SCOTUS Denies Cert to Pharma Industry Challenges to IRA's Negotiation Program, USAA's Section 101 Patent Appeal

"Today, the U.S. Supreme Court issued an order list denying a series of petitions for writ of certiorari filed by major pharmaceutical developers to challenge the Medicare negotiation program established by the Inflation Reduction Act (IRA). The Supreme Court also denied cert to an appeal of Section 101 patent-eligibility issues from a Federal Circuit ruling involving mobile banking technology, as well as a pro se cert appealing copyright and intentional infliction of emotional distress (IIED) against Disney."

"Enacted by Congress in August 2022, the IRA established a Drug Price Negotiation Program codified at 42 U.S.C. § 1320f that establishes maximum prices to be paid by the U.S. government for drugs eligible for Medicare Part B or Part D coverage. Though styled as a voluntary process, pharmaceutical firms have raised issues with excise taxes for noncompliance that, by some measures, reach as high as 1900% of daily sales. Several drugmakers as well as the U.S. Chamber of Commerce filed suit to oppose the program based on several constitutional claims, including due process and takings claims under the Fifth Amendment and compelled speech claims under the First Amendment."

"Despite the chilling effects on new drug development being reported by pharmaceutical executives, legal challenges to the IRA's negotiation program continue to fail. In August 2025, both Boehringer Ingelheim and the U.S. Chamber of Commerce lost out on their respective appeals, with Boehringer failing to prove its constitutional claims and the U.S. Chamber case being tossed for lack of associational standing. In the months following those rulings, appeals from Teva Pharmaceuticals, Novo Nordisk, and both Janssen Pharmaceuticals and Bristol Myers Squibb (BMS) appealing jointly were all nixed by circuit courts."

"Janssen noted [in its SCOTUS petition] that it could be liable for excise taxes approaching $600 million per day... while BMS feared facing up to $1 billion per day in liability."

The U.S. Supreme Court denied multiple petitions for writ of certiorari. The denials included challenges to the Medicare Drug Price Negotiation Program created by the Inflation Reduction Act in August 2022. The program sets maximum prices the U.S. government pays for eligible Medicare Part B and Part D drugs, codified at 42 U.S.C. § 1320f. Pharmaceutical firms challenged the program despite being labeled voluntary, citing excise taxes for noncompliance that can reach very high levels of daily sales. The challenges asserted constitutional violations including due process and takings under the Fifth Amendment and compelled speech under the First Amendment. Prior appeals by Boehringer Ingelheim and the U.S. Chamber of Commerce also failed, and later appeals by Teva, Novo Nordisk, and Janssen and Bristol Myers Squibb were rejected by circuit courts.

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