Monday 10 March, 2008

USV got patent on Donepezil Oxalate

USV Ltd. got a major success in a legal appeal, winning exclusive US rights to a new drug salt of Donepezil oxalate which is effective in treating Alzheimer's disease. USV applied to patent this compound in 2004. USV's patent application described its invention as a "Composition of matter," the legal term used in the US patent statute. Surprisingly, the US Patent Office then refused to issue USV's patent application, arguing that the phrase "composition of matter," which appears in the patent statute itself, is too vague to support proper patent rights. An appeals board in Washington disagreed. Rather, The Board of Patent Appeals and Interferences noted that a 1980 Supreme Court ruling involving another Indian inventor, Sidney A. Diamond v. Ananda Mohan Chakrabarty, concluded that the phrase "composition of matter" is perfectly acceptable. The appeals board thus concluded, in Ex parte Venkatasubraminarian Radhakrishnan Tarur et al., Appeal No. 2007-4478, that USV is entitled to its patent. 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.
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.

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