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:
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. Continue Reading
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:
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
(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
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 Continue Reading
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.