PacBio’s claims not enabled for “full scope of nucleic acids covered”; Oxford’s COVID-related statements not prejudicial

Pacific Biosciences of California, Inc. v. Oxford Nanopore Techs., Inc.

Docket No. 2020-2155, -2156 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-2155.OPINION.5-11-2021_1776046.pdf)

LOURIE, TARANTO, STOLL

May 11, 2021

Brief Summary:  Lack of enablement finding affirmed (e.g., “relevant artisans did not know how to perform nanopore sequencing for more than a narrow range of the full scope of nucleic acids covered”).

Summary:  PacBio appealed DC denial of its motion for a new trial after a jury found the claims of US 9,546,400 and 9,772,323 infringed but invalid for lack of enablement (35 U.S.C. section 112).  The DC also rejected PacBio’s argument that Oxford’s opening remarks regarding “the potential application of its accused products to the then-emerging global COVID-19 crisis” prejudiced the jury against PacBio.  The ‘400 and ‘323 patents are based on the same specification, claim priority to a 2009 provisional application, and claim methods for using nanopore membranes for nucleotide sequencing.  The FC panel explained that a claim is not enabled if “undue experimentation” is required to practice it and reviewed the eight Wands “factual considerations” (quantity of experimentation required, direction or guidance provided, working examples, nature of the invention, relative skill, predictability, and claim breadth) (McRO, FC 2020; AK Steel, FC 2003; Amgen, FC 2021; In re Wands, FC 1988; MagSil, FC 2012 (“[A] patentee chooses broad claim language at the peril of losing any claim that cannot be enabled across its full scope of coverage.”)).  The FC panel concluded the claims were not enabled because, e.g., the jury correctly considered expert testimony regarding whether “a skilled artisan could make and use the full scope of the invention” (“the full range of ‘nucleic acid templates’”), evidence “that the first successful nanopore sequencing…did not occur until 2011”, that “the audience” at Oxford’s 2012 announcement of success in using nanopore sequencing “reacted in a way that suggests that the advance…was a major one”, and “PacBio acknowledged…its reduction to practice was constructive only” (i.e., in the patent applications but not in the “real-world”).  The FC panel found the evidence showed that “before the 2009 priority date of the ’400 and ’323 patents, relevant artisans did not know how to perform nanopore sequencing for more than a narrow range of the full scope of nucleic acids covered by the asserted claims” (Enzo, FC 1999 (“very narrow” working examples may not enable broad claims)).  The lack of enablement determination was therefore affirmed.  The FC panel also found “no abuse of discretion in the district court’s determination that [Oxford’s] opening remarks were not sufficiently likely to have influenced the jury to create a miscarriage of justice” and affirmed the DC’s denial of a new trial on this basis. 

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