On Thursday, the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria unanimously endorsed a report that included very powerful recommendations on delinkage. This is a link to the report that was approved.
This from the report:
- Adoption of some form of a delinkage model as a pull incentive.
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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.
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
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.
These are the notes I used when providing the KEI comments at the July 25, 2017 civil society stakeholder forum at the 19th round of the RCEP negotiation.
My name is James Love. I work for Knowledge Ecology International, an NGO that focuses on the social aspects to the production, management and control of knowledge goods. I am also a member of the board of directors of the Union for Affordable Cancer Treatment.
The IP Chapter is complex, and in the time allocated, I will discuss five issues.
The attached PDF file was prepared by Dr. Diane Singhroy, for Patients for Affordable Drugs. DR. Singhroy performed a keyword search in the NIH RePorter database, (https://projectreporter.nih.gov/reporter.cfm) for all projects since 1993 containing the phrase “chimeric antigen receptor” (CAR), as… Continue Reading
Attached are the slides I used in today’s FDA hearing on the Hatch-Waxman Act and drug pricing. (link to PDF version of slides) Continue Reading
This afternoon USTR published a summary of the negotiating objectives for NAFTA. A press release is here. The summary report is here.
The intellectual property objectives include this welcome statement, which reflects positions taken in the past by USTR, but it not something we took for granted in the Trump Administration, and we are happy to see it.