Merck & Co., Inc. v. Apotex Inc., et al.

Merck & Co., Inc. v. Apotex Inc., et al.

D.N.J. (2007)

Judge Mary Cooper of the United States District Court for the District of New Jersey grants Merck's Motion to Dismiss Apotex's declaratory judgment counterclaims.

On November 15, 2007, Judge Mary Cooper of the United States District Court for the District of New Jersey issued an opinion granting Merck’s Motion to Dismiss Apotex’s declaratory judgment counterclaims seeking declarations of either invalidity or non-infringement of two Merck patents which the company had previously disclaimed. In accordance with this opinion, Judge Cooper also dismissed Apotex’s cross motion for summary judgment of non-infringement, declaring it moot.

This patent dispute arose in December 2006 when Merck claimed infringement of U.S. Patent No. 4,797,413 against Apotex, the second generic maker to file an ANDA with the FDA for generic versions of Merck’s glaucoma eye drugs, TRUSOPT® and COSOPT®. Originally, Merck had listed the ‘413 patent in the FDA’s Orange Book to cover both drugs. Merck also listed U.S. Patent Nos. 6,248,735 and 6,316,443 to cover COSOPT®. Subsequently, in April 2006, Merck filed statutory disclaimers for both the ‘735 and ‘443 patents with the USPTO and twice requested that the FDA “de-list” those patents from the Orange Book. Accordingly, Merck did not claim infringement of either the ‘735 or ‘443 patents. Nevertheless, in its answer, Apotex asserted declaratory judgment counterclaims of invalidity and non-infringement of both patents.

In April 2007, in a related case against the first generic maker, Hi-Tech Pharmacal Co., Inc., the Court of Appeals for the Federal Circuit affirmed the validity and enforceability of the ‘413 patent. Following that ruling, Judge Cooper granted final judgment against Apotex, finding that Apotex’s ANDAs for TRUSOPT® and COSOPT® would also infringe the ‘413 patent. Merck then moved to dismiss Apotex’s remaining counterclaims for lack of subject matter jurisdiction. Agreeing with Merck’s position, Judge Cooper concluded that “there was no actual case or controversy under all the circumstances here to support jurisdiction.” As a result, because the Court lacked subject matter jurisdiction, Judge Cooper also dismissed Apotex’s cross-motion for summary judgment of non-infringement of both the ‘735 and ‘443 patents.