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Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit

On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s Neulasta and Neupogen.  Judge James Cohn of the Southern District of Florida ruled in Apotex’s favor in September 2016 after a bench trial.  On appeal, the Federal Circuit found sufficient evidence in the record to support the judgment of noninfringement.

Neulasta and Neupogen are blockbuster biologic medicines that are used to help cancer patients on chemotherapy fight off infections.  Amgen’s U.S. Patent No. 8,952,138 (the ‘138 patent), which is directed to methods for refolding proteins made in non-mammalian cells at high concentrations, and which Amgen accused Apotex of infringing, is part of the manufacturing process for both.  In its decision dismissing Amgen’s suit, the district court found that the protein concentrations in Apotex’s processes were not as high as those required by the patent and therefore did not infringe the elements of the asserted claims requiring specific protein concentrations.

Amgen argued on appeal, among other things, that the district court failed to consider pre-litigation letters sent by Apotex to Amgen pursuant to the pre-suit exchange described in the Biologics Price Competition and Innovation Act.  Apotex’s letters had articulated a position on the protein concentration levels in its manufacturing process that contradicted the position ultimately adopted by Apotex at trial.  In fact, Apotex’s expert testified at trial that the letters were factually incorrect.  Amgen argued at trial that Apotex’s letters were party admissions proving its theory of direct infringement. The district court disagreed, ruling that the letters “are not probative of the issue of protein concentration.”

The Federal Circuit did not disagree with the premise of Amgen’s argument; it confirmed that letters sent during the BPCIA’s information exchange were party admissions that could not simply be ignored.  The Federal Circuit noted, however, that the pre-litigation letters were not binding on Apotex; they were not dispositive of infringement.  Amgen did not dispute this point in its appeal, but instead argued that the district court had effectively ignored the letters by stating they were “not probative.”  The Federal Circuit disagreed.  It found that the district court had considered the probative value of the letters; it simply found that whatever value they had was outweighed by the credible and contradictory testimony of Apotex’s expert. 

The Federal Circuit also rejected Amgen’s other arguments, finding that the district court did not err in its claim construction analysis or in interpreting the scope of Apotex’s Biologics License Applications permit.  Despite its win, Apotex has not yet received FDA approval of its applications for Neulasta or Neupoegen biosimilars, which were submitted in 2014.  Other biosimilar makers have encountered hurdles in gaining approval for Neulasta biosimilars.  Barring en banc or Supreme Court review, however, the Federal Circuit’s decision means that the remaining barriers to a Neulasta biosimilar are technological or regulatory rather than legal.  

The Federal Circuit affirmed the dismissal of Amgen’s claims against Apotex related to proposed biosimilars of Neulasta and Neupogen.  The Court held that while letters exchanged during the patent dance constitute party admissions, the district court properly weighed their probative value.