Amgen Drops Alexion Blood Drug IPRs, Gets 2025 License

By Dani Kass

Law360 (June 2, 2020, 9:10 PM EDT) — Amgen has agreed to drop three challenges to patents covering Alexion’s blockbuster blood disorder treatment Soliris in exchange for a license that would let it make and sell a biosimilar version two years before the patents expire.

Alexion Pharmaceuticals Inc. disclosed the deal in a U.S. Securities and Exchange Commission filing Friday, and then joined Amgen Inc. in asking the Patent Trial and Appeal Board to terminate the inter partes reviews. The board officially did so Monday.

“Upon consideration of the facts before us, we determine that it is appropriate to terminate the above proceedings and enter judgment, without rendering a final written decision,” the PTAB wrote.

The settlement is mostly confidential, beyond saying Amgen would be granted a nonexclusive, royalty-free license starting on March 1, 2025. All three patents are set to expire on March 15, 2027.

Soliris, or eculizumab, treats paroxysmal nocturnal hemoglobinuria, which Johns Hopkins Medicine describes as a “rare acquired, life-threatening disease of the blood.”

The biologic is Alexion’s top-selling product by a landslide, bringing in more than $2 billion in 2019 in the U.S. alone and almost another $2 billion around the world, according to an SEC filing. That’s more than six times as much as the company’s next drug.

Amgen had requested the IPRs in February 2019, and the board instituted them that August. Combined oral arguments in the three cases had been scheduled for June 16. The companies were not engaged in other litigation over these patents.

Representatives for Amgen and Alexion confirmed the public details of the settlement.

The patents-in-suit are U.S. Patent Nos. 9,732,149; 9,725,504; and 9,718,880.

Amgen is represented by Deborah Sterling, David Holman, Scott Schaller and David Roadcap of Sterne Kessler Goldstein & Fox PLLC.

Alexion is represented by Gerald Flattmann Jr., Lori Gordon, Vanessa Yen and Evan Diamond of King & Spalding LLP.

The cases are Amgen Inc. v. Alexion Pharmaceuticals Inc., case numbers IPR2019-00739, IPR2019-00740 and IPR2019-00741, before the Patent Trial and Appeal Board.

–Editing by Jack Karp.