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 I was looking over the Orphan Drug Tax Credit (ODTC) language. The earlier Senate Finance proposal was a more complex… Continue Reading
Statement by James Love, KEI Director, on GOP proposal to eliminate the Orphan Drug Tax Credit.
The GOP proposal to eliminate the Orphan Drug Tax Credit may create a new opportunity to reform the incentives for rare diseases, even if the tax bill fails or the tax credit survives. The GOP tax bill shows there is weaker support for the existing regime than many thought.
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:
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
Kite Pharma is a California-based biopharmaceutical company working on various types of cell therapies for the treatment of cancer, in a bid to become the first pharmaceutical firm to gain successful FDA approval for this new class of cancer treatment.
Kite closely collaborates with the National Cancer Institute, which conducted significant early research into the forms of cell therapies that Kite is seeking to commercialize. NCI conducts clinical trials under Cooperative Research and Development Agreements (CRADAs) with Kite, and additionally has granted exclusive licenses on over a dozen patents to Kite on the same technologies.
On Wednesday morning, 29 June 2016, Nigeria, on behalf of the African Group, presented a revised proposal (SCP/24/4) for a WIPO work program on Patents and Health at the Standing Committee on the Law of Patents (SCP). The African Group proposal is a welcome breath of fresh air in the patent committee; the proposal aims to make WIPO more responsive to recent developments including: 1) “Challenges to public health …. Continue Reading
July 15, 2014
Knowledge Ecology International (KEI) asks the FTC to investigate Shire decision to abandon efforts to compete in US market for Fabry’s disease treatments. Letter to FTC provides evidence of possible conspiracy to segment markets, involving licensing of an NIH funded invention for use in Europe, in return for abandoning efforts to enter US market.
For More Information:
James Love, Knowledge Ecology International
For background on the Fabrazyme case, see: http://www.keionline.org/fabrazyme
The following statements were made today by civil society on the NIH rejection of the Fabrazyme March-in Request Petition. Contact Judit Rius at email@example.com if your organization would like to submit an statement.
Statement by James Love, Director of Knowledge Ecology International (KEI) (Contact: 1.202.361.3040)