Financial Daily from THE HINDU group of publications
Sunday, Feb 06, 2005
Financial Daily from THE HINDU group of publications Sunday, Feb 06, 2005 |
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Industry & Economy
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Courts/Legal Issues Marketing can be done without a patent: Madras HC Our Legal Correspondent
Chennai , Feb. 5 FROM January 1, 2005, India, as a World Trade Organisation member and signatory of trade-related aspects of intellectual property rights (TRIPS accord), is obliged to grant product patent in all fields, including medicines and drugs. Till the applications are taken up, there is provision to grant Exclusive Marketing Rights (EMR). In a recent judgment, the Madras High Court held that even without having a patent, marketing of various products can be done. Section 24-B(1) of the Act and Rule 40 of the Patents Rules, 2003, make it clear that the authority to issue a marketing approval was not an authority under the Patents Act, Mr Justice R. Balasubramanian said. Once a marketing approval is received, the Patent Controller cannot sit in judgment on whether the applicant has the product patent. The Judge, who was disposing of an appeal filed by two Chennai-based pharmaceutical firms to vacate an ex parte injunction granted in favour of a Swiss company for a patented anti-cancer drug, said that under Section 24-D, once the Centre was satisfied that it was in public interest to allow the sale of the drug by a person not having patent, this can be done. Under sub-section (2) of Section 24-D, the Government has the right to fix the price at which the EMR holder can sell the product. Section 24-D justified the contention of the respondents/defendants that public interest would be affected. The applicants said they invented products `Alpha' and `Beta.' In the manufacture of the anti-cancer drug `Beta,' the crystalline form was used. The product was the Beta Crystalline form of `Imatinib Mesylate.' The first applicant filed applications for the said product patent in several countries, and in some of them, patent had been granted. Marketing approval for an identical product was granted in India in favour of the second applicant (Novartis India Ltd, Mumbai). They contended that the respondents were infringing on the rights of the applicants given under the `EMR' by dealing with the same drug. The applicants sought an injunction, which was granted ex parte on January 20, 2004. The respondents (Adarsh Pharma and Cipla Ltd) submitted, inter alia, that no patent for `Imatinib Mesylate' was ever filed in India, and so there was no question of the applicants being entitled to any protection. They contended that the first applicant wanted a monopoly to take the entire profits out of the sale of drugs covered under the EMR. The Judge said that neither in the Patents Act nor in the Patents Rules, was there any amended provision as to who must apply for the marketing approval in India when a patent claim was filed in the country by the inventor. Under the Drug and Cosmetic Rules, the manufacturer's agent is the only authority to apply for an import licence. Hence, it was clear that the second applicant (applying for an import licence) had not violated Rule 24 of the Drug and Cosmetic Rules. He held the applicants could be treated as one single economic unit. Section 24-B (1) of the Patents Act only contemplated the applicant receiving the approval to sell or distribute the article. Inasmuch as the provisions of the Drugs and Cosmetic Rules enabled the manufacturer's agent to apply for marketing approval, the approval obtained by the second applicant was not an infringement of any statutory requirement either under the Patents Act or under the Drugs and Cosmetic Rules. To agree with the submission of the respondents that at least for six years , no injunction should be granted protecting the rights of the EMR holder, had no meaning as the EMR was valid for less than six years. The Judge noted that the respondents started marketing their product, only after the applicants had done so with their product. On the principles laid down by the Supreme Court in several judgments, the applicants had definitely made out a prima facie case for confirming the order of injunction already granted in their favour. Consequently, the January 20, 2004 order, granting injunction as prayed for, was made absolute.
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