Apotex’s petition for a writ of certiorari involves a dispute over the 180 days of marketing exclusivity awarded by the FDA, earlier this year, to Teva Pharmaceutical Industries. The exclusivity was awarded to Teva as the first company to challenge a patent on Merck’s hypertension drugs Cozaar (losartan potassium) and Hyzaar (hydrochlorothiazide/losartan potassium).

The FDA approved the Israeli generic’s giant Teva’s abbreviated new drug applications in April 2010 with 180-day exclusivity.

Roxane Laboratories and Apotex filed injunctions against the FDA’s decision, claiming that the patents on Cozaar and Hyzaar had already expired. The injunctions were denied, however, by the US District Court of Columbia, and in July 2010 this decision was affirmed by a 3-judge panel of the District of Columbia Circuit.

The Roxane and Apotex motions challenged the FDA’s decision of 26 March 2010 in which the agency reluctantly concluded that Teva did not forfeit 180-day exclusivity eligibility under FDC Act § 505(j)(5)(D)(i)(VI), which states that 180-day exclusivity eligibility is forfeited if “the patents as to which the applicant submitted a certification qualifying it for the 180-day exclusivity period have expired”.

Apotex presents a single question for the Supreme Court’s review – “Whether a generic drug manufacturer may forfeit marketing exclusivity under 21 U.S.C. § 355(j)(5)(D) based on ‘unilateral’ action by the holder of the challenged patent”.

Teva is also under fire from Bristol-Myers Squibb (BMS), which has filed a patent infringement lawsuit against them after the generic-drug maker asked the FDA for approval to market a generic version of BMS’s hepatitis B drug Baraclude.

References

Karst KR. It Lives!! Apotex Asks the Supreme Court to Review Generic COZAAR/HYZAAR 180-Day Exclusivity Decision (Our 1,000th Post). FDA Law Blog. 5 October 2010.

FDA News. Apotex Takes Cozaar, Hyzaar Exclusivity Dispute to Supreme Court. 12 October 2010.

FDA News. BMS Files Patent Suit Against Teva Over Hepatitis B Drug Baraclude. 11 October 2010.