We are legal academics with expertise in patent law, trade law, the TRIPS agreement and the law of India. Each of the signatories has engaged in this field for more than 10 years and has closely followed the developments within India in relation to the prescriptions of the TRIPS agreement.

We make this submission as legal academics to make the core point that, whatever effect India's policies may have on the profits on multinational companies, including those headquartered in the U.S., India's recent enactment and implementation of its patent law is fully in accord with the World Trade Organization's Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Further, India has demonstrated its adherence to TRIPS and to non-protectionism and a national treatment regime by revamping its systems, instituting massive changes to further intellectual property rights and by establishing prudent IP standards that apply equally to both domestic and foreign companies. Each of these standards remains in conformity with the TRIPS agreement and carefully calibrated to accommodate its national objectives within the scope of the flexibilities accorded under the TRIPS agreement.

Countries remain free after TRIPS to tailor their intellectual property laws to their domestic social, economic and cultural needs as they define them, within the bounds of the treaty. Accordingly, as recognized within the World World Trade Organization and the TRIPS Agreement, there is a great deal of lawful pluralism among WTO Members about standards of patentability and about key flexibilities, including both patentable subject matter and grounds for compulsory licenses.  India's laws and implementation thus far remain well within the lawful pluralism allowed by TRIPS.

Specifically, TRIPS Article 31 permits compulsory licenses for ANY reason, including the historically sanctioned grounds of insufficient working of an invention in the country. This flexibility was explicitly clarified in the 2001 Doha Declaration on the TRIPS Agreement and Public Health. Similarly, TRIPS leaves countries free to define patentability criteria, including to define what is not an invention. Along the same lines, each member of the WTO has the sovereign right to determine andestablish the threshold for the nonobviosuness/inventive-step requirement. Thus, India is within its rights to establish that the new forms or uses ofexisting and known molecules that do not significantly increase the therapeutic effectiveness of such substances are not entitled to patent protection.

Most of the questions on the survey used by ITC are irrelevant to the task of ascertaining whether India's policies violate TRIPS.