SEARO RC70: India calls on WHO to take the lead in negotiations of the R&D treaty (General Programme of Work debate)

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). Continue Reading

KEI asks HHS to use Bayh-Dole rights in Zinbryta patent (drug for multiple sclerosis)

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)

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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)
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Intervention of Knowledge Ecology International

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

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2017: 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=463114

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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.

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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.

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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

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