US's "new" proposed TPP IP Chapter still requires patents on medicinal forms with "distinguishing features"
by, Prof. Brook K. Baker, Health GAP
Feb. 7, 2014
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, that that proposed a substantial weakening of patentability criteria, including required patenting of new forms and new uses of existing medicines: "[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 2012-13 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 Parties confirm that: (a) patents shall be available for any new uses or methods of using a known product and (b) a Party may not deny a patent solely on the basis that the product did not result in enhanced efficacy of the known product when the applicant has set forth distinguishing features establishing that the invention is new, involves an inventive step, and is capable of industrial application.”
The identical language in both US proposals is that TPP members would not be permitted to assess enhanced efficacy in determining whether an alleged invention is patentable. This provision is a direct challenge to section 3(d) of India's Amended Patents Act, which was famously used by the Supreme Court of India to deny Novartis's application for a patent on Glivec. Section 3(d) has been used in other opposition proceedings and decisions of the Indian Patents Office to deny secondary patents on minor variations to existing medicines where the variations do not evidence significantly enhanced efficacy in treating humans (not just in terms of physical properties like stability). Other countries are beginning to mimic the Indian provision, e.g., the Philippines, and comparable reforms are being proposed in important pharmemerging markets including Brazil and South Africa.
But in other respects, the new section 8(1)'s language concerning products with "distinguishing features" is linguistically equivalent to the earlier version concerning "new forms." Something new is something that is distinguishable from what existed before. Thus, many of the unpatentable new forms specified in India's section 3(d), e.g., "salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance" would have "distinguishing features" under the US proposal and thus be patentable.
IP maximalist positions in US TPP proposals never go away. The only patent demand that seems to firmly have been dropped is the US position outlawing pre-grant opposition procedures. The US is also reported to be proposing a transition period for Vietnam, Peru, Mexico, and Malaysia with respect to some of its patent and data monopoly demands, but that freedom will be temporary and partial.
Granting patents on new forms of existing medicines – or under the new language on forms with distinguishing features – is the essence of low/weak patent standards that results in evergreening – successive and recursive patenting of a medicine to extend the period of monopoly protection. TPP trading partners should continue to reject this US proposal or their access to affordable generics will be seriously constrained.
New Health GAP Report: “The Politics of Transition & Economics of HIV/AIDS & PEPFAR in South Africa”
Health GAP and partners have released a new report, “The Politics of Transition & Economics of HIV/AIDS & PEPFAR in South Africa,” which accompanies an article forthcoming in Journal of Acquired Immune Deficiency Syndromes.
The report looks at the PEPFAR "transition" in the country--moving from "directly supporting" over 1 million people on ARV treatment in South Africa in early 2011 to a near complete withdrawal from support for "direct services." The report tracks the impact of transition in both of the two main PEPFAR service models: patients in NGO/private clinics who needed to be moved to the public sector as well as those PEPFAR patients already in the public sector when PEPFAR-funded staff, infrastructure, and commodities were pulled out of public clinics.
The report finds that the political transition--toward increased South African ownership and innovative models of shared governance for U.S. funds--is yielding important benefits.
However, interviews across several months reveal that the transition moved far too quickly and was too often driven by contract end-dates than by the readiness of the public sector. Based on the only public study available, we estimate tens of thousands of people may have experienced care disruption because failed to track patients and ensure support for treatment continuity--though without patient tracking the exact size of the problem is not known. Meanwhile important human resources were lost to the AIDS response at a time when many more are needed.
The report recommends an urgent course correction for PEPFAR South Africa—tracing patients and health workers while considering a more measured approach in the country. Beyond South Africa the report recommends putting any further transitions on hold and clarifying PEPFAR’s commitment to support direct treatment support in low- and middle-income countries.
Read the full report online.
By Professor Brook K. Baker
Senior Policy Analyst, Health GAP
January 17, 2014
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 any merit whatsoever. No one checks if alleged innovation is in fact new or well known under existing industry practice. No one checks if the patent application impermissively makes numerous claims or duplicates claims made previously. Pfizer could get a patent on a peanut butter and jelly sandwich tomorrow if it wanted to.
PhRMA also likes the South African patent regime because it doesn’t allow anyone to come in and oppose a patent application even if it has not merit. PhRMA likes the SA patent regime because it’s so cumbersome to get a compulsory license that no such license has ever been issued. Ditto with respect to parallel importation (buying a brand drug more cheaply in another country and importing it when excessive prices are imposed domestically.
