As we first reported Friday in a news alert, a federal appeals court in Philadelphia has tentatively scheduled oral arguments in three key 340B contract pharmacy lawsuits for Nov. 15.
The clerk of the U.S. Third Circuit Court of Appeals on Sept. 21 informed lawyers for drug makers AstraZeneca, Novo Nordisk, and Sanofi, the federal government, and third parties that filed friend-of-the-court briefs about the tentative hearing date next month. The cases were not yet on the court’s calendar as of this morning. The clerk warned the lawyers that arguments might be moved to a different date during the week of Nov. 14.
The clerk’s announcement indicates that by mid-November all six 340B contract pharmacy cases in which a federal district judge has ruled will have been argued before an appeals court.
According to federal court statistics, it usually takes an appeals court about two months after oral arguments to issue a final ruling.
In all six cases, drug makers challenged May 2021 letters they got from the government telling them their refusals to provide 340B pricing to covered entities that use contract pharmacies were illegal and had to stop or the companies could face potentially crippling civil monetary penalties.
The four district judges who heard the six cases set aside and vacated the government’s 340B violation letters to the manufacturers. Their reasons varied.
The judges in AstraZeneca’s case and Novartis and United Therapeutics’ consolidated cases handed down decisions more favorable to the drug industry. The judges in Lilly case and in Novo Nordisk and Sanofi consolidated cases issued opinions more favorable to the government.
At the district court level, the six cases yielded four court rulings: (1) in Lilly’s case heard in Indiana, (2) in AstraZeneca’s case heard in Delaware, (3) in Novartis and United Therapeutics’ consolidated cases heard in New Jersey, and (4) in Novo Nordisk and Sanofi’s consolidated cases heard in Washington, D.C.
This appellate round probably will yield three court rulings: (1) in Lilly’s case heard before the Seventh Circuit Court in Chicago, (2) in Novartis and United Therapeutics’ consolidated cases heard before the District of Columbia Circuit Court, and (3) in Novo Nordisk and Sanofi’s consolidated cases plus AstraZeneca’s related case heard before the Third Circuit Court in Philadelphia.
The first oral arguments will be in Novartis and United Therapeutics’ consolidated cases, on Monday, Oct. 24.
The second will be in Lilly’s case, on Monday, Oct. 31.
The last will be in Novo Nordisk and Sanofi’s consolidated cases plus AstraZeneca’s related case, now set for Tuesday, Nov. 15.
If any of these cases reach the U.S. Supreme Court, the justices probably would not announce their decision until 2024 at the soonest, given the cases’ present status.