Court Blocks Early Generic Topamax Launch

Mylan Laboratories lost its bid to launch generic Topamax capsules and tablets after a federal court barred the company from selling its version of the epilepsy treatment prior to late 2008.

The U.S. District Court for the District of New Jersey upheld the validity and enforceability of the '006 patent, a basic compound patent held by Johnson & Johnson subsidiary Ortho-McNeil Neurologics covering Topamax (topiramate).

The court found that Mylan's generic version would infringe on the brand product if launched prior to the expiration of the patent. It issued a permanent injunction against the generic firm, blocking it from launching its product prior to Sept. 26, 2008. The ruling also directs the FDA to change the effective date of Mylan's approval to market its generic version of the brand drug.

Launch of the generic product had been initially blocked last year when the same district court issued a preliminary injunction.

According to legal experts on pharmaceutical patent litigation, a preliminary injunction blocking a generic drug launch typically increases the odds of the brand manufacturer winning a permanent injunction against the generic firm.

However, a generic firm may be able to fend off a motion for a permanent injunction blocking the launch of its competing product if certain facts in the case were not presented in earlier proceedings. In that case, the brand company would have to prove the generic product launch creates a high risk for its brand products and show that the only remedy would be to keep the generic off the market.