What PhRMA doesn’t like about the proposed SA reform that SA Draft IP Policy recommends: (1) tightening up patenting standards, (2) examining patent applications vigorously, (3) allowing other parties to oppose patent applications, (4) limiting patent terms to 20 years only, no extensions, (5) disallowing monopolies based on data/registration exclusivity and patent/registration linkage, and (6) adopting easier to use parallel importation and compulsory license mechanisms. Each and every one of these provisions is lawful; each and every one is acknowledged by international bodies including WIPO, the WTO, UNDP, UNAIDS, WHO and others; each and every one is a wise exercise of public authority that – in accordance with the Doha Declaration on TRIPS and Public Health – prioritizes public health and access to medicine for all.
Instead of these commonsense, lawful, and indeed modest reforms, the united pharmaceutical industry wants to push for “stronger” and more “comprehensive” IP protections – IP that produces stronger, longer, and broader monopolies, monopolies that exclude competition and allow unfettered monopoly profits.Certainly PhRMA is interested in extra monopoly profits to be made in South Africa, but it is interested in monopoly profits in Africa more broadly and in so-called pharmemerging economies where the bulk of its future profit growth will come from. In other words, PhRMA and the consulting firm it is hiring, Public Affairs Engagement, are worried about South Africa as a precedent:
If the principles in the draft [IP Policy] are adopted, not only will South Africa become less hospitable to the Life Sciences sector, it may also provide the model for other developing nations, inside and outside Africa, including such important aspiring economies such as India and Brazil.
South Africa is now ground zero for the debate on the value of strong IP protection. If the battle is lost here, the effects will resonate. … A robust public affairs program is necessary to create the environment for a sensible IP policy to be adopted by the Cabinet and implemented through legislative processes. … Without a vigorous campaign, opponents of strong IP will prevail – not just in South Africa but eventually in much of the rest of the developing world.
Strong patent rights are the goose that lays the golden eggs for Big Pharma worldwide. For PhRMA, the movement for pro-health reform – the fox in the goose house – must be crushed. The precedent must be defeat, not victory.However, PhRMA does not intend to argue its case on the merits. It plans a disinformation and closed-door lobbying campaign full of lies and innuendos. First and foremost, it plans to argue that IP reform will retard domestic and foreign investment and that stronger IP will open the doors to investment, growth and development. However, if easy patents were good for South Africa, it should be awash in investment now, since it is virtually impossible not to get any patent you want in South Africa today. Indeed, all available evidence shows that stronger IP has not positive correlation with increased investments in South Africa or any other African or lower-income country. But, it isn’t evidence or logic that PhRMA wants to sell – it’s fear.
Second, PhRMA plans to sell fear of competition, most notably from Nigeria, Africa’s other economic powerhouse. Somehow, according to the planned obfuscation game, Nigeria will leap ahead of South Africa if South Africa simply adopts internationally acknowledged IP standards, including fully lawful flexibilities allowing countries to bypass patents to respond to public health needs and to overcome monopoly abuses. It doesn’t matter that Nigeria has poor infrastructure, under-developed human capacity, and the lack of a technological base – all it needs is for South Africa to adopt IP reform and its economic transformation will be complete.
Third, PhRMA wants to argue that “South Africa’s health problems are the result, not of lack of drug access, but of poor health infrastructure, improper management, and, ultimately, poverty.” Here, PhRMA’s not lying per se, but it is guilty of implicature – the half truth that tells a lie. Perhaps PhRMA can explain why excessive drug prices miraculously improve health systems and management. Better yet, maybe it can explain how exorbitant prices cure poverty!
But PhRMA’s shill, the PAE, makes clear that “we do NOT want a debate over individual drug prices to become the focal point of the campaign.” Well, one can certain understand that – just because high prices are the most fundamental feature of the IP regime, why would PhRMA want anyone to talk about that?
Although PhRMA plans to ally with local proxies like the Innovative Pharmaceutical Industry Association of South Africa, SA business groups, and compliant academics, the campaign will be run from Washington. Operating under a euphemism like “Forward South Africa” and ostensibly led by a “respected former government official, business leaders, or academic,” the publicity and intense lobbying campaign would be actually be run by US-based PAE, which promises that “any and all research, op-eds, blog posts, and other material” will be reviewed and commented upon by PhRMA. PAE promises to consult with PhRMA every step of the way.
Big Pharma was shamed in front of the whole world over its 1998-2001 lawsuit against South Africa that used a phalanx of lawyers to try to defeat TRIPS-compliant parallel importation and generic substitution. Tail between its legs, the 39 drug companies and pharmaceutical association that sued Mandela finally withdrew their case following a deluge of negative press in March of 2001. PhRMA, on behalf of that same industry, is now bearing its fangs again, but will use misleading studies, op-eds, and threatening lobby visits to delay and even reverse pro-health reform. Fortunately, the global press and treatment activists are lifting the curtain and shining a spotlight. But it will take concerted effort to win this pro-health campaign against a US-dominated industry that over and over again cries crocodile tears about poor peoples’ health while gouging their governments for every last penny of monopoly profit.
