[Ip-health] Bombay HC upholds Nexavar compulsory licensing decision

Ramya Sheshadri ramyasheshadri8 at gmail.com
Tue Jul 15 03:45:43 PDT 2014

C.H. Unnikrishnan

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Mumbai: The Bombay high court on Tuesday declined to interfere with the
order passed by an appellate board allowing drug maker Natco Pharma Ltd to
manufacture and sell a generic copy of a patent-protected cancer drug made
by German drug maker Bayer AG.

The court was hearing a plea filed by Bayer challenging a March 2013 order
passed by the Intellectual Property Applellate Board (IPAB) permitting
Hyderabad-based Natco Pharma to manufacture and sell a generic copy of the
patented drug Nexavar.

 “We don’t see a reason to interfere with the order passed by IPAB and,
therefore, the case is dismissed,” said justice M.S. Sanklecha.

 In March 2012, the Controller General of Patents Design and Trademarks
gave the first-ever compulsory licence to Hyderabad-based Natco Pharma to
sell a generic version of Nexavar. A compulsory licence allows the
production of a generic version of a patented medicine and sell it at a
cheaper price. Natco Pharma was asked to pay a royalty of 6% on net sales
of the drug to Bayer.

 India’s then controller general of patents P.H. Kurian granted the
compulsory licence to Natco on two key grounds—affordability and
availability of Bayer’s patented drug—that is required by the country’s
intellectual property law. Natco Pharma’s generic anti-cancer drug is
priced at Rs.8,800 for a month’s dosage—a fraction of the Rs.2.8 lakh
Nexavar costs. India’s existing patent law permits any interested party to
seek a compulsory licence for a patented drug if the patent holder cannot
meet demand for the product in terms of affordability and availability
within three years of the patent’s grant. Bayer challenged the ruling at
the IPAB, which refused to stay the compulsory license granted to Natco

“If stay is granted, it will definitely jeopardize the interest of the
public who need the drug at the later stage of the disease, since it is
admitted that this drug improves the quality of life,” IPAB said in its
March 2013 order. “Therefore, the right of access to affordable medicine is
as much a matter of right to dignity of the patients and to grant stay at
this juncture would really affect them...”

 Subsequently, Bayer moved the high court seeking relief.

Currently, there are three brands of this cancer drug available in the
domestic market. These include Nexavar, Natco’s Sorafenat and Cipla Ltd’s
Soranib. Cipla had launched its generic version of this drug challenging
the patentability of the Bayer’s molecule in India. Ads by PlusHD.6Ad

Although Bayer had questioned Cipla’s launch by filing a patent
infringement case in the Delhi high court, the court did not grant an
injunction, awaiting a decision on a post-grant opposition filed by Cipla
and also subsequent to the Court’s own finding that the patented brand was
not affordable and adequately available in the domestic market.

Shares of Natco Pharma surged 5% on the decision to close at Rs.1,071.90
per share on BSE. The BSE Sensex closed at 25,201 points, up 0.8%.

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