The Hindu Business Line : US pharma lobby seeks changes in Patents Act

THE powerful US pharmaceutical lobby, PhRMA, has begun attempts to persuade the Indian Government to change certain provisions of the Patents (Third) Amendment Act.

This comes days after India and the US entered into several agreements during the recently concluded state-visit of the Prime Minister, Dr Manmohan Singh, that is being regarded as the start of a newfound friendship between the two democracies.

According to official sources, the industry body is expected to meet a number of key Government officials on the issue related to granting of patents to mail box applications or pre-2005 molecules.

The Act had specified that if product patents were granted to the mail box applications then the existing domestic producers would be allowed to continue manufacturing generic versions subject to payment of a `reasonable royalty'.

"The multinational companies want the Government to withdraw this provision as this would hurt the innovator company due to the loss of exclusivity," said sources. Estimates by PhRMA have indicated that there are over 200 such molecules in the mail box, which could result in a loss of $1.8 billion. The Indian pharmaceutical industry is estimated to be worth $4 billion.

This specific provision was also part of a note on Policy Towards Pharmaceutical Sector prepared by the Planning Commission Deputy Chairman, Mr Montek Singh Ahluwalia, wherein it has been clearly stated that this was "introduced as part of compromise to achieve legislative support."

It further said, "If the Mashelkar Committee (examining certain aspects of the Act) concludes that the provision is inconsistent with TRIPs (Trade-Related Intellectual Property Rights) there will be demands to amend the Act (especially from the US) and if we don't do so it would be referred to the dispute resolution in the WTO."

The US pharma association is also expected to discuss the definition of patentability.

The multinational companies have been seeking changes that would allow patenting of isomers, polymorphs and admixture. Data protection is yet another issue that is likely to be taken up. This is not the only visit by an international pharma body. Recently, Dr Harvey Bale, Director-General of the Geneva-based International Federation of Pharmaceutical Manufacturers and Associations, also visited India to discuss similar issues.

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