Mumbai / Delhi: A recent order by the Delhi high court in favour of US drug maker Bristol-Myers Squibb Co. (BMS) will effectively link India’s drug regulatory process with its patent regime, throwing the country’s huge and profitable generics or off-patent drugs industry into a tizzy.
Also See A Short History of Patent Linkage (PDF)
Legal experts and health care activists have raised questions on the so-called ex parte injunction—a court order that will remain in place until the actual hearing, in this case in March—that the court issued against Hyderabad-based generic drugs maker Hetero Drugs Ltd.
Apart from the wisdom of linking the process of granting regulatory approval to a drug with the status of its patent, the experts and activists claim the court’s decision goes against India’s Drugs and Cosmetics Act, which doesn’t say marketing approval should be withheld because some other company holds a patent.
Although the US and a few other countries such as Chile and Singapore link regulatory approvals to the status of the patent, this isn’t mandated by the World Trade Organization (WTO). This so-called TRIPS-plus (TRIPS stands for trade related intellectual property rights and is part of the WTO process) provision isn’t recognized by any European country and experts say that even in the US, the capability of the drug regulatory authority to evaluate the validity of patents is suspect.
The injunction seeks to prevent Hetero from pursuing its last year’s application with the drug controller general of India (DCGI), the country’s drug regulator, for approval of a generic version of BMS’ cancer drug Dasatinib. BMS has been selling the drug in India under patent protection since 2006 under the name Sprycel.
The court order, which has been reviewed by Mint, restrains the generics company from “manufacturing, selling, distributing advertising, exporting, offering for sale or in any manner dealing directly or indirectly in any product infringing the plaintiff’s (Bristol Myers) patent…”
“It is expected that the DCGI, while performing statutory functions, will not allow any party to infringe any laws and if the drug for which approval has been sought by the defendants is in breach of the patent of the plaintiffs, the approval ought not be granted to the defendants,” the injunction adds.
This so-called patent linkage necessarily means that DCGI, who is responsible for approving drugs in India after ensuring their safety and quality, will also have to look at the patent status of the drug before granting permission for marketing.
This, experts said, could potentially halt the approval process for generic drugs in cases where the original has a patent in India. The denial of approval could also potentially last through the entire life of the patent, which could be at least a decade in some cases.