D.C. Circuit Affirms District Court Ruling Concerning Losartan 180-Day Exclusivity Forfeiture Issue

July 6, 2010

By Kurt R. Karst –   

Earlier today, a 3-judge panel (Judges Tatel, Griffith, and Kavanaugh) of the U.S. Court of Appeals for the District of Columbia Circuit issued a 2-page per curiam judgment (without memorandum) 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. and Apotex, Inc. concerning 180-day exclusivity for generic versions of Merck’s COZAAR and HYZAAR (i.e., losartan).  The Roxane and Apotex motions challeged FDA’s March 26, 2010 letter decision in which the Agency reluctantly concluded  that Teva did not forfeit 180-day exclusivity eligibility under FDC Act § 505(j)(5)(D)(i)(VI).  That provision states that 180-day exclusivity eligibility is forfeited if “[a]ll of the patents as to which the applicant submitted a certification qualifying it for the 180-day exclusivity period have expired.”  FDA issued its response after soliciting public comment on whether Teva forfeited 180-day exclusivity eligibility because the only exclusivity-qualifying patent – U.S. Patent No. 5,608,075 – “expired” last year after Merck ceased paying certain patent maintenance fees.  FDA’s approved Teva’s ANDAs on April 6, 2010 with 180-day exclusivity.

According to the D.C. Circuit’s July 6, 2010 judgment:

The district court correctly concluded that appellants failed to show a substantial likelihood of success on the merits.  When the Hatch-Waxman Act’s forfeiture provisions are viewed in the context of the statute’s incentive structure, it becomes clear that Congress could not have intended a brand manufacturer’s unilateral decision to cause the premature expiration of a patent (in the face of a generic applicant’s challenge to the patent in a paragraph IV certification) to strip the first generic applicant of the 180-day period of marketing exclusivity granted by the statute.  See Teva Pharms. USA, Inc. v. Sebelius, 595 F.3d 1303, 1317–18 (D.C. Cir. 2010).  We will thus affirm the district court’s decision to deny appellants’ motions for a preliminary injunction.  See Apotex, Inc. v. FDA, 449 F.3d 1249, 1253–54 (D.C. Cir. 2006).

The July 6th judgment follows two orders (here and here) issued by the D.C. Circuit in May 2010, in which the Court denied FDA’s petition for panel rehearing and rehearing en banc of 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 (Judges Henderson, Griffith, and Williams) ruled in a 2-1 decision (Judge Henderson dissenting) also concerning Teva’s ANDAs for losartan drug products, that the patent delisting counterclaim provision at FDC Act § 505(j)(5)(C)(ii)(I) added by the 2003 Medicare Modernization Act must be read together with the patent delisting forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC), and 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.” 

Apotex and Roxane argued in their combined brief to the D.C. Circuit that the “Court should conclude that the plain language of the statute requires a finding that Teva forfeited its 180 days of exclusivity,” and that “FDA’s decision to the contrary was not based on the plain language, or any other tools of statutory interpretation, but on the ‘reasoning’ in . . . [Teva],” under which, according to Apotex and Roxane, FDA falsely believed it was required “to reach a result with which it disagreed.”  Although FDA, in its May 18th brief, agreed with Apotex and Roxane that, “based on the plain text of the statute, 21 U.S.C. § 355(j)(5)(D)(i)(VI), (ii), expiration of a patent for any reason should result in the forfeiture of 180-day exclusivity,” the Agency argued that it “must abide by [the Teva] decision and consider its inescapable effect on the closely related issue involved here” (i.e., forfeiture of 180-day exclusivity based on patent expiration for failure to pay maintenance fees).

Whether the D.C. Circuit’s July 6th judgment is the end of the matter remains to be seen.  Apotex and/or Roxane could petition the Court for rehearing or rehearing en banc; however, given the D.C. Circuit’s May 2010 denial of FDA’s petition for panel rehearing and rehearing en banc, it seems unlikely that the Court would grant such petitions. 

Categories: Hatch-Waxman