Court declines to toll 30-month stay in ANDA case
In Re: Brimonidine Patent Litigation, MDL Docket No. 07-md-1866 GMS, October 31, 2008.
Sleet, C.J. Plaintiff’s motion to stay the action against Excela and toll the 30-month stay, and for leave to use information produced under the protective order in a citizen’s petition to the FDA is denied.
Plaintiff is a drug company that markets ALPHAGAN P for use in the treatment of glaucoma which is covered by its ‘834 patent. Defendants submitted an ANDA to the FDA seeking approval to market a generic version before the expiration of the ‘834 patent. Plaintiff argues that the stay against Excela is appropriate since the partnership between certain defendants has ended and there is no effective ANDA to litigate in this case. The Court concludes that a stay would be unduly prejudicial since it would likely affect Excela’s first filer status. A stay is unwarranted particularly since discovery is nearing completion and a trial date is firmly set. Nor does the Court find persuasive plaintiff’s argument that the case should be stayed until defendants provide the FDA with bioequivalence testing information. The Court finds no dilatory conduct to support tolling the 30-month stay. The Court finds that plaintiff should not be allowed to use defendants’ confidential information in its citizen’s petition.
