The Hindu Business Line : Define patent terms clearly, says drug industry

AS the draft of the Patents (Third Amendment) Bill comes up for review again this Monday, the domestic drug industry has cautioned the Government on the need to "clearly define" terms such as "patentability".

"If not defined clearly in the law, it will not only lead to litigations but also result in `evergreening' of patents depriving public of access to generics on the expiry of the main patent," the Indian Pharmaceutical Alliance (IPA) said in a representation to the Union Health Minister, Mr Anbumani Ramdoss, recently.

The IPA has been knocking the doors of the Union Health Ministry and the Union Commerce Ministry as drugs worth an estimated Rs 3,000 crore are likely go out of the grasp of the local market, according to IPA representatives. "New drugs in the anti-inflammatory segment, anti-asthma and antibiotics are just some of the segments that stand to get adversely impacted," an IPA representative said.

"India embarks a new regime of product patent after a gap of 35 years. The infrastructure needed for the new regime is created, but not yet tested. The Patent Office has yet to demonstrate its maturity and skill sets for dealing with the new regime. Its track record so far has been dismal. It's two of the four decisions on exclusive marketing rights (EMRs) for pharmaceutical products (Glivec, an anti-cancer drug and Cialis, an impotency drug) are embroiled in the High Courts of Delhi, Chennai and Mumbai," the representation points out.

Further, the IPA official elaborates that companies indulge in extending the life of their patents ("ever-greening") by merely tweaking the drug molecule. "So a solid form of medicine is made into a crystalline form, for instance, to keep the monopoly of sales for another few years and keep generic companies away from making similar versions. Such monopolies can cause a shortage of medicines," the official cautions.

Meanwhile, on retaining the provision of pre-grant opposition, where anyone can oppose the patent application of a company, the IPA official said: "It exists in as many as 21 countries and they are as diverse from Argentina, Chile, Ecuador in Latin America; Australia, Indonesia, New Zealand, South Korea, Thailand in the Far East; Denmark, Finland, France, Hungary, Iceland, Norway, Sweden, UK in Europe; Israel, Kuwait, South Africa in the Middle East & Africa; and Mongolia and Pakistan in Asia."

A section of the pharma industry, however points out that there are instances, like a case in Israel where a patent was delayed for 19 years, even as a drug's legitimate patent life is 20 years. "Pre-grant opposition is a delaying tactic," he said.

The IPA representative, however, counters: "The current provision not only allows opponent to challenge the grant, but also defines time limit not to delay the grant of patent." Further, it adds: "data available with the Department of Industrial Policy & Promotion (DIPP) shows that in the past only 0.5 per cent of patent applications were challenged. And, even those that were challenged were heard and disposed off within the stipulated timeframe."

Interestingly, they point out: "The patents for neem and haldi could have been pre-empted, if only the US Patent Law had similar provision. The country would not have had to engage in the costly post-grant litigations for revoking these patents."