Patent Invention Value

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BUSINESS PLAN

PATENT AND IPR

INTRODUCTION

A patent is an exclusive right granted for an invention, which is a product or a process that provides a new way of doing something, or offers a new technical solution to a problem.

Since no empirical studies exist that can confirm the validity of the theoretical assumptions underlying the question of which factors determine an individual patent's value, we cannot quantify the effect of novelty, inventive activity, disclosure, and breadth on a patent's economic value.

The value of a single patent may depend on the overall portfolio to which the patent belongs. The value of a single patent may not only depend on the size of its surrounding portfolio, but also on the function the single patent serves within the portfolio.

Patents granted are of higher value than patents refused or withdrawn is the general assumption. Also, among granted patents those that are often cited, renewed for a longer period, and filed in several countries are assumed to be more valuable.

This does not contradict the view that the few patents with a huge private value designate a large number of countries for protection, but suggests that the size of the patent family does not relate linearly to the value of patents.

PATENT

NeurReCon has highly experienced and world renowned scientists working together to create a cure for the millions suffering from stroke every year by doing extensive research in stem cell technology. The company has been putting in a lot of resources and is looking for more investors to continue their on-going research on the cell line, CTX0E03 that they have obtained. The company is also proud of the successful results in the recent experiment on stroke models of rats that they used to assess the therapeutic effect of the cell line.

Title - Conditionally immortal clonal human stem cell line generated for stroke.

Claims:

The Invention claimed is:

A method for treating brain damage in a mammal, comprising administering pluripotent neural stem cells into the mammal's damaged brain, wherein administration is into the brain hemispheres containing the site of damage, wherein said pluripotent neural stem cells have been genetically modified to be conditionally immortal, wherein said pluripotent neural stem cells are immortal prior to administration, and wherein administration of said pluripotent neural stem cells improves said brain damage of the mammal.

The method, according to claim 1, wherein said pluripotent neural stem cells are from the CTX0E03 clonal cell line and the cell line is MHC Class II negative.

The method, according to claim 1, wherein said brain damage comprises cell loss caused by stroke.

The method, according to claim 1, wherein said pluripotent neural stem cells are administered to the right striatum of the brain, the primary site of damage.

The method, according to claim 1, wherein said pluripotent neural stem cells are also administered to the left striatum of the brain, the primary site of damage.

The method, according to claim 1, wherein the mammal is rat.

The method, according to claim 1, wherein the mammal is rat, and wherein said pluripotent neural stem cells are human cells.

The method, according to claim 7, wherein the said human cells are human somatic cells.

The method, according to claim 1, wherein the pluripotent neural stem cells are genetically modified with c-mycER TAM transgene.

The method, according to claim 1, wherein the pluripotent neural stem cells that are genetically modified with c-mycER TAM transgene are conditionally immortal.

The method, according to claim 1, wherein the administration of said pluripotent neural stem cells improves said brain damage of the mammal by significant improvement in sensorimotor function.

The method, according to claim 1, wherein the administration of said pluripotent neural stem cells improves said brain damage of the mammal by significant improvement in gross motor asymmetry.

PRIOR ART

NeurReCon has derived the cell line, CTX0E03, under good manufacturing conditions (GMP) and that has allowed the cell line to be developed for clinical purposes for therapy for stroke patients. The in vivo study does not show any proliferation of cells suggesting that the cells are not tumorigenic. The delayed grafting of this human stem cell line promotes recovery in the motor asymmetry and the sensorimotor functions.

Many different techniques have been developed to provide suitable cells for transplantation. With regard to neural transplantation, our approach has been to maintain undifferentiated fetal cells under appropriate culture conditions until transplantation in the patient. Once the cells are injected, the cells will show differentiation changes into astrocytes and neurons.

Reynolds and Weiss, discloses the use of epidermal growth factor (EGF) to induce in vitro proliferation of adult mouse brain cells. Also, International Patent No. WO-A-94/16059 discloses a technique for maintaining a primary neuronal cell culture in-vitro in a serum free media.

