The Government of India brought out the Patents (Amendment) Ordinance, 2004 to take care of issues relating to the patent in the country. This Ordinance was replaced by the Indian Patent (Amendment) Act, 2005. India is under the obligation of introducing patent protection in new technologies, chemicals, and pharmaceuticals under the TRIPS agreement of the WTO with effect from 1.1.2005. The new Act introduced some important changes on the legal regime of patent protection so as to address patent issues in technology, chemicals and pharmaceuticals sectors. Some key changes brought about by the Act of 2005 are mentioned below:
Salient Features of the Patent (Amendment) Act, 2005
- In the definition of what are not inventions, the amendment now says “Mere new use or a known substance” is not an invention. In other words, if the applicant can substantiate that it is a new use for a known substance with some technical input such new use can be patented.
- A computer program per se is not patentable but its “technical application to industry or a combination with hardware” is patentable. The scope of patentability of a computer program has now been widened and is more or less on lines with US Patent grant.
- The provision prohibiting product patent for food, medicine, drug and chemical processes has been removed. In India with effect from 1st January 2005 product patent is available for medicine, drug, chemical processes and food. This is the most important amendment introduced by the new Ordinance. Product patent regime in respect of drug, medicine, food and chemical processes is implemented in India.
- If a patent application is accompanied by a provisional specification, the complete specification should be filed within 12 months of the filing of the application. Otherwise, the application shall be deemed to be abandoned.
- A patent application shall be examined only on a request in a prescribed manner. Without a request, the patent applications would not be examined as a matter of routine, as it was prior to the year 2003.
- Provisions relating to Exclusive Marketing Rights (EMR) have been removed. EMR provision was introduced in India in the year 1999 in compliance with TRIPS as product patent for drug and medicine was not available in the Indian Act. As product patents can now be granted for Drugs, medicines, food, and chemical processes the EMR provision has become redundant and has been repealed.
- When a patent has been published but has not been granted, any person can make a representation to the Controller of Patents requesting him to refuse the application on the ground of lack of novelty, inventive steps, and industrial applicability. The Controller shall consider such representation and dispose it off. The person making the representation is not a party to the proceeding. After the grant of a patent but before the expiry of the period of one year from the date of publication of grant of a patent, any person interested may give notice of opposition to the Controller.
- Only after the grant of the patent the application, specification and documents related thereto are opened for public inspection.
- The Act now provides for the compulsory license for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems provided compulsory license has been granted by such country. To avail of this provision, the applicant should satisfy two conditions:
- The country to which export has to be made has insufficient or no facility to manufacture.
- The recipient country should grant the compulsory license for the import and sale of the drug
- The Act also provides for an appeal from the order of decision of the Controller to Intellectual Property Appellate Board (IPAB). The power of revocation is also conferred with IPAB.