As noted in an earlier piece, on 25 August 2017 the WHO published a draft concept note to provide a road map to "underpin WHO's General Programme of of Work from 2019-2023... and serve as the strategic basis for resource mobilization" for the Organization (WHO draft concept note on strategic priorities for 2019-2023 charts a new vision for the organization, 29 August 2017, KEI).

On Thursday, the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria unanimously endorsed a report that included very powerful recommendations on delinkage. This is a link to the report that was approved.

This from the report:

• Adoption of some form of a delinkage model as a pull incentive.
  

Attached is a letter sent on September 14, 2017 to Andrew Bremberg, an Assistant to the President and the Director of the Domestic Policy Council at the White House, and Keagan Lenihan, a Senior Adviser to HHS Secretary Tom Price, regarding Zinbrytra (INN: daclizumab), a drug to approved by the FDA to treat multiple sclerosis. (PDF version here)

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

(More on KEI's work on NIH licensed inventions here: https://www.keionline.org/nih-licenses)

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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.

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:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=463114

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.

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.

“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.

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:

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.

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

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).

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: https://www.keionline.org/node/2801.