Case Nos. IPR2015-01514 and IPR2015-01517
U.S. Pat. Nos. 8,916,157 B2 and 8,916,158 B2
January 14, 2016
Brief Summary: Amgen’s petitions against Abbvie’s ‘157 and ‘158 patents covering stable liquid formulations of anti-TNF antibodies (e.g., HUMIRA) as obvious denied (e.g., “impermissible hindsight reconstruction” and “utter lack of guidance as to which of the many combinations would work”).
Summary: Amgen filed IPRs against Abbvie’s ‘157 and ‘158 patents covering stable liquid formulations of anti-TNF antibodies marketed as HUMIRA. Independent claims of the ‘157 and ‘158 patents encompass “stable liquied pharmaceutical formulation[s]” of a human anti- anti-TNF antibody (variable regions of D2E7) “or an antigen-binding portion thereof, at a concentration of 20 to 150 mg/ml”, “a tonicity agent” (‘157) or “polyol” (‘158), “a surfactant”, and “ a buffer system” with a pH of 4-8. For both patents, the Board first determined that “stable” in the preamble is a limitation (Catalina Marketing (FC 2002) and Pitney Bowes (FC 1999) (does the preamble recite essential structure or steps” or “only…state a purpose or intended use”?)) and means “stable for storage and use”. It also concluded for both patents the broadest reasonable interpretation of “antibody, or antigen-binding portion thereof” includes the heavy and light chain variable regions of D2E7 “or one or more fragments thereof” having specificity for TNF. Amgen argued the claims would have been obvious in view of two combinations of references (Lam and Barrera, and Salfeld and Heavener). The Board first declined to deny the petition under § 325(d) (reliance on substantially the same prior art or arguments previously presented to the PTO) because the “‘same arguments’…were advanced against claims in related patent applications, not the challenged claims”. It then found that the general state of the art would not have provided the skilled artisan with a reasonable expectation of success in arriving at a formulation “of 20 to 150 mg/ml” (“For example, Amgen fails to direct us to a commercially available antibody product that was available in liquid form, within the claimed antibody concentration range…REMICADETM was not a stable antibody formulation…[cited art] suggests a high degree of unpredictability in the antibody formulation art.”) In view of this, it also concluded that neither combination of references were convincing of obviousness (“Instead, the proferred combinations seem to be exercises in impermissible hindsight reconstruction.” (Grain Processing, FC 1988); “At the very least, Amgen’s calculations make too many assumptions and are not explained in sufficient detail for us to rely on them.”; “Heavener would have left one of ordinary skill in the art ‘with an utter lack of guidance as to which of the many combinations would work.”) Thus, Amgen’s petitions were denied.