US statement to SCP 18 on the United States proposal on Patents and Health

The following is the statement read today by USPTO during a meeting of the WIPO Standing Committee on the Law of Patent, on the agenda item for patents and health. I'll provide more commentary later, but in general, this was seen an aggressive attack on a proposal for work by the Development Agenda Group (DAG), and on the notion that countries should grant compulsory licenses on patents to address concerns over access or affordability of drugs.

[Update: KEI wrote to USPTO about the submission: http://keionline.org/node/1420]

The USPTO statement follows:

SCP18

Talking points on the United States proposal on Patents and Health

SCP/17/11 Patents and Health: Proposal by the Delegation of the United States of America

• Thank you Mr. Chairman.

• The availability of medicines is a topic of great importance and interest, and the United States continues to be a global leader in promoting availability of medicines throughout the world. The US is pleased to contribute to this discussion.

• Some of the public health issues facing developing and least developed countries (DC/LDCs) include neglected diseases, the spread of TB, malaria and HIV/AIDS, and availability of medicines to treat these and other ailments. There is no easy solution to these problems. Reducing patent protection is not likely to solve these thorny issues. Furthermore, the notion that all developing countries face identical challenges and should apply the options that exist under international agreements in a single way – or that access to medicines would be enhanced by such an approach – has been rejected by many WIPO member states, including developing nations.

• To the contrary, the lack of effective patent protection can be one of the many factors which prevent the appropriate medicines from reaching the neediest patients in DC and LDCs. Weakening the patent rights granted to pharmaceutical researchers and manufacturers in certain markets not only removes or reduces the incentive to develop new medicines, but also reduces the incentives for innovative medicine developers to invest in those countries and harness their innovation to solving the public health challenges that disproportionately affect developing countries, and are not being solved in other ways.

• Weakening patent protection for innovative medicines is not a productive approach to improving availability of health care, because many other factors other than patents more directly affect the availability of medicines.

• The proof of the weakness of that argument is that although most medicines on the World Health Organization’s List of Essential Medicines are not protected by patents, their availability in many markets is still limited. This is particularly true in DC/LDCs. Many other factors affect the availability of all medicines, patented or not.

• Consequently, assessing the extremely complicated challenges of public health with respect to the patent system as the primary point of intervention, without recognizing the indisputable facts affecting access to medicines, is an imbalanced and ultimately unproductive approach. If not viewed in context, such an approach will invest WIPO’s limited resources to inaccurately quantify the impact of the patenting system on the availability of medicines, and will not help the member states make informed decisions About how to view their patent system in the context of their efforts to address the specific and unique health challenges each country must overcome.

• Mr, Chairman, the United States had set forth at the last meeting of the SCP for consideration by the member states two basic elements:

1) Conducting a study on the positive impact of patent systems in providing lifesaving medicines to developing countries. The study would help restore balance to the discussion by evaluating the role of patent protection in providing incentives for research and development leading to innovative medicines, and in fostering the technology transfer necessary to make generic and patented medicines available in DC/LDCs.

2) Then, Conducting a study to examine the availability of lifesaving medicines that are currently provided in generic form, and of the reasons for their lack of availability. We see this study as a necessary and responsible way to ensure that evaluation of the role of patents in affecting public health outcomes is properly informed and not obscured by the many other important challenges that exist that will not be affected by any patent regime.

• Alternative approaches seek to evaluate patent systems in a vacuum, and draw conclusions about patent protection and public health without acknowledging the complexity of the problem. The United States believes that an isolated and partially-informed inquiry cannot help in the evaluation of how patents do or do not affect extremely serious and important challenges, and therefore would be an inappropriate use of limited resources.

• The US has taken note of the preliminary comments to our proposal that were voiced during the 17th session of the SCP and in the comments received by the secretariat, and compiled in documents SCP/18/inf/3 and SCP/18/inf/3 add.

• Many of the comments have indicated that some issues raised in the US proposal fall outside of the mandate of the SCP, as they involve aspects of national laws, infrastructure, and issues that may be better handled by other UN agencies. One example may be the trilateral cooperation framework maintained by WIPO, the WTO and the WHO.

• If this body chooses to meaningfully address the profoundly serious and complicated issue of public health, it would be a disservice to that effort to ignore the facts that are necessary to understanding how patent regimes can advance public health.

• Without gathering the information that places the role of patent systems in context, no reliable or informed conclusion about how patent systems can or should respond to public health challenges can be drawn.

• Should a forum better equipped to evaluate this complicated issue be agreed upon to conduct studies on the protection of public health and on access to medicines, we would, of course, be amenable to considering the discussion in that forum.

• In light of these issues, if any work programs on health related issues are retained within WIPO and particularly within the SCP, care will have to be exercised to avoid duplication of efforts between the various WIPO committees, in particular with the committees more directly addressing development agenda issues, such as the CDIP.

• In particular, the trilateral framework undertaken by the WHO, WIPO and WTO, is currently finalizing a joint study on the promotion of access and medical innovation at the intersection between public health, intellectual property and trade, which intends to provide a holistic presentation of the full set of issues, including a comprehensive consolidation of their technical cooperation activities in the field.

• To this end, the United States believes that a thorough discussion of the WHO-WIPO-WTO joint study must take place before additional work, if any, is undertaken within the SCP on the subject of Patents and Health.

• Regardless of the forum chosen, the US believes that work on this issue that ignores the interaction of the patent system with the many other factors affecting access to medicine is unproductive and will not result in the stated goal of understanding how patent regimes can improve public health. A balanced approach must, at a minimum, evaluate all the contributions patents have on the availability of medicines, including the development of life-saving medicines and medicines tailored to public health challenges in developing countries.

• The United States believes that reduction in patent protection for innovative medicines is not the solution to overcoming public health challenges. The challenges to access to generic medicines make that clear, and that the one-size-fits-all approach advocating reduction of patent protection is inappropriate.

• Given the resources and expertise of this body, great care will have to be taken to add value, rather than duplicate efforts, by other competent bodies, to the consideration of public health challenges

• Thank you Mr. Chairman

Only the Strong

The "strong" vs "weak" IP discourse is a trope of the United States Chamber of Commerce. It is surprising and disturbing to see this same discourse adopted by the United States Government in meetings on patent law and access to essential medicines. Patent flexibilities - such as compulsory licensing, technology transfer, experimental use, generic springboarding, parallel importation - are being somehow dubbed as "weakening" intellectual property, even though they are recognised under TRIPS, the Doha Declaration, and the WTO General Council Decision.