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2017: Salubris Biotherapuetics: Bispecific, Biparatopic Antibody-Drug Conjugate for Human Liver Cancers

Attached are the August 8, 2017 KEI comments regarding the prospective grant of an exclusive patent license by the NIH to Salubris Bioterapuetics for the development of a bispecific, biparatopic antibody-drug conjugate to GPC3 for the Treatment of Human Liver Cancers. (Copy here).

2017: miRecule/NIH license on MicroRNA Therapeutics for Treating Squamous Cell Carcinomas

Attached (PDF file here) are the KEI comments on the proposed NIH exclusive license to miRecule for MicroRNA Therapeutics for Treating Squamous Cell Carcinomas.

The seven page letter concludes with these words:

USTR Chief Innovation and Intellectual Property Negotiator

In February 2016, the Trade Facilitation and Trade Enforcement Act of 2015 became law, as PL 114-125. Section 609 of the law created a new position in USTR, the "Chief Innovation and Intellectual Property Negotiator." This position creates a position for a presidential poltical appointee confirmed by the Senate, with the rank of ambassador, replacing the current system where the IP negotiators are civil servants, reporting to political appointees.

KEI initial comments on NIH proposed grant of exclusive license on liver cancer treatment to Salubris

On August 8, 2017, Knowledge Ecology International (KEI) submitted comments on the proposed grant of an exclusive license from the National Institutes of Health (NIH) and Department of Health and Human Services (HHS) to Salubris Biotherapuetics, Inc, a corporation headquartered in Guangdong, China, for an important new technology that could be used

NIH response to KEI request for NIH policy on on the licensing of federally-funded CRISPR patented inventions.

On June 6, 2017, KEI wrote to Dr. Thomas Price, Secretary of Health and Human Services (HHS), and Dr. Francis S. Collins, Director of the National Institutes of Health (NIH) requesting the HHS develop a policy on the licensing of federally-funded CRISPR patented inventions. A copy of our letter is available here:

KEI comments at July 25, 2017 civil society stakeholder forum at the 19th round of the RCEP negotiation

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.

KEI and Médecins Sans Frontières propose contractual terms to protect access and affordability of Zika vaccine

25 July 2017
CONTACT: Kim Treanor, 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.

House Appropriations rejects Kaptur amendment (allow competition for gov funded drugs if prices higher than reference countries)

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.

Slides from the KEI testimony at July 18, 2017 FDA hearing on drug pricing

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)

NAFTA negotiating objectives released by USTR

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.

KEI response to Sanofi letter to Senators who asked Army for hearing on Zika vaccine license

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.

Senate Armed Services Committee directive on use of Bayh-Dole rights for DoD funded drugs

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:

German Federal Supreme Court Affirms Compulsory License on HIV Drug

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).

SCP26 - Agreement reached on future work reached at WIPO Standing Committee on the Law of Patents (6 July 2017)

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 amendment to National Defense Authorization Act (NDAA) on federally funded drugs, vaccines

Angus_King,_official_portrait,_113th_Congress-800x.jpgSenator 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.

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