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P.T.Jyothi Datta

Mumbai, March 7 Drug-maker USV Ltd has notched up a patent-related win against the US Patent Office, on donepezil oxalate, a pharmaceutical ingredient effective in treating Alzheimer’s disease.

The development is significant, since an important intermediate, Donepezil base is covered by several patents by the innovator company. USV’s patent on a novel salt, Donepezil Oxalate helps the company make Donepezil Hydrochloride (the active ingredient in Alzheimer drug Aricpet) without violating the innovator company’s patents on the intermediate, a company official explained.

Donepezil Hydrochloride it the active ingredient in Aricept, an over $ 2 billion Alzheimer’s drug from Japanese drug-maker Eisai Co Ltd . The US patent on Aricept, which is co-marketed with Pfizer Inc., expires in November 2010.

The patent-related development comes even as the Mumbai-based USV sets about its strategy of getting a process patent on a drug that is set to expire in the short term. This helps USV get some elbow-room for itself in a competitive generic drugs market.

USV had applied for a patent on donepezil oxalate in 2004, describing the invention as a “composition of matter”, a term used in the US patent statue, said a note from Mark Pohl, patent attorney with Pharmaceutical Patent Attorneys, who argued the case for USV.

The US Patent office though refused USV’s patent application, arguing that the said phrase was too vague, the note said. The company appealed to the Board of Patent Appeals and Interferences, which disagreed with the patent office’s view, the note added.

Generic drug-companies are increasingly fighting each other to protect their turf once a drug goes off-patent, said USV’s Managing Director, Mr Prashant Tewari, explaining his company’s strategy.

A patent allows a company to hold a 20 year exclusivity on its manufacture and sales and when the patent runs out, generic companies begin to make similar versions of the drug resulting in an over 90 per cent erosion on the price of the medicine.

More Stories on : IPR | Pharmaceuticals | Health

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