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No Relief for Innovator Drug Companies When Generic Competitors Fail to Comply with FDA Requirements

May 01, 2002

Decision icon Decision

Last Month at the Federal Circuit - June 2002

Judges: Dyk (author), Gajarsa, and Michel

In Minnesota Mining & Manufacturing Co. v. Barr Laboratories, Inc., No. 01-1369 (Fed. Cir. May 1, 2002), the Federal Circuit affirmed a district court’s refusal to dismiss the suit and grant of SJ of noninfringement.

Minnesota Mining & Manufacturing Company (“3M”) charged Barr Laboratories, Inc. (“Barr”) with infringement of U.S. Patent No. 4,642,384 (“the ‘384 patent”) by Barr’s filing of an Abbreviated New Drug Application (“ANDA”) seeking FDA approval to market a generic version of 3M’s heart medication Tambocor™. Under the Hatch-Waxman amendments (“the Hatch Waxman Act” or“the Act”) to the Federal Food, Drug, and Cosmetic Act (“FFDCA”), the ‘384 patent was listed in the FDA publication known as the Orange Book. That listing in the Orange Book required Barr to “certify” to the ‘384 patent. Barr filed a “Paragraph IV” certification, contending that its ANDA did not infringe the ‘384 patent. Under the Hatch-Waxman Act, the filing of a Paragraph IV certification required Barr to provide 3M with notice of its noninfringement certification, including a detailed statement of the factual and legal basis of Barr’s opinion that the ‘384 patent was not infringed. Although Barr had provided notice of its Paragraph IV filing, 3M contended that Barr refused to provide the required detailed statement supporting its noninfringement opinion. Accordingly, 3M filed suit.

After 3M filed suit, Barr disclosed the detailed basis of its opinion that it did not infringe 3M’s patent and immediately moved for SJ of noninfringement. 3M sought to dismiss the suit without prejudice, arguing that Barr’s refusal to provide a detailed statement of its factual and legal bases of noninfringement was merely an improper attempt to obtain a judgment of noninfringement designed to trigger a 180-day marketing exclusivity period promised to a third party, Alphapharm Pty. Ltd. (“Alphapharm”). The district court refused to dismiss the case and granted Barr’s motion for SJ.

On appeal, 3M argued that the district court should have dismissed the suit without prejudice for lack of subject matter jurisdiction because after the filing of the infringement suit, 3M agreed that no infringement had occurred. Barr argued that 3M could not escape an adverse judgment by voluntary dismissal and, even if dismissed, the suit should be dismissed with prejudice, thus triggering Alphapharm’s exclusivity period. 3M argued that the district court was obligated to use its inherent power to sanction Barr’s failure to comply with the statutory notice requirement.

The Federal Circuit held that, although 3M might well be correct that a case or controversy ceased to exist in the course of litigation, the party’s dispute over the form of the dismissal alone was sufficient to create subject matter jurisdiction. Moreover, the Federal Circuit held that the district court had not abused its discretion in refusing to dismiss the suit without prejudice. With respect to Barr’s alleged violation of the statutory notice requirement, the Federal Circuit agreed that 3M’s claim of Barr’s violation was not insubstantial, but held that 3M was impermissibly attempting to assert a private right of action under the FFDCA. According to the Federal Circuit, the FFDCA proscribes all private rights of action for alleged failures to comply with the FFDCA, and, thus, the district court could not decide the issue of Barr’s compliance with the statutory notice requirement.

In a concurring opinion, Judge Gajarsa emphasized what he perceived as the Court’s inconsistency in holding that the district court had not abused its discretion in finding Barr’s notice adequate and also that the sufficiency of the notice could not be considered under the FFDCA. Judge Gajarsa argued that the Panel’s holding that the sufficiency of the notice requirement could not be considered creates an administrative “quagmire.” Nevertheless, Judge Gajarsa reasoned that the mere listing of the ‘384 patent in the Orange Book was sufficient to create the necessary reasonable apprehension of suit required to confer subject matter jurisdiction over a declaratory judgment suit. Thus, according to Judge Gajarsa, the result was correct because even if 3M had not brought suit, Barr would have brought a declaratory judgment suit.