James Love's blog

Biden presses Colombia to block biosimilar drugs

vp_portrait.jpegOn September 8, 2014, Vice President Joe Biden wrote to Juan Manuel Santos Calderón, the President of Colombia. In the letter, Biden registered a complaint about the regulations in Colombia to register biosimilar drugs. A copy of the letter from Vice President Joe Biden is available here, and includes this quote:

The Gilead HCV license: Glass half empty, or half full?

On Monday, September 15, 2014, Gilead announced licensing agreements with 7 generic drug manufacturers, for two of its HCV drugs, including sofosbuvir, which is currently the most important HCV drug, and the basis for Gilead’s value to shareholders. KEI's statement from Monday, and links to other NGO comments are here: http://www.keionline.org/node/2082.

OMB's Revised Guidance on Appointment of Lobbyists to Federal Advisory Committees, Boards, and Commissions

Following litigation by several lobbyists, OMB is revising its guidance on the appointment of lobbyists to federal advisory committees, boards, and commissions. Now, lobbyists can serve on these committees, including the USTR advisory boards. Money quote:

Some recent cancer drug prices

Attached are two annexes from our 2014 USTR Special 301 comments

Gilead's MPP license for tenofovir alafenamide (TAF) patents

On July 24, 2014, the Medicines Patent Pool announced welcome modifications and expansions of their licensing agreement with Gilead. Among the significant changes were the addition of a new drug, tenofovir alafenamide (TAF), formerly known as GS-7340. TAF is a nucleotide reverse transcriptase inhibitor, and a prodrug of tenofovir. TAF is considered to have similar antiretroviral efficacy to tenofovir disoproxil fumarate (TDF), the drug it may replace in use, but can be administered with smaller doses and with less adverse effect on kidneys and bones.

Hepatitis research and development timeline

KEI is creating a timeline for various events relating to the discovery and the development of diagnostics, vaccines and drugs for Hepatitis. A working draft of the timeline is available here.

Hepatitis C Virus patent assignments: patents with HCV in the patent claim

To get a quick look at who is holding patents on the Hepatitis C Virus, I did some searches of the USPTO database. In each search, I looked for the term HCV in the field for patent claims (ACLM). Note this is fairly arbitrary, and I get different (and higher) numbers if I include HCV in the Abstract. In any case:

There were 1164 patents that have the term HCV in the patent claim.

KEI Policy Brief: Non-Voluntary use of HCV patents in the United States

Attached is policy briefing note that sets out possible mechanisms to overcome the exclusive rights of patents for drugs to treat the Hepatitis C Virus (HCV), in the United States. Each approach involves leadership from different actors. Each has advantages and disadvantages, including legal and practical risks. (Available here)

Table of Contents
1. The Federal Government use of HCV patents, without permission from right holder

Gilead in 2013: AbbVie sought to eliminate competition and dominate market for HCV drugs

I had not seen this lawsuit filed by Gilead against AbbVie and Abbott before. It is an interesting read. According to Gilead:

Abbott executives and “inventors” conspired and carried out the initial steps of the company’s scheme by filing serial fraudulent patent applications asserting that Abbott had invented methods of treating HCV using PSI-7977 as well as the Gilead Combination (as well as thousands of combinations of Abbott’s other competitors’ HCV compounds). The first of these applications is dated October 21, 2011.

KEI asks FTC to investigate Shire decision to abandon efforts to compete in US market for Fabry’s disease treatments

July 15, 2014

Knowledge Ecology International (KEI) asks the FTC to investigate Shire decision to abandon efforts to compete in US market for Fabry’s disease treatments. Letter to FTC provides evidence of possible conspiracy to segment markets, involving licensing of an NIH funded invention for use in Europe, in return for abandoning efforts to enter US market.

For More Information:

James Love, Knowledge Ecology International
Email: james.love@keionline.org
Tel +1.202.332.2670
Cell +1.202.361.3040

US Court issues compulsory license for know-how protected as trade secret

In "Compulsory License as a Remedy for Trade Secret Misappropriation, Dennis Crouch writes* about a July 1, 2014 decision in Sabatino Bianco, M.D. v. Globus Medical, 2:12-cv-00147 (E.D. Tex 2014). The decision by Judge Bryson, a U.S. Circuit Judge in the Eastern District of Texas, concerns trade secrets which:

"consisted of ideas for the design of a medical device known as an adjustable intervertebral spacer or implant. Intervertebral spacers are used in spinal surgery to replace damaged discs in patients’ spines."

Senators Wyden and Grassley launch investigation of pricing of Sovaldi, treatment for Hepatitis C Virus

Senators Wyden and Grassley have written a very tough request for documents about the pricing of Sovaldi, sent to John C. Martin, the Chair and CEO of Gilead Sciences.

The eight page letter sets out in 21 number paragraphs and countless sub-paragraphs a set requests for documents and information related to a very sweeping number of issues relating to Hepatitis C, and the pricing of Sovaldi (Gilead's brand name for sofosbuvir).

The Grassley press release on the letter is here:

Draft conclusions, SCCR 28, 10 PM version

KEI statement on library exceptions at WIPO SCCR 28

These are the notes from my statement on behalf of KEI on July 3, 2014, during the WIPO SCCR 28 discussions of principles and objectives for library copyright exceptions. The WIPO discussions on July 3 focused on the four topics in the US paper, SCCR/26/8.

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I will start with comments on the statements made by the Federation of Independent Journalists, which were critical of library copyright exceptions, and authors who don't make a living directly from royalties.

All authors have used libraries. Some authors still use libraries.

TACD intervention at SCCR 28, on library copyright exceptions, objectives and principles

This was read today at SCCR 28, by Anelise Rose, who works with KEI, on behalf of TACD.

Jamie

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TACD Intervention on US paper SCCR/26/8,

On the first topic, the ADOPTION OF NATIONAL EXCEPTIONS,

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