Education - Higher Education

Engineering the Genes: Ethical Dilemmas in Modern Biotechnology

Part 2: Biotechnology as big business: patenting life from Chakrabarty to Myriad

Introduction

Almost from its very beginnings, recombining genes from different organisms to produce novel traits was conceived of as big business. In the mid-1970s new biotechnology firms (like Genentech) sprang up and many established companies moved aggressively into the biotechnology realm. In the early 1980s, the Reagan administration sanctioned a new, non-governmental source of funding for biotech: the “research and development limited partnerships” between universities and companies. Academic scientists now no longer had to choose either a university career or a role in business—they could do both. In 1980, the Bayh-Dole Act allowed universities to license their patented items to companies, which then took the financial risk to develop them into marketable products. The Act motivated private investors to pick up where federal funding left off, and by the mid-1980s, many universities had technology licensing offices on campus.

In 1980, in yet another indication of the commercialization of biotechnology, the United States Patent and Trademark Office (PTO) granted the first patent on a genetically engineered life form. Whereas earlier the process or technique had been patented, now the organism itself was patent-protected material. Microbiologist Ananda Chakrabarty genetically modified a bacterium to break down the components of crude oil. Although the PTO had at first opposed his attempt to patent a living thing, the Supreme Court overturned the objection. Since it was, in the Court’s view, clearly an invention, and not naturally occurring, Chakrabarty’s organism qualified for a patent.

The case set a key precedent. In 1982 the PTO granted a patent on a gene for human growth hormone. In 1988 the PTO extended its decision, allowing that multicellular organisms (including animals, but not humans) were patentable, and Harvard University patented the “oncomouse,” a mouse containing a human cancer gene. By the early 1990s, more and more genes and DNA sequences were patented. Then director of the NIH Bernadine Healy famously disagreed with James D. Watson, the first director of the Human Genome Project, about whether the DNA sequences of brain genes that the project was uncovering should be patented (Wade, Life Script, p. 34). In 2001, attempting to clarify its policy, the PTO issued new guidelines mandating that an applicant must show “specific, credible, substantial uses” for the gene, and in 2005 it denied a patent application on a hypothetical and never-to-be-created chimera, half human and half chimpanzee, because such a being would be “too human.” Stuart Newman, with the help of the anti-biotechnology activist Jeremy Rifkin, had devised the case to test the limits of the PTO’s policy. In 2006 the Public Patent Foundation (a public interest group) challenged patents on human embryonic stem cells on the grounds that the patents interfered with scientists’ ability to get access to the cells for research purposes. A different argument used occasionally was that such patents interfered with human dignity by turning “life” into a commodity. The proceedings in this case are still ongoing.

In 1997–98, in a visible and contested case, Myriad Genetics was awarded patents on two genes that increase a woman’s susceptibility to breast and ovarian cancer (called the BRCA 1 and 2 genes), and on the diagnostic test that looks for mutations in those genes. In 2009, a coalition of plaintiffs led by the American Civil Liberties Union (ACLU) challenged Myriad’s patents on these human genes. At each level the case reached, the debate had a different outcome. Even the Supreme Court decision in June 2013, though it struck down Myriad’s patents on DNA as it appears in nature, ruled that synthetic DNA created in the laboratory should be patent-protected.

The resources listed below allow students to explore the history of biotechnology as big business, the patenting policies that have supported it, and to enact the debate over Myriad’s patents. The case encourages them to consider what happens when scientific research and commercial incentive meet.

Class 3: Scientific research meets commercial incentive: United States patenting policy and the biotechnology industry

discussion resources

“Diamond v. Chakrabarty.” The Oyez Project at IIT Chicago-Kent College of Law. Accessed November 5, 2013, http://www.oyez.org/cases/1970-1979/1979/1979_79_136/
Krimsky, Sheldon. Biotechnics and Society: The Rise of Industrial Genetics. Westport, CT: Praeger,1991, chapters 3 and 4.
Smith Hughes, Sally. Genentech: The Beginnings of Biotech. Chicago, IL: University of Chicago Press, 2011, chapters 1-3.

