James Love's blog

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.

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:

  • Adoption of some form of a delinkage model as a pull incentive.

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:

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.

2017: miRecule/NIH license on MicroRNA Therapeutics for Treating Squamous Cell Carcinomas

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:

USTR Chief Innovation and Intellectual Property Negotiator

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.

NIH response to KEI request for NIH policy on on the licensing of federally-funded CRISPR patented inventions.

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: https://www.keionline.org/node/2801.

KEI comments at July 25, 2017 civil society stakeholder forum at the 19th round of the RCEP negotiation

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.

Slides from the KEI testimony at July 18, 2017 FDA hearing on drug pricing

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)

NAFTA negotiating objectives released by USTR

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.

KEI response to Sanofi letter to Senators who asked Army for hearing on Zika vaccine license

Last week, Sanofi sent a letter to six U.S. Senators. (Copies here). We responded today. Our letter is attached here.

Some news reports about the Sanofi letter.

Senator Angus King amendment to National Defense Authorization Act (NDAA) on federally funded drugs, vaccines

Angus_King,_official_portrait,_113th_Congress-800x.jpgSenator Angus King proposed an amendment to National Defense Authorization Act (NDAA) that would require the Department of Defense (DoD) to authorize third parties to use inventions that benefited from DoD research funding, when prices exceed the median price charge in the seven largest economies with per capita incomes at least half the per capita income in the United States.

Groups, individuals write to Senator Wyden, appalled at pressure on India over drug patents

On June 23, 2017, Senators Orrin Hatch (R-UT) and Ron Wyden (D-OR) and Representatives Kevin Brady (R-TX) and Richard Neal (D-MA) wrote to President Trump about "trade and investment barriers" in India. The four members of Congress are respectively the chair and ranking members of the Senate Finance and the House Ways and Means Committee.

June 27-29 USTR NAFTA renegotiation hearings schedule

The latest version of the USTR NAFTA renegotiation hearings schedule is out. USTR has a page for the NAFTA hearings, here, which now has the a link to the witness schedule.

There are 26 panels of witnesses over 2.5 days. Doing the math, each witness seems to have less than 10 minutes, including questions from the panel.

The Draft Executive Order on Drug prices

Attached here is the draft Trump Executive Order, titled "REDUCING THE COST OF MEDICAL PRODUCTS AND ENHANCING AMERICAN BIOMEDICAL INNOVATION," as leaked by Politico today.

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