The Managers Amendment for the “Tax Cuts and Jobs Act” is available on the Senate Finance web page here: https://www.finance.senate.gov/imo/media/doc/11.20.17%20Tax%20Cuts%20and%20Jobs%20Act.pdf or here: 11.20.17 Tax Cuts and Jobs Act I was looking over the Orphan Drug Tax Credit (ODTC) language. The… Continue Reading
On November 17, 2017, KEI provided comments in KEI-FDA-2017-N-3615 These were the topics discussed: Transparency Clinical trial costs Data from the Orphan Drug program Costs of trials for government funded research Asset acquisition costs. Licensing Access to Knowhow, data and materials… Continue Reading
From November 21 to 23, the Government of India and the World Health Organization are hosting the “1st World Conference on Access to Medical Products and International Laws for Trade and Health, in the Context of the 2030 Agenda for… Continue Reading
On October 19, 2017, I ran a query of the USPTO database of granted patents to identify patents granted to the Seattle based Fred Hutchinson Cancer Center.
This was delivered the afternoon on October 3, 2017.
Opening statement of Knowledge Ecology International – WIPO General Assembly 2017
Thank you, Mr. Vice President.
KEI notes the controversies around the world regarding the costs and benefits of intellectual property policies, including in particular extended terms of copyright protection in some countries, access to copyrighted works out of commerce and in teaching and research, and the role of patents in both promoting and discouraging innovation, and creating barriers to access medicine.
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