has been attempted to the protection of citizen combine with applying flexibility of TRIPS Agreement as well as the strict standard of patent protection. [90]

Article 30 TRIPS Agreement allows member state can regulated some exceptions for patent under the condition that such exceptions are not conflict with the normal exploitation of the patent and does not unreasonably damage the legitimate interests of the patent owner, and the legitimate interests of the third party also. India applied this provision to set out a exception namely “price control”.

The protection of pharmaceutical inventions lie under the control of price by Government. [91] Protecting pharmaceutical inventions brings both positive aspects and social difficulties. Parallel with the protection  for inventor, the monopoly can leads to the overpriced selling of drugs that potential customers could not reach for their treatment. To overcome this risk, the Indian government has set up drug price controls to set the ceiling for essential drugs. [92] The drug price control was first introduced in India since 1970 but until now, it has been still working successfully to help the government control drug prices very strictly. [93] Determining which drugs should be priced and how pricing will be regulated by National Pharmaceutical Pricing Authority. [94] Price control as one of the many tools to protect the Indian public from nonsense high prices. [95]

 

3.2.3.3. Establish Intellectual Property Appellate Board (IPAB)

IPAB was established since 2003 with the purpose that hearing appeals related in Intellectual Property. [96] Before the establishment of IPAB, The High court in India has received numerous complaints relating to this area, including disputes on patent protection in the pharmaceutical sector. [97] The establishment of the IPAB has reduced the workload of the High Court, after the appearance, pending lawsuits under High Court’s jurisdiction have been referred to the IPAB. [98]

Although there are many views surrounding the establishment of IPAB, some argue that with the fledgling, lacking experience of this “special court”,  will IPAB can do its mission well? Or Does IPAB offer faster and fairer solutions to cases? [99] but from a personal point of view, this is still a remarkable government effort to protect intellectual property rights in general and to protect pharmaceutical patent in particular.

 

3.3. Patent protection for pharmaceutical products in Thailand

 

3.3.1. Brief history of Patent system in Thailand

While Western countries had a long of legal development in the Intellectual property field, Thailand actually has not. [100] Rights for creative ideas of human were adopted and entered into force since 1979 but until September 1992, the issue of patent protection in the pharmaceutical sector was regulated by the Thai legal system.[101]

It has to be noted that Thailand is not to-date party to any international conventions in the field of patent law, nor has it concluded any bilateral treaties on this subject. However, several of the basic principles established in the Paris Convention have had a significant influence on Thailand’s Patent Act. The legal paradigm under the Model Law for Developing Countries, drafted by BIRPI and later WIPO, and the basic rules embodied in developed countries patent legislations were also accepted by the Thai Assembly. The existing features of Thailand’s patent law are less complex than those of industrialised countries, and the level of litigation in this field is very low. Since the concept of inventive protection in the early stage, few legal doctrines and judicial interpretations of law have been established.[102]

In 1992 and 1999, Thailand decided to amend its patent law, the reason of this change is to be considered under pressure from the United States [103]. In 1979, United States opposed certain provisions of the Thai’s Act such as the original ratification. The strongest complaint of US patent owners is that the 1979 Act eliminated pharmaceutical, agricultural and biological products from patent protection, thus causing a significant loss of income. [104] US owners also complained that fifteen years was a term insufficient to patent protection. [105] Finally, the 1979 Act provided that a patent must be issued in Thailand. [106] However, the amendments bring  optimistic prospect for its Intellectual property field, especially in pharmaceutical patent protection. Particularly, the level of patent protection in Thailand increased significantly, including an expansion of the scope of patentable subject matters, an extension of the term of patent rights, the protection of petty patents or utility models, laying down conditions for the application of compulsory licensing, amending the exclusive rights and their limitations, abolishment of the pharmaceutical price review committee. [107] And also from this point on, the duration of patent protection is extended to 20 years as in most developed countries in the world.

However, under the 1992 Patent Protection Act, drugs that have been patented and already presented on foreign markets but have not yet been circulated in Thailand do not receive any protection.[108] The Thai government can issue compulsory licenses for those drugs that have been protected but not yet made in Thailand.[109] From 1993, the Thai government had enacted a regulation for drugs that did not receive protection under the 1992 Act, whereby the maximum period for a drug to be protected exclusively in the market was approximately 5 to 6 years. [110] This rule is not consistent with the world trend of patent protection in the pharmaceutical field. This could be explained by the fact that at the time Thailand was still in the process of finalizing legislation to meet the requirements of accession to the World Trade Organization and the TRIPS Agreement.

Thailand’s Patent Law was amended in October 1998, and came into effect in 1999.[111] Generally speaking, Thai businesses were satisfied with the amendment. The Thai patent law has an aim of providing a temporary monopoly for inventors in order to foster the development of a required technological base, and to assist the acquisition of foreign technologies. [112]

In Western countries, they believe that building a complete patent system will help encourage creativity and inventions. [113] This is reason why the patent system is widely developed in Western industrialized countries. They also thought that that if inventions increase, then economy necessarily benefits. [114] When patents are issued to protect investors, they will be more willing to invest because of the decrease in competition that will increase profits. [115] Thus, in the view of the western states, a patent law system can lead to economic development despite the cost of copyright.

Western governments, typically the United States, believe that they will get benefits from the promulgation and enforcement of pharmaceutical patents while in developing countries, [116] typically Thailand, tend to be inverted. These countries may fear a sharp rise in prices will result in the payment of royalties as well as loss of control over technology, which is important for the development of the country.  Most countries are reluctant to give up control of important internal functions, such as health or food production. [117] Thus, Thailand, which does not yet have strong development economy will naturally resist policies that cause escalating costs. [118] The Thai Patent Act, prior to its recent revisions, is a typical example of restrictions on their patent laws which developing countries were applied.

However, one highlight of the recently amended Patent Act was the creation of a Pharmaceutical Board of Directors with three main functions: (1) comparing the prices of patented pharmaceutical products with the one unlicensed, [119] (2) cabinet advisory on policy issues affecting pharmaceutical patents; 3) Develop a financial support structure for pharmaceutical R & D. [120] Patent applicants must provide detailed information on prices, costs of production and distribution [121] and be granted a pharmaceutical patent or pharmaceutical process. [122] The Board also has the right to “summon a patentee, licensee, or any other person to present facts or opinions or provide any additional materials. Those who do not provide this specific information may be subject to fines, face custody, or both.[123]

By this amendment, Thai’s law brings a progressive outlook regarding to pharmaceutical patent protection. This regulation helps to balance the interests of the patent holders with the interests of the society, simultaneously ensuring that policies affecting the patent are always developed and enforced seriously. Sanctions in this case also contribute to elevate the legal status of the people.

3.3.2. Current impression of practical implementation on pharmaceutical patent under TRIPS in Thailand.

 

3.3.2.1. Issue compulsory license

In recent years, Thailand has made efforts to protect patent law which represents a great change from the country’s longstanding policy regarding the protection of intellectual property rights. [124]

One of the big changes was the issuance of compulsory licenses.

Under ordinary meaning, licensing means allowing to do something legally, such as producing a product, license granted to an individual or a company a right that it did not have before. Some licenses are free, but most require a payment. A license is a legal agreement that may contain some restrictions on how it is used. With this in mind, the issuance of compulsory licenses in Thailand allow to manufacture or import generic drugs without consent of patent holders. This rule comes from the real situation of this country. Under the scheme of the TRIPS Agreement, a country can grant a compulsory license if (among other requirements) the following conditions are met:

(a) authorization of such use shall be considered on its individual merits;

(b) such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use;

 (d) such use shall be non-exclusive;

(f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;

(h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;

(i) the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member. [125]

Under the lights of the TRIPS Agreement, this provision allowed countries issue compulsory lisence in the special mandatory situation.

