Substantial Question of Claim Construction Dooms Preliminary Injunction

Posted on | March 20, 2008 | No Comments

2008-1225 Novo Nordisk v. Sanofi-Aventis
D/NJ 07-cv-3206

Novo appeals from Judge Mary Cooper’s Order denying its Motion for Preliminary Injunction.  Novo asserts 7,241,278 against Sanofi, a patent related to an insulin “pen” for injecting set doses of medicine from a cartridge.  Novo generally describes the asserted claims as including a “novel means of coupling and de-coupling a dose dial sleeve and drive sleeve, thereby reducing the force required of the patient to complete an injection.”

After running through the legal standards and tests (including Genentech and Abbott Lab), the court turned to the reasonable likelihood of infringement.  The main argument is whether or not the claims require a gearbox or direct gearing that avoids transformations of rotational to linear movement between the injection button and piston rod.  Novo argues, based generally on plain meaning, that the claims do not require such gearing; Sanofi, relying on statements about the prior art and advantages of the invention, argues otherwise. The court analyzes these arguments by noting a tension between claim construction principles: claims should be read in light of the specification but one shouldn’t import limitations from the specification into the claims.

Ultimately, however, the court doesn’t decide.  Instead, it finds that Sanofi’s claim construction arguments raise substantial questions regarding infringement:

This Court believes that Sanofi has raised substantial questions regarding whether the specification read as a whole suggests that the very character of the invention requires direct gearing and a non-rotatable piston rod to be part of every embodiment. . . . The Court concludes that Novo has not shown that Sanofi’s asserted defense that the SoloStar does not infringe the ‘278 patent because it lacks direct gearing and a non-rotatable piston rod, lacks substantial merit.

The court therefore denies the preliminary injunction, declining to address the invalidity arguments or any of the other preliminary injunction factors.   

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