U.S. Supreme Court Rules Against Amgen In Cholesterol Drug Patent Dispute With Sanofi

(RTTNews) - The U.S. Supreme Court ruled against Amgen (AMGN) in a long-running patent battle with Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) over cholesterol drug, Repatha.

The ruling affirmed the United States Federal Circuit Court's opinion that Amgen's asserted U.S. PCSK9 patent claims are invalid.

Two pharmaceutical companies—Amgen and Sanofi—each developed a PCSK9-inhibiting drug. In 2011, Amgen obtained a patent for the antibody employed in its drug, and Sanofi received one covering the antibody used in its drug. Each patent describes the relevant antibody by its unique amino acid sequence.

The dispute in the case concerns two additional patents Amgen obtained in 2014 that relate back to the company's 2011 patent.

After Amgen obtained the 2014 patents, it sued Sanofi for infringement. Sanofi replied that it was not liable to Amgen for infringement because Amgen's relevant claims were invalid under the Patent Act's "enablement" requirement. That provision requires a patent applicant to describe the invention "in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the invention.

Sanofi characterized the methods Amgen outlined for generating additional antibodies as amounting to little more than a trial-and-error process of discovery, and thus contended that Amgen's patents failed to meet the enablement requirement because they sought to claim for Amgen's exclusive use potentially millions more antibodies than the company had taught persons skilled in the art to make. Both the district court and the Federal Circuit sided with Sanofi.