Similar to our finding is the patent no WO-A-97/10329 which discloses the technique of conditionally immortalising cell line and administration into the undamaged area of the brain. Also the cells were derived from an H-2K b-tsA58 transgenic mouse, whereas our findings were done on MCAo rats.

Since, the use of conditionally immortal gene technology proved to show better results as the cell line comprises of an immortalising temperature- sensitive oncogene which maintains the cells to remain in the undifferentiated state and only upon transplantation the cells differentiate into the cell types required to repair the damage in the brain.

All the previous findings have led us to mention that even though the cells migrate to the site of damage when transplanted into the brain, the extensive damage caused by stroke there is no certain results showing that the areas of infarction would provide a sufficiently well vascualrised matrix to support the survival of grafted cells.

The incorporation of the c-mycER TAM transgene technology used for conditional immortalization along with the injection of pluripotent human neural stem cells has been done for the first time; we do not infringe any patent that claims to have this kind of incorporated technology.

FREEDOM TO OPERATE

Since no other findings concentrate on the incorporated approach we have chosen, the freedom to operate this kind of approach was not inhibited. The use of the c-mycER TAM technology that we have used is done by becoming the licensee for the technology that the Imperial Cancer Research Technology, UK has developed.

Plasmid DNA (pBabe-puro-mycERTM) encodes the myc-ERTAM sequence that is cloned into the retroviral vector pLNCX-2 developed by Clontech. The MMLV type retrovirus encoding the mycERTAM gene was generated using the TEFLY-A type virus packaging. Since the TEFLY-A cells were manufactured to cGMP standards, CTX0E03 is the first clinical grade approved cell line used for treatment in stroke.

NeurReCon is a licensee holder for this particular technology that helps them maintain cells in the pluripotent state until transplantation. This way of conditional immortalization of cell lines has offered new research possibilities. The company pays the Imperial Cancer Research a total of 9% of the revenue generated every year. The company plans to pay off the remaining sum once more investors associate with NeurReCon that will allow the company to do more fundamental and functional research in developing more GMP approved cell lines.

Being the exclusive license partner with the Imperial Cancer Research Technology, any improvements in the patented technology does not allow NeurReCon to patent or obtain a royalty fee. Also, it completely depends on the parent company (Cancer Research) whether to sub-license it to other companies and research institutes.

Therefore, the safe development and process technology allows NeurReCon to continue its research development in cell therapy for stroke. The company believes in a strong IP position which they will expand with the buying-out of exclusive licenses such as these and others as well that will allow the company to be accredited with more valuable technologies in the stem cell industry.

CONCLUSION

Patents can be used as a means of exchange technology with competitors.

Some of the main motives of patenting are triggered by negotiation considerations. It allows companies to enter cross-licensing negotiations which are inevitable prerequisites for the survival of a company within the biotechnology sector. A patent may grant its owner a very limited right to exclusively use a certain form of his invention or it may award him/her a more general right covering a variety of different realizations of his/her invention.

Patents also provide incentives to individuals by offering them recognition for their creativity and material reward for their marketable inventions. These incentives encourage innovation, which assures that the quality of human life is continuously enhanced. Innovation is carried out to make profits on the introduction of new products. If innovation is a principal engine of growth and companies innovate to capture or hold a share of the market they would not retain otherwise, then perhaps protection of intellectual property might boost long-run growth.

For example, if individuals only innovate to capture or hold a share of market, they may not increase their rate of innovation with stronger intellectual property rights when their share of the market is already guaranteed. Indeed, it is found that stronger intellectual property rights protection may not provide a stimulus to innovation in countries that are highly protected from international trade. In contrast, open trade regimes that are more likely to face competition from foreign producers that use the latest technology exhibit a stronger linkage between intellectual property protection and innovation.

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