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RAS question

Section 3(d) of Indian Patent Act is significant because it:

Correct answer: (C) Prevents 'evergreening' of pharmaceutical patents by requiring enhanced efficacy.

Section 3(d) of the Indian Patents Act prevents evergreening of pharmaceutical patents by denying patentability to new forms of known substances unless they show enhanced efficacy.

  1. (A)

    Bans all drug patents

  2. (B)

    Allows all patents

  3. (C)

    Prevents 'evergreening' of pharmaceutical patents by requiring enhanced efficacy

  4. (D)

    Only applies to IT patents

Explanation

Section 3(d) sits in Chapter II of the Patents Act, under inventions that are not patentable. It says the mere discovery of a new form of a known substance is not an invention if it does not enhance the known efficacy of that substance. The explanation to the clause treats salts, esters, polymorphs, isomers, complexes, combinations and similar derivatives as the same substance unless they differ significantly in efficacy. That is why the provision is central to anti-evergreening in medicines: a modified version of an existing drug cannot receive a fresh patent merely because its form has changed. This principle was applied in Novartis v. Union of India (2013), where the Glivec patent claim failed, reinforcing affordable access to generic medicines.

Why the other options are wrong

  • (A) Section 3(d) does not ban all drug patents; it targets new forms of known substances that fail the enhanced-efficacy test.
  • (B) It cannot be read as allowing all patents because it appears under inventions not patentable and expressly excludes certain claims from patentability.
  • (D) The clause is about known substances, their derivatives and efficacy, not a rule confined to IT or computer-related patents.

Concept

This tests intellectual property rights in science and technology, especially the balance between innovation incentives and public health. It recurs in RAS because Section 3(d) links patent law, access to medicines and landmark Indian judicial interpretation.

Source

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