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2. The entire controversy is with regard to ‗INDACATEROL' in respect of which the respondent No.1 holds the said patent. The said respondents market the said ‗INDACATEROL' under the name ‗ONBREZ'. ‗INDACATEROL' is a bronchodilator and provides symptomatic relief to persons suffering from chronic obstructive pulmonary disease (COPD).

3. The appellant launched its drug ‗UNIBREZ' in October, 2004. However, a suit was filed by the respondents on 09.01.2015 which was ultimately disposed of on the appellant's undertaking to change the brand name of the drug from ‗UNIBREZ' to ‗INDAFLO'. That was an infringement of trade mark action.

17. On the other hand, it was submitted on behalf of the respondents that the fact that they did not manufacture the product in India did not mean that the patent was not being worked in India because sufficient quantities of imports were made which would serve the needs of the patients suffering from COPD. It was also denied by the respondents that the extent of COPD patients was to the tune of 1.5 crore. It was submitted that enough imports were being made which would satisfy the requirements of the COPD patients for ‗INDACATEROL'. It was, therefore, submitted that it was not a case of public interest being disserved in case an injunction was granted. It was also submitted that prima facie the learned single Judge had held the patent to be valid and that has not been challenged, at least not seriously, by the appellant. Therefore, the respondent is entitled to the benefit of Section 48 of the said Act which clearly entitles it to the exclusive right to prevent third parties, who do not have its consent, from the act of making, using, offering for sale, selling or importing ‗INDACATEROL' in India. It was also submitted that the right of patentees under Section 48 was in no manner reduced or circumscribed by the provisions of Section 83, as the latter provision fell under an entirely different Chapter and had an entirely different objective.

19. It was, therefore, submitted on behalf of the respondents that, while public interest considerations may be a relevant factor in certain circumstances such as in the case of life saving drugs, it cannot by itself outweigh the rights of a patentee in the case of infringement of the patent as provided under the said Act. It was further submitted that the only argument that has been raised on the part of the appellant is that Section 48 is subject to Section 83 and, therefore, the argument of public interest would override the rights of a patentee under Section 48 of the said Act. It was submitted that Section 48 is undoubtedly subject to the other provisions contained in the Act but, Section 83 would have no relevance insofar as the rights of the patentees under Section 48 are concerned. The two provisions operate in entirely different fields. Section 83, according to the learned counsel for the respondents, also begins with the words ―without prejudice to the other provisions contained in this Act‖ which would imply that it is without prejudice to all the other provisions in the Act which includes Section 48. Secondly, it was submitted that the provisions of Section 83 are not in respect of the rights of the patentees, but to the powers to be exercised by the controllers and other authorities as conferred on them by Chapter XVI of the said Act which relates to Working of patents, Compulsory Licences and Revocation. Therefore, the element of public interest, which is sought to be introduced by the appellant through the route of Section 83 of the said Act, would not, in any way, impinge upon the rights of the patentees which includes the rights of the respondent in respect of patent No.222346, under Section 48 of the said Act. It was also submitted on behalf of the respondents that the statistics said to have been provided by the appellant with regard to the extent of COPD patients in India is not reliable. References were made to certain articles to suggest that COPD does not include an asthma-like respiratory symptom or chronic bronchitis and, therefore, the number of patients suffering from asthma or chronic bronchitis cannot be considered as part of COPD patients. We may point out at this juncture itself that there are also articles which may tend to indicate that chronic bronchitis is a part of the COPD spectrum and can be considered as surrogate for COPD. However, we need not enter into this controversy and only observe that the number of COPD patients is large.

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. From the presentation of data before us both by the appellant and the respondent in the shape of articles, etc, 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. 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.