District Court Denies Apotex Declaratory Judgment Motion on Generic ARICEPT; Does Not Accept “Prompt Launch” and “Indefinite Delay” Jurisdiction Theories

September 1, 2010

By Kurt R. Karst –   

Some drugs, it seems, are destined for Hatch-Waxman controversy and lore.  Eisai, Inc.s’ ARICEPT (donepezil HCl) Tablets is one of those drugs.  As the battle over pre-Medicare Modernization Act shared 180-day exclusivity takes off – with a recent citizen petition contesting shared exclusivity in this non-mutually-blocking Paragraph IV certification circumstance, notwithstanding two court decision (here and here) that have now recognized shared exclusivity for generic ARICEPT between Teva and Ranbaxy – another battle has been resolved . . . . at least for the moment. 

As we previously reported, last July, Apotex, Inc., filed a declaratory judgment action against Eisai in the U.S. District Court for the Middle District of North Carolina in an effort to “unpark” 180-day exclusivity for generic ARICEPT that Apotex mistakenly believed was held only by by Ranbaxy.  (Apotex subsequently submitted an Emergency Petition for Stay of Action to FDA asking the Agency to strip Teva of its final ANDA aproval – once again based on the mistaken belief that Teva is not eligible for 180-day exclusivity.  FDA has not yet substantively responsed to the petition.)  Eisai followed up with a Motion to Dismiss. (Apotex’s response and Eisai’s reply briefs are available here and here.)  In an August 27, 2010 decision, the court granted Eisai’s motion and dismissed the case, finding that “Apotex has not presented a justiciable Article III controversy in the present case, and that even if it had, the Court within its discretion would decline to exercise jurisdiction over this claim.”

Apotex, which originally argued that Article III jurisdiction exists based on a theory of “indefinite delay,” later amended it to a theory of “inability to promptly launch,” according to the court.  Under the former theory, when Apotex was under the belief that Ranbaxy was the sole applicant eligible for 180-day exclusivity, the company argued that jurisdiction exists “‘because Ranbaxy will not be able to launch its generic product,’ and following 180 days after the November [25,] 2010 expiration of [U.S. Patent No. 4,895,841 (‘the ’841 patent’), upon which shared 180-day exclusivity is based], there will be ‘no opportunity for a triggering event and subsequent generic entry to the market.’”  Under the latter theory, after Apotex acknowledged the possibility of shared 180-day exclusivity, the company argued that “its injury stems not from any purported delay in the triggering of Ranbaxy’s exclusivity period, but that ‘Eisai’s procedural manipulation of Hatch-Waxman creates a situation wherein Eisai can delay Apotex’s market entry by at least half a year’ after the expiration of the ’841 Patent in November 2010 – and before a period of 180-days thereafter” (italics in original).  The court was not convined by either theory. 

With respect to Apotex’s “prompt launch” theory, the court, in applying the Federal Circuit’s 2008 decision in Jannsen Pharm., N.V. & Jannsen, L.P. v. Apotex, Inc. (in which the Federal Circuit held that with respect to Apotex’s “inability to promptly launch” claim, the company did not have standing to bring such a claim because “Apotex’s inability to promptly launch its generic risperidone product because of [first-filer] Teva’s 180-day exclusivity period is not a cognizable Article III controversy, but a result envisioned by the Hatch-Waxman Act”), ruled that:

Apotex’s alleged inability to promptly launch its donepezil hydrochloride product stems from the 180-day exclusivity periods obtained by first-filers Ranbaxy and Teva, which is an intended consequence and a result envisioned by the Hatch-Waxman Act. Accordingly, any injury flowing from Apotex’s inability to “promptly launch” its generic pharmaceutical or obtain FDA approval of its ANDA application prior to the exhaustion of the first-filers’ exclusivity period does not present the Court with an injury that may redressed by means of a declaratory judgment. [(internal quotation and citation omitted)]

With respect to Apotex’s “indefinite delay” theory, the court decided that “Apotex has failed to establish that any delay preventing its entry into the donepezil hydrochloride market following the expiration of the ’841 Patent is sufficiently real or immediate so as to present this Court with a justiciable Article III controversy.”  Why?  Because:

Apotex has failed to present any basis upon which the Court could conclude that both first-filers, Ranbaxy and Teva, will, or are likely to, delay in bringing the generic product to market following the expiration of the ’841 Patent. . . .  Eisai’s ’841 Patent does not expire until November 2010, and Apotex has neither shown that Ranbaxy’s regulatory complications are likely to indefinitely prevent its marketing of donepezil hydrochloride, nor that Teva will fail to begin marketing the generic drug at that point, both of which would be required showings to demonstrate such an injury under these facts.

We'll let you figure out that puzzler on your own . . . .

Categories: Hatch-Waxman