Daily Current Affairs : 14-December-2023

In recent legal developments, Justice Senthilkumar Ramamoorthy of the Madras High Court has delivered judgments that have sparked concerns regarding exclusions to patentability in pharmaceutical and medical patents under Section 3 of the Patents Act, 1970, in India. Two noteworthy cases, Novozymes vs Assistant Controller of Patents and Designs, and Hong Kong and Shanghai University vs Assistant Controller of Patents, shed light on critical issues surrounding patent eligibility.

Novozymes vs Assistant Controller of Patents and Designs

Section 3(e) – Exclusion of mere aggregations

  • Known aggregates can be patent-eligible if individual components meet patent criteria.
  • Evidence is required to demonstrate synergistic properties for patent eligibility.

The Novozymes case highlights the nuanced approach required when dealing with aggregations in patents. It underscores that even known aggregates can be considered for patent protection if they exhibit synergistic properties meeting patent criteria. This challenges the notion that mere aggregations are categorically excluded from patentability.

Hong Kong and Shanghai University vs Assistant Controller of Patents

Section 3(i) – Exclusion of medical treatment processes

  • Exclusion extends beyond in vivo/invasive diagnoses.
  • Encompasses processes for disease diagnosis, emphasizing a broad scope.

This case expands the understanding of Section 3(i) exclusions, asserting that it goes beyond in vivo or invasive diagnostic methods. It includes processes related to disease diagnosis, broadening the scope of exclusions in medical treatment processes.

Emphasis on Clear Rules for Consistency

The judgments underscore the necessity of clear, bright-line rules in patent law. The call for clarity is motivated by the aim to ensure consistency, certainty, and efficiency in decision-making by the Indian Patent Office. Establishing transparent guidelines becomes crucial to navigating the complexities of patent eligibility, fostering a robust and predictable environment for innovation in the pharmaceutical and medical sectors.

Important Points:
  • Novozymes vs Assistant Controller of Patents and Designs:
    • Section 3(e) – Exclusion of mere aggregations
      • Known aggregates can be patent-eligible if individual components meet patent criteria.
      • Evidence is required to demonstrate synergistic properties for patent eligibility.
      • Challenges the notion that mere aggregations are categorically excluded from patentability.
  • Hong Kong and Shanghai University vs Assistant Controller of Patents:
    • Section 3(i) – Exclusion of medical treatment processes
      • Exclusion extends beyond in vivo/invasive diagnoses.
      • Encompasses processes for disease diagnosis, emphasizing a broad scope.
      • Expands the understanding of Section 3(i) exclusions in medical treatment processes.
  • Emphasis on Clear Rules for Consistency:
    • The judgments highlight the necessity of clear, bright-line rules in patent law.
    • Clear guidelines are crucial for consistency, certainty, and efficiency in decision-making by the Indian Patent Office.
    • Aiming to create a robust and predictable environment for innovation in the pharmaceutical and medical sectors.
Why In News

The recent judgments from Justice Senthilkumar Ramamoorthy of the Madras High Court raised concerns regarding exclusions to patentability in pharmaceutical and medical patents under Section 3 of the Patents Act, 1970, in India, emphasizing the need for a nuanced approach to balance innovation and public health interests in this critical sector.

MCQs about Patent Eligibility in India

  1. What did the Novozymes vs Assistant Controller of Patents and Designs case emphasize regarding aggregations in patents?
    A. Aggregations are always excluded from patentability.
    B. Known aggregates can be patent-eligible if individual components meet patent criteria.
    C. Aggregations can only be patented if they are entirely novel.
    D. Evidence of synergistic properties is not required for patent eligibility.
    Correct Answer: B. Known aggregates can be patent-eligible if individual components meet patent criteria.
    Explanation: The Novozymes case highlighted that known aggregates can be considered for patent protection if individual components meet patent criteria, and evidence is required to demonstrate synergistic properties.
  2. According to the Hong Kong and Shanghai University vs Assistant Controller of Patents case, what is the scope of exclusion under Section 3(i) regarding medical treatment processes?
    A. Limited to in vivo and invasive diagnoses.
    B. Excludes only surgical procedures.
    C. Broadly includes processes for disease diagnosis.
    D. Exclusion is not clearly defined.
    Correct Answer: C. Broadly includes processes for disease diagnosis.
    Explanation: The case broadens the understanding of Section 3(i) exclusions, asserting that it goes beyond in vivo or invasive diagnostic methods, encompassing processes related to disease diagnosis.
  3. According to the recent judgments discussed in the essay, why is there an emphasis on clear, bright-line rules in patent law?
    A. To make patent regulations more complex and exclusive.
    B. To provide a lenient approach to patent eligibility.
    C. To ensure consistency, certainty, and efficiency in decision-making.
    D. To discourage innovation in the pharmaceutical sector.
    Correct Answer: C. To ensure consistency, certainty, and efficiency in decision-making.
    Explanation: The essay emphasizes the need for clear rules in patent law to ensure consistency, certainty, and efficiency in decision-making by the Indian Patent Office, fostering a robust and predictable environment for innovation.

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