Thailand is facing with the most dangerous epidemic of 21st century: HIV/AIDS. More than 500,000 people in Thailand are estimated to be living with HIV / AIDS [126] and the incidence of new infections has increased steadily each year [127]. In particular, this rate is rising rapidly for teenagers – the mainstay of the country, for example, HIV prevalence increased from 11% to 17% within only one year (2001 – 2002) [128] that has become a very alarming problem. The increasing incidence of new infections associated with untreated old cases has put Thailand at risk, the number of people living with HIV in Thailand can be compared to the number of people in developed countries [129], even higher than in western and central European countries.[130]

Faced with this situation, ARV drugs are the most effective option used to help people fight the disease for more than a decade. [131] ARV significantly improves the quality of life of the patient and significantly reduces the mortality and morbidity as well. [132] However, although ARVs are largely available and effective, high cost of treatment is a barrier. The percentage of people living with HIV / AIDS in untreated developing countries is still large compare with treated cases. [133] The number of people who have access to prescription drugs only accounts for 15%. [134]

To dealwith this situation, Thai government has stated that HIV / AIDS is a government priority [135] by significantly increasing the budget for HIV / AIDS prevention process. [136] However, only a small proportion of people living with HIV / AIDS actually received treatment due to Thailand’s financial constraints and high drug costs. [137]

Constantly trying to protect the health of the people, the Thai government in 2003 began providing ARV treatment through the national health insurance system. [138] However, Thailand can  be able to treat only certain patients who are at an early stage of less risky, “end-stage” patients at risk of dying needing treatment with stronger, more effective and also more expensive by “second line” ARV drugs. [139] Since the right to health care is a fundamental human right, [140] Thailand has issued compulsory licenses with a desire to reduce at least half the cost of ARV, opening up widespread access to help the patient. [141]

As a result, on November 29, 2006, the Thai government announced a five-year compulsory license for ARV Efavirenz to improve access to HIV drug for patients. [142] Compulsory license allows the manufacture or import of generic versions of ARV drugs without the consent of the copyright holder. [143] The use of patents will be limited to the treatment of no more than 200,000 patients each year [144] and the government will pay a royalty of 0.5% to the patent holder. [145]

To support for this provision, the Thai Government has cited Article 51 of the Thai Patent Act, the TRIPS Agreement and the Doha Declaration which recognize the importance of protecting public health and access to essential medicines. [146] Compulsory License must be  used under some certain conditions. Thai’s Act provides in Article 45,46,47 that a compulsory license may be granted only if the patented product is not produced;  or the patented process is not used or sold domestically; Or if they sell, they will be sold at unreasonably high prices or inadequate domestic demand. [147] In addition, applicants for a license are required to make an effort to obtain a license from the protection owner under reasonable conditions and in a certain time. [148] Besides that, Article 51 provides for exceptions to the above requirements, permitting the use of government patents to “perform any service for public consumption” or “to prevent or reduce the lack of drugs” or to meet the needs of the public without the prior consent of the patent holder. [149]

By issuing these compulsory licenses, Thailand has raised the need for cheaper ARVs to increase the numbers of HIV / AIDS patient who can be accessed to drug. [150]

By the decision to issue compulsory licenses, Thailand has been able to significantly improve access to necessary medicines for people living with HIV / AIDS. On March 2010, the number of patients receiving treatment has increased several times compare with before period. [151] According to a 2010 UNAIDS report on the global AIDS epidemic, Thailand ranks ninth among countries with many people living with HIV ; However, it is also one of only three countries  in this group to have successfully provided ARVs to at least 50% of people in need. [152] Moreover, compulsory licenses also help Thailand saving national budget which approximately 60 million US dollars until 2010. [153]

Moreover, consecutively in November 2006 and January 2007, the Thai government issued decisions which pharmaceutical companies could produce the same drugs as the protected drugs to the public. Major foreign pharmaceutical companies such as Stocrin (Merck’s AIDS drug) or Kaletra (Abbott’s AIDS drug). [154] The government intends to continue removing the Patent Protection of more than 11 kinds of pharmaceuticals. [155] There are many conflicting opinions surrounding this issue. From the Thai government, the minister of health of the country stated that based on the rules of international trade in cases of emergency, cases relating to public health, the decision of the Thai Lan is completely allowed. [156] This decision by the government was fully supported by AIDS activists. They think this is the bravest decision of the Government. However, this decision came with strong opposition from the Western Countries. [157] Some western pharmaceutical companies said they would reconsider their investment in Thailand  because they can not afford to invest in the  market when their property is not properly protected. The United States government has transferred Thailand from the Watch List to Priority Watch List countries. [158] This is totally detrimental to Thailand because they are easy to take measures economic sanctions from the US such as increased import tariffs on Thai goods to the United States. [159]

At the end of 2007, Thailand made the same decision on three drugs: two of the drugs for AIDS and the other of drugs for cardiovascular disease. [160] According to this decision, pharmaceutical companies are allowed to manufacture or import drugs similar to the protected drugs without the consent of owner of such inventions. [161] According to calculations by the Thai government, this will help to add another 20,000 people, access to medicines for serious diseases. [162]

In brief, the Thai government was high determined to increase the accesions to medicines for people, especially HIV/AIDS. This is understandable as Thailand is well known to the sex industry – a favorable condition for AIDS to spread. Although not a developed country, it is clear that the Thai government is striving to improve the living standards of its people, despite the fact that in the short run they will face fierce opposition, even economic punishment.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CHAPTER IV: CURRENT IMPRESSION OF PRATICAL IMPLEMENTATION ON PHARMACEUTICAL PATENT IN VIETNAM & PROPOSAL

 

4.1. Overview of development of Vietnamese Intellectual Property system.

Vietnam is a small country in South East Asia, member of Association of Southeast Asian Nations (ASEAN). In the recent years, Vietnam became prominent country which has economic  growth among 11 countries in ASEAN. Over the past decade, Vietnam has achieved an average growth in per capita GDP of 7%, making it the second fastest growing economy in the world, after only China. [163]

Broadly, legal system in general and the rights to intellectual property rights in particular in Vietnam is a nascent institution that was formed in the late 1960s.

In early 1995, Vietnam applied for WTO accession. At this time, the industrial property protection system operates primarily on a “sub-law” documents. [164] Comparing to TRIPs, at the time of application joining the WTO, Vietnam’s industrial property system does not match TRIPs agreement. Therefore, Vietnam has developed an IPR Action Plan, for example, some decrees and ordinances regarding to copyrights was approved by the State Council such as The Ordinance on the Protection of Industrial Property (1989) and the Ordinance on the Protection of Copyrights (1994). The overall goal is to make Vietnam’s IP system fully compliant with TRIPS. [165] The first important step in implementing the Action Plan is Promulgated the Civil Code in 1995, in which Section VI refers to Wisdom Ownership and transfer of technology. The Civil Code is the highest legal status of comprehensive industrial property activity and a mark a remarkable point in the history of industrial property protection in Vietnam. Between 1996 and 2001, a number of legal documents were issued which  guide the implementation of the Civil Code and provide further regulations on other subjects such as business secrets, geographical indications and trade name, protection against unfair competition for industrial property. However, the IP system still does not fully comply with TRIPs and WTO requirements Contract. Therefore, Gorvement decided to continue to improve legislation to promote innovative activities and also improve the competitiveness of the economy.

Thus, the National Assembly the Intellectual Property Law was promulgated on November 29, 2005 includes 6 sections, 18 chapters and 222 articles which covers the entire  collection of intellectual property rights comprehensively: General Provision (Part I), and Protection (Enforcement – Part V) were applied to all types of IP rights, Part II contains provisions on Copy right and Related Rights; Part III covers all different types of Industrial Properyt Rights which comprise inventions, industrial design and design of semiconductor closed circuits, trade secrets, marks, trade names and geographical indications. [166] Provisions of the 2005 IP Law are completely obey the TRIPS Agreement. The promulgation of the Law on Intellectual Property in 2005 could be considered a milestone marking Vietnam’s efforts during the 10 years of preparation for become WTO member. [167]

In January 2007, by accession to the World Trade Organization (WTO), Vietnam has formally committed itself to fulfilling all intellectual property obligations required by the TRIPS Agreement in its trade relations, including bilateral and multilateral agreement with other countries and international organizations.

