Orange Book Blog

Ortho-McNeil Neurologics, a unit of Johnson & Johnson, announced in a press release today that it won a preliminary injunction against Mylan in its patent infringement case aimed to protect Topamax (topiramate) from generic competition.  Topamax, indicated for the treatment of epilepsy and migraines, had U.S. sales of $1.4 billion last year.

Judge Stanley R. Chesler of the U.S. District Court for District of New Jersey wrote the opinion, in which he concluded that the patent in suit is likely to withstand Mylan’s obviousness defense because Mylan had not presented suffcient evidence of a "motivation, suggestion, or teaching" to modify the prior art.  Thus, this is yet another recent case turning on the Federal Circuit’s suggestion test, the merits of which are currently under consideration by the Supreme Court in KSR v. Teleflex.  Earlier this year, Judge Chesler dismissed Mylan’s inequitable conduct, non-enablement, and indefiniteness allegations on summary judgment.

Ortho-McNeil filed its motion for a preliminary injunction last July "to preserve the status quo" and prevent an at-risk launch when its 30-month stay expired in September.  Ortho-McNeil’s patent on topiramate, U.S. Patent No. 4,513,006, will not expire until September, 2008.