As a U.S. appeals court ruling that restores the original restrictions the FDA imposed on the abortion drug mifepristone in 2000 heads to the Supreme Court for what will likely be full argument, the Biden administration continues to insist that the courts have no business overriding the FDA’s “scientific, evidence-based decisions.” Commenting on the Aug. 16 opinion from the U.S. Court of Appeals for the Fifth Circuit, which reinstated the original use restrictions, Vice President Kamala Harris said, “It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA.”
“Show us your work” is basically the message the U.S. Court of Appeals for the Federal Circuit sent to the Patent Trial and Appeal Board (PTAB) when it vacated a decision by the board in an ex parte review of rejected patent claims submitted by Theripion Inc. While the Aug. 10 Federal Circuit opinion that remanded the case is nonprecedential, the appellate court made it clear that the PTAB must explain its reasoning for whatever conclusions it reaches.
The U.S. Court of Appeals for the Federal Circuit declined an invitation in United Therapeutics Corp. v. Liquidia Technologies Inc. to expand the enablement and written description bar for biopharma claims into the realm of regulatory approval.
With False Claims Act (FCA) whistle-blower lawsuits multiplying amid the complexity of regulations that often are unclear, the U.S. Supreme Court provided some clarity as to what constitutes a false claim in a unanimous opinion handed down June 1. But it’s not what the biopharma and med-tech industries were hoping for.
To the chagrin of some and the joy of others, the U.S. Supreme Court denied cert to Teva Pharmaceuticals USA Inc. v. Glaxosmithkline May 15, leaving standing a split Federal Circuit decision that could threaten the use of FDA-approved label carve-outs, or so-called skinny labels, for generics and biosimilars.
Danco Laboratories LLC’s abortion pill, Mifeprex (mifepristone), and a generic will remain on the U.S. market with tighter restrictions while a challenge to the drug’s 2000 accelerated approval and the FDA’s subsequent loosening of prescribing requirements plays out on appeal. That is unless the Supreme Court says otherwise.
As an April 15 deadline looms, the U.S. Court of Appeals for the Fifth Circuit is being asked to intervene immediately to keep mifepristone on the U.S. market as an abortion option while legal challenges continue to play out in court.
Hundreds of executives from biopharma companies are signing onto an April 10 letter decrying a U.S. district judge’s decision last week to stay the FDA approval of mifepristone, which is used in more than half of all abortions in the U.S.
The U.S. Court of Appeals for the Federal Circuit once again delved into genus claims as it affirmed Gilead Sciences Inc.’s win in its inter partes review (IPR) challenge of several claims in a patent held by the University of Minnesota.
