Resources

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.

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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 are in two parts—class discussion and debate—for exploring the history of biotechnology as big business, the patenting policies that have supported it, and for enacting the debate over Myriad’s patents. The case encourages them to consider what happens when scientific research and commercial incentive meet. Close