Intellectual Property and Sustainable Development

Berkeley Declaration on IP, Enforcement, and Access to Medicines

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
General Gurry.

Amy Kapczynski
Assistant Professor of Law
University of California at Berkeley Law School
---
Berkeley Declaration on Intellectual Property Enforcement and Access
to Medicines

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
medicines.

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
Intellectual Property.

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.

Signed
Farmamundi
Health Action International Africa
Knowledge Ecology International
Public Citizen
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
Centre, Geneva
July 15, 2010

Balancing or Swinging? Genes, ACTA and other Recent Developments in IP

The past thirty days have given those who follow developments in innovation policy quite a bit of material.  First, on March 29th, a US district court (SDNY) held that neither isolated genes nor methods of analyzing or comparing genes were patentable subject matter in Association for Molecular Pathology v. US Patent and Trademark Office (USPTO).   Then, recently, the very controversial and secret Anti-Counterfeiting Trade Agreement (ACTA) was officially released in draft form (available here).

First, in the case of genes, the ACLU is calling the court’s decision “a huge victory for womens' health and scientific freedom.”  

The case centered around Myriad Genetics’ patents over BRCA1 and BRCA2, genes which are associated with breast and ovarian cancer.  The plaintiffs challenged these patents as invalid, arguing that genes are not patentable under the “product of nature” exemption from patentable subject matter (35 USC s. 101).

Seemingly an obvious argument by the plaintiffs, the defendant bio-tech industry has argued (successfully) that genes – in their “isolated” or “purified” form – were not a product of nature and hence, a patentable invention.  The defendants’ lawyers repeated this argument before the court in this case, arguing for the patentability of Myriad’s claims over BRCA1 and BRCA2. 

However, the judge did not agree in the least bit with the defendants.  Judge Sweet held that a purified form of a natural product (e.g. a gene) must have "markedly different characteristics" than the unpurified form of that product to be patent eligible subject matter.  Then, citing in re Bilski (US Court of Appeals for the Federal Circuit), a decision which could invalidate thousands of business method patents if upheld by the US Supreme Court, the judge held that the method for analyzing the genes for cancer were not patentable either. 

If upheld on appeal, the BRCA case will have broadly sweeping implications.  The implication for health are clear – when available, doctors will be able to provide gene based tests, results and treatments at a lower cost, thereby increasing access and potentially lowering national health-care costs.

However, the case could also have implications for the food, biofuel, and other bio-based industries.  For example, patents over isolated genes and methods for their analysis are also found in many commercially viable transgenic plants (a.k.a GM crops/foods, GMOs, etc), owned by Monsanto, Syngenta and others in the very concentrated agriculture biotech industry.  For example, see Monsanto’s patent over “DNA constructs and Methods to Enhance the Production of Commercially Viable Transgenic Plants” (US pat. no 7,575,917).

Regarding genes and biofuels, see DuPont’s patent over genes for polyunsaturated fatty acid production using transgenic algae, bacteria, yeast and/or fungi (US pat. no. 7,695,950).  Algae is a second-generation (non-food crop) biofuel, which can be used to produce biodiesel and other biofuels.  Biodiesels are long chain esters, such as the polyunsaturated fatty acids produced by the transgenic algae claimed in DuPont's patent.  The US Dept of Energy claims that algae-based biodiesels are the only viable alternative energy source for automobiles, and thus it is no surprise that Exxon Mobil is investing heavily in algae biofuels.

Turning to ACTA, negotiating parties to the Agreement (US, EU, Japan, New Zealand, and others) – which is basically a new IP treaty in a thinly-veiled disguise – appear to have bowed to pressure from civil society, officially releasing the ACTA Draft.  Knowledge Ecology International (KEI), a leading NGO in advocating for transparency in ACTA negotiations, has stated that the disclosure comes far to late and is incomplete, lacking information on the negotiating parties‘ positions.  

ACTA negotiators are fudging the meaning of counterfeit, confusing copied products, where the consumer is aware of the authenticity of products such as generic medicine and audio/video reproductions, with actually counterfeit products – those which are intended deceive consumers.  Counterfeit medicines are very dangerous and a serious problem.  Awareness should be raised on this issue, but not by equating low-cost generic medicines to deadly counterfeit medicines.  This is the issue that has been at the heart of the ongoing dispute over the EU’s seizure of generic medicines that were in transit from India to Africa through EU ports. 

