The Indian Patent Controller has released the revised “draft guidelines for examination of patent applications in the field of pharmaceuticals” which will help the examiners and the controllers of the patent office in achieving consistently uniform standards of patent examination and grant of patents.

On Section 3(d) of the Patent Act, the revised guidelines explains that 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 are not patentable inventions within the meaning of the Act.

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.

On Section 3(b), the guidelines explain that 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 inventions within the meaning of the Act. On Section 3(c), it explains that 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 inventions within the meaning of the Act.

The guidelines further explains that "invention" means a new product or process involving an inventive step and capable of industrial application, and an "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.

These 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”.

These guidelines are prepared to 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.