Pharmabiz
 

THE LINKAGE QUESTION

P. A. FrancisWednesday, May 14, 2008, 08:00 Hrs  [IST]

The Union government notified the amended Indian Patent Act in January 2005 making grant of product patent mandatory in pharmaceutical sector. That was a landmark decision of Indian government as per the TRIPS Agreement intended to reward original research in this industry. The transition to this new regime of intellectual property rights has been neither easy to the domestic pharmaceutical units nor to the government. For the national sector of the industry it was quite a bitter pill to swallow as it used to have a 35 year old period of launching copycat versions of any patented drugs under the process patent era. For the government, a full fledged machinery to effectively administer the new mandate is still not in place. It is struggling to appoint adequate number of patent examiners and build up the required infrastructure for the patent office. An important issue that has emerged after the onset of new patent regime is the need for linkage of the patent office and the office of DCGI. Under the changed patent rules, after the grant of patent for a new product by the Patent Controller, marketing approval for that product should be issued to only to the original applicant and not to anyone else. The Drugs & Cosmetics Act or Rules do not say anything specific about the grant of marketing approvals for patented drugs. Because of this, the drug firms used to approach the DCGI for marketing approvals of patented drugs even after knowing that the drugs are under patent. The most recent case is that of Cipla. The company obtained a marketing approval for the cancer drug, Tarceva, after the Patent Controller issued a product patent to Roche some time ago. Roche moved Delhi High Court against Cipla last March but the plea for a stay against Cipla's marketing the generic got rejected and the case is on. Now, the DCGI is preparing a guidance document to deny marketing approvals to copycat versions of drugs for which product patents have been already issued in the country. There is no doubt that the laws and rules pertaining to one industry need to be harmonised to avoid unnecessary legal confrontations within the industry. There are also certain consumer related issues here. Considering the recent track record of most of the top MNCs, very few molecules are really innovative. Therefore, any error in judgement in granting a patent can unjustifiably entitle the patent holder to have a monopoly pricing for several years. Thus granting product patent can turn into a license to overcharge the patients. Many of the patented drugs marketed by multinationals in the country are prohibitively overpriced. Cipla's generic version of Tarceva is just one third the price of Roche. Such exploitive practices of pharma companies have to be curbed at the earliest. The decision of the Union ministry of chemicals to appoint a high level committee to negotiate pricing of patented drugs is thus well intended. But the panel is yet to submit its report after several months. The government has to take matters like this with extreme urgency as thousands of poor patients are being overcharged for want of a simple rule.

 
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