Patent protection for combination/composition claims in India

A specific formulation or dosage form of an active/functional element either alone or with the essential compatible components and carriers for the intended use is usually defined in terms of the combination/composition claims. These claims are important in chemical, pharmaceutical and biotech sectors wherein the invention is usually related to preparing a formulation using a combination of multiple components. Product patents related to food and medicines were not patentable prior to 2005, only the process/method of their preparation was allowed. However, the inclusion of criteria of what is not patentable as suggested under Ayyangar committee report, 1959 under Clause 3(d) “a substance prepared or produced by a chemical process or intended for food or medicine other than a substance prepared or produced by any method or process of manufacture particularly described in the complete specification of the invention or by its obvious chemical equivalent”. The said clause enumerates that mere admixture by aggregation of the known properties of individual components will not be considered as patentable. When the patent statute 1970 came into force the committee’s recommendations were accepted and said clause adopted Section 3(e) of the Indian Patents Act. Generally, claims directed to compositions, combinations, and kits are evaluated under the said provision.

Patent protection for combination/composition claims in India by Pankaj Musyuni and Swati Gupta.