- The Indian Patent Office rejected this application based inter alia on the failure of Novartis to show significantly enhanced efficacy of the beta crystalline form over its original salt as required under Section 3(d) of the Indian Patents Act,1970.
- The drug did not exhibit any major changes in the therapeutic efficacy over its pre-existing form.
- In 2006, Novartis filed 2 Writ petitions in Madras High Court.
- The first appeal stated that section 3(d) of the Patents Act,1970 is Unconstitutional.
- The Second appeal was against the order passed by Madras Patent Office.
- The Madras High Court held that the alleged offending provision is not a violation of Article 14 of the Constitution of India and transferred the case to the Intellectual Property Appellate Board (IPAB) in 2007.
- The IPAB overturned the patent controller's findings on the novelty and inventive steps of a beta crystalline form.
- Novartis alleged invention did not satisfy the test of Section 3(d).
- It is to prevent the evergreening of the already patented product. IPAB rejected the appeal and refused to grant a patent to Novartis.
- Novartis filed a Special Leave Petition before the Supreme Court of India in 2009 against the order passed by IPAB.
Arguments by Plaintiff |
Arguments by the Union of India |
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Novartis contended that there is no clarity as to what constitutes enhancement of efficacy and significant enhancement of efficacy as required, therefore, the law is vague and led itself to an arbitrary decision.
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Beta Crystalline form of imatinib mesylate is neither new (novel) nor is it non-obvious due to publications about imatinib mesylate in Cancer Research and Nature in 1996.
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They argued that the provision related to discoveries does not apply to its patent application which satisfies the criteria of novelty, inventive step and industrial application and is an invention under section 2 (1) (J) of the Patents Act, 1970.
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The efficacy as referred to in section 3(d) should be interpreted as therapeutic efficacy and not just physical efficacy.
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| The respondents also quoted extensively from the Doha Declaration, they took excerpts from parliamentary debates, various petitions by NGOs, WHO etc. to highlight the public policy dimension of the arguments relating to easy affordability and availability of life-saving drugs. |
Supreme Court Verdict
The Supreme Court made it clear that India is a developing country and medicines should be available at an affordable price to safeguard the lives and protect the interests of billions of people.
A reasonable and liberal approach must be followed to grant patents. Hence, the appeal filed by Novartis is dismissed.
Section 3(d) of the Indian Patent Act, 1970
"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, is not patentable".
