New Jersey District Court Says ANDA Approval Delay and Patent Uncertainty Are Insufficient to Support DJ Jurisdiction in Generic DETROL LA Litigation

By Kurt R. Karst –      

The U.S. District Court for the District of New Jersey recently granted a Motion to Dismiss filed by Pfizer, Inc. (“Pfizer”) in an action brought by Impax Laboratories, Inc. (“Impax”) in an apparent attempt to trigger a forfeiture of 180-day exclusivity under the failure-to-market provisions at FDC Act § 505(j)(5)(D)(i)(I) for the first applicant to have submitted an ANDA to FDA with a Paragraph IV patent certification for a generic version of Pfizer’s DETROL LA (tolterodine tartrate) Extended Release Tablets, 4mg and 2mg.  In reaching its decision, the district court found the Federal Circuit’s rationale articulated in Janssen Pharaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353 (Fed. Cir. 2008), concerning declaratory judgment jurisdiction to be controlling, rather than the Federal Circuit’s decision in Caraco Pharm. Labs. Ltd. v. Forest Labs., Inc., 527 F.3d 1278 (Fed. Cir. 2008), given the existence of a stipulation to be bound by a final court decision on patent validity or non-infringement.

As we previously reported, DETROL LA is listed in the Orange Book with four patents: U.S. Patent Nos. 6,911,217 (“the ‘217 patent”), 5,382,600 (“the ’600 patent”), 6,630,162 (“the ‘162 patent”), and  6,770,295 (“the ‘295 patent”), which expire on Aug 26, 2019, March 25, 2012, November 11, 2019, and August 26, 2019, respectively, but are each subject to a 6-month period of pediatric exclusivity.  Impax was sued a few years back based on the company’s Paragraph IV certifications to the ‘600, ‘162, and ‘295 patents contained in ANDA No. 90-235, but was not sued with respect to its Paragraph IV certification to the ‘217 patent.  Pfizer subsequently granted Impax a covenant not to sue with respect to the ‘217 patent, and Impax stipulated to be bound by any decision regarding the validity or non-infringement of the ‘600 patent rendered in another action involving the first applicant. 

Like Impax, the first ANDA sponsor submitted an ANDA with Paragraph IV certifications to all four DETROL LA patents and was sued on all but the ‘217 patent.  The ‘600, ‘162, and ‘295 patents were the subject of a consent judgment of ingringement entered into between Pfizer and the first applicant in July 2011 and a settlement agreement, seemingly leaving the ‘217 patent – the subject of Impax’s declaratory judgment complaint – as the only patent on which to hang a claim of 180-day exclusivity. 

Impax argued that the company has two separate injuries upon which to maintain declaratory judgment jurisdiction: (1) ANDA approval delay resulting from the first ANDA applicant’s eligibility for 180-day exclusivity; and (2) patent uncertainty arising from the absence of a judicial declaration regarding the validity of the ‘217 patent.  Pfizer countered, arguing that Impax suffers no approval delay injury attributable to the ‘217 patent, because Impax voluntarily decided to forego its challenge to Pfizer’s ‘600 patent, thereby deferring approval of its ANDA until September 25, 2012, at the earliest, when pediatric exclusivity on the ‘600 patent is set to expire, and that Impax suffers no patent uncertainty injury, given the irrevocable covenant not to sue on the ‘217 patent.

Noting that “Janssen stands for the proposition that a stipulation to be bound will divest a federal court of declaratory judgment jurisdiction, as such stipulation is not fairly traceable to the Defendant’s actions and will prevent a judgment in Plaintiff’s favor from redressing the injury alleged,” the district court said that the Federal Circuit’s Janssen decision is controlling in the case “by virtue of [Impax’s] stipulation to be bound.”  The stipulation, “presents yet another obstacle to FDA approval, preventing Plaintiff from obtaining FDA approval until the expiration or finding of invalidity of the stipulated to patent.”  As such, the district court granted Pfizer’s Motion to Dismiss, noting that “a favorable judgment in Impax’s favor would not clear the path to FDA approval and does not provide the basis for declaratory judgment jurisdiction.”