Author: Brook Baker

Industry-Led Tiered-Pricing or Country-Led, Real Equitable Access – the Global Fund’s Task Force Proposal Get Worse Instead of Better

Professor Brook K. Baker, Northeastern U. School of Law Policy Analyst Health GAP Full Paper – PDF On or about March 18, 2014, a third draft of the renamed “equitable access” proposal was released by Mark Dybul, Executive Director of the Global Fund, to partners for further input.  If anything, this third draft, the text of which is attached , is worse than the previous two drafts: The equitable access objectives of the Task Force are less tiered-pricing centric, but tiered pricing is still hard-wired in as the single solution that the proponents continue to champion. A key intervention mentioned in the second draft has been deleted, namely IP reform and increased and coordinated use of TRIPS public health flexibilities. This is an intentional exclusion and cannot be justified – overcoming IP barriers is in many circumstances to only way to increase affordability. Most of the proposal addresses the needs of poor people in MICs as if the problem of access to needed health products has been met in LICs, which is clearly untrue. The focus on “basic” medicines only is highly undesirable.  The focus should be on all needed medicines, including medicines for infectious diseases, childhood diseases, neglected diseases, chronic and non-communicable diseases, etc. Low- and middle-income governments should be in the driver’s seat in articulating needs, solutions, and flexibilities; they are inappropriately excluded from input in the...

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Health GAP Response to PhRMA Submission for the Special 301 Review

[Brook Baker and Matt Kavanagh] Health GAP submits these comments in response to written and oral submissions made by PhRMA and other trade associations attacking India’s intellectual property regime, particularly its issuance of a compulsory license on a Bayer cancer medicine and the adoption of section 3(d) to the Indian Amended Patents Act and its Supreme Court decision thereunder denying a patent on a Novartis medicine. The referenced submissions by opponents to the India IP regime can be found at http://www.keionline.org/ustr/Special301. We make the following three comments in opposition to listing India on the Special 301 Watch List: India’s adoption and one-time use of compulsory licensing is TRIPS compliant and does not justify elevation of India on the US’s 2014 Special 301 Watchlist Section 3(d) of the Indian Patents Act is fully legal under the TRIPS Agreement and India’s adoption and use of this provision does not justify elevation of India on the 2014 Special 301 Watchlist. The U.S. President’s Emergency Plan for AIDS Relief and U.S. global AIDS programs are dependent for success on continued, robust Indian generic production of AIDS drugs through continued Indian use of WTO-compliant legal flexibilities. Listing India on the 301 Watch List would undermine President Obama’s declared priority of creating an “AIDS Free Generation,” waste U.S. taxpayer funds, and imperil the PEPFAR program. Click here for the full response to the PhRMA submission...

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US’s “New” Proposed TPP Intellectual Property Chapter Still Requires Patents on Medicinal Forms With “Distinguishing Features”

The US has evergreened its patent proposal requiring patents on new forms of known/existing medicines by requiring patents on medicines with “distinguishing features.”  This is the wine of old IP maximalism – an elixir for Big Pharma – in a new bottle. IP, health and trade activists expressed outrage in early 2011 when the proposed US IP Chapter for the Trans-Pacific Partnership Agreement was first leaked.  Particularly concerning was the language of section 8.1, addressing standards of patentability. Section 8.1 proposed a substantial weakening of patentability criteria, including required patenting of new forms and new uses of existing medicines. It stated: “[T]he Parties confirm that:  patents shall be available for any new forms, uses, or methods of using a known product; and a new form, use, or method of using a known product may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the know efficacy of that product. Other TPP negotiators were reported to be uniformly opposed to the U.S. proposal and the unconfirmed reports were that the U.S. had dropped its demand that new forms be patented. The Wikileak disclosures of more recent IP chapter positions has revealed that the US has not so much dropped the demand that patents be granted for new forms, but rather has hidden the same demand in new language. The new U.S. proposal states: “The...

