Posts Tagged: "generic drugs"

March-In Drive Loses a Wheel: Generics Industry Says No to Biden Framework

In what has to be the unkindest cut of all, those expected to benefit from the proposed misuse of march-in rights so the government can impose drug price controls say they don’t support it either. The proponents promoting this hot house theory have seen it denounced by those who created the Bayh-Dole Act as being unauthorized under their law and seen evidence they can’t refute that it would have little impact on drug prices but would devastate small business entrepreneurs in all fields of federally supported research and development. And now they’ve lost the generic drug industry.

U.S. Government Sides with Teva in Skinny Label SCOTUS Fight

The U.S. Solicitor General on Wednesday filed an amicus brief with the United States Supreme Court advising it to grant Teva Pharmaceuticals’ petition for writ of certiorari relating to generic manufacturers’ liability for infringement through the use of “skinny labels” on generic drugs. The SG’s brief said that the U.S. Court of Appeals for the Federal Circuit (CAFC) got it wrong, and that the decision could upend the careful balance contemplated by the Hatch-Waxman Amendments between incentivizing new brand name drugs and allowing cheaper generics into the market.

GSK Argues Unusual Facts of Case Behind Teva’s SCOTUS Petition Limits CAFC’s Skinny Label Holding

On August 19, British brand name pharmaceutical firm GlaxoSmithKline (GSK) filed a brief with the U.S. Supreme Court opposing a petition for writ of certiorari filed by generic drugmaker Teva Pharmaceuticals. Teva’s petition appeals a decision by the U.S. Court of Appeals for the Federal Circuit (CAFC) reinstating a jury verdict that found Teva liable for inducing infringement of GSK’s patents covering the heart failure treatment, Coreg. GSK’s brief argues that the Federal Circuit properly applied the law on induced infringement and that the “skinny label” arguments raised by Teva’s petition only affect 30% of the damages awarded by the jury in the case.

Senate Judiciary Committee Advances USPTO-FDA Collaboration Bill Toward Floor Vote

Earlier today, the U.S. Senate Committee on the Judiciary convened a brief executive business meeting to discuss a series of judicial nominees selected by the Biden Administration, as well as a pair of proposed bills. One of those bills, the Interagency Patent Coordination and Improvement Act of 2022, follows various efforts to limit certain patent rights in the pharmaceutical industry and was passed favorably out of the Committee via voice vote toward a full vote on the Senate floor.

Tillis Renews Request to FDA and USPTO for Independent Assessment of I-MAK Patent Data

On Friday, April 1, Senator Thom Tillis (R-NC) wrote to the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to once again voice his concerns about several sources advancing data on the effects of pharmaceutical patents on drug pricing. Tillis is specifically troubled that the data seems to be based on opaque methodologies and to contain inaccurate or incomplete information that may mislead policymakers. In a previous letter to these organizations, he requested the agencies conduct an independent assessment of the accuracy and reliability of those sources. In the present letter, Tillis again highlights his concern about work from the Initiative for Medicines, Access & Knowledge (I-MAK). He had previously written to Tahir Amin, Co-Founder and Co-Executive Director of I-MAK, requesting that I-MAK provide a detailed explanation of its methods to allow others to check the accuracy of I-MAK’s patent data and to assess the credibility of its other assertions.