Until now, Vietnam has participated in most of the most important international intellectual property conventions including the Paris Convention for the Protection of Industrial Property, the Madrid Agreement and the Protocol on International Registration of Marks, The Berne Convention on Copyright, the Geneva Convention on Recording Works, the Brussels Convention on Satellite Transmission, the Patent Cooperation Treaty (PCT), the Stockholm Convention on the Establishment of the Intellectual Property Organization World Forum (WIPO) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Vietnam’s legal system on IPR has been assessed as quite complete and compatible with international IP regulations.

 

4.2. Overview of the Vietnamese pharmaceutical industry

According to WHO, Vietnam’s pharmaceutical industry is at a growing level. Vietnam has a domestic pharmaceutical industry, but most of products has to import raw materials, so Vietnam’s pharmaceutical industry is rated still at a medium-low level of development.

International organizations have different categories and ratings for the pharmaceutical industry: United Nations Industrial Development Organization (UNIDO) divides the pharmaceutical industry by five levels, the World Health Organization (WHO) And the United Nations Conference on Trade and Development (UNCTAD) determine the level of development of the pharmaceutical industry in four levels: [168]

– Level 1: The country must import drugs totally.

– Level 2: Countries which product some generic drugs but most drugs have to be imported.

– Level 3: Countries which have their  own domestic pharmaceutical industry; produce some generic drugs and export some medicines.

– Level 4: Countries which produce materials and invent new drugs.

According to the assessment, the current pharmaceutical industry in Vietnam is near level 3 according to WHO classification.

However, it must be notd that Vietnam’s pharmaceutical industry has grown rapidly over the past 10 years. Based on  IMS Heath classification, Vietnam is among the 13 countries with a total drug spend ranging from $1 billion to $ 5 billion in 2013. These countries also have the fastest growth rate of up to 20% per year. [169]  Revenue growth rate of Vietnam’s pharmaceutical companies achieved about 23% during the 2008-2012 period. This is the 2nd highest rate among those pharmerging countries, lower than Argentina (24.8%) and followed by China (22.3%) and other ASEAN countries such as Thailand and Indonesia.

Among Southest Asia Countries, The pharmaceutical market in Vietnam has the highest growth rate, about 16% annually. In 2013, the total drug consumption is $ 3.3 billion which predicted to increase to $10 billion by 2020.

Vietnamese pharmaceutical enterprises developed after 1990, have a relatively young age in comparison with the rest of the world. At present, the capacity of the domestic pharmaceutical industry only meets nearly 50% in revenue, the rest mainly depend on imports.

Overview, the IP system in Vietnam has been constantly improved and currently, in line with international regimes. However, it is difficult to assess its real impact on the country’s economic growth and there are still many inadequacies:

First, awareness and understanding the general public about IP is not appropriate;

Secondly, the number of patents, utility solutions and industrial designs are small due to weak capacity and inadequate investment capacity;

Thirdly, at present, companies are more focused on creating and subscribing to brand protection rather than the creation of other IP assets such as patents or designs;

Last but not least, the enforcement of intellectual property law is weak. There are many violations occurring without strong punishment. The court system is still unfamiliar with civil and criminal cases involving IP.

There is the fact that from 1995 and ealier, enterprises have not paid much attention to the field of pharmaceutical patent protection, only 32 are filed, most of which are related to traditional medicine. [170]

Since 1995, with the development of market economy and Vietnam’s accession to the Patent Cooperation Treaty, the volume of patent applications has increased sharply. Each year, Vietnam has nearly 100 exclusive patents. Granted with regard to pharmaceuticals. However, most of them are foreign pharmaceuticals, while domestic pharmaceutical companies as well as management agencies have not been able to adapt to the regulations related to this issue. [171]

Until now, there are about more than 7000 patent applications related to pharmaceuticals, of which only nearly 200 are owned by Vietnamese enterprises, accounting for 2.6%; Nearly 2,000 patents related to pharmaceuticals were granted, among them only 100 were owned by Vietnamese, accounting for 4%. [172] Additionaly, the number of utility applications accounts for a very small proportion of the patent applications in the pharmaceutical sector (about 1%). Overview, The number of patents issued in the field of pharmaceuticals has fluctuated little over the years and accounts for only 20% to 30% of the total number of patent applications filed in this area. [173]

These figures show that the number of patents which relate to pharmaceutical industry by enterprises and individuals in Vietnam is extremely limited.

The reason of this situation is many pharmaceutical companies and individuals have not yet been fully aware of the benefits of intellectual property protection. On the other hand, Intellectual Property Rights with the pharmaceutical industry is generally more complex than others because of its lengthy, the process of explore is costly. Moreover, companies and individuals have not really paid much attention to the issue of patents so it has led to the fact that the number of applications for registration of pharmaceutical-related inventions of Vietnamese enterprises still stands at rather modest numbers. Under another aspect, the reason comes from government management when innovative policies in the pharmaceutical sector have not had a positive impact on the increase in patent applications over the years. This is the fact that  Vietnam needs to look back and adjust policies that support research and development in the pharmaceutical field so that increasing the total number of patent applications in the coming years.

 

4.3. Implementing of TRIPS Agreement on pharmaceutical patent.

 

4.3.1. Compulsory license

In Vietnam, the term of “compulsory license” were existed for the first time in Ordinance on Protection of Industrial Property (1989) which provide that: The transfer of ownership or the right to use an industrial property object must be through written contracts registered at the Inventions Department and in compliance with the law. [174]

Until 2005, Intellectual Property Law appeared which creates a significant improvement in regulation of compulsory license. IP Law 2005 specify four cases which the right to use an invention to be transferred to other organizations or individuals under decisions of competent authorities as follow: [175]

– The use of the invention is for public purposes, non-commercial purposes, for national defense, security, disease prevention, treatment and nutrition, or for meeting urgent social needs;

– The patent holder fails to fulfill the obligation to use the invention as provided for in Clause 1 of Article 136 and Clause 5 of Article 142 of this Law;

– Person who wish to use the invention fail to reach an agreement with the patent  holder to use patented products even though within a reasonable period of time attempted to negotiate;

– The patent holder is considered to have acted as a restriction on competition prohibited under the law on competition.

Any compulsory license has a time limit and is non-exclusive and nonassignable, except for the case it is assigned as a part of the enterprise transfer. The patent owner shall be paid adequate remuneration depending on the circumstances of each case. [176]

However, Vietnam has still not made full use of the mechanism. Vietnam’s Ministry of Health is drafting a circular on compulsory licensing for pharmaceutical patents so far. Can not deny that the draft circular represents a earnest attempt by lawmakers to provide further guidance on compulsory license in the pharmaceutical sector. It clarifies relevant provisions such as licensing procedures, how to calculate adequacy remuneration when compulsory licenses are applied, then specifies the rules and makes the implementation much more convenient. [177]

However, there are still many limitations surrounding this issue. According to Article 4 of the Circular, compulsory license may apply in cases involving “a drug that essential for life-saving”. The definition of “essential medicine” is considered too broad in this case, this rule put the most drugs in the risk of execution of compulsory license.

In other words, Patent owners may feel the current draft is inadequate, failing to protect their interests. In addition, the draft does not require the applicant to pay a fee, but requires the copyright owner to pay a fee when filing for a mandatory license termination, which is also considered unreasonable.

