Rationale Behind Granting Patents For Human Genes Biology Essay

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Anything under the sun made by man can be patented. This sentence of the Supreme Court of the United States is to be understood literally and expansively. Literally everything under the sun that is made by man is now the subject matter of a patent. The famous case of Diamond v. Chakrabarty involved patenting of a live genetically altered oil eating bacteria. This was the first case where a live organism was patented. This case set the precedent for other cases such as Ex parte Allen which involved patenting of an oyster which was the product of genetic engineering [2] , The Harvard Onco-Mouse case, [3] where the first patent on a "non-naturally occurring non-human multicellular living organism" a mouse genetically engineered to be particularly susceptible to cancer was granted. Now human genes are the subject matter of patents. A study has revealed that one fifth of the human genes are already patented [4] .

Today governments and big corporations have patents on human genes and many other life forms. So its come down to this, humans and their genetic make up are now up for sale or rather it belongs to the person who first isolates the gene.

With the increase in the potential of biotechnology, the U.S. Government Began the U.S. Human Genome Project a 13 year effort in 1990, coordinated by the U.S. Department of Energy and the National Institutes of Health to identify all the approximately 20,000-25,000 genes in human DNA and to determine the sequences of the 3 billion chemical base pairs that make up human DNA and store the information in a database.

The patent regime is heading towards a point where discoveries and products of nature are being patented and made part of private property. Gene patenting adds a whole new dimension to the idea of property. The genes is your body no longer belong to you .They are now the private property of a big corporation. Gene patents give their owners property rights over gene sequences-for example in a diagnostic test, as a test for the efficacy of a new drug, or in the production of therapeutic proteins, While this does not quite boil down to the patent holders owning our genes … these rights exclude us from using our genes for those purposes that are covered in the patent [5] .Since the human gene is unknown and unexplored, patents are granted to the first discoverer.

II. Gene Patenting: The Concept

Under the U.S. Patent Law, the human genetic makeup can be patented. A patent now may be granted for a claim directed to an isolated and purified DNA molecule that is, a gene excised from a natural chromosome or a synthesized DNA molecule. The DNA molecules are treated like any other chemical and hence are eligible for a patent by the USPTO when they are when isolated from their natural state and purified or when synthesized in a laboratory from chemical starting materials An isolated DNA sequence can be patented in the same manner that a new medicine, purified from a plant, could be patented if an inventor identifies a new application [6] .

An isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because:

an excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature, or

synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound [7] .

III. The Rationale behind granting patents for Human Genes :

Proponents of gene patenting justify granting it on the grounds that DNA sequences "isolated and purified" from their natural state are "products of human ingenuity " and must be patentable because without the incentive of patents, there would be less investment in DNA research, and scientists might not disclose their new DNA products to the public [8] . Issuance of patents to such products not only results in the dissemination of technological information to the scientific community for use as a basis for further research, but also stimulates investment in the research, development, and commercialization of new biologics. It is only with the patenting of DNA technology that some companies, particularly small ones, can raise sufficient venture capital to bring beneficial products to the marketplace or fund further research [9] .

Private Companies argue that this incentive-oriented motivation would help to accomplish the Human Genome Project at a much faster rate, as entities seek to reap their rewards through patenting [10] .

Research firms also assert that, contrary to popular belief, patents help to keep information within the public purview because the public must make use of the patented product in order for the company to make a profit. If the firms cannot patent their discoveries, the argument continues, they will not be inclined to disclose their discoveries to the public and would instead hoard their findings [11] .

The USPTO justified granting of gene patents on the grounds that the US. Constitution [12] as well as the patent statute [13] permits granting of patents for discoveries [14] .

IV. Why Human Genes Ought not to be Patented?

The case against patenting human genes is a strong one. Some the reason why gene patenting is undesirable is discussed below.

1. Product of Nature

One of the strongest arguments against patenting of human genes is that it is a product of nature. Human genes are naturally occurring and are not creations of man and hence cannot be patented.It is absured that the genes and DNA which is an intrincic part of our body be made the subject matter of a patent.

The US Supreme Court's application of the 'product of nature' in 'Funk Bros. Seed Co. v. Kalo Inoculant Co.' [15] led it to determine that Kalo had failed to take an inventive step when it mixed bacteria to produce an improved fertilizer: "The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metal, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none".

