[Ip-health] Why is India not following Italy?

[Sean Flynn]

Here India suggests it will not issue a CL for manufacture of a drug
that is patented in India to a country where there is no patent (I
assume).

A refusal to grant a license under similar circumstances was ruled to be
anticompetitive in Italy and subject to a competition based CL.  See
http://www.wcl.american.edu/pijip/competitionpolicyproject.cfm

This looks like a prime area where developing countries should be
following a pro-access competition doctrine established in the north.
Certainly India should have a strong interest in erasing barriers to its
generic export industry.

Using competition as the basis for the CL (e.g. under a theory that a
patent should not be used to expand power into markets where it does not
provide an exclusive right) provides an avenue around the TRIPS
requirement that CLs normally be predominantly for the local market.

-Sean

-----Original Message-----
From: ip-health-admin@lists.essential.org
[mailto:ip-health-admin@lists.essential.org] On Behalf Of robert
weissman
Sent: Thursday, April 03, 2008 10:14 AM
To: ip-health
Subject: [Ip-health] Report: (unnamed) Indian official skeptical of CLs
for export, cancer drugs

http://economictimes.indiatimes.com/News/News_By_Industry/Healthcare__Bi
otech/Healthcare/Govt_may_use_compulsory_licensing_for_drug_companies_on
ly_in_emergency/articleshow/2921237.cms

Govt may use compulsory licensing for drug companies only in emergency
3 Apr, 2008, 0007 hrs IST,Sanjeev Choudhary & Khomba Singh, TNN

NEW DELHI: Global drug companies that under attack from Indian generic
companies and healthcare groups on compulsory licensing (CL) issue can
breathe easy.

The government will not invoke CL unless the country is faced with an
epidemic-like situation. It feels that the recent applications for CL
may not be able to convince the government to take the extreme step.
Hyderabad-based Natco Pharma has recently applied for CL to export
generic versions of two cancer drugs -Roche's Tarceva and Pfizer's
Sutent-to Nepal.

"We are not in favour of CL unless there is an extraordinary problem.
There is no point in going in for CL unless there is an epidemic which
impacts a large chunk of the population, and needs immediate solution, "
a senior official of DIPP (Department of Industrial Policy and
Promotion), the nodal government department which oversees patent
offices in India told ET.

On being asked if a disease like cancer may qualify under CL, he said,
"It may not." In addition to Natco Pharma, an NGO Cancer Patient's Aid
Association (CPAA) with the support of Indian and global NGOs is
planning to demand CL for about 20 cancer drugs. CPPA say that the cost
of patented cancer drugs are highly expensive and deny access to
treatment to thousands of cancer patients in the country.

Once a drug gets patent, the government provides the innovator company
with exclusive marketing rights of the drug for 20 years from the date
of grant of the patent. However, under the product patent laws in India
and other countries, the government can invoke CL to enable non-patent
drug makers to manufacture and sell patented drugs in national or public
interest. The government is of the view that the provision in the law
for CL is there to deal with extraordinary situations and safeguard
national interest.

"Research-based companies invest millions of dollars and several years
of research to develop new products and secure their patent. We respect
genuine research and can't infringe upon any company's patent rights
without much reason, " the official added. The government's thinking
seems to be in sync with the views of research-based drug companies.

Organisation of pharmaceutical manufacturers and producers (OPPI) (which
represents research based companies in India) VP Tapan Ray said, "CL is
a provision in the patent law which the government can use to meet the
demand in unusual circumstances like epidemic for a limited period. CL
should not be invoked for anything else. If it is invoked for any other
reason, the whole sanctity of patent gets lost."