Antares Pharma, Inc. v. Medac Pharma Inc. and MEDAC GmbH


Docket Nos. 2014-1648

DYK, REYNA, TANTARO
November 17, 2014

Brief Summary: Reissue claims found invalid for violating the original patent requirement of § 251 (“[t]he original claims are significantly different in scope and coverage than the asserted claims”).

Summary: Antares appealed DC denial of a preliminary injunction to enjoin alleged infringement of claims 31, 34, 35 and 37 of RE44,846 related to devices for self-administering pharmaceuticals. Reissue was requested under 35 USC § 251 about 22 months after issuance of Antares’ US 7,776,015 disclosing a system for injecting medicant in which a needle punctures the skin before the medicant is expelled (new jet injector) which eliminates problems related to the medicant itself rupturing the skin (typical jet injectors). The original claims all contained the “jet injector” limitation which was repeatedly relied upon by the applicants during prosecution as distinguishing the claims from the prior art. The reissue added new claims 23-37 which Antares’ admitted recite a different invention from what was originally claimed. Defendant Medac sells pre-filled hand-powered methotrexate syringes; it filed a 505(b)(2) NDA which was an act of artificial infringement under 35 USC § 271(e)(2)(A). Medac argued that the asserted reissue claims were invalid for violating the recapture rule (In re Mostafazadeh, FC 2011) and failing the original patent requirement of § 251 (the original specification must expressly disclose the particular invention claimed on reissue). The DC found that Antares failed to show a likelihood of success on these grounds. In their appeal, Antares argued that the DC failed to consider the “overlooked aspects” (“patentably distinct (1) inventions; (2) embodiments; or (3) species not originally claimed[,] not mere incidental features of the originally-claimed invention” (citing Mostafazadeh), not including “what was expressly surrendered” during prosecution as it could not have been overlooked). However, the FC held that the asserted claims failed to original patent requirement and therefore did not answer this particular question. The opinion reviews the history of the original patent requirement, explaining that the Industrial Chemicals (US, 1942) standard does not include an “‘intent to claim’ test” and that the “standard is analogous to the written description requirement [which]…requires that the patent description ‘clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed’” (“…it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification’…Rather, the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention.”) Here, the FC panel found the new claims invalid because “[t]he original claims are significantly different in scope and coverage than the asserted claims”, the new claims being “focused on particular safety features and do not contain the jet injection limitation” (“Nowhere does the specification disclose, in an explicit and unequivocal manner, the particular combinations of safety features claimed on reissue, separate from the jet injection invention.”)

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