ALERT: Second USPTO-Pfizer meeting in Delhi on 9 October 2009

[Guest guest]

ALERT: SECOND USPTO-PFIZER MEETING IN DELHI ON 9 OCTOBER 2009

The United States Patent and Trademark Office (USPTO),

in collaboration with multinational pharmaceutical company, Pfizer Limited, is

organizing a series of meetings in India for NGO's and the media titled

“Intellectual Property and Innovation in the

Pharmaceutical Industry.

Their second meeting is being held from 2:30-5:30 p.m. at the Taj Mansingh Hotel

in New Delhi on 9 October 2009.  The meeting is being organized with the

assistance of the US Embassy in India.

On 9 September 2009, a similar meeting was held in Mumbai.

Pushing TRIPS-plus Measures

 

Participants at the USPTO-Pfizer Mumbai meeting have confirmed that the agenda

of the meeting related to controversial TRIPS Plus measures - Data Exclusivity

and Patent Linkage.

These measures are designed to delay the registration of generic medicines by

several years, besides seriously interfering with the implementation of public

health safeguards such as compulsory licensing.

Even if a company is given authority to produce a generic drug under a

compulsory license, it still needs to register the drug

with India’s drug regulator - the Drug Controller General of India or DCGI.

The DCGI will be reduced to enforcing private commercial rights and will become

in effect the “patent policeâ€.

In addition, Data Exclusivity will undermine one of India’s

most important legal safeguards – section 3(d) that seeks to prevent the

patenting of new forms, combination, uses of known medicines.

Even when a patent is rejected on a known medicine, “data exclusivity†will

create a new patent-like monopoly by blocking the registration of generic

medicines.

The US government representative reportedly quoted the example of the increase

in foreign direct investment in Jordan after it introduced data exclusivity.

Interestingly, a study conducted by Oxfam of the impact of TRIPS-plus provisions

in Jordan (which was forced to implement these provisions under a free trade

agreement with the US) compared drug prices in Jordan as a result of data

exclusivity with those in neighbouring Egypt that does not enforce these

provisions.

The study found new medicines for diabetes and heart disease

between 2 and 6 times more expensive in Jordan.

See http://www.oxfam.org.uk/resources/policy/health/bp102_trips.html

It is important to note that the most recent report of the UN Special Rapportuer

on the Right to Health has highlighted concerns with the adverse impact of such

TRIPS-plus measures on access to treatment and has recommended that developing

countries not adopt these. See

http://daccessdds.un.org/doc/UNDOC/GEN/G09/127/11/PDF/G0912711.pdf?OpenElement.

The WHO has also cautioned developing and least developed countries against such

provisions.

See http://www.searo.who.int/LinkFiles/Global_Trade_and_Health_GTH_No3.pdf

Attacking Section 3(d)

The Mumbai meeting also featured an attack on India'ss strict

patentability standards embodied in Section 3(d) of India’s patent law.

Section 3(d) was introduced by the Indian Parliament using TRIPS flexibilities

to prohibit evergreening, the practice of pharmaceutical companies to extend

their patent monopolies by making changes to existing medicines.

India and the US have very different patentability standards. While US is faced

with a proliferation of patents on new uses, combinations and new forms of known

medicines which is instrumental in keeping generics out of the market and

lowering of patentability standards of novelty, non-obviousness and industrial

application; India on the other hand strictly limits the patenting of known

medicines and has rejected a number of such applications related to several

antiretrovirals, cancer medications.

These meetings highlight several issues of concerns – among them is the link

between a regulator like the USPTO and US pharmaceutical companies. 

About Pfizer

Pfizer Ltd. is a US based multinational pharmaceutical company. Pfizer has

actively lobbied for patent linkage and Data Exclusivity in developing and least

developed countries the past; going the extent of suing the Philippines FDA

officials for starting the process of registration of a generic version of the

medicine ‘amlodipine besylate’ just before the patent expired.

Pfizer has just been fined a record 2.3 billion dollars

in the US for unethical drug promotion. See

http://www.newsdaily.com/stories/tre5813xb-us-pfizer-settlement/

Pfizer CEO is the Chairman elect of Pharmaceutical Research and Manufacturers of

America (PhRMA). PhRMA is the business

lobby comprised of US drug manufacturers who have actively pushed for both -

Data Exclusivity and Patent linkage in developing countries including India.

They were extremely successful in the past. On behalf of PhRMA, the US

Government and United States Trade Representative (USTR) negotiated a number of

free trade agreements under which developing countries (Chile, Jordon) were

forced to adopt such TRIPS

Plus measures.

Kajal Bhardwaj

e-mail: <k0b0@...>