In last five years, the Indian parliament has amended the patent law twice. Despite the government’s efforts to make the patent law compliant with the TRIPs Agreement, the international community’s qualms about India’s patent law remains unchanged. The debate on TRIPs compliance is heating up again since the publication of a report on various patent law issues by a government-appointed panel of experts.

India has been a member of the WTO since its creation in 1995. Being a member of the WTO and a signatory of TRIPs imposes various obligations on the country. India was given 10 years, from 1995 to 2005, to amend its national laws and to comply with the TRIPs Agreement. India was also required to provide pipeline protection in the meantime. India amended its laws in 2002 to provide pipeline protection and again in 2005 to comply with TRIPs.

The Indian government was under pressure from the international community to comply with TRIPs and from a domestic industrial lobby to somehow bypass or delay TRIPs compliance. The government tried to strike a balance in the Patents Amendments Act of 2005.

Immediately after the amendments of 2005, the Indian government convened a committee of technical experts to review the amended patent law. The Committee comprised of five leading IP academics and was chaired by R A Mashelkar, former head of the Council of Scientific and Industrial Research. It conducted thorough research, invited comments from various industries, IP lawyers and patent owners. The Committee studied all available information and submitted its report in December 2006.

Two main issues considered by the Committee were the patentability of micro-organisms and the definition of “pharmaceutical substance” for patentability purposes.

The task given to the Committee was to evaluate whether “pharmaceutical substance” should be defined as a “new chemical entity” or a “new medical entity”. They were supposed to ascertain which definition would be complaint with TRIPs and, simultaneously, be less adverse to domestic industry. The other task assigned to the Committee was to evaluate whether India could exclude micro-organisms from patentability and still be TRIPs-compliant.

At the moment, Indian patent law does not allow patentability of new medical entities (that is, second medical use claims are excluded from patentability). Micro-organisms, however, are patentable.

The Committee found that the exclusion of new medical entities would be non-compliant with the obligations under TRIPs. On the issue of patentability of micro-organisms, it commented that TRIPs allows patentability of micro-organisms that are created through human intervention. As a result, excluding mico-organisms per se from patentability would violate TRIPs.

Also relevant to this issue is the challenge to the Indian patent law by Swiss pharmaceutical company Novartis. While appealing against a decision of the Indian Patent Office, Novartis claimed that Indian patent law is not compliant with TRIPs. The Committee’s findings support Novartis’ claim.

Even before the publication of this report, many academics and IP professionals had argued that the amendments of 2005 fall short of India’s obligations under TRIPs. The Committee’s report confirmed that. IP professionals in India and abroad welcome the report.