In October 2014, in a submission to India’s health ministry, Mumbai-based Cipla requested either a compulsory licence or the indacaterol patent’s revocation. To back up its request, Cipla claimed that Novartis was “not working” its patents in India and that only a small quantity of the product was being made available despite a large demand for it. Cipla followed this by launching a generic version of the drug, citing an “urgent unmet need”.
In response to the launch of the generic, dubbed Unibrez, Novartis sued Cipla for alleged infringement of its patent and trademark.
In January, the Delhi High Court issued a temporary injunction barring Cipla from selling the generic, a ruling that the Indian company has appealed against. Te lawsuit concerning actual alleged infringement of the patent will be heard at a later date.
A spokesperson for Cipla tells LSIPR it was concerned that the judgment will deny patients access to the drugs they need. Unsurprisingly, Novartis tells us on the other hand that it “welcomes the positive outcome”.
But with an appeal against the injunction decision, the full case, and a government ruling on the compulsory licence looming, could there yet be success for Cipla?
What makes the case interesting, says Ashwani Balayan, partner at ALG India Law Offices in New Delhi, is that the injunction against Cipla’s generic actually has no bearing on its attempt to obtain a compulsory licence. He tells LSIPR: “Tis ruling is limited to
Under attack
Onbrez (indacaterol) is a once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with COPD. Novartis collaborates with Lupin, an Indian company, to provide Onbrez to patients in India.
the court’s prima facie view on the alleged infringement of patents.”
However, he adds, since Cipla’s defences were “heard and rebutted”, it might “set the tone” that it doesn’t have a good case for a compulsory licence.
Archana Shanker, partner at law firm Anand
and Anand in Mumbai, says it will be difficult to predict what will happen.
“A compulsory licence is typically filed only aſter the voluntary licence route has been exhausted and the applicant has not already marketed the product,” Shanker tells LSIPR. “In the present case, Cipla’s generic is already on the market. We will have to see how the IPO interprets the court order and whether the lack of a voluntary licence route and the sale by Cipla of the allegedly infringing goods will be bypassed.”
Shanker says Cipla will also have to show that the drug is not meeting the “reasonable” requirements of the public at a “reasonable” price. She adds that this may be difficult because as Novartis has local partners that license the patented drug, including Mumbai-based Lupin Pharmaceuticals, some lawyers in the industry believe that the demand for the drug is in fact being met.
“To get an idea, the working statements Novartis has filed with the IPO will need to be examined,” Shanker adds.
Cipla’s application for a compulsory licence fell under a special provision, section 92(3), of the Patents Act, which grants licences only in cases of emergency.
Tis means, according to Balayan, that in addition to establishing grounds for granting a licence (invention not available at reasonably affordable price, or the invention not being ‘worked’ in India), Cipla will have an “additional burden of proof”.
Tis will be to establish that COPD has
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