[Ip-health] Times of India predicts India government will reject CIPLA compulsory license request

Jamie Love james.love at keionline.org
Thu Dec 18 17:15:26 PST 2014


|The Times of India|The Economic Times|

Government may not act on Cipla’s patent plea
Sidhartha, TNN | Dec 15, 2014, 04.23AM IST

NEW DELHI: In a setback to Cipla, the homegrown generics medicine company,
the government has so far found little merit in its plea for waiver and
cancellation of patent rights for five drugs over which Novartis has
exclusive rights.

Sources told TOI that the health ministry has suggested that Cipla's
proposal for a compulsory licence for the medicines under section 92 of the
Patents Act — a rarest of rare provision to be used in case of national
emergency or in extreme urgency or for public non-commercial use — may not
be "fit" to pass legal scrutiny.

And, with several patent disputes related to Novartis' respiratory drug
Onbrez already in court, the government is unlikely to use section 66 of
the Patents Act, the other suggestion made by Cipla. In any case, the
government has resorted to the use of section 66 only on two occasions —
once in 1994 and a second time in 2012 — as the provision is meant to be
used if a patent is "mischievous to the State or generally prejudicial to
the public".

Cipla had approached the department of industrial policy and promotion
(DIPP) a few months ago arguing that the patents should be revoked as
Novartis imported small quantities of the medicine, estimated at around
54,000 units, allegedly depriving 1.5 crore patients who need the drug.

The move by the Indian generics firm was the latest demand before the
government to use flexibilities available in the Patents Act to issue a
compulsory licence, which effectively waives the patent rights and allows a
local player to manufacture the medicine and share a part of the revenue as
royalty to the patent holder.

So far, compulsory licence has been issued only once in 2012, when Natco
was allowed to manufacture a cancer drug whose patent was held by Bayer.
Sources said in the case of Cipla's request, the health ministry has said
if at all there is an argument for a compulsory licence, it should be
considered under section 84. But, the government has no powers to use the

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