4.3.2. Exception

As mentioned abow, Vietnam Intellectual Property Law 2005 lists the cases which the patent holder is not allowed to prohibit others from using the invention for personal or non-commercial purposes; for the purposes of assessing, analyzing, researching, teaching, testing, trial production or gathering information to carry out procedures for product, import or circulation of products. [178]

However, such listing does not clarify the requirements for the limitation of patent rights under Article 30 of the TRIPS Agreement.

There are two requirement that provide the condition for apply exception on pharmaceutical patent; the first condition is exceptions do not unreasonably conflict with a normal exploitation of the patent and the second condition is such exceptions do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. [179]

These condition must be explained in relation to each other. In other words, these conditions must be satisfied at the same time so that the exception can be used legally, but Article 125 in Vietnam IP Law does  not mention the compliance with these conditions as an indispensable basis for the application of exceptions, just simply to the extent that lists the permitted exemption. This has highlighted the lack of Vietnamese law in relation to the TRIPS agreement which Viet Nam has signed and obliged to comply with.

4.3.3. Parallel import

Vietnamese intellectual property law allows parallel imports of goods and products under intellectual property rights including pharmaceutical products. Accordingly, parallel import behavior is not considered an infringement of intellectual property rights. This is regulated by the Law on Intellectual Property 2005 in Articles 20 and 125, and also performed in Decree 97/2010 of the Government and Circular 37/2011 by the Ministry of Science and Technology.

Although pharmaceutical prices in Vietnam are still very high, it can not be denied that

The adoption of parallel imports in Vietnam has created favorable conditions for people and businesses in the country to get benefit from imported products at low prices, especially for pharmaceuticals. Parallel import brings a significance meaning to the common sense of society, especially for the pharmaceutical industry in countries that are not sufficiently capable of produce drugs due to financial problems.

In 2004, in order to stabilize and reduce the “fever” in the domestic market and prevent abuse of foreign pharmaceutical companies, the Ministry of Health issued Decision 1906/2004 on parallel import of specific medicines for patient. [180]

4.4. Difficulties

IP Law 2005 is considered the most comprehensive law on patent protection in Vietnam’s history. However, there are still many shortcomings that existed in this Act which will be pointed out as following:

 

4.4.1. Whether the Patent Confers the Right to Use the Patented Invention?

A patent grants the inventor a monopoly over a certain amount of time [181] with condition that the inventor must disclose the invention in such a way as to allow a person with ordinary knowlegde in the same field can use that invention without further explanation. [182] Rely on WIPO, the inventor or the patent owner does not have the freedom to create, use or sell anything worldwide. [183] Patent is a right to prohibit others from using the technology which protected by grant a patent for patent holder. Even patentees can not use the technology claimed in the patent under certain circumstances. Aside from, improving patent owners (inventions dependent) are not free to exploit their inventions without the permission of the owner of the basic invention whose enhancements have been made. [184] In this sense, the owner of a pharmaceutical patent is not free to make pharmaceuticals without the permission of the competent authority. [185]

In addition to not allowing others to use patented inventions, Vietnam also provides  for patentee to be used and allows others to use patentable patents, [186] depending on the requirements of Applicable law. [187] This right of use is unnecessary and creates confusion for the patentee because the law grants the inventor unenforceable rights.

 

4.4.2. Failure to Prevent Patenting of a Known Invention.

The IP Law 2005 regulates the following cases where a patent application is denied:

– There are grounds for asserting that the object stated in the application does not fully meet the conditions for protection; [188]

– The application satisfies the conditions for being granted a patent but is not the one with the earliest priority date or the first filing date; [189]

– In the case of multiple applications that meet the same conditions for the grant of a patent and the same priority date or the first filing date, the patent can only be issued for a single application of those who get the agreement of all other applicants. If no agreement can be reached, all applications will be refused. [190]

Therefore, Vietnamese patent Law does not provide for the exclusion of patents for known inventions and also does not provide the basis for determining whether the two patents are identical or not. This problem lead an invention that has been granted previously continues to be granted a new patent. For example, an applicant has created a new description of the compound and an accompanying method for preparing the compound. However, in the application submitting to NOIP, they only request to be protected designation of the compound. Shortly thereafter, another person know this invention and also filed another application including exactly the same description but they only claimed a single modulation which need to be protected. In this case, the NOIP assessor is able to treat the inventor of the second person as the new invention. [191] The examiner can not refuse to apply the following method under Art. 117 (b) because this Article does not exclude the grant of patents based on the same invention [192] but have the  different claims. That is, the law does not prevent the patenting of known inventions.

4.4.3. Internal priority

The new IP Law of Vietnam brought a great change related to priorities is the application of domestic prioritie (“internal priority”) combined with the priority of the Paris Convention (Convention priority) [193]. As a member of the Paris Convention, Vietnam has followed the Conventions Priority Principle. The priority right in Paris Convention stipulated as follows: If the applicant claims his or her first industrial patent right in a member State within a certain period,  after the first date of application (12 months for patents and utility models, 6 months for trademarks and industrial designs), they also can fill the application in any of the member countries and the following applications are considered as the same filing dates with the first application. The principle allows Vietnamese enterprises to enjoy the benefits of receiving protection from States that are members of the convention. At present, Vietnam’s intellectual property law allows applicants to request priority based on the first application filed in Vietnam or in another country that is a member of the Paris Convention. However, the Vietnamese patent system does not provide for the treatment of the first application from which the applicant claims priority for a subsequent application. In some countries, the patent office may permit the first application to exist with the following application. [194] In Vietnam, this is still an open question.

4.4.4. Re-issue Provision

The Vietnamese Patent Law allows patent holders an opportunity to amend the requirements on the patent in the conditions of payment of fees and charges [195].

There are two options in this case. The first is to issue a new patent that has been modified through re-issuance procedures. The second is to issue a certificate of correction. [196] The certificate will be appropriate in circumstances to remedy minor mistakes such as typographical errors or providing pantentee’s wrong information. [197] On the other hand, re-issuance proceduce would be more appropriate in cases where the inventor claimed more protection rights than they had previously requested. However, the law does not specify how NOIP should handle these requests by which way?! Therefore, the application is still very vague.

4.4.5. Shortcoming in parallel import

Although Vietnam’s legal documents mentioned about parallel import but it was not defined fully, clear and accurate that make difficult for competent authorities to distinguish counterfeit goods and parallel import goods as well as lack of legal basis in solving this kind of problem.

In some cases, the interests of parallel importers are not ensured due to the difficulties in proving the goods, in addition, some of the restrictions that exist in the price management mechanism can have consequences that parallel imports only bring benefit to importers without bringing back to consumers.

4.5. Proposal

4.5.1. Principle of improving the law of Vietnam on the protection of the patent for pharmaceutical products.

There is the fact that some medicines in Vietnam now cost 40% higher than the price in other countries in the world while the average income of Vietnamese people is very low, the annual health expenditure in Vietnam is  also not high. The high cost of drugs beyond the affordability of the Vietnamese people can be explained by  many reasons but 5 remarkable causes as follow: [198]

  • Government management;
  • Consumer psychology;
  • Information about the pharmaceutical situation;
  • The technology of drug production in Vietnam has not yet developed;
  • Monopoly in drug distribution.

Beside all the reasons above, the protection of pharmaceutical invention also has a strong impact on drug prices. The increase of costs of patenting pharmaceuticals, the absence of competing products on the market during patent protection has created incentives for patent holders to increase prices. The high price of drugs which exceeds the affordability of large of the population, seriously affects one of the basic human rights of being entitled to health care. Unlike ordinary goods, medicines are a special goods, when they are sick, even if they are not able to pay for medicines, patients and their relatives will have to mobilize the whole financial power to heal. Consumers may also not find alternative products because in many cases the patient will not have the same medication as regular goods. Therefore, in the pharmaceutical sector, there is a need for the goverment to take positive action, offering important solutions for pharmaceuticals to consumers with reasonable price and quality. The problem is that how to maintain balance between patent protection and right to approach pharmaceutical products of citizen?

