Close on the heels of the health ministry’s statement regarding patent revocation, Novartis has sued Cipla for infringing patents covering Onbrez (Indacaterol-drug used to treat chronic obstructive pulmonary disease) and sought damages.
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).
Earlier last month Cipla had launched a low cost generic version of Onbrez and petitioned to DIPP requesting them to revoke Novartis ‘patents. Cipla argued that chronic obstructive pulmonary disease has reached “epidemic” proportions and the Central Govt should exercise its powers under Section 92(3) (compulsory license under special circumstances of national emergency, extreme urgency) and Section 66 (patents which are prejudicial to the public)to revoke Novartis’ Onbrez patents.
Cipla contended that Novartis was not manufacturing the drug locally and imported only limited quantities through Indian licensee Lupin.
Novartis however refuted Cipla’s claims and stated that there was ample supply of Onbrez and Cipla’s contentions were unfounded. According to this Reuters report a Novartis spokesperson was quoted as saying “Cipla did not use any of the processes provided for in the Indian legal system to either challenge validity of the patents, establish non-infringement or to seek a license for these patents”
After hearing both parties, the Delhi HC (Justice Manmohan Singh) reserved the judgement.
Terming chronic obstructive pulmonary disease as a “public health crisis”, Cipla maintained that there is an urgent need to ensure that Indacaterol is available at an affordable price. Cipla sought a definitive reply from Govt regarding patent revocation. Earlier the health ministry had indicated that there wasn’t a compelling case for Compulsory license under Section 92.
On a separate note, I found that there was also a trademark angle to the dispute. Initially Cipla had launched its generic version of Novartis’ Onbrez under the name Unibrez. Novartis moved to court arguing that Cipla’s trademark was deceptively similar and likely to cause confusion amounting to passing off and unfair competition. The Delhi high court granted a permanent injunction in Novartis favor. The defendant Cipla proposed to adopt the trademark Indaflo. The order can be accessed here.
Traditionally, courts have employed a stricter standard to evaluate infringement /passing off with respect to pharmaceutical trademarks. Although doctors and chemists who prescribe medicines are competent enough to distinguish between similar sounding names, allowing use of similar trademarks in the pharmaceutical arena introduces the possibility of an honest error which is likely to have severe repercussions and should be avoided at all costs.