After several rounds of discussions with the stakeholders, the Controller General of Patents, Designs and Trademarks (CGPDTM) has finally issued the “Guidelines for examination of patent applications in the field of pharmaceuticals”, which are aimed to standardise and bring about uniformity in the examination of pharmaceutical patent applications in the country.

The guidelines are supplemental to the practices and procedures followed by the Patent Office as published in the ‘Manual of Patent Office Practice and Procedure’, “Guidelines For Examination of Biotechnology Applications” and the “Guidelines For Processing of Patent Applications Relating to Traditional Knowledge and Biological Material”.

The present guidelines are prepared with the objective that the Guidelines will help the Examiners and the Controllers of the Patent Office in achieving consistently uniform standards of patent examination and grant.   In case of any conflict between these Guidelines and the Patents Act, 1970 and the Rules made thereunder, the provisions of the Act and Rules will prevail.

On the controversial issue of Section 3 (d) of Indian Patent Act, the guidelines state that it is not patentable “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant”.

It further explains that for the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

As per the guidelines, an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment is not patentable. Further, the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature is also not patentable as per the guidelines.

The guidelines further states that a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is also not patentable. Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process  for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products is not patentable as per the guidelines.