Therefore, the first principle to improve domestic law regarding to protect patents in pharmaceutical section is  Vietnam needs to comply with international commitments while researching and effectively exploiting regulations on exceptions and restrictions on IPR as stipulated in the international treaties. Beside the establishment of minimum standards of protection and the requirements for WTO members to comply with; the TRIPS Agreement has given Member States the right to self-determination in the development of legislation in accordance with their respective national policies and conditions [199] such as provisions on transitional deadlines for developing country members, rules on exceptions to IP protection, IP rights, parallel importation, the provisions of not protecting some IP objects … especially applicable to the patent protection of pharmaceuticals.

The second principle is patent protection for pharmaceuticals needs to determine the goals that affect the patent system, the socio-economic issues of Vietnam, and the national interests as well as the international relations in the process of completing the legislation. The improvement of Vietnamese legislation on the protection of pharmaceutical patents must be in line with the situation of Vietnam as well as with the country’s economic development, in order to achieve the objectives of economic and society development. However, Vietnam’s law must establish regulations that avoid the abuse of the rights from developing countries, take advantage of TRIPS exceptions to the patent protection of pharmaceuticals to harm the interests of patent holders, affecting the investment environment as well as international cooperation.

The third, studying and referring selectively the experience of developed countries in the protection of pharmaceutical inventions, then applying them in accordance with the situation of Vietnam. The legislation on patents in general and the legislation on pharmaceutical inventions in particular in some countries around the world has been formed for decades before Viet Nam. Hence, the learning experience of countries, especially developed countries will be useful for Viet Nam in improving the Vietnamese legislation on IP in general and the law on the protection of pharmaceutical inventions in particular. However, should be aware that there is no legal model that fits all other models, so the improvement of Vietnamese legislation on pharmaceutical patent protection must be based on country’s specific conditions.

The last, the most importance thing in the field of pharmaceutical patent protection is the balance of interests between the patent owner and the interests of the society, national interests are the basic principle, throughout the process of building and enforcement law. Increasing protection of IPR when Vietnam integrate deeply into globalization will bring Vietnam more challenges than opportunity. In that context, Vietnam needs to ensure its national interests, social benefits and the interests of individual organizations under the pressure of international integration, also need to respect and implement international commitments.

4.5.2. Proposal.

“The goal of the pharmaceutical industry is to change the rules internationally, to change global norms with a new monopoly that is cheaper for the companies and stronger,”[200]

In Vietnam,  some arguement that intellectual property law including patent regulations is quite modern and meet the need to regulate the social relations, also approaching the international standards. Otherwise, other opinons show that Vietnam has very few internal inventions, the exploitation of foreign patents at the lowest cost is considered the shortest way to develop the country and raise the living standard of the community. However, it seems to contradict the integration process. With the international treaties that Viet Nam has recently entered to such as the TRIPS Agreement or TPP, the monopoly trend of patent holders is clearly recognized and become a challenge to the development of country. The downside of monopoly can lead to consequences such as limiting legitimate public demand for exploitation and rational use of scientific achievements, especially in critical areas human health care. [201]

The question is what developing countries like Vietnam need to do to actively integrate, ensuring sufficient respect for the rights of patent holders; as well as ensure the proper exploitation of technical solutions such as patents in the pharmaceutical field so that the citizen can access drugs at affordable prices. How does Vietnamese intellectual property law do so that ensures the balance of interests between patent owners and social interests?

This chapter will suggest solutions to answer these questions:

 

4.5.2.1. Proposal of amendment patent legal system

 

a. Improvement of Vietnamese law on compulsory licensing of inventions for export of pharmaceuticals

Vietnamese law allows to issue compulsory license for provide primarily for the domestic market [202] which consitant with TRIPs Agreement [203]. However, by ratifying the protocol which amend TRIPs, some states also amend national legislation to allow the exportation of pharmaceuticals in accordance with such Protocol. Therefore, together with the ratification of the Protocol, Vietnam should issue a regulation detailing the implementation of this issue. By this provision, allowing the exportation of pharmaceuticals manufactured under the compulsory license to enter into markets of WTO Member States that do not have sufficient pharmaceutical production capacity to assist them in addressing the Public health problem.

 

b. Issue a circular of Government detailing the issue of parallel import.

As analysized above, building new regulations relate on parallel import is necessary. For instant, regulation on definition of parallel import; the measure to identify and distinguish counterfeit goods and parallel import products, issued together with the list of goods banned from parallel import. It to be noted that new regulations should be repair the limitations of previous legal documents.

Moreover, although at present, Vietnam Intellectual Property Law 2005 has allowed the parallel import of pharmaceutical products, however, other relevant regulations such as tax, circulation permits, drug price management are not so favorable that they can encourage the parallel import of drugs. Therefore, Vietnam should create favorable conditions, including creating a comprehensive legal corridor for enterprises to carry out the parallel import of pharmaceuticals.

 

c. Amending current patent law on the basis of compliance with international commitments and overcome shortcomings of national law.

First of all, it must be affirmed that in Vietnam, both previously published intellectual property laws and current regulations have created the legal basis for intellectual creativity, including patent sector, plays an important role in safeguarding the rights and legitimate interests of the subjects of law. Besides, however, many restrictions still exist which analyzed in section 4.4.  Hence, the necessary work at the moment is to revise the legal corridor, based on the limitations that have been analyzed above so that the implementation and enforcement of intellectual property rights in general and patent rights in particular bring more brighter results in the future.

 

4.5.2.2. Proposal of enforcement measures.

 

a. Improve science and technology to invest in biosimilar production.

Basically, biologic drugs have a double-acting effect on the Vietnamese pharmaceutical market. Biologic drugs are produced from biotechnology including vaccines, antitoxins, proteins, monoclonal antibodies. This drug is very difficult and expensive to build and develop. It is one of the highest priced drugs in the world (average 22 times higher than other drugs). In order to save costs, most companies tend to focus on developing the next biosimilars when the original biological drugs expire. [204]

Therefore, Vietnamese pharmaceutical companies should invest in the biosimilars sector instead of producing generic drugs which have a lot of competitors and low profitability. It will open up the opportunity to help Vietnamese medicines not only serve domestic demand but also are exported to foreign markets. If Vietnamese pharmaceutical companies refrain from investing in advanced high-end products, they do not create the substainable development. [205] Hence, Vietnam must seriously consider upgrading its science and technology solutions to meet this requirement.

 

b. Improving the professional capacity and the sense of responsibility of the competent authorities in the field of pharmaceutical invention.

In pharmaceutical patent protection field, legal staff need a deep knowledge not only about IP but also about pharmaceutical law, competition law, contract law, even knowledge of economics and finance. Therefore, law enforcement authorities in this area should be equipped both with their legal expertise and professional, economic, political and social experience.

 

c. Establishment of the Intellectual Property Court.

This proposal is deemed necessary when intellectual property disputes now account for a large proportion of civil dispute resolution in Vietnam. The past few years have shown that very few intellectual property rights disputes are brought to court, which does not properly reflect the status of intellectual property rights in present social life. [206] From 2000-2005, the disputes on intellectual property were brough to courts are 93 cases. [207] From 2012 until now, the number of disputes has increased, but the courts could handled about 50 cases per year [208] which does not meet the actual needs.

