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13th December 2023 (8 Topics)

Patent exclusions

Context

Courts dealing with pharmaceutical and medical patents must be mindful of the conflicting interests involved and strive to establish a robust equilibrium.

Challenges in Pharmaceutical Patents

  • Clarity of Scope: There is a need for clarity in defining the boundaries of patent protection in pharmaceuticals to balance innovation and accessibility.
  • Exclusions under Section 3: There is extreme significance of Section 3 of the Patents Act, focusing on exclusions that impact patentability.
  • Judicial Gap: There are lack of bright-line rules in Indian courts regarding patent exclusions, except for the notable Novartis judgment on Section 3(d).

Recent Judicial Perspectives

  • Section 3(e) Clarification: Summarizes the Madras High Court's ruling on Section 3(e), stating that known aggregates aren't excluded from patent protection.
  • Section 3(i) Interpretation: Examines the court's view on Section 3(i), excluding certain medical processes, and the nuanced approach based on claims and specifications.
  • Evidentiary Standards: Acknowledges the court's insistence on evidence to prove composition synergies, enhancing clarity on Section 3(e).

Imperative for Clear Rules

  • R&D Challenges: Stresses high R&D costs, advocating for clear rules to ensure consistent and certain decision-making.
  • Administrative Efficiency: Argues that clear rules simplify the patent office's processes, benefiting inventors, companies, and civil society groups.
  • Balancing Interests: Recognizes the importance of balancing competing interests and suggests potential legislative adjustments in pharmaceutical patent law.
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