Roche v natco


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Roche v natco

  2. 2. TRIPS AGREEMENT ON COMPULSORY LICENCES <ul><li>The TRIPS Agreement allows the use of compulsory licences. Compulsory licensing enables a competent government authority to license the use of a patented invention to a third party or government agency without the consent of the patent-holder. Article 31 of the Agreement sets forth a number of conditions for the granting of compulsory licences. These include a case-by-case determination of compulsory licence applications, the need to demonstrate prior (unsuccessful) negotiations with the patent owner for a voluntary licence and the payment of adequate remuneration to the patent holder. Where compulsory licences are granted to address a national emergency or other circumstances of extreme urgency, certain requirements are waived in order to hasten the process, such as that for the need to have had prior negotiations obtain a voluntary licence from the patent holder. Although the Agreement refers to some of the possible grounds (such as emergency and anticompetitive practices) for issuing compulsory licences, it leaves Members full freedom to stipulate other grounds, such as those related to non-working of patents, public health or public interest. </li></ul>
  3. 3. DOHA DECLARATION <ul><li>The Doha Declaration states that each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted </li></ul>
  4. 4. TIME PERIOD FOR FILING REQUEST FOR COMPULSORY LICENCE <ul><li>At any time after the expiration of three years from the date of the grant of a Patent, any person interested may make an application to the Controller for grant of Compulsory Licence on Patent. </li></ul>
  5. 5. GROUNDS FOR MAKING APPLICATION FOR COMPULSORY LICENCE <ul><li>That the reasonable requirements of the public with respect to the Patented invention have not been satisfied or </li></ul><ul><li>That the Patented invention is not available to the public at a reasonably affordable price or </li></ul><ul><li>That the Patented invention is not worked in the territory of India. </li></ul>
  6. 6. LEGAL STATUTES <ul><li>Section 92 and 92 A of Indian Patents Act 1970. </li></ul>
  7. 7. COMPULSORY LICENSING CASE IN INDIA <ul><li>FACTS OF THE CASE </li></ul><ul><li>The first ever compulsory license application made in India was by Natco Pharma for the manufacture and exportation of Roche’s patented anti-cancer drug Erlonitib to Nepal, the sub-Himalayan kingdom. Besides Erlotinib, Natco Pharma had also applied for the issue of a second compulsory licence to the IPO for manufacture and export of sunitnib [sutent] also an anti-cancer drug. </li></ul><ul><li>The issue of grant or non-grant of the compulsory licence was still under consideration when Natco filed an interlocutory petition before the Controller of Patent asserting that since the application for grant of Compulsory license was made by them under S. 92 A of the Patents Act 1970, the Patentees should not be provided with an opportunity of being heard. In other words, Natco Pharma requested the Controller to disallow Roche (the Patentees) the right to actively represent them in the compulsory license proceeding before him. </li></ul>
  8. 8. ARGUMENTS <ul><li>The patentees' central argument that it was entitled to be heard during the consideration of Natco's compulsory licence application was based on the premise that under both statutory and common law, the Patent Controller was required to grant the patentees a hearing before exercising any discretionary action adverse to their interests. </li></ul><ul><li>To buttress its argument that the Controller was required to do so, the patentees pointed to provisions in the Patents Act that required the Patent Controller to grant a &quot;patent applicant&quot; or any &quot;party to a proceeding&quot; a hearing prior to exercising any discretionary power adversely. They argued that there was no material difference between &quot;patent applicant&quot; and &quot;patentee,&quot; and therefore these provisions (section 80 and rule 129) obligated the Controller to grant a hearing before granting a compulsory licence under section 92A. </li></ul>
  9. 9. Contd… <ul><li>It should be noted, however, that the language of section 92A is mandatory, not discretionary, and the Controller is required, upon receipt of an application in the &quot;prescribed manner,&quot; to grant a compulsory licence for export. </li></ul><ul><li>The patentees also argued that under fundamental common-law principles of &quot;natural justice&quot; (similar to the doctrine of &quot;due process&quot; in other jurisdictions), an opportunity to be heard was required before any action adverse to the patentee's interests was taken by the state. </li></ul>
