In a Rare Move, District Court Extends 30-Month Stay on FDA ANADA Approval

June 20, 2011

By Kurt R. Karst –      

Although many have tried (see, e.g., here), in our experience, few have succeeded in convincing a court to decide to grant a motion to extend a 30-month stay on FDA’s approval of a generic drug application.  (The most recent case we can think of is from 2009, when the U.S. Court of Appeals for the Federal Circuit in Eli Lilly & Co. v. Teva Pharms. USA, Inc. affirmed a district court decision extending a 30-month stay with respect to an ANDA for a generic version of EVISTA (raloxifene HCL) Tablets – see our previous post here.)  It’s even more rare to see such a motion granted under the animal drug Hatch-Waxman counterpart, the Generic Animal Drug and Patent Term Restoration Act (“GADPTRA”).  But that’s what happened in Bayer Healthcare, LLC v. Norbrook Labs. Ltd. when the U.S. District Court for the Eastern District of Wisconsin ruled earlier this month to extend the 30-month stay of approval of Norbrook’s Abbreviated New Animal Drug Application (“ANADA”) for a generic version of Bayer’s Baytril® 100 (enrofloxacin) Injectable Solution, which is covered under New Animal Drug Application No. 141-068 and listed in the Green Book (the animal drug equivalent of the Orange Book) with U.S. Patent No. 5,756,506 (“the ‘506 Patent”), which expires on June 27, 2015. 

Under FDC Act § 512(n)(1)(H), as added by GADPTRA, an ANADA sponsor must submit a certification or statement with respect to each Green Book-listed patent for the reference product.  As under Hatch-Waxman, a timely filed patent infringement lawsuit stemming from a Paragraph IV certification triggers an automatic 30-month stay on ANADA approval.  In that case, “the [ANADA] approval shall be made effective upon the expiration of the [30-month stay] . . . or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action. . . .” 

In Bayer Healthcare, LLC v. Norbrook Labs. Ltd., Bayer timely sued for patent infringement based on Norbrook's Paragraph IV certification to the '506 Patent, thereby triggering a 30-month stay on ANADA approval that was reportedly originally scheduled to expire on March 29, 2011.  Bayer alleged that Norbrook failed to reasonably cooperate in expediting the patent infringement action by, among other things, changing “its [ANADA] after the close of fact discovery and after the submission of expert reports, just months before trial” (italics in original) as part of a strategy to delay the patent infringement litigation, and by failing to serve “discovery responses for more than three months, not withstanding [sic] that the Federal Rules [of Civil Procedure] mandate a response within 30 days.”  Bayer asked the court to extend the 30-month stay of FDA’s approval of Norbrook’s ANADA through the February 6, 2012 trial date set by the court. 

Norbrook contended, among other things, that “the 30-month stay is not intended to enable the parties to fully resolve their patent disputes before its expiration and that Bayer should file for preliminary injunctive relief if it wants to prevent the FDA from approving Norbrook’s ANADA,” and that the Federal Circuit’s decision in Eli Lilly “does not apply because Norbrook’s ANADA amendment does not change the method for which it seeks FDA approval, whereas in Eli Lilly, the [ANDA] amendment materially changed the product in question.”  Norbrook also cited a recent decision out of the U.S. District Court for the Southern District of New York – Bayer Schera Pharma AG v. Sandoz, Inc. – in which “Bayer contended that a motion to dismiss for lack of personal jurisdiction, which had been pending three months until it was withdrawn, established that the movant had failed to reasonably cooperate in expediting the action,” but the district court did not grant a 30-month stay extension.

Relying heavily on the Federal Circuit’s decision in Eli Lilly where the Court upheld a district court decision extending a 30-month stay because the ANDA sponsor reportedly changed a manufacturing specification eight months before the trial date, Judge Rudolph T. Randa ruled that “Norbrook’s actions – in waiting four months after the close of discovery and only five months before trial to change its ANADA – provide a strong basis for this Court to extend the stay, compared to those of Eli Lilly.”  Judge Randa was not convinced by Norbrook’s contention that Bayer Schera applied and easily dispensed with the case, writing that in Bayer Schera the district court held that “Bayer – the plaintiff – had not sought to expedite the litigation,” whereas in the case at bar, “Norbrook’s December 2010 ANADA amendment has resulted in a delay of the litigation.”