Please follow CIEL's new blog at: http://intlenvlaw.wordpress.com/
Please follow CIEL's new blog at: http://intlenvlaw.wordpress.com/
In a recently filed amicus brief, the US Department of Justice (DOJ) departed from long standing US case law and policy that allows for the patenting of isolated genes, arguing that isolated genes are part of nature and thus not patent eligible. Both biotechnology and medical industry trade associations argue that these patents continue to be critical to incentivizing future innovation. The amicus brief is regarding the case of breast cancer genes, held unpatentable by a US District Court in the Southern District of NY, which is currently being appealed.
The DOJ’s amicus brief can be accessed here: http://graphics8.nytimes.com/packages/pdf/business/genepatents-USamicusbrief.pdf
UPOV is entering a new era of transparency & inclusiveness.
The decision of the International Union for the Protection of New Varieties of Plants (UPOV) to grant observer status to civil society and farmers’ organizations at its annual ordinary session on October 21, 2010 suggest the possibility of a new era of transparency and inclusiveness in UPOV’s discussions.
On 21 October 2010, UPOV’s Council agreed to grant observer status to the Association for Plant Breeding for the Benefit of Society (APBREBES) and to European Coordination Via Campesina (ECVC) for the Council, the Administrative and Legal Committee (CAJ), the Technical Committee (TC) and the Technical Working Parties (TWPs).
UPOV is an intergovernmental organization headquartered in Geneva (Switzerland) where international rules on plant variety protection are defined with major impacts for food sovereignty, biodiversity and farmers’ rights.
“Farmers are the main users of seeds protected through the intellectual property rights-based system of UPOV. We are therefore grateful to the UPOV member states for granting ECVC observation status. Farmers have the right to be informed and to observe what happens in UPOV”. -- Josie Riffaud, head of biodiversity, seeds and environment in ECVC, which represents 24 farmers’ organizations in 16 European countries, and around 200 000 producers.
“We hope that our participation in UPOV deliberations will widen UPOV’s perspective and enable a balanced approach to plant variety protection that stresses on farmers’ rights and the sustainable use of genetic resources” -- Francois Meienberg, Berne Declaration, a founding member of APBREBES
“UPOV’s decision to grant observer status to ECVC and APBREBES is in line with the current trend of increased transparency and inclusive participation in intergovernmental organizations such as seen in the World Intellectual Property Organisation. This decision should be seen as a first step towards more transparency and inclusive discussions in UPOV. We look forward to constructive collaboration with UPOV -- Sangeeta Shashikant from Third World Network (APBREBES).
No observers are allowed to the main decision making body of UPOV, the Consultative Committee. Only a limited number of UPOV documents are available to the public at the organisation’s website, while a major part of documents are only accessible by passwords at restricted areas.
ECVC is a member of Via Campesina, the biggest international movement of peasants, small- and medium-sized producers, landless, rural women, indigenous people, rural youth and agricultural workers. ECVC is composed of 24 farmers and agricultural workers’ unions from across Europe.
APBREBES is founded by organizations working on plant breeding and issues related to UPOV regulations. APBREBES is made up of the following organizations: Berne Declaration (Switzerland); Center for International Environmental Law (USA); Community Technology Development Trust (Zimbabwe); Development Fund (Norway); Local Initiatives for Biodiversity, Research and Development (Nepal); Searice - The Southeast Asia Regional Initiative for Community Empowerment (Philippines); and Third World Network (Malaysia).
The adoption of the new treaty came at the end of the five-day meeting of the governing body of the Cartagena Protocol on Biosafety (known as the Conference of the Parties serving as the meeting of the Parties to the Protocol or COP-MOP 5) and concluded six years of negotiations.
The new supplementary Protocol provides international rules and procedure on liability and redress for damage to biodiversity resulting from living modified organisms (LMO). Setting the stage for its adoption, small group of government negotiators had resolved contentious issues and agreed on the text of the supplementary Protocol just six hours before the opening of the COP-MOP 5 meeting on Monday.
Mr. René Lefeber of the Netherlands, one Co-Chairs of the Group of the Friends that negotiated the text of the new treaty said: “It has been many years since the last global environmental agreement was agreed.
