These are the notes I used when providing the KEI comments at the July 25, 2017 civil society stakeholder forum at the 19th round of the RCEP negotiation.

My name is James Love. I work for Knowledge Ecology International, an NGO that focuses on the social aspects to the production, management and control of knowledge goods. I am also a member of the board of directors of the Union for Affordable Cancer Treatment.

The IP Chapter is complex, and in the time allocated, I will discuss five issues.

25 July 2017
FOR IMMEDIATE RELEASE
CONTACT: Kim Treanor, kim.treanor@keionline.org or +1 (202) 332-2670

Washington, 25 July 2017 - Knowledge Ecology International (KEI) and Médecins Sans Frontières (MSF) have sent a letter today to the Command Judge Advocate of the U.S. Army Medical Research and Materiel Command (USAMRMC), recommending two specific contractual terms for the proposed license of the US Army’s Zika vaccine technology to Sanofi Pasteur.

On 19 July 2017, Rep. Marcy Kaptur (D-OH) introduced an amendment at the markup in the U.S. House Appropriations Committee of the FY2018 State and Foreign Operations, Labor, Health and Human Services Appropriations bill that would direct the Department of Health and Human Services to use its authority to break patent monopolies for government-funded inventions priced higher in the U.S. than seven other high-income countries.

Attached are the slides I used in today's FDA hearing on the Hatch-Waxman Act and drug pricing. (link to PDF version of slides)

This afternoon USTR published a summary of the negotiating objectives for NAFTA. A press release is here. The summary report is here.

The intellectual property objectives include this welcome statement, which reflects positions taken in the past by USTR, but it not something we took for granted in the Trump Administration, and we are happy to see it.

Last week, Sanofi sent a letter to six U.S. Senators. (Copies here). We responded today. Our letter is attached here.

Some news reports about the Sanofi letter.

• Ed Silverman, Sanofi denies rejecting Army request for a fair price on a Zika vaccine, Statnews, 17 July 2017

The report of the Senate Armed Services Committee on the National Defense Authorization Act of 2018, S. 1519, published July 10, 2017, includes a directive that links exclusive patent rights to the prices of drugs, vaccines and other medical technologies that are based upon DoD-funded inventions.

The text of the directive, approved unanimously by the full Senate Armed Services Committee, is as follows:

On July 11, 2017, the German Federal Supreme Court announced that it had affirmed the decision of the Federal Patent Court last year to issue a compulsory license allowing Merck to continue selling its HIV drug, raltegravir (marketed as Isentress).

On Thursday afternoon, 6 July 2017, the 26th session of the WIPO Standing Committee on the Law of Patents (SCP), chaired by Ms. Bucura Ionescu (Romania) reached agreement on future work on the following issues: i) Exceptions and Limitations to Patent Rights, ii) Quality of Patents, including Opposition Systems, iii) Patents and Health, iv) Confidentiality of Communications between Clients and Their Patent Advisors and v) Transfer of Technology.

Senator Angus King proposed an amendment to National Defense Authorization Act (NDAA) that would require the Department of Defense (DoD) to authorize third parties to use inventions that benefited from DoD research funding, when prices exceed the median price charge in the seven largest economies with per capita incomes at least half the per capita income in the United States.

Today at WIPO, KEI hosted a side event to discuss the ability of countries to deny injunctions in patent infringement cases.

On July 4th, 2017, Andrew Goldman delivered Knowledge Ecology International's intervention on patents at health at the 26th session of the WIPO Standing Committee on the Law of Patents (SCP).

KEI Statement on Patents and Health
WIPO Standing Committee on the Law of Patents - 26th Session

July 4th, 2017

Since the African Group and Development Agenda Group first tabled their proposal on a work program on patents and health in May 2011, much has happened.

On June 23, 2017, Senators Orrin Hatch (R-UT) and Ron Wyden (D-OR) and Representatives Kevin Brady (R-TX) and Richard Neal (D-MA) wrote to President Trump about "trade and investment barriers" in India. The four members of Congress are respectively the chair and ranking members of the Senate Finance and the House Ways and Means Committee.

On March 31st, KEI joined Prescription Justice, EFF, and Public Citizen at RightsCon 2017 to discuss the issues of sales of medication over the Internet. I was in attendance on KEI's behalf; Gabe Levitt represented Prescription Justice; Jeremy Malcolm presented for EFF; and Burcu Kilic was there for Public Citizen. It was one of the few panels at RightsCon dedicated to medicines/health.

After the session, the panelists convened to draft an agreement on a series of overarching principles that may help guide policy and shape the conversation.

The latest version of the USTR NAFTA renegotiation hearings schedule is out. USTR has a page for the NAFTA hearings, here, which now has the a link to the witness schedule.