The U.S. Health Resources and Services Administration (HRSA) ordered six drug companies May 17 to immediately resume providing 340B discounts to contract pharmacies without restrictions and to credit or refund overcharges stemming from those restrictions.
The casual observer may think that physician speaker programs sponsored by makers of drugs and medical devices have drawn less attention from U.S. federal attorneys, but reality has failed to meet that expectation. Mark Gardner, managing attorney of Gardner Law of Stillwater, Minn., said on a Nov. 19 webinar that “there’s a lot coming through right now in terms of settlements,” including a settlement with a drug maker that sent the company into bankruptcy.
Assignor estoppel doesn’t enjoy the glamour of subject matter eligibility in the U.S. patent system, but a case heard recently at the Court of Appeals for the Federal Circuit has resurrected this relatively arcane bit of patent doctrine. The outcome of the case of Hologic v. Minerva addressed the less-than-princely sum of roughly $5 million, but Judge Kara Stoll of the Federal Circuit said this issue calls for a deeper examination by a 12-judge panel.
In a decision that seems to have yet again roiled the patent subject matter eligibility question, the U.S. Court of Appeals for the Federal Circuit determined that a district court had erred in determining the 7,941,207 patent held by Cardionet LLC, of Conshohocken, Pa., is not eligible for patent protection.
Device makers only can watch when cardiologists grapple with federal agency officials over device utilization. However, cardiologists are punching back hard against a rule used to judge whether a coronary artery stent is appropriately used, thus ensuring these devices won’t suffer a significant drop in utilization.
The case of Arthrex v. Smith & Nephew, Inc., has raised a host of questions about the appointment of judges to the Patent Trial and Appeal Board (PTAB), and witnesses at a congressional hearing said a Supreme Court review might be two years in coming. Any such resolution might not clear out the thicket of underlying legal questions, however, and thus the witnesses urged Congress to take action quickly even as the Federal Circuit considers an en banc hearing of the matter.
The U.S. Department of Justice (DoJ) has taken action to tamp down on False Claims Act (FCA) lawsuits. However, according to attorneys with the law firm of Gibson, Dunn & Crutcher LLP, the courts have come to different conclusions as to whether federal attorneys have appropriately dismissed FCA cases, a development that opens a new area of concern for drug and device makers.
