Property Rights to the Cancer Genes

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Table of Contents

Abstract
Introduction
Overview of BRCA1 and BRCA1 genes
Pros
Cons
Moral and Philosophical Arguments
Discussion
Conclusion
References

Abstract

Patenting of the BRCA1 and BRCA 2 is a venture that the Patenting Office should assess. Control of the genes and the ethical questions that they raise have been contentious concerns. The patenting authority has the discretion not to patent. The Myriad Genetics Company has been unfairly advantaged over other companies that are willing to conduct research in cancer genes. The ethical questions presented in the case will be resolved to the best interest of the public.

Introduction

Patents protection in the United States has taken a new direction with the innovation of drugs. Substantial control has been enhanced throughout the world and is more specific in the area of patents. Massive protection of inventions has been ensured under the United Nations treaties. This has been under consistent attack by those who oppose the protection of essential drugs. The World Intellectual Property Organization has spearheaded the protection.

The easiest way to understand the protection of patents and the rationale behind them is by appreciating the fact that patents are part of human rights (ACLU, 2012b). Numerous companies in the United States have sought protection for the generic patentability of BRCA1 and BRCA2. The Myriad Genetics Company has maintained that it is entitled to patents of certain procedures related to the cancer genes (Copyright Trademark Patent, n.d.)

Overview of BRCA1 and BRCA1 genes

BRCA1 and BRCA2 are gene mutations in the human genome that are responsible for causing breast cancer and ovarian cancer in some instances. BRCA1 and BRCA 2 mutations are usually deletions. These genes are mainly hereditary, thus incidences of these genes are found along the family line. An increase in age is also a determinant factor for the presence of these genes, especially the mutations that lead to invasive ovarian cancer (Zhang et al., 2011).

The Discovery of BRCA1 and BRCA2 was important since it enhanced the development of targeted treatment for breast and invasive ovarian cancers. Researchers are looking at the possibility of developing treatments that target these mutations. It, therefore, means that companies that may get exclusive rights to the study of these genes will exclude other research companies and individuals from studying the genes, thus delaying the quick discovery of solutions to ovarian and breast cancers.

Pros

The arguments in the Supreme Court have demonstrated levels of divisions in the legal position in answering the moral question. Some support the companies having a monopoly on the genes. Their main arguments have been based on the fact that once companies patent genes they can use them without any competition. This means that the said companies will not be concerned about other companies making discoveries along that line. This argument is advocated by smaller companies that do not have the financial power to match the competition. The unlikely event that may be caused by such a monopoly is that when bigger companies have the monopoly, smaller companies will not be able to utilize the discovery (Wartburg & Julian, 1999).

Secondly, encouragement of research in the private sector has been inevitable. Companies are investing in research bearing in mind that once they get a breakthrough their discovery will be protected. Protection of patents is an incentive that research companies have taken seriously (Chuang & Lau, 2010). Research has become a business and the beneficiaries are companies. Invention and innovation have been supported by allowing companies to have the rights to gene sequences.

The need to be in control of a specific discovery has led companies to invest heavily and employ staff to push the creative agenda to obtain a patent. At the end of the registration of a patent, a company may choose to invest in the patent, thus promoting research and development. It, therefore, means that financial support is offered to areas that would have been deserted if there were no monetary considerations. Research control has shifted from being government-controlled to companies’ control.

It was hard to think of quality research being offered by a company. Patenting has opened up the opportunity to interested parties; hence many private institutions are taking a lot of research interest. Patenting biotechnology has been the last part of the venture of private companies and individuals. Venture capital firms have taken the incentive given in patents seriously, thus encouraging new methods of conducting research. It has been through quality research that major companies have come up with inventions. The research has been broadened to incorporate key players at a collaborative point (Tagliaferro, 2010).

It has become easy to have many companies working on the same type of research since the processes can be shared. Patenting has been made easy in the essence that one company may own rights of a certain step, while the other company holds exclusive rights to another one. It, therefore, follows that companies are called upon to maintain elaborate coordination to arrive at the end product that benefits the entire public. The hindrance caused by restricting companies from holding certain types of patents may be devastating (Suzuki & Peter, 1990). The process of coming up with a patent is long and takes up resources, thus it is important to consider the benefits associated with patents.

