Apotex Cert Petition on 180-Day Exclusivity Forfeiture Decision is DOA, Says Teva in Opposition Brief

December 13, 2010

By Kurt R. Karst –      

Last Friday, Teva Pharmaceuticals USA, Inc. (“Teva”) filed its opposition brief to Apotex, Inc.’s (“Apotex’s”) Petition for Writ of Certiorari, which Apotex filed with the U.S. Supreme Court in October asking for a review of the U.S. Court of Appeals for the District of Columbia Circuit’s decision involving Teva’s 180-day exclusivity for generic versions of Merck’s COZAAR and HYZAAR (i.e., losartan).  Teva’s 180-day exclusivity for losartan expired on October 3, 2010, the day before Apotex filed its petition with the Supreme Court. 

Apotex’s petition arises from the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius.  In that case, a 3-judge panel of the D.C. Circuit ruled in a 2-1 decision concerning 180-day exclusivity for losartan that there is “no reason to conclude that the 2003 addition of forfeiture provisions meant to give the brand manufacturer a right to unilaterally vitiate a generic’s exclusivity.”  Thus, a mere patent delisting request is not enough to trigger a forfeiture event under the failure-to-market forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I). 

In July 2010, in separate litigation, a 3-judge panel of the D.C. Circuit issued a per curiam judgment affirming the U.S. District Court for the District of Columbia’s April 2, 2010 order denying motions for preliminary injunction filed by Roxane Laboratories, Inc. (“Roxane”) and Apotex.  The Roxane and Apotex motions challeged FDA’s March 26, 2010 letter decision in which the Agency reluctantly concluded that, as a result of the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius, Teva did not forfeit 180-day exclusivity eligibility.  (For additional background on the litigation over 180-day exclusivity for losartan see our previous post here.)

As an initial matter, Teva argues that Apotex’s petition should be denied because it moot, and therefore, dead on arrival:

Apotex’s complaint — and the preliminary injunction motion addressed by the sole D.C. Circuit decision at issue here — sought only prospective relief challenging Teva’s entitlement to 180-day marketing exclusivity.  But Teva’s 180 days of exclusivity have come and gone, and while this Court can do many things, it can’t turn back time.  There is thus no case or controversy left for the Court to resolve; any opinion regarding the merits would be purely advisory.

Nor, according to Teva, does the case present an exceptional situation involving an issue that is “capable of repetition while evading review:” 

Though Apotex has identified a handful exclusivity-grounding patents that the brand manufacturer deliberately let lapse, there is no reason why the question it seeks to raise here will evade review if, as Apotex speculates, it ever arises again. After all, challenges to the legal rules FDA applies in making exclusivity decisions can be brought well before an exclusivity period is scheduled to begin — and with ample time for this Court to review the issue Apotex seeks to raise in a case where it actually matters. [(Internal citations omitted)]

Even if the case were not moot, “it would be a poor vehicle to address the question it purports to present, because it arises in the interlocutory context of a preliminary injunction proceeding,” states Teva.  The lack of a circuit split “on the issue Apotex purports to raise” and that “Apotex in any event exaggerates the likelihood that it will recur” are separate grounds on which the Court should deny the petition, according to Teva. 

Finally, Teva argues that there is no need for the Supreme Court to grant review because the D.C. Circuit’s preliminary analysis of the merits was correct: 

As three different panels of the D.C. Circuit now have recognized, it upends both law and logic to think that Congress created an elaborate incentive scheme designed to encourage generic companies to challenge dubious brand-name patents, but simultaneously empowered the brand companies who assert those dubious patents to eviscerate that incentive scheme.  In short, because Apotex’s interpretation of the statute would allow brand companies to manipulate the exclusivity incentive despite the absence of any suggestion in the text, history, or structure of the statute that Congress intended to give brand companies that power, the D.C. Circuit properly held that Apotex was unlikely to prevail on the merits.

The case, Apotex, Inc. v. Sebelius, is docketed as Case No. 10-453.  AARP filed an amicus brief in the case on November 4th.