Discussion questions:

What is a patent, and how have United States patenting policies evolved from the 1980s to the present?
Does commercialization compromise scientists’ objectivity or impartiality, and is there anything wrong with having a financial stake in the outcome of one’s research?
Is academic research different from commercial research; can they coexist, or are conflicts of interest the inevitable result?

Class 4: The debate over Myriad’s gene patents—should a company own a gene?

Students portray the opposed sides in the debate: Myriad, the United States Patent and Trademark Office, the American Civil Liberties Union, the Public Patent Foundation, and patient advocacy organizations (such as breast cancer awareness organizations). Students can be given a “mission statement” for each organization, available on that organization’s website.

debate resources:

Council for Responsible Genetics. GeneWatch: Gene Patents issue, 23, no. 5 (Oct-Dec 2010). http://www.councilforresponsiblegenetics.org/GeneWatch/GeneWatchBrowser.aspx?
archive=yes&volumeId=23.
Browse the whole issue, but the following articles are especially recommend:
- “Genes, Patents, Common Sense, and the Law” by James Evans
- “When the Grass Eats the Cows” by John Conley and Dab Vorhaus
- “The Plaintiffs” by CRG Staff
- “The Defendants” by CRG Staff
- “The Danger of the Broad Brush” by Christopher Holman
- “The Sky is Not Falling” by CRG Staff
- “Why Banning Patents Would Hurt Patients” by Sharon Terry
- “Why Genes Must Remain Eligible for Patenting” by Kevin Noonan
- “Naturally Occurring Genes and the Commons By Necessity” by David Koepsell
- “Freedom of Genes” by Debra Greenfield

Williams-Jones, Bryn. “History of a Gene Patent: Tracing the Development and Application of a Commercial Gene Patent.” Health Law Journal 10 (2002): 123-146.
Association for Molecular Pathology et al. v. Myriad Genetics et al., 569 U.S. 1 (2013). Accessed November 20, 2013. http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf.
News articles about the Myriad case:
- Schwartz, John. “Cancer Patients Challenge Patenting of a Gene.” New York Times, May 12, 2009.
- --- and Andrew Pollack. “Judge Invalidates Human Gene Patent.” New York Times, March 29, 2010.
- Dwyer, Jim. “In Patent Fight, Nature: 1, Company: 0.” New York Times, March 30, 2010.
- Pollack, Andrew. “After Patent on Genes is Invalidated, Taking Stock.” New York Times, March 30, 2010.
- David, Jeffrey and Kristin Yohannan. “The Myriad Appeal: Is Isolated Human DNA Patentable?” Morrison and Foerster Client Alert. (April 4, 2011) Accessed November 20, 2013. http://www.mofo.com/files/Uploads/Images/110404-Myriad-Appeal.pdf.
- Pollack, Andrew. “Ruling Upholds Gene Patent in Cancer Test.” New York Times, July 29, 2011.
- ---. “Justices Send Back Gene Case.” New York Times, March 26, 2012.
- Reuters. “Court Reaffirms Right of Myriad Genetics to Patent Genes.” New York Times, August 16, 2012.
- Liptak, Adam. “Justices, 9-0, Bar Patenting Human Genes.” New York Times, June 13, 2013.
- Kevles, Daniel. “Can They Patent Your Genes?” New York Review of Books, March 7, 2013.
- ---. “The Genes You Can’t Patent,” New York Review of Books, Sept 23, 2013.

debate questions

Should human genes be patent eligible subject matter? Are Myriad’s genes creations of human ingenuity, or products of nature? Are genes the sort of thing that should be patented? Or do they represent a commons that should not be carved up into intellectual property?
Do the BRCA gene patents reward innovation? Or do they stifle research and interfere with treatment? Is the 2013 Supreme Court decision in the Myriad case a good one?
Is the new model of corporate science distorting science?