The United States Supreme Court case, Amgen Inc. v. Sanofi, has significant implications for patent law, particularly in the realm of pharmaceuticals and biotechnology. This case revolved around the enablement requirement of the Patent Act, 35 U.S.C. § 112 (a).

Background

Amgen and Sanofi, two pharmaceutical giants, each obtained a patent in 2011 for the antibody used in a PCSK9-inhibiting drug. PCSK9 is a naturally occurring protein that degrades LDL receptors responsible for extracting LDL cholesterol from the bloodstream. High levels of LDL cholesterol can lead to cardiovascular disease, heart attacks, and strokes.

Amgen later obtained two additional patents in 2014 that claimed the entire genus of antibodies that bind to specific amino acid residues on PCSK9 and block PCSK9 from binding. These patents were based on the description of 26 antibodies and methods for making other antibodies that perform the described functions.

The Dispute

Amgen filed a suit against Sanofi alleging infringement of multiple patents, including the two at issue in this case. The jury concluded that the patents were not invalid for lack of written description and enablement. However, the U.S. Court for the Federal Circuit reversed and remanded, finding the jury instructions regarding enablement were erroneous.

On remand, the court ruled in favor of Sanofi on the issue of lack of enablement and for Amgen on the issue of lack of written description. Amgen appealed, and the Federal Circuit affirmed the district court’s determination that the asserted claims were invalid for lack of enablement.

The Supreme Court’s Decision

The Supreme Court agreed with the lower courts that Amgen’s patents were invalid for lack of enablement. The Court held that the patents failed to describe the invention in a way that would enable any person skilled in the art to make and use the entire scope of the claimed invention. Regarding the teaching in Amgen’s patent specification, the court opined that the patents described little more than a “research assignment”.

Justice Neil Gorsuch delivered the unanimous opinion of the Court. The Court affirmed that if a patent claims an entire class of process, machines, manufactures, or compositions of matter, its specification must enable a person skilled in the art to make and use the entire class.

The Supreme Court’s decision in Amgen Inc. v. Sanofi was based on a detailed analysis of the enablement requirement of the Patent Act. The Court began its analysis with a detailed description of three of its seminal enablement cases: O’Reilly v. Morse, 15 How. 62, The Incandescent Lamp Patent, 159 U.S. 465, and Holland Furniture Co. v. Perkins Glue Go. 277 U.S. 245. These cases stand for the proposition that if a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.

Sanofi contended that Amgen’s patents failed to meet this standard because they sought to claim for Amgen’s exclusive use potentially millions more antibodies than the company had taught scientists to make. The techniques Amgen offered to generate each of the potentially millions of antibodies in the claimed genus would not reliably yield a desired antibody without “painstaking experimentation”.

In the end, both the district court and the Federal Circuit sided with Sanofi. The Supreme Court agreed with the lower courts that Amgen’s patents were invalid for lack of enablement. The Court held that the patents failed to describe the invention in a way that would enable any person skilled in the art to make and use the invention.

Implications on Biotechnology Patenting

The decision in Amgen Inc. v. Sanofi has significant implications for patents on biological products (biologics) and for innovation and competition in the pharmaceutical industry. It underscores the importance of the enablement requirement in patent law and the need for patent applicants to provide sufficient detail in their patent specifications.  While Amgen strove to leave the blackletter law of patent enablement unaltered by relying heavily on its enablement precedents, its application of those cases to modern pharmaceutical patents will likely make it harder in practice to patent functionally described genus claims, particularly for biologics.

The U.S. Patent and Trademark Office (USPTO) has now issued much-anticipated patent examiner guidance that takes into account the implications of the Amgen decision. 

Resources:

Amgen Inc. v. Sanofi https://www.supremecourt.gov/opinions/22pdf/21-757_k5g1.pdf

Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et. Al. https://www.federalregister.gov/documents/2024/01/10/2024-00259/guidelines-for-assessing-enablement-in-utility-applications-and-patents-in-view-of-the-supreme-court