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Note on Reported Gilead Licenses for Hepatitis C Medicine

Gilead is reported to be in talks to issue voluntary licenses to Indian generic manufacturers for the production of sofosbuvir, an important new drug to fight hepatitis C. If the intended territorial scope of licenses is only 60 countries, it will be far less than what Gilead first offered through it voluntary licenses for ARVs and much more limited than the licensed territory negotiated with the Medicines Patent Pool.  Moreover, if the territories are limited to sub-Saharan Africa, India, and low-income countries, it will miss key countries with with very high HEP C burdens, e.g., Egypt. In addition, there is a certain cynicism in Gilead seeking voluntary licenses with a select number of preferred supplier in India, especially since the underlying patent is facing a fierce opposition by I-MAK.  In its initial ARV voluntary licenses, Gilead tried to restrict licensee challenges to its IP – a clause that was per se anti-competitive under several the law of multiple nations.  Although it seems doubtful that Gilead would try to impose such a clause again, it is possible that it’s preferential voluntary licenses will undermine generic oppositions. However, even if the opposition in India is successful, it will not directly address sofosbuvir’s patent status in other countries. In addition, the initial price of $2000, though welcome compared to extortionate pricing in the U.S., is still far too high.  Reports on projected...

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US PhRMA Bares its Fangs – South Africa Patent Law Reform and Access to Medicine at Risk Yet Again

PhRMA (Pharmaceutical Researchers and Manufacturers of America) is putting $350,000 on the table to stop proposed patent law reform in South Africa and instead to lobby for even more monopoly protections for medicines.  Why would a pharmaceutical association from the US be so interested in an African country that comprises only a tiny fraction of global pharmaceutical sales?  Why, after having faced universal public scorn for having sued the Nelson Mandela government 1998-2001 to stop earlier, completely lawful access-to-medicines reforms, would the industry once again risk humiliating publicity and an all-but-certain defeat?  More particularly, when every reform that South Africa is proposing is completely lawful under international intellectual property law, most particularly the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), why would PhRMA choose to a clandestine, public-relations and think-tank strategy not only to derail the propose reform, but advocate for even stronger monopoly protections? The answer is simple – dirty lucre and precedent. The current South African patent regime is a PhRMA dream.  Although South Africa has legislation mandating patent examination, an examination system has never been established.  This means that virtually every drug company patent filed in South Africa, so long as the applicant can fill out the form and pay the filing fee, will be and is granted.  No one – I mean no one – double checks whether a patent application has...

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Analysis of Territorial Access Issues in the MPP/BMS Atazanavir License

On December 11, the Medicines Patent Pool announced a new licensing agreement for a 2013 WHO recommended second-line antiretroviral, atazanavir (ATV).  At this point, it is important for IP activists, generic companies, and countries to understand both the express territorial coverage of the license (110 countries) and its “effective” territorial coverage as well (144 countries plus the possibility of compulsory licensing expansion).  Because royalty payments are actually limited to situations where granted patents are in effect – and with some exceptions even then, it is also important to identify the limited circumstances where royalties will be imposed.  Finally, it is important to analyze some of the licensed or patent-free availability or ritonavir or cobicistat for co-formulated boosting. Click here for the full analysis...

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Differential Treatment and Developing Country Transition Periods in the IP Chapter of the TPP

Inside U.S. Trade (Nov. 27, 2013) has reported that the U.S. floated a non-paper proposal for differential treatment and a transition period for developing country partners (Vietnam, Peru, Mexico, and Malaysia) with respect to some of its intellectual property demands in the Trans-Pacific Partnership Agreement negotiations.  According to Inside U.S. Trade, the mid-November non-paper would give developing country partners a reprieve from three specific elements of the U.S.’s TPP demands:  (1) no mandatory requirement for patent term extensions to compensate for regulatory delays in patenting or regulatory approval, (2) no additional 3-year extensions of data exclusivity beyond the initial, presumptive 5-year period, plus potentially an explicit public health exception to data exclusivity and a push clause that would start the 5 year exclusivity from the first date of approval by a TPP partner if the developing country achieves fast-track product registration within 6 months of application, and (3) no requirement of patent-registration linkage that would automatically stay the processing of generic registration applications along long as there are measures permitting patent-holders the right to defend their patents in court. The Inside U.S. Trade article (Nov. 29, 2013) suggests that the transition period will be based on graduation to upper-income country status based on World Bank criteria that currently sets the graduation threshold at $12,616 per capital GNI per annum.  As I reported, Mexico and Malaysia are already close to...

