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.

US Advisory Group: ‘Near Perfect Storm’ Coming On Gene Patents In The US

Intellectual Property Watch » Blog Archive » Advisory Group: ‘Near Perfect Storm’ Coming On Gene Patents In The US

Appropriately quoted for a week of record snowfall in the US Capitol, IP Watch reports that a Health and Human Services Advisory Committee has released a report which shows a significant concern about accessing research tools - genes in this case - for health-related tests.

An related extension of this concern is the access of research tools to test their potential environmental impact - for example the environmental risks of patented variations of nanomaterials. Pursuant to the US Federal Circuit's narrow interpretation of the experimental use exemption in Madey v. Duke, institutions would be hard pressed to access these research tools for basic public-health research.