Cons

Equally, it should be observed that many disadvantages come along with the benefits mentioned. There is a forced specialization that acts as a way of creating fear of infringement to those who do not seek permission before they use the patent. There is a continued waste of resources through litigation by those who seek infringement damages. Injunctions granted may hinder the utilization of the patent right. The result is that the cost of drugs will be raised. The companies under the control of the rights may choose to bar other people from using their patents. The license to use the patent may be highly monetized to the extent that it will discourage the smaller companies from venturing into the research (Lohr, 1990).

Another disadvantage of patents is that they hinder research. Since the patent right offers a duration of seventeen to twenty years, the patenting of the genome sequence may act as a hindrance for the next twenty years. For instance, the patenting of the BRCA1 and BRCA2 gene variants may present a situation whereby Myriad Genetics will have a monopoly, thus preventing other companies from using the genes. The fact that the company has exclusive rights to conduct diagnostic tests means that other companies will either get a license or wait for the duration of protection to lapse (Chuang & Lau, 2010).

It, therefore, means that Myriad Genetics Company is better placed to develop research on the genes than any other company. It implies that if the company chooses not to use the research for the development of the genes, the public will not get to benefit from the genes. The potential to develop the genes will not be realized since the company may capitalize on making profits out of using the genes. A secretive culture may be fostered in the research companies. This means that the companies’ indoor management will try to prevent other interested parties indirectly (Grace, 1997).

If a company holds a gene patent, it will not be possible for results to be achieved. The rights to the gene rest on the company and it becomes extremely hard to jump all the bureaucracies to exploit the advancement of the medical results (Micklos & Greg, 2002). In a case that concerns a disease such as cancer, the patent issuing authorities should limit the scope of protection. The patent issuing authorities create a reversionary clause to limit protection to medical substances that are to the benefit of the public.

Research has been commercialized, and the regulating bodies should step in to provide an elaborate way of how the protection should be handled. The world’s intellectual property regulating body should be allowed to step in and do away with any form of protection that is contrary to public policy. The World Intellectual Property Organization has to come up with ways to interfere with states’ protection to let other parties develop the genes. Without such strategies, powerful companies will continue having a monopoly of the patents.

It has been a battle of control between small companies and relatively financially powerful companies. The Myriad Genetics Company falls in the class of a powerful company that has got of the patent right which the entire world desires to use to further research. In terms of research, it is unethical to leave the patent in the hands of financially powerful companies only. It is practically impossible to have small companies get their way through to the top of the research discovery (Speaker et al., 1993).

Moral and Philosophical Arguments

The position of patentability in Europe is different. In Europe, human genes sequences are patentable. This is based on the reasoning that extra human effort is required to purify them. The human genes patentability has for some time been thought to be settled. The courts of law have shown a critical issue that was not yet settled as regards patents. Myriads Genetics has considered the decision as infringing on their rights since it owns BRCA1 and BRCA2, which are human.

The genes are linked to ovarian and breast cancer, which is an alarming disease to many human beings. Since Myriad Genetics are the patent owners, it means that they can prevent any other party that seeks to use the genes without its permission (ACLU, n.d.). Many issues and ethical reasons are arising from the fact that the company got the patent and can prevent other people from using the genes for diagnostic and therapeutic applications (Chuang & Lau, 2010). The company may opt to license its rights to other companies and individuals. The charging bit by the company may be misused by the company to overcharge. This will ideally mean that the company will overcharge.

The overcharging part can be an effective way of discouraging other companies from using the patent. There are many implications brought about by the monopoly of patents on medicine. The prohibition has the effect of hindering further research, whereby the potential researchers will be limited. The philosophical reasoning is that human dignity should be prevented from any form of patent. The inalienable right should prevent ownership of any person’s part of the body. Some critics have argued that the healthcare sector should not allow patenting of diagnostic tests (Flynne, 2008).

Discussion

Things that are considered medically necessary should be prevented from any form of patentability. Since the Myriad Genetics Company is given a monopoly, the focus will be on maximizing profits rather than health purposes. The restrictive nature of the owner of the patent has led to the deterioration of health care. Such patent protection may lead to an inflation of patents rights (Chuang & Lau, 2010). In assessing the protection offered under intellectual property, it is imperative to note that an invention is designed to benefit many people. The registration of a patent should not be to hinder further research that is to the benefit of the public.

