Cipla-Novartis patent row: DIPP looking into merit of case

Under Section 66 of IPA, Centre can revoke a patent in 'public interest' if it is of the opinion that a patent or the mode in which it is exercised is "mischievous to the State"

The Commerce and Industry Ministry is looking into the merit of Cipla's demand for revocation of patents of Swiss drug major Novartis for respiratory drug Indacaterol citing the need for public health access.

The Department of Industrial Policy and Promotion (DIPP) has started the exercise on Cipla's demand. It is examining whether the issues of "public interest" or "mischievous to the State" as prescribed in the Section 66 of the Indian Patent Act (IPA) 1970 is applicable, according to sources.

"The department has received the Cipla's case and it is looking into the merit of the case," a source said.

Under Section 66 of IPA, the Centre can revoke a patent in "public interest" if it is of the opinion that a patent or the mode in which it is exercised is "mischievous to the State" or generally prejudicial to the public.

However, as per the Act, the department is bound to give an opportunity to Novartis to be heard before taking any decision on the matter.

Since the procedure undertaken by the DIPP is quasi-judicial in nature, the case could take substantial time to reach a final decision.

Cipla has asked the DIPP to revoke five patents of Novartis relating to the product citing need for public health access and stated the patent holder Novartis does not manufacture the drug in India.

Last week, the Indian firm launched its low-cost generic version of the Swiss drug maker's respiratory drug Indacaterol sold under the Onbrez brand.

Elaborating the reasons for approaching the Department of Industrial Policy & Promotion (DIPP) to revoke the patents, Cipla had said: "Novartis has been granted these patents since 2008-09 but has chosen not to manufacture the same in India."

Novartis merely imports a negligible quantity of these products manufactured in Switzerland as per its own data filed before the Patent office, Cipla had said.

The import for 2013 as declared by Novartis in the Patent office is a meagre 53,844 units which do not satisfy even 4,500 patients annually. The shortage is more than 99.97%, it added.

Cipla claimed there are more than 1.5 crore patients in India who need the drug. These are the declared numbers of patients and it could be even more considering the high prevalence of the chronic obstructive pulmonary disease in urban and rural areas.

Last year in April, Novartis had lost a seven-year long legal battle for getting its blood cancer drug Glivec patented in India and to restrain Indian companies from manufacturing generic drugs, with the Supreme Court rejecting the multinational company's plea.