Novartis has sued Cipla for infringing patents covering Onbrez (Indacaterol-drug used to treat chronic obstructive pulmonary disease) and sought damages.
The drug 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). 
Last year, in November, Cipla launched copies of Indacaterol, the generic name of Onbrez, under its own brand nameUnibrez in the Indian market, while simultaneously calling for revocation of five of 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.
Report says that Novartis filed an injunction plea against Cipla, alleging infringement of its patent rights. Cipla had priced Unibrez, its versions of the drug, at Rs 130 per pack of ten tablets, compared with Rs 677 for Onbrez.
In January this year, Cipla was restrained from selling copies of the drug, following which both companies filed cross appeals in the Delhi High Court.
Cipla has also given a representation to the Centre to revokethe exclusive patent rights granted to Novartis, claiming that the pharma firm was not working the patent in India and not manufacturing the drug locally and imported only limited quantities through Indian licensee Lupin, which makes it unaffordable to local patients.
Novartis however refuted Cipla’s claims and stated that there was ample supply of Onbrez and Cipla’s contentions were unfounded. Novartis argued it is not obligated to manufacture the drug in India. It also said that Cipla was "trying to commercialise" the drug and use the formula which had been developed by Novartis after spending huge funds in research.
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, it was 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.
Experts said Cipla's contention to dispute the patent was primarily based on grounds of affordability and local manufacturing.
In an interesting twist, Cipla offered to pay Novartis a reasonable royalty fee, if it was allowed to continue selling generic version of Onbrez. Reportedly Novartis was not enthusiastic and flatly refused Cipla’s offer.
Source: spicyIP
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