India to Pass Amendment for Pharmaceutical Patents

India’s Parliament is expected to pass the long-awaited Third Patent Amendment Bill in January 2005, providing for more transparency and security in India’s six billion dollar pharmaceutical industry, comprised of around 20,000 foreign and domestic drug makers. The Third Amendment Bill will cover all the remaining provisions India must meet in order to comply with the Trade-related Intellectual Property Rights (TRIPs) Agreement, including the granting of pharmaceutical patents. The Parliament hopes this new Bill will attract more foreign companies to India and encourage those already in India to begin expanding their Research and Development sectors.

The new Bill has two main objectives: (1) to introduce the patent regime for all products, including pharmaceuticals, and (2) to introduce the granting of compulsory licenses. Previously, only methods or processes of manufacturing could be patented for some products in India. Under the new provision, specific product patent protection may be granted in almost all areas, including patent protection for most pharmaceuticals. However, biological material and new uses of known substances will not be subject to patent protection under the new Bill.

The pre-grant opposition system will be replaced with a third party system, which will determine patentability before the granting of a patent. Under this new patent system, companies should be able to receive patents in about 2 ½ years from the date of application.

The conditions for granting a compulsory license for pharmaceuticals have been redefined in the new Bill. Compulsory licenses will be available for the manufacturing and exporting of a patented pharmaceutical product to another country, if that country has insufficient or no manufacturing capability of that product, but is in need of the product in order to address public health problems. Licenses may also be granted in the case of a national emergency or for public, non-commercial use. The term of the compulsory license will be the same length as the term of the patent. However, if the license is not used for a two year period after it was granted, the license can be revoked.