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HZNP Medicines LLC v. Actavis Laboratories UT, Inc.

Questions About Invention’ Features for “Consisting Essentially Of” Claim Lead to Indefiniteness

HZNP Medicines LLC v. Actavis Laboratories UT, Inc., __ F.3d __, 2019 WL 5076226 (Fed. Cir. Oct. 10, 2019) (Prost, Newman (CIP/DIP), REYNA) (D.N.J.: Hillman) (3 of 5 stars)

Fed Cir affirms judgment, in Hatch-Waxman case, of indefiniteness as to some claims, noninfringement as to others, and (on cross-appeal) confirmation of nonobviousness (and thus liability for Actavis) as one more. The case involved twelve patents owned by Horizon (business name of HZNP) relating to treatment/formulations for osteoarthritis, and are in the Orange Book for Horizon’s PENNSAID (diclofenac sodium) 2% topical treatment.

Indefiniteness: The district court correctly determined that three terms are indefinite, and claims containing them are invalid. The first indefinite term, “impurity A,” appeared in only one claim and one described example, neither of which expressly defined it, and the district court did not clearly err in determining that extrinsic evidence would not sufficiently inform a POSITA as to its identity with reasonable certainty. The second indefinite term, “degrades [by/at] less than 1% over 6 months,” was defined by Horizon with reference to “impurity A,” and so suffers the same lack of definition.

The opinion’ discussion of the third indefinite term, ”consisting essentially of,” focuses on identification of the “basic and novel properties of the invention” (because “consisting essentially of” permits the presence of unlisted ingredients that do not materially affect those properties). It concludes that the district court did not err in determining that a person of ordinary skill would be unable to determine the boundaries of “better drying time”—one of the invention’s basic and novel properties—at least because the description contained inconsistent, and sometimes contradictory, statements about drying time, “a POSITA would not know under what standard to evaluate the drying rate of the invention, thus rendering the basic and novel property of ‘better drying rate’ indefinite.” Op. at 32.

Noninfringement: The district court correctly entered summary judgment of no infringement as to the method-of use patents. Actavis’s label did not induce use of its ANDA product (a generic version of PENNSAID 2%) in an infringing manner. The label’s instruction that a user should wait for the treatment to dry before covering it did not instruct the user to actually cover the treatment (or to wait for it to dry), as Horizon’s claims required.

Confirmation of nonobviousness (cross-appeal): The record supported the district court’s determination that Actavis had not proved nonobviousness, and the district court did not clearly err in finding that the changes between Horizon’s prior art PENNSAID 1.5% formulation and the claim at issue were not obvious optimizations that would produce a predictable result.

Dissent: Judge Newman would have held Horizon’s “consisting essentially of” definite, on the grounds that a skilled artisan’s knowledge would fill any gap in the claim. She also would not have affirmed the summary judgment of no inducement, noting that “the instructions in [Actavis’s] ANDA label are identical to the method-of-use claimed in the Horizon patents.” Op. at. 2.