Senju Pharmaceutical Co., Ltd. Et al. v. Apotex Inc. and Apotex Corp.


Docket No. 2013-1027

NEWMAN, PLAGER, O’MALLEY(D)
March 31, 2014

Brief Summary: DC decision granting Apotex’s motion to dismiss a second suit based on Senju’s reexamined patent (following a decision in a first suit based on the original patent) for claim preclusion affirmed.

Summary: Senju appealed DC grant of Apotex’s motion to dismiss a second suit regarding US 6,333,045 based on amended claims resulting from re-examination on the basis of claim preclusion. The ‘045 patent relates to a ophthalmic solution containing the drug Gatifloxacin and EDTA to allow the drug to pass into and treat the space between the cornea and the lens of the eye. A DC 2010 decision held that the Apotex’s ANDA infringed certain claims of the ‘045 patent but that others were invalid as obvious. In December 2011, the DC again concluded claim 7 was invalid for obviousness and the FC affirmed the decision in 2012. In February 2011, Senju filed a request for reexamination of certain of the claims determined to be obvious (claims 1-3, 6, 8 and 9). In October 2011, the PTO issued a reexamination certificate certifying amended claim 6 and new claims 12-16. On November 28, 2011 Senju filed a new action against Apotex alleging infringement of re-examined claims 6 and 12-16. The DC dismissed the second action because “the reexamined claims ‘[did] not create any new cause of action that plaintiffs lacked under the original version of the patent.” The FC panel first concluded “the product in the second action completely overlaps with the product of in the first action” and “there is on that basis no new cause of action.” On the second “more difficult” question, whether “precisely the same patent rights, were involved in both suits”, the FC panel agreed with Apotex (“Apotex has the better argument”) that “reexamined claims cannot create a new cause of action that did not exist before” (“Senju has engaged in ‘claim splitting’”). Both parties attempted to support their position on Aspex Eyewear (FC, 2012) but the FC panel explained that that case stands for, in relevant part, the principle that “new claims that emerge from reexamination must not be broader than the original claims” and cannot “create a new legal right against infringement that [the patentee] lacked under the original version of the patent” (the “‘reexamined patent’ is the original patent; it has just been examined a second time…a reexamined patent claim cannot contain within its scope any product or process which would not have infringed the original claims”). The DC decision was therefore affirmed. The FC panel noted, however, that “[w]hether it is possible that a reexamination could every result in the issuance of new patent claims that were so materially different from the original patent claims as to create a new cause of action, but at the same time were sufficiently narrow so as not to violate the rule against reexamined claims being broader than the original claims, is a question that we need not opine-that is not a case before us.” Judge O’Malley’s dissent argued that the DC failed to “conduct the necessary comparison” of the original and reexamined claims and should have been remanded for further analysis.

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