ABSTRACT

The Novartis v. Union of India case epitomizes the delicate balance between patent protection and public health in the pharmaceutical sector. This landmark ruling in 2013 pivoted on the interpretation of Section 3(d) of the Indian Patent Act, underscoring the significance of enhanced drug efficacy for patent eligibility. The decision, favoring public health interests, denied Novartis patent protection for the cancer drug Glivec, thereby safeguarding access to affordable generic alternatives. This ruling, celebrated as a triumph for equitable healthcare, underscores the imperative of reconciling innovation incentives with the broader imperative of ensuring universal access to essential medicines.

INTRODUCTION: PATENT AND PUBLIC HEALTH

Patent is granted to protect the invention of an individual or group of individuals from infringement. It protects the rights of the patent holder by denying access to unauthorized use of their product by others. The pharmaceutical industry is driven by creation of minds of people. It involves extensive research and thus it is quite expensive and highly unpredictable and any new creation can be useful. However, a major challenge which is prominent here is to maintain a balance between public health and p tent protection. In the case of, Bandhua Mukti Morcha v. Union of India , the court held that, ‘Right to Health’ is a part of Article 21 of the Indian constitution.

From the past century India has been facing various health crisis, the situation gets worse when there is unavailability of medicines and inadequate healthcare infrastructure. Based on such scenarios, it becomes essential that the patented medicine shall be provided at a reasonable rate by pharmaceutical companies. The main objective of Section 83 of the Indian Patent Act, 1970 is that ‘granting patent to patentee is to encourage further invention and to protect any form of exploitation of the rights of patent holder but such grant should not act as a hinderance but will rather act as an instrument to promote public interest’. Therefore, it is clear that public health plays an essential role as a part of the patent laws in India.

NOVARTIS v. UOI : BALANCING PATENT RIGHTS AND PUBLIC HEALTH

FACTS

Novartis filed a patent application for their anti-cancer medicament known as ‘Glivec’, which is formerly based on the original drug ‘imatinib’. The patent application meant to cover pharmaceutically acceptable salt forms of ‘imatinib’. This patent was granted to them by the US Patent and Trademark Office. In 1997, they filed a patent application for a specific variation of imatinib mesylate, which is its beta crystalline form and subsequently the patent for it was also granted. The patent for the same was applied in India. In 2006, the Indian Patent Office rejected this application under section 3(d) of the Indian Patents Act as Novartis failed to show “significantly enhanced efficacy” from their original salt to their beta crystalline form and the same was confirmed by the Indian Intellectual Property Appellate Board (IPAB) in 2009. Novartis further appealed to the Supreme Court.

 ISSUES

1. Whether the Novartis’s cancer drug Glivec’s modification, constituted a significant enhancement in efficacy, warranting patent protection or if it is merely constituted a minor modification of a known substance ?

RULE

Section 3(d) of the Indian Patent Act

APPLICATION

At the heart of the issue was the interpretation of section 3(d) of the Indian Patent Act, which prohibits patenting of modifications of known substances unless they demonstrate significantly enhanced efficacy. Novartis argued that glivec represented a substantial innovation deserving of patent protection, citing its improved bioavailability and efficacy compared to its base compound imatinib. The court in this case held that improved bioavailability does not necessarily result in improved therapeutic efficacy.

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The Supreme Court’s ruling in favor of the Union of India underscored the importance of prioritizing public health concerns over patent monopolies. By rejecting Novartis’s patent application for Glivec, the court upheld the availability of generic versions of the drug, ensuring greater affordability and accessibility for the patients in need. This decision was hailed as a victory for public health, as it prevented the potential abuse of patent rights that could have resulted in exorbitant drug price and limited access to life-saving treatments.

Furthermore, they highlighted the need for balanced approach to intellectual property rights that takes into account both innovation incentives and public health considerations. While patent protection is essential for promoting innovation and incentivizing pharmaceutical research and development, it should not come at the expense of access to medicines for those in need. This ruling thus struck a balance between these competing interests, affirming the principle that patent laws should serve the broader goal of advancing public health and well-being.

CONCLUSION

The balance between the Patent Protection and Public Health should be in such a way that, the patentee gets due recognition for sharing his information in the public domain and on the other hand it should also ensure that public health, being a common interest shall be available to a common man without hinderance of unreasonable prices.

Author : Saarah Rizwana N, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.