Author: James Love

Attached are two annexes from our 2014 USTR Special 301 comments Continue Reading →

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.

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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. Continue Reading →

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.

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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
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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.

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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.”

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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:
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