Originally printed in The Lancet: Global Health, January, 2014.
The US President's Emergency Plan for AIDS Relief (PEPFAR) has been one of the most effective foreign aid programmes in history. It reached 6·7 million people with antiretroviral therapy in 2013,1 and has also strengthened country health systems, provided billions of dollars in aid to biomedical and behavioural prevention programmes, and helped to drive declines in morbidity and mortality in many countries in sub-Saharan Africa.2 PEPFAR began as an emergency response, after relative inaction by wealthy nations, and rapidly built disease-response capacity by funding non-governmental organisations. Although PEPFAR, even in the early years, helped to strengthen health systems,3, 4 it also faced criticism that it created parallel structures;5 criticism the programme has responded to in recent years by shifting much of its clinical funding to local partners. The programme has increasingly emphasised country ownership and has responded to aid effectiveness concerns, creating innovative shared governance structures, such as those in South Africa. Similarly, PEPFAR's recent structured coordination with the Global Fund to Fight AIDS, Tuberculosis, and Malaria is a laudable effort to harmonise bilateral and multilateral health programming.
However, transparency has declined rather than improved. A recent analysis in the Aid Transparency Index ranked PEPFAR as very poor—50th of 67 aid agencies worldwide.6 The report noted that, “PEPFAR does not disclose information on contracts to prime partners and sub-partners in a machine-readable and open format consistent with the US Open Data Policy.”
Just a few years ago, countries met after the Paris Declaration on Aid Effectiveness and agreed to an Accra Agenda for Action6 that put public transparency at the centre of the global aid effectiveness project:
“Donors will publicly disclose regular, detailed and timely information on volume, allocation and, when available, results of development expenditure to enable more accurate budget, accounting and audit by developing countries” (section 24).
It is striking that there is probably more data for the planning, spending, and outcomes of PEPFAR programmes than for any other aid programme in the world. PEPFAR undertakes a careful and detailed planning process every year for every country that receives aid—a process of creating Country Operational Plans that includes consultation with governments and detailed interagency priority setting. PEPFAR has also done expenditure analyses that show, in detail, what the provision of specific AIDS-related services cost in various geographical and implementation settings.
However, PEPFAR refuses to make data fully public in a timely manner. Country Operational Plans are published only many months after the year's programming has already finished, and then with unexplained redactions of nearly all relevant data. Programmatic goals and targets for each country are inexplicably missing, making the published plans largely useless to increase understanding of the successes or failures of the programme. In a departure from the early years of the programme, the most recent reports to the US Congress do not contain even the most basic data about how programme funds are allocated to programmatic areas.
It is time for PEPFAR to become a leader in transparency, to share its data in the service of its mission to end the AIDS crisis, and to expand real country ownership. If published as soon as they are approved for the coming year, with details about the interventions funded, geographic areas of activity, and specific goals and targets, then Country Operational Plans could be important instruments for partner governments and civil society. Knowledge of exactly what PEFPAR-funded non-governmental organisation are doing, what gaps they are filling, and what outcomes they are expected to achieve should be central to the planning of the AIDS response in these countries. Civil society in countries that receive PEPFAR funding could be mobilised to help to monitor the effectiveness of PEPFAR programmes, as well as their own government's efforts alongside donor-funded efforts. Meanwhile, PEPFAR costing studies could be crucial for national programme planners—how much the delivery of antiretroviral therapy costs in a given region should be essential information to be shared with the world. A bill recently passed by US Congress will require greater PEPFAR reporting,8 but is unlikely to change practice for the Country Operational Plans, which is a missed opportunity.
Even more importantly, PEPFAR can engage in a planning process that is itself transparent and consultative. Global health initiatives miss important opportunities to strengthen public health systems and civil society capacity when they do not structure governance mechanisms for substantive engagement with the organised end-users of their programmes.9 When PEPFAR supports a major portion of AIDS services in a country, lack of knowledge of and ability to affect allocation decisions results in a major democratic deficit. A recent diplomatic cable instructed PEPFAR teams to begin engaging civil society,10 but there is a danger it will be simply be a pro forma exercise. If, instead, engagement is substantive, and Country Operational Plans and costing studies are made public, PEPFAR could use its data and planning processes to drive not only AIDS objectives, but democracy-strengthening too.
We declare that we have no conflicts of interest.
1 The White House. Fact sheet: shared responsibility to strengthen results for an AIDS-free generation. Office of the Press Secretary, Dec 2, 2013. http://www.whitehouse.gov/the-press-office/2013/12/02/fact-sheet-shared-responsibility-strengthen-results-aids-free-generati-0. (accessed Dec 4, 2013).
2 US Department of State. Blueprint for Creating an AIDS-free Generation. Available from: http://www.pepfar.gov/documents/organization/201386.pdf. (accessed Oct 28, 2013).
