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On November 13, 2017, the U.S. Court of Appeals for the Federal Circuit upheld the District Court verdict in Amgen v. Apotex (Amgen v. Apotex, No. 2017-1010, slip op. at 3 (Fed. Cir. Nov. 13, 2017), in which the court ruled that the commercial marketing of Apotex's proposed biosimilar versions of Amgen's Neulasta® and Neupogen® do not infringe Amgen's U.S. Patent No. 8952,138 (the '138 patent). The claims of the ‘183 patent are directed to a method of refolding recombinant proteins expressed in non-mammalian cells. At the center of the dispute was whether information provided during the information exchange process of the “Patent Dance” pursuant to 42 U.S.C. § 262(Ɩ)(3) can later be used as evidence during a District Court patent infringement litigation.
The '138 patent is generally directed to a method of refolding misfolded proteins, known as "inclusion bodies,” expressed in non-mammalian cells. Claim 1 of the '138 patent recites a "refold mixture" and specific protein concentrations that the District Court interpreted as a high protein concentration "at or above 1 g/L." As part of the Patent Dance, Apotex stated in several "pre-litigation letters” that it did not infringe Amgen's '138 patent because the relevant inclusion body concentration in its product was limited to 0.9-1.4 g/L. Apotex's abbreviated Biologics License Application, or aBLA, also identified the relevant inclusion body concentration in its product to be in the range of 0.9-1.4 g/L. During the infringement trial, however, Apotex's fact witness testified that the "pre-litigation letters" were "factually inaccurate," and Apotex presented two batch records showing the protein concentration in its "refold mixture" never exceeded 0.56 g/L. Based on this new evidence, the District Court sided with Apotex and found that Amgen had failed to prove direct infringement of the '138 patent. On appeal to the Federal Circuit, Amgen argued that the District Court erred, in part, in finding that Apotex's "pre-litigation letters" lacked probative value. On this issue, the Federal Circuit found that the District Court properly considered the statements in the "pre-litigation letters" and properly found that they lacked probative value in light of the other evidence presented at trial. The Federal Circuit also noted that Amgen did not present any evidence to contradict the statements from Apotex's fact witness, and furthermore, did not attempt to challenge the accuracy of the witness's testimony. In its decision, the Federal Circuit clarified that statements made in the "pre-litigation letters" are party admissions and therefore have some probative value. The Federal Circuit’s decision underlines the importance of statements made during the Patent Dance and their potential use in a subsequent patent infringement litigation. Parties on both sides should be careful of what they say during the Patent Dance exchange because, as clarified by the Court in this decision, such statements are treated as party admission. These statements therefore carry probative weight and must be considered in view of other evidence presented at trial. This decision also further emphasizes the importance of fact witness testimony and other evidence to support arguments regarding infringement. To this end, the parties in a biosimilars patent infringement litigation should be prepared to rebut or support these statements with their own expert witness testimony and other intrinsic and/or extrinsic evidence.
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