Extending Bayh-Dole March-in rights

In a recent exchange with Senator Durbin, NIH Director Francis Collins expressed his concern that the NIH would alienate potential collaborators if the NIH applied the march-in remedy to address excessive prices of drugs. Separately, some have advocated broader use of the US “government use” statute, 28 USC 1498(a) to address excessive prices, and while 1498 can clearly play a role in such disputes, it is not designed with this task in mind, and there is considerable uncertainty how much compensation is required for such a non-voluntary authorization.

Zack Struver has done a video on the 1498 issues, including a remedy proposed by Senator Sanders in the context of the Department of Veterans Affairs, here.

One other statutory remedy would be to extend the Bayh-Dole march-rights beyond NIH funded inventions, to apply to all patents in a field of use relating to any FDA approved drug, vaccine, medical device or diagnostic test.

35 U.S.C. § 203 – March-in rights

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(c) The Department of Health and Human Services may also authorize a non-voluntary use of a patent on the same procedures and grounds set out in (a), for any patented invention in the field of use for any FDA regulated medical invention, including but not limited to drugs, vaccines, medical devices and diagnostic tests.

Such a short amendment to 35 U.S.C. § 203 would eliminate the need to use the 28 U.S.C. § 1498(a) compensation standards, which are problematic, and eliminate concern that the use of the march-in rights would uniquely be burden for a drug manufacturer that licensed a federally funded invention.

Durbin Collins video: https://www.youtube.com/embed/wpo5sOQV9HY
Struver 1498(a) reform video here: https://www.youtube.com/embed/wpo5sOQV9HY

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