Source: http://www.fdalawblog.net/2010/04/district-court-decision-sidesteps-30month-stay-tolling-issue-denies-patent-infringement-litigation-s/
Timestamp: 2019-04-20 12:26:21+00:00

Document:
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.
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.
. . . 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.
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).
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.

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