Author: Brook Baker

Canada Blinks in Face of US/Pharma Pressure

Supreme Court Adopts Wink-Wink Patent Utility Rule In a stunning reversal of policy, on June 30, 2017, the Supreme Court of Canada overturned decades of precedent making it easier for the biopharmaceutical industry to gain patents on medicines without any real proof of a claim that a putative invention has any meaningful utility.  This reversal in AstraZeneca Canada Inc. v. Apotex, Inc. is particularly disconcerting because Canada had just won an investor-state arbitration award in the long awaited Eli Lilly v. Canada case upholding its more stringent promise/utility doctrine that had been used successfully to overturn two dozen secondary patents, particularly those claiming new uses of known medicines, where patent claimants failed to present evidence in support of the prediction of therapeutic benefit promised in their patent applications. Canada had been under intense pressure from the US, which had placed Canada on its Special 301 Watch List for five years threatening that the promise/utility doctrine unreasonably harmed Big Pharma in the US and from the pharmaceutical industry itself which claimed that the doctrine violated global patentability criteria.  President Trump’s hardball campaign promise to rewrite or leave the North American Free Trade Agreement because of its failure to adequately protect US intellectual property interests may also have played a role.  Likewise, President Trump’s more recent assertions that US payers are unreasonably subsidizing biomedical research and development because other countries, like...

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International Collaboration on IP and Access to Medicines: Birth of South Africa’s Fix the Patent Laws Campaign

Abstract: In 2000, my colleague Yousuf Vawda and I became active in the global campaign to address intellectual property rights (IPRs), human rights, and barriers to access to affordable medicines for treating HIV and AIDS in South Africa. This paper details their academic collaboration, their activist-oriented “clinical” offering, and the vibrant campaign that it helped to spawn. It also situates the Fix the Patent Laws Campaign (the “Campaign”) within the global framework of pro-Pharma legal rules and diplomatic pressures, showing the connections between the global political economy and local reform efforts grounded in the right to health enshrined in the South African Constitution. In Part II, I discuss the beginning of my involvement in IP and access-to-medicines work. Part III describes law reform efforts that address upstream barriers to the right to health and the collaboration between academics, practitioners, funders, and social movements that help energize needed reforms. Part IV explains the creation of IP systems that block access to generic medicines. Part V outlines the IP flexibilities permitted by the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Part VI discusses the deficiencies of the South African Patents Act of 1978. Part VII focuses on my involvement in developing a two-week IP course at the University of KwaZulu-Natal (UKZN). Part VIII details the creation of the Fix the Patent Laws Campaign. Part...

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Submission by Academics, Experts, Scholars and Pro-Access Advocates to South Africa’s Intellectual Property Consultative Framework

Joint submission authored by Yousuf Vawda, Andrew Rens, Andrew Rens, Brook Baker, Tobias Schonwetter, and Achal Prabhala; and co-submitted by 44 other academics, experts, scholars and advocates.  The full submission is available here as a printable PDF.  The introduction follows. The Department of Trade and Industry’s (the dti) Intellectual Property Consultative Framework (the Framework) identifies the intersection between intellectual property (IP) and public health as a priority area that requires immediate domestic review. Thus, the focus of this submission is on this priority area. In crafting an IP policy framework affecting, among other things, medical technologies, policy and lawmakers must address the tension that exists between the protection of IP rights and human rights – the rights of the public to have access to medicines and other health technologies necessary for their well-being. If there had been any doubt about how to resolve this tension, then the issue must surely have been settled with the release of the Report of the UN Secretary-General’s High Level Panel on Access to Medicines on 14 September 2016 (the Panel Report). The Panel Report states: “Human rights are fundamental, universal entitlements that people inherently acquire by virtue of their birth. In comparison, intellectual property rights are ‘one policy tool among many for encouraging innovation and technological research and development.’ Intellectual property rights are temporary, revocable, transferable privileges granted by states and can be...

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Trans-Pacific Partnership Provisions in Intellectual Property, Transparency, and Investment Chapters Threaten Access to Medicines in the US and Elsewhere

Baker BK (2016) Trans-Pacific Partnership Provisions in Intellectual Property, Transparency, and Investment Chapters Threaten Access to Medicines in the US and Elsewhere. PLoS Med 13(3): e1001970. doi:10.1371/journal.pmed.1001970 Introduction: A new Pacific-Rim trade agreement threatens future access to affordable medicines in the United States and abroad. Buried in 6,000-plus pages of text, annexes, and side letters, there are multiple provisions—complex in their articulation, but simple in their effect: they dramatically increase monopoly protections for the transnational originator pharmaceutical industry. With the Trade Promotion Authority, a procedure for accelerating congressional approval of trade agreements, enacted after a brutal and circuitous congressional battle in June [1], parties to the Trans-Pacific Partnership Agreement (TPP) finally reached a draft agreement on October 4, 2015 [2], and released the text one month later [3]. This trade pact, negotiated by the US for more than five years, involves 12 countries controlling nearly 40% of the global economy. The biggest players are the US and Japan, but there is a mix of other rich and middle-income countries, including Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam. Critical issues affecting future access to affordable medicines are at the center of the agreement. One of the most contentious chapters in the TPP is the Intellectual Property (IP) Chapter [4], whose patent, undisclosed-test-or-other-data, and enforcement provisions could dramatically affect access to affordable medicines. Equally contentious is...

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Health GAP Submission to U.S. House of Representatives Ways and Means on the Trans Pacific Partnership and Access to Medicine

U.S. House of Representatives Ways and Means Committee Hearing, Dec. 8, 2015 Written Submission from Health GAP (Also available as a PDF) In its issue analysis paper, the Committee on Ways and Means posed three basic questions about the Trans Pacific Partnership and its impacts on access to medicines: 1) Does the current TPP text provide an appropriate balance between the need to incentivize innovation and to provide access to affordable medicines for patients in developing countries, like the balance struck under the May 10 Agreement of 2007?  2)Does the current TPP text either require changes to existing U.S. health or intellectual property laws, or prevent the United States from making reasonable changes to those laws?  3)What period of exclusivity is provided for biologic medicines, and is the period sufficient to incentivize the production of new biologic medicines in the future while also ensuring access to affordable medicines? This submission from Health Global Access Project (GAP) discusses each of these issues and includes a chart analyzing relevant textual provisions and their impact on access to medicines. The TPP does not provide an appropriate balance between innovations and access to affordable medicines for patients in developing countries. Four parties to the TPP are classified as developing countries: Vietnam, Malaysia, Mexico, and Peru. These four countries are at different stages of development, but for each of them their gross national product...

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TPP = Transnational Pharmaceutical Profiteering – Big Pharma’s Monopolies Strengthen and Multiply in Trans Pacific Partnership Trade Agreement

After five years of secret negotiations directed and controlled by pharmaceutical lobbyists and drug-company-dominated trade advisory groups, the official text of the Trans Pacific Partnership negotiated by the Obama administration has been released. The text confirms critics’ worst fears – pharmaceutical behemoths like Pfizer, Bristol-Myers Squibb, Merck, Glaxo-Smith Kline, and Abbot Laboratories have gain expanded monopoly protections and greatly enhanced enforcement rights. Patients, both domestically and abroad, will suffer delayed access to more affordable medicines and biologics. In the U.S., resulting prices increases will lead to even more rationing and burgeoning out-of-pocket payments. In low- and middle-income TPP partners, excessive prices that neither patients nor governments can afford can and will result in death. In the mind-numbing blur of thousands of pages, killer text can be found. There are express mandates requiring patent term extensions beyond the twenty years required by international law. There are mandatory monopolies on new uses of know medicines and provisions that make it easier to get secondary patents that are only weakly inventive and that also lengthen patent monopolies. There are additional monopolies on the regulatory data submitted by Big Pharma on small molecule medicines, monopolies blocking generic competition that start at five years but can be extended for successive three-year periods. And there are new monopolies on biologic regulatory data that effectively forestall the marketing of biosimilars for at least eight years. To...

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LDCs Be Damned: USTR and Big Pharma seeks to eviscerate Least Developed Countries’ Insulation From Pharmaceutical Monopolies

In November of 2001, at the height of the global AIDS pandemic, every WTO member country in the world, including the United States, voted unanimously in the Doha Declaration on the TRIPS Agreement and Public Health that WTO Least Developed Countries members should be granted an unconditional extension of any obligation to grant or enforce patents, data protections, or exclusive marketing rights on pharmaceutical products.  These countries desperately needed access to affordable generic medicines and freedom from the pillage of Big Pharma’s monopoly pricing.  This sensible and humane transition policy was confirmed by votes of the WTO TRIPS Council and General Council in 2002. Fast forward to 2015, and LDCs are again seeking an extension of that same no-pharmaceutical-monopolies policy, which expires on January 1, 2016.  Their request has reportedly received approval in nearly every capital of the world – except Washington D.C. (with some weakening opposition from Australia, Canada, and Switzerland).  Nothing in the plight of least developed countries has changed – they remain desperately poor, they continue to lead the world in negative health statistics and early death, and they continue to struggle with development challenges and inadequate capacity in their industrial, technological, and administrative sectors.  More to the point, they continue to need access to affordable medicines, and, if possible, new manufacturing capacity and expertise to produce at least some medicines on their own. What the LDCs seek is simple: rather than another...

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Corporate Power Unbound: Investor-State Arbitration of IP Monopolies on Medicines – Eli Lilly v. Canada and the Trans-Pacific Partnership Agreement

Brook K. Baker and Katrina Geddes Abstract: Despite the deep irony of free trade agreements being subverted to codify and extend anti-competitive monopoly rights and despite the equally deep irony of foreign investors having greater enforcement rights than local investors, the joining of enhanced intellectual property rights (IPRs) and protections and strengthened investor rights is creating a wild-west opportunity for unbounded corporate power. Two current contestations show the dangers of this expanded power in sharp relief. In the Trans-Pacific Partnership Agreement (TPPA), at the behest of its powerful pharmaceutical lobby, the United States is seeking the most extreme forms of pharmaceutical patent, data, and enforcement rights that have ever been proposed at the same time that it is seeking enhanced IP-related investor rights in the most recently leaked Investment Chapter. In the pending investor-state-dispute-settlement case under an older but parallel North America Free Trade Agreement (NAFTA) investment clause, an American pharmaceutical company, in Eli Lilly v. Canada, is for the first time claiming $500 million in investment-related damages because of Canada’s sovereign decision to invalidate previously granted patents on two medicines on the grounds that those patents failed to meet well-established Canadian standards of patentability. This article is not written as an abstract juxtaposition of these two current events. It is written to expose the dangers that countries face, especially low- and middle-income countries, in trade negotiations with the...

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Will the U.S. Create Barriers to LDCs’ Future Access to Medicines?

Earlier this year, WTO Least Developed Country Members requested an unconditional extension of the expiring WTO TRIPS transition period that exempts them from having to implement pharmaceutical patents and other intellectual property protections that constrain their ability to make or procure low-cost generic medicines. Informed sources indicate that the U.S. is currently opposing the LDC draft extension. While the exact US government position has not yet been made public, it seems likely from past US positions that the US Trade Representative might be opposing several of the most important elements of LDC request that make the extension truly meaningful for access to medicines. As the next TRIPS Council meeting is on October 15, it is likely that the USTR has begun bilateral negotiations with LDCs with respect to their request for an unconditional extension from the requirements of the TRIPS Agreements with respect to pharmaceutical patents, data protections, marketing exclusivity, and mailbox requirements. LDCs are seeking an extension for as long as they remain LDCs. They ground their request both on the language of the Doha Declaration on the TRIPS Agreement and Public Health and Article 66.1 of the TRIPS Agreement. These binding, unanimous-consent documents grant LDCs the right to seek further extensions of their TRIPS transition period and require that such extensions “shall” be accorded upon properly motivated request. The USTR is continuing its traditional silence on its...

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Removal of “New Forms” Patent Protection in Most Recent TPP Draft

After a long campaign by right-to-health activists and TPP partners, it appears that the U.S. has finally dropped its efforts in TPP negotiations to require patent coverage for new forms of known products that lack evidence of enhanced efficacy. The most recent previous leaked draft TPP patent chapter contained Article QQ.E.1.2 which stated that a “patent may not be denied solely on the absence of enhanced efficacy of a known product where the applicant has set forth distinguishing features.” This provision – or any equivalent – is now absent from the draft text leaked by KEI yesterday. The deleted provision had been proposed as a direct challenge a patent exclusion/standard-of-inventiveness used by India in section 3d of its Amended Patents Act to prevent ever greening of patent monopolies by minor changes to the chemical form of a known substance or by a mere new dosage, new formulation, or new combination of known substances in the absence of evidence of a significant therapeutic effect. This anti-evergreening standard is gaining traction in state practice elsewhere having been adopted by several other countries and under discussion in others. The universal opposition to the U.S. “new form” proposal by other TPP partners, rich and poor, bodes well for the defense of India’s section 3d against ideological attacks by the U.S. and for further adoption of comparable provisions in law reform efforts in Brazil,...

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