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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:]

The USPTO statement follows:


Intervention of Chile at WIPO's Standing Committee on the Law of Patents: Patents and Health

On Wednesday, 23 May 2012, Chile delivered the following statement on patents and health at the 18th session of the WIPO Standing Committee on the Law of Patents (SCP). In particular, Chile made a strong case for the WIPO SCP to study existing flexibilities in the international patent system.

Obligations to fund R&D, under CEWG recommendation

The World Heath Organization is now debating proposal in a report form a Consultative Expert Working Group (CEWG) on R&D for a new medical R&D treaty, focusing on the special health needs of developing countries. The following table shows how much money various regions and countries would be obligated to spend on R&D, under the treaty proposal, which is .0001 of GDP, of which 20 percent would be invested through pooled funding mechanisms.

BIO memo opposing transparency of drug development costs, sales, prices, and clinical trial outcomes

Senator Sanders has offered an amendment to the Food and Drug Administration Safety and Innovation Act of 2012 that would require drug sponsors to disclose the costs of pre-clinical research, clinical trials and related R&D, as well as grants, economic incentives that subsidize drug development costs, and also report quarterly sales and revenues, register all clinical trials at, and report detailed descriptions of each clinical trial participant’s results.

Kenyan resolution to the 65th World Health Assembly: WHO Convention on Research and Development Financing and Coordination

During the week of 14 May 2012, the Republic of Kenya submitted a resolution to the 65th session of the World Health Assembly entitled, "WHO Convention on Research and Development Financing and Coordination". The resolution will be published by the World Health Organization (WHO) as a conference paper for discussion in Committee A under agenda item 13.14 Consultative Expert Working Group on Research and Development: Financing and Coordination. It is expected that this agenda item on the CEWG will be brought forward for early discussion at the Assembly.

My testimony for Senate HELP hearing on S.1138, the Prize Fund for HIV/AIDS

This is the latest draft of my written testimony for the May 15, 2012 Senate HELP hearings on S.1138, the Prize Fund for HIV/AIDS.

Some additional relevant data are available on the following pages

Key WIPO committee on patents to discuss patents and health, exceptions and limitations to patent rights and opposition systems

The World Intellectual Property Organization (WIPO) will convene the 18th session of the WIPO Standing Committee on the Law of Patents (SCP) from 21 May 2012 to 25 May 2012 (during the same week as the 65th session of the World Health Assembly). The agenda of the SCP is reproduced below.

Statement of Sen. Bernard Sanders (I-VT) on the Mark-up of FDA Reauthorization Package

This was the 3,500 word statement of Senator Bernie Sanders during Senate HELP committee markup of the PDUFA legislation. The statement covers a lot of ground, and illustrates why consumer groups love Bernie Sanders, while making one wonder why other Senators have not been more supportive of the consumer protection issues that Sanders discusses. Here are some highlights:

  • The proposal for a new extended monopoly for antibiotics and antifungal drugs is a "huge giveaway" that will lead to high prices and harm consumers.

Selected US AIDS drug prices, May 9, 2012

Manon Ress obtained the following quotes for various antiretroviral drugs on May 9, 2012.

The products are described briefly in the following chart, which provides details on the recommended dose:

The FDA web page on Antiretroviral drugs used in the treatment of HIV infection:

The prices were obtained from for pharmacies in or near Arlington, Virginia or Washington, DC.

Senate HELP subcommittee hearings on S.1138, the HIV/AIDS prize fund

Update: the hearing web page is here:

On May 15, 2012, the Primary Health and Aging Subcommittee of the Senate HELP Committee will hold hearings on S.1138, the Prize Fund for HIV/AIDS.

Primary Health and Aging Subcommittee


Is the WHO CEWG proposal for the R&D treaty "too small"?

The WHO's Consultative Expert Working Group (CEWG) on R&D proposal for a new WHO Convention on health R&D has been widely praised by public health groups (See The CEWG proposal for a treaty has also, at least so far, avoided much criticism from the pharmaceutical industry, even though it strongly embraces the notion of delinkage of R&D costs from product prices, open innovation, and technology transfer and capacity building in developing countries.

More notes on the USTR 2012 Special 301 List

The USTR's 2012 Special 301 list was published on April 30, 2012. Below are some comments about certain portions of the Special 301 Report that concern access to knowledge and access to medicines.

USTR cites the "TEAM" approach to access to medicines

USTR's 2012 Special 301 Report, focuses on largest developing country markets, and Canada

The 2012 USTR Special 301 Report was published on April 30, 2012. The report details USTR's unilateral standards for the granting and enforcement for a diverse set of intellectual property rights, and singles out countries that USTR claims do not meet those standards. The Report places the offending countries into different categories, including those on the “Priority Watch List,” the “Watch List” and those to have a “Special 306” review. According to USTR:

Senate HELP Committee proposes evaluation of Innovation Inducement Prizes, as alternative to product monopolies

In the United States Senate, the Committee on Health, Education, Labor and Pensions (HELP) is trying to move forward a bill titled the "Food and Drug Administration Safety and Innovation Act." Among other things, the bill would "amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, establish user-fee programs for generic drugs and biosimilars," and address a number of other topics, such as extend the legal monopoly on antibiotic drugs by 5 years.

Senate HELP Committee Markup of FDA Bills on Wednesday, April 25, 2012

On Wednesday, April 25, 2012 at 10:00 AM, the Senate Health, Education, Labor and Pensions (HELP) Committee will have an executive session to do a markup of FDA bills.

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