  10. 10. Contd… <ul><li>Counsel for Natco, Mr. S Majumdar, responded by arguing that the history of the Doha Declaration and the 30 August Decision fully justified the differential treatment of compulsory licences for export under section 92A, in which no right of hearing is expressly provided, with the normal procedures governing compulsory licences (as provided under sections 84-92) in which the patentee's right to a hearing is expressly recognised. (Even under these &quot;normal&quot; compulsory licensing provisions however, expedited measures for granting compulsory licences in situations of national emergency, situations of extreme urgency, or for public non-commercial use are available, and the requirement for providing the patentee with an opportunity to be heard can be dispensed with by the Controller in such circumstances.) </li></ul>
  11. 11. Contd… <ul><li>Natco argued that the Doha Declaration expressly recognised the gravity of public health problems that developing countries were facing, and sought to &quot;balance the needs&quot; of both patent holders and countries facing an urgent need to provide affordable medicines to its people. Natco argued that &quot;when there is a need [for drugs produced under compulsory licence], there should be a rapid response.&quot; </li></ul>
  12. 12. Contd… <ul><li>In support of its argument that there was no requirement to give a patentee the opportunity to be heard prior to the issuance of a compulsory licence, counsel for Natco pointed to Canada's Access to Medicines Regime, which similarly does not grant the right of a hearing to the patent holder during the application process (section 21.04), but merely gives the patentee the right to challenge the validity of the compulsory licence after the fact in a federal court (section 21.14). Similarly, Natco argued, the patentees in India retained the right to challenge the grant of a compulsory licence in the courts if and when the compulsory licence was granted. </li></ul>
  13. 13. Contd… <ul><li>In response to the patentees' argument that the Controller could only determine the amount of adequate remuneration with the assistance of the patentees, counsel for Natco relied on the WHO/UNDP's publication, &quot;Remuneration Guidelines for Non-Voluntary Use of a Patent Medical Technologies“ which laid out several easily calculated methods for determining adequate remuneration in such circumstances without the involvement of the patentees. </li></ul>
  14. 14. Contd… <ul><li>Responding to the patentees' assertion that &quot;patent applicant&quot; and &quot;patentee&quot; were essentially the same, Natco pointed to the definition of &quot;patentee&quot; in the Patents Act to show that a &quot;patent applicant&quot; and &quot;patentee&quot; were distinct entities under the law, and thus the provisions relating to the use of discretionary power for patent applicant had no application to the current proceedings. Finally, counsel for Natco argued that even the common law doctrine of natural justice recognised that the right to be heard was not absolute, and could be dispensed with in situations that required prompt action in the public interest. Counsel for Natco argued that this was precisely such a situation in which prompt action was required. Natco pointed out that its compulsory licence application was filed in December 2007, and that the intervention of the patentees had already delayed the application's consideration by several months. </li></ul>
  15. 15. Contd… <ul><ul><li>On rebuttal, counsel for the patentees distinguished the comprehensive nature of Canada's legislation from the spare language contained in section 92A. He pointed out the numerous safeguards contained in the Canadian legislation that ensured that the patentee would be treated fairly, such as the requirement that the applicant for the compulsory licence first attempt to obtain a voluntary licence (which Natco apparently had not done in this instance); and that the holder of a compulsory licence provide notifications to the patentee of the impending export of the product produced under the compulsory licence. Counsel for the patentees argued that no such requirements were included in the Indian legislation, and in the absence of such comprehensive safeguards as contained in the Canadian legislation, the very least that the Controller could do was to allow the patentee to be heard during the application process to ensure fair treatment. </li></ul></ul>
  16. 16. Contd… <ul><li>Counsel for patentees further argued that the &quot;notice&quot; by the Nepal government that Natco was relying upon was insufficient to amount to a formal notification of an intent to import drugs produced under a compulsory licence. He alleged that Natco, in its application for a compulsory licence, had merely submitted a letter from the Nepal government recommending that one consignment of erlotinib be approved for import from India during the period 2006-2007. He argued that this was insufficient to demonstrate Nepal's intent to utilise the 30 August mechanism to import drugs produced under a compulsory licence. In contrast, he pointed to the formal notification provided to the WTO by Rwanda of its intent to utilise the paragraph 6 implementation. </li></ul>
  17. 17. JUDGEMENT <ul><li>RESERVED </li></ul>
  18. 18. <ul><li>THANK YOU </li></ul>