IPR2017-01488 (US 6,407,213B1; IPR2017-02139 joined (Samsung Bioepis Co.))
Final Written Decision
November 29, 2018
Brief summary: Certain claims of Genentech’s US 6,407,213B1 shown by a preponderance of the evidence to be unpatentable for obviousness. Only claims 12, 42, 60, 65, 71, 73-77 and 79 were found either not anticipated or obvious in view of the cited art by a preponderance of the evidence.
Summary: The ‘213 patent claims “[a] humanized antibody variable domain comprising Complementarity Determining Region (CDR) amino acid residues” with particular “Framework Region (FR) amino acid substation[s]”. This FWD notes that the ‘213 patent is the subject of multiple ongoing litigations with Amgen, Pfizer or Celltrion and has been the subject of several pending and terminated IPRs. Pfizer alleged obviousness on nine different grounds of anticipation or obviousness, each directed at different claims and based on different references or combinations of references. The Board explained that to anticipate under § 102 “a single prior art reference must expressly or inherently disclose each claim limitation…with sufficient precision and detail to establish that the subject matter existed in the prior art”, although “the reference need not satisfy an ipsissimis verbis test” and “it is proper to take into account…inferences which one skilled in the art would reasonably be expected to draw therefrom” (Finisar, FC 2008; Verve, FC 2002; In re Gleave, FC 2009; In re Preda, CCPA 1968; In re Arkley, CCPA 1972 (“without any need for picking choosing and combining various disclosures”); Wm. Wrigley, FC 2012 (one “could ‘at once envisage’ each member of the genus”)). The Board reviewed obviousness by making the “underlying factual determinations” of Graham (US 1966) and taking into “account…inferences and creative steps that a person of ordinary skill in the art would employ” (KSR, US 2007; In re Magnum Oil, FC 2016 (“reasonable expectation of success”)). The person of skill in the art was determined to “have a Ph.D. or equivalent” of an M.D., and “experience with” antibodies, the Board noting “that the prior art itself demonstrates this level of skill in the art at the time of the invention” (Okajima, FC 2001). The terms “consensus human variable domain” and “lacks immunogenicity compared to a non-human parent antibody” were construed under the broadest reasonable construction (BRC). The Board found that Pfizer had met its initial burden to show the Kurle and Queen 1990 reference was prior art under § 102 (Dynamic Drinkware, FC 2015) but that the disputed claims were entitled to a priority date of less than one year before the publication date of the reference (i.e., was not § 102(b) prior art), and that Genentech provided sufficient evidence of prior invention (i.e., antedating evidence; antibodies met all claim limitations, worked for their intended purpose, inventor’s testimony is credible and sufficiently corroborated (e.g., cannot depend on “unwitnessed notebook alone” (Medichem, FC 2006; Proctor & Gamble, FC 2009) or “solely on statements or writings by the inventor” (Cooper, FC 1998); NFC Tech., FC 2017 (evidence considered “as a whole, not individually”, “rule of reason”)).
Claims 1, 2, 25, 29, 80, and 81 were found to be anticipated and obvious in view of other references (Kurrle and/or Queen 1990). It also found the substitutions of claims 63, 66, 67, and 72 inherently anticipated by the Kurrle reference, noting that “[a]lthough it may be difficult to predict in advance which of Kurrle’s substitutions preserve binding affinity, binding is an inherent property of the antibody itself, and which would become evident upon routine testing”. Claims 75-76 were not found anticipated because “[t]he 48 potential single substitutions disclosed in Kurrle provide a large number of potential two-way combinations” (one would not have “‘at once envisage[d]’ this particular combination” (Wm. Wrigley, FC 2012); “selection of both of these residues amounts to improper ‘picking and choosing’” (Arkley, CCPA 1972). Claim 63 found anticipated since “the discovery of a previously unappreciated property…does not render the old composition patentably new” (Atlas Powder, FC 1999). Claims 4 and 62-64 were found anticipated for similar reasons but in view of the Queen 1990 reference.
The Board also considered Pfizer’s obviousness arguments, finding some claims invalid for obviousness and others valid (e.g., prior “sets of candidate amino acids for mouse-to-human substitution” provided “a reason to combine the teachings” and “consensus light chain” in the prior art (re: claims 4, 62 and 69), “three-part substitutions of claim 77” not obvious since “substituting framework region residues for any particular antibody were-and quite possibly remain-unpredictable” (KSR, US 2007; Ortho-McNeil, FC 2008); “one of ordinary skill in the art would have reasonably applied the principles of Kurrle and/or Queen along with routine testing to arrive at antibodies” of claims 30, 31 and 33). The Board was not persuaded with Genentech’s secondary consideration arguments (e.g., “no evidence that the ‘consensus’ approach has any advantage over the ‘best fit’ approach”, “Dr. Wilson does little to establish that the recited [most successful antibodies] embody any claim of the ‘231 patent”, “no evidence that” claimed “substitutions” are “required for…superior binding affinity”, “limited evidence for nexus” (In re Huang-Hung Kao, FC 2011; Allergan, FC 2014; In re Greenfield, CCPA 1978)). In the end, the Board concluded only claims 12, 42, 60, 65, 71, 73-77 and 79 were found either not anticipated or obvious in view of the cited art by a preponderance of the evidence.