Ministry wants patent units off drug sale approvals

The Drug Controller General of India's (DCGI's) plans to seek help from the patent offices to deny marketing approval to copycat versions of patent-protected medicines may not succeed as the commerce ministry "" the administrative ministry for intellectual property matters "" does not want patent offices intervening in the drug approval process.

Commerce ministry officials say grant of patents cannot be a criterion to decide a medicine's marketing eligibility.

"Neither is in the job of the patent offices to suggest if a medicine should be given manufacturing/marketing approval," said an official.

Officials say marketing approval to a low-cost version of a patented drug does not amount to patent infringement.

"The drug authority's approval only indicates the safety and efficacy of a medicine. It has nothing to do with patents. If any generic-drug maker decides to market his version of patent-protected product in the country, there are provisions to legally challenge the move," he added.

The DCGI had recently asked the industry for details of the patents granted for their new medicines. Its intention was to pass on the patent details of the medicine to the patent office for an opinion whenever a second applicant applies for marketing approval for a similar product.

The move was triggered by an ongoing litigation involving domestic drug firm Cipla and Swiss multinational Roche. Roche had taken Cipla to court alleging infringement after the Indian company launched a low-cost version of Roche's patented-medicine. The DCGI wants to avoid such instances and the patent linkage plan is a part of that effort.

"There is no need to involve the patent office for ascertaining the patent status of a product. It's all there online in the public domain," said a commerce ministry official.

The Indian Pharmaceutical Alliance (IPA), the association of leading domestic drug firms, says the DCGI move may harm the "genuine" interests of Indian drug makers by preventing them from marketing the low-cost versions of medicines that enjoy doubtful patent protection.

"If the patent-linkage system is introduced, the domestic industry will not be able to introduce low-cost variants of patented products even at the risk of litigation. It could delay the entry of cheaper alternatives of patented medicines by years," said IPA secretary general DG Shah.

The US is among the very few countries that provide "patent linkage" in drug marketing approvals. Under the US law, a generic manufacturer may submit along with its ANDA (abbreviated new drug application), a declaration that the medicine does not infringe on any patent.

If the innovator company files a patent infringement action against the generic firm within 45 days, the application gets an automatic 30-month stay. The generic firms get marketing approval after this (30-month) period.

Domestic industry feels if the Indian drug regulator rejects low-cost applications of patent medicines without such a timeline, it may indefinitely delay the entry of cheaper alternatives in the market.