Cipla asks government to cancel Novartis patents onrespiratory drug

Indian generic drug maker Cipla Ltd. has requested the Indian government to revoke five patents held by Swiss Firm Novartis AG on respiratory drug ‘Onbrez’. Cipla asked the Department of Industrial Policy & Promotion to cancel the patents on the grounds that the Novartis has held them for six years without making the medicine locally or importing it in the quantity that’s required. The action was filed under section 66 of the Indian Patents Act which empowers the Central Government to revoke a patent on the grounds of it being mischievous to the State or prejudicial to the public.

Previously in 2012, the Government had revoked Avasthagen’s Patent invoking the provisions of Section 66. Avasthagen had obtained a patent protection for a medicine/tonic for controlling diabetes from the Indian Patent Office. The patent was for the composition consisting of jamun, lavangpatti and chundun and this composition was to be used for treatment of diabetes. The patent which was granted in April, 2012 was revoked on the grounds of being mischievous and prejudicial to the public.

The Government of India referred to the Traditional Knowledge Digital Library (TKDL) to revoke the patent. The Government ensured that public interest is not disturbed due to grant of those patents. Section 66 acts as a correctional provision and the Government is considered as the adjudicating authority, which ensures that interest of public is given more priority than personal interests.

Cipla alleged that Novartis has had patents on the drug since 2008/09, but did not make it in India, and instead imported a “negligible quantity” from Switzerland, leading to a shortage of supply. Onbrez, chemically called indicaterol, is used to treat breathing problems associated with chronic obstructive pulmonary disease. Cipla estimates more than 15 million Indians are afflicted with the disease. Cipla has claimed to have launched its indacaterol drug under the mark Unibrez in some parts of the country.

Now the industry and the patent fraternity will be watching the response of Novartis and how the Government interprets the provision of Section 66 to bring in “non- working” of patent within its scope.