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IPR reforms elicit controversy and the sides are backed by strong advocates and lobbyists

Cook-Deegan, et. al., June 2024 Robert Cook-Deegan, Janis Geary, Kara Hapke, Zuzana Skvarkova, Marina Filipek, Jillian Leaver Sorry you asked? Mayo, Myriad, and the battles over patent-eligibility Journal of Law and the Biosciences, Volume 11, Issue 1, January-June 2024, lsae010, https://doi.org/10.1093/jlb/lsae010

Efforts to revise §101 are also apt to elicit strong conflict among constituencies, similar to the inability to find common ground regarding the recommendation for an exemption from infringement liability for second opinions and verification testing. Stakeholders in the fight—firms with starkly different business models and patent preferences, the patent bar, and disease advocacy groups—all have armies of advocates and lobbyists at their disposal. A carefully crafted exclusion from patent-eligibility might be possible to craft that would improve the status quo, but the proposed statutory language does not address the core concerns about patents affecting molecular diagnostics that gave rise to Mayo and Myriad in the first place. Instead, the proposed language in S. 2140 would revert to pre-Mayo-Myriad standards. Fervent disagreement about optimal policy will likely translate to political conflict in restoring patent-eligibility, and invite future litigation should the law revert to pre-Mayo status. The future thus seems destined to entail continued disagreement, litigation, debate in Congress, and perhaps incremental change on one or more fronts.

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