James Love's blog

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.


To the Editor:

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

Maryland House of Delegates passes bill on prescription drug price gouging by vote of 137 to 4

On March 20, 2017, the Maryland House of Delegates approved a prescription drug price gouging bill by a vote of 137-4. A copy of the bill, as it passed the House, is attached.

This is a March 20, 2017 Report by Erin Cox, published in the Baltimore Sun:

Maryland's attorney general could sue drug companies for price gouging under a bill approved by the House of Delegates Monday.

Leaked document: March 15, 2017 Note by Switzerland on India EFTA TEPA IP Chapter

Attached is a March 15, 2017 note by Switzerland on the India EFTA TEPA IP Chapter.

The EFTA is the The European Free Trade Association. The EFTA member states are Iceland, Liechtenstein, Norway and Switzerland. The document refers to a proposed "Trade and Economic Partnership Agreement," or TEPA, between India and the four members of the EFTA. The EFTA page on this negotiation is here.

Leaked: Three documents from RCEP negotiations

The Regional Comprehensive Economic Partnership (RCEP) is a proposed trade agreement involving 16 countries in the Asia/Pacific region, that have a combined population of 3.5 billion persons, and about 30 percent of world GDP. They include the members of the Association of Southeast Asian Nations (ASEAN) (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, Vietnam), and six additional countries: Australia, China, India, Japan, South Korea and New Zealand.

Company disclosures of R&D costs on SEC filings

Today I attended a work session of the Maryland House of Delegates subcommittee on Health Facilitates and Pharmaceuticals of the Health and Government Operations Committee. I was there to testify in support of HB 666, a bill titled: Public Health – Expensive Drugs – Manufacturer Reporting and Drug Price Transparency Advisory Committee. (PDF version here).

All 12 Zhang/Broad Institute CRISPR patents declare US funding and rights in inventions

February 15, 2017, the USPTO ruled that 12 genome-editing CRISPR-Cas9 patents and one patent application assigned to the Broad Institute of Harvard and MIT did not interfere with a patent application from scientists at the University of California. A copy of the ruling is available here.

Following the ruling by the USPTO that the Broad Institute and the University of California both issued statements, as did several firms with an interest in the dispute.

Spinraza: KEI asks DHHS Office of the Inspector General (OIG) to investigate a failure to disclose federal funding in patents

KEI has asked the DHHS Office of Inspector General (OIG) to investigate a failure to disclose federal funding of patents on nusinersen, a drug developed by Ionis Pharmaceuticals (formerly known as Isis Pharmacetuicals) with BioGen, and sold under the trade name Spinraza.

A copy of the 22 page letter to OIG is available here.

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