NOVARTIS AG VS.

UNION OF INDIA
GROUP 11
JOEL NORONHA PRAMOD KUMAR PRINCE AGARWAL RAHUL SACHDEVA SWETHA JAYARAMAN TANURAG CHOWDHARY

AGENDA
PATENT LAW HISTORY BRIEF FACTS OF THE CASE SUPREME COURT JUDGMENT IMPLICATIONS OF JUDGMENT RECOMMENDATIONS FOR NOVARTIS

PATENT LAW HISTORY

1911: Patents & Designs Act - allowed for both product and process patents 1972: Patents Act, 1970 came into force on April 20, 1972. 1999: Amendments to 1970 Act Section 5 2004: Ordinance passed allowing for product patents for pharmaceutical and agricultural chemical substances 2005: Patents (Amendment) Act 2005 in compliance with TRIPS agreement

FACTS OF THE CASE

Zimmerman Patent, 1993: Novartis granted patent for imatinib under both US and European Patent laws Chennai Patent Office - July 17, 1998 : Novartis applied for patent for the beta-crystalline form of imatinib mesylate, drug named Gleevec

Application moved to mailbox since Patents law was in a transitional phase

EMR grant Nov 10, 2003 : Novartis was granted exclusive marketing rights of Gleevec under Section 24(A)

Application was opposed by CPAA and four generic pharmaceutical manufacturers, 2005

FACTS OF THE CASE

Patent denied by Asst. Controller of Patents & Design on January 25, 2006 Novartis moved Madras High Court challenging Asst. controller's decision & Section 3(D)s validity Appeals by Novartis rejected by IPAB, 2009 Special Leave Petition filed by Novartis in Supreme Court - August 11, 2009

SUPREME COURT JUDGMENT

Novartis claim for patent rejected by Supreme Court on April 1, 2013 Failed test of invention and patentability Section 3(D) - the mere discovery of a new form of a known
substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

No enhanced therapeutic efficacy Evergreening

IMPLICATIONS OF JUDGMENT
Curtailment in grant of frivolous patents Boost to healthcare in poorer countries Reassessment of patent laws by countries worldwide

RECOMMENDATIONS FOR NOVARTIS

Invest in more R&D Enter into the generics market in emerging economies Broaden reach of GIPAP

THANK YOU