Indian Patent Act
To understand the significance of the changes, it is worthwhile to review the history of the Indian Patent Act. The Indian Patent Act was created in 1970 and on the one hand was implemented to encourage innovation by protecting proprietary research and development.
This philosophy, however, was at odds with Indias desire (dare it be said necessity) to encourage and allow access to foreign technologies (e.g., pharmaceuticals) to Indian society that otherwise might be unavailable to its people due to cost and pricing structures under a proprietary intellectual property protection system.
Thus, to bridge this gap, patents were only issued for methods of producing products (also referred to as compositions of matter), but not for the products themselves (i.e., pharmaceuticals). This allowed one to commercialize a drug that was a proprietary product of another as long as ones own method of producing that product was used.
Furthermore, the patent term of an Indian patent for chemicals, food, and drugs was seven years; far short of the WTO mandated 20-year term from application filing date. Finally, imported products were not themselves protected, only the means of producing that product.
The cornerstone of the Act is the recognition of product (or composition of matter) patents for chemicals (including drugs), and provision of a 20-year term from the filing date of such applications. This includes so-called mail-box applications. Mail-box applications are product patent applications that were filed with the Indian Patent Office from 1995 to present, but were held in limbo (and unexamined) pending resolution of policies and laws regarding treatment of these product patents.
The infrastructure and timing issues to deal with the sudden flood of processing of about ten years worth of applications is a further point of contention and current debate.
In regard to known substances, the Act addresses a number of aspects. New uses of a known substance are not patentable. It is possible, however, that position might change in the future. New dosage forms are patentable as long as an unexpected or surprising result is established.
The Act also defines a pharmaceutical substance as a new entity involving one or more inventive steps. To be patentable, however, the pharmaceutical substance must demonstrate a synergistic effect, and not simply be an admixture where efficacy is merely that based on the individual ingredients independently.
Finally, the Act provides that derivatives, esters, salts, particle size, metabolites, polymorphs, isomers, complexes, combinations, and other derivatives of a known substance would be considered the same substance absent a showing of enhanced therapeutic efficacy.
More particularly to biotechnology, vectors, sequences, plasmids, and the like could be patentable under the revised laws, provided that a demonstration of industrial application is shown. Method of treatment of animals or humans are not patentable, while methods of treatment of plants are patentable. Diagnostic procedures, particularly those involving in vivo analysis, are not patentable.
From an enforcement standpoint, importation of a patented product or a product made by a patented process is now considered as infringing activity under the Act. It is noteworthy, however, that the import, use, or sale of a patented product for the purpose of obtaining data intended to be submitted to any regulatory authority is exempted from classification as an infringing act.