Sandoz Challenges Amgen's Enbrel Patents in Antitrust Lawsuit

Sandoz, the Swiss generics and biosimilars specialist, has filed an antitrust lawsuit against Amgen in federal court, challenging the pharmaceutical giant's patents on the blockbuster drug Enbrel. This legal action marks the latest chapter in an ongoing battle over biosimilar competition for the decades-old inflammatory disease treatment.

Patent Protection and Market Exclusivity

Enbrel, originally approved by the FDA in 1998, has maintained its market exclusivity in the United States due to Amgen's robust patent portfolio. The current patent protection is set to expire in 2029, a timeline that Sandoz aims to alter through its legal challenge.

The lawsuit, filed in Virginia, alleges that Amgen has unlawfully extended its monopoly on Enbrel by purchasing patent rights from Swiss pharma company Roche. Sandoz claims that without these acquired patents, Enbrel would have faced biosimilar competition as early as 2016, mirroring the situation in Europe.

Impact of Biosimilar Competition

The stark contrast between Enbrel's market performance in Europe and the United States underscores the potential impact of biosimilar competition:

• In Europe, where Sandoz launched its Enbrel biosimilar Erelzi in 2017, Enbrel's price reportedly declined by 50% within a year, with biosimilars capturing 40% of market share.
• Pfizer's Enbrel sales outside the U.S. and Canada plummeted from a peak of $3.8 billion in 2014 to $690 million in 2024.
• In contrast, Amgen's U.S. Enbrel sales remained robust at $3.3 billion in 2024, though down from $5.2 billion in 2019 due to competition from other products.

Legal Battles and Patent Challenges

This isn't the first time Sandoz has challenged Amgen's Enbrel patents. Previous legal efforts have been unsuccessful:

• In 2019, a New Jersey court ruled in favor of Amgen in a patent dispute with Sandoz.
• The U.S. Supreme Court declined to hear Sandoz's appeal in 2021.
• That same year, Amgen successfully defended its patents against Samsung Bioepis, preventing the launch of the biosimilar Eticovo.

Sandoz's current lawsuit seeks an injunction to prevent Amgen from using the disputed patent rights to block biosimilar competition. The company is also pursuing treble damages under antitrust law.

The outcome of this case could have significant implications for the U.S. pharmaceutical market, potentially opening the door for biosimilar versions of Enbrel to enter the market earlier than 2029. As the industry watches closely, the resolution of this legal battle may shape the future landscape of biosimilar competition in the United States.