Author: Brook Baker

Analysis: India’s Supreme Court Upholds Strict Patent Standards and Patients’ Right to Access to Affordable Medicines; Court dismisses unmeritorious court challenge by drug giant Novartis

In a stunning victory for poor patients throughout the developing world, the Indian Supreme Court today ruled against a Novartis challenge of a denial of a patent on its cancer medicine Glivec.[1]  The Court upheld strict standards in the India Patents Act thereby limiting pharmaceutical monopolies and speeding access to more affordable generic medicines.  The Indian generic industry, the pharmacy of poor in the Global South that supplies over 80% of AIDS medicines for the 8 million people in low- and middle-income countries, will not have to delay introduction of medicines year after year as Big Pharma evergreens its patent monopolies by seeking new 20 year patents on minor variations to existing medicines.           See also: Debunking Pharma’s Cant Against the Novartis Judgment:  Myth and Fact Novartis, the Swiss pharmaceutical giant that challenged section 3(d) of the Indian Patents Act, had one goal in mind – to expand its pharmaceutical empire and price impunity in India and the countries that imports Indian generic medicines.  Novartis said that it was appealing an adverse decision on the patentability of Glivec as a matter of principle – and that principle was to maximize profits and to pave the way for a flood of easy-to-get patents on medicines.  Novartis tried every legal trick in the book.  It first challenged the constitutionality of India’s strict prohibitions against unwarranted patents and its compliance with the WTO...

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Detailed Analysis of the Medicines Patent Pool-ViiV Pediatric ARV License and Memorandum of Understanding

Introduction: On February 27, the Medicines Patent Pool (MPP) and ViiV Healthcare UK Limited (ViiV) announced their License Agreement on an older antiretroviral (ARV), abacavir (ABC), for pediatric treatment only, in 118 countries where 98.7% of child living with HIV live.  They also entered into a separate, non-binding Memorandum of Agreement (MoU), which promises collaboration on pediatric licensing of pipeline ARVs, development of novel combination pediatric formulations, and availability of novel pediatric formulations outside of the licensed territory.   Abacavir, which is widely protected by a range of primary and secondary patents in dozens of low- and middle-income countries, is a WHO preferred medicine for 1st and 2nd-line pediatric use.  This License Agreement and its subsidiary Sublicense Agreement will be a presumptive template for pediatric access to all of ViiV’s current pipeline ARVs once they are approved by for use by the US Food and Drug Administration (FDA) or by the European Medicines Authority (EMA). Although there are important improvements in this License Agreement over the status quo and although gaining licensed access to an important pediatric ARV is vitally important to the development of pediatric fixed-dose combinations and to the treatment of pediatric AIDS, the precedential value of this license will be tested by ViiV’s future agreements with respect to adult formulations for dolutegravir (DTG) an extremely important pipeline medicine, whose approval is currently pending at the FDA...

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LDCs collectively request an indefinite extension of their TRIPS-compliance transition periods

Led by Haiti, least developed country Members of the WTO have on November 5 filed a so-called “properly motivated” request under Art. 66.1 of the TRIPS Agreement for a collective extension of the transition period within which they must become TRIPS compliant.  [See, WTO  IP/C/W/583] .   The request specifically averts that LDCs have not developed technologically and that they need continuing and future freedom from IP rules and the high prices associated with IP rights if they are to develop economically and technologically. LDCs had previously been granted two pharmaceutical-related extensions of their original 11-year TRIPS transition period (1995-2006) following the adoption of the Doha Declaration on the TRIPS Agreement and Public Health. Those limited extensions are not set to expire until Jan. 1, 2016.  However, shortly before the original broader 2006 transition period was set to expire, LDCs also requested an extension of all of their TRIPS compliance obligations with respect to patents, copyright, industrial designs, and trademark more broadly, as they were permitted to do. Although a short 7 1/2 year extension was granted (set to expire June 30, 2013), it came with undesirable strings attached.  This main condition, not required by TRIPS, was that LDCs had to lock-in any existing IP legislation they had previously passed, at least with respect to its TRiPS-compliant terms.  Unfortunately, many LDCs by that point still had vestiges of colonial era...

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Indonesian Compulsory Licenses Show Values of Pro-Access TRIPS-Flexibility Terms in Voluntary Licenses

It is a tremendous victory for people living with HIV in Indonesia that it has issued new compulsory licenses on seven anti-retroviral medicines, allowing the government to access generic versions of those medicines – domestically or by importation – at much cheaper prices.  Indonesia now stands at the head of the pack of countries that have stood up to Big Pharma’s corporation power and to the trade and diplomatic pressure exerted by US and EU powers that consistently advance the IP monopoly rights of pharmaceutical multinationals. A little discussed aspect of the government’s compulsory license is that certain Indian generic producers will be able to supply Indonesia’s purchase of Gilead’s tenofovir + emtricitabiine and tenofovir + emtricitabine + efavirenz because of smart provisions in the Medicine Patent Pool’s voluntary license with Gilead. People might remember that Indonesia was included within the territory of the license granted by Gilead to the Medicines Patent Pool in 2011 and was one of only two such countries (India being the other one) that had even a putative, though weak, patent claims by Gilead.  That license properly received substantial criticism because of its exclusion of the vast majority of middle-income countries including all of Latin America, most of Asia, and all of North Africa and Eastern Europe/Central Asia, but the license include some favorable terms as well. A unique feature of the Gilead/MPP license...