Medecins Sans Frontieres (aka, Doctors Without Borders) is concerned that the key elements of the ACTA - injunctions, border measures, criminal penalties and enforcement practices - may obstruct and deter legitimate generic competition.  MSF is also concerned about another anti-counterfeiting measure - the 2008 Kenyan Anti-Counterfeiting Legislation, which could not only impact the supply of anti-retroviral medications in Kenya, but throughout the African continent, given the influence of Kenya's laws on the legislative activities of other African countries.  Of particular concern are provisions in the Kenyan legislation on enforcement, and the vague definition of "counterfeit."  For more opinion and information, also see Michael Geist's blog and website on the ACTA (thanks Philip). 

Under current international IP and Trade agreements, TRIPS and the GATT, goods in transit - such as the generic medicines that were seized by the EU- are exempt from IP laws, which are territorial, while the goods are in transit.  In other words, under current international law, a Dutch patent on XYZ drug compound is inapplicable to a generic copy of that drug whose final destination is not in the Netherlands.  The enforceable patents in importing territory are what is applicable.  However, as suspected for some time, the draft ACTA agreement has the potential to go beyond current international IP norms and limiting access to medicines, depending on how the final negotiations shape up (see Dr. Henning Grosse Ruse-Kahn’s analysis of the ACTA text here)

So, are IP norms and laws moving towards a more balanced, a less “one-size-fits-all” approach?   In the case of gene patents, it depends what happens with the BRCA case on appeal, which might in turn depend on what the US Supreme Court has to say about the Federal Circuit Court of Appeals opinion in Bilski.  In the case of ACTA, in the end it will depend on what negotiators agree upon as the final text, which could depend on how much transparency is provided in the negotiations.  We'll see if US Trade Representative Ambassador Ron Kirk is correct when he said "people will walk away from the table" if the ACTA negotiation is made public.

WIPO Committee on Patents (SCP) Concludes with No Agreement on Future Work & Fragmentation Apparent

The 14th session of the WIPO Standing Committee on the Law of Patents (SCP or SCP 14) concluded late Friday evening, with no agreement on future work (see the IP Quarterly for a summary of the meeting).  The tenor of the negotiations of how to proceed and on which studies are extremely divided in the SCP.  Developing countries are pushing for studies on topics where IP is known to be an impediment, and industrialized countries are pushing for topics that would appear to support arguments for harmonizing some aspects of national patent laws.  The agenda item on the future work of the SCP was never discussed in the plenary and NGOs did not have the opportunity to comment specifically on the future work and/or direction of the Committee.

Discussions regarding Technology Transfer, Opposition Systems, Exceptions and Limitations in the SCP highlighted the development dimension of patents, which in all cases were emphasized as lacking appropriate consideration by the Secretariat, according to intervening developing countries.  One of the most interesting and unresolved issues of the meeting is how, exactly, the SCP will interact with the Committee on Development and IP (CDIP) to coordinate the implementation of the WIPO Development Agenda. 

Work on the subject of Technology Transfer in WIPO is suffering under the Member States' and the Secretariat's confusion regarding how to reconcile and coordinate Development Agenda recommendations with the work of the Standing Committees of WIPO. 

Intra-organizational Fragmentation?

A long-standing concern in international law has been the issue of fragmentation, i.e. the concern that treaties and institutions on specialized topics will be implemented without due regard for the activities of other related bodies of international law or organizations.  Regarding the specialized topic of IP, numerous fora have dealt with the topic, including: the World Health Organization, the Food and Agriculture Organization, the World Trade Organization (WTO), the UN Office of the High Commissioner for Human Rights, the UN Conference on Trade and Development - and the list goes on. 

What is especially troubling with the subject of Technology Transfer under WIPO's Development Agenda is the potential for there to be intra-organizational fragmentation within WIPO, i.e. the inability for topics to be coherently addressed between Committees.  Transfer of Technology is currently discussed and debated in the SCP and the Standing Committee on Copyright and Related Rights (SCCR), as well as the Committee on Development and IP (CDIP).  The issue of a Coordination Mechanism for WIPO was left unsettled at the last CDIP meeting (see related documents CDIP/4/11, CDIP/4/9 and CDIP/4/10 and a transcript of the debate in CDIP/4/14 Prov, from paragraph 242).  The CDIP is mandated with approving and monitoring project to implement the WIPO development agenda.  However, the last CDIP failed to approve the project on Technology Transfer (see earlier posting)

Other fora have also seen the problem on intra-organizational fragmentation.  On the topic of Environmental Goods and Services (EGS), division of the topic among three different WTO committees has compounded the pre-existing problem of diverging economic, social and commercial interests.  As of July 2007, Members of the WTO had failed to agree on a common approach to the methodology for EGS negotiations.

