PATENTS IN BIOTECHNOLOGY OR PHARMACEUTICALS ARE NOT IN THE INTEREST OF THE MAJORITY

Published Sept. 12, 2019, 11:45 a.m. by Moderator


Introduction


Patents in biotechnology have never been in the interest of the majority. They only serve the commercial interests of corporations. This argument was vindicated by the United States Supreme Court on June 13, 2013 which ruled that just because a scientist has isolated a DNA component, it essentially doesn’t make it the sole property of an entity or individual (Simoncelli and Park 2013, pg. 106) and thus rendering Myriad Genetics’ patents over BRAC1 and BRAC2 invalid. This was after the American Civil Liberties Union Women’s Rights Project challenged the patents held by Myriad Genetics. This was hailed as a victory for women, researchers and a great boon for the future of medical research. This was the culmination of a 4 year legal battle.


The United States Patent Office (USPTO) issued the first DNA patent to the University of California in 1982. This triggered a scramble for DNA patents with various groups of scientists acquiring patents for any genes they discovered. In 1991, the National Institutes of Health (NIH) attempted to patent 350 DNA components which was a measure to protect the rights of the citizens and also to prevent the arbitrary patenting by money-hungry corporations. This was rejected by the USPTO.


In 1992, the United States Department of Health and Human services withdrew National Institutes of Health’s provision allowing it to acquire patents. By 1996 the USPTO had over half a million pending DNA patents (Simoncelli and Park 2013, pg. 108). In 1999, the USPTO watered the utilitarian requirement ensuring that corporations could now patent even DNA components that they did not really fully understand. DNA patenting became speculative and corporations acquired patents hoping to profit from them in the future as new medical discoveries are made. The corporations only care about profits. Expensive drugs and medical procedures are not in the interest of the majority of patients who required these lifesaving drugs at an affordable cost and to scientists and academics DNA exclusivity hampers scientific innovation.


How Patenting Works?


Robert Cooke-Deegan and Christopher Heaney describe patents as government issued documents that give individuals or entities the right to deny others the utilization, enjoyment, modification, and commercialisation of an invention as stated in the patent document (Cooke-Deegan and Heaney 2010, 384). The issuance of a patent is protected by law and any infringement is subject to a court process that can lead to imprisonment and/or financial penalties. Patent laws are generally uniform across the globe but might differ in terms of procedural rules country by country. For patents to be issued they have to meet three requirements. First, the invention has to be an original creation, second it has to be non-obvious (not easily understood) and thirdly it has to have a utilitarian component to it (Cooke-Deegan and Heaney 2010, 384). In addition to the three requirements, the inventor has to submit a detailed written manual of how the inventions works. The written instructions should be clear that a person with limited knowledge on its usage can learn quickly and use it.Patents are granted by governments to enable the inventor to recoup their investment up to a specified period of time.


After submission, the patent will be subject to a process of examination to determine that it meets the threshold. However this process of examination varies in different jurisdictions leading to different interpretations. This is more common in the field of biotechnology. For example the United States issues more DNA patents than Japan and Europe. DNA.The United States issuesanalogous patents that cover wide areas while the European Union and Japan issue narrow patents that cover testing in breast and ovarian cancer.DNA Patents are also issued much faster in the United States compared to Europe and Japan(Cooke-Deegan and Heaney 2010, 385). Disputes usually arise between scientists and in the United States, the patent usually goes to the first inventor, in their case the first person to formally request for a patent. Disputes are settled through an interference process which decides the priority of the invention. In the case ofthe United States the patent law identifies the inventor as the ‘first person to invent’  which is different from the rest of the world where the inventor is the ‘first person to file’ (Cooke-Deegan and Heaney 2010, 385).


Majority of DNA patents usually go through the interference process which involves settling out arising patent disputes. According to Robert Cooke-Deegan and Christopher Heaney DNA patents are twice as likely to end up in adjudication compared to other patents (Cooke-Deegan and Heaney 2010, 385). United States usually gives inventors a one year grace period before making the information public. This is to ensure that patent claims in other jurisdictions are not rejected based on the ‘principle of public disclosure’. In an attempt to harmonize patenting rules across different jurisdictions world governments signed The Patent Cooperation Treaty of 1970. In 1973, the European Union established the European Patent Office (EPO) to issue patents accepted by all member countries (Wagner and Wakeman 2016, 1091).  In 1976, African countries established the African Regional Intellectual Property Organization to oversee their patenting process. In 1995, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) treaty obligated member countries to adopt a model of strong patent protection (Cooke-Deegan and Heaney 2010, 385) and this included medical inventions such as lifesaving drugs. This was the beginning of biotechnology patenting. In 1998, the Europe Union issued the Biotechnology Directive to all its member that permitted the patenting of genes. All member countries were required to comply with the law despite opposition from some members. The European patent law is stricter compared to the United States and requires patentees that the patent claim has to explain the functions of the protein and its industrial application (Malerba and Orsenigo 2015, 665). To appease moral objectors the European Union included a clause that gives them the right to deny patent claims based on moral grounds. It also includes a provision known as opposition which allows it to challenge a patent after it has been issued (Cooke-Deegan and Heaney 2010, 386). However these provisions are only applicable in member states. The United States does not have a provision to challenge issued patents. There is need for the United States to reform its patent legislation to align it with the rest of the world.