Further, gene sequencing is not an invention, rather is a discovery.But The United States Patent and Trademark Office (USPTO) has rejected the claim that genes are discoveries rather than inventions [16] .

2. Requirements of Patents not satisfied

In order for an applicant to receive a patent, an invention must be useful, novel, and non-obvious [17] .


One major contention regarding patenting human genome sequences is the claim that partial gene sequences or Expressed Sequence Tags (ESTs) are neither novel, nor new. Researchers do not invent human genome sequences, but merely discover facets present in each cell of every human being [18] .It has also been argued that gene patents on partial sequences are not useful because they have no function on their own in that partial sequences do not code for any specific protein [19] .A patent ought not to be given for isolating a known naturally occurring substance.


The Supreme Court in Brenner v. Manson [20] held that in order to be patented, an item must have "substantial utility" or "confer a specific benefit" in its currently available form. Thus, granting patents for products with no known utility may confer power to block off whole areas of scientific development. Discoveries that have no use except for further experimentation, therefore, can not be patented [21] .Although the guidelines require that the application for a patent for a isolated gene must disclose a specific substantial and credible utility for the claimed isolated and purified gene ,often given the complexity of claim, this requirement is circumvented. Further, the patentee is required to disclose only one utility of the isolated gene. Therefore, once the patent is granted, the patent holder can restrict access to the patented claim thereby hindering research.

Since Gene Sequencing does not satisfy the requirements for novelty and utility , gene patenting should not permitted.

3. Common Heritage

Yet another argument against the patenting of human genes is it is part of the Common Heritage that belongs to whole of mankind and hence cannot be the subject of private property. A basic tenet of the Common Heritage principle is the emphasis placed on preserving the territory for future generations rather than focusing on economic interests [22] .

Traditionally the concept of common heritage has been applied in relation to deep sea beds, Antarctica the moon and other celestial bodies. But when applied to human genetics, it maintains that beyond the individual, the family, or the population, there is a common shared interest in the genetic heritage of mankind. Therefore, the Human Genome Project ( HGP) should benefit all humanity [23] .

The Common Heritage of Mankind principle is an international legal concept which conveys equal property interests to all people. The DNA structure that each person inherits is the result of millions of years of evolution, a natural process caused by human adaptation and development. Allowing private companies to own our genome is like allowing companies to own another part of the human body, such as an eye nose [24] .

Applying this definition to the HGP would result in the following determinations: 1) the genome could not be appropriated by any country or private corporation within that country; 2) all states would share responsibility for setting regulations and laws for permissible uses of the genome; 3) all states would share in the benefits derived from the HGP, which would mean that all gene sequences would be publicly accessible; 4) the genome would be reserved exclusively for peaceful use; and 5) the worldwide community would have a shared responsibility for preserving the genome intact for future generations [25] .

The Human Genome Organization (HUGO)has done considerable work in this area.

The Hugo Statement on the Principled Conduct of Genetic Research lays down four principles:

Recognition that the human genome is part of the common heritage of humanity

Adherence to international norms of human right

Respect for the values, traditions, culture, and integrity of participants

Acceptance and upholding of human dignity and freedom.

The HUGO Ethics Committee has given certain recommendations in connection with genetic research and gene patenting [26] .They are :

1) that all humanity share in, and have access to, the benefits of genetic research.

2) that benefits not be limited to those individuals who participated in such research.

3) that there be prior discussion with groups or communities on the issue of benefi sharing.

4) that even in the absence of profits, immediate health benefits as determined by community needs could be provided

5) that at a minimum, all research participants should receive information about general research outcomes and an indication of appreciation.

6) that profit-making entities dedicate a percentage (e.g. 1% - 3%) of their annual net profit to healthcare infrastructure and/or to humanitarian efforts.

The Common Heritage principle is the best method by which to balance the public's interest in keeping genome information freely accessible against private companies' interests in profiting from genome research. Privatizing genes is also a violation of the public trust doctrine.

4. Impediment in Advancement of Science and Technology :

The biggest danger of granting a gene patent is that it will hinder further research in the patented field. As one professor puts it "You can find dozens of ways to heat a room besides the Franklin stove, but there's only one gene to make human growth hormone [27] ."

