Universal Drugs and Pharma Limited, a multinational pharmaceutical company, was incorporated and registered in Chennai. The company filed a patent application in India under the Patents Act, 1970, for its cancer drug Gli
CS Executive · Economic, Commercial and Intellectual Property Laws · PYQS · June 2025
Universal Drugs and Pharma Limited, a multinational pharmaceutical company, was incorporated and registered in Chennai. The company filed a patent application in India under the Patents Act, 1970, for its cancer drug Glivec (Imatinib Mesylate). The application sought to patent a beta-crystalline form of imatinib mesylate, claiming it to be a new form with improved bioavailability and efficacy. However, the Patent Controller of India rejected the application, stating that the drug did not meet the criteria for patentability under Section 3(d) of the Patents Act, 1970. The rejection was based on the ground that Section 3(d) prohibits the patenting of new forms of known substances unless they demonstrate enhanced therapeutic efficacy compared to the original compound. Universal Drugs and Pharma Ltd. challenged the decision before the Intellectual Property Appellate Board (IPAB), but the IPAB upheld the Patent Controller's decision. The company then filed an appeal before the Supreme Court of India, raising the following key legal issues : Whether the beta-crystalline form of imatinib mesylate qualifies for patent protection under Section 3(d) of the Indian Patents Act, 1970, given that the substance was already known but had been presented in a new form ? Whether the patentability criteria under Section 3(d) are consistent with international standards, or whether they are excessively restrictive ? In view of the above case study, answer the following questions in accordance with the provisions of the Indian Patent Act, 1970 : What are the rights of patentee under the Patent Act, 1970 ?
Answer & Explanation:
Section 48 of the Patent Act, 1970 provides that subject to the other provisions contained in the Patents Act and the conditions specified in section 47, a patent granted under the Act shall confer upon the patentee: Where the subject matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for, those purposes that product in India. Where the subject matter of the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India. A patentee enjoys the exclusive right to make and use the patented invention. The patentee also has the right to assign the patent, grant licences, or otherwise deal with the patent, for any consideration. These rights, created by statute, are circumscribed by various conditions and limitations as prescribed under the Patents Act, 1970.
Topics: Patents Act, 1970
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