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Intellectual Property Policy Incoherence at the African Union Threatens Access to Medicines

Proposed Pan-African IP Organization a Terrible Idea In a stunning development, following an obscure vote of Heads of State at the Africa Union in 2007 (Assembly Council/AU/Dec. 138(VIII)), the AU Scientific, Technical, and Research Commission has proposed a draft statute to establish the Pan-Africa Intellectual Property Organization (PAIPO).  This proposed legislation will be presented to a meeting of the African Ministers in charge of Science and Technology on 6-12 November 2012 in the Democratic Republic of Congo. The statute, drafted by true believers of IP-maximalist ideology, proposes to establish a region-wide intellectual property organization with the sole agenda of expanding IP rights, strengthening enforcement, harmonizing regional legislation, and eventually facilitating the granting of IP monopolies by a central granting authority that may well be legally binding on Member States. The Preamble eulogizes the expansion of IP as the engine of economic growth; of creativity, innovation, and invention; of technology transfer and competitiveness; of protection of indigenous knowledge; and of dissemination of knowledge and knowledge-based goods.  The objectives of PAIPO (Art. 5) include:  “the harmonization of intellectual property systems of its Member States, with particular regard to protection, exploitation, commercialization and enforcement of intellectual property rights;” the provision of common services in the “administration and management” of IPRs; “activities that strengthen the human, financial and technical capacity to Member States to maximize the benefits” of the IP system and to...

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Leaked TPP Investment Chapter Presents a Grave Threat to Access to Medicines

The leaked Trans-Pacific Partnership Investment Chapter has been analyzed extensively with respect to its dangerous intellectual property protections and enhanced enforcement mechanisms and its equally dangerous extra-judicial investor-state dispute settlement (ISDS) provisions.  In contrast, this analysis focuses on the particular risks of the Investment Chapter with respect to access to medicines because of the direct and indirect inclusion of intellectual property rights in the Chapter’s coverage.  These risks are cumulative because of other provisions in the proposed US IP chapter that would strengthen, broaden, and lengthen intellectual property rights with respect to pharmaceutical patent, data, and pricing provisions and that would expand both private IP enforcement mechanisms via mandatory injunctions and expanded damages and impose new enforcement obligations on governments in terms of border measures and criminal enforcement. In essence, the IP-Chapter gives IP-“investors” new substantive “investment rights” upon which to base their abusive ISDS claims against sovereign governments’ regulations and adjudicatory decisions. There are four main dangers in the Investment Chapter that threaten access to medicines: First, the minimum standard of treatment, including fair and equitable treatment, and indirect expropriation concepts contain significant ambiguities that could greatly restrict countries’ ability to enact, use, and defend flexibilities that enhance access to medicines. Second, it is dangerous to include IP rights at all in the investment chapter, given the extensive private enforcement rights that rightholders already have, including administrative remedies...

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Treating People Right Means Taking the IP Yoke Off Our Back: A 10 Point Plan to Ensure Access to new and IMproved AIDS Medicines

[Reposted from treatpeopleright.org] “Treating people right” means many things, but one of the things it means is that people living with and at risk of HIV/AIDS must have immediate and affordable access to new medicines, diagnostics, and other medical technologies to ensure that their rights to health, to reduced risks of transmission to and from others, and to beneficial treatment are maximized. In a world that treats people right, medical research would be targeted to real needs (increased potency, durability, tolerability, stability, and ease-of-use), important medicines would be quickly brought to market, quality and safety standards would be safeguarded, and the medicines would be made available affordably to all in need by maximizing robust generic competition. AIDS activists have fought the IP and Pharma monopoly system for over two decades. We’ve been most successful in driving down costs for older antiretroviral medicines in some of the poorest and hardest hit regions, but IP barriers are getting worse, not better, and limited access to the latest and future generations of life-saving medicines could mean treating people wrong. The TRIPS and TRIPS-plus intellectual property system engineered by Big Pharma and their captive rich country trade negotiators presents grave threats to access to newer and improved medicines and diagnostics needed to treat and prevent HIV/AIDS and the many other health conditions afflicting poor people in low- and middle-income countries. That same IP...

