Tuesday, 28 October 2014
Pharma Patents in India
These points are from a talk given by Pravin Anand at fieldfisher’s Pharma Patents Seminar on 16 October 2014.
1. There is an anti-patents environment in India where patent protection is provided due to the compulsion of TRIPS rather than to advance innovation. During the Novartis case the Additional Solicitor General called India the ‘Pharmacy of the World’ to justify its stance towards patents.
2. At present new guidelines are being discussed for pharmaceutical inventions at the Indian Patent Office. There have been allegations they show anti-pharm patent bias.
3. The Novartis Gleevec case concerned Section 3(d) of the Indian Patents Act which requires a new form of a therapeutic substance to have enhanced efficacy. Novartis lost because they could not demonstrate the required efficacy. This section is meant to prohibit evergreening.
4. India has used compulsory licencing provisions for pharma patents. There are 3 types of compulsory licensing. Under the normal Section 84 type a licence will be given three years after grant if reasonable requirements of the public are not met, or the product was not available at a reasonably affordable prices or if the invention was not worked in India.
5. India has Bolar provisions which allow making, using and selling of the patented invention in a way which is reasonably related to development and submission of information.
6. Since 2009 Indian practice has changed as to granting of ex parte injunctions. Since then 15 ex-parte injunctions have been granted at a pre-launch stage.