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US’s Proposed TPP Transition Period for Middle-Income Parties is Fools Gold

Inside US Trade[1] and the USTR[2] have announced that the U.S. is floating new proposals on IP in its marathon Trans-Pacific Partnership Agreement negotiations.  Although the U.S. touts its new proposals as being balanced, as prioritizing access to medicines, and as recognizing the interests of developing country negotiating partners, particularly, Peru, Vietnam, Mexico, and Malaysia, its actual proposals offer modest temporary respite at best from only a small fraction of U.S. demands.   The U.S. is essentially sticking by all of the demands revealed in the latest Wikileak disclosures, except with respect to its grudging acceptance of pre-grant oppositions (it had previously given up demands for mandatory patents on new forms of existing medicines).  Required patents for new uses, required granting of patents on medicines even in the absence of improved therapeutic effects, data/regulatory monopolies on clinical trial data (data exclusivity), mandatory patents on virtually all medical, surgical, and diagnostic procedures, enhanced damages for patent infringement, mandatory injunctions, and stronger border measures will all be mandatory the minute the TPP is signed.  Even more ominously, IP will remain in the investment chapter, meaning that drug companies will immediately be able to sue TPP members if the companies’ expectations of IP-based profits are thwarted by fully lawful legislative, regulatory, or judicial decisions. Even more ominously, as soon as countries cross a threshold of $12,616 GNI per capita – roughly fourth...

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Investor-State Disputes Under Trade Agreements and the Affordability of Medical Care

Investor-state dispute resolution is a growing concern for governments like Canada that should want to preserve policy space for regulating business activity.  From licenses for fracking, mining, and timber cutting, to health and safety regulations, to labor policy, and to intellectual property rules, countries are finding their regulatory rules and decisions attached by investors whose expectations of future profits are affected by even-handed regulations or by appellate court decisions. Canada is currently embroiled in negotiations for a Trans-Pacific Partnership Agreement with the U.S. And ten other countries where a proposed investment chapter would reimpose all of the risks of abusive corporate claims that Canada is now experiencing under NAFTA.  As described in a story in last weekend’s Globe and Mail, one of the most egregious claims currently pending is one for $500 million by Eli Lilly challenging decisions by Canada’s appellate courts revoking or invalidating previously granted patents on two medicines.  Eli Lilly lost in Canadian courts fair and square, but it is pursuing a third bite at the apple by taking Canada to private arbitration, where a panel of three trade lawyers might undo Canada’s effort to require strict standards of patentability with respect to the “promise” made in patent applications on medicines. U.S. Negotiators seem blind to the possibility that the same kind of claims might be brought in the U.S. by foreign corporations who are upset...

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US Pharma v. India Patent Act: Myths Abound

The U.S. pharmaceutical industry and its Big Brother Chamber of Commerce have launched an all-out disinformation campaign against the India Patent Act and decisions rendered thereunder.  They have enlisted allies in the U.S. government, including Members of Congress, the United States International Trade Commission, Secretary of State Kerry, and even President Obama, to carry their claims to the highest levels of the Indian government.  They have threatened to insist that the U.S. file a WTO trade complaints against India in 2014 and that India no longer be permitted to export duty-free products to the U.S. under the Generalized System of Preferences.  As evidence for their campaign, the representatives of Big Pharma have claimed that India is violating US-based global norms for protecting patent rights, that it is adopting new patenting criteria not authorized by international law and allowing generic competition when it is not permissible, and that it is discriminating against U.S. pharmaceutical companies in favor protectionist policies that shield Indian generic companies and steal U.S. jobs.  Each and every one of these claims is false – and false in multiple ways. The U.S. cannot unilaterally impose global IP norms binding India In challenging each of the “dirty dozen” patent cases that U.S. and European pharmaceutical companies have lost in India in the past few years, the U.S. industry makes a background claim that the drugs at issue had...

