Horizon’s petition for en banc rehearing regarding indefiniteness denied (four judges dissented regarding “consisting essentially of”))


HZNP Medicines LLC et al. v. Actavis Laboratories UT, Inc.

Docket No. 2017-2149, -2152-53, -2202-3, -2206
PROST, NEWMAN, REYNA
October 10, 2019 (update Feb. 25, 2020)

Update (2/25/20): Petition for en banc hearing denied. Judges Lourie, Newman, O’Malley and Stoll dissented, arguing that the majority “erroneously construed the ‘consisting essentially of’ language” of claim 49 “in evaluating the definiteness requirement of 35 U.S.C. § 112” because “better drying time is not in the claim, and it is the claims that the stature requires be definite” and “[t]he possibility of inclusion of other[]” ingredients “implied by the language at issue here, does not make what is recited and essential indefinite” (“[T]he advantages of an invention and disclosure of how to make and use an invention are not incorporated into claims for purposes of evaluating their indefiniteness…the meaning of the ‘consisting essentially of’ language should boil down to…whether the presence of an unrecited material in an accused product is in fact inconsistent with, or defeats the purpose of, the claimed composition…the principle of importing an uncertainty in measuring an advantage of an invention could have unintended potential effects well beyond this particular case” and “should not be sound precedent.”)

Brief Summary: DC findings of indefiniteness, no induced infringement, and no invalidity for obviousness regarding Horizon’s OB patents for Pennsaid® affirmed.

Summary: Horizon appealed DC judgment of invalidity and noninfringement of certain Orange Book (OB) patents relating to methods and compositions for treating osteoarthritis (Pennsaid®, topical 2% diclofenac sodium, “the first FDA-approved twice-daily topical diclofenac sodium formulation for the treatment of pain of osteoarthritis of the knees”), and Actavis (which filed ANDA 207238) cross-appealed the DC’s judgment of non-obviousness regarding other patents. The FC panel opinion split the OB patents into methods-of-use (e.g., “method for applying topical agents to a knee of a patient with pain”) and formulation groups (“topical formulation consisting essentially of’).

The DC found indefiniteness for the identity of the claimed “impurity A” (“identity…is unknowable”), “the formulation degrades by less than 1% over 6 months” (“neither the claims nor the specification disclose the means to evaluable degradation”), and the “consisting essentially of” limitation in the formulation patents (no identification of “basic and novel properties” that would not be “materially affect[ed]” by “unlisted ingredients”). The FC panel agreed with the DC that “impurity A” and the “degrades” term are indefinite (e.g., “[t]he claims do not make clear that ‘impurity A’ refers to an impurity of diclofenac sodium” as opposed to the “several other excipients” in “the entire topical formulation”, “written description provides no clue”, no supporting extrinsic evidence). Regarding “consisting essentially of”, the FC panel agreed that “the basic and novel properties of the formulation patents…are implicated” by the phrase, and agreed with the DC’s application of the Nautilus definiteness standard (US 2014, “inform, with reasonable certainty”), and that it was “indefinite based on its finding that the basic and novel property of ‘better drying time’ was indefinite” (detailed analysis of the specification and relevant case law is included in the FC panel opinion). Judge Newman dissented on this point.

The DC also granted summary judgment (SJ) to Actavis since Horizon did not “show that Actavis’s label induced infringement of the method-of-use patents.” The FC panel explained that “[i]t is undisputed that Actavis’s label is substantially similar to Horizon’s”, but that Actavis’s “instructions…only require the first step of” Horizon’s “patented method”, and “is broader than step three of Horizon’s claimed method” (e.g., “Actavis’s label also warns about clothing, cosmetics…and other substance” that “operates in an ‘if/then’ manner” and “does not encourage infringement” (e.g., AstraZeneca, FC 2010)).

Actavis’s ‘913 claim 12 patent obviousness theory (the only claim appealed on this point) was that the 2% formulation would have been obvious in view of a prior art 1.5% formulation, which Horizon argued “were not routine optimizations, and that the results of the various changes could not be predicted by the prior art” (e.g., “the field is…complex and unpredictable”). The FC panel found no error with the DC’s findings (e.g., “the variables involved in this case, including the inventive formulation, interact in an unpredictable or unexpected way, such that the results emanating into [the 2% formulation] were not obvious.”) Accordingly, the DC decision was affirmed.

This entry was posted in comprising, consisting of, Generics / ANDA, Indefiniteness. Bookmark the permalink.

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