AstraZeneca is throwing one last Hail Mary following a string of Big Pharma defeats challenging the legality of the Inflation Reduction Act (IRA) Medicare price negotiation program.
The British drugmaker has petitioned the Supreme Court, requesting a review of a unanimous decision by the Third Circuit Court of Appeals in May, which denied a due process claim.
In its petition, the company argues that the Medicare negotiation program “deprives AstraZeneca of its investment-backed patent rights and the right to sell its drug at market prices, without providing even the most rudimentary procedural safeguards."
With its prior appeal, AZ tried contesting a ruling that went against the drugmaker in March of 2024. At that time, a Delaware federal court ruled that because participation in Medicare is voluntary, AZ does not have the right to control the prices it charges on patented drugs.
AZ brought its IRA lawsuit in August of 2023 after its diabetes, heart failure and chronic kidney disease drug Farxiga was named as one of 10 products slated to face Medicare price cuts in 2026. Farxiga was the company’s best-selling drug last year, generating revenue of $7.7 billion, which was a 28% increase from 2023.
The company was one of several drugmakers that filed lawsuits, none of which have been successful.
AZ had hoped to be successful with a different approach in its claims, one of which is that Medicare price negotiations “run headlong into the goals” of the Orphan Drug Act. The 1983 legislation provides incentives to companies that create drugs for rare diseases.
This has been a rough month in court for other companies challenging the IRA program. Two weeks ago, a federal appeals court in Philadelphia unanimously rejected an effort by Novartis to overturn a lower court ruling.
A week before that, the same court dismissed a joint appeal from Bristol Myers Squibb and Johnson & Johnson, though that decision was split on the three-judge panel. The court is also weighing a Medicare price negotiation appeal from Novo Nordisk.
Also striking out in court with their IRA challenges have been Boehringer Ingelheim, Merck & Co. and industry association PhRMA.