On March 27, oral argument was held before the Supreme Court (read here) in what promises to be a landmark decision for patent law, Amgen v. Sanofi.  Jeffrey Lamken argued on behalf of the patentee, Amgen, and Paul Clement argued for Sanofi, with support from the DOJ attorney, Colleen Sinzak, who also supports the Federal Circuit enablement test at issue.

 

After winning two jury verdicts with respect to blockbuster cholesterol-lowering drugs, Amgen had their patent claims invalidated by the Federal Circuit for lack of enablement, resulting in this appeal.  The claims at issue are genus claims with functional language, including this one:

 

1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.

 

Amgen’s patents fully described the amino acid sequence for 26 embodiments meeting claim 1, and provided the roadmap for making others.  Both sides agree that there may be millions of distinct sequences that meet the claim language, most of which are unknown, but most of which can be made by substitution of analogous amino acids in some locations.  The Federal Circuit found that the millions of potential embodiments were not enabled.  Although Mr. Clement and Ms. Sinzak both said the Federal Circuit decision was correct, there was not a vigorous defense of the Federal Circuit’s “full scope of enablement” test, which has been interpreted by some to require that those skilled in the art must find in the patent disclosure enough detail to cumulatively identify and make all or nearly all embodiments of the claimed invention without substantial cumulative time and efforts.

 

The justices spent a large portion of the argument time asking questions related to the amount of effort required to make other embodiments.  According to Mr. Lamken, no one (other than the Federal Circuit) would ever want to find them all, and Mr. Lamken assured the justices that making new embodiments according to the “roadmap” in Amgen’s patents was routine in the industry, largely automated, and did not involve undue experimentation.  He also pointed out that there was no evidence at trial that anyone had difficulty making embodiments as described in the patents.

 

Mr. Clement and Ms. Sinzak countered interestingly, not by relying heavily on trial evidence, but instead on an amicus brief filed by a Nobel-prize winning scientist, Sir Gregory Winter, which supported the position that Amgen’s roadmap randomly produces antibodies that still must be tested for proper function, and also be tested for infringement, as a potential infringer that finds a workable formulation would then have to test its binding to PCSK9 to determine whether it infringes.  They argued that such testing was burdensome and undue, mainly because of the functional way in which Amgen’s claims were drafted.

 

There was also substantial discussion regarding a legal paper, The Death of the Genus Claim, D. Karshted et al., Harvard Journal of Law & Technology, vol. 35, no. 1 Fall 2021, which mapped the evolution of the Federal Circuit’s current enablement test and its potential effect in discouraging expensive research that cannot be effectively protected.  It was claimed that one of the authors of this paper did not think Amgen’s claims should survive.  The law professor has also mused that the doctrine of equivalents would perhaps be a solution and replacement for functional genus claiming.  Mr. Lamken claimed that such an approach would not work and would stifle research.

 

It is potentially concerning that the Court may give weight to what is essentially an end run around trial expert testimony by relying on Winter’s “expert” legal brief, or that it will be moved in a direction by a law professor’s views on enablement and economic impact, rather than returning to a proper construction of the statute itself.  Although oral argument does not necessarily inform which way the Court will decide, it seems unlikely that Amgen’s claims will be found enabled, and it seems unlikely that the Court will endorse the current Federal Circuit test as it stands.  If anything, the Court could be expected to expand on its own prior jurisprudence regarding undue experimentation to “update” the tests for current technology, where machine and computer automation assists in many areas of research.  Given the Court’s struggles with the functional aspect of the genus claims at issue, it seems likely that we will soon have a new interpretation of whether, and under what circumstances, a functional genus claim can be enabled.