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.
You may also wish to see related articles Top
10 Things You Need to Know about Biosimilars and Top
10 Points on the Trans-Pacific Partnership.
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