Arguments against DNA patenting


The main argument against DNA patenting by biotechnology companies is the “creation” of a monopoly that has negative consequences for public health. According to Cooke-Deegan and Heaney the majority of DNA patents are owned by a few institutions and companies (Cooke-Deegan and Heaney 2010, 386).  The list includes universities, research institutes, hospitals, the United States government, pharmaceutical companies and biotech firms. Biotechnology firms also hold substantial number of patents that are exclusively for profit and this raises the moral issue of corporations profiting from sick people. Bonnie Chojnacki and Ronald F. White write in their report that at least 63% of all DNA patents issued are held by private firms (for profit) and 28% are held by academic institutions (non-profit); the leading patent holder in gene patents is Incyte Corporation which holds around 2000 patents (Chojnacki and White 2013, 276).  Incyte Corporation, Myriad Genetics, Isis Pharmaceuticals and Celera Genomics hold most of the DNA patents some of which like the BRAC1 and BRAC2 have proven to be essential in prevention of breast cancer. Opponents of DNA patenting had argued for decades that it was unethical to patent parts of the human body and patenting limits the scope of any scientific research (Gold and Carbone 2010, S39). Speculative patenting deviates from the original social purpose of patents which was to promote research and innovation. Patenting had been a way for researchers and innovators to recover their investments on the event that their research proved to be valuable in solving a specific problem (Cockburn and Long 2015, 7). When the USPTO loosened the ‘utility’ requirement it became a conduit for corporations to commercialize health care making it the preserve of the rich and poor.


A good example of profit over public healthcare is exemplified by Myriad Genetics that held the patents for two genes BRCA1 (Breast Cancer 1) and BRCA2 (Breast Cancer 2) that are important in detecting a patient’s prevalence to breast or ovarian cancer (So and Joly 2013, 98). Myriad Genetics monopolistic approach to research in breast and ovarian cancer has been the subject of heated debate in the United States, the European Union and the rest of the world. In 1997 Myriad Genetics acquired all patents associated with BRCA1 and BRCA2 including associated mutations and diagnostic tests (So and Joly 2013, 98-99). In 2001 Myriad acquired its Canadian patents. It proceeded to send out cease and desist letters to Canadian laboratories insisting that all BRCA1and BRCA2 diagnostic tests should be done through Myriad or its licensed affiliate MDS Laboratories. The switch to Myriad technology would have increased the cost of the diagnostic test from $1200 CAD to $3800 CAD, a whopping $2600 CAD profit for Myriad Genetics (So and Joly 2013, 100).


The second argument against DNA patenting is that it stifles medical research and innovation. The DNA patents that Myriad Genetics acquired essentially locked out other researchers and scientists who had been involved in breast cancer research for decades (Chojnacki and White 2013, pg. 279). This was such a significant setback for the scientific community and breast cancer research. Breast cancer is the second most common cancer in both sexes.


According to Robert Gold and Julia Carbone’s article, 10% of all women will develop a form of breast cancer during their lives and at least 4 will die of the disease. It is estimated that between 5% and 10% of the patients diagnosed with breast cancer, are carriers of a mutated gene that increases their risk of breast cancer.The article further states that carriers of BRCA1or BRCA2 have a higher breast cancer risk of between 3% and 10%. In the case of hereditary breast cancer, patients with familial history of breast cancer can commence prophylactic treatment to prevent the cancer from developing. This can only be done through diagnostic tests which Myriad Genetics claimed sole ownership. All hospitals and physicians all over the globe were required to use only Myriad Genetics’ diagnostic tests that were very expensive (Gold and Carbone 2010, S39).


Myriad Genetics is a perfect example that illustrates how DNA patents have been detrimental to scientific research. After acquiring its BRCA1 and BRCA2 patents, Myriad Genetics sent out cease and desist letters to institutions involved in breast cancer research. In one example widely covered by the United States media; Myriad Genetics sent out a cease and desist letter to the University of Pennsylvania’s research team (Sterckx 2017, 85). The University administration took the matter to media houses claiming that Myriad Genetics was trying to stifle its scientific research. Myriad Genetics denied this claim but insisted that it was the only party that could profit from the breast cancer research. Note that Myriad Genetics and the University of Pennsylvania are co-owners of the BRCA2 patent and the University has granted Myriad Genetics the license to use it (Mills 2016, 116). This was clear evidence that Myriad’s patent acquisition had negative consequences for breast cancer research. Myriad Genetics also does not share its data with the public despite getting partial public funding. There is no clear evidence to show that Myriad diagnostic tests are superior to other methods as competing researchers do not have access to this data to ascertain that assertion (So and Joly 2013, 99).


