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Novartis Judgement Report

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Novartis V. Union of India & Others – A Landmark Judgement on Indian Patent Law & Pharmaceutical Industry: A Report

The Supreme Court judement on the Novartis v. Union of India & Others is a landmark decision on the issue of pharmaceutical patent in India. The decision taken after a seven year long litigation fought by pharmaceutical major Novartis is based on a case pertaining to grant of Indian patent on a compound called Imatinib Mesylate in Beta Crystalline Form (referred as Imatinib hereinafter as convenience of brevity). The Supreme Court decided that Imatinib, the substance for which Novartis sought patent does not qualify the test of invention as laid down in section 2(1)(j), section 2(1)(ja) and the test of efficacy under section 3(d) of the Indian Patent Act, 1970. The decision generated widespread discussion and debate on affordability of life saving drugs in India for public good and impact on R&D for further innovation in pharmaceutical industry.

The report covers following contents.

1. Background of the Novartis Case

❖ Fact of the case

❖ Underlying legal provisions

2. Overview of patent law in India with special focus on pharmaceutical industry

3. Supreme Court Decision in Novartis Case

4. Impact of the Supreme Court Judgement

❖ On affordability of life saving drugs

❖ On innovation for future improvement and development

❖ Overall impact on pharmaceutical industry both global & Indian.

5. A Proposition on future strategy for Novartis

Background of the Case

Fact of the Case

In 1996, United States and European patent offices granted patent right to Jurg Zimmerman, the inventor of Imatinib in free base form and derivatives, which was acquired by Novartis for commercial usage. Novartis started manufacturing and selling the drug...

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