The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained finality, many in the pharmaceutical and biotechnology industries received the opinion under a cloud of uncertainty and concern for exclusivity rights broad enough to both protect clinical candidates and deter competitors. While the patent bar may remain apprehensive, the Supreme Court kept the door open to genus claims.  The impact of the decision may not be as far-reaching as feared.

At the center of the dispute were Amgen’s U.S. Patent Nos. 8,829,165 and 8,859,741, which are directed to genera of anti-PCSK9 antibodies. Instead of protecting the antibodies based on their sequence, these patents claimed the antibodies functionally by their ability to bind to a specific region on PCSK9 and their ability to block PCSK9 from binding and degrading the LDL receptor.

While the parties stipulated to infringement, the case still included two jury trials, two appeals to the CAFC, and the demise of the U.S.P.T.O.’s “antibody exception” for satisfying the written description requirement before arriving at the Supreme Court. The second jury found claims 19 and 29 of the ’165 Patent and claim 7 of the ’141 Patent not invalid for lack of written description and not invalid for lack of enablement. The district court then denied Sanofi’s motion for judgment as a matter of law regarding written description but granted its motion regarding enablement—overriding the jury’s determination.

On appeal, Amgen argued, inter alia, “that the embodiments in the patent are structurally representative for the purpose of fulfilling the written description requirement, and such evidence is sufficient to indicate a structure/function correlation establishing enablement.” The CAFC disagreed. Relying on its own precedent of In re Wands, the court affirmed the determination that the patents required undue experimentation to practice the full scope of the claims and accordingly were not enabled.

The CAFC reiterated that “[w]hile functional claim limitations are not necessarily precluded, such limitations pose high hurdles for fulfilling the enablement requirement for claims with broad functional language.” The court further stated (seemingly akin to the representative species analysis for written description) that: “[i]t is appropriate, however, to look at the amount of effort needed to obtain embodiments outside the scope of the disclosed examples and guidance.”

The Court took up the case to assess whether the CAFC applied a heightened enablement standard to genus claims. A multitude of amicus briefs were filed, with many warning of a potentially dire impact on investment in research and development. However, oral arguments dealt little with this issue. As discussed by the Court, the parties appeared to agree on the controlling law and appropriate standard. The parties’ dispute focused on the theoretical size of the claimed genus and the number of species necessary to enable the full scope.

In a unanimous decision, the Court implicitly affirmed In re Wands and the CAFC’s undue experimentation test for enablement. Relying on 19th and early 20th century precedent, the Court confirmed that the full scope of a claim must be enabled. However, the Court made clear that it is not necessary to describe how to make and use every embodiment within a genus. While the number of examples necessary to enable a claim will vary from case to case, the Court stated that “it may suffice to give an example (or a few examples) if the specification also discloses ‘some general quality running through’ the class that gives it ‘a peculiar fitness for the particular purpose.’”

Exactly how Amgen v. Sanofi will impact functional genus claims remains to be seen, but the Court kept the door open for finding such claims valid and enforceable. As the CAFC noted in its en banc decision Ariad v. Eli Lilly, “written description and enablement often rise and fall together.” Maybe Amgen’s argument tying the written description standard to the enablement standard was not that farfetched—enablement’s “general quality running through” and written description’s structure-function correlation are similar concepts with different emphasis. It remains the most prudent course for patent drafters to provide robust examples and clear guidance on how to make and identify species within a well-defined genus in order to ensure a patent can withstand validity attacks based on § 112.

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Photo of Fangli Chen Fangli Chen

Dr. Fangli Chen is a partner in the Litigation Department and chair of the Life Sciences Patent Practice. She represents all types of companies in the biotech and pharmaceutical industries, and has deep scientific expertise and a strong business sense. Fangli effectively identifies…

Dr. Fangli Chen is a partner in the Litigation Department and chair of the Life Sciences Patent Practice. She represents all types of companies in the biotech and pharmaceutical industries, and has deep scientific expertise and a strong business sense. Fangli effectively identifies and transforms technological developments into valuable intellectual property assets for her clients and specializes in the strategic development of complex IP portfolios for companies that align with their business goals.

Fangli’s practice also focuses on post-grant review before the USPTO, oppositions, pre-litigation and litigation strategy, due diligence investigations, freedom-to-operate, non-infringement and invalidity analysis, licensing and other IP matters in connection with commercial transactions. She handles a variety of technology areas including biochemistry, molecular and cell biology, immunotherapy, enzyme replacement therapy, nucleic acid based technologies including messenger RNA therapy, gene therapy, gene editing, antisense and oligonucleotides based therapies, vaccines, bioinformatics, and small molecule compound drugs.

Fangli also has a wealth of experience in the following areas:

  • Post-grant challenges: representing clients in inter partes review interference and various foreign opposition proceedings.
  • Technology transactions & licensing: advising clients on matters relating to technology or material transfer, licensing and research collaborations.
  • Investment or acquisition counsel: assisting investors in assessing the technology and intellectual property assets and risks for potential target investments and counseling companies on intellectual property matters in connection with public offering or acquisition.

Fangli has been repeatedly noted for her top-tier work by industry publications, including being listed as a World’s Leading Patent Practitioner by IAM Patent 1000 and recognized as one of the Top 250 Women in IP nationwide by Managing Intellectual Property. In 2019, she was named Patent Strategy & Management Attorney of the Year in Massachusetts by LMG Life Sciences. She has also been recognized by Best Lawyers in AmericaClient Choice, Legal 500Massachusetts Lawyers Weekly and Massachusetts Super Lawyers. Prior to joining Proskauer, Fangli was a partner at a leading Boston law firm.

Photo of Nicholas C. Prairie Nicholas C. Prairie

Nicholas (“Nick”) Prairie is an associate in the Litigation Department, and a member of the Life Sciences Patent practice. He works with life science and pharmaceutical clients of all sizes and counsels through the life cycle of U.S. and foreign patent assets.

Nick…

Nicholas (“Nick”) Prairie is an associate in the Litigation Department, and a member of the Life Sciences Patent practice. He works with life science and pharmaceutical clients of all sizes and counsels through the life cycle of U.S. and foreign patent assets.

Nick is experienced at conducting freedom-to-operate and patentability analyses to identify opportunities in crowded therapeutic fields, as well as developing and implementing prosecution strategies to support commercial efforts. He has prepared non-infringement and invalidity opinions, evaluated litigation risk, and developed potential litigation strategies. He has conducted infringement analyses and has prepared complaints for federal district courts and the International Trade Commission. Nick is also heavily involved in supporting opposition practice in Europe, on the sides of both Opponents and Patentees.

Nick’s technical expertise is diverse. While trained as a synthetic organic chemist, he works with an array of therapeutics in the chemistry space, including small molecules, macrolides, and multifunctional molecules, as well as therapeutics in the biotechnology space including antibodies, enzyme replacement therapies, engineered cells, nucleic acid-based therapies, and gene editing technologies. Prior to joining Proskauer, Nick was an associate at another Boston firm where he assisted in patent prosecution and district court litigation.

Before law school, he worked for about eight years as a chemist where he designed and synthesized a variety of pharmaceutically interesting compounds including; small molecules, peptides, peptide-drug conjugates, proteins, and protein-polymer conjugates, and is an inventor on several patents/patent applications. As a graduate student his research focused on natural product synthesis. In addition to staying up to date on the ever-shifting patent case law, Nick enjoys spending time with his dog and staying active.