New drugs may take time to reach India

NEW DELHI, JAN 5: By deciding to issue an ordinance to amend the Patents Act of 1970, the government has demonstrated that it does not wa...

NEW DELHI, JAN 5: By deciding to issue an ordinance to amend the Patents Act of 1970, the government has demonstrated that it does not want to take chance. The deadline for putting in place legislative changes to provide for exclusive marketing rights EMRs to patents is April 19.

But the ordinance does not mean that the latest drugs sold across the globe will be available in India immediately. It will be at least two to three years before a new drug finds its way on the shop shelves. While foreign and some Indian companies will apply for EMRs for new patented drugs, it will take about two years for the Patent Office to examine application and grant the EMR. Once it receives the EMR, the company will take a few months to study the market and introduce the product. 8220;A new product will not reach the consumer before 2003 or so. This will leave only a couple of years for the EMRs to be effective, for India will have to recognise product patents when the transition period ends on December 31, 2004,8221; says anofficial of a large Indian drug company.

The decision of issuing an ordinance will send positive signals to foreign investors especially from the US which have been asking for strict intellectual property protection in India. While the government could get the Bill passed in the Rajya Sabha on December 22, confusion and uproar in the Lok Sabha ensured that it was adjourned before the Bill could be tabled. Interestingly, the decision comes close on the heels of the BJP National Executive meeting in Bangalore last week which endorsed the government8217;s stand on patent changes.

The government could have waited till the Budget session, which begins in the last week of February, to pass the Bill by the Lok Sabha, but that would have been cutting it too fine. The ordinance ensures that in the not so unlikely event of the Bill not being passed in the Budget session, the government would not end up facing sanctions from the US for missing the deadline. The US had filed a case in the Dispute Settlement Body of theWTO for not meeting the patent change commitments under the trade body. India lost the case and was given 15 months time which expires on April 19. If the Government misses this deadline, the US will be free to initiate any retaliatory actions against Indian exports. The government was supposed to make the changes by January 1, 1995 but couldn8217;t get Parliament8217;s approval that year.

Though the Congress forced the government to make an amendment in the Bill in the last session, its support ensured that the Rajya Sabha passed it without much fuss. The move was to be repeated in the Lok Sabha, but a combination of government bungling and uproar over the Vananchal Bill did not leave any time for the Bill to be passed. The ordinance will instantly allow foreign companies to file for EMRs with the Controller of Patents. After getting it examined, the applicant will be granted rights to import and sell drugs and chemicals in India. Only the products which have been patented abroad after January 1, 1995 will beeligible for the marketing right, while the government will reserve the right to deny the right if it feels so. Also, the government can put a cap on the prices of the products thus sold and will have the right to acquire the right if public interest so justifies. The exclusive marketing rights will be valid for a period of five years. Indian firms which are currently producing variants of the patented products under the process patent legislation will be allowed to manufacture them until January 1, 2005 when India will have to accept product patents.