Court Orders and Declares that Teva Has Not Forfeited 180-Day Exclusivity for generic COZAAR/HYZAAR

March 17, 2010

By Kurt R. Karst –      

It has been quite a wild ride since a 3-judge panel of the D.C. Circuit issued its March 2, 2010 opinion ruling that FDA’s interpretation of the 180-day exclusivity forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) fails at Chevron step one and that the patent delisting counterclaim provision at FDC Act § 505(j)(5)(C)(ii)(I) added by the 2003 Medicare Modernization Act (“MMA”) 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.”  The D.C. Circuit’s decision reversed a decision from the U.S. District Court for the District of Columbia.  The case, which concerns the availability of 180-day exclusivity for generic versions of Merck & Co., Inc.’s (“Merck’s”) COZAAR (losartan potassium) Tablets and HYZAAR (hydrochlorothiazide; losartan potassium) Tablets, was remanded to the district court for further proceedings “as the court has yet to address the appropriateness of each form of relief that Teva has sought. . . .”  Teva’s Complaint requested declaratory and injunctive relief.  

Shortly after the March 2, 2010 decision was issued, Teva filed an Emergency Motion To Issue Mandate Forthwith, because althought FDA ordinarily has 45 days within which to seek rehearing, the earliest date that the D.C. Circuit’s mandate could be issued under that order (i.e., April 23, 2010 in this case) would be 17 days after the anticipated April 6, 2010 approval deadline for ANDAs for generic COZAAR/HYZAAR.  FDA’s opposition brief threw a new issue into the mix: did Teva forfeit 180-day exclusivity under FDC Act § 505(j)(5)(D)(i)(VI) because the only exclusivity-qualifying patent – U.S. Patent No. 5,608,075 (“the ‘075 patent”), which was previously identified in the Orange Book as expiring in March 2014 – “expired” in March 2009 after Merck had ceased paying certain patent “maintenance fees”?  (In conjunction with its brief, FDA also established a public docket (Docket No. FDA-2010-N-0134) requesting public comment (here and here) on the issue.)  FDC Act § 505(j)(5)(D)(i)(VI) 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.”  Teva, characterizing this new issue as a “thirteenth-hour attempt” to deprive Teva of the benefit of the D.C. Circuit’s decision, vigorously argued in its reply brief that the court should reject FDA’s new argument. 

The D.C. Circuit promptly granted Teva’s motion to issue the mandate (but noting that “the mandate would be recalled if rehearing en banc were granted”).  And in doing so, the court stated that its decision was based “[u]pon consideration of appellant Teva Pharmaceutical’s emergency motion to issue the mandate forthwith, and the opposition thereto.”  That is, the court considered Teva's arguments in the company's reply brief and rejected FDA’s new patent expiration forfeiture theory. 

Now back to the district court, where Judge Rosemary M. Collyer granted Teva’s request for an expedited status conference (which was held on March 15, 2010) and was asked to consider a renewed motion by Apotex to intervene in the case. . . .

On March 16, 2010, Judge Collyer issued an Order declaring that Teva has not forfeited its right to 180-day marketing exclusivity, and ordering FDA not to approve ANDAs for certain strengths of generic COZAAR and HYZAAR until the expiration of Teva’s 180-day exclusivity.  Judge Collyer also granted Apotex’s renewed motion to intervene in the case. 

This case is not likely over yet.  FDA or Apotex could appeal the decision.  Stay tuned . . . .

Categories: Hatch-Waxman