This, experts say, is essentially because Clause 24 (B)(a) of the bill allows EMR when "an invention has been made whether in India or in a country other than India and before filing such a claim, filed an application for the same invention claiming identical article or substance in a convention country on or after the first day of January, 1995 and the patent and the approval to sell or distribute the article or substance on the basis of appropriate tests conducted on or after the first day of January, 1995, in that country has been granted on or after the date of making a claim for patent covered under sub-section (2) of section 5".

Experts say that this clause would facilitate EMR applications based on valid pharmaceutical patents and marketing approval in member countries perceived as "easypatent" markets. "It is generally perceived that it is easier to get a product patent in member countries like Uganda, Malaysia etc. Imagine the consequences if a cardiovascular drug gets EMR approval in India based on valid patents in one such easy patent market," they say.

Under the TRIPS agreement, the "black box" or "mail box" clause gives a patentee five years of EMRs in a country like India for completely new drugs which are not in the public domain at the operative date and for which marketing approval is granted in India before the end of the 10-year transitional period (ie 2005).

Experts also add that clause 24 (B) may also inadvertently encourage claims that do not, technically, satisfy the cut off date criteria laid down (ie. January 1, 1995). This is because an applicant is expected to file claims in all countries (in which patent protection is sought) within 12 months of the original patent claim. So, an new anti-impotence drug for which an original product patent claim was made well beforeJanuary 1, 1995, can still make its way into India by filing a subsequent claim after the cut-off date.

Under Article 70/9 of TRIPS, the following conditions have to be fulfilled for claiming EMRs:

1) A patent application has to be filed in India;

2) A patent should have been granted for the product in another member country;

3) A marketing approval must be obtained in such member country and

4) The product must obtain marketing approval in India.

Experts also add that a lack of "search" proviso could lead to the grant of EMRs for items which have been in "public domain".

Significantly, the Indian Drug Manufacturers' Association (IDMA) claims that the provision of compulsory licensing (part of the new bill) will only give rise to a monopolistic situation. While the bill extends the provision for compulsory licensing to EMRs, the domestic industry has been seeking the inclusion of Section 87 and 88 of the Patents Act 1970 which incorporates the "licence of right". The license of rightproviso allows a manufacturer make a patented product on payment of a specific royalty to the inventor.

IDMA also says that a first reading of the new Bill gives an impression that it is virtually a replica of the Patents Bill of 1995, then staunchly opposed by the BJP.

Cross-patenting bid

The government of India is working towards facilitating "cross-patenting" rights for Indian pharmaceutical firms, according to the Drugs Controller General of India, Dr P Dasgupta.

The move, Dasgupta said, will not only reduce the time factor involved in filing patent claims but also facilitate payment of fees in Indian rupees rather than forex. The move is being co-ordinated by the Centre for Scientific and Industrial Research (CSIR).

Referring to the impending product patent regime, Dasgupta said that in case of strategic diseases like TB, polio, leprosy etc, the government cannot afford to allow the existence of monopolies on the medicines front.