The adoption of new supplementary Protocol during the International Year Biodiversity will give new impetus to multilateral environmental negotiations. This agreement will also make important contribution to the on-going work under the Convention on Biological Diversity to protect life on earth.”
The new treaty shall be open for signature at the United Nations Headquarters in New York from 7 March 2011 to 6 March 2012 and will enter into force 90 days after being ratified by at least 40 Parties to the Cartagena Protocol on Biosafety. .
The historic meeting of the Parties to the Protocol, held in the city of Nagoya, in Aichi prefecture, Japan, adopted seventeen other decisions. These included adoption of a ten-year Strategic Plan for the implementation of the Protocol, a programme of work on public awareness, education and participation concerning LMOs, and further guidance on risk assessment and risk management.
At the closing ceremony of COP-MOP 5, Ms. Masayo Tanabu, Parliamentary Secretary of Ministry of Agriculture, Forestry and Fisheries, speaking on behalf of the Government of Japan, stated: “The new supplementary Protocol is a turning point for the Cartagena Protocol on Biosafety. There have been many challenges successfully overcome. Let us rekindle the spirit of cooperation to confront the biodiversity challenges as well.”
Mr. Ahmed Djoghlaf, Executive Secretary of the Convention on Biological Diversity praised Japan as an outstanding host and paid tribute to delegates for the outcomes of the meeting. He said: “I congratulate all of you on this remarkable achievement. We have dreamt of this event for more than six years. This is indeed a historic event not only for the biodiversity family but also for the world community at large.”
Notes for Journalists
1. The Cartagena Protocol on Biosafety, a supplementary treaty to the Convention, seeks to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology. To date, more than 120 countries have developed legal and administrative frameworks necessary to implement the Protocol and 159 countries and the European Community are party to the Protocol. The Secretariat of the Convention on Biological Diversity and its Cartagena Protocol is located in Montreal.
2. Since the adoption of the Protocol on 29 January 2000, the COP-MOP has held five meetings – in Kuala Lumpur in February 2004; in Montreal in June 2005; in Curitiba, Brazil, in March 2006; in Bonn, Germany, in March 2008; and in Nagoya, Japan, in October 2010.
3. Article 27 of the Protocol states that: “The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms, analysing and taking due account of the ongoing processes in international law on these matters, and shall endeavour to complete this process within four years.”
4. At its first meeting, the COP-MOP established an Ad Hoc Open Ended Working Group of Legal and Technical Experts on Liability and Redress to elaborate options for elements of international rules and procedures on liability and redress under the Protocol. At its fourth meeting, the COP-MOP on the basis of the final report of the Working Group further negotiated and produced proposed operational text for the international rules and procedures on liability and redress as the basis for further negotiations. To continue the process, the COP-MOP established a Group of the Friends of the Co- Chairs Concerning Liability and Redress in the Context of the Protocol.
5. The Group of the Friends of the Co-Chairs further negotiated the proposed operational texts and produced draft text for a supplementary protocol on liability and redress to the Biosafety Protocol. The draft text was further negotiated at second and fourth meetings of the Group. The fourth meeting of the Group was held in Nagoya from 6 to 11 October 2010, prior to COP-MOP 5 to resolve outstanding issues and finalize its work for subsequent submission to the COP-MOP 5.
6. The Protocol is one of the important instruments contributing to the protection of biodiversity from potential adverse effects of living modified organisms.
For more information visit www.cbd.int/biosafety
The 2010 International Year of Biodiversity: www.cbd.int/2010 or
Google states that, "the coolest thing about Google TV is that we don't even know what the coolest thing about it will be."
The truth in this statement is due in large part because, like the it's Android platform, Google is using an open-source platform for developing applications and features for Google TV.
So, developers, entrepreneurs and activists can make of Google TV what they want, right from the get go. Just imagine what a clever application could do for promoting access to information on critical issues of global concern...
The economic tension between the United States and China escalated on Friday, as the Obama administration pledged to investigate Beijing’s subsidies to its growing clean energy industries while delaying a politically volatile report on the Chinese currency. The approach — part carrot, part stick — reflected the delicate balance the administration is trying to strike in a campaign year by taking a newly assertive posture over China’s trade and commercial policies, while pursuing delicate negotiations as an alternative to confrontation.
On Tuesday, the US Dept. of Energy announced it was distributing $575 million USD in grants to 22 projects in 15 states, in an effort to deploy Carbon Capture and Storage / Sequestration (CCS) technology within the next 10 years. The money was allocated under the Economic Stimulus package (ARRA 2009).
The Washington Post reports that the Dept. of Energy has invested $4 billion USD in CCS, leveraging $7 billion USD from the private sector. Interestingly, this massive investment comes as a grant – not as a prize. The difference being that prizes reward for success, whereas grants allocate money up front, creating jobs, but not necessarily ensuring the desired outcome. In the case of CCS, the desire outcome is an environmentally sound means of reducing carbon emissions.
There are many concerns over the environmentally soundness of CCS, including:
The Washington Post only mentions the risk of asphyxiation due to a massive leak of stored CO2 near populated regions. This is certainly a concern, but just one.
As the Deepwater Horizon disaster has shown, the ability to stop underwater leaks is very difficult. Detection of slow leaks above and below ground is also very difficult. The increased consumption of coal with carbon storage will correspond to increased production of mercury, requiring more effective abatement technologies than are currently available and environmentally sound storage of mercury (which is uncertain at this time), to prevent increased atmospheric emissions of mercury.
Perhaps a series of prizes to identify and design effective solutions to the environmental risks of CCS, simultaneous to or preceding the development of the technology, would be a worthwhile investment - to say the least. In this way, ad hoc remedies may be less necessary to correct for inadequate risk assessment, as witnessed by the catastrophic disasters and series of failed corrective measures that took place in the Gulf of Mexico over the course of nearly three months.
Government energy ministers gathering in Washington, D.C., today launched 11 energy-efficiency and renewable energy initiatives around the world, which they claim will avoid the need to build 500 midsize power plants during the next 20 years.
Of particular note is that "the United States and a dozen other nations will create what is being called the Carbon Capture, Use and Storage Action Group to develop a strategic plan for deploying carbon-capture-and-storage (CCS) infrastructure around the world by 2020. Hopefully the development of this "strategic plan" is transparent and allows for the participation of NGOs representing a range of interests, in particular the public interest.
For example, one might recall the issue with lead in paint. While not saying that lead in cement/limestone brick is analogous to lead in paint, BUT - consider the following example of what some companies are doing at the pilot scale with CCS technologies: capturing carbon dioxide and other toxic heavy metals and forming a carbonate mineral brick that embeds the toxic heavy metals, for use in buildings and other infrastructures .
Coal-fired power plants represent the largest source of mercury emission in the United States, but most operate with minimal controls designed to capture particulate matter that remove less than 35% of the mercury from their flue gas. This removal percentage can increase to greater than 50% when a sulfur scrubber is added, but capture levels are dependent upon coal type. With new federal and state regulations emerging, many power plants are contemplating the use of activated carbon injection (ACI) or other additional controls to remove more mercury from flue gas. The Calera CMAP process has the potential to not only capture mercury that would otherwise be emitted, but to bind it into the mineral output in a way that will prevent leaching to the environment..As with mercury, other trace metals can be captured by the CMAP process, including lead, chromium, cadmium, selenium, zinc, and others." Available at: http://www.arb.ca.gov/cc/etaac/meetings/102909pubmeet/mtgmaterials102909/basicsofcaleraprocess.pdf
Studies indicate that leaching of heavy metals from the mineral, while being below US guidelines, does indeed occur. Moreover, what happens in the case of intentional demolition? Or, what about earthquakes stronger than the specifications of building codes? Perhaps the settlement of the "9-11 illness" victims, including many first responders, warrants consideration? (see article on the 9-11 Settlement here)
While these toxic heavy metals may be contained for a period of time, these solutions do not appear to offer a permanent solution, to say the least. All the more reason for transparency and public participation in the development of these "strategic guidelines" for CCS.
