India’s patent law was originally designed to suit a closed national economy. The Patents Act 1970 contained several provisions intended to support the domestic industry, especially the pharmaceutical industry, enabling it to enjoy a soft-patent regime. Until recently, the national patent law provided only for a very limited term of patent protection for process inventions in respect of ‘food’, ‘drug’ and ‘medicines’. In addition, the old law also contained provisions for compulsory licensing and licences of right so that the Government of India could mandate patentees to compulsorily license patented inventions in certain circumstances.

These were some of the considerations that prevented India from acceding to the Paris Convention for a long time. However, India, on joining the WTO as a founder member on January 1, 1995, ratified the TRIPS Agreement. Consequently, the Government of India undertook a series of amendments, the latest being the Patents Amendment Act, 2002, which came into force on May 20, 2003.

The recent amendments in the Patents Act have a direct bearing on the pharmaceutical industry. The two recent amendments – the Patents Amendments Act, 1999 and the Patents Amendment Act, 2002, aim to abolish the system of short-term process patents for pharmaceutical inventions. These inventions will now be given full term (20 years) product patent protection from January 1, 2005. Until then, the transitional protection mechanism of Exclusive Marketing Rights is available whereby, the relevant pharmaceutical or agricultural chemical product can be marketed exclusively by the applicant for five years, or until a decision on a product patent is taken, whichever is shorter.

The Patents Amendment Act, 1999 provided for filing Mail Box Applications for pharmaceutical products, allowing applicants to file patent applications for such products and obtain a filing date, even though the applications will not be processed until after December 31, 2004.

The new amendment has also expanded the meaning of drug and medicine to include inter alia the following:

  • Chemical Intermediates

  • Pharmaceutical Intermediates

  • Insecticides

  • Germicides

  • Fungicides

  • Weedicides

This has brought a wide range of substances, including agricultural chemicals, under the definition of ‘drug’. Consequently for these categories of inventions (claiming products), Mail Box Applications can be made and Exclusive Marketing Rights (EMR) sought, if the applicant fulfills the EMR requirements. To obtain an EMR in India, the Applicant must have filed and obtained a patent for the same invention after January 1, 1995 in a WTO Member Country, and must have obtained Marketing Approval for that product.

It is pertinent to note that the new law provides a new definition of ‘Chemical Processes’. ‘Chemical Processes’ now includes ‘biochemical, biotechnological and microbiological processes’. This is relevant because it now makes ‘microorganisms’ and ‘micro-biological processes’ patentable, which means thereby, that in the cases of inventions relating to substances produced by chemical processes, patent applications will be dealt with in the same manner as in the case of pharmaceutical products.

The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances.