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 : Are the patentability criteria under Section 3(d) in accordance with international standards ?
Answer & Explanation:
The Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement is essential for facilitating intellectual property, trade settling intellectual property, trade disputes and giving WTO members the freedom to pursue their own national goals. The Trips agreement is an attempt to put these rights under common international law and to close the gap in how they are safeguarded and upheld globally. It provides minimal requirements to enforcement and protection of intellectual property owned by citizen of other WTO members by each Government. Accordingly, the Patent Act, 1970 including section 3(d) is in compliance with India's International obligation under Trips, as the law did not prevent the patenting of genuine innovations but instead focused on preventing the patenting of minor modification that did not offer signific therapeutic benefits in this instant case.
Topics: Patents Act, 1970
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