A set of access to medicines groups and experts met last week at the University of California at Berkeley Law School, and have prepared the
attached "Berkeley Declaration on Intellectual Property Enforcement
and Access to Medicines." The declaration calls attention to the
dangers that the new IP enforcement agenda poses to access to
medicines -- please distribute widely. It's also available at http://www.law.berkeley.edu/files/Berkeley_Declaration.pdf
The Berkeley Declaration is being released on the occasion of Friday's
joint WTO, WIPO and WHO "Technical Symposium on Access to Medicines."
The Declaration, along with the below cover letter, will be delivered
tomorrow to Director-General Lamy, Director-General Chan, and Director
Assistant Professor of Law
University of California at Berkeley Law School
Berkeley Declaration on Intellectual Property Enforcement and Access
All people have the right to access the medicines they need to be
healthy. As public health groups, humanitarian and inter-governmental
organizations, experts and academics that work on access to medicines,
we gathered at the University of California at Berkeley to analyze the
serious threats that recent ?intellectual property enforcement?
initiatives pose to this right. The enforcement agenda threatens the
last decade of efforts to achieve access to medicines for people in
low- and middle-income countries, and compromises the attainment of
health-related Millennium Development Goals. We make this Declaration
to call upon policy makers in governments and international
organizations to reject the cynical and dangerous efforts that have
been made through this agenda to prioritize commercial interests over
the right to health.
The IP enforcement agenda promotes new standards that will require
increased surveillance of goods and more intrusive police powers for
government officials without adequate procedural protections. It aims
to substantially increase the penalties for people alleged to have
infringed patents, trademarks, and copyrights. It would require judges
to consider a range of measures that would restrict the freedom of
people to use knowledge goods, and would impose new punishments for
third parties without due regard for the implications on access to
Access to medicines in developing countries depends on the ability of
countries to produce, export, and import generic medicines.
Restrictions on generics impede competition, leading to increased
prices, and preventing people with limited resources from accessing
the medicines that they need. New enforcement measures have been used by customs officials to disrupt the supply of legal generic medicines
between developing countries as they transit through Europe. The draft
Anti-Counterfeiting Trade Agreement (ACTA) represents a deliberate and
non-transparent attempt to bypass multilateral institutions, while
ultimately aiming to impose its standards on developing countries. The
enforcement agenda commandeers public money for private gain, and has
a chilling effect on the manufacturing of and trade in legitimate
generic medicines. Contrary to assurances, it undermines key public
health safeguards that allow countries to balance the right to health
with their obligations under the World Trade Organization’s Trade
Related-Aspects of Intellectual Property Rights Agreement (TRIPS).
While enforcement norms are typically considered procedural, it is
clear that this new agenda goes far beyond procedures and has serious
implications for substantive areas of intellectual property law.
The recent IP enforcement agenda is being promoted in many fora:
globally, in the ACTA negotiations; regionally, with the East African
Community draft ?anti-counterfeit? policy and Bill; and nationally in
free trade agreement negotiations with the European Union and national
”anti-counterfeiting” laws, among others. Additional sites of these
initiatives include the World Customs Organization SECURE project, the
World Health Organization International Medical Products Anti-
Counterfeiting Taskforce (IMPACT), and Interpol. Public safety is
being cynically used as a pretext to promote these initiatives. In
particular, we reject the attempt to conflate the serious public
health issue of medicines quality with private concerns about the
enforcement of intellectual property rights.
IP enforcement initiatives must not interfere with access to
medicines, and should:
- Be grounded in human rights principles
- Protect innovation, competition, and consumer rights
- Be negotiated through a transparent, inclusive, and open
process, that does not bypass existing multilateral institutions
- Protect the full use of TRIPS flexibilities that promote
access to medicines
ACTA represents some of the worst enforcement practices on both
substance and process. The agreement has been conducted through a
secretive, illegitimate process, and there is no evidence that its
procedural or substantive shortcomings can be remedied in the current
structure. ACTA should be abandoned.
The European Union should cease its efforts to export its much-
criticized enforcement policies to low- and middle-income countries.
