What's New :
IAS Mains 2024: Complete (GS & Optional) Syllabus Revision & Updation. Get Details
13th December 2023 (8 Topics)

Patent exclusions


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.
You must be logged in to get greater insights.

Verifying, please be patient.

Enquire Now