Life Sciences

Gene Patents: Sequencing Scientific Controversy

Do you have the rights to your own DNA?  A question Genae Girard never considered until she was denied that right.  How can someone else own your DNA?  Current models estimate that as much as 20% of all human genetic material has been patented [1].  Recently this practice has entered the national spotlight with the landmark case Association for Molecular Pathology, et al. v. United State Patent and Trademark Office, et al.  In this case the American Civil Liberties Union (ACLU) organized six cancer patients including Genae Girard, professional organizations of pathologists and several individual genetic researchers to file suit against the United States Patent and Trademark Office (USPTO) and Myriad Genetics, a Utah-based genetic testing company [2, 3].  The prosecution argues that Myriad’s patents on two human genes, BRCA1 and BRCA 2, associated with breast and ovarian cancer mar the progress of a cure as well as prevent women from receiving their full medical care.  For Genae Girard, after receiving a positive test for a BRCA mutation, she could not receive a second opinion since Myriad owns the sole rights to the BRCA testing [3].  In response to the case, Myriad defends gene patenting, asserting that patents provide financial security to the research and development industry which undoubtedly aids society.

Gene patenting is a broad term referring to the patenting of either a process that involves isolation of DNA or a chemical substance related to DNA.  This controversy first surfaced in the public arena in the spring of 2000, when the scientific world entered a ground breaking phase.  Two independent organizations announced that they had successfully mapped the human genome.  The Human Genome Project, as it is known, has redefined the capabilities of scientific research.  With such a vast array of information at scientists’ fingertips, the potential discoveries were endless.  However, shortly thereafter, private and public organizations submitted a deluge of patent requests for genes and small pieces of gene sequences [4].  Thus, a new issue of intellectual property over public health plagued the scientific and legal communities.

Early criticism of gene patenting revolved around the basic principles of obtaining patents.  A patent grants the right to exclude others from making, using, and selling the invention for a limited term of 20 years [5].  The USPTO judges a patent application on four criteria.  In order to be patentable, an invention must be useful, novel, non-obvious, and have an intended use.  In other words, the invention must be practical, original, not easily reproduced by someone trained in the relevant area [5], and the inventor must detail the creation and intended use of the invention.  Based on these conditions, physical products of nature are not patentable.  Logic implies that because scientists have only isolated something that already exists in nature, they have therefore not directly invented or produced anything.  However, patent applicants have asserted that since the DNA or genes that they wish to patent have been isolated from cDNA, complementary DNA, which does not naturally occur in nature, and rather it is a product of the laboratory, such genes are patentable.  In fact, intellectual property of genetic information dates back to the 1980 Supreme Court case Diamond v. Chakrabarty. The Supreme Court ruled that genetically engineered bacteria could be patented [4].  As a result, companies perceived lab-altered genetic material as intellectual property, in turn, the USPTO began granting patents for isolated segments of human genes and related genetic testing.

By gaining a gene patent, companies reserve the sole right to pursue research and development surrounding that specific genetic sequence.  Such monopolies of gene sequence research essentially translate into total control of gene function and disease related-research such as treatment development, and detection of malignant genes.  Thus, gene patenting extends far beyond a nucleotide code and stretches into the public health arena.

Supporters of gene patenting believe that it fuels scientific research and development.  They claim that because researchers are rewarded for their discoveries with patents, the royalty money can be used to further support their research. In addition, they assert that monopolies of certain genes prevent the waste of funds and effort [6].  Finally, because the USPTO requires a detailed explanation of the invention so that it could be made and used by others, the scientific community’s knowledge is increased.  Many say that without patents, scientists would resort to secrecy in order to ensure sole access to a new product or discovery.  With patents, however, all information is open and shared throughout the world.  The argument for gene patenting is also derived from facts about commercial patents.  Normally post-invention development costs are significantly greater than pre-invention research costs.  Based on this principle, organizations become reluctant and even unwilling to make substantial investment without protection from competition [4].  Companies therefore, tend to pursue research and development if they perceive a high probability of a profitable return.  Gene patenting provides the framework for such quasi-guaranteed successful turnout. Henceforth by eliminating the scientific competition, companies feel comfortable investing in research and development and thus gene patenting propagates scientific discovery. Patents thus protect the financial investments of companies.  In general, patents are generally considered to be very positive and many believe gene patenting to be no different.

There are however, many opponents to gene patenting. Critics say that patenting such discoveries is inappropriate because it places undue control over the commercial fruits of genome research [6].  In fact many patents actually grant companies the rights to future mutations discovered on a gene [8].  Similarly, companies often patent multiple parts of a genome sequence, such as a gene fragment, the gene, and the protein.  This patent ‘stacking’ puts financial strain upon researchers and allows patent holders to monopolize certain genes [9].  Other scientists examining the gene must then pay the patent holder for each patent, while just utilizing the one genomic sequence. This limits the research potential for scientists and thus the development of new innovations. They believe that science will advance more rapidly with an unlimited exchange of research ideas, in essence without patents.  Scientists are contrastingly swayed by the law of intellectual property which states that without exclusive rights no one will be willing to invest in research and development [4].  Gene patenting also directly affects individuals outside of the scientific field.  If scientists need to pay more to perform research, their eventual findings and inventions will cost more as well.  Thus the cost of pharmaceuticals, biotechnology, and other science discoveries will increase dramatically [9].

