The Patent Amendment Act, passed by Parliament in 2005 brings the Indian Patents Act in full conformity with the intellec­tual property system in all respects. This replaced the ordinance promulgated on December 23, 2004 to meet WTO obligations from January 1, 2005. It may be pointed out that, earlier the patient Act had been amended twice in 1999 and 2002.

In 2001 the provision of EMRs was introduced. This was a transitional arrangement till the introduc­tion of TRIPS-mandated product patients appli­cable in pharma, agro-chemicals and food sec­tors. The 2002 amendment introduced a 20 year duration for patents thus complying with TRIPS and substantially modifying compulsory licens­ing provisions. The main provisions of the Patent Amendment Act, 2005 are:

(a) Extension of product patent protection to all fields of technology, i.e. drugs, food and chemicals.

(b) The Act empowers the government to issue compulsory licenses for drugs whose price or production does not suit an existing public need.

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(c) It also allows the patent holders to challenge the license so that they can block general production of the drug.

(d) Pre-grant and post-grant opposition clause has been provided.

(e) The EMRs have been removed.

(f) Embedded software can be patented.

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(g) It strengthens the provisions relating to national security to guard against patenting abroad of dual use technologies.

The government has clarified that the new patent regime will not affect the prices of 3500 life saving drugs available in the market. About 97 per cent of the drugs available in the market have been made off patent and are not to be pat­ented in India. But the industry representatives feel that the new patent Act has not utilized all the flexibility for Doha Declaration and TRIPPs agreement.

As for example, they think that in or­der to avoid repeated renewal of the patent, ‘ever greening’ should not be allowed and appli­cation for patenting of salts, insomorphs etc. need to be rejected. Once proper safeguard are put in place, the pharma industry can certainly be a pro­vided ‘sunrise’ sector. What effect the Patent Act will have on India and its economy is being awaited anxiously.