History of Patent laws and pharma industry in India
Initial patent filings and product launches
Initial patent prosecution and litigation
Arguments before the Supreme Court
Supreme Court decision
- "Novartis v. Union Of India & Ors on 1 April 2013".
- "Patenting Landscape in India 2009".
- "Pharma to topple IT as big paymaster". The Economic Times. 8 June 2010. Retrieved 8 Jun 2010.
- "History of Patent Law in India".
- "Product v. Process Patent in India".
- Controller General of Patents Designs and Trade Marks, Department of Industrial Policy and Promotion, Ministry of Commerce and Industry The Patents Act 1970 (incorporating all amendments till 26-01-2013)
- Erklärung von Bern. May 8, 2007 Short questions and answers about the court case initiated by Novartis in India
- Kevin Grogan for PharmaTimes. February 27, 2012 Novartis explains stance over India patent law challenge
- W.P. No.24759 of 2006
- Finally, the patients prevail, Sarah Hiddlestone, The Hindu, 7 April 2013
- Switzerland page at WTO
- Note: Further complicating matters, India's 1993 notification to the WTO indicating that it would join, included a list of countries whose priorities dates it would recognize for patenting, and Switzerland was not on the list as it was not a member of the WTO at that time.(Sudhir Ahuja, D P Ahuja & Co, Calcutta, India. India Decides to Join the Paris Convention and Ratify the Patent Cooperation Treaty. So What? Patent World Issue #106, October 1998). Additionally the EPO was not mentioned in the notification from India; it was not until 2003 that EPO became officially recognized by India, fully normalizing patent reciprocity between India and Europe. (G 0002/02 (Priorities from India/ASTRAZENECA) of 26.4.2004)
- US Patent Application No. 08/042,322). This application was abandoned and another continuation-in-part application was then filed on April 28, 1994 which matured into (US Patent 5,521,184).
- See here for worldwide filings]
- US Patent 5,521,184
- Staff, European Medicines Agency, 2004. EMEA Scientific Discussion of Glivec
- Note: The Indian patent application does not appear to be publicly available. However according to the decision of the IPAB on 26 June 2009 (page 27) discussed below, "The Appellant’s application under the PCT was substantially on the same invention as had been made in India."
- Published PCT application WO1999003854
- Novartis v UoI, para 168
- US Patent 6,894,051
- Investigational New Drug Application (IND # 55,666) for Gleevec was filed on 9 April 1998 and on February 27, 2001, the original New Drug Application (FDA Drug Approval Package for Gleevec NDA # 21-335) was filed before the US Food and Drug Administration for imatinib mesylate for the treatment of patients with Chronic Myeloid Leukemia
- Closing In On Cancer by Alice Park, TIME Magazine, 21 May 2001
- Novartis' Gleevec Cancer "Magic Bullet" Extends Life In GIST Patients, 6 June 2011
- FDA Orange Book; Patent and Exclusivity Search Results from query on Appl No 021588 Product 001 in the OB_Rx list.
- Novartis v UoI, para 8-9
- Staff, LawyersCollective. September 6, 2011 Novartis case: background and update – Supreme Court of India to recommence hearing
- R. Jai Krishna and Jeanne Whalen for the Wall Street Journal. April 1, 2013 Novartis Loses Glivec Patent Battle in India
- Application No.1602/MAS/1998
- The patent application attracted five pre-grant oppositions by M/s. Cancer Patients Aid Association, NATCO Pharma Ltd., CIPLA Ltd., Ranbaxy Laboratories Ltd. and Hetro Drugs Ltd. The Assistant Controller of Patents and Designs heard all the parties on December 15, 2005, as provided under rule 55 of the Patent Rules, 2003.
- Intellectual Property Appellate Board decision dated 26 June 2009, p 149
- Shamnad Basheer for Spicy IP March 11, 2006 First Mailbox Opposition (Gleevec) Decided in India
- Article 136 of the Indian Constitution
- "Supreme Court rejects Novartis patent plea for cancer drug Glivec".
- Novartis v UoI, para 105-108
- The Novartis Patent Intervention by Prof. Shamnad Basheer
- Novartis v UoI, Para 157
- Novartis v UoI, Para 158
- Novartis v UoI, Para 187, 188
- Novartis v UoI, Para 189, 191
- Novartis A.G. v. UOI & Ors. – Hon’ble Justice Aftab Alam’s Swansong, Rudrajyoti Nath Ray, RDA, 8 April 2013
- Novartis and Health - An analysis, Rajeev Dhavan, 11 April 2013
- Novartis v UoI, Para 24-25
- Novartis v UoI, Para 191
- Rama Lakshmi for the Washington Post April 1, 2013 India rejects Novartis drug patent
- Gardiner Harris and Katie Thomas for the New York Times. April 1, 2013 Published: April 1, 2013 Top court in India rejects Novartis drug patent
- Sarah Boseley for The Guardian, April 1, 2013 Novartis patent ruling a victory in battle for affordable medicines
- Staff, BBC. April 2, 2013 Novartis case: Media hail 'key victory' for India
- "How the Indian judgment will reverberate across the world".
- "Patented drugs must be priced smartly".
- Patent with a purpose, Prof. Shamnad Basheer, Indian Express, 3 April 2013
- M Allirajan, TNN April 4, 2013 SC decision on Glivec is negative credit for branded drug firms: Moody’s
- Sampat BN et al. Challenges to India's Pharmaceutical Patent Laws Science 27 July 2012: Vol. 337 no. 6093 pp. 414-415
- Charlotte Harrison Patent watch Nature Reviews Drug Discovery 12, 336–337 (2013)
- "Supreme Court rejects bid by Novartis to patent Glivec".
- Major victory on affordable drugs
- Salve on cheaper medicine Patent blow to Big Pharma, The Telegraph
- "Drug price cut signal after court victory".
- Why Novartis case will help innovation, Achal Prabhala and Sudhir Krishnaswamy, The Hindu, 15 April 2013
- A New Template for Pharma Research, Yogesh Pai, The Hindu Business Line, 11 April 2013
- Nothing wrong with setting high standards of patentability, Srividhya Ragavan and Aju John, myLaw.net, 10 May 2013
- Shift in Novartis Strategy, The Telegraph
- Supreme Court judgement dated 1 April 2013
- Intellectual Property Appellate Board decision dated 26 June 2009
- Madras High Court decision on constitutionality of section 3(d) dated 6 August 2007
|Novartis AG v. Union of India|
|Court||Supreme Court of India|
|Full case name||'Novartis AG v. Union of India (UOI) and Ors.; Natco Pharma Ltd. v. UoI & Ors.; M/S Cancer Patients Aid Association v. UoI & Ors.|
|Decided||1 April 2013|
|Citation(s)||Civil Appeal No. 2706-2716 of 2013|
|Prior action(s)||Application for patent by appellant denied by Assistant Controller of Patents and Designs on 25 January 2006; Intellectual Property Appellate Board (IPAB) partially reversed the decision by the Assistant Controller but still denied patent on 26 June 2009.|
|Upheld the rejection of the patent application (1602/MAS/1998) filed by Novartis AG for Glivec in 1998 before the Indian Patent Office.|
|Majority||Mr. Justice Aftab Alam , joined by Ms. Justice Ranjana Prakash Desai|
|Sections 2(1)(j), 2(1)(ja) and 3(d) of Indian Patent Act, 1970 (as amended in 2005)|