The term EMR means the exclusive marketing rights to sell or distribute the article or substance coverered in a patent or patent application in the country. The purpose of EMRs is to ensure that the innovator can market free copies of his product.
To comply with the requirements of TRIPS, pending the transition to a full-fledged product patent regime, provisions relating to exclusive marketing rights in the areas of drugs and agro chemical products were incorporated in the Patents Act, 1970 with cut of date from January 1, 1995. Chapter IVA incorporated the relevant provisions. Section 24 of the Act stipulates that India has to receive applications for patents containing claims for drugs and agro chemical products with the condition that such applications can be taken up for consideration of granting EMR if an application is made.
The application for the grant of an EMR can be made for an invention relating to an article or substance intended for use or capable of being used as a drug or medicine, developed after 1.1.2005, which has been claimed in a Black Box application. The Act specifically debars grant of EMR to substance based on traditional system of medicine. Upon getting the EMR, the applicant has the exclusive right to sell or distribute the product of the invention for a period of five years from the date of grant or till the date of grant or rejection of the application for patent, whichever is earlier. The corresponding patent application would be taken up for examination after 1.1.2005, which is the time provided to India to bring a product patent regime in all the fields of science and technology.
Hitherto, four EMRs were granted by the Patent Office:
· Novartis AG for blood anti-cancer medicine, Glivec/Gleevec (beta crystalline form of imatinib mesylate)
· Eli Lilly & Company, USA for erectile dysfunction medicine, Cialis (Tadalafil)
· Wockhardt for ‘Nadifloxacin’ under the brand name NADOXIN
· United Phosphorus for ‘fungicide saaf, a combination of carbendazim and mancozeb’
India has entered in the full fledged product patent regime on 1.1.2005 as per Article 65 of TRIPS agreement. In view of extension of product patent to drugs and food products provisions relating to exclusive marketing rights have been abolished by omitting chapter IVA from the Patents Act. The EMRs granted before 1.1.2005 will continue to enjoy the same terms and conditions on which it was granted.