Patent evergreening is a strategy, typically used in the pharmaceutical industry, to extend the life of a patent beyond its original expiration date. This is often done by making minor modifications to an existing drug—such as changing its formulation, dosage, or delivery method—and then filing for new patents.

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While technically legal, evergreening is controversial because it can delay the introduction of cheaper generic alternatives, keeping drug prices high, limiting access for patients and severely compromising healthcare systems. While critics argue that it prioritizes profit over public health, proponents claim it incentivizes continued innovation. Regulatory reforms are being discussed globally to curb abusive evergreening practices while preserving genuine innovation.

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Novartis AG v. Union of India & Others: The Landmark Judgment

In April 2013, the Supreme Court of India pronounced one of the most influential verdicts in the history of Indian patent law. Popularly known as the “Glivec Case”, the Novartis AG v. Union of India[1] judgment, was an inflection point in state intervention for balancing intellectual property rights with public health needs.

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The Background

Novartis, a global pharmaceutical company, applied in India for a patent on the beta crystalline form of Imatinib Mesylate, marketed as Glivec, a life-saving cancer drug. The company claimed that this new crystalline form was more stable, had better flow properties, and was less hygroscopic than the known form of the compound.

The Patent Office-Chennai rejected the patent application on the grounds that the formulation was not only anticipated by prior publication, but also failed to satisfy the requisite criteria of novelty and non-obviousness. It also held that the invention was non-patentable under  Section 3(d) of the Patents Act, 1970, which proscribes the grant of patents on new forms of known substances, unless such inventions demonstrate a significant enhancement in therapeutic efficacy.

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Thereafter, Novartis challenged the rejection citing violation of the Constitution and non-compliance with the TRIPS Agreement of World Trade Organization (WTO). The Intellectual Property Appellate Board (IPAB) dismissed the appeal holding that while the invention did satisfy the tests of novelty and non-obviousness, the patentability of the product was hit by Section3(d) of the Patents Act, 1970.

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The IPAB dismissal too was challenged in the Supreme Court of India.

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The Core Issue

At the heart of the dispute before the Court was the following cardinal question:

"Do improvements in physical properties, like stability or solubility, qualify as “enhanced efficacy” under Section 3(d)?"

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An affirmative answer would mean the invention was patentable, which would help Novartis secure a new patent and effectively extend its monopoly. On the contrary, an answer in the negative would enable Indian generic manufacturers to continue supplying affordable versions of Glivec.

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Supreme Court’s Ruling

The Supreme Court of India dismissed Novartis’ appeal with many observations of paramount importance:

1. Therapeutic Efficacy Matters: For medicines, “efficacy” under Section 3(d) means therapeutic efficacy. Improvements in stability or flow do not count, unless they lead to a real therapeutic advantage for patients.
2. No Evidence of Enhanced Therapy: Novartis failed to show that the beta crystalline form provided better treatment outcomes than the known form.
3. Section3(d) is Constitutional: The Court rejected the arguments that Section 3(d) of the Act is vague, arbitrary, or inconsistent with India’s TRIPS obligations. It was held to be a legitimate safeguard against evergreening— the practice of seeking repeated patents on minor modifications to extend monopoly.

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Importance of the Judgment

The judgment categorically established that trivial modifications of existing drugs cannot earn new patents unless they deliver real therapeutic benefits. By rejecting Novartis’ contentions, the Court ensured that Indian manufacturers could produce affordable generic drugs at a fraction of the cost of the patented version.

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The case drew international attention, with many hailing it as a perfect example of jurisprudence for balancing innovation and public health. As a result of the judgment, India etched its footprint on the global pharmaceutical market and consolidated its position as a leading supplier of medicinal products to the developing world and beyond.

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Conclusion

The Novartis case is more than a legal battle over a single drug. It is a landmark precedent that redefined India’s perspective on pharmaceutical patents— a view that promotes genuine innovation, while protecting public access to essential medicines and not compromising public interest.

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At BLAZE VENTURES, we have elaborate processes and qualified professionals for assisting  innovators and enterprises obtain patent rights effectually for their ideas, innovations and inventions.

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[1] (2013) 6 SCC 1

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