Madras HC decision on Section 3 of the Indian Patent Act- Patent exclusions

Source: The post Madras HC decision on Section 3 of the Indian Patent Act has been created on the article “Patent exclusions” published in The Hindu on 13th December 2023.

UPSC Syllabus Topic: GS Paper 3- Indian Economy- Trade (patent issue)

News: This article discusses two recent court decisions in India about what can and cannot be patented in the pharmaceutical field. These decisions help clarify the rules for patenting medicines and processes, which are important for balancing innovation, accessibility, and public health interests.

Background

Section 3 of the Indian Patent Act, 1970 outlines what cannot be patented, serving as a filter for determining an invention’s patentability. Notably, the Supreme Court of India’s landmark Novartis judgment addressed an exclusion under section 3(d), focusing on the need for enhanced therapeutic efficacy in patents. However, Indian courts have not yet provided clear guidelines for interpreting other exclusions in the Act.

In this context, two recent judgments by Justice Senthilkumar Ramamoorthy of the Madras High Court have shed light on these issues, significantly contributing to the discussion of pharmaceutical patent law in India.

What are the recent decisions of the Madras High Court in Indian pharmaceutical patent law?

Novozymes vs Assistant Controller of Patents and Designs (Section 3(e) of the Indian patent Act, 1970):

Case Focus: This case examined whether a composition that is simply an aggregation of known components can be patented.

Court’s Decision: The Madras High Court ruled that such compositions can indeed be patented if any of their individual ingredients independently meet the patent eligibility criteria.

Hong Kong and Shanghai University vs Assistant Controller of Patents (Section 3(i)of the Indian patent Act, 1970):

Case Focus: This case dealt with the patentability of processes used for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic, or other treatments of humans or animals.

Court’s Decision: The court clarified that not all processes in these categories are excluded from patentability. Specifically, a process is not patentable if it directly diagnoses or treats a disease. However, if a process is involved in such treatments or diagnostics but does not itself directly diagnose or treat a disease, it may be patentable.

What are the benefits of these decisions?

Clear Guidelines for Patentability: The decisions provide specific guidelines on what can be patented, particularly regarding pharmaceutical compositions (as seen in the Novozymes case) and diagnostic processes (illustrated in the Hong Kong and Shanghai University case).

Reduction in Legal Ambiguity: The clear interpretation of sections 3(e) and 3(i) reduces ambiguity, aiding in more straightforward legal decisions regarding patent applications.

Beneficial for Stakeholders: The clarity from these decisions assists various stakeholders, including inventors, pharmaceutical companies, and civil society groups, by delineating the boundaries of patentable inventions in healthcare.

What should be done?

According to Madras HC suggestions:

Develop Bright-Line Rules- Implement clear, straightforward rules for patentability, to aid consistent decision-making.

Simplify the patent office’s decision process to reduce the burden of lengthy patent prosecution.

Ensure patent laws balance pharmaceutical innovation with public health needs and medicine accessibility

Judicial Contribution in Legislative Gaps- Encourage judiciary roles, like that of the Madras High Court, in suggesting legislative changes for areas not adequately covered by existing laws.

Question for practice:

Discuss the recent decisions of the Madras High Court in Indian pharmaceutical patent law and their implications for patentability in the pharmaceutical field.