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Earlier this month, I wrote that the ACLU filed suit on behalf of patients and researchers against Myriad for its patents related to breast cancer. This suit is particularly interesting as a direct challenge to whether human genes should be the subject of a patent–to many a question that is long overdue. This question was glossed over after the 1980 case of Diamond v. Chakrabarty, in which the Supreme Court held that a genetically modified bacterium is patentable subject matter. The likely suspects to challenge such patents, other biotech companies that depended on patents to secure investment, had an interest in not having all patents of this type declared invalid. Why did the ACLU wait such a long time to bring this suit? It’s likely that recent decisions addressing the scope of patentable subject matter signaled that the time was ripe to address the issue, perhaps in a way that would result in a narrower interpretation of subject matter eligibility (Bilski, Comiskey, Classen).
The suit raises several questions, though I focus on the following four issues:
1. Are human genes within the scope of patentable subject matter? This is the question that follows naturally from the Bilski decision that patent claims must be narrowly tailored to cover a particular application of a fundamental principle, such as a law of nature, rather than preempting the principle itself. A claim would need to be tied to a machine or be transformative to be patent-eligible. The method claims at issue are not tied to a particular machine. One could argue that identifying a gene that corresponds with an increased susceptibility to disease is transformative-it takes biological material and transforms it into information about disease risk. For the composition of matter claims, isolating DNA would physically transform it, though it’s unclear whether such a transformation would be seen as insignificant extra-solution activity.
2. Does imposing high costs for patented tests that implicate human health violate the First Amendment or fail to promote progress? I think this is a hard argument to make, given that this is the essence of the patent bargain. If you invest and discover something, you can charge what you want for 20 years from your filing date. We don’t invalidate patents on MRI systems or life-extending pharmaceuticals based on the costs their patent holders decide to charge, though the courts have imposed a reasonable royalty in response to unauthorized use (eBay v. MercExchange) or (rarely) compulsory licensing has been required.
3. Does allowing a patent that (potentially) excludes others from correlating information violate the First Amendment? It’s hard to imagine standing would be satisfied here. I doubt that any patent holder, even Myriad, would bring suit against a doctor for performing a correlation, whether performed mentally or even after disclosing the results to a patient.
4. Does allowing a patent that prevents a second opinion of a medically relevant test conflict with the First Amendment or fail to promote progress? The First Amendment argument seems a bit of a stretch, though perhaps preventing a patient from obtaining a second opinion does undermine the purposes of the patent system. More particularly, it prevents the public from verifying what the patent holder claims to own, which seems to be part of the disclosure requirement of the patent system.
I think these types of patents are becoming less important, in part because of the narrowed scope of patentable subject matter eligibility, the broadened ability to show obviousness, and the likelihood of finding invalidating prior art from the Human Genome Project. The decreased pace of discovery of single genes that correlate with disease also lessens the significance of this suit. It’s challenging to get decent empirical evidence on under what circumstances these types of patents ultimately encourage or hinder innovation, but in light of the importance of these discoveries to health, the more prudent approach is to assume that they encourage it.
Other discussions related to this suit: