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.
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.
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.
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
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.
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.
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 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.
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.
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.
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 NGO delegation to the Board of UNITAID offers its strong support for the proposal of WTO least developed country Members to extend the transition period for enforcing protections for pharmaceutical related patents and clinical data “for as long as the WTO member remains a least developed country.” The proposal, IP/C/W/605, was offered by Bangladesh on behalf of LDCs at the 24-25 February 2015 meeting of the WTO TRIPS Council and will be taken forward at its next 1 June 2015 meeting.
In addition to seeking an unconditional extension of the current pharmaceutical transition period set to expire on 1 January 2016, the LDCs also seek a waiver from the General Council with respect to two additional transition measures, namely mailbox and exclusive marketing rights provisions under Articles 70(8) and 70(9) of the TRIPS Agreement.
LDCs Members have submitted a duly motivated request for an unconditional extension of the 2002-2016 pharmaceutical transition period (covering patents and data) and for relief from the requirements of TRIPS Article 70.8 and 70.9 (mailbox and marketing exclusivity provisions). This expert analysis confirm LDCs’ need and entitlement to the requested extension.