ANDA counterclaim of non-infringement not mooted by dedication of INTUNIV patent to public

guanfacine HCl

On August 20, 2012, the United States District Court for the Northern District of California granted Watson and Impax’s motion for summary judgment of non-infringement of U.S. Patent No. 5,854,290 listed in the Orange Book against Shire’s extended release guanfacine hydrochloride tablets.


Watson and Impax had filed ANDAs in October 2010 containing pIV certifications against three patents listed in the Orange Book against INTUNIV, including the ‘290 patent.  Neither Impax nor Watson was the first ANDA filer containing a pIV certification.  Shire sued the defendants on all three listed patents. After pleadings closed, the inventors of the ‘290 patent dedicated the ‘290 patent to the public and Shire requested that the FDA delist the ‘290 patent from the Orange Book. Shire, acknowledging that that the defendants cannot infringe a patent that was dedicated to the public, sought the dismissal of both the claims and counterclaims.  The defendants opposed the dismissal of the counterclaim and brought a summary judgment motion of non-infringement of the ‘290 patent in order to attempt to create a potential forfeiture event under 21 U.S.C. § 355(j)(5)(D)(i)(I)(bb)(AA) for the first ANDA filer (likely Actavis, see here) containing a pIV certification.

Shire opposed the defendant’s summary judgement motion on the basis that the dedication to the public mooted any case or controversy such that the Court lacked jurisdiction to adjudicate the defendants’ counterclaim.  In the alternative, Shire requested that the Court decline to exercise is discretionary jurisdiction.  The Court, following the decisions of the Court of Appeals for the Federal Circuit in Caraco v. Forest,  Teva v. Eisai and Dey v. Sunovionconcluded that the defendants’ injury flowed from the listing of the ‘290 patent in the Orange Book and was not mooted by the dedication of the ‘290 patent to the public. Since the FDA has not delisted the ‘290 patent, a  declaration of non-infringement could remove the ’290 patent as a stumbling block to market entry for later ANDA filers under the Hatch-Waxman framework.

The Court also refused to decline jurisdiction over the defendants’ counterclaim holding, among other things:

Fourth, and most fundamentally, for all the reasons set forth above, declining jurisdiction would deny defendants effective relief under the Hatch-Waxman Act, and permit Shire to manipulate the regulatory framework unfairly by creating a disclaimer “loophole.”

A copy of the Order granting the defendants’ motion for partial summary judgment may be found here.