AV&H Defeats Motion for Preliminary Injunction in Hatch-Waxman Case

Axinn Veltrop & Harkrider LLP secured an important victory for its clients Mutual Pharmaceutical Company, Inc. and United Research Laboratories, Inc. (“Mutual”) in patent litigation pending in the United States District Court for the District of New Jersey.  Plaintiffs Tyco Healthcare Group LP and Mallinckrodt Inc. filed a motion for a preliminary injunction to prevent Mutual from selling a generic version of 7.5 mg Restoril™, a drug for treating short-term insomnia.  The motion raised significant legal questions regarding (a) the types of evidence a court should consider in addressing infringement claims brought pursuant to the Hatch-Waxman Act, and (b) the effect of a brand pharmaceutical company’s sales of an authorized generic version of its drug product on the company’s claims that it would be irreparably harmed by the launch of an unauthorized generic version of the same drug.

After a two-day hearing in which the district court heard testimony from four experts and a fact witness, Judge Stanley R. Chesler denied Plaintiffs’ motion, holding that Plaintiffs failed to establish a likelihood of success on the merits of their claim that Mutual’s generic drug infringed Plaintiffs’ patent.  In addition, the Court entered judgment of noninfringement in favor of Mutual on Plaintiffs’ claims brought under 35 U.S.C. § 271(e)(2)(A).  The decision allows Mutual to begin selling its generic drug on final approval from the Food & Drug Administration. 

The AV&H litigation team was led by partners Fran Morrison and Jeremy Lowe, with assistance from associates Ted Mathias, Jason Murata and Thomas Hedemann.