James Love's blogs

Senate tax bill will not make orphan drug tax credits transparent as to company, drug and disease

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 indication, a victory for pharma, making R&D outlays and public subsidies less transparent. Lobbyists for …

Add new comment Read more

Senate proposes to cut Orphan Drug Tax Credit to 27.5 percent, and make it public

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 formula that ranged from 25 to 50 percent, based upon the increase in R&D spending, …

Add new comment Read more

KEI comments in FDA-2017-N-3615

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 Non-Voluntary use/Compulsory licenses/Exceptions to Rights and Remedies The UACT proposal Extending March-in Rights Bayh-Dole Rights …

Add new comment Read more

KEI Presentation at World Conference on Access to Medicines, New Dehli

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 Sustainable Development”.  The program for then meeting is here:  (pdf) I make a presentation on …

Add new comment Read more

Fred Hutchinson Cancer Center often fails to disclose federal funding of inventions on initial patent


  • A review of the “certificate of correction” to patents assigned to the Fred Hutchinson Cancer Center finds frequent failures to disclose federal funding on initial patent applications.
  • When Fred Hutchinson reported no federal funding on patent applications, it was wrong 45 percent of the time, according to corrections later filed with the USPTO.

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.

Add new comment Read more

KEI’s opening statement at WIPO’s 2017 General Assembly focuses on role of Chief Economist

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.

Add new comment Read more

Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria unanimously endorses delinkage

paccarb_logo.jpgOn 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:

Kymriah, the Novartis $475,000 CAR T treatment, received 50 percent Orphan Drug tax credit on trials

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:

Add new comment Read more

KEI statement regarding Gilead’s Acquisition of Kite Pharma

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.

Add new comment Read more