In 2005, significant circumstances prompted the amendment to Section 3(d) of the Indian Patent Law, 1970. This provision was introduced to address concerns regarding evergreening, a practice where pharmaceutical companies extend patent protection by making minor modifications to existing drugs. The amendment aimed to ensure that patents were granted only for genuine innovations rather than trivial modifications. This became particularly relevant in the case of Novartis’ patent application for “Glivec,” a cancer drug. The Supreme Court of India utilized Section 3(d) in its landmark judgment to reject Novartis’ patent application, citing that Glivec did not demonstrate enhanced efficacy over existing formulations, merely involving a modification in the salt form. The court’s decision was lauded for upholding the intent of the law to promote access to affordable medicines by preventing the monopolization of essential drugs. It set a precedent that prioritized public health over pharmaceutical profits and encouraged innovation in genuinely beneficial drugs. However, the decision also sparked debate over its potential impact on research and development investments. Critics argued that stringent patent laws might discourage pharmaceutical companies from investing in developing new drugs, fearing that their innovations could be easily replicated or rejected under similar circumstances. Balancing the interests of innovation, public health, and accessibility remains a challenge, and the Glivec case serves as a pivotal example in navigating these complex dynamics within the framework of patent law in India.
Tag: Issues relating to intellectual property rights.
Decoding the Question:
- In Intro try to define the patent system.
- In Body,
- Discuss about Indian Patent Act 1970 and explain Section 3 of the act.
- In the second part of the answer you need to discuss the Novartis VS Union of India case and explain how the Supreme court used section 3 of the act to strike down Novartis’ claim.
- Try to Conclude with WHO’s Public Health,Innovation and Intellectual Property Rights Report, 2006, with underlining significant of judgement for masses
Answer:
A patent system is a type of contract between the inventor/creator and authority whereby the creator gets exclusive rights for 20 years in return for disclosing full details of the invention. The main purpose of the patent system is to encourage innovation and eventually result in technological development.
Indian Scenario: The present Patents Act, 1970 came into force in the year 1972 and amended through the Patent (Amendment) Act 2005. The Amendment to the Act brought following changes:
- Section 3(d) was introduced and introduced pharmaceutical product patents in India.
- The Act 2005 defines what invention is and makes it clear that any existing knowledge or thing cannot be patented.
- The provision defines a ‘novelty’ standard – which, along with ‘non-obviousness’ or ‘inventive step’ and industrial applicability, are the three prerequisites for ‘patentability’.
- “Discovery” essentially refers to finding something which already existed in nature but was unknown or unrecognized.
The most recent case, Novartis AG v Union of India5 decided by the Supreme Court of India in 2013 where the case began in the year 1997 related to drug name GLIVEC which was slightly a different version of their 1993 patent for ANTI LEUKAEMIA drug. In this case the petitioner challenged the constitutionality of section 3(d) before the High Court at Madras.
The applicant in the present appeal contented on two issues:
- Section 3(d) of the Act is unconstitutional as it violates the provision of the TRIPS agreement.
- The Indian patent act doesn’t define the term ‘efficacy’ and provides unguided power on the Controller. Hence it is arbitrary, illogical and vague.
In response to the above contention the Court held that:
- The WTO’s Dispute Settlement provides the exclusive remedy and a comprehensive dispute mechanism for violation of TRIPS Agreement. The High Court looked into the conflict between the international law and municipal law and decided that municipal law prevails in such conflict.
Appraisal of the Decision:
- It was initially considered that such a case can affect the invention zeal in pharma companies and R&D will suffer. Also, clouds of unfavorable conditions for FDI in the pharma sector were expected.
- The provision under section 3(d) has been approved by WHO Public Health,Innovation and Intellectual Property Rights Report, 2006, that countries can adopt legislation and examination guidelines requiring a level of inventiveness that would prevent ever-greening patents from being granted.
- Further, Section 3(d) prevents frivolous patenting without neglecting valuable incremental innovations in pharmaceuticals and is very well compatible with TRIPS agreement.
The ruling of the Novartis’s case in Indian patent law represents a major victory for community’s access to inexpensive medicines in developing countries and influences the access of medicines to the poor.
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