Indian Patent Act and Pharmaceutical substances patenting in india
The patenting system in india is governed by Patent act 1970 and the latest amendment was implemented on April 2005. The Patent system is administrated under department of industrial policy and promotion ministry, Ministry of commerce and industry, and there are four patent offices in india, which are located respectively at Delhi, kolkatta, mumbai and chennai, headed by the Controller General of Patents, Designs and Trade Marks.
The latest Amendment enabled Patent Act to grand Product patent for Pharmaceutical substances and brought deletion of exclusive marketing rights from the act.
Important and Intresting parts of Patent Act:
1) Oppositions (Pre & Post Grant)
2) Section 3(d) & 3(e)- Specific to Pharmaceutical substances and Other Not patentable inventions
3) Compulsory Licenses
4) Parallel Imports
1) Opposition proceedings:
As Opposition proceedings have importance in Patenting system, Patent Act 1970 has two different opposition proceedings which are Pre-grant opposition and Post-grant opposition.
Features of Opposition proceedings changes country to country, section 25 (1) & (2) deals pre as well as post grant oppositions and grounds of opposition. Pre-grant opposition is to avoid grant of patent rights to invention which will not qualify as a patentable invention under S.25(1) and Post-grant opposition is to either revoke or amend the patent claims which are already granted to not patentable inventions under S.25(2).
2) Section 3(d) & 3(e):
Patent Act explains on various inventions which are not qualified as patentable under Section 3 and 4 of Patent Act 1970. S. 3(d) & 3(e) are very specifically excludes pharmaceutical substances which are not patentable under this act.
S. 3(d) says “…the mere discovery of any new property of new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant..“
S. 3(e) says “…a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance..“. These two sections are major obstacles for new forms (salts, polymorphs, solvates.. etc) of pharmaceutical drugs substances, unless until patentee shows imporved effectiveness over existing product.
3) Compulsory Licensing:
Compulsory Licensing is the provision exists in various countries patent systems, which enable other person to work, use, supply of patentable invention, when it was not worked in territory or not available to public, under reasonable terms and conditions.
Patent rights generally prevents others from use or working of patentable invention, this compulsory licensing avoids exploitation of patent rights by patentee.
Patent Act 1970 deals grounds of compulsory licensing under S.84 and S.92A enables to grant compulsory license to export pharmaceutical substances to any country which does not have proper infrastructures to manufacture and bring remedy to countries need.
4) Parllel Imports:
Section 107A explains on certain acts which will not be considered as act of infringement provided that such imports were from an exporter who is dualy authorized under law.
2(j): Invention:means a new product or process involving an inventive an inventive step and capable of industrial application.
2(ja): inventive step: means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obivious to person skilled in the art.
2(i): New Invention: means any invention or technology which has not been anticipated by publication in any document or used in the country or elasewhere in the world before the date of filing of patent application with complete specification, i.e., the subject matter has not fallen in public domain or that it does not form part of the state of the art.