We call for a moratorium on exporting these policies through free
trade agreements and technical and financial assistance. The review of
EU customs regulations that was prompted by the recent generic drug
seizures must be concluded with amendments to these regulations that
remedy the threat that they pose to access to medicines.
The East African Community ?anti-counterfeiting? draft policy and
proposed legislation introduces unprecedented IP norms at the regional
level, threatens access to medicines, and should be discarded. It is
particularly inappropriate because it seeks to impose TRIPS-plus
provisions when TRIPS itself does not require the majority of the
participating countries to enforce patents on medicines. The East
African Legislative Assembly, national governments affected, and the
EU Parliament should investigate the origins of such laws at the
national and regional level. We also welcome efforts made to challenge
the recent ?anti-counterfeiting? law in Kenya in court.
We recommend all developing countries approach IP enforcement and
?anti-counterfeiting? initiatives with caution and reject any such
initiatives that affect the ability to produce, export, import, and
use generic medicines. We also call for enhanced South ? South
collaboration in developing frameworks for the management of IP from a
public health perspective.
Finally, WHO should immediately disengage from IMPACT, and instead
take a public health approach to the problem of medicines quality,
safety, and efficacy. Such an approach must strengthen drug
regulatory authorities, ensure the availability and affordability of
medicines to diminish incentives for unregulated and unsafe medicines,
promote rational use, and require transparency and accountability in
the pharmaceutical sector. WHO should scrutinize and publicize the
implications of IP and its enforcement on public health, and WHO
member states should focus on and lead the implementation of the
Global Strategy and Plan of Action on Public Health, Innovation and
Against the background of continued problems with excessive drug
prices, falling donor commitments, the real danger of not meeting
Millennium Development Goals targets, and the failure of the TRIPS
Agreement to meet the expectations of developing countries on access
to medicines, innovation for unmet health needs, and technology
transfer, a focus on IP enforcement is hypocritical and immoral. It
will deepen global health inequality, and exacerbate inequity in
access to medicines.
Health Action International Africa
Knowledge Ecology International
Third World Network
Universities Allied for Essential Medicines
William L. Aldis MD, Assistant Professor (Global Health), Faculty of
Public Health, Thammasat University, Bangkok, Thailand
Kajal Bhardwaj, Lawyer (HIV, health and human rights), India
Michelle Childs, Director Policy Advocacy, M?dicins Sans Fronti?res
Campaign for Access to Essential Medicines
Gwen Hinze, International Director, Electronic Frontier Foundation
Busingye Kabumba, Lecturer on Law, Human Rights and Peace Centre
(HURIPEC), Makerere University
Amy Kapczynski, Assistant Professor of Law, University of California
at Berkeley Law School
Els Torreele, Project Director, Access to Essential Medicines
Initiative, Open Society Institute
German Velasquez, Senior Adviser for Health and Development, The South
July 15, 2010
An interesting development in Afghanistan, in particular regarding the large scale commercialization of electric vehicles. Apparently, the US has recently learned that Afghanistan holds vast supplies of lithium, a essential component of most batteries for electric vehicles. Some have speculated about the likelihood of limited supplies of lithium as a limiting factor in the meaningful growth of the electric vehicle market. See our earlier post on the topic here.
In addition, the war-ravaged country also holds vast reserves of iron and copper, based on geological surveys conducted by the Russians several decades earlier, the NY Times Reported recently.
The NY Times writes, quoting government officials:
“No one has tested that law; no one knows how it will stand up in a fight between the central government and the provinces,” observed Paul A. Brinkley, deputy undersecretary of defense for business and leader of the Pentagon team that discovered the deposits.
At the same time, American officials fear resource-hungry China will try to dominate the development of Afghanistan’s mineral wealth, which could upset the United States, given its heavy investment in the region. After winning the bid for its Aynak copper mine in Logar Province, China clearly wants more, American officials said.
Another complication is that because Afghanistan has never had much heavy industry before, it has little or no history of environmental protection either. “The big question is, can this be developed in a responsible way, in a way that is environmentally and socially responsible?” Mr. Brinkley said. “No one knows how this will work.”