While the FDA has yet to take a stance on whether risk evaluation and mitigation strategy (REMS) patents can be listed in its Orange Book, the U.S. Court of Appeals for the Federal Circuit weighed in Feb. 24 with a decisive “no” when those patents only claim a system.
Neither the courts nor the Department of Health and Human Services (HHS) get to fill in the gaps in the law that created the 340B prescription drug discount program, the U.S. Court of Appeals for the Third Circuit said, as it struck down HHS’ interpretation that requires drug companies to provide the drug discounts to an unlimited number of contract pharmacies.
As the FDA has in the past when a court issued an opinion it didn’t agree with, the U.S. agency is trying to limit the fallout from an appellate court ruling in Catalyst Pharmaceuticals Inc. vs. Becerra, which involved the breadth of orphan drug exclusivity, to that case alone.
Citing federal preemption, the U.S. Court of Appeals for the First Circuit tossed multidistrict litigation (MDL) involving GSK plc’s labeling of Zofran, an antiemetic approved for postoperative use and in conjunction with chemo or radiation, but that is commonly used off-label in pregnancy.
Upholding a 2021 jury verdict against a hedge fund adviser accused of making fraudulent statements to drive down Ligand Pharmaceuticals Inc.’s stock price, the U.S. Court of Appeals for the First Circuit shot down Gregory Lemelson’s arguments that his statements related to the company and its lead drug, Promacta (eltrombopag), were opinions protected by the First Amendment and that they were not material.
The government in France has just launched the Health Innovation Agency. This new government agency aims to improve identification of future health technology and better anticipate the impact of innovation in France.
How many patents does it take to violate U.S. antitrust law? That question isn’t a lead-in to a lame joke. Neither is it a valid question for a patent challenge, according to the U.S. Court of Appeals for the Seventh Circuit, which Aug. 1 affirmed the dismissal of a payer suit against Abbvie Inc. that claimed the North Chicago drug company violated the Sherman Antitrust Act when it obtained 132 patents on Humira (adalimumab) and then invoked them against biosimilars.
Although Pfizer Inc. has the only drugs approved in the U.S. to treat a rare, progressive heart disease, the U.S. Court of Appeals for the Second Circuit agreed this week with the Department of Health and Human Services, and a lower court, that Pfizer’s proposed copay assistance program for middle-income Americans covered by Medicare would violate the federal Anti-Kickback Statute – even if the company has no “corrupt” intent.
Novartis AG is not going quietly into the night after the U.S. Court of Appeals for the Federal Circuit reversed itself, invalidating a method patent covering a dosing regimen for the company’s blockbuster multiple sclerosis drug, Gilenya (fingolimod). After the split opinion came down June 21 from the three-judge panel, Novartis said it planned to file a petition seeking further review of the decision by the full court.
