D.C. District Court Denies Apotex Motion for Injunctive Relief in Generic PRILOSEC Case

September 17, 2007

Earlier today, the U.S. District Court for the District of Columbia denied Apotex’s motion for a temporary restraining order and preliminary injunction in a case against FDA involving Apotex’s ANDA for a generic version of AstraZeneca’s PRILOSEC (omeprazole) Delayed-Release Capsules and the effects of AstraZeneca’s pediatric exclusivity. 

The case stems from a June 14, 2007 judgment from the U.S. District Court for the Southern District of New York in which the court concluded that Apotex’s omeprazole drug products infringe certain PRILOSEC claims in patents that naturally expired in April 2007, and that “pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of [Apotex’s ANDA] and related ANDAs shall be not earlier than October 20, 2007” when AstraZeneca’s pediatric exclusivity expires.  Although FDA had approved Apotex’s ANDA (#76-048) in October 2003, subsequent to the New York court’s judgment, FDA sent Apotex a letter informing the company that “in light of the [New York court’s] order, the Agency hereby converts the final approval of ANDA 76-048 issued on October 6, 2003, to a tentative approval. . . .  Final approval cannot be granted earlier than October 20, 2007.” 

Apotex promptly filed a complaint and a motion for injunctive relief.  Apotex argued that:

FDA has unlawfully revoked the final approval of Apotex’s generic omeprazole capsules. FDA’s decision ignores and violates the Agency’s own precedent [(i.e., pediatric exclusivity issues concerning amlodipine)] and constitutes a complete abdication of the Agency’s statutory authority and obligation. The Court therefore should —indeed must— set aside that decision as arbitrary, capricious and contrary to law under the Administrative Procedures Act (“APA”), and enjoin the revocation of Apotex’s lawful final approval.

Essentially, Apotex’s argument rests on the premise that the New York District Court’s order only “purports to reset the effective date of [the company’s] approval to the expiration of [AstraZeneca’s] supposed pediatric exclusivity on October 20, 2007,” and that FDA is not obligated to follow that order.  FDA respectfully disagreed. 

FDA’s opposition memorandum, which heavily relies on the November 2004 U.S. Court of Appeals for the District of Columbia decision in Mylan v. Thompson (concerning DURAGESIC), states:

As an administrative agency, it is not FDA’s role to second-guess a district court’s order granting relief in a patent infringement suit between two private parties.  Nor is FDA free to simply ignore the order of the New York court.  This is particularly true here, where the district court issued its order pursuant to its “general equitable powers,” which is not part of the FDCA and which FDA is not charged with administering.

Once the New York court determined that Apotex’s ANDA should have a delayed effective date until October 20, 2007, FDA gave effect to that order, in recognition of the New York court’s judicial power to grant relief.  Although FDA was not a party to that case, FDA properly determined in Mylan ([D]uragesic) and here that it would respect the authority of a district court to issue orders that collaterally require the agency to take action. Indeed, the district court’s authority to issue orders awarding relief under 35 U.S.C. § 271(e)(4)(A) inherently depends upon FDA’s compliance with those orders, even when, as here, FDA is not a party to a private patent infringement litigation. [(citations omitted).]

AstraZeneca’s brief in the D.C. District Court case, not surprisingly, sides with FDA: 

Apotex’s argument challenges the central assumptions of the pediatric exclusivity provisions of the Food and Drug Administration Modernization Act (“FDAMA”), Pub. L. No. 105-115, 111 Stat. 2296 (1997).  In FDAMA, Congress recognized that far too little drug research was being conducted on pediatric populations, and it created an incentive . . . for manufacturers that conducted such research.  This reward is designed to apply to any holder of a valid patent that conducts pediatric research at the request of FDA. . . .  Under Apotex’s argument, however, pediatric exclusivity could be denied to manufacturers who did everything requested of them by the statute and by FDA, simply by virtue of a generic producer’s infringing conduct and the uncontrollable timing of a court’s decision on patent validity and infringement.  There is no support for such a result in the statute, and it would introduce unacceptable uncertainty into the availability of pediatric exclusivity, substantially undermining the legislative scheme to the detriment of children’s health.

Ultimately, Apotex’s argument is that, as a consequence of Apotex’s decision to take the risk of going to market before the patent infringement suit was decided, Astra should lose all the benefit of the pediatric exclusivity period it earned through extensive research efforts.  The judge in the patent litigation properly termed such a result anomalous and at odds with the statute.  And it is surely inconsistent with principles of equity for Apotex to turn its own infringing activity into a basis for inflicting further loss on Astra.

D.C. District Court Judge Ricardo M. Urbina sided with FDA (and AstraZeneca) in his 18-page opinion and concluded that Apotex had not established by a clear showing that FDA improperly applied the New York District Court’s June 2007 order by converting the status of ANDA #76-048 from a final approval to a tentative approval.  Indeed, Judge Urbina’s opinion states that “once the [New York] court issued its ruling establishing pediatric exclusivity, the FDA had no authority to issue final approval to [Apotex].  Quite simply, the FDA believes that it had no choice but to convert the plaintiff’s approval from final to tentative.”

Categories: Hatch-Waxman