Although they reside in our bodies, the BRCA genes are effectively owned by a bio-tech giant, Myriad Genetics, which patented the genes in the mid-1990s. Should a single corporation control access to DNA that exists in every human cell? Numerous scientific organizations and consumer health groups have decried the patents, saying they restrict critical research and prevent many women from having access to the tests. The patents also mean women can’t seek second opinions from other labs and they mean that the BRCA genes must be excluded from other more comprehensive test panels, which are offered elsewhere for much less money. The company argued before the U.S. Supreme Court last month that the patents are appropriate because of its technology used to isolate and analyze the genes, and that without patent protection it would not be able to recoup its research development costs.
With Myriad, the Court stands on the verge of endorsing a venerable principle in biotechnology patent law: human beings are improper subject matter for patenting. Under U.S. law, humans may not be property. Even human body parts, such asorgans, may usually not be owned and sold as property, whether from the living or the dead. The evidence from attempts to maintain patent rights covering hESCs, IVC products, human thought, and human genes are in accord: intellectual property may not confer ownership over human beings or human-related inventions. Add to this the force of AIA Section 33, banning patent claims “directed to or encompassing a human organism,” and it is likely the Supreme Court will answer its question on appeal in the negative: human genes are not patentable. Such a result will roil the biotechnology industry, while delighting the many critics of patents claiming human genes. However, the full effect on biotechnology may be modest because synthetic genes are quite likely to remain patentable.
Charles Rothfeld’s related argument:
The Court’s doctrine invites it to add up the pluses and minuses of the patent: does it do more good than harm? The context here would seem to make that an easy calculation. On the minus side: documented higher prices and less help for women who fear breast or ovarian cancer; less research; and fewer scientific advances – effects that would be felt widely as other genes are patented. On the plus side: not much. A Court that began its most recent patent decision by worrying about patents that “would risk disproportionately tying up the use of the underlying natural laws” is unlikely to find this a difficult decision.
Robert Merges has a different perspective:
The question is not so much whether the isolated gene is, in its essence, a new thing; it is instead whether it takes significant human intervention to go from the chromosome in its native state to a purified and isolated gene. I think it does; and that the gene as claimed ought therefore be deemed a new (patentable) thing. The fact of significant human intervention, and the importance of purified genes “commercially and therapeutically,” leads me to conclude that we should call them non-naturally occurring inventions.
So does Kevin Noonan:
Any number of biologic drugs have been developed that, according to a recent Federal Trade Commission report, “have improved medical treatments, reduced suffering, and saved the lives of many Americans.” These drugs were developed by companies that isolated the genes – including, but not limited to, erythropoietin, human growth hormone, interferon, blood clotting Factors VIII and XI, human insulin, tissue plasminogen activator – encoding them, because only by doing so could these therapeutically important proteins be produced in useful quantities. The patent incentive was instrumental in supporting investment in these companies, and in developing a biotechnology industry in the U.S. that has been a world leader for twenty-five years. As anyone following the debate on follow-on biologics will recognize, the need for patent protection to attract investment in what remains a fundamentally risky industry has not diminished.
Recap of oral arguments here. SCOTUS is expected to rule on the case before the end of this term.