TMPatentDismissed 1 April 2013
Novartis AG v. Union of India & Others
CIVIL APPEAL Nos. 2706-2716 OF 2013
- Court
- Supreme Court of India
- Bench
- Aftab Alam, J., Ranjana Prakash Desai, J.
- Outcome
- Dismissed
- Date of judgment
- 1/4/2013
Statutory provisions
Section 2(1)(j), Patents Act 1970 — Definition of inventionSection 2(1)(ja), Patents Act 1970 — Definition of inventive stepSection 3(d), Patents Act 1970 — Non-patentable inventions (discovery of new form of known substance)Section 5, Patents Act 1970 — Inventions where only methods or processes of manufacture patentable (prior to amendment)Section 10(4), Patents Act 1970 — Contents of complete specification (description and claims)Section 83, Patents Act 1970 — General principles for working of patented inventionsArticle 27, TRIPS Agreement — Patentable Subject MatterArticle 70, TRIPS Agreement — Protection of Existing Subject Matter
Key issue
Does the beta-crystalline form of Imatinib Mesylate, a derivative of an already known substance, demonstrate enhanced therapeutic efficacy sufficient to qualify for patent protection under Section 3(d) of the Indian Patents Act, 1970?
Summary
This case concerns a patent application by Novartis AG for a beta-crystalline form of Imatinib Mesylate, a drug used to treat chronic myeloid leukemia (marketed as 'Glivec'). The Assistant Controller and then the IPAB rejected the patent application, finding it fell under Section 3(d) of the Patents Act, 1970, which prevents 'evergreening' of existing patents. The Supreme Court reviewed the legislative history of Indian patent law, particularly the 2005 amendments, to understand the intent behind Section 3(d). The Court ultimately upheld the rejection, concluding that the beta-crystalline form did not demonstrate enhanced therapeutic efficacy over the known substance, Imatinib, as required by Section 3(d) of the Patents Act.
Result: Appeals filed by Novartis AG seeking patent for Imatinib Mesylate in beta crystalline form dismissed, upholding lower court decisions.
Tags
#patent law#pharmaceuticals#Section 3(d)#evergreening#TRIPS Agreement#Imatinib Mesylate#therapeutic efficacy
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