In general, Laws on the protection of intellectual property are relatively new in Vietnam. Due to the complexity and diversity of disputes over intellectual property rights, some judges find it difficult in solving these cases. [209] Another difficulty pointed out is the determination of damage caused by the infringement of intellectual property rights and the base for determining compensation for damages caused by infringement of intellectual property rights. [210] The Intellectual Property Law sets out the principles for determining damages caused by infringements of intellectual property and the basis for determining the level of compensation for damage caused by infringement of intellectual property rights. [211] But due to the specific nature of the property, many plaintiffs fail to prove the damage or inadequately determine the damage that has occurred in practice. Therefore, when resolving this issue, the court has encountered many difficulties in determining damages to obtain accurate and lawful findings, ensuring legal rights for the involved parties. Besides, another difficulty is the overload of High Court which causes the time to handle cases is too long. As a result, Vietnam needs to set up an Intellectual Property Tribunal, which will focus on these professional judges to handle those cases.[212]

CHAPTER V: CONCLUSION

Intellectual property rights are an important motivation for research and development, commercialization of innovations in the pharmaceutical sector to provide novel medications for the prevention of disease. Meanwhile, patients should be given new medications for their treatment at a affordable price compared with their income. This is a paradox that countries and international organizations are facing. Patent exclusivity leads to limitation of affordability and accessment to patented drugs of population. The balance of rights and benefits between pharmaceutical companies and patients is generally not an easy matter, depending on the social & economic conditions of each country.

Many countries around the world have modified their patent issue in their domestic legislation very early and are gradually improving over time. In general, under most of countries law, especially developing countries, focus on facilitating access to medicines for people by specific regulations, in addition to assuring intellectual property rights under its patent system.

For Vietnam –  a developing country and to be suffering from many diseases as HIV/ AIDS, tuberculosis, malaria as well as diabetes and cancer…Vietnam also is one among ten countries in the world which most affected by climate change. Therefore, the demand for healing of people is extremely tremendous but the cost of drugs is too high. The high price of pharmaceutical products is the consequence of many causes, one of the main causes is the establishment of patent system under national law as well as international agreement. However, on behalf of a member of the TRIPS Agreement, Vietnam must comply with international commitment in good faith. Thus, the problem is

how to establish an effective legal system under the TRIPS Agreement while still taking into account the interests of the majority of the Vietnamese people in accessing essential medicines to cure illness?!

Although the IP Law 2005 and the implementing Decrees and Circular combine with relevant documents provide a good legal basis for patent rights which is almost completely adhering to TRIPs Agreement but it truly not enough. The improvement of the legislation on the protection of pharmaceutical inventions must be considered as an important factor and simultaneous with other solutions in the current situation of the country. Some recommendations to perfect Vietnam’s patent law will be raised in hopes of opening a brighter future for the pharmaceutical industry in Vietnam.


[1] Article 27, Section 5,Uruguay Round Agreement.

[2] [FD&C Act, sec. 201(g)(1)].

[3] Revitalizing the Patent System to Incentivize Pharmaceutical Innovation: The Potential of Claims with Means-Plus-Function Clauses, 62 Duke L.J. 1069, 1091–92 (2013).

[4] Id.

[5] Id.

[6] Id.

[7] See: http://mpasearch.co.uk/product-process-formulation-patents

[8] Under Art.28 TRIPs Agreement.

[9] Bruce Lehman, President, International Intellectual Property Institute, “The Pharmaceutical Industry and the Patent System” .

[10] Article 29 TRIPs Agreement.

[11] Joan Costa-Font, Aaron Burakoff, An Overview of Progress in the International Regulation of the Pharmaceutical Industry, p.103, 105, 2002.

[12] Article 27.1 TRIPs Agreement

[13] Section 103, chapter 10, Part II, US Patent Act

[14] supra note 10.

[15]Art.5 Paris Convention

[16] Art.30 TRIPs Agreement

[18] The Doha Declaration provides for circumstances where governments may issue compulsory licenses on otherwise patentedmedications when deemed necessary to protect the public health. See http:// www.worldtradelaw.net/doha/tripshealth.pdf

[19] Jennifer Bjornberg, “Brazil’s Recent Threat on Abbott’ss patent: resolution or retaliation?”, p.214, 2006.

[20] Article 33 of TRIPS Agreement

[21] Article 41.2 of TRIPS Agreement

[22] Article 50 of TRIPS Agreement

[23] Canada’s laws on pharmaceutical intellectual property: the case for fundamental reform https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307559/

[24] Douglas K, Jutras C. Patent protection for pharmaceutical products in Canada — chronology of significant events, 2008, available at: www.parl.gc.ca/content/LOP/ResearchPublications/prb9946-e.htm

[25] Id.

[26] Hore E, A comparison of United States and Canadian laws as they affect generic pharmaceutical market entry, p.88, 2000.

[27]  Bouchard RA, Cahoy D, Domeij B, Structure–function analysis of global pharmaceutical linkage regulations. Minnesota Journal of Law Sci Technol , p.391–461, 2011.

[28] Canada’s laws on pharmaceutical intellectual property: the case for fundamental reform, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307559/

[29] Grootendorst P, Hollis A, The Canada–European Union comprehensive economic and trade agreement: an economic impact assessment of proposed pharmaceutical intellectual property provisions, p.103, 2011.

[31] https://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html

[32] Accoring to the 2015 PRPRB Annual Report.

[34] Article 66(1)(a), Patent Act, 1985. Except where indicated otherwise, references in this paper to the Canadian Patent Act refer to the current (1985, as amended) version.

[35] Allan Z. Litovski, The Law of Unintended Consequences: How Will the Affordable Prescription Drugs and Medical Inventions Act Affect American Health Care?,  p.20, 21, 2012.

[36] Sections 41.18 to 41.24 of the Patent Act.

[37] new Section 41.18(1) of the Patent Act.

[38] new Section 41.19(1) of the Patent Act.

[39] Section 41.19(1).

[40] new Section 41.24.

[41] new Section 41.15(5) of the Patent Act.

[42] DSB 114, https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds114_e.htm

[43] Id.

[44] Id.

[45] WT/DSB 114, supra.

[46] Id.

[47] EC Oral Statement, First Meeting, paragraph 59; EC Second (Rebuttal) Submission, paragraph 67

[48] EC First Submission, paragraph 51

[49] EC First Submission, paragraph 57

[50] Initially, the EC took the position that, while a wide list of other products from foodstuffs to aircraft were subject to regulatory review requirements in Canada and other countries, the legal scope of Section 55.2(1) was confined only to pharmaceuticals (EC First Submission, paragraph 58) . Canada, however, has explicitly denied having conceded that point, and has reaffirmed without qualification that the legal scope of the statute is as broad as the words indicate (Canada, First Submission, paragraph 131; Oral Statement at Second Meeting, paragraph 30) .

[51] On the record before the Panel, there was no occasion to consider the question raised by certain third parties — whether measures that are limited to a particular area of technology – de jure or de facto – are necessarily “discriminatory” by virtue of that fact alone, or whether under certain circumstances they may be justified as special measures needed to restore equality of treatment to the area of technology in question. The Panel’s decision regarding Section 55.2(1) did not touch upon that issue.

[52] Law No. 50/2005/QH11 On Intellectual Property, adopted by the National Assembly on November 29, 2005 (effective from July 1, 2006), and proclaimed by the President of the State pursuant to Order No. 28/2005/L-CTN On the Proclamation of the Law on Intellectual Property on December 12, 2005. The Law was amended and supplemented by the Law on Amendment of the Law on Intellectual Property No. 36/2009/QH12, adopted by the National Assembly on June 19, 2009 (effective from January 1, 2010).

[53] Susan Fyan, Pharmaceutical patent protection and section 3(D): A comparative look at India and US, Virginia Journal of Law & Technology, Fall 2010.

[54] Novartis Patent Challenge Dismissed in India, Sept. 5, 2007, http://ictsd.org/i/news/bridgesweekly/7819/.

[55] The Indian Patents and Designs Act, 1911, No. 2, Acts of Parliament, 1911, (amended 1930).

[56] supra note 25, at 920.

[57] Id

[58] Id

[59] supra note 28, at 580-81.

[60] Id.

