GUIDELINES FOR EXAMINATION OF PATENT APPLICATIONS IN THE FIELD OF PHARMACEUTICALS

Controller General of Patents, Designs & Trade Marks publishes "GUIDELINES FOR EXAMINATION OF PATENT APPLICATIONS IN THE FIELD OF PHARMACEUTICALS ". The present guidelines are prepared with the objective that  the Guidelines will 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  there under, the provisions of the Act and Rules will prevail.

The following sections of the Patents Act, 1970 are emphasized in the context of  examination of applications in pharmaceuticals and allied fields: 

a. Section 2 (1) (j): Novelty, inventive step & industrial applicability of products or 

processes, 

b. Section 3 specifies that the following are not patentable inventions within the  meaning of the Act: 

        (i) Section 3 (b): Inventions contrary to morality or which cause serious  prejudice to human, animal or plant life or health or environment,  

         (ii) Section 3  (c): Discovery of any living thing or non-living substance occurring  in nature, 

        (iii) Section 3 (d): Mere discovery of new form of known substance which does  not result in enhancement of known efficacy or mere discovery of any new  property or new use for a known substance, 

         (iv) Section 3 (e): Mere admixture resulting only in aggregation of the properties 

of the components thereof or a process for producing such admixture, 

          (v) Section 3 (i): Method of treatment and diagnosis, 

      (vi) Section 3 (p): An invention which in effect is traditional knowledge or which is  an aggregation or duplication of known properties of traditionally known  component or components, 

c. Section 10 (4): Sufficiency of disclosure, the best method of performing the 

invention and claims defining the scope of invention, and 

d. Section 10 (5): Unity of invention and clarity, succinctness and support of the claims.
Apart from this the guidelines cover Claims of Pharmaceutical Inventions and prior art search .

Find the guidelines here:-

http://www.ipindia.nic.in/iponew/Guidelines_Pharma_PatentApplication_28February2014.pdf