The U.S. Court of Appeals for the Third Circuit may have ruled last year that the Department of Health and Human Services doesn’t get to fill in the gaps in the law that created the 340B prescription drug discount program, but some states and lawmakers are coming up with their own workarounds to force drug manufacturers to give the discounts to an unlimited number of contract pharmacies.
The news about how the U.S. False Claims Act (FCA) is adjudicated in the courts is typically dismal, but the U.S. Court of Appeals for the Ninth Circuit recently provided an exception.
With two U.S. courts rejecting constitutional challenges to Medicare drug price negotiations, every company that had a drug selected for the first round of negotiations countered Medicare’s initial offer of what it considered a maximum fair price by the March 2 deadline, according to the Biden administration.
Instead of inter partes review (IPR) being a streamlined alternative to costly patent litigation as intended, a precedential decision by the U.S. Circuit Court of Appeals for the Federal Circuit could make appeals of IPR decisions, regardless of their merits, another way to delay competition.
One down, eight to go. That’s the scorecard for the constitutional challenges to mandatory Medicare drug price negotiations now that a U.S. federal court has dismissed a suit filed by the Pharmaceutical Research and Manufacturers of America, the National Infusion Center Association and the Global Colon Cancer Association.
The U.S. SEC denied a petition asking it to amend its 50-year-old no-admit/no-deny settlement policy that slaps a perpetual gag on parties that opt to resolve SEC allegations through settlements rather than in court.
California’s First District Court of Appeal opened an avenue, in that state at least, for lawsuits against drug and device companies based on their pipeline development priorities.
One of the latest state laws impacting prescription drug prices is a per se unconstitutional taking, a U.S. district judge said last week, but he refused to grant a preliminary injunction to shield manufacturers from the effects of Colorado’s new law while Teva Pharmaceuticals USA Inc.’s constitutional challenge moves through the courts.
Wading into the “muddied waters” of rounding the numbers used in a range claimed in two drug patents, the U.S. Court of Appeals for the Federal Circuit refused to set a “bright line rule.” Instead, it tossed a lower court win for Actelion Pharmaceuticals Ltd. against Mylan Pharmaceuticals Inc. and sent the case back to that court with instructions to consider the extrinsic evidence and its impact on the claim construction.
Even as the court challenges continue, the first round of U.S. government price negotiations for selected Medicare Part D drugs officially began Oct. 1 with manufacturers of those drugs having to sign agreements to participate in the process. While the Centers for Medicare & Medicaid Services had yet to disclose, as of press time, how many manufacturers signed the negotiation agreements, all the companies with selected drugs reportedly had indicated they would sign by the deadline even as they pursue litigation.