[Ip-health] Wall Street Journal: India Blames Roche for Patent Problems

Thiru Balasubramaniam thiru at keionline.org
Tue Aug 6 02:54:59 PDT 2013


   - ASIA BUSINESS<http://online.wsj.com/public/page/news-asia-business.html>
   - Updated August 5, 2013, 1:21 p.m. ET

India Blames Roche for Patent Problems

*Government Says Drug Maker Failed to Follow Correct Procedures*

   - **

   - By RAJESH ROY <http://topics.wsj.com/person/A/biography/7512>, KENAN
   MACHADO <http://topics.wsj.com/person/A/biography/7386> and MARTA

MUMBAI—The Indian government, on the defensive following several recent
rejections of patents on world famous cancer drugs, on Monday blamed Roche
for its failure to win intellectual-property protection for additional
patents related to Herceptin.

A news release from India's patent office said Roche failed to follow the
correct procedures, made incorrect filings and its agents didn't show up
for hearings on patents related to Roche's breast-cancer drug Herceptin.
Roche continues to hold a patent for Herceptin in India.

Roche declined on Monday to comment on India's accusations. The company had
said Sunday that a regional patent office in the city of Kolkata in eastern
India revoked two patents related to Herceptin, one of the first of a new
generation of targeted therapies against cancer.

The Swiss company had said Sunday that it was reviewing the Indian patent
office's decision and considering how to proceed.

An application for a patent on Herceptin was filed on Oct. 11, 2000, and a
patent granted on April 6, 2007, the Indian patent office said. Three more
patent applications related to the original patent were termed as withdrawn
under Indian law because Roche failed to meet legal deadlines, the release
added. While one patent application missed a deadline to file for the
examination of the patent, the other two were made after the granting of
the original patent for Herceptin, which is not allowed under Indian patent

Monday's press statement was an unusual move for a reticent Indian
government. Almost all administrative actions are overseen by bureaucrats
here who seldom speak on record or are available for clarifications.

But the Indian government has been under pressure from the U.S., concerned
about several recent rejections of patents on medicines with
intellectual-property protections that have been widely accepted globally.
U.S. Secretary of State John Kerry and Vice President Joe Biden both raised
the issue on their recent visits to India.

India set tougher standards for awarding patents when it recognized
intellectual-property protections in 2005 as part of its membership in the
World Trade Organization. India required companies to demonstrate
significant clinical efficacy over already-patented compounds to qualify
for additional intellectual-property protection.

In Roche's case, the rejection of patent applications related to Herceptin
was for technical reasons.

Groups fighting to make lifesaving medicines accessible globally have
praised the Indian government for its tough standards, saying it is right
to deny patent protections for variations that don't improve efficacy. By
implementing tougher standards, India is allowing additional companies to
make and market cheaper, copycat versions, making medicines accessible to
millions more people globally.

In July, India's Intellectual Property Appellate Board revoked
patent on cancer drug Tykerb, saying it didn't find the drug provided
sufficient "enhanced therapeutic efficacy" over the underlying patented
drug to justify further intellectual-property protections. Tykerb, a
derivative salt of a previously patented medicine, is used to treat women
with advanced breast cancer.

The development came on the heels of
 high-profile failure in April in the Indian Supreme Court to win
patent protection for its flagship cancer drug Glivec, known in the U.S. as
Gleevec. Other companies, including
failed to win patents in India that they've secured elsewhere.

In its news release Monday, the Indian government also said the decision on
the patent application wasn't related to the pricing of Herceptin. The
government also tried to distance itself from the decisions, saying they
were mostly made by the courts.

A patient diagnosed with advanced breast cancer needs to take one dose of
Herceptin a month for a year, said Dr. Arun Behl, a cancer surgeon in
Mumbai. The treatment currently costs $7,843 a year in India, he said. The
drug previously cost $24,314 a year. Prices fell after Roche licensed the
manufacturing of Herceptin to an Indian generic drug maker, Emcure
Pharmaceuticals Ltd., the Indian company's website said. Roche said it
doesn't disclose pricing information.

The development is unlikely to hurt Roche's business. India is still a
small market for Roche. The company's pharmaceutical sales in India in 2012
were 64 million Swiss francs, or about $70 million, representing about 0.2%
of Roche's global pharmaceutical sales.

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