Harish S. Adwant
Pfizer filed a patent for the self-engineered rheumatoid arthritis medicine; Tofacitinib which was rejected by the Patent Office on the ground that the drug does not enhance the efficacy of the existing approved drug.
It was rejected for the second time after the Intellectual Property Appellate Board (IPAB), vide order passed on March 26, 2015, set aside the order of the Patent Office and directed an express reconsideration of the application.
“After having considered the submissions submitted by the applicant in the hearing, the written submission and amended claims filed… it is hereby ordered that the invention disclosed and claimed in the instant application… is not considered as an invention under the provisions of the Act,” Assistant Controller of Patents and Designs Bharat N S said in an order.
The order also pointed out that it is highly imperative that the applicant establishes the therapeutic enhanced efficacy of the claimed compound over the base compound.
“I do not admit that the claimed compound has enhanced efficacy over the base compound…and hence not patentable under Section 3(d) of Patents Act… and I therefore, hereby refuse this Application,” Bharat added in his order.
“Following this decision from IPAB, we are reviewing our options for further action. Pfizer remains committed to innovation and the long-term viability of its research and development programmes for the benefit of patients and healthcare practitioners in India and across the world,”the company said.
The order passed by the Patent Office has invited widespread criticism at the hand of multi-national companies (MNCs) and IP professionals. They allege that India’s Intellectual Property Rights (IPR) regime is not in consonance with the global norms. These criticisms lead to a sense of urgency for the NDA government to introduce and effectively implement the Draft National IPR Policy.
It is observed that cases dealing with patent applications, product based or process based, must strictly adhere to Section 3(d) of the Patents Act, 1970. This section was newly introduced by the Amendment Act, 2005 and provides for the inventions which are not patentable. It is particularly important as the amendment allowed Patent Offices across India to grant patents on pharmaceutical products for the first time in India.
A bare perusal indicates that there are three parts to the interpretation of the provision-
- Non-patentability of a mere discovery of new form of a known substance;
- Explanation; and
Apart from the issues of non-patentability and its explanation, the exception to the provision has been exhaustively adjudicated upon by the Supreme Court in the landmark judgement of Novartis AG v. Union of India.
The Supreme Court, while interpreting the connotations of the term ‘efficacy’, observed that patents can be granted to new forms of a known substance; provided that the applicant proves significant enhancement in its therapeutic efficacy or its curative property as compared to the old form in order to secure patentability.
The current rejection proves that the Patent Office, while following the rule of precedence, is exercising its authority in accordance with the interpretation observed by the Supreme Court with the respect to the oft-cited Section 3(d) of the Patents Act, 1970.