[Ip-health] Reuters: Two Indian generics makers end battle to copy drugs amid patent debate

Joanna Keenan joanna.l.keenan at gmail.com
Wed Apr 13 03:31:58 PDT 2016

Two Indian generics makers end battle to copy drugs amid patent debate
Published: 11:23 GMT, 12 April 2016 | Updated: 11:23 GMT, 12 April 2016
By Zeba Siddiqui

MUMBAI, April 12 (Reuters) - Two Indian drugmakers said they had given up a
battle to copy drugs developed by Bristol Myers Squibb and AstraZeneca,
blaming a lack of government support for cheap generics and pressure from
Big Pharma.

Both companies, BDR Pharma and Lee Pharma, had been seeking so-called
compulsory licenses that override patents and allow generics firms in India
to launch cheap copies of medicines manufactured by big Western drugmakers.

But now the two mid-sized generics players say their efforts have been
thwarted by Prime Minister Narendra Modi's target to boost foreign
investment in India and the resulting emphasis on protecting intellectual
property, which is getting in the way of the government's promise to
provide cheap drugs for the poor.

"There is no point in pursuing it anymore," Dharmesh Shah, BDR's managing
director, told Reuters.

The debate over cheap drugs is hugely emotive in India, home to 1.2 billion
people, most of who live on less than $2 a day. It grabbed fresh headlines
last month after a U.S. business lobby group said New Delhi assured it that
compulsory licences would no longer be issued for commercial purposes.

India's commerce ministry, however, said there was no change to its policy,
although campaigners and watchdogs including India's National Human Rights
Commission said they were worried about what looked like a shift in

India first issued a compulsory license for a medicine in 2012, allowing
Natco Pharma to sell a copy of German drugmaker Bayer's cancer drug Nexavar
at a tenth of the original price. The move was criticised by large

But BDR's application to copy Bristol Myers' cancer drug dasatinib, with an
aim to sell it at about $122 for a month's course versus the original price
of about $2,491, was rejected in 2013.

Lee Pharma was rejected in January this year after a second review of its
application seeking to make a cheaper form of AstraZeneca's type 2 diabetes
drug saxagliptin. The patent controller said Lee did not make a strong
enough case.

Both BDR and Lee said they were now no longer appealing, in moves they
described as emblematic of an exasperated industry.

"If the government itself is not inclined then why unnecessarily slog on
this issue?" said A. Venkata Reddy, Lee's managing director.

A health ministry official did not comment and referred the matter to the
commerce ministry. Officials at the commerce ministry declined to comment.
India's Controller General of Patents and Trademarks, part of the commerce
ministry, did not respond to requests for comment.


Modi, who came to power in 2014, has led a campaign to boost investment and
manufacturing to speed up growth and create jobs, and is also reviewing the
country's patent rules. A new intellectual property policy is due out soon.

As a result, enthusiasm for compulsory licenses has cooled among government
officials, industry executives and lawyers representing BDR and Lee told

Rajeshwari Hariharan, the lawyer who represented Natco in the 2012 case,
said other companies had considered applying for licenses, but dropped
plans. She declined to name them.

Sujay Shetty, who leads the life sciences practice for consultants PwC in
India, agreed the government would be reluctant and use licenses sparingly.

But he added: "You can never say never in India because of pressure on
prices and access to medicines."

India represents a lucrative market for drugmakers, especially in diseases
such as cancer and diabetes, as the population ages and gains weight. The
country already has a $15 billion generics industry.

But stringent regulations around clinical trials and price control on
medicines have made the operating environment tough.

Several large Indian drugmakers also aspire to expand to countries like the
United States and Europe, another reason to strike friendly deals with Big

In recent months, several Indian firms have struck such licensing deals,
under which profit-sharing and drug prices are decided mutually by
companies. In contrast, the government sets royalty rates for compulsory
licenses. ($1 = 66.4950 Indian rupees) (Additional reporting by Ben
Hirschler in LONDON; Editing by Clara Ferreira Marques and Himani Sarkar)

Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: @joanna_keenan


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