[61] § 53(1)(b), The 1970 Act, supra note 11.

[62] Telephone Interview with Dr. Peter C. Richardson, Patent Counsel, (Oct. 25, 1994) (hereinafter Richardson Interview I).

[63] Compare Embassy of India, Intellectual Property Rights in India, http://www.indianembassy.org/policy/ipr/ipr_2000.htm (last visited Sept. 10, 2006) (2000 policy statement) with Embassy of India, Intellectual Property Rights in India,

[64] See generally Rebecca Mayer, A Passage for India, 24 Med Ad News 4, Feb. 1, 2005, available at 2005 WLNR 3520883 (describing Indian pharmaceutical companies’ practice of reverse engineering).

[65] The Patents (Amendment) Act, 2005, No. 15, Acts of Parliament, 2005 [hereinafter 2005 Amendment].

[66] Patents Act, 2005, supra note 9, at comment 52.

[67] Centre to curb evergreening of patents in amended Bill, Fin. Express, Mar. 21, 2005.

[68] https://en.wikipedia.org/wiki/Pharmaceutical_industry_in_India#cite_note-et-1

[69] Pharmaceuticals & Healthcare Forecast–Q4 2004, 1/12/2004 (remarking that this accounts for just below 10 percent of global production).

[70] See generally KUANPOTH, supra note 1, at 112–13 (providing a breakdown of the hierarchy of developing nations based on their pharmaceutical manufacturing capabilities).

[71] Lalitha, supra note 16.

[72] Rumman Ahmed & Amol Sharma, Novartis Fights India for Cancer Pill Patent, 19/8/2012. According to PricewaterhouseCoopers LLP, India’s pharmaceutical industry amounted to $11 billion in 2011.

[73] Mueller, supra note 3, at 500. The success story of its IT sector is admittedly the clearest example of India’s growing stature in the knowledge economy, but innovation in the pharmaceutical and biotechnology sectors is also on the rise. Many Indian-born scientists who have trained in the U.S. are returning to India, bringing home their experience in pharmaceutical research and development. The country’s ever-expanding pool of scientifically-trained workers is also available to the Indian pharmaceutical industry. Almost forty percent of India’s university graduates obtain their degrees in science and engineering, in contrast with declining enrollments in those fields in the U.S. India’s pharmaceutical industry is fast becoming a force to be reckoned with in the global marketplace because of its strikingly lower costs of drug research and clinical testing.

[74] Central Government of India, 1970.

[75] Indian Parliament Approves Controversial Patent Bill, Bridges Weekly Trade News Digest,23/3/2005, http://www.ictsd.org/weekly/05-03-23/story1.htm.

[76] Id.

[77] Radhika Bhattacharya, Are Developing Countries Going Too Far on TRIPS? A Closer Look at the New Laws in India, p.395, 408, 2008.

[78] Someshwar Banerjee & Aruna Verma, Compulsory Licenses Are Pro-Public, Not Anti-Inventor, 3/4/2013, www.iam-magazine.com/reports/Detail.aspx?g=05dbb612-d26d-4dc8-b4dc-8ff0f0e04127.

[79] Bayer Corp. v. Natco Pharma. Ltd., Order No. 45/2013 (Intellectual Property Appellate Board, Chennai, 2013).

[80] Kevin E. Noonan, The Anatomy of a Compulsory License: Natco Pharma Ltd. v. Bayer Corp. (Indian Patent Office), http://www.patentdocs.org/2012/03/the-anatomy-of-a-compulsory-license-natco-pharma-ltd-v-bayer-corp-indian-patent-office.html

[81] Id.

[82] Id.

[83] Section 84(1)(c)

[84] Id.

[85] According to the international agreements on intellectual property including TRIPS, Paris convention and the Indian Patent statutes including 83, 90, 84(6).

[86] Id.

[87] See Bayer Corporation v. Natco Pharma Ltd., Order No. 45/2013, ¶ 40 (Intellectual Property Appellate Board, Chennai).

[88] http://www.noip.gov.vn/noip/cms_vn.nsf/vwDisplayContentNews/5D674E61E0

BDF16B47257B4700102234?OpenDocument

[89] Section 84

[90] Prabhu Ram, India’s New “Trips-Compliant” Patent Regime Between Drug Patents and The Right to Health, 2006.

[91] Janice M. Mueller, The tiger awakens: The tumultuous transformation of India’s patent system and the rise of India pharmaceutical innovation, 2007.

[92] See Sudip Chaudhuri, The WTO and India’s Pharmaceuticals Industry: Patent Protection, TRIPS, and Developing Countries, 2005.

[93] See National Pharmaceutical Pricing Authority Frequently Asked Questions, at http://nppaindia.nic.in/frequent.html#4 , stating in response to Question 4 that “only 74 out of about 500 commonly used bulk drugs are kept under statutory price control. All formulations containing these bulk drugs either in a single or combination form fall under price controlled category. However, the prices of other drugs can be regulated, if warranted in public interest.”

[94] See generally Functions of NPAA, at http:// nppaindia.nic.in/function.html.

[95] Sri Kamal Nath, Union Minister of Indus. & Commerce, Kamal Nath’s Statement on the Ordinance Relating to Patents (Third) Amendment, 27/12/2004, available at http:// pib.nic.in/release/rel_print_page.asp?relid=6074.

[96] See Intellectual Property Appellate Board, http:// www.ipab.tn.nic.in/

[97] Posting of Shamnad Basheer to Spicy IP, Novartis Case Before the IPAB?, http://spicyipindia.blogspot.com/2007/04/novartis-case-before-ipab.html (3/4/2007).

[98] IPAB, supra note 149, however, infringement and criminal proceedings would be continued in the High Courts.

[99] India to set up fast track courts, available at http:// news.bbc.co.uk/2/hi/south_asia/5227038.stm), India’s judicial system is notoriously slow. Some sources have described a backlog of 18 million pending cases, of which 16 million cases are criminal ones.

[100] Jakkrit Kuanpoth, Intellectual property rights and pharmaceuticals: A Thai Perspective on prices and technological capability.

[101] Vol.50, No.1, J. Kuanpoth, “Major Issues in the Thai Patent System”, Thai Bar Law Journal, pp.55-84, 1995, available at: www.thailawforum.com/articles/jakpat1.html

[102] Jakkrit Kuanpoth, Major issues in the Thai patent system: A Thai Perspective on prices and technological capability

[103] Id.

[104] supra note 21, § 9.

“Inventions of the following kinds are not patentable:

(1) foods, beverages, medicines, or medical ingredients;

(2) machinery used directly for agriculture;

(3) animals, plants or biological processes for the production of animals or plants ….”

[105] supra note 21, § 35. “An invention patent shall be effective for a period of fifteen years from the date of the patent application.”

[106] supra note 7, at 425-27. The act of “working” a patent is a term of art in patent law that means to utilize or exploit a patent. In the context of pharmaceutical patents, it means using the patented technology to manufacture the drug within the country that grants the patent. See Patents, Trademarks, and Related Rights.

[107]  J. Kuanpoth, “Thailand” in C. Heath (ed.), Intellectual Property Protection in Asia (Kluwer Publisher International, London, 2002), pp.337-362.

[108] Id.

[109] Id.

[110] Article 36(2) Patent Act B.E.2522, amended by Patent Act B.E. 2535.

[111] Susannah Markandya, Timeline of Trade Disputes involving Thailand and access to medicines, July 23, 2001. See more at http://www.cptech.org/ip/health/c/thailand/thailand.html

[112] Jakkrit Kuanpoth, Intellectual property rights and pharmaceuticals: A Thai Perspective on prices and technological capability.

