Patent Office publishes final version of Guidelines for Examination of Biotechnology Applications for Patents

Image from here.

The Patent Office has published the final version of the “Guidelines for Examination of Biotechnology Applications for Patents”, accessible over here, dated March 25, 2013. The draft version of these guidelines was published initially in December, 2012 and made available for public comment on the Patent Office website. The public comments received by the Patent Office, most of which were negative, were published on the patent office website and I’m told that the Patent Office did organize a meeting with the important stake-holders. 

It is most important to note that in the final version of the guidelines, the Patent Office has itself conceded that it has no rule-making authority and that these guidelines do not have the force of law. The pertinent statement on page 1 reads as follows “However, these guidelines do not constitute rule making. In case of any conflict between these guidelines and the provisions of the Patents Act, 1970 and the Patents Rules, 2003, the said provisions of Act and Rules will prevail over these guidelines. The guidelines are subject to revision from time to time based on interpretations by a Court of Law, statutory amendments and valuable inputs from the stakeholders.” This is a vital point, which we had pointed out in our first post on the issue in December. The Controller General should clarify in adequate detail to his staff that any objection to a biotech patent will have to be based on the Patent Act and judicial precedents. If the Patent Office rejects a biotech patent application citing these guidelines as the controlling authority, the IPAB will most certainly reverse such an order since the guidelines do not have the force of the law. Controllers may thus cite only the reasoning contained in the guidelines provided that such reasoning itself is based on the Patent Act or judicial precedents.