Docket No. 2017-1010
LOURIE, O’MALLEY, TARANTO
November 13, 2017
Brief summary: DC decision of no infringement of Amgen’s process patent by Apotex’s ABLA applications regarding Amgen’s Neulasta® and Neupogen® affirmed.
Summary: Amgen appealed DC conclusion that Amgen failed to prove that Apotex’s marketing of two products pursuant to Amgen’s BLA’s (125031 and 103353 for pefilgrastim (Neulasta®) and filgrastim (Neupogen®)) would infringe US 8,952,138 directed to “[a] method of refolding a protein”, either literally or under the DOE. Apotex filed for approval of those products in abbreviated BLA Nos. 761026 and 761027 under 42 USC § 262(k), Neulasta® and Neupogen® being the reference products. The parties engaged in the information exchange described in the BPCIA, 42 U.S.C. § 262(l)(3) (Sandoz, US 2017), and Amgen identified the ‘138 patent as one Apotex’s proposed products would infringe. Apotex provided Amgen “a detailed statement describing, claim by claim, the factual and legal basis for its opinion that it did not infringe”, with which Amgen did not agree. Amgen then filed infringement suits for each of Apotex’s applications (§ 271(e)(2)(C), (a) and (g)), which were consolidated. The FC panel opinion explains that the limiting preamble of sole independent claim 1 “calls for protein present in ‘a volume at a concentration of 2.0 g/L or greater.’” Amgen argued “the claimed ‘volume’ was the volume of protein before, not after, the contact with the refolding buffer that forms the refold mixture” (from which the protein is ultimately isolated) that “based on the specification…must have a protein concentration at or above 1.0 g/L.” Apotex argued “‘volume’ refers to the refold mixture” which “must”, therefore, “have protein concentration of 2.0 g/L or more.” The DC agreed with Amgen, about which Amgen alleged only literal infringement. Based on Apotex’s expert testimony that “‘pre-litigation’ letters” were “factually incorrect” and explaining that “the inclusion bodies in Apotex’s process were not pure protein, but, rather, were a paste of which about two-thirds was water”, however, the DC found “Amgen had failed to prove” literal infringement “by a preponderance of the evidence”. The FC panel agreed, concluding the DC did not ignore the “factually incorrect” pre-litigation letters and that those letters “do not render the finding of fact regarding the protein concentration clearly erroneous.” The FC panel also disagreed with Amgen’s “protein concentration” argument (i.e., it is “interchangeable with ‘washed-inclusion body concentration’”), finding “the specification pervasively disproves rather than supports” it (e.g., it “repeatedly makes clear that the proteins are the same as, but instead are ‘in’ or ‘deposit[ed]…into’ or ‘disposed in’, the ‘aggregates’ called ‘inclusion bodies’”, “the language of ‘expressed in the form of’ does not imply interchangeability”). The FC panel also disagreed with Amgen that the DC’s “noninfringement finding rests on too restrictive a view of Apotex’s FDA applications” and contrary to the FC’s Sunovion (FC 2013) decision. The difference, the FC panel explained, is that in Sunovion the ANDA “on its face, authorized the applicant to engage in actions that would, in fact, infringe the patent in question” while here “in contrast,”, the DC “had a sufficient basis” (e.g., expert testimony) “for reading Apotex’s applications as not authorizing processes that infringe, indeed, as constraining the process to non-infringing levels” (“the most that we could conclude…is that they are silent on the point” (Glaxo, FC 1997 (the court looked to extrinsic evidence, such as the samples and data submitted to the FDA)). Regarding Amgen’s argument that “Apotex failed to provide batch records for the other 89 times it has run the process”, the FC panel explained that “it was not Apotex’s burden to prove non-infringement” but “Amgen’s burden to prove” infringement. Thus, the DC decision was affirmed.