J&J Wins Injunction Blocking Mylan Generic Topamax

Reuters reported yesterday, October 24, 2006:

Johnson & Johnson on Tuesday said a New Jersey federal court has granted the company a preliminary injunction that prohibits Mylan Laboratories Inc. from launching a generic form of J&J's widely used Topamax anticonvulsant.

Judge Stanley Chesler of the U.S. District Court for the District of New Jersey in Newark, New Jersey, granted the injunction on Monday, J&J said in a release.

Mylan in September won U.S. approval to sell generic versions of three dosage strengths of Topamax that have combined annual sales of about $1.4 billion.

Topamax is one of J&J's biggest selling products, with 2005 global sales of $1.7 billion.

The Orange Book Blog reports that annual sales of Johnson & Johnson's Topamax are $1.4 billion.

According to Johnson & Johnson's 2005 annual report the 30 month stay for Mylan's generic Topamax was scheduled to expire in September 2006.

In Johnson & Johnson's Form 10-Q for the quarter ended April 3, 2005 it was reported "[i]n the action against Mylan relating to Ortho-McNeil's TOPAMAX (topiramate), Mylan on October 8, 2004 filed a motion for summary judgment of non-infringement of Ortho-McNeil's patent. The court heard argument on the motion on April 18, 2005 and held a further hearing on the motion on May 6, 2005. A decision is expected in the third or fourth quarter of 2005."

The Pittsburgh Post-Gazette print edition reported today that the preliminary injunction will "stop Mylan Laboratories from launching a generic version of Topamax before the final court decision on the validity of the patent.  The patent for Topamax, an antiepileptic drug, expires in September 2008.  Ortho-McNeil said a trial date hasn't been set.