JNJ, BMS’s IRA Loss Is First Time Court Rejects Industry’s First Amendment, Takings Claims

The fourth court loss for pharma in industry's attempts to kill Medicare’s drug price negotiation program adds to the list of reasons courts have rejected legal challenges to the Inflation Reduction Act.

toddler making a mess eating spaghetti
Pharma has thrown a lot of spaghetti at the wall in its IRA fight, but so far nothing has stuck. • Source: Shutterstock

Janssen Pharmaceutical Cos. and Bristol Myers Squibb Company failed to convince a district court judge that the Inflation Reduction Act’s drug price negotiation program violates the drug industry’s First Amendment rights, the Takings Clause of the Fifth Amendment or the Unconstitutional Conditions Doctrine, per a summary judgement issued in favor of the government 29 April.

The opinion from Judge Zahid Quaraishi of the United States District Court in the District of New Jersey, adds to the list of industry’s legal arguments that have failed...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Litigation

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By 

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

More from Legal & IP

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By 

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.