Federal Circuit Affirms a 30-Month Stay Extension for Generic EVISTA

February 24, 2009

By Kurt R. Karst –      

In a rare move, the U.S. Court of Appeals for the Federal Circuit affirmed a district court decision extending a 30-month stay available under the Hatch-Waxman Amendments with respect to Teva Pharmaceutical USA, Inc.’s ANDA for a generic version of Eli Lilly and Co.’s (“Lilliy’s”) EVISTA (raloxifene HCL) Tablets. 

Under the FDC Act, an NDA holder or patent owner may choose to sue a generic applicant for patent infringement if the generic applicant submits an ANDA containing a Paragraph IV certification to an Orange Book-listed patent covering the NDA holder’s product.  If such patent infringement lawsuit is made within the statutory 45-day period, then the law mandates a 30-month stay of ANDA approval.  In that case, “the [ANDA] 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 . . . .”  FDC Act § 505(j)(5)(B)(iii) (emphasis added).  Since the enactment of the Hatch-Waxman Amendments in 1984, there have been only a few cases of which we are aware where a court has extended the statutory 30-month stay on ANDA approval. 

In the current case, in late 2008, the U.S District Court for the Southern District of Indiana ruled that Teva had “recast its product more than eighteen months after it provided the original sample to Lilly and only eight months before trial is set to commence,” and that an extension of the 30-month stay was appropriate because Teva failed to cooperate in expediting the patent litigation.  Teva appealed the district court decision to the Federal Circuit.  In affirming the district court’s decision, the Federal Circuit ruled that the district court “acted within its discretion in this area.” 

In his dissent, Judge Prost emphasized that “[t]he thirty-month stay described in [FDC Act § 505(j)(5)(B)(iii)] may be extended for one reason and one reason only: ‘because either party to the action failed to reasonably cooperate in expediting the action,’” and that the district court “never related Teva’s conduct to the statutory standard.”  Judge Prost also warns of the potential consequences of the majority’s decision:

The consequences of the majority opinion are of particular importance here.  Rarely have district courts had the opportunity to address the circumstances under which the thirty-month stay may be extended or shortened.  Those courts that have addressed the issue have recognized the statutory standard and strictly abided by it in determining whether to modify the stay . . . .  To affirm in this case is to effectively eliminate the statutorily required finding, and to prematurely terminate the development of appropriate standards governing modification under [FDC Act § 505(j)(5)(B)(iii)].    

Categories: Hatch-Waxman