Healthcare Industry News:  Mylan Laboratories 

Biopharmaceuticals Neurology Generics Litigation

 News Release - October 24, 2006

U.S. District Court Grants Request for Preliminary Injunction to Ortho-McNeil Neurologics, Inc. for TOPAMAX(R)

TITUSVILLE, N.J., Oct. 24 (HSMN NewsFeed) -- A U.S. District Court has granted the request of Ortho-McNeil Neurologics, Inc., a subsidiary of Johnson & Johnson, for a preliminary injunction against Mylan Laboratories, Inc. prohibiting Mylan from launching a generic version of topiramate (TOPAMAX®) prior to a final court decision on the validity of the patent.

On October 23, 2006, Judge Stanley R. Chesler of the U.S. District Court for the District of New Jersey in Newark, N.J. granted the injunction.

The preliminary injunction will be in effect until the district court has rendered a final decision regarding the validity of the TOPAMAX patent. A trial date has not yet been set. The TOPAMAX patent expires in September 2008.

TOPAMAX is indicated as monotherapy in patients with newly diagnosed epilepsy or for conversion to monotherapy in patients with epilepsy. It also is indicated as adjunctive therapy for adults and children (aged 2 and above) with partial onset seizures or generalized tonic-clonic seizures, and in adults and children as adjunctive therapy for the treatment of seizures associated with Lennox Gastaut syndrome. TOPAMAX® is indicated in adults for the prophylaxis of migraine headache. The usefulness in the acute treatment of migraine headache has not been studied.

Headquartered in Titusville, N.J., Ortho-McNeil Neurologics, Inc. focuses exclusively on providing solutions that improve neurological health. The company currently markets products for Alzheimer's disease, epilepsy, and acute and preventive migraine treatment. Ortho-McNeil Neurologics, Inc., in conjunction with internal and external research partners, continues to explore new opportunities to develop solutions for unmet healthcare needs in neurology.

Source: Ortho-McNeil

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