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Brazilian Patent Law Report

The Brazilian Center for Strategic Studies and Debates has just released the English version of its major report – Brazil’s Patent Reform: Innovation Towards National Competitiveness. This 363-page report comprehensively addresses the need for patent law reform in Brazil.  The report addresses TRIPS compliance, TRIPS flexibilities, public health, and industrial policy rationales.  Scholars, experts, policy makers, and IP/access to medicines activists will benefit from close study of the Report.  I urge them further to signal their support for these positive changes by signing the academics/experts letter of support (and/or short technical brief) or the civil society support letter. The Report and the patent reform process will be formally launched in Brasilia on October 9, 2013.  Public officials from India and South Africa will be invited to attend, given that India’s approach to patent law policy has deeply informed the Brazilian approach and since the South African government has just issued its own draft IP Policy that proposes many of the same reforms that are being pursued by Brazil.  It is a positive signal to low- and middle-income countries more broadly that Brazil and South Africa join other countries like Uganda, Zambia, Botwana, and Malawi that are also taking proactive steps to incorporate lawful TRIPS compliant flexibilities including stringent standards of patentability, pre- and post-grant opposition procedures, easier-to-use compulsory and government use licenses, and restrictions on data/regulatory monopolies among others....

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Threat of Pharmaceutical-Related IP Investment Rights in the Trans-Pacific Partnership Agreement: An Eli Lilly v. Canada Case Study

After losing two patent cases before the appellate courts of a Western democracy, should a disgruntled foreign multinational pharmaceutical company be free take that country to private arbitration claiming that its expectations of monopoly profits had been thwarted by the courts’ decisions? Should governments continue to negotiate trade agreements where expansive Intellectual Property-related investor rights and investor- state dispute settlement (ISDS) are enshrined into hard law? Should we be concerned about the impact of billion dollar arbitral judgments on the willingness of governments to regulate pharmaceutical companies and to corral their efforts to expand their patent and data protection monopolies? Ultimately, should policy makers be concerned about the impact of investor rights on the affordability and accessibility of medicines both in rich and low- and middle-income countries? The answers to these questions become more urgent given proposed IP and Investment Chapters in the Trans- Pacific Partnership Agreement (TPP) and the recent NAFTA investor dispute notifications by Eli Lilly against Canada. The Eli Lilly case clarifies the risks of including IP rights in investment chapters and the boundary- pushing claims that can be brought on behalf of foreign pharmaceutical companies. Investment Treaty News 8-10 (2013), available at, http://www.iisd.org/pdf/2013/iisd_itn_sept_2013_en.pdf...

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With One Exception Current Trade Agreements Do Not Appear to Include Biologic Medicines in their Data Protection/Data Exclusivity Provisions – Implications for TPP Negotiation

The U.S., acting on behalf of the U.S. biologics industries, will soon be trying to convince parties to the TPP that they should adopt extended data exclusivity for biologics (at least 12 years) as part of the intellectual property chapter.  As part of its marketing strategy, the U.S. is trying to convince parties behind the scenes that biologic data exclusivity is already included in US FTAs and indeed in some of the FTAs already binding certain TPP parties.  Contrary to this assertion, there is no precedent for data protection for biologics at all in existing US FTAs, let alone for for the extended data exclusivity that the US will be seeking.  TPP parties should reject the US data exclusivities as TRIPS-plus, both for chemical entity pharmaceuticals and biologics. CLICK HERE FOR THE FULL...

