[Novartis defeated in its appeal trial, a triumphant victory of World patients fighting back Patent Exclusivity]
Welcome the ruling of the Supreme Court of India
1. The protracted Novartis’ appeal from 2006 for a patent to Gleevec (Leukemia medicine), and against Indian Patent law has finally reached a conclusion. On Apr1, Indian Supreme court dismissed Novartis’ appeal. The Supreme Court of India has given the reason for rejecting Novartis’ argument by holding that the physio-chemical properties of the beta crystalline form of imatinib mesylate i.e. flow properties, decreased hygroscopicity and thermodynamic stability may be beneficial for patients in some manner but they do not meet the standard of efficacy required by Section 3(d). In a word, Gleevecis not qualified for a patent because the active ingredient of Gleevec (beta crystalline form of imatinib mesylate) is no better than imatinib(free base) and imatinib mesylate in terms of effectiveness.
2. The ruling of the Supreme Court is not simply confined to whether to give a patent to Novartis, and has emblematic features of deciding what kind of invention is eligible for a patent in India. In 2005 when the Indian patent law was under revision, many activists and patients inserted various safeguards into the law for protecting public health and health right through joint actions with their solidarity. The very examples of the safeguards are compulsory licensing, pre, post-grant opposition, and section 3(d). The section 3(d) states that unless newly invented medicine, compared with the ones invented before 1995, does prove significantly enhanced efficacy, even if the invention is composed of a new form and/or a new composition, and has a new use, that is not patentable. That is all about obstructing ‘ever-greening’. The patent for PEGASYS, medicine for Hepatitis C and B, became invalid in Nov 2011 by the reason of that does not meet the conditions of section 3(d) of Indian Patent law. A patent application for IRESSA, lung cancer medicine, was dismissed for the same reason. HIV/AIDS movement groups are also taking full advantage of section 3(d) in order to block issuing a patent to HIV/AIDS medicine. The ruling of the Supreme Court of India will have an impact on those medicines.
3. The reason why the world pays attention to the Novartis patent case is that this legal battle is not merely restricted to the struggle in between Novartis and Indian cancer patients but the struggle to protect ‘Pharmacy of the World’, and the fight of world patients and activists against the patent-exclusivity of a transnational pharmaceutical company. Not only Novartis’ appeal but Bayer’ appeal against the decision of Indian Patent Office approved the first-ever compulsory licensing on medicine and India-EU FTA has oppressed India, and now India are facing more pressures from the outside world powers like transnational pharmaceutical companies, the USA, EU and etc. Novartis case is a symbolized case riddled with many issues reflecting the conflicts in between the patent right of a Transnational pharmaceutical company and the health right of a patient. Accordingly, patients of the developing world, who need Indian generic medicines, public health NGOs, HIV/AIDS human rights groups, and other groups related to intellectual property has organized international campaigns and engaged in protesting against Novartis. The ruling of the Supreme Court of India is a triumphant victory of all patients and activists’ struggle and solidarity.
4. The Supreme Court’s ruling would have an effect on other neighboring countries to take Indian patent law as a model.WHO/UNDP/UNAIDS mentioned the compulsory licensing of Thailand and the section 3(d) of Indian patent law as success stories in ‘Using TRIPS flexibilities to improve access to HIV treatment (2011)’. Several countries are modeling after the Indian patent law. In May 2005, Argentina announced a new patent-guideline inclusive of strict patentability standards similar to the section 3(d) of Indian patent law. South Africa Treatment Action Campaign and MSF are organising ‘Fix the Patent Laws’ campaign by modeling after the Indian patent law.
5. The Supreme Court of India has addressed how harmful indiscreetly issuing a patent is to people. However, we should not stay on this stage and should move forward further. Once product patent is instituted, Indian people cannot block all patents. The utilization of compulsory licensing is a critical way to secure public health as universal right and sustain ‘Pharmacy of the World’. Moreover, India-EU FTA that is more likely to damage ‘access to affordable medicines’ by ISD, border measure, and IP enforcement should be withdrawn. Indian government has announced to provide free medicine to all patients visiting National medical facilities from Oct 2012. 22% of Indian population benefits from healthcare services by the public sector. The Indian government should increase essential drugs list more and expand the population receiving free-supply. In order to bear the financial burden, purchasing generic drugs is inevitable. On Mar 12 2012, first-ever compulsory licensing of India was permitted, and Indian pharmaceutical company BDR filed compulsory licensing application for Sprycel (Dasatinib), leukemia medicine in 2013. Media has announced that Indian government has been under consideration to compulsory licensing for 3 anti-cancer medicines. Indian government should be expanding compulsory licensing rather than counting on pharmaceutical pricing negotiation.
6. We, Korean activists all welcome the ruling of the Supreme Court of India and very happy to hear it as have been engaged in the struggle for access to medicine. But, on the other hand, this victory does sound regretful to us that is not able to model after the Indian patent law. Many poisonous clauses beneficial to pharmaceutical companies, like ISD and patent-approval linkage have been adopted in S. Korea because of KORUS FTA.Furthermore, Korean government does not take any steps to obstruct unjust actions of the patentees to block the release of generic drugs.Fair Trade Commission of S. Korea has surveyed about the present condition of intellectual contract/dispute (document investigation on the condition of dispute-contract and patent application for main prescription drugs that was applied for approval to Korea Food and Drug Administration, or came into the market from 2000 till 2009). The result of the investigation on 429 contracts obtained showed that ‘trade-in ban for competitive product’ clause and ‘Sales-target limit’ clause by patentee pharmaceutical companies, oppressing generic pharmaceutical companies occupied nearly 55%. However, the Korean government did not take any actions against the revealed situation no other than simply released ‘Guidelines for fair trade of pharmaceutical sector’.
April 2, 2013
Korea Leukemia Patient Group
The Daegu-Gyeongbuk HIV People Self Sopporting Community HAEMAIL
Health Right Network
Korean Progressive Network Jinbonet
Intellectual Property Left
People’s Solidarity for Social Progress
SARANGBANG Group for Human Rights
Korea Alliance Defeat AIDS
Solidarity for HIV/AIDS Human Rights Nanuri+ [ Korean Pharmacists for Democratic Society/ CHINGUSAI-Korean Gay Men’s Human Rights Group/ Public Pharmaceutical Center/ Solidarity for LGBT Human Rights of Korea(DongInRyun)]
Korean Federation of Medical Groups for Health Rights [ Association of Korea Doctors for Health Rights/ Association of Physicians for Humanism/ Korea Dentists Association for Health Society/ Korea Health and Medical Workers Union/ Korean Pharmacists for Democratic Society]
Rainbow Action Against Sexual-Minority Discrimination [ CHINGUSAI – Korean Gay Men’s Human Rights Group/ Collective for Sexual Minority Cultures PINKS/ GongGam Human Rights Law Foundation/ Korean Sexual-Minority Culture and Riughts Center(KSCRC)/ LGBTAIQ Crossing the damn world <Wanbyun> (It means Totally Queer)/ LGBT Human Rights Committee in HanYang University/ Lesbian Counseling Center in South Korea/ Lesbian Human Rights Group ‘Byunnal’ of Ewha Womans University/ Sexual-Minority Committee in The Unified Progressive Party/ Solidarity for HIV/AIDS Human Rights Nanuri+/ Solidarity for LGBT Human Rights of Korea (DongInRyun)/ the Korean lesbian community radio group, Lezpa/ Unninetwork ]