[113] A. Samuel Oddi, The International Patent System and Third World Development: Reality or Myth?, p.837, 1987. Inventors benefit from grants of a temporary monopoly on an invention. Society benefits immediately through the economic stimulation caused by the use of the invention and through the public disclosure of the working of the invention. After the patent lapses, the invention is in the public domain. Even before the lapse of the patent, the knowledge provided by the disclosure stimulates additional invention by members of the public. There are two ways of viewing the relationship between the public and the inventor. Some commentators consider a patent as a contract where the monopoly is given to the inventor and, in return, the inventor gives the invention to the public. Another view is that a patent is simply a direct reward for an invention. See generally Miller & Davis, supra note 8.

[114] The developed economies of WICs are “invention-bound.” They require invention to stimulate continued economic growth. Consider the economic impact of such technological advances as VCRs, faxes, and cellular telephones. A developing economy may still be trying to implement “old” technology and would be ill-advised to pay the premium prices of “new” or patented technology.

[115] Id.

[116] Gerald J. Mossinghoff, Research-Based Pharmaceutical Companies: The Need for Improved Patent Protection Worldwide, 1987; see also supra note 7.

[117] The economies of many developing countries are largely agricultural. The government may consider it a threat to the nation’s sovereignty as well as its economic existence to allow patents to restrict agriculture or healthcare.

[118] Id.

[119] supra note 23, § 55 quartre (1).

[120] Id. § 55 quartre (4).

[121] Id. § 55 bis (2).

[122] Id. § 55 bis (3).

[123] Id. § 83 bis.

[124] Asian Wall St. J, Thailand Clears Patent Amendment for Drugs, Feb. 28, 1992, at 4.

[125] supra note 18, Art. 31.

[126] HIV and AIDS in Thailand, AVERT, http://www.avert.org/thailand-aids-hiv.htm.

[127] supra note 28, at 576.

[128] Id. (citing U.N. Dev. Programme, Thailand’s Response to HIV/AIDS: Progress and Challenges (2004)).

[129] Thailand, UNAIDS, http:// www.unaids.org/en/regionscountries/countries/thailand

[130] Id.

[131] Benefits of Antiretroviral Drugs: Evidence that the Benefits of HAART Outweigh Its Risks, AIDSTruth.org, http://www.aidstruth.org/science/arvs (last visited Dec. 31, 2011).

[132] Collins-Chase, supra note 61, at 768.

[133] Id.

[134] Id.

[135] Kuanpoth, supra note 28, at 577.

[136] Id.

[137] Id.

[138] supra note 9.

[139] Id. at 787; see also Arthit Khwankhom, Thailand to Break HIV Drug Patent, Nov. 30, 2006,

[140] Thailand Constitution 1997, § 52; id. § 51 (amended 2007).

[141] Darren Schuettler, Activists Hail Thai Move to Make Generic AIDS Drug, Reuters, Nov. 30, 2006, available at http:// uk.reuters.com/article/2006/11/30/thailand-aids-drug-idUKBKK1441220061130.

[142] supra note 7.

[143] supra note 95.

[144] supra note 7.

[145] Id.

[146]  TRIPS Agreement, supra note 4; Doha Declaration, supra note 6.

[147] Id. § 46.

[148] Id.

[149] Id. § 51.

[150] supra note 9.

[151] supra note 93.

[152] Global Report: UNAIDS Report on the Global AIDS Epidemic, Table 4.1, p.98, 2010, available at http:// www.unaids.org/globalreport/documents/20101123_GlobalReport_full_en.pd

[153] Treerutkuarkul, supra note 93.

[154] World Health Organisation, Improving access to Medicines in Thailand: The use of TRIPS flexibilities, Report of a WHO Mission, Bangkok, 2008.

[155] Id.

[156] Id.

[157] Id.

[158] Id.

[159] Id.

[160] Id.

[161] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2893582/

[162] Id.

[163] Bertelsmann Transformation Index 2016, http: //www.bertelsmann-transformationindex.de.

[164] The Ordinance on the Protection of Industrial Property (1989) and the Ordinance on the Protection of Copyrights (1994).

[165] It is the deadline for developing countries or countries in transition to comply with the requirements of the TRIPs.

[166] Art.3.2. Intellectual Property Law 50/2005.

[167] Nguyen Phuong Mai, MA – Nguyen Vo Hung, MA – Tran Ngoc Ca, Ph.d (Researchers), National Insitute for S&T Policy and Strategy Studies, Nguyen Tuan Hung – National Office of Intellectual Property. WIPO – UNU Joint Research Project Impact of the Intellectual Property System on Economic Growth Fact-Finding Surveys and Analysis in the Asian Region, Country Report – Vietnam.

[168] Hoang Hieu Tri (Senior Analyst), Pharmaceutical sector report, April 2014.

[169] Id.

[170] Id.

[171] Id.

[172] Data provided by the NOIP in 2014

[173] Id.

[174] Article 10, Ordinance on Protection of Industrial Property, 1989.

[175] Article 145 Intellectual Property Law 50/2005

[176] Article 146, Intellectual Property Law 50/2005.

[177] Thomas J. Treutler , Vietnam: Draft Circular on Compulsory Licensing, Managing Intellectual Property, 8/9/2016.

[178] Article 125.2, Intellectual Property Law 50/2005.

[179] Article 30 TRIPS Agreement

[180] Decision 110/2005/QD-TTg of the Prime Minister, 16/5/2005

[181] Article 93 Intellectual Property Law 50/2005.

[182] 35 U.S.C, 112, 2001, the specification must contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

[183] No.888, Tran Huu Nam’s translation, WIPO Intellectual Property Handbook: Policy, Law and Use, p.17, 2001.

[184] Philip W. Grubb, Patents for Chemicals, Pharmaceuticals, and Biotechnology: Fundamentals of Global Law, Practice and Strategy, 1999 at p.56.

[185] Id.

[186] Article 123(1b), Decree 63/ND-CP, 24/10/1996.

[187] Id. at Art. 7(2).

[188] Article 117 (a) Intellectual Property Law 50/2005.

[189] Id, 117 (b).

[190] Id, 117 (c)

[191] Article 60, Intellectual Property Law 50/2005.

[192] Article 90, Vietnam Intellectual Property Law 50/2005. The new IP Law of Vietnam provides that “where two or more applicants filed patent applications for the same invention, a patent shall be granted only to the valid application having the earlier priority date or filing date”,

[193] Vietnam Intellectual Property Law 50/2005, Art. 91(1a).

[194] Manual of Patent Office Practice, Canadian Intellectual Property Office, Chapter 7 – Internal Priority and Convention Priority, available at http://strategis.ic.gc.ca/sc_mrksv/cipo/patents/mopop/ch07-e.pdf.

For example, the applicant in Canada is allowed either to go along with both applications or to abandon the first application and proceed with the second one.

[195] Article 97(3) Intellectual Property Law 50/2005, Art.

[196] Id.

[197] See McCarthy, supra note 101, at 128.

[198] Report from Vietnam Academy of Social Sciences in 2015.

[199] Article 8 TRIPS Agreement.

[200] Judit Rius Sanjuan, A legal policy adviser for Doctors Without Borders’ medical access campaign, which wants lower-cost drugs on the market faster, 26/8/2015.

[201] Civilla Win, Some issues of the mechanism for dispute settlement for patent in Vietnam, look at the experience from the United State, 30/11/2016.

[202] Article 146(b) Intellectual Property Law 50/2005

[203] Article 31(f) of TRIPS Agreement

[204] How does TPP affect the Vietnamese pharmaceutical industry, 12/10/2015.

[205] Id.

[206] Mai Thoa, It is necessary to establish an Intellectual Property Court, 16/10/2016.

[207] According to the report of Vietnamese High Court in 2016.

[208] Id.

[209] Id.

[210] Mr. Vu Van Tien, Deputy Chief Justice of the High Court.

[211] Article 205 Intellectual Property Law 50/2005.

[212] Mr. Le Ngoc Lam – Deputy Director General of the National Office of Intellectual Property.

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