E-DRUG: Status of triple combination ARVs under Indian Act
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Dear colleagues
Very important triple combination ARV tablets have been produced by several Indian generic companies.
One example is
stavudine / lamivudine / nevirapine
The patents on these 3 individual drugs expire 2007/ 2009/ 2010 respectively.
Please could someone clarify the impact of the new Indian Patent
legislation concerning production and export of this and other similar
products.
Is my understanding correct - that they can continue producing and exporting products they already produce, so long as they pay an appropriate royalty?
Thank you very much
Beverley
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Beverley Snell
Centre for International Health
Macfarlane Burnet Institute for Medical Research & Public Health
GPO Box 2284, Melbourne 3001 Australia http://www.burnet.internationalhealth.edu.au
Telephone 613 9282 2115 / 9282 2275
Fax 61 3 9282 2144 or 9282 2100
Time zone: 10 hours ahead of GMT.
email <bev@burnet.edu.au>
E-DRUG: Status of triple combination ARVs under Indian Act (2)
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As per the Indian Law, medicines patented before January 1, 1995 (irrespective of the date of launch by Indian companies) can be freely marketed without any arrangement with the innovator company irrespective of the expiry date of the patent.
Drugs patented subsequently up to January 1, 2005 (when the new Patent Law came into force) can be launched by manufacturers in India with approval from the innovators only.
If the drug has already been launched prior to January 1, 2005, the Indian manufacturer is required to make arrangements with the patent holder for continued manufacture and marketing.
However no compensation can be claimed by the patent holder for the preceding period when the drug was being manufactured and sold without consent of the patent holder.
What is important in Indian law is not the date of launch of a medicine or the expiry date of the molecule but the effective date of start of patent.
Dr. Chandra M. Gulhati
Editor, MIMS
(Monthly Index of Medical Specialities)
New Delhi 110019. India.
e-mail: seeemgee@yahoo.co.uk