res judicata : CAFC Alert

Reexamined patent claims are assumed to be subset of original patent claims unless proven otherwise, for application of res judicata (claim preclusion).

Le-Nhung McLeland | April 24, 2014

Senju Pharmaceutical Co., Ltd., Kyorin Pharmaceutical Co., Ltd., and Allergan, Inc. v. Apotex Inc. and Apotex Corp.

March 31, 2014

Panel: Newman, Plager (author) and O’Malley (dissent).

Background: Appeal from U.S. District Court for the District of Delaware.

Senju Pharmaceutical Co., Ltd. and Kyorin Pharmaceutical Co., Ltd. (collectively referred to as “Senju”) jointly own U.S. Patent No. 6,333,045 for aqueous pharmaceutical formulations of the antibiotic Gatifloxacin. Allergan is the exclusive licensee under this patent for ophthalmic uses, and produces under license eye drops for treating the “pink eye” infection. The eye drop formulation contains disodium edetate (EDTA) which improves passage of the antibiotic through the cornea of the eye.

Apotex Inc. is a Canadian generic drug manufacturer which plans to formulate an ophthalmic solution containing the antibiotic, to be marketed by Apotex Corp. which is based in the U.S. Following the procedure enacted under the Hatch-Waxman Act, Apotex (referring collectively to Apotex, Inc. and Apotex, Corp.) filed with the FDA in July 2007 an Abbreviated New Drug Application (ANDA) for a generic version of the ophthalmic drug containing the antibiotic. Also under this procedure, Apotex filed a patent certification with the FDA and notified Senju about the certification. [This notice is required when the ANDA applicant certifies that a patent named in the New Drug Application (NDA) for the original drug is “invalid, unenforceable, or will not be infringed by the manufacture, use, or sale” of the generic drug. After receiving the notice, the NDA holder may sue the ANDA applicant for patent infringement under the provisions of 35 USC §271(e)(2)(A).] As would be expected, Senju filed suit against Apotex, alleging infringement of claims 1-3 and 6-9 of the patent.


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