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After the landmark grant of Compulsory license (CL) for Bayer’s
Nexavar to Natco last year, a trend of CL application seems to have started in
India. Recently, health ministry has recommended CL for a breast cancer drug
Trastuzumab after various campaigns held regarding the affordability of this
expensive drug in India. However, Department of Industrial Policy and Promotion
(DIPP) has refused the CL for Trastuzumab (Herceptin) manufactured by Swiss
It was previously reportedthat the health ministry has suggestedrevoking
the patent in public interest under section 66 of Indian patent act 1970.
However, a recent clarification from Kolkata patent office suggests that the
three patents for Herceptin were not revoked but were abandoned or withdrawn
because Roche failed to file the documents before deadline and did not appear
for the hearing concerning its Herceptin patent.Although, Roche did not make
any comments regarding the lapse of its patent; the Herceptin patent IN205534
is diminishing due to its post-grant opposition. India awarded patent for
Roche’s Herceptin in 2007 which is currently extended till 2019. Three more
patents related to the original patents were further filed, but were withdrawn
since Roche failed to meet the deadline. The request for examination of one of
the patents was not filed before deadline, while the same was filed for other
two after the patent grant, which is not permitted in Indian patent law.
Herceptin is said to be the third biggest seller by Roche.
Although, the Herceptin patent is abandoned, the generic version of
this drug may not come to the market anytime soon. Currently, Roche’s Herceptin
sells for Rs.1,34,000 per vial but Roche also sells the cut price version of
this drug through an Indian generic company Emcure Pharmaceuticals Ltd. at the
cost ofRs.70,000 per vial. Any generic
version of this drug in Indian markets will lead to patent infringement. Besides,
this drug is a Biotech drug and developing such a drug under generic company
set up is not easy.
There are speculations that CL was refused by DIPP after widespread
criticism from International community on CL to Nexavar. In the recent times,
Indian IP office has been serious about the submission of ‘statement of
working’ or form 27 by the companies regarding their working of patents in
India. However, last year for the first time this information from various
companies has been made available to public. Although the reason behind the
disclosure of such confidential information is not known but it is wondered
that lack of such information by the company regarding the working of the
patent in India or information on non-working of patent may favour companies
seeking CL. On one hand,with government enabling affordability of lifesaving
drug to patients and on the other hand critics pointing fingers at Indian IP
laws, only time will where India’s healthcare is heading.