Contact: Kim Treanor 202-332-2670; kim.treanor@keionline.org January 5, 2018 The National Institutes of Health (NIH) has proposed an exclusive license with Gilead for certain patent applications for inventions that target CD-30 proteins and CAR T technologies. The proposed license is to… Continue Reading
In a reversal from the version that passed out of the Senate Finance Committee, the version of the tax bill that passed the Senate eliminated the requirement that the Orphan Drug tax credit be transparent as to taxpayer, drug and… Continue Reading
Attached is the Civil Society input to the 1st World Conference on Access to Medical Products and International Laws for Trade and Health in the context of the 2030 Agenda for Sustainable Development that took place in Delhi, India in… Continue Reading
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