인도 대법원의 글리벡 특허소송 최종 판결 및 인도 특허법의 WTO TRIPS 협정과의 합치성에 대한 고찰

Abstract

On April 1, 2013, the Supreme Court of India made a landmarkjudgment on patentability of imatinib mesylate, commercialized as“gleevec,” life-saving medicine used for the treatment of chronicmyeloid leukemia. The Supreme Court of India ruled that the betacrystalline form of imatinib mesylate, which was filed by Novartis in1998, is not patentable because it inherently existed in its originalcrystalline form in prior arts and it did not meet the criteria of article3(d) of the Indian Patent Act. Introduced as part of the 2005 amendment to the Indian PatentAct, article 3(d) prohibits granting a patent to a mere discovery of a newform of a known substance that does not result in the enhancement ofthe known efficacy of the substance. The provision was enacted with apublic policy objective to prevent “evergreening” and to provide easyaccess by the Indian citizens to life saving drugs. However,multinational pharmaceutical companies have continuously raiseddoubts about whether article 3(d) is compatible with the World TradeOrganization (WTO) Trade-Related Aspects of Intellectual PropertyRights (TRIPS) agreement. By reviewing the past interpretation of the article 3(d) by theSupreme Court of India and previous decisions of the WTO DisputeSettlement Body (DSB), if the case is brought in front of WTO DSB, itis unlikely that DSB would find the article 3(d) is violation of TRIPS. First, enhanced efficacy that article 3(d) requires is deeply related withpatentability, such as novelty, inventive step, and industrial application -the criteria TRIPS allows its members to define accordingly to suit theirspecific national interests. Thus, disproving India’s argument may not beeasy if India alleges that article 3(d) is within its discretion underTRIPS. Second, regarding a complaint that article 3(d) is a violation ofTRIPS article 27.1 that prohibits discrimination of a field of technology,the complaining country may have to prove de jure and/or de factodiscrimination of article 3(d). An interpretation by the WTO panel of theCanada Patent Protection of Pharmaceutical Products case may serve assuch proof. Article 3(d) may not effectively consist de jurediscrimination because the provision includes no explicit expression thattreats a certain technological area differently and Madras High Courtexplicitly interpreted that the provision is applicable to inventions of alltechnological areas. It is also difficult to prove that article 3(d) is defacto discrimination with wrong objectives. That is because itslegislative purpose is to promote public health and the article may beapplicable to other technological areas in the future. Third, since TRIPS provides some flexibility to its membersespecially for public policy and health, legislative authority of article3(d) may also be at the discretion of India. In addition, as part of theDeclaration on the TRIPS Agreement and Public Health in 2001, theWTO members have agreed that they would interpret and implement theTRIPS agreement in a manner supportive of each member’s right toprotect public health and to promote access to medicines. This furtherevidence that particularly for public health matters, there may be moreflexibility in interpreting TRIPS. Article 3(d) is an extraordinary approach around the world, which trys to address side-effect of evergreening patent strategy by legislationon patentability. Even though the judgment of the Supreme Court ofIndia has made some clarification on its meaning, there are stillquestions remaining to be answered regarding the interpretation ofarticle 3(d). How much improvement should be made for enhancedefficacy? What kind of data is necessary to prove it? Should reducedside effect and toxicity be regarded as efficacy within the meaning ofarticle 3(d)? It is necessary to pay further attention to subsequentjudgments of courts and patent office in India.