Cipla Limited vs. Novartis AG & ANR 9 March, 2017
A case for permanent injunction was filed in the High Court of Delhi by Novartis AG, a Swiss company against Cipla Limited, an Indian Company, for infringement of their Indian patent no. 222346. The product, Onbrez, comprising INDACATEROL claimed in the patent, was manufactured by the plaintiff in Switzerland and imported into India according to an agreement, dated 22.03.2012, with Lupin Laboratories. The product is a bronchodilator providing symptomatic relief against chronic obstructive pulmonary disease (COPD). The judgment and / or order dated 09.01.2015 IA vide 24863/2015 delivered by a single judge of the Court, restrained the defendant from infringing the patent for INDACATEROL. However, the court order allowed injunction till the case of grant of compulsory license by the competent authority is decided for the product, in case such an application was filed by the defendant. In case of a decision of compulsory license in favour of the defendant, an application for modification of the impugned order could be filed otherwise injunction would continue till the suit is decided.
In a separate case of infringement of trademark, Cipla was restrained from using the trademark name, Unibrez, which was subsequently changed to INDAFLOW on 09.01.2015. Cipla appealed against the decision. However, the Court did not agree with the contention of the appellant and the injunction was maintained as ordered by the single judge.
Section 48 of The Indian Patents Act 1970 (the Act) relates to the Rights of Patentees and it says that subject to other provisions contained in the Act and the conditions specified in Section 47, a patent granted under this act shall confer upon the patentee …..The sub-sections (a) and (b) of Section 48 relate to the rights of a patentee with respect to a patented product or a patented process respectively and preventing third parties from making, using, offering for sale, or importing the patented invention without the consent of a patentee. It appears from the language of section 48 that the rights of a patentee are subject to other provisions of the Act and also Section 47 which relates to the grant of patents subjected to certain conditions like the use of the patented invention by the Government of India for its use or in case of medicine, distribution for public service. Another condition relates to the use of a patented invention for research purposes or academic purposes. None of the conditions of Section 47 are applicable in the instant case.
Section 83 deals with General principles applicable to the working of a patented invention and lays down that without prejudice to other provisions contained in the Act, patents are granted to encourage inventions but some considerations have to be kept in mind. The considerations have been specified in sub-sections (a) to (g) of Section 83 deal and lay down that inventions have to be worked in India on a commercial scale and to the fullest extent possible. Further, a Monopoly for importation cannot be enjoyed by a patentee. One of the subsections also deals with making available the benefits of a patented invention at reasonable and affordable prices to the public.
In its application, the applicant/ defendant submitted that the invention is not worked in India as the manufacturing unit of the product was in Switzerland and the product was imported into India. It was also alleged that the imported quantity was not enough to meet the public demand. Further, the price of the product was five times that at which it was sold by the applicant. Thus, it was alleged that the respondent/ plaintiff had failed to fulfill the provisions of section 83. The applicant argued that since the plaintiff had failed to fulfill the requirements of section 83 of the Act, the rights of a patentee, as stated in Section 48, could not be conferred on the plaintiff. The appellant referred to the case of Franz Xaver Huemer vs New Yash Engineers wherein the injunction was refused by the Court as the invention was not worked in India.
The respondent argued that the patentability was not challenged seriously and even though the patent was not worked in India, a sufficient quantity was imported into India to meet the public demand. The respondent referred to the Division Bench decision of the Delhi Court in the case of Telemecanique & Controls (I) Limited v. Schneider Electric Industries , which averred that as long as the public is getting the product and is not deprived of the same, public requirement is met. The respondent stated that it was not possible to manufacture a drug in all the countries where a patent was granted. The plant in Switzerland is a state-of-the-art facility and is capable of meeting public demand in India and elsewhere. Figures were quoted in support of meeting public demand. It also argued that Sections 48 and 83 are not interrelated as the latter is applicable without prejudice to other sections of the Act, which includes section 48.
The Court averred that for an injunction, the prime consideration is whether a credible challenge to patentability has been raised. It appeared that no credible challenge to patentability had been raised. While the rights of a patentee as stated in Section 48 are subject to other provisions of the Act, section 83 cannot be considered to fall amongst those other provisions as the section itself begins with a prelude without prejudice to other sections. In other words, Section 83 exists without any prejudice to section 48. The two sections are not interrelated / married and need to be seen separately. Chapter XVI relates to the working of patents, compulsory licenses, and revocation and section 83 falls under the same. While drawing reference to Telemecanique & Controls (I) Limited v. Schneider Electric Industries2, the Court averred that a patent can be worked in India even through imports. However, in the instant case, based on the available data, the Court could decide during the trial whether sufficient quantity was imported for meeting the public demand. It also needs to be kept in mind that COPD is not a lifesaving drug and there are other suppliers of the drug as well. The case of Franz Xaver Huemer vs New Yash Engineers1 was different from the instant case as it was a case of a non-user and the patent was not at all worked in India.


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