NOVARTIS AG. V/S UNION OF INDIA & OTHERS

APPEAL NO: 2728 of 2013.

DECIDED ON: 1-04-2013.

CASE IN BRIEF:This case is a landmark decision by a two-judge bench of the Indian Supreme Court on the issue of evergreening of pharmaceutical patents. Application filed in India for patent of “Imatinib mesylate” in Beta crystalline form, by appellant (“Novartis”) denied by Assistant Controller of Patents and Designs on 25^th January, 2006.

Intellectual Property Appellate Board (IAPB) partially reversed the decision by the Assistant Controller,but still denied patent on 26^th June, 2009 citing reason that the compound fails to satisfy the requirements of ‘Novelty’ and ‘Non-obviousness’ as per Sec 3(d)of Patents Act, 1970.

BRIEF FACTS OF THE CASE: In 2004, NATCO Pharma Ltd (An Indian Generic Pharma Company) was restrained by Novartis after it was found that NATCO was marketing a generic version of Gleevec ( imatinibmesylate) a cancer curing drug, in UK in violation of the 1996 Zimmerman patent.

Later, In India, Novartis sought to patent imatinibmesylate in betacrystalline form (a specific polymorph of imatinibmesylate) rather than imatinib or imatinibmesylate itself.

The Assistant Controller of Patents and Designs rejected the application on 25th January, 2006 as failing to satisfy requirements for ‘Novelty’ and ‘Non-obviousness’.

Novartis mounted a separate and concurrent litigation before the Madras High Court arguing that section 3(d) of the Indian Patent Act is unconstitutional.

FINAL DECISION: The Apex court (“Court”) rejected the patent application.

REASONS FOR REJECTION:

• On perusal of the documents the Court concluded that imatinib mesylate is a known substance from the Zimmermann patent itself. Further its pharmacological properties are also known in the Zimmermann patent (also an earlier patent of Novartis). Therefore imatinib mesylate in beta crystalline form does not qualify the test of invention as laid down in section 2(1)(j) and section 2(1)(ja) of the Patents Act, 1970.

• The imatinib mesylate in beta crystalline form does not possesss any therapeutical efficasy on the users of the drug.

• Another reason for rejection of the application of patent was that Novartis was engaging in “Evergreening process”(used by manufacturers of a particular drug to restrict or prevent competition from manufacturers of generic equivalents to that drug).

The decision of the Apex Court ensured steady availability of low cost generic versions of life saving drugs based on imatininb or imatinib mesylate.