“Novartis AG v Union of India” Patent Case
In 2006, the Indian patent office had rejected the patent application for Novartis cancer drug, “Glivec” on grounds that –
– The original molecule imatinib was in public domain before 1995—the cut-off year for grant of drug patents in India; and
– The crystal form did not demonstrate any enhanced efficacy to treat the disease.
Later, Novartis challenged this decision before High Court at Madras stating that –
1. Section 3(d) is unconstitutional as it violates the provision of the TRIPS agreement; and
2. Indian patent act doesn’t define the term ‘efficacy’ and provides unguided power on the Controller.
Court’s Decision & Its Repercussions
In the rulings (by both Madras high court in 2006 and the apex court in April 2013), it was declared that –
– An incremental innovation in case of a drug product is patentable only if it demonstrates “enhanced therapeutic efficacy”.
– In case of any conflict between the norms and the patents act of 1970 and its rules, the act and rules will prevail
So although the court’s decision established that the Novartis’ patent application for the beta-crystalline form of Imatinib Mesylate (polymorph B) did not pass the test of section 3(d), it failed to clearly define the scope of enhanced efficacy as well as rationalize why subject matter lacks enhanced efficacy.
Thus, some amendments in the existing norms were much needed to bring in clarity that what counts as “enhanced efficacy”.