Date : 14/12/2023

Relevance: GS Paper 2 - Social Justice - Health

Keywords: Pharmaceutical Patents, Novartis judgement, Indian Patent Act of 1970

Context-

In the intricate realm of pharmaceutical patents, where the balance between innovation and accessibility is paramount, the Madras High Court has recently delivered two noteworthy judgments shedding light on delineating the boundaries of patentability within the pharmaceutical sector.

Background:

• The Indian Patent Act of 1970, specifically Section 3, outlines the criteria for patent exclusions, acting as a sieve to determine the patentability of inventions.
• While the landmark Novartis judgement by the Supreme Court focused on enhanced therapeutic efficacy under section 3(d), other exclusions in the Act lacked clear interpretation from Indian courts.
• The clarity surrounding the scope of patent protection is crucial for all stakeholders involved in the pharmaceutical industry.
• It ensures that innovators, researchers, and even civil society groups are aware of the limitations and possibilities within patent law.

First Judgement: Novozymes vs Assistant Controller of Patents and Designs (Section 3(e)):

• The Madras High Court's analysis of Section 3(e), which excludes compositions amounting to a mere aggregation of their components, offers clarity on patent eligibility.
• The court asserts that known aggregates do not fall under this exclusion. It emphasizes that if individual ingredients independently meet patent requirements, their inclusion in a composition does not render it ineligible for patent protection.
• Crucially, the court demands evidence from patentees to substantiate that the composition is more than the sum of its parts, enhancing the precision of Section 3(e)'s scope.

Second Judgement: Hong Kong and Shanghai University vs Assistant Controller of Patents (Section 3(i)):

• The second case explores Section 3(i), excluding inventions related to processes for the treatment of humans or animals.
• The court's nuanced interpretation distinguishes between in vivo/invasive diagnoses and non-invasive diagnostic tests.
• It proposes evaluating claims in the context of the complete specification to determine if a process constitutes a diagnostic test.
• The judgement provides an illustrative example of a non-invasive prenatal disease test, clarifying that if a test can diagnose a disease, it is ineligible, irrespective of its definitiveness.

Recommendations by the Madras High Court:

• The Need for Bright-Line Rules: Considering the substantial costs involved in pharmaceutical research and development, establishing clear and consistent rules becomes imperative. Bright-line rules streamline decision-making processes at the Indian Patent Office, providing certainty and reducing the burden on the system. These rules are particularly crucial in patent infringement litigation, allowing inventors and pharmaceutical companies to navigate challenges with a clearer understanding of the scope of protection.
• Balancing Competing Interests: The Madras High Court's proactive approach also suggests legislative considerations for in vitro processes, coupled with compulsory licensing provisions. Acknowledging the delicate balance required in pharmaceutical and medical patents, the court advocates for a comprehensive approach that considers the socio-economic conditions of the nation. This dialogical function of the court becomes pivotal in situations where legislative and executive actions might fall short, underlining the judiciary's role in advancing public health interests.
• Opportunities for Judicial Interpretation: As India's patent law jurisprudence is still evolving, the courts have a unique opportunity to shape the interpretation of the Patents Act, 1970. The courts must take into account the socio-economic conditions of the country and recognize the far-reaching consequences of their decisions, particularly in the pharmaceutical and medical patent domain.

Benefits of the Decisions:

• Clear Guidelines for Patentability: The decisions establish specific guidelines for patenting, especially in the realms of pharmaceutical compositions (highlighted in the Novozymes case) and diagnostic processes (illustrated in the Hong Kong and Shanghai University case).
• Reduction in Legal Ambiguity: The precise interpretation of sections 3(e) and 3(i) minimizes ambiguity, facilitating more straightforward legal decisions concerning patent applications.
• Beneficial for Stakeholders: The clarity derived from these decisions is advantageous for various stakeholders, including inventors, pharmaceutical companies, and civil society groups. It provides a clear understanding of the limits of patentable inventions in the healthcare sector.

Conclusion

The recent judgments from the Madras High Court provide a significant contribution to the evolving landscape of pharmaceutical patent law in India. The emphasis on evidence-backed decisions, the nuanced interpretation of exclusions, and the call for legislative consideration demonstrate a holistic approach to balance the interests of innovators, the public, and the industry.
As India continues to grapple with the challenges of providing access to medicines while fostering innovation, these judicial insights play a pivotal role in shaping a robust and equitable patent framework.
The courts, by actively participating in the dialogue, have the potential to steer the trajectory of patent law in a direction that aligns with the nation's socio-economic goals and public health imperatives.

Source- The Hindu