Gene patenting actually extends far beyond the DNA itself.  As disease genes are identified, gene tests are then developed to screen for the gene in humans who may be at risk for that disease.  Such tests are eligible and usually become patented by the gene patent holder.  Royalties must therefore be paid to patent holder each time the tests are administered.  Gene patents can make genetic testing prohibitively expensive and thus unavailable to deserving patients [4].  This argument has come to fruition with the Association for Molecular Pathology, et al. v. United State Patent and Trademark Office, et al. case.  Women, with a family history of breast and ovarian cancer, often undergo genetic testing for cancer-related mutations in the BRCA gene to determine their risk of developing those diseases.  This invaluable information helps women decide on a plan of action be it increased observation or preventive mastectomies or ovaries removal [7].  However, Myriad’s gene patents give the company the exclusive right to perform BRCA genetic testing.  Several negative consequences for patients ensue: many women cannot afford the $3,000 or more Myriad charges for the test; patients are prevented from getting second opinions on their test results, such as with Genae Girard; and patients whose tests come back with inconclusive results, do not have the option to seek additional testing elsewhere [8].  As Sandra Park, staff attorney with the ACLU, said “The patents on the BRCA genes block women’s access to medical information necessary for making vital health care decisions, impeding their control over their own bodies.” [8] This lawsuit combines patent law, medical science, breast cancer activism and an unusual civil liberties argument in ways that have made it a landmark case. [3].

On March 29, 2010, Judge Robert Sweet ruled against Myriad Genetics.  Stating that Myriad’s patents did not display “markedly different characteristics from what is found in nature” [11], his verdict invalidated many of those patents.  Yet despite this ruling, the United States continues to grant gene patents.  Most recently, Myriad Genetics has obtained a new gene patent for the pancreatic cancer gene, PALB2. [12]

The limiting nature of gene patenting threatens to place the United States behind other countries.  Rulings in 2004 by the European Patent Office eliminated U.S. patent jurisdiction in Europe.  Now while U.S. scientists are forced to pay fines or stop research altogether, other researchers around the world have free access to the patent information, via internet databases, and can examine them without any penalties [10].  While the future of gene patenting in the United States remains uncertain, the European Union has recently taken decisive steps limiting the propagation of gene patents.  In the European Union, the question of gene patents’ originality and inventiveness has prompted many to support a decrease in the number of gene patents [10].

In conclusion, the dilemma over issuing patents for genetic reasoning is an uncharted territory.  The unrequited question remains is genetic discovery novel or is it simply the uncovering of that which already exists in nature.  The direction that the US has taken in comparison to the European Union serves as a call to arms for scientists opposing gene patents. They cite the EU as a pioneer in unrestricted scientific communication and the recent ruling against Myriad Genetics as ignition for their cause.  Additionally, gene patenting raises a moral issue; many believe that gene patent holders, despite the USPTO’s ruling, are actually being allowed to patent a part of nature.  In contrast, many argue that without gene patents scientific progress would stagnate because companies would no longer feel confident investing in an unguaranteed endeavor [8].  Such a dichotomy within the hearts and minds of scientists creates the friction evident in the gene patenting controversy.  This division has left the world wondering which direction the United States will take in the gene patenting quandary.  The question to ask is what takes precedence intellectual property or public health?

References:

[1] Department of Health & Human Services. U.S. System of Oversight of Genetic Testing: A Response to the Chanrge of the Secretary of Health and Human Services Report of the Secretary’s Advisory Committee on Genetics, Health, and Society. National Institute of Health. April 2008

[2] J. Mullin. Lawsuit Looks to ‘Take Down’ Patents on Human Genes. IP Law & Business. May 15, 2009.

[3] J. Schwartz. Cancer Patients Challenge the Patenting of a Gene. The New York Times. May 12, 2009.

[4] C. Dummer. Genetics and Patenting. Human Genome Project Information. 29 Aug. 2006. <http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml>.

[5] American Medical Association. Guidelines: Gene Patents. AMA: Helping Doctors Help Patients. 19 Feb. 2008. <http://www.ama-assn.org/ama/pub/category/3607.html>.

[6] “‘Owning’ Genes: The Debate Over Patents (sidebar).” Issues & Controversies On File28 Apr. 2000. Issues & Controversies. Facts On File News Services. <http://www.2facts.com>.

[7] National Cancer Institute. BRCA1 and BRCA2: Cancer Risk and Genetic Testing. <www.cancer.gov>.

[8] American Civil Liberties Union. Gene Patents Stifle Patient Access to Medical Care and Critical Research. May 12, 2009. <www.aclu.org>.

[9]  American Medical Association. Gene patenting. AMA: Helping Doctors Help Patients. 17 Mar. 2008. <http://www.ama-assn.org/ama/pub/category/2314.html>.

[10] A. Coghlan. Europe revokes controversial gene patent, New Scientist (19 May 2004).

[11] A. Kesselheim. M. Mello. Gene Patenting — Is the Pendulum Swinging Back? The New England Journal of Medicine. April 7, 2010.

[12] S. Barton. Myriad Genetics Acquires Exclusive Rights to Pancreatic Cancer Gene Patents From Johns Hopkins. Myriad Genetics Announcements. October 15, 2009.

By Timothy Buckey and Marie Smithgall of Georgetown University. Follow The Triple Helix Online on Twitter & join us on Facebook

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