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Plan restores certainty immediately – it’s not a new legal framework, it’s the pre-2012 status quo

Courtenay C. Brinckerhoff, 24 – registered patent attorney and have been representing chemical, biotech, and pharmaceutical clients before the USPTO for over 30 years. Answers To Questions For The Record from Senator Padilla, before the U.S. Senate Committee on the Judiciary Subcommittee on Intellectual Property, “The Patent Eligibility Restoration Act”, 1/23, www.judiciary.senate.gov/imo/media/doc/2024-01-23_-_qfr_responses_-_brinckerhoff.pdf //DH

5. The Courts and the U.S. Patent Office have had 10 years to develop the Alice/Mayo caselaw and guidance for the innovation ecosystem. PERA introduces new terms and standards that would have to be newly interpreted by the Courts. How long do you think it would take the Courts and the Patent Office to bring certainty to the application of the new Section 101, should PERA become law? Can you explain why a potential new period of uncertainty would be more attractive than the current status quo?

As I noted above, for life sciences technologies such as diagnostics and isolated natural products, PERA would restore patent eligibility to what was eligible for patenting before the 2012-2014 Supreme Court decisions in Mayo, Myriad, and Alice. Thus, rather than signify a new paradigm, it would restore the status quo prior to Mayo. Additionally, the current draft of PERA itself provides specific examples that will inform its interpretation and application.

When considering this issue, I think it is important to keep in mind that even though Mayo, Myriad, and Alice were decided 10 years ago, still today there is no certainty or predictability in how a court will apply the “judicial exceptions” to Section 101. As one example, in my written testimony I discussed the Federal Circuit decisions in Yu v. Apple Inc.10 (invalidating claims to a digital camera) and Cardionet, LLC v. Infobionic, Inc.11 (upholding claims to a medical device) as emblematic of this unpredictability, which seems especially acute for applications of the “abstract idea” exception.12 Additionally, although the U.S. Patent Office has issued guidance for examiners, courts are not bound by that guidance, and have expressly declined to follow that guidance.13 This undermines confidence in the validity of patents granted today, since they still could be challenged under a new extrapolation of Mayo, Myriad, or Alice.

Thus, rather than supporting a cautious approach to PERA, the case law that has developed over the past 10 years and that continues to expand the “judicial exceptions” underscores the urgent need for legislative action.

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