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 InternationalSeventieth Session of the Regional Committee – SEARO: 8.3 Access to medicines – SEA/RC70/9
Saturday, 9 September 20172017: Nanobernetics proposed exclusive license for NIH patents on Apparatus for Microarray Binding Sensors
(More on government funded inventions here. Other KEI comments on NIH licenses are found 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… Continue Reading
2017: 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:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=463114US 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. Continue Reading
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. Continue Reading