On May 18, 2023, a groundbreaking verdict was reached in the Supreme Court case Amgen Inc. v. Sanofi. The court unanimously affirmed the Federal Circuit’s holding that U.S. Patent Nos. 8,829,165 and 8,859,741 did not enable certain functional genus claims describing a class of antibodies with unknown amino acid sequences.
This marks a significant milestone for patent law in the biotechnology sector, and corporate legal teams around the world need to pay attention to its potential impacts.
The key issue in this case revolved around two patents held by Amgen, both of which related to antibodies used for the treatment of hypercholesterolemia. However, rather than specifying exactly what these antibodies were in the patents, Amgen had instead described a broad “genus” of antibodies with particular functional characteristics.
However, the Federal Circuit ultimately agreed with Sanofi that these claims were not “enabled” because they did not provide sufficient guidance for a person of ordinary skill in the art to make and use the full scope of claimed genus without undue experimentation.
This is the first time since the Baxalta Inc. et al. v. Genentech, Inc. case that the Federal Circuit has evaluated enablement for antibody claims. The case acted as a significant precedent, placing limitations on the scope of antibodies that can be claimed under a single patent, a common practice that had previously drawn criticism for being susceptible to overbroad claiming, which could hamper innovation.
Given the current trend towards an incredible rate of medical and biotechnological advancement globally, this judgement makes it clear that careful patent drafting is more essential than ever. Legal professionals must guard against providing an overly broad or non-specific description of the technology at stake to avoid invalidation of their patents on the grounds of non-enablement.
Protection of intellectual property assets in the pharmaceutical industry relies heavily on having well-strategized and precisely-drafted patents. This judgement reiterates the importance of adhering to the fundamentals of patent law, ensuring that sufficient detail is provided to allow a person skilled in the art to recreate the patented invention without undue hardship.
For those in the legal profession, especially those working with biotechnology companies, this judgement is a reminder of the vital role that precise legal drafting and strategic patent prosecution play in maintaining robust intellectual property protection.