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 : Will Universal Drugs and Pharma Ltd. succeed in its arguments as per the provisions of the Patents Act, 1970 ?

Answer & Explanation:

Section 3(d) of the Patent Act, 1970 is the key issue in this problem. It may be emphasized that owner modifications of existing compounds would not qualify for Patent Protection unless they demonstrate a significant enhancement in therapeutic efficacy. The Universal Drugs and Pharma Ltd. had failed to prove that the new form of imatinib mesylate provided a substantial increase in efficacy compared to the original substance. Further, public interest in ensuring affordable access to essential medicines outweighed the interest of patent holders, otherwise patent of incremental innovations could lead to monopolistic pricing and prevent affordable access to medicines, especially in the case of life-saving drugs. Hence, the decision given by the Patent Controller and the Intellectual Property Appellate Board refusing to grant patent protection to the Universal Drugs and Pharma Ltd. is correct. This case study is based upon Novartis AGL v/s Union of India, (2013) 6 SCC1 as decided by the Supreme Court of India.

Topics: Patents Act, 1970

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