Appeals Court halts preliminary injunction against generic maker of Tussi-12D.

MedPointe Healthcare v. Hi-Tech Pharmacal (Fed. Cir. November 17, 2004) (unpublished opinion).

MedPointe was awarded a preliminary injunction against Hi-Tech to prevent Hi-Tech from manufacturing or selling cough medicine in violation of MedPointe’s patent.  (U.S. Patent No. 6,417,206).  The patent covers MedPointe’s oral medicine known as Tussi-12D

Hi-Tech conceded infringement, but argued that the district court erred in concluding that it had not raised a substantial question of validity.  Hi-Tech produced some evidence indicating that compositions similar to the MedPointe’s patent have been in use since 1938 (Candettes Throat Lozenges).

Preliminary Injunction Rule: Issuance of a preliminary injunction rests on an overall process of balancing, a preliminary injunction cannot be granted if the movant is unable to show a reasonable likelihood of success on the merits. 

In this case, MedPointe “must present a ‘clear case’ supporting the validity of the patents in suit, thus showing that Hi-Tech’s invalidity defense lacks substantial merit.” 

Holding: The court found that Hi-Tech’s uncontroverted testimony showing the similarity between the patent and Candettes to be sufficient to prevent an issuance of a PI.

Dissent by C.J. Mayer: “Because I cannot join in the court’s de novo review of the district court’s findings of fact, I respectfully dissent.”

The case is now remanded to the New Jersey District Court for trial.