A $450 million federal contract that calls for Regeneron Pharmaceuticals (REGN) to supply its Covid-19 treatment contains weaker than usual protections for taxpayers. And consumer advocates complain the agreement could make it harder for the U.S. government to constrain pricing should the drug maker attempt to engage in price gouging.
However, a spokesperson for the Department of Defense and Department of Health and Human Services, which awarded the contrast last July as part of the Operation Warp Speed project to help fund development or manufacturing of Covid-19 therapies and vaccine, disagreed with the contention. As part of the deal, Regeneron is receiving funding in order to supply up to 300,000 doses of its antibody treatment.
The advocacy group, Knowledge Ecology International, contended the contract does not contain the usual provisions for preserving taxpayer rights when federal funding is involved. A provision of the Bayh-Dole Act, known as march-in rights, allows the U.S. government to reclaim patents as a way to address prescription drugs that are out of reach for different reasons, such as shortages or pricing.
I’m not sure that is the correct link.
Which link are you referring to?
ed at pharmalot
I’m puzzled by this story. How can a licensing agreement specify that Bayh-Dole does not apply. It’s a federal statute. There are procedures for declaring “exceptional circumstances” where Bayh-Dole does not apply (separate from march-in and from government-use rights). Were those employed? Otherwise, I don’t understand how an executive agency, even if through a nonprofit intermediary, can approve an agreement that says “the law does not apply.”
Thanks for writing in. If you go the link for the agreement, which I’m including here…
and look for section 7.2, it says “The parties agree that the Bayh-Dole statute does not apply to this Project Agreement.” As to why, well, I asked HHS and still waiting to hear back.
I’ll update the story if/when I do.
ed at pharmalot
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