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Novartis AG vs Union Of India & Ors

Civil Appeal Nos. 2706-2716 of 2013

Bench: Aftab Alam, Ranjana Prakash Desai

Introduction

Intellectual property is a type of intangible property, and patents are a subset of intellectual property. A patent gives the creator of an invention a statutory right from the state to prevent others from manufacturing, using, or selling their creation for a period of 20 years.

The case of Novartis AG v. Union of India, decided by a two-judge panel of the Hon’ble Supreme Court of India, is one of India’s landmark decisions.

Novartis challenged IPAB’s rejection of its patent application for the Beta crystalline form of “Imatinib mesylate,” but the Supreme Court of India dismissed the challenge on the grounds that the said drug did not produce an enhanced or superior therapeutic efficacy when compared to the known substance, i.e., “Imatinib mesylate” means that the said drug did not involve an invented substance.

One of the main reasons for Novartis’ patent application being rejected was to prevent small modifications from evergreening previously protected items.

Facts

In 1998, Novartis International AG, one of the world’s largest pharmaceutical companies, applied to the Chennai Indian Patent Office under the TRIPS agreement for a patent for the anticancer drug ‘Glivec,’ which is made from the Beta crystalline form of “Imatinib mesylate” and is used to treat Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumours (GIST).

This medication is well-known for its usage in cancer treatment, and it is patented in more than 35 countries.

When Novartis applied for a patent, the award was limited to techniques or processes rather than products in India, as specified by section 5 of the Patent Act, 1970. Section 5 of the Patent (Amendment) Act of 2005 was abolished, allowing patents to be awarded not just for techniques or processes, but also for goods.

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In 2005, the Madras Patent Office considered Novartis’ patent application for the drug Glivec, which was rejected on the grounds that the drug had been anticipated by prior publication and had failed to satisfy the requirements of novelty and non-obviousness, as well as declaring the alleged invention unpatentable under section 3(d) of the Patent Act, 1970, as the said drug had been anticipated by prior publication.

In 2006, Novartis filed two writ petitions in the Madras High Court under Article-226 of the Indian Constitution. The appeals then said that section 3(d) of the Patent Act, 1970 is invalid because it does not comply with the TRIPS agreement and also violates Article 14 of the Indian Constitution and that the order issued by the Madras Patent Office is unlawful.

The matter was referred to the IPAB (Intellectual Property Appellant Tribunal) by the Madras High Court in 2007.

The IPAB ultimately heard the case and rejected it, finding that the invention passed the novelty and non-obviousness criteria, but the product’s patentability was harmed by section-3(d) of the Patent Act of 1970. The IPAB’s decision aims to avoid the ever-greening of previously patented products by making small adjustments and to allow Indian residents simple access to life-saving medications.

Novartis then filed an SLP (Special Leave Petition) with the Supreme Court of India in 2009, challenging the IPAB’s ruling under Article 136 of the Indian Constitution.

Issues

1. What is a known material, according to section 3(d) of the Patent Act of 1970?

2. What does Efficacy mean according to section 3(d) of the Patent Act of 1970?

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3. Does an improvement in bioavailability qualify as an increase in therapeutic effectiveness under Section 3(d) of the Patent Act of 1970?

4. Is Novartis’ innovation “Beta crystalline form of imatinib mesylate” more effective than the material from which it was produced, i.e. “Imatinib mesylate”?

Judgment

In April 2013, a two-judge panel of the Supreme Court of India dismissed Novartis’ appeal, ruling that the beta crystalline form of Imatinib Mesylate is a novel version of the well-known chemical Imatinib Mesylate, with well-established effectiveness.

The Supreme Court made it plain that “Efficacy” in section-3(d) exclusively refers to “Therapeutic Efficacy” in the case of medicine, and that all other qualities of the medication are irrelevant; the properties that directly pertain to efficacy in the case of medicine are its therapeutic efficacy.

In the third issue, the Supreme Court decided that, if a proof is presented, a 30 percent improvement in bioavailability qualifies as an increase in therapeutic effectiveness under section-3(d) of the Patent Act, 1970.

Supreme Court thought about the viability of “Beta Crystalline type of Imatinib Mesylate” with “Imatinib Mesylate” regarding its stream properties, better thermodynamic strength, and lower hygroscopicity, and held that none of these properties add to increment in remedial adequacy as indicated by segment 3(d) of Patent Act, 1970 and Novartis not gave any report that shows that the adequacy of “Beta Crystalline type of Imatinib Mesylate” is more when contrasted with the adequacy of “Imatinib Mesylate”.

Conclusion

The Supreme Court’s decision aims to prevent the ever-greening of copyrighted items and to provide assistance to people who cannot afford life-saving medications since pharmaceutical firms sell them at exorbitant prices, making them expensive to the average person.

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The Supreme Court stated in its decision that India is a developing country and that access to affordable medications is critical for the lives of 1 billion people.

Section 3(d) of the Patent Act of 1970 prohibits these large pharmaceutical corporations from acquiring a secondary patent by making modest modifications to existing technology. Novartis was unable to demonstrate that the therapeutic effectiveness of “Beta Crystalline version of Imatinib Mesylate” is superior to “Imatinib Mesylate.” As a result, the Supreme Court denied Novartis’ patent application.

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