3 Kruk ME, Jakubowski A, Rabkin M, Elul B, Friedman M, El-Sadr W. PEPFAR programs linked to more deliveries in health facilities by African women who are not infected with HIV. Health Aff (Millwood) 2012; 31: 1478-1488. CrossRef | PubMed
4 Kiwanuka N, Stover B, Lim T, et al. Did PEPFAR funding affect non-HIV health indicators? Longitudinal study of facility-based baby deliveries in Uganda, 2005—10. Lancet 2013; 381: S74. Summary | PDF(42KB) | CrossRef | PubMed
5 Biesma RG, Brugha R, Harmer A, Walsh A, Spicer N, Walt G. The effects of global health initiatives on country health systems: a review of the evidence from HIV/AIDS control. Health Policy Plan 2009; 24: 239-252. CrossRef | PubMed
8 Menendez R. PEPFAR Stewardship and Oversight Act of 2013: 113th Congress, Sept 18, 2013.
9 Cohn J, Russell A, Baker B, Kayongo A, Wanjiku E, Davis P. Using global health initiatives to strengthen health systems: a civil society perspective. Glob Public Health 2011; 6: 687-702. CrossRef | PubMed
10 US Department of State. Unclassified cable to all diplomatic and consular posts: involving civil society as part of country-level planning. Washington DC. http://www.pepfar.gov/press/releases/2013/211026.htm. (accessed Oct 28, 2013).
7 Accra Agenda for Action. Accra: Organisation for Economic Co-operation and Development, 2008.
a University of Pennsylvania and Health Global Access Project, Philadelphia, PA 19104, USA
b Northeastern University School of Law and Health Global Access Project, Boston, MA, USA
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Contact: Brook Baker: +1 617 259 0760 * B.Baker@neu.edu
Paul Davis: +1 215 833 4102 * firstname.lastname@example.org
Medicines Patent Pool agreement with Bristol-Myers Squibb expands access to critical second-line AIDS medicine, even while BMS excludes some middle-income countries. More companies should join the Pool and offer expanded geographic coverage.
Health GAP applauds the announcement of a new licensing agreement negotiated by the Medicines Patent Pool with Bristol-Myers Squibb (BMS) for a key second-line protease inhibitor, atazanavir (ATV). Although the official territory is comprised of 110 low- and middle-income countries, a key clause allows generic licensees to sell without obstacles in another 34 countries where no ATV patent is in force. In addition, generic licensees will be able to supply countries that issue compulsory licenses. The new agreement effectively extends coverage to many more people with HIV than the prior 49-country deal BMS had previously confidentially negotiated with three generic licensees.
The scope of the license covers nearly 90% of people living with HIV in low- and middle-income countries, but the remaining 10%, who live in middle-income countries, are still not covered. Some of the excluded 10% are left without coverage because they fall under a separate bilateral agreement made between BMS and the Brazilian Government. People living with HIV need 100% coverage and thus urge the MPP, BMS, and other MPP licensors like Gilead to expand geographic coverage.
“Companies with existing MPP agreements should commit to expanding coverage,” said Professor Brook Baker, Senior Policy Analyst for Health GAP. “But it is also essential that other companies with critical new medications enter into open-access licenses with the Pool and ensure coverage for all low- and middle-income countries. This is particularly urgent for ViiV, whose majority shareholder, GlaxoSmithKline is demanding extremely narrow coverage for dolutegravir. Abbvie should open access to lopinavir and ritonavir separately so that ritonavir can be used as a booster with ATV and other protease inhibitors. Also, Merck and Johnson & Johnson, the last two hold-outs, must speedily license their HIV drugs,” said Baker.
“Achieving an AIDS-Free Generation requires expanding access to better ARV treatment regimens, and that depends on a critical mass of companies joining the Medicine Patent Pool with overlapping territories. There is urgency with respect to existing WHO-recommended regimens, but we also demand rapid access to critical new, improved ARVs like dolutegravir and tenofovir pro-drug," said Paul Davis of Health GAP.
“People with HIV in low- and middle-income countries have a right to expedited access to the latest treatments that are more effective, longer lasting, and have fewer side effects. Many of the ground-breaking new medications will be much, much cheaper to produce because they contain simpler molecular structures and lower amounts of active ingredients,” said Health GAP’s Maureen Milanga in Nairobi. “We need GSK and Merck to speed up talks with the Patent Pool for game-changing new products like TAF and DTG.”
“Governments that aren't included in MPP licenses should issue compulsory licenses and use all other public health flexibilities that are part of the WTO’s TRIPS Agreement,” stated Health GAP’s Asia Russell. “Such options will have a much more positive impact on affordability and access than industry-oriented proposals such as tiered-pricing initiatives.”