The Indian Patent Office has, on 28-2-2014, issued draft guidelines for examination of patent applications in the field of pharmaceuticals. Comments from the public have been invited by 21st March, 2014. These guidelines are intended to assist Examiners and Controllers of the Patent Office in achieving uniform standards of patent examination in the pharma sector. Perhaps recognizing lack of statutory basis, the draft guidelines clearly state that in case of any conflict with the Patents Act, 1970 and the rules the provisions of the Act and rules would prevail.
As the name suggests, focus of these draft guidelines is essentially on the assessment of novelty, inventive step and industrial applicability in relation to products and processes in the field of pharmaceuticals. The guidelines also include discussion on non-patentable subject-matter. Most sections of the guidelines are explained by means of illustrative examples. There is also some assistance in terms of assessing sufficiency of disclosure and unity of invention.