To comply with its TRIPS obligation to grant product patents for agrochemicals and pharmaceuticals, India has enacted the Patents Amendment Ordinance 2005 which came into effect on January 1,2005. Apropos, this ordinance, “Invention” is any new process o product, which involves an inventive step and is capable of industrial application.
Product patents are now available in all categories – pharmaceuticals. Agrochemicals. Food, alloys, chemicals, optical glass, microorganisms etc. Although novelty-new invention is “ any invention or technology which has not been anticipated by publication in any document or used in the country or else here in the world before the date of filing of the patent application with complete specification” Prior publication or prior use any where in the world could destroy novelty of an invention. The inventive step- is a feature of an invention that involves technical advances as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.
What are the changes to the patent law-
The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance
The mere discovery of any new property or new use for a known substance and the mere use of a known process machine or apparatus- unless such process results in a new product or employs at least one new reactant “ is not paten table.
New form of a known substance having no therapeutic efficacy is not paten table. This means that salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances will be considered the same substance unless they differ significantly in properties with regard to efficacy. With the old law, mathematical methods, business method or a computer program per se or algorithm were not paten table.
The new ordinance allows, hardware, software in combination with hardware are paten table. However, soft ware per se and business methods are not paten table. There is requirement for Indian resident to obtain foreign filing permit for filing outside of India unless 6 weeks have passed since the filing of a corresponding Indian application.
Additional fees are applicable to more than 10 claims. The no. of pages of the specifications should preferably be 30. Examination of complete specification may be done 36 months from the date or filing from the earliest priority date whichever is earlier. Currently, 12 months after date of examination report to place application in condition for grant – must file a first response with in 4 months of the date of the action. The new provision- 6 months to obtain grant after issuance of examination report (3 months extension is available).
There is an obligation to advice the controller as to the status of foreign applications and the supply prosecution details (if requested) has been extended from the acceptance date up to the date of grant. It is the duty of the patentee to supply list of prior art cited in corresponding applications.
Priority may be claimed from applications file at the EPO, ARIPO or other organizations that are parties to a regional international or bilateral treaty or arrangement to which India is also a party.
A working statement must be filed every year. The working requirement can b met by importation. There is a penalty for no filing a working statement reflecting the working of the invention in India has been increased from about 500 USD to 23,000 USD. Permitted importation of patented product form a person who is authorized by the patentee or who is duly authorized under law to produce and sell or distribute the product.
There is a possibility that more compulsory license will be granted in the future, especially in the pharmaceutical field. Opposition are possible both pre- and post -grant of the patent. Pre-grant oppositions – challenge grant based on lack of novelty, inventive step, wrongful obtainment, and anticipation by traditional knowledge etc. Post-grant opposition – to be filed within one year from the date of grant also on the same grounds as the pre-grant opposition.
Using, making, selling or importation of a patented product is an act of infringement. Importation of a product made by a patented process is also an infringement. Importation, use or sale of a patented product for purposes of obtaining date which is to b submitted to any regulatory authority is exempted and is not an infringement act.
Shruti U. Bhat