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USPTO Official Misleads Congress on Permissible Scope of Compulsory Licenses to Increase Access to Medicines

In testimony before the U.S. House of Representatives Subcommittee on Intellectual Property, Competition and the Internet on 27 June 2012 (Hearing: Protecting Patents, Trade Secrets, and Market Access), the Deputy Director of the U.S. Patent and Trademark Office, who also serves as Undersecretary of Commerce for Intellectual Property, grossly misrepresented the scope of permissible compulsory licensing under the WTO TRIPS Agreement. In her misleading testimony, Teresa Stanek Rea said:  “We are consistent on our efforts … of trying to stop these compulsory licenses.” Rea said she was particularly disappointed in March, when India’s Patents Office ordered Bayer AG to grant an Indian generics maker (Natco) a compulsory license for the cancer drug Nexavar, ruling that it was too expensive for most people to afford.  (Note:  the generic was 3% the cost of overpriced Bayer product and reached only a tiny fraction of eligible cancer patients in India.)  “I was quite dismayed and surprised when they issued that compulsory license,” Rea told the committee, saying she believes the issuance of the Indian compulsory license was in violation of the Agreement on Trade Related Aspects of Intellectual Property Rights, an international pact administered by the World Trade Organization which sets minimum standards for intellectual property regulation.  Rea said the USPTO is working to stem the tide of IP infringement in foreign countries by the use of a host of training programs and educational efforts aimed at foreign officials...

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Bayer Appeals Indian Compulsory License for Nexar

Just as Novartis appealed from an order denying its patent application on Glivec, Bayer has now appealed the granting of a compulsory license on Nexavar. Rather than honestly state that it likes selling its cancer medicines for $67,000 to only the richest patients in India, which means that only 200 or so patients get the medicine instead of the tens of thousands who need it, Bayer still makes a nifty profit of nearly $13 million dollars on those sales.  If the price excludes the 99%, that’s fine with Bayer – that’s the logic of what it calls the international patent regime. Bayer makes three claims in support of its decision to appeal.  First, it notes that there are other roadblocks to access to medicines for poor patients in India as revealed by the fact that many patients do not get access to even non-patented medicines on the essential drug list.  This is the trivial argument Big Pharma has been making for years to cover the impact of its monopoly pricing policies.  Of course, there are other barriers to access, but does Bayer want to seriously argue that medicine priced 60 times more than the newly announced Cipla price doesn’t adversely impact access? Second, Bayer argues that one compulsory license on one hyper-expensive cancer medicines threatens the international patent regime.  Of course, there is no truly uniform international patent regime,...

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Protestors Rock Novartis on Eve of Annual Meeting ­Decry Novartis’s Court Challenge to India’s Strict Standards of Patenting Medicines that Increase Access to Affordable Generics

Fifty AIDS activists, students, and community group members protested at Novartis’s Institute for BioMedical Research in Cambridge, Massachusetts, on February 22, the eve of the Swiss pharmaceutical company’s annual shareholders meeting in Berne Switzerland.  The protest was part of two days of global  action drawing attention to the pharmaceutical giant’s pending lawsuit against cancer patients and the government of India, aiming to reinterpret India’s strict patent standards. Novartis is seeking to establish a binding court precedent that will make it much easier to obtain overlapping and successive patents on minor variations to existing medicines ­ a precedent that will increase the number of patents on medicines and extend the length of patent monopolies thereby limiting and delaying generic competition.  In the absence of generic competition, Novartis and other Big Pharma companies will be able to set price affordable to elites, but unaffordable to the broad mass of poor people in India.  Because India is the “pharmacy of the developing world,” Novartis’s case threatens future access to affordable generics in all categories of life-saving and health-enhancing medicines . Background of the Novartis Case This court case is part of a long series of legal actions by Novartis designed to eviscerate India’s lawful efforts to restrict the widespread practice of “evergreening” by pharmaceutical companies whereby they seek new or additional 20-year patent monopolies for minor changes to existing chemical entities and...

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Treatment Access Campaign Efforts to Increase the Use of TRIPS Flexibilities for Access to Medicines in South Africa

The Treatment Action Campaign has issued a Briefing providing a great summary of the campaign launched last year trying to convince/force the S. Africa government to adopt TRIPS-compliant flexibilities in its patent regime and thereafter to use them to increase access to medicines:  http://www.tac.org.za/community/node/3241. People should also take a look at the wonderful Equal Treatment magazine that TAC produced about this campaign. This is an inspiring example of efforts, ten-years after the Doha Declaration to get developing countries to adopt the flexibilities that activists helped to win.  Strict patent regimes, opportunities for patent oppositions, easy-to-use procedures for compulsory licenses all have an important role to play in countering the offensives of Big Pharma and US and EU trade negotiators to gain broader, stronger, and longer patent and data monopolies and to push an enforcement and anti-counterfeiting agenda that chokes off the supply of low-cost medicines of assured quality. This campaign was spawned out a network of activists in Southern and East Africa who brainstormed IP related campaigns and also out of a two-week short course for activists and others taught at the University of KwaZulu Natal in Durban, South Africa, where three full days was devoted to developing the outline of this and other campaigns....

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