Wretches and Genes: We Come For You

The ownership and exploitation of human genes

Ken Cates, Staff Writer 

Reagan’s Cult and Crichton’s Nightmare

For those who identify themselves as part of Generation Y, I have always wondered how much they know about growing up alongside the birth of corporate America? It was a key era in history that marked the infancy of the winner-takes-all system characterized by the massive income inequality between the top 1% and everyone else. It was a system nourished under the tender care of the administration of Ronald Reagan and the believers of his magic words: Greed Is Good.

Despite the rhetoric of competition and free market capitalism, over the last 3 decades markets have become anything but free. Banks and corporations have become too big to fail, abandoning the less affluent as they continue to expand their profits through commercializing and eliminating what we used to consider as the public sphere.  Some have also achieved the convenience of being too big to jail, as was the case for HSBC and its laundering of cartel drug money. Various industries including the media (run by Newscorp, Time Warner, GE, etc.) and energy sectors (BP, Halliburton, etc.), are now characterized by a handful of megafirms calling the shots. Indeed, the revolving door relationship between corporate, government, and academia has accelerated like never before, stifling innovation as well as diversity in not just business but public discourse as a whole.

When the Supreme Court ruled 9-0 against the Salt Lake City based Myriad Genetics and its patent claims for the BRCA 1 and BRCA 2 genes, the first thing that crossed my mind was the warning against gene patents issued by the late Michael Crichton, author of Jurassic Park and creator of the TV series ER. His thriller Next is a comprehensive and well-researched assault on the cutthroat business practices of biotechnology firms, politicians, and universities claiming and hoarding ownership on human genes and exploiting the gene holders by all means possible. One story line includes a tac-team of repo men abducting a little girl for the rare genes in her body, which the lawyer of the team’s employer phrased the operation as collecting what is rightfully his boss’s “property.”

In other words, the fear of our genes being parted from our body like the houses of homeowners evicted by the police and the megabanks during the 2008 financial crisis, is all too relevant in the metastasizing of corporate greed in the bosom of our daily lives. This was a job preformed by the bank-employed Yakuza in the late 1980s and the early 1990s in the case of Japan.

But does the relevancy of such fears make it accurate as well as justifiable? While I have unending respect for Crichton, as a writer I am obligated to the truth and the separation of fact and fiction. So starting from the Myriad ruling, I would like to dive into the world of gene patents and explore how far the firms and research institutes actually embody the cult of greed. Moreover, I would also like to explore if Gen Y entrepreneurs can play a role in pushing corporate back from our bodies and our lives, rather than becoming the next Goldman Sachs, Newscorp or Halliburton.

Are Human Genes Patentable?

This was the question that the U.S. Supreme Court faced in the Association for Molecular Pathology v. Myriad Genetics, where the 9 justices unanimously agreed that naturally occurring genes are a product of nature and cannot be patented. As the court invalidated Myriad’s claims based on the isolation of the BRCA 1 and BRCA 2 genes, the key argument was that the mere isolation of human genes in the lab does not count as a novelty invention. On the other hand, the justices also stated that cDNA – a reverse engineered synthetic copy of the gene – can be patented. In writing the courts opinion, Justice Clarence Thomas stated that DNA manipulated in the lab is patent eligible, since it is markedly different from its natural state.

Made famous by the double mastectomy of actress Angelina Jolie – who would have made headlines by clipping her toenails since her name is Angelina Jolie – the BRCA ½ genes are the genes identified to be the main cause of hereditary breast cancer or ovarian cancer. They are key in genetic testing to assess if patients are at risk and whether or not patients should take preventive measures, as did Jolie.

The American Civil Liberties Union (ACLU) and the Public Patent Foundation – representing more than 20 plaintiffs – filed suit in 2009, in protest of Myriad’s monopolization of the use of BRCA ½ genes and of commercial practices regarding gene patents as a whole. Myriad first claimed ownership of the genes in 1994 and 1995, collaborating with the University of Utah (to which Myriad’s cofounder Mark Skolnick belonged) and the National institute of Environmental Health Sciences. Its patents cover the isolated gene sequences and methods to analyze and compare these genes in order to determine the susceptibility of female test takers to breast cancer. The comprehensive BRCAAnalysis test established in 1996 made Myriad $326 million in molecular diagnostics in 2009, due in part to the near doubling of the test price from $1600 (1994) to $3150 (2009).

With the patent being exclusive, Myriad can charge at risk patients whatever price it wanted while other entrepreneurs cannot sell cheaper tests, regardless of the application of different methods and technologies in the testings. Myriad’s stance also inhibited patients looking to get a second medical opinion. Doctors argued that their ethical obligation to their patients was compromised as they were not allowed to tell women the test results.

The use and abuse of gene patents also affects the state of scientific research as a whole. When the SARS epidemic was spreading on a global scale, researchers studying the disease were hesitant in doing their job because of patent concerns and the entailing risks of litigation. At least for these researchers, it seems lawyers are more of a threat than a global pandemic could ever be. In a post ruling review, Lori Andrews, director of the Institute of Science, Law and Technology at the IIT Chicago-Kent Collage of Law stated, “prior to the Supreme Court decision, 53% of genetic labs had stopped doing research due to concerns about gene patents. 49% of American Society of Human Genetics members had to limit their research due to gene patents.”

