In my first post on the Subcommittee Hearings held last week, I noted the absence of many witnesses from the life science industry, as opposed to groups such as IPO, AIPLA, BIO, ACLU and PhMA. The third and final panel, held yesterday, remedied this absence and then some. This panel included Laurie Hill (Genentech), Gonzalo Merino (Regeneron), Sean George (Invitae), Peter O’Neill (Cleveland Clinics Innovations), David Spetzler (Caris Life Sciences), Corey Salsberg (Novartis) and Robert Deberadine (Johnson and Johnson). The witnesses were rushed, and the written testimony that was submitted provides more thorough accounts of their positions.
Chairman Tillus opened this hearing by summarizing some of his takeaways from the previous hearings, agreeing that the current judge-made law of patent eligibility is a “complete mess”, and that the draft definitions of utility and the amendments to s. 112 (f) as proposed need further work. He also recognized the need for an enhanced experimental use exception to infringement. He criticized the ACLU for advancing a “false narrative” that an individual’s genes would be patent eligible, were the draft bill to become law. He said that he was hopeful that a revised final bill would be sent to the Judiciary Committee and come up for vote in the Senate.
Apart from the general uncertainty about the effect of the proposed amendments to s. 112(f) (one witness suggested dropping them out of the draft bill at this time), there was a nearly a consensus among the witnesses, both from the info-tech and life sciences areas, on the need to amend section 101. As stated by Dr. Spetzler: “Any invention relying even in part upon the relationship between a gene and disease, or a gene and treatment benefit, may be characterized as an unpatentable ‘natural law.’ And any invention relying even in part upon analyzing large amount of molecular data may be characterized as an unpatentable ‘abstract idea.’” He described the use of “machine learning algorithms” to select therapies when alternative ones are available, and to detect the origin of tumors based on molecular analysis, so as to better choose from treatment options, but stated that “the systems and methods we have developed to inform treatment decisions may be alleged to be unpatentable natural laws, abstract ideas or both.”