Summary
granting extension of thirty-month stay until the entry of final judgment where drug applicant that made a Paragraph Certification failed to meet the case management deadline for serving its expert witness reports
Summary of this case from Novartis Corporation v. Dr. Reddy's Laboratories, Ltd.Opinion
Cause No. IP99-0038-C-H/G
March 8, 2001
EXTENSION OF DELAY FOR FDA APPROVAL OF NEW DRUG APPLICATION
Plaintiff Eli Lilly and Company has sued defendant Zenith Goldline Pharmaceuticals, Inc. for infringing U.S. Patent No. 4,375,547. The '547 patent claims a compound called nizatidine, the active agent in Lilly's gastric antisecretory product called "Axid." Lilly filed this action in response to an Abbreviated New Drug Application (ANDA 75-461) filed by Zenith Goldline which certified pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that Zenith Goldline believed Lilly's patent is invalid. By operation of 21 U.S.C. § 355(j)(5)(B)(iii), the filing of this patent infringement action required the Food Drug Administration to delay for 30 months any approval of Zenith Goldine's application. That 30-month period will expire on or about May 30, 2001.
In connection with Lilly's motion filed February 14, 2001, to modify the case management plan and continue the trial now scheduled for May 14, 2001, Lilly has moved for an order extending the 30-month period. Zenith Goldline opposed all aspects of Lilly's motion. In a hearing on March 7, 2001, the court granted Lilly's motion in part, continued the trial to September 10, 2001, and directed the parties to confer on modification of interim deadlines.
Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), the court hereby grants Lilly's motion for an extension of the period during which the FDA is barred from approving Zenith Goldline's application. The court finds that Zenith Goldline has failed to reasonably cooperate in expediting this action by failing to meet the case management deadline for serving its expert witness reports on the central issue of the case — invalidity, as to which Zenith Goldline bears the burden of proof and persuasion. Under the current case management plan, such reports were due no later than 90 days before trial. Zenith Goldline missed that deadline. At the hearing on March 7, 2001, counsel for Zenith Goldline stated that he expected such reports could be served by mid-April, approximately 30 days before trial. That schedule would not allow reasonable time for those experts to be deposed and for Lilly's experts to prepare and serve their reports and be deposed before the trial.
Although counsel indicated that the reports would not contain any surprises, if their content had in fact long been known, there would have been no reason to delay their production so long.
The court recognizes that the parties may share responsibility, at least to some degree, for various delays that may have contributed to Zenith Goldline's failure to meet the deadline for service of expert witness reports. Much of the delay is attributable, however, to Zenith Goldline's belated motion to bifurcate the trial. In any event, the fact remains that Zenith Goldline missed the deadline for producing expert witness reports, which is on the critical path of this trial schedule.
Accordingly, the court hereby EXTENDS until the entry of final judgment in this action the period under 21 U.S.C. § 355(j)(5)(B)(iii) during which the FDA is barred from approving ANDA 75-461.
So ordered.