Hatch’s Swan Song: A Bill to Block Generic Companies’ IPR Filings image

RAPS Regulatory Focus, December 14, 2018
by Zachary Brennan, quoting Jonathan Darrow (Student Fellow Alumnus)


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From the article: 

Retiring Sen. Orrin Hatch (R-UT) and two Republican colleagues in the House and Senate proposed a bill earlier this week to prevent generic drug applicants from taking advantage of the inter partes review (IPR) created under the America Invents Act.

The bill, known as the Hatch-Waxman Integrity Act of 2018, would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between the Hatch-Waxman legal framework and the IPR.

Generic drugmakers have embraced the IPR and successfully challenged patents about 50% of the time, according to a recent study published in Applied Health Economics and Health Policy.

Read more here!

pharmaceuticals regulation