USV wins appeal against USPTO decision.

At the examination stage the examiner had allowed Claim 32 (Donepezil oxalate) and 37 but had refused to grant Claims 33-36 and Claims 38-52 because they failed the requirements of 35 U.S.C. § 112, second paragraph. § 112 basically lays down the requirements of a specification in a patent application. Para 2 lays down that “The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”
The examiner rejected the Claims (which were based on the previous Claims 32 and 37) because they used the words ‘composition of matter of claim 32’, although these words lack basis in either the prior mentioned Claim 32 or anywhere else in the specification.

The Appellants contended that 35 U.S.C. § 101 refers to a “composition of matter” as a statutory class of patentable subject matter and was therefore a legally acceptable claim term.

The Appeals Court accepted this interpretation of the Appellants and read with this the interpretation of ‘composition of matter’ by the U.S Supreme Court in the famous Diamond v. Chakraborty Case. In that case the Supreme Court had read the term “composition of matter”, “consistent with its common usage to include “all compositions of two or more substances and . . . all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders, or solids.”

Since Claim 32 (Donepezil Oxalate) was a chemical substance which was a result of a chemical union the Board of Appeals agreed with the “Appellants that describing the subject matter of dependent claim 33 as a “composition of matter” is merely characterizing it as the specific statutory class of patentable subject matter to which it belongs and does not require antecedent basis in claim 32.” Therefore it was held to meet the requirements of second paragraph of § 112 by distinctly claiming the patentable subject matter. The Board thereby reversed the decision of the USPTO in regards Claims 33-36 and Claims 38-51.

The PharmaBiz article is pasted below:

USV wins US rights to novel drug salt donepezil oxalate
March 10, 2008, 0800 IST

Mumbai-based drug maker USV Ltd. scored a decisive win in a recent legal appeal, winning exclusive US rights to a new drug salt.

The new drug salt, donepezil oxalate, 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.

Mark Pohl, patent attorney with Pharmaceutical Patent Attorneys LLC of Morristown, New Jersey, argued on behalf of USV Limited; Celia C. Chang of Arlington, Virginia argued on behalf of the United States Patent Office.

Talking about the new patent on donepezil oxalate, USV Ltd’s managing director Prashant Tewari said, “The patent on our novel drug salt donepezil oxalate is very important for us. That is why when US patent office rejected our case we went for the appeal”. The company’s R&D head Radhakrishnan said that donepezil oxalate is a novel salt for making the donepezil hydrochloride which is the final API product. It is very essential for us for meeting the international quality in our products. “There were several questions from the US Patent office regarding the product. We explained them all their doubts that is why we have received the patent now”, Radhakrishnan said.