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  • Federal Circuit Finds Accused Infringer’s Reference To Covid-19 Fight Insufficient To Undo Invalidity Verdict

    On May 11, 2021, the United States Court of Appeals for the Federal Circuit (“CAFC”) issued an opinion affirming a judgement of the United States District Court for the District of Delaware finding all asserted claims of appellant’s patents on DNA-sequencing technology invalid and denying appellant’s motion for a new trial.  Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., __ F.3d __ (Fed. Cir. May 11, 2021).  In its decision, the CAFC upheld a jury verdict finding the asserted claims invalid under 35 U.S.C. § 112 for lack of enablement, and affirmed the district court’s decision that appellee’s opening statement respecting the impact of the trial on the fight against Covid-19 did not warrant a new trial.

    Appellant filed its patent infringement suit in the District of Delaware in 2017.  The asserted patent claims describe methods for sequencing nucleic acids, e.g., DNA, in which a nucleic acid is drawn through nanopores formed in a substrate so that sequences of nucleotides can be identified based on changes in electric current passing through the substrate.

    Before trial, the district court granted appellant’s motion in limine (“MIL”) to prevent appellee from presenting evidence about the consequences of the litigation.  The trial began on March 9, 2020.  The night before, appellee told appellant that it planned to mention the relevance of the DNA-sequencing technology at issue to the fight against Covid-19 in its opening statement.  Appellee, however, exceeded its notice during opening remarks when it made references to appellant seeking to exclude appellee’s products from efforts to combat Covid-19 and to previous litigation between the parties.
    Appellant objected, and the district court criticized appellee for violating its MIL order.  The district court also agreed to give curative instructions to the jury, including one clarifying that only money damages are being sought by appellant, not the exclusion of appellee’s products or research.  Ultimately, the jury found all asserted claims infringed, but invalid for lack of enablement.

    Appellant moved for judgment as a matter of law (“JMOL”) on enablement, and for a new trial based on appellee’s opening statement regarding Covid-19.  The district court denied both motions.

    With respect to the JMOL, appellant argued that the jury's verdict of non-enablement was unsupported by substantial evidence.

    A claim is not enabled if a relevant artisan would not be able to practice the claimed invention without undue experimentation, a determination typically guided by the following factual considerations (Wands factors):  (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.  The CAFC focused on the last factor, the scope of the asserted claims, which in this case, noted the CAFC, do not differentiate between particular types of DNA.

    In arguing for JMOL, appellant relied primarily on appellee’s expert’s deposition testimony, that a person of ordinary skill in the art would have been able to successfully perform the asserted claims if they had reviewed a particular grant application to the National Institutes of Health made prior to the filing of the asserted patents.

    In upholding the jury verdict of non-enablement, the CAFC concluded that the jury could have understood appellee’s expert to be saying no more than that a relevant artisan could have performed the asserted claims on the particular subset of nucleic acids addressed in the grant application.  In support of this conclusion, the CAFC noted that the jury could have relied, for example, on other testimony from appellee’s expert, that the asserted claims lack enablement respecting a limitation requiring a determination of how many nucleotides affect the current measurement during transit of nucleic acid through the nanopores.  Another witness also testified that the full scope of the asserted claims was not enabled until well after the filing of the asserted patents.  Also, noted the CAFC, appellant offered no evidence of actual reduction to practice.

    The CAFC next reviewed the district court’s decision denying appellant’s request for a new trial for an abuse of discretion that resulted in a miscarriage of justice.  It found none.

    The CAFC explained that a new trial based on improper remarks is only warranted if it is reasonably probable the remarks influenced the jury’s verdict.  In this case, noted the CAFC, appellant itself mentioned the possible connection between Covid-19 and the technology at issue in its opening statement.  And despite knowing that appellee would mention Covid-19 in its opening, appellant did not object in advance.  When appellee, in its opening statement, made a considerably more extended mention of Covid-19 and appellant’s alleged effort to exclude appellee’s products, appellant objected as a violation of the MIL order. The district court agreed and gave exactly the curative instructions that appellant requested.  Not until after the verdict, noted the CAFC, did appellant request a new trial based on appellee’s opening statement.

    In the CAFC’s view, the curative measures, as well as appellant’s decision to proceed with the trial, supported the district court’s decision denying a new trial.  The CAFC found that it was also reasonable for the district court to infer a lack of prejudice based on the questions the jury asked before reaching its verdict and based on the jury’s distinction of a written-description challenge (which it rejected) from the enablement challenge (which it accepted).