Mylan Lab suffered another setback in its battle to sell a generic version of the epilepsy drug Topamax (Topiramate), after a federal appeals court on Monday upheld a summary judgment ruling that Ortho-McNeil Pharma's patents for the blockbuster pharmaceutical were valid.
The patent in dispute is US4513006 (Expiry: Sep 26, 2008), which covers Topiramate as product. The District Court in New Jersey had concluded that the 006’ patent should be construed to contain two subsets of compounds, and the District Court issued summary judgments in favor of Ortho-McNeil on the Mylan defenses that the patent was invalid due to obviousness and enablement or was otherwise unenforceable due to inequitable conduct. The Court of Appeals affirmed this ruling, concluding the claims construction proper, that Mylan infringed, and that the patent was valid and enforceable. The Court entered final judgment in favor of Ortho McNeil and prohibiting Mylan from marketing its product until the expiry of 006’ patent.
The following orange book listed patents were not litigated
US5998380 (Expiry: Oct 13, 2015)
US6503884 (Expiry: Oct 13, 2015)
US7018983 (Expiry: Oct 13, 2015)
Topiramate
Topiramate (2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate) is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson. Generic versions are available in Canada and were FDA approved in September 2006 .It was discovered in 1979 by Drs. Bruce E. Maryanoff and Joseph F. Gardocki during their research work in McNeil Pharmaceutical.This drug is used to treat epilepsy in both children and adults. In children it is also indicated for treatment of Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delay). It is also USFDA approved for, and now most frequently prescribed for, the prevention of migraines. It has been used by psychiatrists to treat bipolar disorder. (Court Opinion)
link to orangebookblog analysis on this case
