Cipla from manufacturing and selling a generic version of Novartis’ patented respiratory drug ‘INDACATEROL’(sold as ‘Onbrez’).The judgment is significant in that it acknowledges ‘public interest’ as a separate factor to be considered for grant of an interim injunction, although it was found to play no role in the case. The court rejected Cipla’s ‘public interest’ argument (based upon vitality, low availability and five times more price of Novartis’ drug) seemingly for the reason that this drug is not a life saving drug (unlike an anti-cancer drug) and there are other drugs available in the market for treatment of COPD.
Background
INDACATEROL’, a bronchodilator drug approved for the treatment of chronic obstructive pulmonary disease (COPD) is protected under patent number 222346 held by Novartis. The drug is manufactured by Novartis in Switzerland and is imported into India and marketed by Lupin, under the trade name ‘ONBREZ’.
In 2004, Cipla had launched a cheaper generic version (about one-fifth of the price) of this drug under the trade name ‘UNIBREZ’, which it agreed to change to ‘INDALFO’ pursuant to a trademark infringement suit filed by Novartis. Thereafter, Novartis filed a patent infringement suit before the Del HC seeking a permanent injunction restraining Cipla from infringing its patent over ‘INDACATEROL’ along with an application seeking interim injunction against the same.
DECISIONS
Novartis does not work the patent in India as it does not manufacture the drug in India
The Bench rejected this argument, noting 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”. It relied upon the Telemecanique case (2002), to observe that it can be worked in India even through imports and “all that is to be seen is that the imports are of sufficient quantity so as to meet the demands for the product”, especially in the case of pharmaceutical products. However, the Court could not definitively conclude whether the quantities of imports were sufficient to meet the demand for the drug in India on the basis of the data submitted at this stage and left it to be determined during the trial.
Novartis’ rights under S.48 of the Patents Act are subject to S.83 of the Act
The Court rejected this argument as well, noting that S.83 itself begins with ‘without prejudice to other provisions of the Act’ and moreover, it belongs to a different Chapter of the Act titled ‘Working of the Patents, Compulsory License and Revocation’ and thus, does not impinge upon the exclusive rights granted under S. 48. It rightly observed that it is the authorities under the Act who are enjoined by the general principles laid down under S.83 in exercise of powers conferred under Chapter XVI such as grant of compulsory license etc.
Public interest would be disserved by grant of an injunction against Cipla’s sale of the drug
The Court refused to find any merit in this argument. It first observed that, “even though the question of public interest may be a factor in considering the grant of an injunction, it is only one of the factors which needs to be kept in mind”. Secondly, it noted that in any case, Cipla had not been able to establish that public interest would be disserved by the grant of an injunction in the present case. It further found that prima facie validity of patent was established by Novartis, that the balance of convenience also lay in favor of Novartis and that Novartis would also be subjected to irreparable harm in the circumstances an injunction is not granted.
The court, therefore, refused to interfere with the Single Judge’s grant of injunction and dismissed Cipla’s appeal. This judgment marked yet another setback to Cipla’s attempt to save its generic version of Novartis’ drug.
