In Senju Pharmaceutical Co. Ltd., et al. v. Apotex Inc., et al., Civil Action No. 07-779-SLR, the U.S. District Court for the District of Delaware, by and through a memorandum opinion entered by The Honorable Sue L. Robinson on June 14, 2010, entered judgment in favor of defendants, Apotex Inc. and Apotex Corp. (“Apotex”), and against plaintiffs, Senju Pharmaceutical Co. Ltd (“Senju”), Kyorin Pharmaceutical Co. Ltd. (“Kyorin”) and Allergan, Inc. (“Allergan”). The case is an infringement action that was tried by bench trial on January 12-14, 2010. In rendering judgment in favor of defendants, the Court concluded among other things that, although plaintiffs had demonstrated by a preponderance of the evidence that defendants’ ANDA product infringed claims 1-3, 6,7, and 9 of the patent in dispute, U.S. Patent No. 6,333,045 (“the ‘045 patent”), defendants demonstrated by clear and convincing evidence that those claims are invalid based on obviousness given the asserted prior art. Id. at 15-21 and 37.
A complete copy of the Court’s Memorandum Opinion is attached.
By way of background, plaintiffs Senju and Kyorin, are co-owners of the ‘045 patent and plaintiff Allergan is the holder of an approved New Drug Application (“NDA”) for a 0.3% gatifloxacin ophthalmic solution containing disodium edetate sold under the trade ZYMAR®. Id. at 1. The Orange Book lists, among other things, the ‘045 patent and U.S. Patent No. 4,980,470 (“the ‘470 patent”) in connection with ZYMAR®. Id. In July 2007, Defendant Apotex filed an Abbreviated New Drug Application (“the ANDA”) with the United States Food and Drug Administration (“FDA”) seeking approval, prior to the expiration of the ‘045 patent, to manufacture, market and sell a generic version of ZYMAR®. Id. at 1-2. On October 17, 2007, defendants sent plaintiffs written notification that the ANDA contained a Paragraph IV certification for the ‘045 patent. In the Paragraph IV certification, defendants contended that the ANDA product would not infringe claims 4, 5, 10 and 11 of the ‘045 patent and that all claims of the ‘045 patent are invalid. Id. at 2.
In November 2007, plaintiffs brought this action, pursuant to 35 U.S.C. § 271(e)(2)(A), alleging that the ANDA product would infringe claims 1-3,6,7 and 9 of the ‘045 patent. Id. Defendants responded with affirmative defenses and counterclaims seeking declaratory judgments of non-infringement, invalidity and unenforceability of the ‘045 patent. Id. The parties stipulated that, if the claims were found valid, the ANDA product would infringe claims 1-3 and 9 of the ‘045 patent. Infringement of claims 6 and 7 had to be proven by plaintiffs because defendants disputed that the ANDA product would infringe those claims. Id.
After considering all of the documentary evidence and testimony, the Court found and concluded as follows: (1) plaintiffs demonstrated by a preponderance of the evidence that defendants’ ANDA product infringes claims 1-3,6,7 and 9 of the ‘045 patent; (2) defendants demonstrated by clear and convincing evidence that claims 1-3 and 6-9 of the ‘045 patent are rendered obvious by the prior art; (3) defendants failed to demonstrate by clear and convincing evidence that claims 6 and 7 of the ‘045 patent are invalid for lack of enablement; and (4) defendants failed to demonstrate by clear and convincing evidence that the ‘045 patent is unenforceable due to inequitable conduct. Id. at 50.