Minutes - TRIPS Council - View details of the intervention/statement

H.E. Ambassador Lundeg Purevsuren
14 INTELLECTUAL PROPERTY AND THE PUBLIC INTEREST: R&D COSTS AND PRICING OF MEDICINES AND HEALTH TECHNOLOGIES
613.   We support the statement delivered by South Africa. 614.   At the outset, allow me to thank and compliment my South African colleague for this extremely pertinent and timely submission that attempts to facilitate sharing of experiences between countries on the steps taken by them to maintain a balance between the pricing of medicines and the public interest. 615.   The National IPR Policy introduced by the Government of India in 2015 envisions an India where creativity and innovation are stimulated for the benefit of all. The policy emphasizes that a dynamic and vibrant intellectual property system must focus on enhancing access to health care, food security and environmental protection among other sectors of vital social, economic and technological importance. Our existing laws were either enacted or revised after the TRIPS Agreement came into existence and are fully compliant with it. India has incorporated a wide array of flexibilities available under the TRIPS Agreement in its Patent Law. 616.   Certain specific examples of such flexibilities include-higher patentability standards to ensure a balance between the public interest and intellectual property rights protection. Prior to 2005, India prohibited the grant of pharmaceutical product patents, which had to be changed as part of the TRIPS commitment. The concern at that time was that while genuine inventions should be patented, evergreening should not be allowed. Higher patentability standards have tried to address this concern. 617.   A system of pre-grant opposition that allows any third party to oppose a patent application that is awaiting a decision at the patent office has augmented the examination capabilities of our patent office so that frivolous inventions are not patented. This has helped to keep the prices under control. Robust compulsory licence provisions to address situations where prices become unreasonable or where supply of the medicine is inadequate, strong disclosure requirements and transparency provisions that require a patent applicant to disclose the status of his application in other countries and the requirement that every patentee and every licensee furnish a statement as to the extent to which the patented invention has been worked on a commercial scale in India have helped in creating an equilibrium between the obligations taken under the TRIPS Agreement and the rights available. 618.   The Bolar provision is very important for entry of generics as soon as the patent expires. The Indian Patent Law allows a generic company to seek regulatory approval ahead of the expiry of the patent. This in turn facilitates the entry of the generics as soon as the patent expires, thereby ensuring that the patent monopoly does not extend beyond the required period. The patent landscape is recognized by our National IPR Policy to be critical for enabling innovation and also to know whether there is freedom to operate. The Policy mentions that efforts should be made for the creation of a public platform to function as a common database of IPRs. It states that such a platform would help in scouting the technology landscape to identify white spaces and thereby promote innovative activities in uncovered areas. In India patent landscape work is being carried out by the Unit for Research and Development of Information Products (URDIP) of CSIR. They carry out landscaping work across technologies for small and medium enterprises, start-ups, research institutions among others. 619.   Lastly, we want to mention that the questions raised in the submission address the issue of access to medicines as a whole and Members need time to respond. Therefore, the issue should be kept open for inputs/experiences to be shared by Members in subsequent meetings of the TRIPS Council.
The Council took note of the statements made.
68.   The Chair noted that the item had been put on the agenda at the request of South Africa. A communication on this topic had been circulated in document IP/C/W/659. It included questions to guide the discussion. He invited South Africa to introduce the item.
69.   The representatives of South Africa; India; the European Union; China; Chinese Taipei; Brazil; Switzerland; Japan; the United States of America; and the WHO took the floor.
70.   The Council took note of the statements made.
IP/C/M/93, IP/C/M/93/Add.1