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SEARO RC70: Statement of Knowledge Ecology International on Access to Medicines

Knowledge Ecology International (KEI) delivered the following statement during discussions at the WHO South East Asia Region (SEARO) Regional Committee on Access to Medicines on 9 September 2017 in the Maldives.

(Photo taken by Cristina Bajar)

Intervention of Knowledge Ecology International

Seventieth Session of the Regional Committee - SEARO: 8.3 Access to medicines - SEA/RC70/9
Saturday, 9 September 2017

2017: Nanobernetics proposed exclusive license for NIH patents on Apparatus for Microarray Binding Sensors

(More on KEI's work on NIH licensed inventions here:

The attached file (copy here) is the KEI questions and initial comments on the Prospective Grant of an Exclusive Patent License: Apparatus for Microarray Binding Sensors Having Biological Probe Materials Using Carbon Nanotube Transistors to Nanobernetics, LLC (“Nanobernetics”) , as noticed in the Federal Register, 82 FR 41970.

Kymriah, the Novartis $475,000 CAR T treatment, received 50 percent Orphan Drug tax credit on trials

Missing in the reporting on the Novartis price for Kymriah, its new $475,000 CAR T treatment, is that Novartis received an Orphan Drug designation in February 3, 2015, and sequently received a tax credit subsidy from the United States equal to 50 percent of the cost of qualifying clinical trials.

From the FDA database on Orphan Designations:

US Federal rights in patents on Probuphine, to treat opioid addiction

Probuphine is an expensive medication used to treat opioid dependence by providing maintenance treatment and lessening withdrawal symptoms. The U.S. federal government also has considerable leverage over the pricing of this product, because of the federal funding of the the research that lead to the sole Orange Book patent on the product, and phase 3 trials that were used the register the product.

WHO draft concept note on strategic priorities for 2019-2023 charts a new vision for the organization

On 25 August 2017, the World Health Organization (WHO) published a draft concept note to provide a strategic framework to underpin WHO's General Programme of of Work from 2019-2023.

KEI statement regarding Gilead’s Acquisition of Kite Pharma

KEI statement regarding Gilead’s Acquisition of Kite Pharma.

“Congress should require the NIH to enforce the Bayh-Dole obligation to make the Kite Pharma Chimeric Antigen Receptors Technologies (CAR T) treatments available to the public on reasonable terms.

KEI notes that Kite reported spending $317 million in R&D from 2012 to June 30, 2017, and is selling the company for $11.9 billion.

Workshop: Patents, the Public Interest and Two New Medical Technologies: CRISPR and CAR T

Workshop: Patents, the Public Interest and Two New Medical Technologies: Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), Chimeric Antigen Receptors (CAR) technologies

On September 15th, 2017, Knowledge Ecology International will be hosting a workshop on: “Patents, the Public Interest and Two New Medical Technologies: CRISPR and CAR T.”

If you are unable to attend in person, a livestream of the event will be available 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

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).

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.

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