Does Bilski bar patents on genetic diagnostics? All the Justices in Bilski agreed that patents may not "preempt" (or "pre-empt") something, but what does "preempt" mean? Is a gene patent that can't be designed around preemptive? Rochelle Dreyfuss (NYU Law) and James Evans (UNC Genetics and Medicine) tackle these question in the third paper in Stanford's Bilski symposium: From Bilski Back to Benson: Preemption, Inventing Around, and the Case of Genetic Diagnostics.
Like Lemley et al. and Menell, Dreyfuss and Evans agree that the fractured Bilski opinions were uninformative. (Does anyone think the Bilski opinions were great? That would be a novel argument.) They write that "preempt" is used "entirely within the legal domain" and has no meaning in "technological discourse." (It addition to describing displacement of state law by federal law, the term frequently came up in law review article discussions: a "preempted" piece failed the novelty prong for a good law review article.) In Part I, Dreyfuss and Evans argue that § 101 does not tell us "whether" a new technology can be patented, but rather "how" the technology is claimed: "claims that 'preempt' competitive development—that cover prospects that cannot be efficiently mined by individual rights holders—are barred." This is very similar to the argument by Lemley et al. that § 101 is about claim scope, not gatekeeping.
In Part II, Dreyfuss and Evans apply these ideas to patents on genetic diagnostics, which is a subset of what are often called "gene patents," and I will use the "gene patent" shorthand in this post. Lawyers who are unfamiliar with genetic diagnostics will enjoy II.A on "The Science of Genetics." II.B then reviews the SACGHS report on genetic diagnostic patents (Evans was chair of the SACGHS task force). The piece reports that "when there were patents held exclusively by a single entity, both clinical practice and scientific development were impaired," which is a different message from the SACGHS draft report, which concluded that "patents covering genetic tests ... do not appear to be causing wide or lasting barriers to patient or clinical access," as I quoted in Access to Bio-Knowledge: From Gene Patents to Biomedical Materials. But because the draft report found that patents do little to help the development of new genetic diagnostics, I argued in Access to Bio-Knowledge that the report still supported calls for exempting genetic diagnostics from patentability—a conclusion that the final report makes even stronger.
Dreyfuss and Evans hint in Part III that a legislative carve-out may be unnecessary because patents on genetic diagnostics might "preempt" competitive development for at least four reasons: (1) inventing around gene patents is impossible, (2) gene patents limit interoperability, (3) gene patents create broad unmined prospects, and (4) patentees for genetic diagnostics tend to be academics who are not primarily motivated by patents. (This last factor seems like an important policy concern, but the link to preemption is less obvious than for the other three.) The authors never actually say that they think genetic diagnostic patents are not patentable subject matter under Bilski, but they note that "it is no wonder that courts have begun to question the validity of these patents" (citing Association for Molecular Pathology) and that "one Federal Circuit judge has already suggested that Bilski's preemption test raises serious questions about patents on isolated DNA molecules" (citing Judge Dyk's opinion in Intervet v. Merial).
I wish that the paper had a more explicit conclusion—even if the authors do not feel comfortable claiming that genetic diagnostic patents do preempt development and are thus unpatentable subject matter, they could at least lay out what factors still need to be examined to decide whether this is true—but I still think the paper does a nice job of highlighting the preemption concern and thinking about factors that might be relevant in investigating preemption.
