ICYMI: STAT: Lawmakers introduce bill to require drug makers to provide key info to both FDA and U.S. Patent Office

WASHINGTON – In case you missed it, U.S. Senator Maggie Hassan introduced a bipartisan bill to help lower prescription medication costs by preventing pharmaceutical companies from taking advantage of oversight gaps in the patent and drug approval process.

Read more from STAT here or below:

By Ed Silverman

Amid concerns over monopolies held by drug makers, a bipartisan group of lawmakers introduced a bill that would require the companies to certify they have provided the same information to different federal government agencies when seeking marketing approval and patent protection.

The goal is to ensure the Food and Drug Administration and U.S. Patent and Trademark Office coordinate efforts to prevent pharmaceutical companies from unfairly extending monopolies on their medicines, according to Sen. Maggie Hassan (D-NH), who spearheaded the legislation.

The bill emerges two years after the Biden administration issued an executive order directing the agencies to work together to promote more competition and lower drug prices. The move came in response to complaints that drug companies regularly file inconsequential claims to win extra patent protection and misuse patent laws to inhibit or delay competition.

[…]Under patent law, a manufacturer cannot obtain a patent on a manufacturing process it used more than a year before submitting its application. But in a letter to the agencies last year, Hassan and Sen. Bill Cassidy (R-La.), noted the PTO has granted these patents to drug makers that disclosed the process to the FDA more than a year before submitting a patent application.

“We must continue to stand up to these big corporation and help people afford the medications that they need,” said Hassan in a statement announcing the legislation. Co-sponsoring the bill is Sen. Mike Braun (R-Ind.), and two members of the house – Rep. Ann Kuster (D-NH) and Rep. Diana Harshbarger (D-Tenn.).

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