Sunday, April 28, 2019

Indian Patent - Exclusive Marketing Rights (EMR)

The term EMR refers to the exclusive sale of the goods or substances covered in the sale or distribution of patents or patent applications in that country. The purpose of EMR is to ensure that innovators can sell free copies of their products.

In order to comply with the requirements of TRIPS, prior to the transition to the complete product patent regulations, the provisions on exclusive sales rights in the pharmaceutical and agrochemical sectors have been incorporated into the 1970 Patent Law, which has been reduced since January 1, 1995. Chapters IVA incorporate relevant provisions. Article 24 of the Act stipulates that India must receive a patent application for a claim containing drugs and agrochemicals, provided that the application is considered for approval of the EMR.

The application for granting an EMR can be made for an invention relating to an article or substance intended to be used or capable of being used as a drug or drug developed after January 1, 2005, which is claimed in the Black Box application. The Act specifically prohibits the granting of EMR substances based on traditional medical systems. Upon obtaining an EMR, the Applicant has the exclusive right to sell or distribute the Product of the Invention within five years from the date of grant to the date of grant or refusal of the patent application, whichever is earlier. The corresponding patent application will be reviewed after January 1, 2005, which is the time for India to provide product patents for all scientific and technical fields.

To date, the Patent Office has approved four EMRs:

· Novartis AG for blood anticancer drugs, Glivec / Gleevec [beta crystalline form of imatinib mesylate]

· Eli Lilly & Company, a US drug for the treatment of erectile dysfunction, Cialis [Tadalafil]

·Wockhardt is 'Nadifloxacin' under the NADOXIN brand name

·Combined phosphorus for the combination of fungicide saaf, carbendazim and mancozeb '

According to Article 65 of the TRIPS Agreement, India entered the comprehensive product patent system on January 1, 2005. In view of the extension of product patents to pharmaceuticals and foods, the provisions relating to patent sales rights have been abolished, omitting Chapter IVA of the Patent Law. EMR granted prior to January 1, 2005 will continue to enjoy the same terms and conditions as it was awarded.





Orignal From: Indian Patent - Exclusive Marketing Rights (EMR)

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