Court clarifies earliest launch date for generic product
Takeda Pharmaceutical Company Ltd., et al., v. Teva Pharmaceuticals USA, Inc., et al., Civ. No. 06-33-SLR, November 9, 2009.
Robinson, J. The court grant’s plaintiff’s request for clarification with respect to the court Final Judgment Order.
The Court rules that the effective date for any FDA approval of defendants’ ANDAs shall be no earlier than November 11, 2009. The patent expired on May 10, 2009, but the FDA granted an additional 6 months extending plaintiff’s exclusivity through November 10, 2009. The patent-in-suit is directed to lansoprazole, a compound in the family of proton pump inhibitors. Defendant contends it is entitled to launch on November 10, 2009 in line with the 180-day marketing exclusivity period to which defendant is entitled. The court concludes there should be no overlap between the expiration of a patent’s exclusivity period and the commencement of a generic’s period of marketing exclusivity, and that the patentee should have the benefits of its exclusive rights until the patent expires.
