[Ip-health] The Hindu: Bayer plea against Natco on cancer drug dismissed

Shailly shailly.17 at gmail.com
Sat Sep 15 23:46:53 PDT 2012


*Pharma major contested grant of licence to Hyderabad firm for making a
drug to treat liver and kidney cancer*

In a major relief to generic medicine makers and needy patients, the
Intellectual Property Appellate Board on Friday rejected a petition of
pharma major Bayer Corporation, seeking a stay on an order of the
Controller of Patents, granting compulsory licence to the Hyderabad-based
Natco Pharma Limited, a generic drugmaker, for a drug used to treat liver
and kidney cancer.****

On March 9, the Controller of Patents, Mumbai, granted the first-ever
compulsory licence to Natco to make sorofenib tosylate, a generic version
of Bayer’s high-priced anti-cancer drug Nexavar. Indian patent law allows
grant of a compulsory licence to an applicant if the patented drug is not
available to the public at a reasonable price.****

Bayer obtained a patent in India in 2008 for Nexavar, which cost Rs. 2.8
lakh for a pack of 120 tablets, equivalent to a month’s dosage. Natco was
told to sell the pack at Rs. 8,800. As per the licence conditions, Natco
had to pay a six per cent royalty to Bayer from its net sale and

Bayer appealed against the Controller’s order before the IPAB. Among other
reasons, it pointed to the fact that Cipla had started selling its generic
version at a lower price, rendering the compulsory licence unnecessary as
the drug was indeed available at a reasonable price.****

Dismissing the petition, the Board said: “If [a] stay is granted, it will
jeopardise the interests of the public who are in need of the drug. The
appellant has not made out any case…”****

The grant of compulsory licence to Natco created ripples in the
pharmaceutical industry across the globe. One group felt that it would
press the generic industry to provide more affordable drugs to the needy
and another felt that it would affect innovation. In its petition, Bayer
said Cipla was selling its product Soranib, at a maximum retail price of
Rs.6,840 for one month’s treatment — a much lesser price, in fact, than
Natco’s — thereby creating an overall anti-competitive environment. Bayer
also argued that its drug was made available at Rs. 30,000 to patients on
the recommendation of the oncologist.****
The Board said: “The appellant cannot ride piggy-back on, or take shelter
under, the sale by Cipla. It is the duty of patentee that its own supply be
made available at [a] reasonable price to the requirement of the public.”
Dismissing another miscellaneous petition of Bayer, the Bench declined to
go into the merits of its charge that Natco was exporting the drug to
Pakistan and China, noting that the allegation was denied by Natco.****
Shailly Gupta
Policy Advocacy Officer
MSF Access Campaign
New Delhi, India

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