On October 17, 2017, KEI sent a letter to the NIH regarding the failure of the University of Pennsylvania to disclose federal funding of five patented inventions for CAR T.
Today (October 18, 2017), we received this statement from the University:
“We have reviewed the letter and have confirmed that each of these patents was reported to the government as having NIH funding.
There is an update on this issue, here: /node/2882, noting that the University filed a correction to each of the five patents, reporting federal funding of the inventions.
On Wednesday, 4 October 2017, Knowledge Ecology International (KEI) delivered the following statement at the WIPO General Assembly during discussions on the Report of the Standing Committee on the Law of Patents (SCP).
WIPO General Assembly 2017 – Statement of KEI on the Report on the Standing Committee on the Law of Patents (SCP)
4 October 2017
Agenda item: 14. Report on the Standing Committee on the Law of Patents (SCP)
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)
(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
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
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: 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
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:
(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) Attached are the August 8, 2017 KEI comments regarding the prospective grant of an exclusive patent license by the NIH to Salubris Biotherapuetics for the development of… Continue Reading