After Novartis sued Cipla alleging infringement of its Onbrez patents, in the latest salvo the Delhi high court has granted temp.injunction restraining Cipla. The judgement can be accessed here.Earlier in November 2014, 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.
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). .Following is summary of arguments presented by either side. (Long post warning!)
Arguments presented by Cipla
Cipla reiterated its arguments presented in the DIPP petition earlier and argued that Novartis’ product Onbrez is imported and there is no justification for not manufacturing products locally. Cipla relying on three cases also argued that the Court while adjudicating the injunction suit should take into account the working requirement as set forth in Section 83 of the patent act.
Cipla also contended that their generic version is cheaper and available at a cost of Rs. 130/10 pills which is almost 1/5th the price of Onbrez i.e. Rs. 677/10pills.
They further presented data showing that adequate amount/supply of drug is not available and that only 0.03% of the requirement of the drug is being fulfilled by Novartis and Lupin Limited. In summary, Cipla alleged that Novartis is trying to perpetuate its monopoly with multiple patents and continuing to import Onbrez at a lower quantity and a very high price.
Novartis counter- arguments:
Regarding Cipla’s representation to DIPP under Sections 66 and 92(3) of the Act – Novartis argued that the very fact that Cipla filed a representation to revoke the patent – is a tacit admission that the patent in question is otherwise valid and infringed by the Defendant (Cipla). Novartis also argued that Cipla did not even wait for adjudication of the CL application by Govt and went ahead with the launch of their generic version.
Regarding local manufacture and working the patent– Citing Telemecanique vs Schneider {2002 (24) PTC 632 (DEL) Novartis argued that requirement of law is limited to working the patent in India so that the same is available to public at large. It is not essential that the patent must be worked by manufacturing the patented product in India.
Regarding price – Novartis submitted that INDACATEROL” is in fact a brilliant invention and significantly improved lung functioning. The research and development leading to INDACATEROL entailed a huge financial investment and risk involving billions of USD and other resources. They also cited the recent Tufts study detailing the costs involved in R&D.Novartis argued that Cipla could sell its drug a tad cheaper as it has not invested huge sums in R&D and in clinical trials demonstrating the efficacy and safety of the drug.
Regarding adequate supply and reasonable requirements of drug – Novartis refuted Cipla’s statements that 99% of the population’s requirement for the drug is not being met. They asserted that Cipla’s statements are misleading should be verified, since there are several categories of COPD patients and Onbrez is suitable only for monotherapy suitable only for mild to moderate COPD patients. Novartis however stated that if there are any shortfalls and after such verification, would be willing to supply any amount of patented drug to fulfill the requirement
In order to prevent a Glenmark like salt form gaffe , Novartis in its submissions clarified that INDACATEROL can exist as different salt forms. Salts are formed to improve physicochemical parameters, whereas active moiety is the part of the molecule that is responsible for the physiological or pharmacological action of the drug substance. In both Indacaterol and Indacaterol maleate the active moiety is still Indacaterol and it is this compound which has the effect in the body.
Observations by the court and Conclusion.
The judgement placed reliance on the Roche vs. Cipla and observed that, if there is a strong prima facie case and the validity is not further seriously questioned, then there is a clear way out to grant injunction.
It seemed like the court applied the 6 year rule for presumption of validity of the patent.
The main question considered by the court was whether the Court will allow a party to infringe the registered patent which is prima facie held to be valid, the infringement is established and there is no credible defence raised by the other side?
The answer to this question is “NO”. Justice Manmohan Singh observed that the Court would never encourage the infringement in view of the exclusive and statutory rights granted under section 48 of the Act. The effect of registered patent is defined in the statute and the same is not capable of being misunderstood. The statutory and monopoly rights cannot be reduced to a nullity as by virtue of section 48 of the Act till the term of validity of the suit patents. In the present case, the compulsory license has not been granted by the authority to the defendant. Even its application for the same is not pending.
The court further observed that merely citing grounds and conditions for compulsory licensing do not absolve the defendant to infringe the registered patent.
The judgement was very well reasoned. Justice Manmohan Singh stated that the defendant is at the liberty to move an application seeking modification/ vacation of the interim injunction in case the application seeking CL is decided by the competent authority in its favour or the parties otherwise arrive at some consensus on the licensing terms. However according to latest news reports it seems like Cipla was aggrieved with the order and has moved to court challenging the grant of injunction.
The Appeal Bench also did not give any interim relief today to Cipla (14 Jan). I had given the link to the original Order as comment to the earlier post.
I could not get the Judis link for today’s appeal order.
Thank you Sandeep for the update and for providing a link to the original order too.
I will update the post as soon as I get a link to the new appeal order.