assumed “epidemic proportions” in India and has created circumstances described as a national emergency or extreme urgency. Balayan adds: “Considering that the patented drug is only for a subset of patients with COPD—Onbrez is targeted at patients with a mild or moderate condition—and may not be categorised as the exclusive life-saving drug for patients, the chances of a compulsory licence succeeding under this provision appear low.”
In its January order, the Delhi High Court observed that Cipla did not provide any figures about the alleged inadequacy or shortfall in the supply of Onbrez. Te court added that it did not agree with Cipla’s proposal to allow it to make a generic version of the drug without compensating Novartis for its “innovation”. According to Shanker, regardless of what happens with Cipla’s compulsory licence application, that a judge has ruled in favour of a pharma company with a view to “protecting innovation” sends out a positive message about the state of IP protection in India.
Although Balayan says he believes that courts go “by the merits of the case” when granting an injunction, irrespective of the industry involved, he adds that the wording of the judgment could
innovation as being equally important as public interest issues.”
show that the courts are “getting more sensitive” about the IP rights of pharma companies. Shanker explains that while Novartis had a “very good case and a strong patent”, Cipla’s product already being on the market was a key factor in Novartis being granted its request for a temporary injunction.
“Having said this,” she adds, “Judge Manmohan Singh dealt with protecting
Despite the positive signs of a court supporting innovation, Balayan adds that Cipla’s patent challenge was somewhat “half-hearted”. “Te fact that Cipla attempted to revoke the patent, applied for a compulsory licence and said it was willing to pay royalties from the sales of its generic to Novartis, was deemed an admission of validity of the patent-in-suit.
“Since neither a pending application by the defendant for a compulsory licence nor the revocation of the patent is a valid defence in a lawsuit for infringement ... an injunction seemed inevitable,” Balayan says.
Cipla could yet prove that there is indeed an “urgent” unmet need for Onbrez in India and, if so, news of another compulsory licence could soon be making the headlines, although there are no clear signs when the decision will be made. Regardless of any decision, that this dispute has attracted a high level of interest and has been carefully considered by both the courts and the government, shows just how important pharma issues are in India.
Te final outcome of the case is still up in the air, but the signs are there that India could be turning a corner when it comes to protecting the patents of big pharma companies.
HOW TO FORTIFY YOUR INNOVATIONS, IDEAS AND TRADEMARKS
Innovations, models and trademarks are a valuable asset in any business. They enhance a company’s distinguishing capacity, boost its impact, strengthen its competitive position and make it more attractive to investors. Therefore, there is every reason to give Intellectual Property a prominent place in your business strategy. We can support you by protecting and enriching your innovations, models and trademarks, thanks to our extensive range of services and the expertise of our trademark, design and patent specialists who find solutions where others don’t. We are the largest consultancy in Intellectual Property in the Netherlands and one of the most pioneering firms in Europe. If you would like to know more, visit
www.nlo.nl
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