By granting a patent for a gene, scientists will be burdened with patent infringement issues while researching in a particular field. Data sharing is the key to the future of genetic discoveries and bioinformatics, and gene patents impede research aimed at identifying the role of genes in medical conditions [28] .

A patent on a gene sequence prevents other researches from researching on the same gene without permission from the patent holder. Since the patent gives the patent holder the right to exclude others, it the prerogative of the patent holder to choose to whom a license may be granted. This would lead to two things :

Firstly, the patent holder may not grant a license and hence maintain his monopoly thereby restricting research. Secondly, the cost of research increases with the added licensing and legal fees.

The Myriad Genetics case is a prime example of gene patents hampering research. The corporation sent 'cease and desist' letters to many universities and research centers, herby stopping research on Breast Cancer since it involved isolated DNA encoding BRCA1 or BRCA2 whose patent Myriad owned.

According to Dr. Fiona Murray who received a grant to research the impact of gene patenting on scientific research and commercialization, 4382 of the 23,688 genes listed in the database of the National Center for Biotechnology Information - nearly 20% of human genes - are explicitly claimed as United States intellectual property. After devising a study to gauge the impact of gene patenting on public knowledge that utilized the time lag between publication of papers on a gene sequence and the issuance of a patent claiming that gene sequence, Dr. Murray concluded that the Myriad patents have negatively impacted the public knowledge of the BRCA1 and BRCA2 genes by 5-10% [29] .

Further, Myriad has withheld critical data concerning genetic predisposition to breast cancer from the Breast Cancer Information Core ("BIC"), an international, open access online database that is a central repository for information about the BRCA1/2 genes and their genetic variants [30] .

Therefore, clearly gene patenting instead of encouraging invention and fostering research is hampering and restricting research.

4. Other Ethical Issues

The biggest ethical question arises is how can the building blocks of life, the most important and integral part of the human body be patented. DNA present in every human being cannot be made private property of an individual or corporation.

Other fears expressed in connection with transgenic research are [31] (1) the rights of privacy of patients whose genetic make-up predicts a propensity to develop certain diseases; (2) discrimination on the basis of genetic heredity; and (3) a loss of human moral dignity. In addition, when the human genome map is complete, a person's genotype, which is highly revealing information, will be recorded and obtainable.

Public disclosure in a patent of a person's genetic information might constitute a badge of slavery because those having knowledge of the phenotype expressed by patented genetic material conceivably could anticipate how one possessing the phenotype would react to certain stimuli. The ability to predict and control responses through the selection of stimuli would limit the person's external and internal autonomy. However the link between behavior and DNA is anything but certain and it is unlikely that disclosure in a patent of genetic components would lead to control and subjugation of those who received patented genetic implants [32] .

V. A critical study of Association for Molecular Pathology Et. Al v. USPTO Et. Al

29th March 2010 proved to be doomsday for all biotechnology companies and research institutes that held patents on gene sequences. Judge Robert Sweet of New York District Court invalidated the patent of Myriad on the BRAC1 patent in the case of Association for Molecular Pathology Et. Al v. USPTO Et. Al [33] 

Facts of the Case

The case challenged the validity of the patents for isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequence and methods for "comparing" or "analyzing" BRCA1 and BRCA2 gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer granted to Myriad Genetics and the University of Utah Research Foundation. Mutations in the BRCA1/2 genes correlate with an increased risk of breast and ovarian cancer. Women with BRCA1 and BRCA2 mutations face up to an 85% cumulative risk of breast cancer, as well as up to a 50% cumulative risk of ovarian cancer. The existence of BRCA1/2 mutations is therefore an important consideration in the provision of clinical care for breast and/or ovarian cancer. A patient will not only learn of her risk for hereditary breast and ovarian cancer, but also can gain information that may be useful in determining prevention and treatment options. Myriad offers multiple forms of BRCA1/2 testing to the general public. Its standard test, called Comprehensive BRAC Analysis, originally only consisted of the full sequencing of the BRCA1/2 genes. But these tests are not only expensive but are also not covered by most insurance policies and are therefore not within the reach of many women who require the test.

