James Love's blog

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 moderation 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.

Groups ask Army to reconsider decision that would allow French firm to charge U.S. anything it wants on federally-funded vaccine

23 May 2017

Groups ask Army to reconsider decision that would allow French firm to charge the US anything it wants on a federally funded Zika vaccine

CONTACT: Zack Struver, zack.struver@keionline.org, +1 (914) 582-1428
Andrew Goldman, andrew.goldman@keionline.org
James Love, james.love@keionline.org, +1 (202) 361-3040

KEI submission to OECD consultation on "Sustainable access to innovative therapies"

This was the KEI submission to the OECD consultation on "Sustainable access to innovative therapies," which involved four questions posed by OECD on access to medicines.

Question 1: Reflecting on the last 5-10 years, what do you think have been the major changes affecting access to medicines?

Democrats in House and Senate introduce new drug pricing bill

The House version is HR 1776. Attached below. The Senate bill is identical, and also attached.

Senator Franken's press release is here.
Representative Schakowksy's press release is here:
Senator Franken's facebook statement is here.

Dr. Elias Zerhouni defends Sanofi/Army proposed license on Zika patents, and KEI responds

On March 21, 2017, the New York Times published a letter signed by Dr. Elias Zerhouni, defending the proposed Sanofi monopoly on the US Army patents to the Zika virus. The letter is available from the NYT from the following link, and also reprinted here, followed by commentary.

https://www.nytimes.com/2017/03/21/opinion/developing-a-zika-vaccine.html

To the Editor:

Re “Trump Should Avoid a Bad Zika Deal” (Op-Ed, March 11):

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