(1.) THE Invention relates to "A process for preparing 4 -R substituted Anthracyclines" for which Patent No:224413 was filed as a NP application on 7th December 2005 claiming priority date of 21 -5 -2003. The applicant seeks revocation of the patent. In the application the grounds raised were lack of novelty, lack of inventive step, non -patentability under S.3(d), wrongful priority, insufficient disclosure, Inequitable conduct. The pleadings cited -U.S. Patent No.6,844,455 ( 455 in short), U.S. Patent No.5,103,029 ( 029 in short) and Japanese Patent No.2002255888 as prior art.
(2.) IN the counter statement, the respondent claimed that the prior arts taught away from the inventions, and that the starting material in the invention included the sugar moiety attached to the aglycone of the molecule through a glycoside bond, thereby eliminating the glycolysation step required by the prior art methods. The respondent claimed novelty in the process and submitted it was non -obvious. The prior arts had nothing to do with the invention; S.3(d) did not apply to this case. They also filed the affidavit of Dr. Aleksandr Itkin as evidence.
(3.) WHILE making his submissions the learned counsel appearing for the Applicant submitted that Anthracyclines were known from 1987. So "4 -R substituted Anthracyclines" are only new forms of the known substance. The mere fact that there is increase in yield cannot satisfy the therapeutic efficacy test. Once an active ingredient is known then all reactants are known and all processes as such are known. The respondent has not provided any information on the improved efficacy. The learned counsel submitted that the Monsanto case (1986 AIR 712 - Monsanto Company Vs. Coramandal Indag Products (P) Ltd) where the invention was Butachlor, was applicable. It was held that "the Herbicide CP 53619 (Butachlor) was publicly known before Patent Number 125381 was granted. Its formula and use had already been made known to the public by the report of the International Rice Research Institute for the year 1968. No one claimed any patent or any other exclusive right in Butachlor. To satisfy the requirement of publicly known as used in clauses (e) and (f) of Sec.64(1) of Indian Patent Act, it is not necessary that it should be widely used to the knowledge of the consumer public. It is sufficient if it is known to the persons who are engaged in the pursuit of the knowledge of the patented product or process either as men of science or men of commerce or consumers. Emulsification was the well -known and common process by which any Herbicide could be used. Neither Butachlor nor the process of Emulsification was capable of being claimed by the plaintiff as their exclusive property. .In the instant case, the solvent and the emulsifier were admittedly not secrets and they were ordinary market products. From the beginning to the end, there was no secret and there was no invention by the plaintiff. The ingredients, the active ingredient, the solvent and the emulsifier, were known; the process was known, the product was known and the use was known. The plaintiffs were merely camouflaging a substance whose discovery was known throughout the world and trying to enfold it in their specification relating to Patent Number 125381". The learned counsel submitted that the invention lacked inventive step. The learned counsel for the respondent submitted that in this case S.2(1)(j) is the key. The International Search Report showed all the claims were novel and non -obvious. He submitted that the glycosyl group is responsible for the anti -cancer property. None of the processes used in the prior arts has used a starting material which has a glycoside group. Each step in the process is tailor made for the invention. Step (c) is unique to this invention. Since the yield is increased and the steps are reduced there is economic significance. The problem was adding the glycon reactant at the end. It was solved by using a starting material that has the sugar moiety. The learned counsel also gave a tabular column to show the basic differences between the Invention and the Cited documents.