India decided to enterinto the WTO and to follow the worldwide intellectual property standards under the TRIPS agreement. As per this agreement, India made changes to its patent law. Earlier patents on products were not allowed in India, but afterwards they were, albeit with restrictions.
Novartis, a pharmaceutical company, manufactured a drug named Gleevec (beta crystalline form of imatinib). This was already patented in many countries including by US PTO. The patent application was submitted before the Controller of Patents in 2006, but it got rejected after hearing oppositions filed by pharmaceutical companies including Ranbaxy, Cipla, Hetero and the Cancer Patient Aid Association (CPAA). Novartis then filed an appeal with the Madras High Court which subsequently transferred it to the Intellectual Property Appellate Board (IPAB). The rejection of patent was upheld by it. Finally, the Novartis Company appealed to the Supreme Court in the form of an SLP.
The case was decided by the Hon’ble Supreme Court on 1st April 2013 by a bench of two judges namely,
• Justice Aftab Alam
• Justice Ranjana Prakash Desai
Novartis raised an argument that they are attempting to patent imatinib mesylate in beta crystalline form rather than imatinib mesylate which is publicly disclosed in the 1993 patent application and in scientific articles of Zimmerman. Section 3(d) of the Indian Patents Act sets out certain exclusions to patentable subject matter in India. The Court decided to regard "efficacy" stated in Section 3(d)of the Indian Patent Act as "therapeutic efficacy" because the compound used for medicinal value is theessence of the patent. The Court accepted that the physical efficacy of imatinib mesylate in beta crystalline form is intensified as compare to other forms and that the beta crystalline form of imatinib mesylate has 30 per cent increased bioavailability as compared to imatinib in free base form.But no report and evidence has been submitted to indicate that the beta crystalline form of imatinib mesylate will produce superior therapeutic efficacy. So, the Patent application of Novartis was rejected by the Apex Court.
Validity of Section – 3(d) of the Indian Patents Act was also questioned. The Supreme Court upheld the constitutional validity of the section and stated that this section is in the compliance with the provisions of TRIPS.
Thus, this judgement prevented the multinational firms to evergreen their medicines.
To read the full judgement, find the enclosed attachment