James Love's blog

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.

Comment on proposed Trump Executive Order on drug prices

I wrote an 1800 word comment on the proposed Trump Executive Order on drug prices in medium, here. The bulk of the comment focused on the first of the “principles” and “talking points” reported by Emily Kopp in Kaiser Health News.

KEI comments to USTR on the negotiating objectives for the modernization of NAFTA

USTR has a request for comments on negotiating objectives for the moderation of NAFTA, docket USTR-2017-0006, and will hold a public hearing on June 27, 2017. KEI filed a set of comments and a request to testify, available here.

KEI's comments cover an eclectic set of issues.

Apple obtains compulsory license on patents owned by WARF, by District Court Judge in Wisconsin

On June 6, 2017, Judge William Martin Conley, a United States District Judge of the United States District Court for the Western District of Wisconsin, issued a compulsory license allowing Apple Computers to use a patent it had infringed, owned by the Wisconsin Alumni Research Foundation (WARF), in return for an ongoing royally. Apple was found to infringe U.S. Patent No. 5,781,752, titled "Table based data speculation circuit for parallel processing computer. WARF asked for a permanent injunction to prevent future infringement.

Lexmark: The Supreme Court's patent exhaustion case and parallel trade in drugs

Lexmark: The Supreme Court's patent exhaustion case and parallel trade in drugs
KEI Briefing Note 2017:2. James Love. Revised 31 May 2017.

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