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Civil Society Statement in Support of Brazilian Patent Law Reform

[UPDATE:  Spanish version of the statement added July 21.]  Activists and progressive health forces in Brazil have succeeded in catalyzing a proposal to reform Brazilian patent law to take advantage of key TRIPS flexibilities in order to increase access to affordable medicines. In August 2013, Brazil will issue a major report and proposed legislative reforms that will: eliminate patent term extensions and data exclusivity, restrict patents on new forms and new uses and tighten the inventive step requirement (following the India example), adopt government use procedures, and clarify the role that ANVISA, its drug regulatory agency, plays in the patent examination system. We hope to gain sign-ons from hundreds of civil society/activist organizations. To read and endorse the Civil Society Statement, please visit...

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Open for Signature: Letter in Support of Proposal to Amend Brazil’s Patent Law to Take Advantage of TRIPS Flexibilities

As many of you may have heard, Brazil has been engaged in a long process of studying patent law reform and in August 2013 (originally scheduled for July 10, 2013) will be issuing a major report and proposed legislative reforms.  In sum, as detailed below in (1) an open letter and (2) its attached brief technical review which has the text of the proposed bill as an annex, Brazil is seeking to incorporate lawful TRIPS flexibilities, into its patent law including: eliminating patent term extensions and data exclusivity, restricting patents on new forms and new uses and tightening the the inventive step requirement (following the India example), adopting a government use procedures, and clarifying the role that ANVISA, its drug regulatory agency, plays in the patent examination system. Sean Flynn, Amy Kapczynski, and I have worked on an academics/experts letter and brief technical review, both of which are open for signatures. CLICK HERE FOR THE SIGN-ON LETTER AND TECHNICAL...

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Congressional Letter Challenging Indian IP Policy Falsely Condemns Protectionism While Trouble-Shooting for Big Pharma

On June 18, 2013, 170 Members of Congress wrote to President Obama complaining about Indian trade policy and more particularly India’s intellectual property “climate.”  Under the umbrella of claiming that policies of the Government of India favor domestic producers over U.S. Exporters – in other words, that India is protectionist – the Members of Congress claimed that “the intellectual property (IP) climate has become increasingly challenging in India.” In particular, the letter complained about IP issues affecting pharmaceuticals:  “For example, last year several biopharmaceutical companies inappropriately had their patents revoked or their appeals denied by the India courts to market a variety of life-saving drugs in India.  Additionally, the Indian Government issued its first compulsory license (CL) on a stage three liver and kidney cancer drug.  It has been reported that additional drugs may be subject to CLs imminently and that the decisions related to these CLs are being improperly driven by an interest in growing the pharmaceutical market in India.  These actions by the Indian Government greatly concern us because innovation and the protection of intellectual property are significant driving engines of the U.S. economy.” Under the WTO TRIPS Agreement, India has every right to define standards of patentability so long as they satisfy minimum standards of patentability set forth in TRIPS, namely novelty, inventive step, and industrial activity.  India has elected to define and apply standards of...

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The Interaction of the Proposed LDC Extension Request and the 2016 Pharmaceutical Product Extension

The current request of WTO LDC Members for an unconditional extension of the time period within which they must become compliant with the TRIPS Agreement covers all forms of intellectual property protection under TRIPS.  Even though it is true that some LDCs have signed other treaties that might impose some IP obligations, e.g., the Paris Convention on Industrial Property or the Berne Convention for the Protection of Literary and Artistic Works, freeing themselves from the broader and stronger spectrum of IP mandates in TRIPS will enable their access to broad classes of essential public goods, including all medical commodities, educational and informational resources, agricultural resources, and green/climate control technologies. Some observers have wondered whether the current LDC Extension Request would cover the previous extension granted to LDCs in 2002 pursuant to Paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health covering “pharmaceutical products.”  In technical terms, that 2002 Extension applied with respect to Section 5 and 7 of Part II of the TRIPS Agreement, namely the sections dealing with patents and data protection.  The pharmaceutical product extension allowed countries not to implement, apply, or enforce patent and data rights with respect to pharmaceutical products. The term “pharmaceutical products” is not defined in the 2002 LDC Extension (which runs until Jan. 1, 2016), but whatever its interpretation it application is not as broad as all the...

