EMRs and other patent jargon

What is meant by transitionary changes, EMR and pipeline protection?

Under the WTO agreement all signatories have to provide product patent protection. Under the transitionary arrangement underlined in the TRIPS agreement of the WTO, the countries which do not provide product patent protection will have time till 2005 to make the necessary legal changes. Until then, they have to put in place legal changes which will lead the way to a product patent regime.

This arrangement (also known as pipeline protection)has certain key aspects: First is to accept product patent application for drugs patented after January 1, 1995 (the date on which TRIPS came into force). These applications would be kept locked until 2005 when product patents is required to come into force in India. (this is also called mail-box arrangement).

The second part relates to providing exclusive marketing rights or EMR to the applicants which will allow them to import and sell the original drugs in India.

Why is adopting the EMR route better than going in for product patent right away?

During the EMR period local companies will be free to continue to copy the original drug and even produce their variants. Thus even though the Government would have accepted the product patent application from the original patent holder, it would not be enforced till January 1, 2005. This will also give time for the Indian company to wind down its copying business and focus on off-patent drugs or to develop new drugs.

Does it have enoughsafeguards?

Under the Bill envisaged by the Government, it will maintain the rights to control the price of the imported original drug. The company will not be able to charge super normal profits from the consumers. Also the Government will have the right to examine the application before granting EMR to ensure that drugs which are in the public domain are not sought to be protected. The Government will also reserve the rights to license the drug to another company if it feels that this would be in the public interest.

What is the urgency of making pipeline protection legal?

India was supposed to have the pipeline protection in place by January 1, 1995 under the WTO agreement. The Narasimha Rao Government passed an ordinance to this effect in 1995 but it lapsed as the Patents Bill of 1995 was not cleared by the Parliament. The US and the EU lodged a case in the WTO against India in 1997 for failing to meet this requirement. India lost the case with the US and now has to be put the changes inplace by April 1, 1999.

What is product patent and what is process patent?

Both grant protection to inventors to market or further develop their products. `Process patents’, such as those prevalent in India are applied only for drugs, pharmaceuticals and some chemicals. These allow companies/individuals to take existing products, say a new medicine, and do `reverse engineering’.

That is, a company can take a new painkiller drug from the US, figure out what chemicals went into its formulation, change the composition or the process of manufacture just a wee bit, and get a `process patent’. As the process patent allows Indian drug and pharmaceutical industry to copy patented drugs using a different method of preparation, they make cheaper versions of popular drugs without facing the pains of R&D.