Orchid sued by Roche, Sepracor over generics

Orchid Chemicals & Pharmaceuticals, an Indian drugmaker, was sued by Sepracor and Roche Holding over plans to sell two new generic drugs in the US.

Orchid is seeking the US Food and Drug Administration approval to introduce generic versions of the allergy pill Clarinex, for which Sepracor owns patent rights, and Roche's osteoporosis drug Boniva. Both drugmakers sued last week in the Federal Court in Newark, New Jersey, to block the approvals until patents expire.

Clarinex, which first received regulatory approval in 2001, is the successor to the allergy pill Claritin, a medicine now available in the US without a prescription. Schering-Plough Corp sells the drugs, and Sepracor, based in Marlborough, Massachusetts, receives patent royalties on the sales.

Sepracor and the University of Massachusetts, which co-owns the patents, claimed in a suit filed September 26 that the copy would infringe three patents that expire in 2014 and 2015.

Boniva, made by Basel, Switzerland-based Roche, is a tablet taken once a month. Roche contends a generic version would infringe one patent expiring in 2019 and another ending in 2023. The drug generated sales for Roche of 374 million Swiss francs ($319.9 million) in the first half of this year. The Roche suit against Orchid was filed September 25 in Newark.

Orchid spokesman C H Ram declined to comment on the suits.

Roche also sued Genpharm, a unit of Germany's Merck, over its application to sell generic Boniva. The complaint, filed September 28 in Newark, cites the same two patents. Officials with Genpharm in Toronto didn't immediately return a message seeking comment.

Sepracor shares fell 9 cents to $27.41 in Nasdaq Stock Market trading. Roche rose 1.6 Swiss francs to 212.7 francs in trading in Zurich. Orchid fell Rs 2.15 to 223.55 in Mumbai.

The cases are Sepracor versus Orchid Chemicals & Pharmaceuticals, and Hoffmann-La Roche versus Orchid Chemicals & Pharmaceuticals, both US District Court, District of New Jersey (Newark).