The third argument against DNA patenting was that it encouraged unethical behavior such as over medication which would lead to drug addiction and unscrupulous physicians misused the diagnostics to falsely diagnose diseases to sell more drugs and tests. Analytical products and services such as diagnostic tests generally do not require clinical trials. They can be introduced to the public without going through strict due diligence. Myriad Genetics’ bought opposing patents to make it the sole provider of diagnostic technology with a requirement that all diagnostic tests be done by Myriad and its affiliates. Myriad’s marketing approach targeted physicians who were encouraged to get more patients for testing (Voet 2016, 74).


Myriad required these physicians to offer counselling to patients before and after the diagnostic tests but the workers were neither trained as analysts nor as counselors. The advertisements also targeted women with a familial history of breast cancer. Myriad Genetics misled them that its BRCA testing was good for public health and that it would empower them. The advertisements were overly misleading highlighting the advantages of the tests without stressing the risks that were inherent with the medical procedures that would involve (Gold and Carbone 2010, S42). The diagnostic tests also consumed precious clinic time that would have been better utilized in other pressing medical concerns. (Dutfield 2017, 78).


For example in the United Kingdom, the diagnostics tests were done through the state run National Health Service (NHS). The format of the testing followed that of other specialized tests. Patients would share their family history with their local physician who would categorize the patients either as low, moderate or high risk. The NHS decided to scrap the BRCA test because it did not provide any remarkable differences when compared to their indigenous tests. Myriad Genetics then threatened the health practitioners’ with lawsuits citing patent infringement (Parthasarathy 2005, 236). It requested that all diagnostic tests should be sent to its lab in Utah. This claim was disregarded and the testing service scrapped from the National Health Service.


Myriad then contacted the UK Department of Health demanding that the department pays a license fee for all diagnostic tests; a move that did not pay off. Myriad also tried sourcing for local affiliates to help it collect mutation data to send to their Utah laboratory. An action that was met with resistance from geneticists who believe that the monopoly would hurt indigenous testing methods (Parthasarathy 2005, 236).


Conclusion


It is very clear that patents in biotechnology are not in the interest of the majority.There is need for extensive patent reforms especially in the United States where the patent laws are so broad and granting entities to have exclusive rights to life saving drugs or research. This goes against the Universal Declaration of Health for all and the Bill of Rights which ensures that no one should be denied critical healthcare. Monopolies be should strongly discouraged especially within healthcare which is constantly evolving as new diseases and treatments are discovered. To safeguard the future of public healthcare DNA patents should be held for a limited period and then it has to be released to the public as open source. The Human Genome Project is already addressing this issue.




 


References


Chojnacki, B and White, R. 2013, The BRCA Gene Patents: Arguments over Patentability and Social Utility, World  Medical&  Health Policy, Boston, vol.5, no. 3, pp. 276-298.


Cockburn, I. and Long, G., 2015. The importance of patents to innovation: updated cross-industry comparisons with biopharmaceuticals.


Contreras, L. J. And Knoppers, B. 2018, The Genomic Commons,Annual Review of Genomics and Human Genetics, Montreal.


Cooke-Deegan, R. and Heaney, C. 2010, Patents in Genomics and Human Genetics,Institute for Genome Sciences and Policy, North Carolina.


Dutfield, G., 2017. Intellectual property rights and the life science industries: a twentieth century history. Routledge.


Gold, R. and Carbone, J. 2010, Myriad Genetics: In the Eye of the Policy Storm,Lippincott Williams & Wilkins, New York.


Jolie, A. 2013, 'My Medical Choice' New York Times, New York.


Malerba, F. and Orsenigo, L., 2015. The evolution of the pharmaceutical industry. Business History57(5), pp.664-687.


Mills, O., 2016. Biotechnological inventions: moral restraints and patent law. Routledge.


Parthasarathy, S. 2005, The Patent is Political:The Consequences of Patenting the BRCA genes in Britain,University of Michigan, Michigan.


So, D. and Joly, Y. 2013, Commercial Opportunities and Ethical Pitfalls in Personalized Medicine: A Myriad of Reasons to Revisit the Myriad Genetics Saga,McGill University, Montreal


Simoncelli, T. and Park, S., 2015. Making the Case against Gene Patents. Perspectives on Science45(5), Vol 23, pp.1091-1102.


Sterckx, S., 2017. Biotechnology, patents and morality. Routledge.


Voet, M., 2016. The generic challenge: understanding patents, FDA and pharmaceutical life-cycle management. Universal-Publishers.


Wagner, S. and Wakeman, S., 2016. What do patent-based measures tell us about product commercialization? Evidence from the pharmaceutical industry. Research Policy45(5), pp.1091-1102.

 ⋅  0 comments have been posted.

Post your comment

Required for comment verification