The verdict was handed down and the ACLU declared victory. However, I felt hesitant to celebrate just yet, and not just because of my skepticism towards the Supreme Court, who declared that racism is no more just before the acquitting of George Zimmerman and the Paula Dean scandal. If Myriad had suffered a crushing blow to its business it did not act like it did. In fact, it stated in a press release, “following today’s decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test.” Joined by the University of Utah, the University of Pennsylvania, Ontario’s Hospital for Sick Children and Endorecherche Inc., Myriad launched a new set of law suits against companies such as Ambry genetics (who charged $2200 for their BRCA tests) and Gene by Gene Ltd. (charging $995 for theirs), claiming the infringement of its upheld patents.

Over a telephone interview, Bernard Dickens, professor emeritus of Health Law and Policy at the University of Toronto, argued that overall the Myriad ruling was “not that influential.” Dickens and other experts seem to agree that patenting isolated DNA is a thing of the past, while the future of biotech lies in cDNA. Indeed, the relevance of isolated DNA patents has been fast declining since 2005, while the prominence of cDNA as research tools, as therapeutic agents and as ingredients of therapeutic proteins for biologic drugs has risen. In an email interview, Yann joly, Lawyer and an Assistant Professor at the Faculty of Medicine, Department of Human Genetics at McGill University, also agreed that the biotech industry has moved on from the patent application of isolated DNA. He also stated that the door remains open for other types of DNA that aren’t considered a product of nature.

In the end, the reasoning of the Supreme Court was based on the technicality of the legal status of patents rather than on the moral grounds of the practice. In the case of BRCA 1/2, key components of Myriad’s patents were struck down since the isolated DNA sequences did not fit the criteria of an eligible patent: novelty, non-obviousness, and usefulness. As the isolation – or purification – of the BRCA genes did not make the genes markedly different from its natural state in the human body, the justices argued that Myriad’s mere identification – or discovery – of the gene was not enough for a patent. Hence, facts of nature cannot be owned, while the edited cDNA version of a gene legally constitutes as an invention and can be owned.

But what does this mean in terms of morality and for society? Can the patentability of cDNA still lead to Crichtonian nightmare of corporate ownership of the building blocks of life? Are patents to blame for the genetic monopoly of Myriad and other biotech giants or are we being too simplistic with this conclusion? And finally, what would patents and the biotech industry bring to our future?

The Sale of Science and the Role of Patents

The U.S. Patent and Trademark Office (PTO) have granted patents on at least 4,000 human genes. A good number of patent applications for human genes were filled during the 1990s when strong commercialization frameworks were adopted in almost all developed countries. Prior to the ruling, patents constituted up to 40% of the human genome – or up to 20% of human gene sequences – according to some studies. The monopolization on genes also encompasses pathogens as well, where human pathogens such as Hepatitis C and Haemophilius Influenza are legally considered as private property.

And it’s not just corporate that’s profiting off human genes. Universities, hospitals and research institutes, as seen in the assault on Ambry and Gene by Gene, are also contenders of the race to claim gene sequences and testing methods. A key stepping stone in the commercialization of academia and scientific research was the Bayh-Dole Act of 1980, which was drafted on the premise that financial investments were necessary to bring innovative and life-saving discoveries lying in the crypt of university archives into the open (the act should not be confused with patent law itself).

Through the act, small businesses and nonprofit organizations can patent government funded research results by allowing them to retain patent ownership, while federal agencies can apply for and hold patents, and can license their patents to the private sector. This, of course, is provided they diligently file patent applications and promote commercial development of their inventions. A 1983 Reagan Memorandum, endorsed by Congress in a housekeeping provision to a 1984 change in the law, extended the Bayh-Dole Act to large businesses as well. While the field of biology – the largest recipient of federal funding – was booming both technically and commercially in the 1980s, not only have research results become much more marketable and lucrative, but the commercialization of inventions entailing this boom also came to be perceived as more acceptable.

For Crichton, this was the turning point in which university professors and researchers have increasingly come to hold corporate ties, where “humanitarian scientists are now businessmen concerned with profit and loss” as the distinction between the practices of universities and biotech firms have become either absent or non-existent. While disagreeing with the dystopian notions of Crichton’s claims, Adrian Zahl, patent lawyer of Ridout & Maybee LLP, stated in an email interview that regarding how gene patents are pursued, there are no real noticeable differences between universities and the industry.  Accordingly, “in all cases, researchers seek to obtain as much protection for their innovations as the law will allow.”

For Zahl, the Bayh-Dole Act has brought beneficial changes for the industry. The transfer of technology to the private sector has led to important life-saving innovations that were perfected and delivered to patients through the market place, as was the case with the blood thinner warfarin developed by the University of Wisconsin.

