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    India: Balancing Public And Private Interests In The Intellectual Property Regime

    Published on 18 September 2012 @ 2:03 pm

    By for Intellectual Property Watch

    NEW DELHI – In this month, there have been two court orders in India that underscore the complexities underlying the country’s intellectual property regime. Last Friday (14 September), the Chennai-based Intellectual Property Appellate Board (IPAB) which is responsible for hearing appeals on patent applications, rejected a petition by German pharma major Bayer AG, seeking a stay on an order of India’s Controller of Patents granting a compulsory licence (CL) to Indian generic drug maker Natco Pharma Limited, for a drug used to treat liver and kidney cancer.

    “We are happy. That is all I want to say at this point,” M Adinarayana, Natco company secretary, told Intellectual Property Watch by telephone soon after the IPAB came out with its order.

    The IPAB order is available here [doc] or here.

    Public health advocates have welcomed the order. “This decision once again affirms that courts can and should act in the interest of public health in the case of pharmaceutical products,” Leena Menghaney of Médecins Sans Frontières’ Access Campaign said in a public statement. The case (IPW, Public Health, 20 May 2012) is India’s first compulsory licence (CL).

    At the time of writing, Bayer’s future course of action is not known. In May this year, in an emailed statement, Bayer told Intellectual Property Watch, “We will rigorously continue to defend our intellectual property rights which are a prerequisite for bringing innovative medicines to patients.”

    James Love, director of Knowledge Ecology International (KEI), said in a statement, “It is possible and indeed likely that Bayer will continue to litigate this issue, which will soon be scheduled for another hearing on its merits, now that the stay has been rejected.”

    “It is important that the U.S. and German governments, and the European Commission, resist the temptation to interfere with the Indian legal system while this matter is litigated,” Love said. “What is at stake is nothing less than the right to live.”

    “The decision,” Love continued, “is also a test of the 2001 WTO Doha Declaration on TRIPS and Public Health, which says that WTO Members should implement their patent laws ‘in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.’” KEI, an international non-governmental group, has been working on the access to medicines movement for more than 20 years. TRIPS is the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights.

    Other Key Cases

    The IPAB order in the Bayer versus Natco case comes hot on the heels of the Delhi High Court ruling this month involving Cipla, another Indian generic drug maker, and two pharma multinationals, namely Swiss drug maker F. Hoffmann-La Roche Ltd. and the New York-based OSI Pharmaceuticals Inc. In this case, Cipla was being accused of infringing Roche’s patent on cancer drug Tarceva, which Cipla sells under the brand name Erlocip.

    The Delhi High Court in its order [pdf] on 7 September held that Roche’s patent on the drug is valid. However, it also said that Cipla did not infringe Roche’s patent as it has been selling the polymorph B (variant of the basic drug compound) form of the drug which is known as erlotinib in generic terms.

    The two recent court orders provide a backdrop to another landmark case involving Indian generic drugmakers and a multinational pharma company that is in the news this week.

    Today, 18 September, arguments in the final hearing of the much-talked about Glivec patent case were scheduled to resume in the Supreme Court. Swiss drug major Novartis AG is challenging the denial of patents to its blood cancer drug called by its brand name Glivec in India (Gleevec in the United States). In this case, Novartis is pitted against the Government of India, top Indian generic drug manufacturers (Natco, Cipla, Hetero, Ranbaxy) as well as the Cancer Patients Aid Association(CAPA). Newly appointed Additional Solicitor General Paras Kuhad is representing the Union of India; CAPA’s case is being argued by Anand Grover, another top Indian lawyer who is also currently the United Nations Special Rapporteur on the Right to Health. Other top Indian lawyers like Harish Salve are defending the generic companies.

    The legal dispute in the Glivec case centres around a provision of India’s 2005 patent law, called Section 3(d), which states that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” The dispute brings to the fore a fundamental question: what is an “invention”? Or more precisely, how much innovation is required to obtain a patent in India?

    The ongoing case (IPW, Developing Country Policy, 3 February 2012) in India’s highest court is the final act in a legal battle that has been going on since 2006 when Novartis unsuccessfully pitched for a patent for Glivec. The case has already moved through various rungs of India’s legal system including the IPAB and is now in the country’s top court.

    Final Arguments

    The final arguments in this case began on 11 September in a packed room in India’s Supreme Court, For many in the court room, it seemed like a crash course in chemistry as Gopal Subramanium, a distinguished lawyer and formerly the country’s solicitor general and now senior counsel for Novartis, quoted chunks from various chemistry textbooks and cited international conventions to make his client’s case that Glivec was indeed a genuine medical breakthrough, had been granted a patent in nearly 40 countries and was deserving of a patent in India. Treatment with Glivec, the Novartis brand, costs about `1.2 lakh Indian rupees (or around USD 2,250) per month. The monthly tab for the Indian generic versions is below `10,000 Indian rupees (about USD 185).

    Novartis says it is not fighting this legal battle for money but to vindicate its “honour”. During the court hearing, the company’s lawyers have repeatedly sought to draw attention to its patient assistance programme in India. Novartis claims that 85 per cent of the patients in India were being provided Glivec free of cost. “The purpose is not to make money from the poor. This is not the purpose but am I not entitled for patent for our drug? We are fighting the case on principle,” Subramanium said in the Court last week. Public health advocates point to the discretionary nature of such assistance programmes.

