PHA-Exchange> Indian Patents Act - Part II - Suggestions to amend - Amit Sen Gupta-

[Claudio]

(edited)

Suggestions for Patents (Third) Amendment Bill

to Amend the Indian Patents Act 1970

 

As per the provisions of the TRIPS agreement under the WTO, India is required to amend its Patent Laws to provide for a TRIPS compliant regime. There has been extensive debate within the country about what the contours of India's Patent Laws should be.

 

The 1970 Patent Act was formulated after an exhaustive process of discussions within the country - both inside and outside Parliament. The 1970 Act served the country well and was instrumental in development of the indigenous industry - to a point where the Indian pharmaceutical Industry is the leader in the developing world. It is thus imperative that any fundamental changes in the 1970 Patents Act need to be carefully examined, so as not to compromise the interests of the country, both in terms of our ability to safegaurd the health of our people and our interest in promoting a self-reliant indegenous Pharmaceutical Industry.

 

Since before the signing of the WTO agreement, and in the ensuing 10 years till date, globally as well as in the country, diverse contentions have emerged about the impact of TRIPS compliant Patent Laws on domestic industry - especially in developing countries. There is, however, a wide consensus that domestic laws, while being TRIPS compliant, need to make full use of "flexibilities" available in the TRIPS agreement. This was reiterated in unequivocal terms by the WTO Doha Declaration on TRIPS Agreement and Public Health (2001), which, inter alia, commented that countries have the sovereign right to enact laws that safeguard domestic interests. It recognised the gravity of public health problems in developing countries and clearly provided that the member countries had the right to protect public health and to promote access to medicines for all.

 

Experience with TRIPS since 1995

 

It needs to be underlined that a wide body of experience has accrued in a large number of countries since the TRIPS agreement came into force in 1995. 

 

Several economists have recognised the inherent inequity in the TRIPS agreement and some have even questioned the logic of incorporating TRIPS into the WTO system in the first place. a Commission of the Government of U.K has made a pointed reference to the likely adverse impact of the global enforcement of the new intellectual property regime on the cost and availability of medicines to developing countries and the need to use the mechanism of "compulsory licensing" to mitigate such impact.  

 

The HIV-AIDS epidemic across the globe, and particularly in African countries, has devastated entire countries. The epidemic has served to focus on the inhuman conduct of global pharmaceutical MNCs who continue to sell drugs to treat HIV-AIDS at 20-50 times their actual cost by seeking shelter under laws mandated by the TRIPS agreement. In fact it was left to Indian companies like Cipla to offer these drugs at vastly reduced prices and thereby provide some succour to those affected by HIV-AIDS. The conduct of these MNCs has also led to an upsurge of public opinion the world over, including in the US and EU, questioning its rationale, particularly in the area of public health. Organisations such as the Medecens Sans Frontieres have provided a powerful voice to this upsurge and soon became a global force contending the rationale of the new IPR regime. These developments ultimately resulted in the Doha Declaration on TRIPS Agreement and Public Health (November 2001) seeking to limit, to some extent, the damage done by the TRIPS agreement and its underlying philosophy.

 

These experiences of the last 10 years clearly call for a independent approach when India is poised to amend its Patent laws to make it fully "TRIPS compliant".

 

Safeguard National Interests

 

In pursuance of the necessity to make India's Patent Laws TRIPS compliant, the Indian Parliament has enacted two legislations. In order to fulfil the conditions in the TRIPS agreement, a Third Amendment is now to be tabled in Parliament. Unfortunately, the Patents (Amendment) Bill of 2002 did not make full use of the flexibilities available in the TRIPS agreement, which were further emphasised in the Doha Declaration. It is necessary that the draft Patent Bill 2003 incorporate amendments that address the gaps in the Indian Patent Act 1970  so that we make full use of flexibilities available in TRIPS. It is also necessary to press for a review of the TRIPS agreement itself - something that is mandated in the original agreement, but has not been followed up. Such a review is necessary to address the imbalance in favour of developed countries inherent in the TRIPS agreement.

 


The Government is now poised to introduce a Bill (drafted by the earlier  government). Any hasty passage of the Bill, without an informed discussion, will not be in the larger interests of the country.

 

Broad Areas of Concern

 

The broad areas which require further amendments in the Indian Patent Act 1970  are in relation to. 

 

Patentable Subject Matter:  

What are not inventions (and thus not patentable):  

Compulsory Licensing:  Export by a Licensee: 

 Transitional Arrangement and Mailbox: 


Royalty payments:  

Pre-Grant Opposition:

For details contact Amit Sengupta at ctddsf at vsnl.com  
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://phm.phmovement.org/pipermail/phm-exchange-phmovement.org/attachments/20041216/37b4ce91/attachment-0001.html>