In a hearing before the House Energy & Commerce Subcommittee on Health, Dr. Francis Collins, Director of the National Institutes of Health, explained the agency’s position on the Bayh-Dole rights and high drug prices. In the hearing, focused on the… Continue Reading
(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) On November 30, 2017, KEI has received a response from the National Institute of Allergy and Infectious Diseases regarding our previous joint comments with MSFon the proposed exclusive… Continue Reading
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)
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
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:
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: /node/2801.
On June 6, 2017, Knowledge Ecology International wrote to the U.S. Department of Health and Human Services (DHHS) asking the Department to adopt a policy on the licensing of federally-funded CRISPR patented inventions. (Copy here).
February 15, 2017, the USPTO ruled that 12 genome-editing CRISPR-Cas9 patents and one patent application assigned to the Broad Institute of Harvard and MIT did not interfere with a patent application from scientists at the University of California. A copy of the ruling is available here.
Following the ruling by the USPTO that the Broad Institute and the University of California both issued statements, as did several firms with an interest in the dispute.
In a recent exchange with Senator Durbin, NIH Director Francis Collins expressed his concern that the NIH would alienate potential collaborators if the NIH applied the march-in remedy to address excessive prices of drugs. Continue Reading