Disputed claims are found to be obvious after ANDA trial
Senju Pharmaceutical Co. Ltd., et al. v. Apotex Inc. and Apotex Corp., Civ. No. 07-779-SLR, June 14, 2010.
Robinson, J. Judgment issues in favor of defendants after bench trial. Plaintiffs prevailed on claims of infringement, no lack of enablement, and no inequitable conduct. Defendants prevailed on their obviousness defense.
The product in dispute is a generic version of ZYMAR (0.3% gatifloxacin ophthalmic solution) used for the treatment of bacterial conjunctivitis. This action was filed 11/29/07. With respect to the obviousness arguments, the court declines to accept the characterization of the prior art disclosure as among a “laundry list” of excipients compatible with quinolones. While the Federal Circuit has predicated a finding of nonobviousness on a sheer number of variable combinations, the Court did so in the face of a prior art disclosure of “potentially infinite genus.” Here, since disodium edentate is listed among eight “conventional ingredients” in one patent-in-suit and a similarly small number in the other, this case does not approach an infinite genus. Secondary considerations favor neither party. Here there is evidence of contemporaneous invention with respect to certain claims. The inference of nonobviousness by the commercial success of the branded drug is weakened where, as here, an earlier patent precludes the market entry of a generic and the patentee attributes commercial success to the later patent. Defendants have failed to demonstrate lack of enablement. Further, the court concludes that the applicants did not make material misstatements or withhold material information and does not reach intent to deceive.
