In a crucial turn of events, according to TOI, the health ministry stated that Cipla’s petition does not make a compelling case for revocation of Novartis’ Onbrez patents.
As readers may remember last month Cipla had launched a low cost generic version of Novartis’ Indacetorol marketed under brand name Onbrez, a drug used to treat chronic obstructive pulmonary disease. Cipla had further petitioned to the DIPP and argued that chronic obstructive pulmonary disease has reached “epidemic” proportions and the Central Govt should exercise its powers under Section 92(3) and Section 66 to revoke Novartis’ Onbrez patents. Section 92(3) deals with compulsory license under special circumstances of national emergency, extreme urgency or public non-commercial use. Section 66 relates to revocation of patents when the patent is exercised in a manner which is generally prejudicial to the public. Cipla’s petition to DIPP can be accessed here. We had blogged about it here.
Onbrez is protected by 5 patents in India – IN222346 (product patent- expiring in 2020); IN214320 (composition patent- expiring in 2021); IN230049, IN210047 and IN230312 (process patents- expiring in 2024).
Cipla had alleged that Novartis imports only about 54,000 units of Onbrez annually which meets the demand of only 0.03% of the population -which is insufficient to meet reasonable requirements of the public. Cipla further contended that Onbrez is not available to the public at a reasonably affordable price- Cipla’s generic version the medicine is priced at about Rs 130/10 pills, compared to Novartis’ Onbrez, which is sold at Rs 677/10 pills. Cipla further argued that Novartis was not manufacturing the drug locally and imported only limited quantities through Indian licensee Lupin. Cipla in its plea stated that chronic obstructive pulmonary disease (COPD) had reached “epidemic” proportions and could be termed as a public health crisis and also stated alternative therapies currently available for COPD had several disadvantages.
It seems like the health ministry does not see merit in Cipla’s Section 92 compulsory license argument. As for revocation under section 66 – it’s primarily used as a rectification tool to revoke patents granted in error/ in contravention to patentability provisions. However the health ministry has suggested “if at all there is an argument for a compulsory licence, it should be considered under section 84.”
For compulsory license under Section 84, firstly a potential CL applicant has to make a credible attempt to procure voluntary license from the patent holder. If efforts to procure a voluntary license are infructuous after a reasonable period of time (at least 6 months) then the applicant can proceed further and apply for compulsory license under Section 84. After reviewing the facts and evidence, If the Controller is satisfied that the conditions for issue of CL under section 84 are met i.e. then a CL may be issued with appropriate royalties paid to the patent holder.
However one wonders whether an attempt to procure voluntary license can be made at this stage –after launch of the generic version?
Nevertheless, the health ministry’s stand shows that the Government is exercising caution in employing compulsory license under Section 92 purely as a cost control tool. It would be interesting to see how this case shapes up.