Besides mainstreaming the development dimension into all of WIPO's activities, the Development Agenda is also expected to "explore...policies and measures Member States, especially developed countries, could adopt for promoting transfer and dissemination of technology to developing countries" (per Rec. 28).  One way of doing this is to create a mechanism to gather and compile data in a useful format, for developing countries "to explore IP-related policies and initiatives necessary to promote the transfer and dissemination of technology, the benefit of developing countries.." (per Rec. 25). 

Creating scientific methodologies should not be a far reach for a science oriented organization like WIPO.  These methodologies to explore policies and measures with empirical evidence, incarnated as "projects" in the CDIP, would help produce useful information for use and deliberation in other committees. There would be no fear of a hierarchy of committees, which is a major concern in discussions in the CDIP on the Coordination Mechanism.  Rather, the CDIP could enable objective criteria to facilitate evidence-based policy making in WIPO, while the debate over coordination continues.  

Moreover, the issues selected for preliminary study by the SCP also indicate intra-organizational fragmentation.  For example, both the ongoing study on exceptions and limitations and the suggested study on climate-related technologies have technology transfer components.  These are three different studies at various stages of examination.  How do these studies harmonize and synergize with each other?  Are the outside experts commissioned for work on Exceptions and Limitations to ensure that their findings do not conflict with that of the Secretariat?  Would the Secretariat revise the Technology Transfer study based on the findings of 2 out of the 5 experts on Exceptions and Limitations?  

These and other, more existential questions regarding the viability of the SCP long-term remain to be seen.  But, it will take a while.  The report on exceptions and limitations to patent rights, commissioned to outside experts, will be ready to review 18 months after it was approved in SCP 13.  With another 1 to 2 sessions of the SCP for revisions and expansion, it does not appear that any action will be taken on this report for about 2 years from now.  Given the pace of progress and the absence of any sense of urgency in WIPO, one could easily forget that what we are really talking about in the report on exceptions and limitations is how to improve lives with medicines, educate our youth, and preserve a rapidly deteriorating environment, for starters.  Lets hope technology transfer doesn't hold up the discussion too.

3rd Quarter CIEL-South Centre IP Quarterly Released

The latest edition of the CIEL-South Centre joint publication, IP Quarterly, has been released.  It is available here:  http://www.ciel.org/Publications/pubipqu.html

This Focus Piece discusses the new mandate of the WIPO Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC) that was renewed by the WIPO General Assembly IN 2009 and identifies challenges that lie ahead in the future work of the IGC under the new mandate for text based negotiations towards an international legal instrument or instruments for the effective protection of GR, TK and TCEs. It points to the need for greater coordination on the part of developing countries between themselves and with their national stakeholders to overcome these challenges and also stresses on the need to ensure that the work of the WIPO IGC complements the work currently undertaken on related issues in other multilateral fora, particularly the WTO negotiations on the relationship between TRIPS and CBD, and the CBD International Access and Benefit Sharing Regime.

Following the Focus Piece is a summary of major developments in the third quarter of 2009 on IP related issues in multilateral organizations including: UNFCCC, WTO, WIPO, WHO, CBD, FAO, regional and bilateral free trade agreements, national legislations, and other related processes like ACTA and G8.

World Bank discusses Trade and Climate Change

The World Bank, along with two other NGOs, held a panel discussion today on the trade implications of the ongoing climate negotiations.  The final presentation, on Technology Transfer and Climate Change was the most substantive, as detailed below.  The presentations did not address either labeling schemes, standards, border carbon adjustments, or subsidies.  For an in depth discussion of these topics, please see the 2009 CIEL publication, Is World Trade Law a Barrier to Saving our Climate?, available at: http://www.ciel.org/Publications/ClimateTradeReport_foee-ciel_sep09.pdf

Richard Baldwin began by discussing possible implications of Copenhagen outcomes for the world trading system, and coping policies to minimize conflicts in the trading system.  In order to prevent what he called a "train wreck" in the making, he encouraged Industrialized Countries and Emerging Economies like Brazil, India, China and Russia, to agree upon climate change rules for trade outside of the WTO system.  He especially emphasized not letting the WTO's Dispute Settlement Body take up the issue of climate related trade measures.

Dominique van der Mensbrugghe, Lead Economist at the World Bank, followed with an outline of some of the probable changes in patterns of international trade that rising global temperatures might precipitate.  His primary emphasis was on the implications of climate change on agriculture.  A representative of the World Health Organization (WHO) questioned why the health related aspects, i.e. the human rights implications of climate change, were not being addressed by the presentation, which was not answered by Mr. van der Mensbrugghe.

