[Ip-health] Amit Sengupta in the Economic Times: Should compulsory licensing be allowed?

thiru at keionline.org thiru at keionline.org
Wed Mar 14 02:09:37 PDT 2012


14 Mar, 2012, 10.30AM IST, TNN
Should compulsory licensing be allowed?

Yes, benefits of invention must reach those who need it: Amit Sengupta,
The All India People's Science Network

The decision by the Indian Patent Office to issue a compulsory licence
(CL) to Natco for Bayer's anti-cancer drug Sorafenib means the drug will
now be available at Rs 8,800 per month, a 97 % reduction from Bayer's Rs
2.8 lakh. Globally, people working on public health and access to
medicines have welcomed the decision.

This, the first CL issued in India, can set a precedent. The 2005 Patents
Act provided broad grounds for issuing a CL including: (a) the reasonable
requirements of the public with respect to the patented invention have not
been satisfied or (b) it is not available to the public at a reasonably
affordable price and (c) the patent is not being worked.

This is a rare instance globally where a general CL has been issued, not
bound by 'government use' provisions or those allowed only in cases of
'extreme urgency ' or 'national emergency'. A CL that can be utilised by a
generic company without encumberances means CLs could possibly be used to
promote competition.

The CL on sorafenib does not only help cancer patients, it also is a step
towards building domestic manufacturing capacity and knowhow in a new
range of drugs.

Sorafenib is one of the first among a group of new drugs that specifically
target cancer cells. Similar drugs with better results are likely to be
available over time and it is important that generic manufacturers develop
capacity to manufacture these.

Big Pharma has predictably responded by saying this would make it
difficult for innovator companies to recoup R&D costs. It needs to take a
hard look at how it prices new drugs. At nearly Rs 3 lakh for a month's
treatment, Bayer is pricing out almost everybody in a country like India.

In effect, the patent is not being 'worked ' in such situations since the
benefits of the invention are not accruing to those who need the drug.
Patents represent a balance between the rights and obligations of a patent
holder. At the core of the patent system lies the effort to make available
to the largest numbers the fruits of any new innovation, while providing a
fair return to the innovator.

Compulsory licensing is a key instrument in maintaining this balance. It
allows regulators to break a patent holder's monopoly in situations where
the monopoly is abused to deny access to the innovation to a very large
number of people.

The research used by Big Pharma to develop new products is often crucially
based on publicly-funded research. Why should it be free to use
public-funded research while simultaneously criticizing all attempts to
make sure that the benefits of new research also serve public health goals


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)

thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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