[Ip-health] Wall Street Journal: Drug Makers Decry Indian Patent Law

[thiru@keionline.org]

http://online.wsj.com/article/SB10001424052748703455804575057621354459804.h=
tml?mod=3DWSJ_World_MIDDLENews

Drug Makers Decry Indian Patent Law


By GEETA ANAND

MUMBAI=97Multinational drug companies have pushed big-time into India in
recent years after the country agreed to respect intellectual property
rights for pharmaceutical products.

But India's patent office and courts have repeatedly declined to defend
patents widely accepted in many other countries on some of the world's
best-selling medicines. As a result, multinational pharmaceutical firms
have been thrown a curve ball as they seek to expand in one of the world's
fastest-growing markets.

In the latest example, Bayer AG failed this week to persuade the Delhi
High Court to direct India's chief drug regulator to not give marketing
approval to a competitor's copy of its cancer medicine Nexavar.

Top-selling, life-saving medicines, including the anticancer treatment
Glivec from NovartisSA; anticancer drug Tarceva from Roche SA; and HIV
medicine Viread from Gilead Sciences Inc. all have failed to win
protection from India's patent office or the judicial system.

The Drug Controller General of India is the equivalent of the U.S. Food
and Drug Administration. But the Indian agency has a higher bar for
issuing patents, and doesn't automatically refuse to approve copies of
patented medicines while any outstanding patent issues are being resolved
in court, as the FDA does.

Without the regulator holding off on approvals, companies that get patents
in India frequently are left to pursue copycats in court=97where they also
have run into unfavorable decisions.

Executives at multinational drug companies say India will suffer if it
fails to recognize patents that are widely accepted elsewhere or protect
patent holders from copycat competitors.

"If this science and innovation can't be patented, it is sending a very
strong message about how limited India's patent protections are," says
Gregg Alton, executive vice-president of corporate and medical affairs at
Gilead Sciences.

Until 2005, Indian law recognized only process patents for making
pharmaceutical products=97and not the actual products. Indian companies wer=
e
well-known for selling lower-cost copies of some of the most expensive,
branded medicines in the world.

This made Indian companies such as Cipla Ltd. the champion of HIV patients
in Africa, where poor people needed access to life-saving medicines, but a
problem for the multinational drug industry, which relies on intellectual
property protection of innovation to fund the high cost of research.

As a member of the World Trade Organization, India faced increasing
pressure to enact legislation recognizing intellectual property laws on
medicines. But the trade organization rules allowed countries some
flexibility on the nature of the laws passed.

When India finally adopted its expanded patent law, it was widely hailed
and multinational firms began expanding with gusto. They now sell their
latest branded medicines here, expecting the burgeoning middle class and
slowly growing health insurance system will pay for them. Pharmaceutical
manufacturing has boomed, as has the clinical trial industry.

But little noticed at the time was that the new law sets a higher bar than
Europe and the U.S. for approving patents, says D.G. Shah, head of the
Indian Pharmaceutical Alliance, a Mumbai-based industry group.

Among the tougher provisions is one that says patents be will granted only
when products are more efficacious=97a provision the Indian patent office
has used to deny several patents, he says.

In court and in interviews, Indian officials and companies contend the
Indian system is fair and that, by contrast, international patent offices
grant patents where there isn't significant innovation or benefit. They
say it is India's duty to grant patents only when there has been
significant innovation, and to foster a competitive environment that keeps
prices low so the country's vast and mostly poor population can afford
medicines.

"The U.S. would grant a patent to a piece of toilet paper," says Amar
Lulla, chief executive of Cipla, the Indian generics drugmaker. "Just
because the U.S. granted a patent, doesn't mean it should be valid."

In its Tuesday decision to dismiss Bayer's appeal, the Delhi High Court
made a blistering attack on the company's efforts to block copies of its
cancer medicine Nexavar. Calling the appeal "a speculative foray," the
court added that "the petitioner, no doubt, is possessed of vast resources
and can engage in such pursuits."

The court ordered Bayer to pay the expenses of the Indian government as
well as those of Cipla, which wants to market a copy of Nexavar.

Mr. Shah, the industry group head, said the patent law gives India a way
to deny patents when needed to protect its poorer population against high
prices. Nexavar is sold in India for about $2,000 a month, he said,
compared to Cipla's planned $200 price for its generic version. Bayer and
Cipla said the prices in general were accurate.

In response, the U.S. government has lobbied the World Intellectual
Property Organization, a United Nations group, to require member countries
to adopt a common patent law that can be widely applied. That proposal
hasn't received much traction, says Jamie Love, director of Knowledge
Economy International, a Washington-based research and advocacy
organization.

In denying Novartis's patent application for Glivec last year, the Indian
patent office said the company didn't demonstrate improved efficacy for
the patentable form of the medicine over an earlier version.

Novartis filed an appeal of the decision to the Indian Intellectual
Property Appellate Board, where it was denied. The Swiss drug maker has
since appealed to the Supreme Court.

A Novartis spokeswoman said the drug sells for about $2,500 a month in
India, far more than locally made copies, but that 99% of Indian patients
get the medicine free or for a steeply reduced price through an access
program.

The Indian Patent Office approved a Roche patent on its cancer drug
Tarceva, but the company has lost legal efforts stop copycat versions of
the drug being sold in the market. The Delhi High Court and the Supreme
Court last year both declined to issue injunctions to restrict the sale of
the copies.

Commenting on the Supreme Court decision, a Roche spokesman said in an
interview Wednesday that "any research based company will need to consider
carefully what this ruling means for future investments in this country."

Also last year, the Indian Patent Office rejected patent applications from
Gilead on Viread, a widely patented and prescribed antiretroviral medicine
for HIV. The patent office dismissed the innovations as obvious.

The patent had been challenged by Cipla, which was already selling its own
version, as well as by patient groups worrying the Viread price would be
too high.

Gilead said it had been trying to find ways to make lower-cost versions
available in India. Gilead licensed the Viread patent to 13 companies in
the country in exchange for a 5% royalty on finished product sales. Some
of those companies sell the medicine for as little as $8.50 a month in
parts of India; the same supply costs about $400 in the U.S., according to
Gilead officials.

=97Arlene Chang, John W. Miller and Alicia Mundy contributed to this articl=
e.




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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997