Aaron Cosbey of the International Institute for Sustainable Development discussed technology transfer and development assistance.  In using the IPCC 4 definition of Technology Transfer, he argued that weakening IPRs to stimulate the transfer of climate technologies is insufficient for the dissemination of these technologies to developing countries.   Rather, Mr. Cosbey emphasized the need for developing countries to have  enabling environments in place for investment.  He suggested learning from the experience of the trade regime, vis-a-vis Aid for Trade, to improve the investment climate in these countries, rather than looking at the experience of the WTO in handling another global challenge - access to medicines - with the Doha Declaration on Public Health.  He cited three reasons for the relative insignificance of IPRs in the dissemination of climate technologies: (1) the requirement for trade-secret protected know-how to implement patented technologies; (2) the significant barrier of a poor investment climate in many developing countries; and (3) the inapplicability of public health and IP lessons to energy-related technologies. 

However, in response to a question posed by CIEL, Mr. Cosbey did acknowledge that his analysis did not account for either patents on the most cutting edge of alternative energy technologies (i.e. cleanest), or the expected emergence of Carbon Capture and Sequestration (CCS) for "Clean[er] Coal."  These advancements will be covered by patents for several years to come, and likely will not have the same level competition enjoyed by current climate technologies.  The World Bank, in its 2010 Development Report, projects that about 25% of the necessary reduction of greenhouse gasses (GHGs) by 2050 will come from CCS technology, which is expected to be an exceptionally concentrated industry. 

Indeed, his hypothesis on the impact of IPRs assumes a sufficiently competitive environment, where alternative suppliers of solar panels, wind turbines, etc, are readily available.  This is the case with older technologies that are in the public domain.  However, in order to reduce greenhouse emissions to 350 PPM, the World Bank, IPCC, and other researchers are united in stating the necessity that more efficient technologies be developed, deployed and disseminated to developing countries.  Thus, it is entirely possible that as advancements in energy generation/GHG reduction are developed (in large part with public funding) the importance of patents held by the private sector will increase tremendously.  

WIPO's Committee on Development Begins Work on Technology Transfer

Formed in 2007 to address Development concerns associated with IP, WIPO's Committee on Development and IP (CDIP) is - finally - starting to address Technology Transfer. By way of background, the Development Agenda is comprised of 45 Recommendations, ranging from Capacity Building, to Norm-Setting, to the Governance of WIPO . Recommendations 24-26, and 28-31 (cluster C) are directed to Technology Transfer. At the most recent CDIP, the Member States agreed to take a thematic approach" to implementing Recommendations - realizing that there was some overlap between individual recommendations. However, one key pre-condition to the thematic approach was that the individual recommendations would be discussed before projects were decided upon. In making progress towards the implementation of Recommendations 19, 25, 26 and 28, WIPO presented its "Project on Intellectual Property and Technology Transfer: Common Challenges - Building Solutions" at the Open-ended Forum on Proposed Development Agenda Projects. As far as we can tell, none of these Recommendations have been discussed in the Plenary of the CDIP, as required under the thematic approach. The proposed project consists of five "Key Activities:"

1. Organize a high-level forum to facilitate Access to Knowledge/Technology and to form the "New Platform" on Technology Transfer and IP collaboration
2. Perform a series of studies
3. Hold a WIPO forum on transfer and collaboration
4. Hold regional consultations
5. Strengthen existing activities within WIPO

The project is projected to cost about 1.5 million CHF, and take 27 months. How these figures were arrived at, without having concrete plans for which studies would be carried out and how existing activities would be strengthened, is uncertain. Thankfully, WIPO is holding its anticipated "Conference on Building Partnerships for Mobilizing Resources for IP and Development" in a few weeks, just in case additional resources are needed. Moreover, the function of this new platform is quite vague, which is perhaps an appropriate precaution, given the fact that WIPO's Member States have not discussed these recommendations in the plenary. Briefly, CIEL, while welcoming this activity, would recommend that:

1. Individual Recommendations be discussed first in the CDIP so as to not provide for definitions of individual Recommendations through their associated projects for implementation;
2. WIPO view holistically the issue of Technology Transfer and include WIPO's Copyright Section in the relevant divisions implementing Technology Transfer recommendations. The proposal included Patent and Information Communication Technology sections, but not Copyright;
3. WIPO create a mechanism to gather empirical evidence regarding the International Transfer of Technology to help generate evidence based policies for issues of global concern; and
4. WIPO create distinct points of contact and input with relevant Intergovernmental Organizations, as required under Recommendations 30 and 40, in order to capitalize on previous efforts on Technology Transfer by the WTO, WHO, UNEP, UNCTAD and other IGOs.

Labels: Development, ESTs, Green Innovation, IP, Technology Transfer