The Indian Patent Office has refused patent to Wyeth, a group company of Pfizer Inc., in response to representation for Pre-grant opposition filed by Fresenius Kabi (formerly Dabur Pharma Ltd.). The pre-grant opposition is against a divisional patent application filed by Wyeth (1155/KOLNP/2007) claiming stable parenteral formulations having a rapamycin hydroxyester (CCI-779).
The grounds for the opposition were that: the invention has been published already [Sec25(1)(b)]; the invention was publicly known in India [Sec25(1)(d)]; the invention is obvious and does not involve any inventive step [Sec25(1)(e)]; the invention is not an invention and not patentable as per the Indian Patent Act [Sec25(1)(f)]; the description of the invention is insufficient and diffuse [Sec25(1)(g)] and the information under section 8 was not furnished by the applicant [Sec25(1)(h)].
In the hearing during opposition proceedings, Fresenius Kabi did not argue on novelty grounds since Wyeth had amended the claims in response to the First Examination Report (FER), after the filing of representation for opposition. Wyeth had claimed that the problem of chemical instability and poor solubility of the parenteral form of CCI-779 was solved by solubilizing CCI-779 with a co-solvent having an antioxidant and/or a chelating agent in the solution. Fresenius Kabi had submitted relevant prior arts to prove lack of inventive step in Wyeth’s claims.The patent office decided not to consider Wyeth’s application as a divisional application under Section 16 of the Patents Act since the parent application did not claim distinct inventions. Also, Wyeth’s amendments to the divisional application was not considered since divisional status was not allowed for the present application. So Wyeth’s application was not entitled to its priority claim of the parent application’s filing date and Form 1 as well as Form 13 submitted by Wyeth were not allowed by the Patent office.
The patent office concluded that Wyeth’s claims are obvious and does not have inventive step as per section 2(1)(j) and section 2(1)(ja) that define “invention” and “inventive step” respectively. Further, the patent office concluded that the invention is not patentable under section 3(d) since efficacy is related to therapeutic efficacy and not to stablility of the compound and the applicant has not given any data with regard to enhancement of efficacy in the description. The invention is also not patentable under section 3(e) since Wyeth claims a formulation comprising two mixtures without any proof in the description for synergistic effect of the formulation, thus rendering the formulation into a mere admixture. Based on the above reasonings, the patent office refused Wyeth’s application for patent grant.