Docket Nos. 2018-1551 and -1552

LOURIE, O’MALLEY, REYNA
May 8, 2019

Brief summary: DC claim construction findings and grant of SJ of non-infringement to Sandoz regarding its Neupogen® and Neulasta® biosimilars affirmed.

Summary: Amgen appealed two DC decisions finding Sandoz’s biosimilars to Amgen’s Neupogen® and Neulasta® (filgrastim (a recombinant analog of granulocyte-colony stimulating factor (“G-CSF”) and pegfilgrastim (polyethylene glycol (“PEG”)-conjugated filgrastim) do not infringe claim 7 of Amgen’s US 8,940,878 (by Summary Judgment (“SJ”)) directed to “[a] method of purifying a protein” by particular steps and using a non-affinity separation matrix. In 2014, Sandoz submitted an abbreviated Biologics License Application (“aBLA”) referencing Neupogen® to the FDA to market a biosimilar filgrastim product but “elected not to provide Amgen with its eBLA or manufacturing information” (§ 271(e)(2)(C) (submission of an aBLA is an act of patent infringement), 42 USC § 262(1)(9)(C)). Amgen then “filed a complaint for, inter alia, a declaration judgment that Sandoz’s proposed biosimilar would infringe” Amgen’s US 6,162,427 directed to “[a] method of treating disease” using G-CSF and “a disease treating-effective amount of at least one chemotherapeutic agent.” In 2015, the FDA approved Sandoz’s application and Sandoz launched Zarxio, after which “Amgen amended its complaint to plead infringement of the ‘878 patent” (§ 271(e)(2)(C)(ii), (g)). Sandoz then “submitted an aBLA for a biosimilar pegfilgrastim product referencing Neulasta®” (not yet approved), and Amgen filed a complaint for infringement of the ‘878 patent. Amgen stipulated to noninfringement of the ‘427 patent following the DC’s claim construction of the chemotherapeutic agent limitation. The DC “treated the Neupogen® and Neulasta® cases together” with respect to the ‘878 patent and “construed limitations (f) and (g) of claim 7 (the ‘washing’ and ‘eluting’ steps) as separate steps and further clarified that the eluting step ‘must occur after the step of ‘washing the separation matrix’”). The FC panel opinion explained that “it is undisputed that Sandoz’s process only involves one step-applying the refold solution to the matrix, with no separate washing or eluting steps” and that, therefore, the DC granted Sandoz SJ of noninfringement. In this appeal, Amgen argued the DC “misconstrued the ‘washing’ and ‘eluting’ claim limitations…as requiring distinct solutions added to the matrix at different times” since “the claims cover any number of solutions of steps as long as the functions of washing and eluting happen in sequence” (“the claim construction only generally requires that washing precede elution”; “Amgen’s argument…at its core, [is] that the ‘washing’ and ‘eluting’ limitations describe functions, rather than actual process steps”). Sandoz countered “that the claim logically requires a series of steps” that must “be performed in the order written” (Mformation Techs., FC 2014; TALtech, FC 2008). The FC panel agreed “with Sandoz that the washing and eluting steps of claim 7 require discrete solutions” and that “as in Mformation, the claim language logically requires that the process steps, lettered (a) through (g), be performed in sequence” and “washing and eluting are consistently described in the specification as separate steps performed by different solutions.” The FC panel also rejected Amgen’s doctrine of equivalence (“DOE”) arguments since, e.g., “Sandoz’s…process does not function in the same way as the claimed process” (DOE “cannot be used to effectively read out a claim limitation” (Duncan Parking, FC 2019 (citing Primos, FC 2006)). The FC panel also concluded “that the [DC] was not obligated to postpone [SJ] until Sandoz submitted its amended pegfilgrastim aBLA” since, e.g., “there is no genuine dispute that the process Sandoz will likely use…will not infringe claim 7” (Ferring, FC 2014 (a DC “has discretion to consider an amended ANDA after issuing a decision but before final judgment”)). The FC panel also noted that “Amgen is not…left without a remedy for possible future infringement” since Amgen could allege infringement in the future “to the extent permitted by the Patent Act and the principles of res judicata and collateral estoppel” (Bayer AG, FC 2002). Amgen also argued that the DC misconstrued the “disease treating” and “stem cell mobilizing-effective amount” limitations of the ‘427 claims but the FC panel disagreed since “different claim terms are presumed to have different meanings” (“Had Amgen simply wanted to claim a method of mobilizing step cells, in any context, it could have done so.”) (Helmsderfer, FC 2008; Merck, FC 2005). Thus, the DC grant of SJ to Sandoz was affirmed.

View Original Source
Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.