[Ip-health] Financial Express on data exclusivity debate in India

[Mike Palmedo]

*http://www.financialexpress.com/fe_full_story.php?content_id=3D35135

*

*Pharma Cos In Grip Of Feverish Debate On Data Exclusivity*
No obligation under TRIPS, says PMO official

AJAY JAIN
Fnancial Express

*New Delhi, May 27: * In a clear indication that could further divide
the pharmaceutical industry, the government believes that data
exclusivity for the industry is not binding on World Trade Organisation
(WTO) member-countries.

Additional secretary in Prime Minister=92s Office Prodipto Ghosh told FE
that =93the government does not have a position on data exclusivity at the
moment. But it is clear that we have no obligation under TRIPS (trade-
related aspects of intellectual property rights) to have provisions for
the same in the country.=94

While multinational (MNC) pharma companies in the country are making a
strong case for data exclusivity, the domestic sector has views ranging
from supporting the MNC position to that of others like the Indian
Pharmaceutical Alliance (IPA), which is against government conceding any
demand for data exclusivity, including market exclusivity.

Data exclusivity provides for a period of protection during which test
and clinical trial data of one company may not be relied upon by another
company to obtain a marketing authorisation of the same drug.

When manufacturers of generics apply for approval for their drug, they
claim bioequivalence, or having a similar molecular structure, to the
originator=92s product. Instead of conducting tests themselves, they make
a reference to the latter=92s submitted data for approval. Data
exclusivity would then ensure that such data may not be referred to for
marketing approval for a given number of years. It varies from five
years in USA, six in China and up to 10 years amongst European Union
members.

This enables the originator to get market exclusivity for the given
period, unless the generic manufacturer goes through the process of
conducting its own tests.

IPA says that =93TRIPS does not call for market exclusivity as understood
in the USA or EU. Regulatory authorities are not prohibited from relying
upon such data for determining the safety and efficacy of a previously
approved product, when marketing approval is sought by generic
manufacturers who do not infringe patents. This is particularly
necessary to obviate the social and economic costs of repetitive animal
and human testing.=94

Another senior government official told FE that =93TRIPS only requires us
to protect test data against unfair use under Article 39.3, but there is
nothing that says that we have to provide marketing exclusivity.
Interpretations vary depending on which side you are on. It is only when
a case comes up at the Appellate Authority at WTO can there be clarity.=94

He added that =93under the existing circumstances, it is highly unlikely
that marketing exclusivity would be provided for any period of time. It
would be possible only if TRIPS is modified, which one cannot see
happening. With new products not coming to the market, new uses are
being found for the existing ones. While patents would not cover these,
data protection is being seen by American companies as a new form of
intellectual property right to effectively extend patent life.=94

Pharmaceutical Research and Manufacturers of America (PhRMA) associate
vice president Susan Kling Finston, representing the US pharma industry,
told FE during a recent visit to the country that =93both the logic and
negotiating history of Article 39.3 of TRIPS leave no doubt that
providing data exclusivity for a certain period of time was the
envisaged way to protect data against unfair use as prescribed by
Article 39.3. Whether any system other than data exclusivity over a
reasonable period of time would meet the requirements of Article 39.3 of
the TRIPS agreement is to be assessed on a case-to-case basis, but
examples of actual application by WTO members of alternative - and TRIPS
compliant - systems to non-reliance over a reasonable period do not
appear to exist.=94

According to Aventis Pharma India managing director Ramesh Subrahmanian,
=93patents are a =91social contract=92 between the innovator and society. T=
hey
provide incentives for discovery and development of innovative drugs.
But data exclusivity is about limiting a government=92s ability to use an
individual=92s proprietary data. Derived from considerable effort, this
data is needed to demonstrate safety, quality and efficacy of innovative
drugs to regulatory authorities. Hence, both forms of protection are
independent forms of protection and necessary.=94

The IPA is also opposing evergreening of patents. This implies that if
data exclusivity in the country is allowed for say, five years, and a
patented drug is introduced in the 17th year of the 20-year patent life,
it could effectively extend the patent to 17 plus five equalling 22
years. Dispelling any such fears, Ms Finston said =93such a situation
would not arise as most products are introduced in or before the 15th
year. Thus data exclusivity period would run concurrently with that of
the patent.=94

Despite expressing this view, Ms Finston said PhRMA would not agree for
a provision that data exclusivity period would not run beyond the life
of a patent, one of the safeguards Indian industry has been asking for.

Eli Lilly India chairman and managing director Rajiv Gulati says that in
principle his company supports data exclusivity in the country, as long
as it does not lead to evergreening of patents. Ranbaxy Laboratories
senior vice president Bimal K Raizada added that =93we support data
exclusivity in India but for a period not beyond when data exclusivity
is over in any other part of the world. Once it is over in say USA,
which is usually the first such country, it should be over in India also.=
=94

Gorlin Group, USA, president Jacques J Gorlin, who advises pharma
companies on matters including data exclusivity, told FE during a recent
visit to the country that =93positions like those adopted by Ranbaxy were
just excuses to prevent data exclusivity in India. But these very
companies owe a lot of their success to similar legislation in USA, a
major market for Indian generic manufacturers, and thus it is in their
interests to have data exclusivity in India.=94

Nicholas Piramal president (corporate relations) Harinder Sikka adds
that =93India is obligated to implement Article 39.3. The only leeway we
have is deciding the time of exclusivity which could be between 5-10
years. Major Indian pharma companies have publicly proclaimed their
desire to be global companies. India must also talk the global language
to avoid losing out to China and Brazil which have taken strong
positions on data exclusivity.=94

What are the implications for India not introducing data exclusivity?
The MNC pharma companies are almost unanimous in their view: =93More
product introductions, research and development and clinical trials
business will come to the country only if data exclusivity is in place.
This is even more important to us than patents.=94 But Indian firms and
authorities say =93these are all claims; we will have to see how much of
it happens even if data exclusivity is enforced in the country.=94

So, what does future hold? According to an industry source, =93India
signed TRIPS for product patents only after the Indian industry realised
its benefits and pushed for the same in the government. The decision of
data exclusivity could largely rest on what domestic pharma lobbies for.=94