Guidelines for examination of patent applications inthe field of pharmaceuticals launched by CGPDTM

Controller General of Patents, Designs & Trade Marks launched “Guidelines for examination of patent applications in the field of Pharmaceuticals” after extensive consultation with stakeholders on 29th October 2014.

It is realized that pharmaceutical patenting in India is of utmost concern not only to the people of India, but also for the world community, as India has emerged as “the pharmacy of the world”. Therefore, there was a need to develop guidelines for examination of pharmaceutical patents, incorporating the analysis of the Courts decisions, with the objective that the guidelines would help improve the examination standard and would introduce harmonious practice amongst the technical Officers of the system.

The guidelines are supplemental to the practices and procedures 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 these will help the Examiners and the Controllers of the Patent Office in achieving uniform standards of patent examination and grant.

The guidelines also contain, where feasible, certain illustrations. These illustrations, however, are not intended to exhaust the manner in which the relevant guidelines are to be applied in practice and the Examiners are requested to examine applications on a case-to-case basis, without being prejudiced by the specific illustrations provided in the Guidelines. The Guidelines are mandated to be dynamic and Patent Office will update the same with time.

The guidelines provide with a detailed description of the provisions covered by it and also highlight as to how the claims in case of pharmaceutical patent applications are to be drafted with the help of illustrations.