March 17, 2021 CLE: Bypassing Patents in the Pandemic? The Biden Administration Should Beware Revisionist Accounts of March-In Rights and Sec. 1498

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Event Notes: Bypassing Patents in the Pandemic? The Biden Administration Should Beware Revisionist Accounts of March-In Rights and Sec. 1498
This presentation material is provided by Professor Sean M. O’Connor as a courtesy to the WSPLA members. The use of the slides and any information contained therein by the recipient does not constitute legal advice.

The pandemic has spurred renewed calls for the government to “bypass,” “seize,” or “break” patents on therapeutics. Proponents seem to misunderstand the laws they believe support such actions. As the Biden Administration continues to assemble its team, one key hire—Xavier Becerra as head of HHS—has been one of the leading voices in using Bayh-Dole’s march-in rights and other measures to bypass patents. If these calls are heeded, they could have a major impact on the value of patents, even as such moves would not necessarily lower the price of drugs in the marketplace. The presentation will examine each of the three statutory avenues available to the federal government: march-in rights and the government use license under the Bayh-Dole Act; and 28 USC 1498. It will show the limits of each of these as price controls, which is what proponents are calling for. If time permits, we will also cover state sovereign immunity as a different avenue to “break” patents.