Recent Indian patent developments
January 1, 2005 was a crucial milestone in the history of India’s patent system as it marked the end of the transition period granted by TRIPS to comply with its provisions on pharmaceutical product patents. Since then, India has introduced a revolutionary and promising regime, popularly known as the ‘product patent regime’.
Under this regime, India has opened its doors to product patents for food, chemicals and pharmaceuticals. Now, pharmaceutical companies can obtain full-scale patent protection on their products and prevent local companies from manufacturing generic versions of their patented products.
While the new patent regime offered a host of new opportunities to multinationals and innovator companies, it became a major issue of concern for the generic pharmaceutical industry in India. The provisions of pre-grant and postgrant oppositions led to a drastic change in the patent prosecution pattern. Patent offices were flooded with an unprecedented number of oppositions against the patents/applications of innovator pharmaceutical companies. Some of the patents faced multiple challenges.
During this period, the courts were busy and India saw some revolutionary patent litigation, which not only gave fresh interpretations to the patent law but also new dimensions to patent litigation in India. Therefore, the post-2005 period can be marked as an era of patent litigation.
Such landmark developments shall be the guiding principles for several years to come.
Recognition of the principle of selection patents
In Novartis v. Union of India, the Intellectual Property Appellate Board (IPAB) recognised the principle of selection patents, even though there is no reference to them in the Indian Patent Act. IPAB held that the applicant for a selection patent has to demonstrate the inventive step by way of ‘inventive selection’ from a field that is, in general terms, already known.
Further, in the context of a selection patent, the inventive step will generally lie in making the discovery that what has been selected provides a genuine advantage over the generality from which it was selected. The advantage should be one that could not have been predicted.
IPAB reaffirmed the principle laid down in I G Farbenindustrie A.G’s Patents and held that in chemical patents, the concept of a ‘selection patent’, where the inventive step (also novelty) is demonstrated by way of an inventive selection of even a new, unexpected or unpredictable single function, with previously unknown advantageous properties from a known series disclosed in the art, can be accepted in Indian law. IPAB further listed the following minimum requirements:
