GNA Patent Gurukul has submitted the required revisions to the guidelines for processing of Patent Application relating to Traditional Knowledge to the Controller General of Patents: Design and Trademarks (CGPDTM).

The revisions to the guidelines came out of a brainstorming session organised recently. The draft of guidelines for patenting traditional knowledge and biological materials was issued on November 8, 2012 by the CGPDTM and the industry was asked to comment for the required changes.

These included grant of patents for processes that demonstrate improvements. For example, better extraction processes, better dosage forms, stable formulations and better tastes or aromas not known or reported in traditional knowledge.

Patents for processes which can give plants or cultivars which give higher yield of either the vegetations per se, foliage or specific compounds present in the biological material or herbs.

The panel of experts represented by Dr GopaKumar G Nair, head GNA Patent Gurukul, DBA Narayana, member Indian Pharmacopoeia Commission (IPC) along with the Pravin Gandhi College of Law and Indian Drug Manufacturers Association (IDMA) had officials from pharma and Ayurveda companies like Charak, Emcure, Indoco, GNA, IPCA and Piramal among others who called for processes that involved biotechnological interventions, improve bioavailability of herbs, synergy of activity which provides improved efficacy or increased safety.

Processes for standardization, fractionation, isolation were also required to be patented. This is because while processes of fractionation and or isolation of compounds identified are easily understandable and the process of standardization is really an inventive step in certain cases. Mere development of an analytical or measurement method for one or more phyto-compounds from a biological material or herb does not meet the inventive step criteria. For instance, determination of gallic acid in fruits. However disclosures of specific processes that identifies a bioactive compound or a set of bioactive compounds or such compounds to be  present in specific rations etc., or compounds that may be produced due to improper processing leading to unsafe compounds and development of analytical methods to analyse these would need to be protected, pointed out the panel.

In the case of patents for products, the panel called for grant of the same for formulations that are novel and inventive. Novel combinations involving selection of specific ingredients, specific proportions and specifically processed materials need to be considered for grant of patents.

Patents should also be granted for products standardized in a novel way to provide specific quality including ratio of components and bioactive compounds. In addition it should also be granted for uniquely delivered special packaging or delivery apparatus or devices for ophthalmic preparations. It should also be granted for a combination of processes and compositions.