Cipla Limited v Novartis AG (2017)

Summary

“The present appeal is directed against the judgment and/or order dated 09.01.2015 delivered by a learned Single Judge of this Court in IA 24863/2015 which was an application under Order XXXIX Rules 1 and 2 of the Code of Civil Procedure, 1908.” “The suit filed by the respondents was one for permanent injunction restraining infringement of patent No. 222346 granted under the Patents Act, 1970” (para 1). The drug “is a bronchodilator and provides symptomatic relief to persons suffering from chronic obstructive pulmonary disease (COPD).” (para 2) The appellant submitted that “the respondents are not working the patent in India and consequently, they are not entitled to an injunction” (para 6), and that “the said rights of patentees under Section 48 would be subject to other provisions in the Act, including Section 83 of the said Act.” (para 7) “A cross-objection (CM No.2090/2015) had also been filed on behalf of the respondent by way of challenge to paragraphs 86 and 132 which limited the injunction until the compulsory licencing was granted.” (para 23)

The Bench held that “the injunction granted by the learned single Judge ought not to be disturbed” since “First of all, there is no credible challenge to the respondent’s patent No.222346.” (para 25) It held that “Section 83 is not one such provision” and that “the provisions of Section 83 do not curtail or circumscribe the rights of the patentees under Section 48, except in the backdrop of compulsory licences and ancillary issues” (para 25). It held 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.” (para 25) On public interest, “we do not feel that the appellant has even made out a case that public service would be disserved by the grant of an injunction.” (para 25) “In view of the foregoing discussion, no interference with the impugned judgment and / or order is called for. The appeal is dismissed.” (para 26)

What the court decided

1. No credible challenge. “First of all, there is no credible challenge to the respondent’s patent No.222346. Therefore, prima facie, the respondent is straightaway entitled to an injunction in view of the rights available to it as a patentee under Section 48 of the said Act” (para 25)
2. Section 48 and Section 83. “Secondly, although Section 48 is subject to the other provisions contained in the Act and the conditions specified in Section 47, this would only have relevance where the other provisions of the Act impinge upon the provisions or the rights of the patentees under Section 48. Section 83 is not one such provision. Section 83 itself is without prejudice to the other provisions in the said Act and, therefore, is also without prejudice to the provisions contained in Section 48 of the said Act.” (para 25)
3. Section 83 and Chapter XVI. “Section 83 deals with the general principles and, in fact, enjoins the authorities under the Act, who exercise powers conferred under Chapter XVI to have regard to the general considerations specified in sub-clauses (a) to (g) thereof.” “But, all these considerations to which regard has to be had, are directed towards the authorities, who exercise powers conferred under Chapter XVI.” “It is immediately clear that the provisions of Section 83 do not curtail or circumscribe the rights of the patentees under Section 48, except in the backdrop of compulsory licences and ancillary issues” (para 25)
4. Working by importation. “Thirdly, 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.” “As pointed out in Telemecanique (supra), a patent can be worked in India even through imports. All that is to be seen is that the imports are of a sufficient quantity so as to meet the demands for the product. This is of particular importance in the case of pharmaceutical products.” (para 25)
5. Life-saving drugs. “We may also point out that apart from INDACATEROL, there are other drugs which deal with the management of COPD” (“chronic obstructive pulmonary disease”) “which are also available in the Indian market.” “INDACATEROL also does not fall in the category of a life saving drug, such as a cancer medicine.” (para 25)
6. Public interest. “Fourthly, 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. In any event, in the present case, we do not feel that the appellant has even made out a case that public service would be disserved by the grant of an injunction.” (para 25)
7. Balance of convenience and irreparable injury. “The balance of convenience is also in favour of the respondent. We are also of the view that in case an injunction is not granted in the circumstances, the respondents would suffer irreparable injury as their rights under Section 48 would be seriously impaired in a manner which cannot be restituted by damages.” (para 25)
8. The cross-objections. Of the cross-objection “by way of challenge to paragraphs 86 and 132 which limited the injunction until the compulsory licencing was granted” (para 23), the Bench held: “Because of the aforesaid conclusion, we are also not inclined to uphold the cross-objections of the respondents in CM No.2090/2015.” (paras 23, 25)
9. Disposition. “In view of the foregoing discussion, no interference with the impugned judgment and / or order is called for. The appeal is dismissed. There shall be no order as to costs.” (para 26)

What the court did not decide

Of the number of patients, the Bench held: “However, we need not enter into this controversy and only observe that the number of COPD” (“chronic obstructive pulmonary disease”) “patients is large.” (para 19) On the sufficiency of imports, “we cannot make a definitive conclusion as to whether the extent of imports is not sufficient for meeting the demands of COPD patients in India. This would be a matter of evidence which can only be thrashed out in the course of a trial.” (para 25)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 27 October 2026.