James Love's blog

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.

Groups Object to Army Proposal to Give Sanofi a Monopoly on Patents for Taxpayer-Funded Zika Vaccine

12 JANUARY 2017

CONTACT: Zack Struver, zack.struver@keionline.org, +1 (202) 332-2670

Groups Object to Army Proposal to Give Sanofi a Monopoly on Patents for Taxpayer-Funded Zika Vaccine

KEI Dec 9, 2016 comments to NIST on Bayh-Dole Act Regulations

In November, NIST proposed to amend the regulations implementing the Bayh-Dole Act, 35 U.S.C. 200 et seq., which concerns intellectual property arising from federally-funded research, including 37 CFR sections 401 and 404. There were 15 comments, including a letter from KEI on December 9, 2016. EFF also provide comments. The other 13 comments to NIST were from Universities, associations or individuals taking the side of right-holders.

The KEI comments are available here.

SCCR 33, KEI's intervention on legal protection for technological protection measures

This was our intervention at SCCR 33 on the topics of exceptions to the legal protection for technological protection measures.

TPMs are an legitimate and important measure to protect certain works, data and technologies from unauthorized uses.

The issues raised by libraries and archives concern the legal protection that one gives the technological protection.

SCCR 33: Notes from KEI NGO statement on WIPO broadcast treaty negotiations, November 16, 2016

Today, after two and a half days of negotiations, mostly off the record in informals, NGOs were given a few minutes to make statements on the broadcasters treaty. We were asked to keep things short, and focus on discussions this week. These are the notes from our intervention.

Notes from KEI NGO statement on Broadcast treaty
November 16, 2016

Right to prohibit

India Patent Office denies patent for prostate cancer drug sold under brand name Xtandi, generic name enzalutamide

According to this story, the India Patent Office has denied a patent for the prostate cancer drug sold under the brand name Xtandi (generic name Enzalutamide). Opponents of the patent claimed it was a new form of a known substance, and not eligible in India under Section 3(d) of its patent act.

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