Public policy dictates that individuals with patents touching the health line should be limited. This is to enhance further research without the fear of being sued. The case has been different in situations whereby powerful companies such as Myriad Genetics own the patent. The public has not been able to benefit since the price for the patent has been hiked in favor of fellow powerful companies. The event is disastrous and the registration of the patent’s office should have anticipated such an occurrence.

The debate on patenting in the United States has taken a new turn. Cases have been filed in court to challenge the patentability of some steps. The proponents of the debates have employed the moral aspect when seeking courts indulgence. There was an unanticipated impact on the possible patenting of the gene-based medical therapies. Biotechnology companies have opined that the rejection to patent gene-based products should be considered with a lot of care (ACLU, n.d.).

However, much of the legal debates have been based on the patents’ doctrines. The legal arguments have not taken time to consider the significant policy aspects raised by patenting such products. It is, therefore, imperative to access the healthcare issues, scientific and ethical issues raised by the patients. Patents have had the effect of giving the owners exclusive rights to an innovation (ACLU, 2012a). A specific duration of time is stated once the patent’s rights have been registered. There are certain requisites that one must fulfill before a patent right is issued. There are things expressly excluded from protection. They include physical phenomena and abstract ideas (Euro Abstracts, 1989).

Conclusion

The decision on whether research should be reserved in the hands of powerful companies remains a hard puzzle to the patent issuing authorities. In the public policy interest, it has to be remembered that medical-related research should be let to develop. The debate on monopoly has become a hard one to come up with a final say on the topic. Since the domain of patents law is evolving fast, the stringent measures on patents should be ignored for some time.

The law should not be imposing restrictions to rendering the smaller companies unable to make research. Allowing every individual to use the patents is important in enhancing discovery. It has been observed that by patenting, the companies in the private sector will be allowed to compete. The competition is healthy and has many other advantages. The benefits should be assessed in a way that they do not outweigh the aim of the research.

References

ACLU. (2012a). ACLU and PUBPAT ask Supreme Court to rule that patents on breast cancer genes are invalid. Web.

ACLU. (n.d.). Association for Molecular Pathology v. Myriad Genetics. Web.

ACLU. (2012b). Supreme Court to hear case challenging patents on breast and ovarian cancer genes. Web.

Chuang, C. S., & Lau, D. T. (2010). The pros and cons of gene patents. Publications. Paper 170. Web.

Euro Abstracts. (1989). Euro Abstracts: The Abstracting Journal of Scientific and Technical Publications of the Commission of the European Communities. Luxembourg: Commission of the European Communities, DG XIII Telecommunications, Information Industries and Innovation, in association with ECOTEC Research and Consulting.

Flynne, W. G. (2008). Biotechnology and bioengineering. New York, NY: Nova Science Publishers.

Grace, E. S. (1997). Biotechnology unzipped: Promises & realities. Washington, D.C: Joseph Henry Press.

Lohr, K. N. (1990). Breast cancer: Setting priorities for effectiveness research. Report of a study by a Committee of the Institute of Medicine, Division of Health Care Services. Washington, D.C: National Academy Press, 1990. Print.

Micklos, D. A., & Greg, A. F. (2002). DNA science: A first course. New York, NY: Cold Spring Harbor Laboratory Press.

Speaker, S., Lindee, S., & Elizabeth, H. (1993). A guide to the Human Genome Project: Technologies, people, and institutions. Philadelphia, PA: Chemical Heritage Foundation.

Suzuki, D. T., & Peter, K. (1990). Genethics: The ethics of engineering life. Cambridge, MA: Harvard University Press.

Tagliaferro, L. (2010). Genetic engineering: Modern progress or future peril? Minneapolis, MN: Twenty-First Century Books.

Wartburg, W. P., & Julian, L. (1999). Gene technology and social acceptance. Lanham, MD: Univ. Press of America.

Zhang, S., Royer, R., Li, S., McLauglin, J. R., & Rosen, B. et al. (2011). Frequencies of BRCA1 and BRCA2 mutations among 1,342 unselected patients with invasive ovarian cancer. Gynecologic Oncology 121, 353–357.

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