The Centre issued the ordinance on patents on Sunday incorporating some significant improvements in the Patent Bill introduced last year making the country complaint with the TRIPS regime of WTO. The ordinance, which extends the product patent protection to the fields of drugs, food and chemicals, has deleted the provisions relating to Exclusive Marketing Rights (EMRs) and has introduced a transitional provision for safeguarding EMRs already granted.
As far as the drug sector is concerned, the Ordinance has introduced provision for enabling grant of compulsory licence for export of medicines to countries, which have insufficient or no manufacturing capacity, to meet emergent public health situations (in accordance with the Doha Declaration on TRIPS and Public Health). It has also modified the provisions relating to opposition procedures with a view to streamlining the system by having both Pre-grant and Post-grant opposition in the patent offices.
In addition, a new provision to circumscribe rights in respect of mailbox applications has brought so that patent rights in respect of the mailbox shall be available only from the date of grant of patent, and not retrospectively from the date of publication has also been incorporated. Strengthening the provisions relating to national security to guard against patenting abroad of dual use technologies, the new regime would also rationalize provisions relating to time-lines with a view to introducing flexibility and reducing the processing time for patent applications, and simplifying and rationalizing procedures.
After issuing the Ordinance, Kamal Nath, Union Minister of Commerce & Industry, said that the Patents (Third) Amendment ensures that the reasonable requirements of the public with respect to availability and affordability are taken care of and public interest particularly public health and nutrition is protected.
"The law effectively balances and calibrates Intellectual Property protection with public health concerns and national security. By participating in the international system of intellectual property protection, India unlocks for herself vast opportunities in both exports as well as her potential to become a global hub in the area of R&D-based clinical research outsourcing, particularly in the area of bio-technology," he said.
The important public interest provisions in the Patent Law announced today are:
(a) Conditional grant of patent [Section 47]: This empowers the Government to import, make or use any patent for its own purpose. For drugs, it also empowers import for public health distribution.
(b) Revocation of patent in public interest [Section 66]: This empowers the Government to revoke a patent where it is found to be mischievous to the State or prejudicial to the public.
(c) Grant of compulsory licence [Sections 82 to 94]: Chapter XVI deals with the general principles and circumstances for grant of compulsory licenses in order to protect public interest particularly public health and nutrition. These provisions check the abuse of patent rights. They can be invoked if the reasonable requirements of the public with respect to patented inventions have not been satisfied, and the patented invention is not available for public at a reasonably affordable price, and if the patented invention is not worked in the territory of India. This provides for action in case of national emergency, extreme urgency and public non-commercial use, and can be invoked without the grace period of 3 years from grant of patent.
(d) Use of invention for the purpose of Government [Sections 100 & 101].
(e) Acquisition of invention and patent for public purpose [Section 102] empowers the Government to acquire a patent to meet national requirements.
(f) Bolar provision [Section 107 (A) (a)] to facilitates production and marketing of patented products immediately after expiry of term of patent protection by permitting preparatory action by non-patentees during life of patent.
(h) Parallel import [Section 107(A) (b)] to provide for import so that patented product can become available at the lowest international price.
Though there are clarifications to be emerged on the patentability of drug products, the Ordinance gives an indication that the new use and new therapeutic properties of existing molecules cannot be patentable as per the amended provisions. However, the minister said that 3 per cent of the generic brands in India would be affected in the new patent regime as it may be under the hold of new patents to be granted in the country in the post product patent regime. The Ordinance is expected to come up in the Parliament for discussion during the Budget session.