In Warner Chilcott Labs. Ireland Ltd. v. Mylan Pharms. Inc., No. 2011-1611 (Fed. Cir. Dec. 12, 2011), the Federal Circuit vacated a preliminary injunction entered by the U.S. District Court for the District of New Jersey to prevent Mylan from launching a generic version of 150 mg Doryx, which is the branded name for the doxycycline hyclate delayed-release tablets sold by plaintiffs Warner Chilcott and Mayne Pharma International (the “Plaintiffs”). Doryx is covered by United States Patent No. 6,958,161, which discloses a modified release coated form of doxycycline.
Upon approval of Mylan’s ANDA, the Plaintiffs sued for infringement within the period prescribed by the Hatch-Waxman Act. Mylan responded that the ‘161 patent was not infringed, and was invalid and unenforceable. The question of infringement turned on whether Mylan’s generic Doryx product included a “stabilizing coat” as required by the only asserted claim. In addition to pursuing an infringement claim against Mylan, Plaintiffs also moved for a preliminary injunction shortly before the FDA’s thirty-month stay of final approval was set to expire. In particular, Plaintiffs argued that (1) they were likely to succeed in proving that Mylan’s product infringed the ‘161 patent by incorporating a “stabilizing coat” in its capsule formulation; (2) they would suffer irreparable harm absent an injunction; (3) the balance of hardships favored Plaintiffs; and (4) public policy interests demanded that an injunction be entered. The district court agreed.
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