PHARMACEUTICAL PATENTING IN INDIA - BREAKING MYTHS
NATCO PHARMA LIMITED VS. PFIZER PRODUCTS INC.
A Pre-grant opposition was filed by Natco Pharma Limited [hereinafter referred to as Natco] against the grant of a patent to Pfizer Products Inc. [hereinafter referred to as Pfizer] for the patent application titled “Quinazoline Derivatives Compounds and Composition Thereof”. The Controller rejected the grounds taken up by Natco including but not limited to Section 3(d) of the Act and granted a patent to Pfizer.
The order of the Controller in the matter is significant as the Controller recognized and acknowledged that data establishing therapeutic efficacy and synergistic effect of a pharmaceutical invention may not be available with the Applicant at the time of filing such application. In light of the fact that the research and development of pharmaceutical inventions is a long and gradual process, and that the purpose of examination under Section 3(d) of the Act is not to scrutinize the Applicant for the contents of the specification, but instead to evaluate the true intent and efficacy of a pharmaceutical invention, the Controller allowed the Applicant to submit further data and evidence to rebut the challenges made by the Opponent under Section 3(d) of the Act.
The Controller inspected and analysed the evidence submitted by the Applicant and on account of sufficient establishment of enhancement of therapeutic efficacy of the claimed invention by way of said data given by the Applicant, the Controller was pleased to grant the patent. Relevant excerpt from the order of the Controller is reproduced hereinbelow:
“…The applicants submit that the providing of efficacy data at filing was not possible. However, the same has been given as and when asked by Controller. The data regarding survival rate increase has been significant as indicated in the Journal The Oncologist, Feb 5th 2007. In view of the fact that the opponents have not substantiated and elaborated this ground of objection. And further once the invention has been found inventive, the invention cannot be held non-patentable under section 3(d) of the Patents Act. Therefore, the invention cannot be held non-patentable under section 3(d) of the Patents Act, 1970”.
“.. in order to be successful on this ground the opponent has to prove beyond doubt that the alleged invention is either a mere discovery of any new property or new use for a known substance or it is a mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or it is a mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Since the opponents have proved neither clearly nor explicitly, this ground fails”.
– Indian Patent Office