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Global Academics’ Expert Letter on LDC Extension

Over 130 academics from around the world have signed a letter supporting the unconditional extension of the transition period within which least development country Members of the WTO must become fully compliant with the TRIPS Agreement until any such country ceases to be a least developed country. The letter articulates 10 reasons supporting the proposed extension, many drawn directly from the language of Article 66.1 itself. LDCs are locked in tense negotiations with other WTO Members at this time concerning the proposed extension and the EU and United States are reported to be taking the position that IPRs are good for development, that the extension must be time limited to 5 – 7-1/2 years, that it must preserve a requirement that LDCs maintain current levels of IP protection, and that they must use the transition period primarily to become TRIPS compliant rather than using it to develop their technological base and overcome capacity constraints.  The academics condemn this reasoning, arguing that granting the requested extension is mandatory once properly motivated, that Article 66.1 authorizes no conditions on extensions, and that the whole purpose of the transition period was to allow countries to eschew IP protections in order to develop their technological base and related capacities. Global Academics’ Expert Letter on LDC...

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Investors’ IP Rights Unbound: The Danger of Investment Clauses to Access to Medicines

[Cross posted from Equilibri.net] Although access to medicines activists have been wise to focus our attention intently on convincing low- and middle-income countries to adopt and use all possible TRIPS-compliant flexibilities and to oppose the TRIPS-plus IP chapters in free trade agreements, we have neglected to interrogate another chapter in free trade agreements and bilateral investment treaties that perhaps pose an even greater threat to our collective access to medicines – investment chapters. Access-to-medicines activists have recently had much to celebrate.  In India, the Supreme Court upheld India’s strict standards of patentability and rejected an “evergreening” patent on Glivec, an important cancer medicines that Novartis sells for $70,000 per year [i]. Earlier last year, the Indian Comptroller of Patents issued India’s first compulsory license on a Bayer cancer medicine, Nexavar, to Natco, thereby shaving the price by 97%.  The Intellectual Property Appellate Board of India affirmed that decision which is now on appeal to the High Court [ii].  On the trade front, India health activists succeeded in convincing the Indian government to reject European demands in EU-India trade negotiations that would have imposed data monopolies and extended the length of patent monopolies [iii].  Fortunately, India is not acting alone; Indonesia also quietly issued compulsory licenses on seven hepatitis and HIV antiretroviral medicines last year [iv], and Argentina recently adopted proactive guidelines to restrain secondary patents on minor modifications to existing...

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Legal Academics’ Expert Letter on LDCs’ TRIPS Extension Request

Several of IP justice academics are soliciting signatures from legal and other academics around the world who focus on human rights, intellectual property, trade, and development and who are in favor of the request by WTO least developed country Members that they be granted  an extension of the time period within which they must become compliant with the TRIPS Agreement.  WTO LDC Members were initially given an extension with respect to all TRIPS requirements except national and most favored nation treatment until 2006.  That transition period was further extended until June 30, 2013 in 2005 (a separate extension was granted on pharmaceutical products only until 2016) but with some unfortunate conditions (beyond the unreasonably short term), such as a requirement that LDCs must keep their current level of IP protections, something that was not required by TRIPS Article 66.1.  The  current request from LDC Members is for an unconditional extension of the transition period so long as an LDC Member is an LDC.  It is hoped that a longer and unconditional extension permitting rollback of improvidently adopted IP standards will allow LDCs to build their technological base and improve limiting domestic capacities.  This request has received support from 350 civil society organizations, from some industry groups, from several multilateral organizations, and from many developing country members of the WTO. We are seeking signatures to the letter appended below beyond...

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