    Novartis lawyer Subramanium has argued in court that the grant of patent to Glivec would not hurt public health in India as “authorities were free under the law to direct the company to compulsorily part with licences relating to the drug any time three years after the grant of patent,” as the legal correspondent of one Indian newspaper pointed out in his report.

    The flexibility issue is a severely contested territory. In a report titled “India’s patent laws under pressure” this month in The Lancet, one of the world’s most prestigious medical journals, Peter Roderick and Allyson M. Pollock pointed out: “The Obama Administration has been consistent in its efforts to stop compulsory licences, with the Deputy Director of the US Patent and Trademark Office describing the granting of this licence as the “most egregious” example of anti-TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) behaviour. ”

    But significantly, these provisions of India’s IPR regime are inspiring health and IPR activists in other developing countries.

    “The Treatment Action Campaign (TAC) and Médicins Sans Frontières are currently lobbying for South Africa to adopt a number of the public health safeguards that are upheld in India’s law. In our campaign, we have looked at the Indian laws as a model of pro-public health interpretation of TRIPS,” Catherine Tomlison of TAC’s Fix the Patent Laws Campaign told Intellectual Property Watch.

    “In our campaign we are calling for South Africa to reject new use and new formulation patents, as rejected in section 3(d) of India’s patent laws,” Tomlison said. “Currently South Africa does not exclude new uses and new patents from patentability and as a result many medicines are under patent and extremely expensive in South Africa, where affordable generics are available in India.”

    “We are also calling for South Africa to require examination of patent applications and to allow for opposition by third parties. We have looked extensively at the Indian experience in implementing examination and opposition as well as the financial and capacity requirements. The Indian experience has shown us that implementing patent examination not only pays for itself with user fees but also generates a significant amount of money for government that can be put back into service delivery. We have been informed by South Africa’s Department and Trade and Industry that the IP policy should be made available this month and that the public comment process will last three months,” she added.

    Other African countries, including Botswana and Swaziland, are also in the process of amending their laws to better utilise the flexibilities allowed under TRIPS to protect health. Botswana, for example, has adopted pre-grant
    opposition.

    A spokesperson for MSF told Intellectual Property Watch that MSF has chosen not to comment on the Novartis hearings because it felt that doing so might interfere with the judicial process, but the medical and humanitarian NGO was taking a very keen interest in the case and awaiting the outcome of the court’s decision.

    Speaking on the wider context, however, Michelle Childs, director of policy advocacy for the MSF Access Campaign, told Intellectual Property Watch: “It’s now more important than ever that developing countries use all the public health flexibilities in international trade law; this includes effective compulsory licensing provisions to ensure access if a patent has been granted, but medicines are unavailable or priced out of reach for those who need them. Countries need all the tools at their disposal – it is not an either/or choice; you need preventative measures to stop monopolies being wrongly granted, as well as an antidote to high priced patented medicines.”

    Will India strike the balance between patents, patients and profits? It is hard to predict. The ongoing cases raise fundamental questions about the definition of “invention”, what qualifies for a patent under India’s IP regime and the challenges of striking a balance between public and private interests in an emerging economic power, where, paradoxically, the vast majority are still not covered by health insurance and where most people have to pay for their own treatment.

    The final outcome of the cases may not be known for weeks, possibly months. But one thing is clear: they could change the game in the health care sector as well as the intellectual property rights regime in India and across the developing world.

    Patralekha Chatterjee may be reached at info@ip-watch.ch.

     

    Comments

    1. Emerging Countries Take Note: Big Pharma's Losing Patent Battles In India says:

      [...] fought back, and appealed against that decision. Now we learn from Intellectual Property Watch that Bayer has lost: Last Friday (14 September), the Chennai-based Intellectual Property Appellate Board (IPAB) which [...]

    2. Pharma Outlook: Don’t Yield On IP, Work On Trust-Building, Call For Global Cooperation | Intellectual Property Watch says:

      [...] India, one of the largest manufacturers of generic medicines, has been the target of critics from the research-based pharmaceutical industry about its IP regime, and in particular for a provision of its 2005 patent law, called Section 3(d), which creates a high standard for what is patentable. The country’s law has been challenged in court by several pharmaceutical industries (IPW, IP Law, 18 September 2012). [...]

    3. Novartis Loses Patent Bid: Lessons From India’s 3(d) Experience | Intellectual Property Watch says:

      [...] discussion about India’s interpretation of intellectual property rights and its attempts to balance public and private interests. The outcome of this case has grabbed national and international headlines because it is seen to [...]

    4. No Disclaimers › Pharma Patents: Some Interesting Numbers says:

      […] submitted by American inventors actually cover pharmaceuticals. And, India, notorious for lax patent protection over pharmaceuticals, and also one of the top foreign submitters to the US, has a full 23.5% of its patents submitted to […]


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    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

    6. You understand and agree that the discussion forums are to be used only for non-commercial purposes. You may not solicit funds, promote commercial entities or otherwise engage in commercial activity in our discussion forums.

    7. You acknowledge and agree that you use and/or rely on any information obtained through the discussion forums at your own risk.

    8. For any content that you post, you hereby grant to IP Watch the royalty-free, irrevocable, perpetual, exclusive and fully sub-licensable license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform and display such content in whole or in part, world-wide and to incorporate it in other works, in any form, media or technology now known or later developed.

    9. These terms and your posts and contributions shall be governed and interpreted in accordance with the laws of Switzerland (without giving effect to conflict of laws principles thereof) and any dispute exclusively settled by the Courts of the Canton of Geneva.

     

     
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