The Delhi High Court today said it is not necessary that for a patent to be worked in India, the product in question must be manufactured in the country.
The observation by the court came while dismissing Indian pharma company Cipla's bid to make and sell a generic version of Swiss drug major Novartis' patented respiratory disease medicine Indacaterol without a compulsory licence.
Cipla had contended that Novartis was not working its patent in India and was only importing small quantities of its drug, marketed under the name of Onbrez through its licencee Lupin.
"We are of the view that it is not at all necessary that for a patent to be worked in India, the product in question must be manufactured in India," a bench of justices Badar Durrez Ahmed and Sanjeev Sachdeva said.
The court dismissed Cipla's appeal against a single judge order restraining the it from selling its respiratory disease drug - Indaflo, till it obtains a compulsory licence.
"After considering the submissions for all the parties and examining the relevant papers, we are of the view that the injunction granted by single judge ought not to be disturbed," the bench said.
It also observed, "We cannot make a definitive conclusion as to whether the extent of imports is not sufficient for meeting the demands of chronic obstructive pulmonary disease (COPD) patients in India.
"This would be a matter of evidence which can only be thrashed out in the course of a trial. We may also point out that apart from Indacaterol, there are other drugs which deal with the management of COPD which are also available in the Indian market.
(Reopens LGD 30)
The division bench also declined Cipla's contention that public interest may be a factor in considering the grant of an injunction.
The bench noted its 27-page judgment that Indacaterol does not fall in the category of a life saving drug, such as a cancer medicine.
Novartis in its application before the single judge had sought to restrain Cipla from selling its product during pendency of the patent infringement suit filed by the Swiss pharma firm.
The single judge in its interim order had restrained Cipla from manufacturing its drug sold under the name of 'Indaflo', but allowed it to sell the stock remaining with it.
It had said the restraint on Cipla would remain till its application for compulsory licence was decided by the relevant authority.
It had asked Cipla to apply for the licence within two weeks of the order, if not already done so, and had directed the relevant authority to decide the same within six months of receiving the application.
