[Ip-health] Natco targets drugs ripe for compulsory licensing

Shailly shailly.17 at gmail.com
Sat Jul 21 10:19:37 PDT 2012

Livemint, Fri, Jul 20 2012


Natco Pharma Ltd, which has started selling a generic version of Bayer AG’s
patented cancer treatment Nexavar in India at a fraction of the price
charged by the German firm, plans to use the so-called compulsory licensing
route to try and win the right to copy more patented drugs, said
vice-chairman and chief executive officer Rajeev Nannapaneni.

The Hyderabad-based company has already identified the patented drugs for
which it will seek a compulsory licence, Nannapaneni said in an interview
on Wednesday.

“There are certain products which are eligible for compulsory licensing,”
he said.

Natco Pharma made global headlines in March when it became the first Indian
drug maker to win a compulsory licence from the Indian patent office to
produce and sell a generic version of a patented drug without the consent
of the patent holder. The patent office acted on the grounds that the
life-saving drug was not available at a reasonably affordable price even
three years after the Nexavar patent had been granted to Bayer.

Natco has started selling its copy of the liver and kidney cancer drug,
whose generic name is sorafenib, at Rs.8,800 for a month’s treatment, a
fraction of Bayer’s Rs.2.8 lakh for a month’s therapy. The patent office
stipulated that Natco pay 6% of net sales as royalty to Bayer.

Experts such as Shamnad Basheer, a professor of intellectual property (IP)
law at the Kolkata-based National University of Juridical Sciences (NUJS),
say the company may be eyeing compulsory licences for drugs such as Pfizer
Inc.’s anti-HIV/AIDS treatment Selzentry and anti-cancer therapy Sutent,
and Roche Holding AG’s Tarceva, another anti-cancer drug.

Nannapaneni declined to disclose the drugs that Natco Pharma will target.
In an interview with *The Economic Times *newspaper published in March, he
had said the company was collecting data on drugs that could be potential
candidates for compulsory licensing.

Natco sought a compulsory licence for Nexavar after Bayer rejected its
request for a commercial licence to manufacture it. Natco has indicated
that the market size of Nexavar in India could be around Rs.25-30 crore.

“I don’t want to get into the pipeline,” Nannapaneni said. “Again, nobody
likes disclosing their pipeline.”

Multinational drug makers and the US government have expressed concern over
the provision of compulsory licensing, saying it may dilute safeguards for
IP rights of innovator companies in India. Bayer has appealed against the
patent office’s ruling on Nexavar at India’s Intellectual Property
Appellate Board.

“It’s a big concern,” said Sanjit Singh Lamba, president of Eisai
Pharmatechnology and Manufacturing Pvt. Ltd, the Indian subsidiary of
Japanese pharmaceutical company Eisai Co. Ltd.

“Protection of intellectual property is extremely important, specially in a
situation where the pipeline is completely drying up for new molecules;
otherwise there will be no incentive for research and development of
innovative products,” he said.

Prices of cancer treatment drugs have fallen sharply, meanwhile.

Shares of Natco Pharma have gained 12.76% on BSE since 12 March, when the
company won the compulsory licence for Nexavar, while the benchmark Sensex
index has declined 1.76% in the same period. Natco Pharma stock rose 1.24%
on Thursday to close at Rs.355.15, on a day the Sensex gained 0.55%.

Drug makers may not find compulsory licences easy to come by, said Hemant
Bakhru, an analyst at Mumbai-based foreign brokerage firm *CLSA
Asia-Pacific Markets*. “The government will be under pressure from WTO
(World Trade Organization), from other organizations, as well as the US and
Western Europe to limit the number of licences,” he said.

While the domestic industry has backed the compulsory licensing provision,
concerns that the Nexavar ruling would open the way to a flood of such
applications are “uncalled for”, said D.G. Shah, secretary general of the
Indian Pharmaceutical Alliance, which represents domestic drug
manufacturers. “As of now, domestic companies are not looking at compulsory
licences as a business model.”

“The cost of development, the litigation cost, it is not a business
proposition. It’s more of a social need,” Shah said.

According to the World Health Organization, India has an estimated 29,000
liver and kidney cancer patients at whom Nexavar is targeted.

An email sent on Wednesday to the Organisation of Pharmaceutical Producers
of India, the body that represents multinational drug companies, did not
elicit a response.

The licence granted to Natco for Nexavar hasn’t sparked a chain reaction
yet, said Basheer of NUJS.

The reason could be that “for the patents and drugs that really matter,
some of the generic companies could think that they have a good shot at
invalidating the patents”, he said. “Invalidating a patent is better than
compulsory licensing because you need not pay royalty.”

Nannapaneni stressed that to win a compulsory licence, a drug maker had to
make an “iron-clad case” and clearly demonstrate the benefits it could
bring, and not merely rely on “a very minor price difference” to seek a
ruling in its favour. It would have to demonstrate that a multinational
company hadn’t put a strategy in place to make a life-saving drug available
to those who couldn't afford it.

Over and above its compulsory licensing strategy, Natco has locked horns
with innovator companies elsewhere, challenging product patents.

The company recently lost a patent infringement case in the US with
Israel-based Teva Pharmaceutical Industries Ltd over a drug called
Copaxone, used in the treatment of multiple sclerosis and with an estimated
market size of $2.5 billion.

Natco has challenged patents owned by Celgene Corp. on Revlimid, used to
treat multiple myeloma, Shire Pharmaceuticals Group Plc’s patent on kidney
drug Fosrenol, Gilead Sciences Inc.’s influenza treatment Tamiflu and
GlaxoSmithKline Plc’s breast cancer drug Tykerb.

In order to mitigate high litigation costs in the US, Natco Pharma enters
partnerships with other big generic drug makers such as Lupin Ltd, Dr
Reddy’s Pharmaceuticals Ltd, Mylan Inc. and Watson Pharmaceuticals Inc.

“Our whole model is that our litigation is funded by our partners,” said

In the year ended 31 March, Natco Pharma sales grew 15% to Rs.555.58 crore,
of which the oncology segment contributed about 60%. It earned a net profit
of Rs.58.47 crore, an increase of 12.29% over the previous year.

Nannapaneni said he is confident the company will maintain 15-20% growth
both in profit and revenue this fiscal year.

Shailly Gupta

Policy Advocacy Officer

Medecins Sans Frontieres

Access Campaign

C 236 Defence Colony

New Delhi, India

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