Professor Joly also disagrees with the viewpoint that the act has led to a seemingly totalitarian ownership of genes by corporations and their academic partners. In regards to the patents on human genes and pathogens, Joly notes, “the fact that these patents have been granted doesn’t necessarily mean that they are actually valid.” The legal ownership of the patents of the human genes and pathogens such as Hepatitis C and Haemophilius Influenza are no longer valid due to the Myriad decision as well as other Supreme Court rulings.

Isolated gene patents represent a mere fraction of the biotech landscape, where methods of testing, a specific strand of a mutation of the gene, or even the use of non-human genes in fields such as agriculture by firms such as – cue Darth Vader sound track – Monsanto and its ever infamous GMOs. Thus, regarding the integrity and the future of the ownership of the building blocs of human life, the Myriad ruling can indeed be considered as a modest victory for bodily and genetic integrity. However, as mentioned earlier, the biotech industry has moved on to cDNA and its possibilities, where the ghost of Reagan and his followers of the cult of greed still prominently linger in the realm of research and the life sciences.

A Call of Arms to Generation Y

With the push back of Myriad’s monopoly of the BRCA genes, as with the announcements of the new BRCA, a resulting increase in competition in the biotech market can benefit the public good through the attainability of cheaper and more diverse genetic tests. With the decoding of the human genome, the rising importance and effectiveness of targeted gene treatments, and the increasing success of curing diseases that can arise from a one odd gene within the human body, the future of health and medicine would become inseparable from the access to the nano-verse lying within the building blocks of our body and of life itself.

However, the developments of the last 30 years such as the privatization of research have also proved to be a double-edged sword, as actors within the previously public sphere have come to know the taste of profits and of greed. While warfarin has indeed saved lives previously unsaved, the namesake organization of the drug (WARF – Wisconsin Alumni Research Foundation – which is actually a private entity) has used its patent on a number of stem cell lines to demand royalties from any related invention by the non-profit California Institute for Regenerative Medicine. It was established by California voters to accelerate stem cell related research. WARFs actions and demands seemed to mimic that of Myriad or even that of General Motors, Exxon Mobile or Goldman Sachs, where it stopped advancing it claims only after caving into the pressure of public opinion and the threats by the NIH to use its march-in claims retained under the Bayh-Dole Act.

Even some of the most highly esteemed institutions are showing psychological characteristics that remind us of the plutocrats on Wall Street. To extend its Axel Transformation patents (which claimed a scientific method to introduce foreign proteins into nucleated cells), Columbia University has worked behind the public view in successfully asking for Patent Office continuations. They even went as far as lobbying a US senator to add an amendment to a completely unrelated bill to achieve its goal. With the risk of losing over $50 million in revenues, the primary role of universities to foster innovation, transfer knowledge and improve social welfare are thrown out for short-term profits and institutional gain. The financial stake that universities now have shows how much academia has drunk from the poison chalice of greed, which former GE spokesman Ronald Reagan said was simply good for us. Like the most aggressive form of cancer, with enough pressure and incentives the public institutions entrusted with the future of scientific progress and our tax dollars can use its power and responsibility to betray the public good for the sake of itself (which was also the base story line of Walter White in the Breaking Bad saga).

With its inclination towards the private sphere and the spirit of individualism, Joly notes that while most developed countries rely on patents, such actions is more likely to be structurally inherent in the U.S. than in other developed nations where the ideals of universal coverage are stronger. Though even in the Canadian context, the commercialization of scientific research remains differentially successful and is largely concentrated in a handful of universities, he further states in a policy brief for Genome Canada.

For those without an army of lobbyists or massive tax dollar funding, patents are perhaps the only way to have a shot at success in the biotech industry. Zahl argues that this is especially the case for start-ups and spin-offs that lack the resources to protect a new drug via the drug approval process, where in the post-Myriad era for biotech entrepreneurs the role of patents can take up an ever-important role.

While the odds have long been stacked against entrepreneurs in the science market, with the modest victory over Myriad and other biotech giants a fresh wave of modern and forward thinking entrepreneurs are needed more than ever. Thus, the rise of freelancers and entrepreneurs can act not just as a means to increase market diversity and to lower prices for much needed drugs and treatment, but also as a counter-reaction to the bloating and swelling of a centralized corporate elite in business as a whole. As AIG and Goldman Sachs executives lavishly treat themselves with bonuses and golden parachutes funded by taxpayer dollars, at the expense of the poor and the downtrodden at home and abroad, I believe its time for a long overdue change in practice.

In sum, I hope that this article can serve as a rallying cry for the Generation Y entrepreneurs whose moral compass has yet to be blown out by the crushing wave of greed and cronyism taking hold of our sciences, our economy, and the governance of almost every aspect of our lives as well as our body in its own meager way. The fight must continue if you agree to the obvious and ever important statement declared by the ACLU as well as many others: OUR GENES BELONG TO US, NOT CORPORATIONS.

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Ken Cates has studied international relations at the University of Toronto, while currently pursuing a career in writing as well as a certificate in freelance writing. Inspired by writers such as Christopher Hitchens and Chris Hedges, Ken blogs about religion, politics, ethics, societies, and on the little bits of irony surrounding our daily lives.