District Court Decision Sidesteps 30-Month Stay Tolling Issue; Denies Patent Infringement Litigation Stay

April 19, 2010

By Kurt R. Karst –   

The U.S. District Court for the District of Delaware’s recent decision in Millennium Pharmaceuticals, Inc. v. Teva Parenteral Medicines, Inc., denying a stay of patent infringement proceedings concerning generic versions of Schering’s INTEGRILIN (eptifibatide) Injection is (to our knowledge) the latest case in which a court has been asked to “toll” the 30-month stay of ANDA approval provided under FDC Act § 505(j)(5)(B)(iii) in an effort to preserve 180-day exclusivity eligibility.  As we previously reported, last year the U.S. District Court for the Northern District of Illinois (Eastern Division) in Abbott Labs. v. Matrix Labs., Inc., No. 09-cv-1586 (N.D. Ill. Nov. 5, 2009) ordered the tolling of the 30-month stay in the context of patent infringement litigation over generic KALETRA (lopinavir; ritonavir) Tablets. 

Under FDC Act § 505(j)(5)(B)(iii), the 30-month stay may be “for such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action . . . .”  FDA commented in the preamble to the Agency’s 1994 final regulations implementing the Hatch-Waxman Amendments that “[t]he statute leaves the issue of extending the 30-month period (based on a lack of cooperation between the parties in patent litigation) to the discretion of the trial court.  The agency believes that the trial court should make determinations of cooperation on a case-by-case basis.”  FDA also commented, without qualification, that “[u]nder the statute, the reduction or enlargement of the 30-month period is left to the trial court’s discretion.” 

In the latest case, Teva filed a Motion to Stay requesting an order from the court “(1) staying the present actions until May 11, 2012 (subject to a showing of good cause by any party that the stay should be lifted earlier), and (2) tolling the [FDA] thirty-month stays of approval of Teva's [ANDAs] for the drug at issue here, eptifibatide.” 

INTEGRILIN is covered by five Orange Book-listed patents.  Two of the patents, to which one of Teva’s ANDAs reportedly contains Paragraph III certifications, are scheduled to expire in 2014.  The three other patents, to which one of Teva’s ANDAs reportedly contains Paragraph IV certifications, are scheduled to expire in 2015.  As we previously discussed, this sets up a scenario whereby an early court decision on the Paragraph IV certification patents – that is, a decision well before the Paragraph III certification patents expire – could trigger the 75-day period under FDC Act § 505(j)(5)(D)(i)(I)(bb)(AA), such that, if Teva is a first applicant eligible for 180-day exclusivity, that eligibility could be forfeited under the “failure-to-market” forfeiture provisions.  Those provisions provide that 180-day exclusivity is forfeited based on the “later of” two events – (aa) the earlier of “75 days after the date on which the approval of the application of the first applicant is made effective under [FDC Act § 505(j)(5)(B)(iii)]” or “30 months after the date of submission of the application of the first applicant,” and (bb) 75 days after a final court decision finding certain patents invalid or not infringed with respect to a “first applicant or any other applicant (which other applicant has received tentative approval)” or patent delisting.   

Citing the court’s three-factor stay standard articulated in In re Brimonidine Patent Litig., No. 07-md-1866 (D. Del. Oct. 31, 2008), in which an NDA sponsor requested (and was denied) a stay and tolling of the 30-month stay, Teva argued that: (1) the company would be “greatly prejudiced if the requested stay is not granted;” (2) a “stay could simplify the issues or render litigation unnecessary;” and (3) although the INTEGRILIN patent infringement litigation is in its infancy, case law supports granting a stay at this early stage of litigation.  

Schering and Millennium opposed Teva’s motion arguing that the three factors in In re Brimonidine Patent Litig. are not met.  Most significantly, they argued that:

Teva’s motion is grounded in the incorrect assertion that this Court has complete discretion to extend the FDA’s thirty-month stay.  Although a district court often has broad discretion to stay litigation to control its own docket, there is no such discretion here because Teva is asking this Court to extend the FDA’s statutory thirty-month stay. [(italics in original)]

. . . Congress has expressly provided that the thirty-month stay can not be altered unless a “party to the action failed to reasonably cooperate in expediting the action.” 21 U.S.C. § 355(j)(5)(B)(iii).  The Federal Circuit has made it clear [in Eli Lilly & Co. v. Teva Pharm. USA, Inc., 557 F.3d 1346 (Fed. Cir. 2009) and Andrx Pharm., Inc. v. Biovail Corp., 276 F.3d 1368, 1376 (Fed. Cir. 2002)] that failure to reasonably cooperate in expediting litigation is the sole ground for which a court may extend the thirty-month stay in an ANDA litigation.

And with respect to the decision in Abbott Labs. v. Matrix Labs., Inc., Schering and Millennium commented that:

Even apart from the fact that a decision from a district court in Illinois is not binding in the District of Delaware, Abbott Labs does not justify Teva’s proposed stay. Most critically, the Abbott Labs court improperly did not recognize that the “failed to reasonably cooperate” restriction in section 355(j)(5)(B)(iii) limits the court’s discretion to enlarge the thirty-month period. . . .  As such, the Abbott Labs decision plainly runs afoul of the Federal Circuit’s holdings in Eli Lilly and Andrx and Chief Judge Sleet’s decision in Brimonidine.

Teva replied that the court does, in fact, have the authority to toll the 30-month stay, and that the patent infringement actions “should be stayed regardless of whether the Court also tolls the stays at the FDA.  Tolling at the FDA is not a prerequisite to a stay here” (italics in original).  

Finding, among other things, that “Plaintiffs would be prejudiced in not being able to timely ‘clear the cloud’ that has been cast over the validity of their patents,” Judge Joyner ruled in his brief opinion that:

Although it would be permissible to grant a stay at this stage of the proceedings, given the balancing of the other factors discussed above, we do not believe that it would be appropriate to exercise our discretion to do so at this time.  Granting a stay would cause a hardship to Plaintiffs and any hardship caused to Defendants was the foreseeable result of Defendants’ choice to file their ANDAs when they did.

With respect to the court’s ability to toll the 30-month stay of ANDA approval, Judge Joyner decided to sidestep the issue, commenting that “we do not find it necessary to address these arguments as we have decided against staying the present action, and, therefore, there is no reason to extend the FDA’s stay.”

Categories: Hatch-Waxman