India: Revisions to Guidelines for examination of pharmaceutical patent applications under way

The Indian Patent Office is currently revising the "Draft Guidelines for the Examination of Patent Applications in the Field of Pharmaceuticals". According to a news release published on 20 March 2014, interested parties had an opportunity to submit their comments on the "Draft Guidelines for the Examination of Patent Applications in the Field of Pharmaceuticals" by 4 April 2014. These guidelines serve as complementary material to the Patents Acts, 1970, the Patent Rules, the "Manual of Patent Office Practice", "Guidelines For Examination of Biotechnology Applications" and "Guidelines For Processing of Patent Applications Relating to Traditional Knowledge and Biological Material".

The guidelines focus on the following sections of the Patents Act, 1970 from the perspective of the pharmaceutical applications:

  • Section 2 (1) (j): Novelty, inventive step & industrial applicability of products or processes,
  • Section 3 specifies that the following are not patentable inventions within the meaning of the Act:
    • Section 3 (b): Inventions contrary to morality or which cause serious prejudice to human, animal or plant life or health or environment,
    • Section 3 (c): Discovery of any living thing or non-living substance occurring in nature,
    • Section 3 (d): Mere discovery of new form of known substance which does not result in enhancement of known efficacy or mere discovery of any new property or new use for a known substance,
    • Section 3 (e): Mere admixture resulting only in aggregation of the properties of the components thereof or a process for producing such admixture,
    • Section 3 (i): Method of treatment and diagnosis,
    • Section 3 (p): An invention which in effect is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components,
  • Section 10 (4): Sufficiency of disclosure, the best method of performing the invention and claims defining the scope of invention, and
  • Section 10 (5): Unity of invention and clarity, succinctness and support of the claims.

The complete draft version of the guidelines and all other related legal documents can be found on the Indian Patent Office's website.

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