A number of research centers have the resources and the expertise to offer the test at lower costs, but are stopped to the patent. Further, Myriad sent search and desist letters to a number researchers for infringing upon the patent in course of their research. Enraged by the activities of Myriad, a number of organizations such as Association for Molecular Pathology, College of American Pathologists, Breast Cancer Action came together and filed the present suit against Myriad

The decision:

The decision is a landmark judgment not only because of the outcome of the case but also because it is a summary judgment.

Patentable Subject Matter

The court referred to a series of decisions relating to patentable subject matter, the court reiterated that products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product [34] .The requirement is that the invention must be markedly different [35] . Something that is derived from product of nature must "possess a new or distinctive form, quality or property in order to become patentable subject matter [36] ."

The court held that " … the clear line of Supreme Court precedent establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess "markedly different characteristics" in order to satisfy the requirements of s. 101."

Myriad argued that isolated DNA molecules should be treated no differently from chemical compound for patent eligibility and also that the difference in structured and functional properties of isolated DNA rendered the claimed DNA patentable subject matter. According to Myriad, the invention claimed in its patents required the identification of the specific segments of chromosomes 17 and 13 that correlated with breast and ovarian cancer (BRCA1 and BRCA2) followed by the isolation of these sequences away from other genomic DNA and cellular components.

But the court rejected both the arguments. It held that DNA cannot be compared to a chemical compound because of its double nature: i.e on one had it is a chemical but on the other hand they are physical carriers of information. The proper comparison is between the claimed isolated DNA and the corresponding native DNA, and the presence or absence of chromosomal proteins merely constitutes a difference in purity that cannot serve to establish subject matter patentability. The court further observed that the identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent.

Invalidation of Patent Claims:

a) Thus, according to the court Myriad's claim on the isolated BRCA 1/2 DNA does not satisfy the requirement of "marked difference" of the isolated DNA from the naturally occurring DNA and hence was unpatentable subject matter.

b) The Method Claims are Invalid Under 35 U.S.C. s.101

One claim of the Myriad patent is directed to the process of "analyzing" a BRCA1 sequence and noting whether or not the specified naturally-occurring mutations exist. The claimed process is not limited to any particular method of analysis and does not specify any further action beyond the act of analyzing.

The Court applied the test of transformation in granting a process patent [37] .

Under this "machine or transformation" test, "[a] claimed process is surely patent-eligible under s.101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." In addition, "the use of a specific machine or transformation of an article must impose meaningful limits on the claim's scope to impart patent-eligibility," and "the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity [38] In other words, the transformation must be central to the purpose of the claimed process.

The court held that the myriad patent claim failed to satisfy this test. The method claims was essentially the identification of a predisposition to breast cancer based on "analyzing" or "comparing" BRCA1/2 gene sequences which is a mental process and thus fails to satisfy the transformation test. The court also invalidated the claim for comparing the growth rate of cells on similar grounds.


The Myriad decision is significant because it has invalidated a gene patent on the grounds of non patentable subject matter. All eyes are now directed to the Supreme Court where an appeal is expected to be filed soon.

One of the biggest problems created by Gene Patenting and also one of reasons for the myriad case is impediment in research. Clinical trials have been stopped and research and knowledge creation restricted. It is unlikely that gene patenting will be prohibited or that the existing patents would be withdrawn. A less drastic solution as compared to prohibiting gene patenting would be to allow research even on patented genes without the requirement of licensing. The advantages of this approach are two fold. Firstly, it will permit further research in the same field without patent infringement issues. Secondly, it will lower the cost of research since license and legal fees are reduced. This has been supported by HUGO. [39] It has suggested that a statutory research exemption be introduced on a universal basis irrespective of the final goal of the research.

To prevent monopoly, HUGO has suggested that a clearing house be established that would expedite the rapid and the low cost licensing of patented DNA sequences which have potential applications in clinical diagnosis. The presence of a clearing house would restrict the uncontrolled power of the patent holder to grant licenses and lead to increase in the number of licenses granted for research [40] .

Under Indian Law, life forms are not patentable. Section 3(j) specifically excludes life forms as patentable subject matter. While in the light of the decision of Diamond v.Chakrobarty , the non patentability of life forms under the Indian Patent Act may be questioned, gene patenting should not be permitted.