James Love's blog
European Medicines Agency (EMA) recommends approval of Harvoni, Gilead's all oral HCV combination productSubmitted by James Love on 26. September 2014 - 8:37
The European Medicines Agency (EMA) is recommending approval of Harvoni, a combination of 9mg of ledipasvir (LDV) and 400mg of sofosbuvir (SOF), for the treatment of chronic hepatitis C virus (HCV) infection in adults. This is the "all oral" combination product, delivered in daily does of just 490 mg of API, for the "cure of patients with chronic HCV infection without the need for treatments involving interferons."
Comments of KEI regarding the White House OSTP call for comments on its Strategy for American InnovationSubmitted by James Love on 23. September 2014 - 22:19
Comments of KEI regarding the White House OSTP call for comments on its Strategy for American Innovation
(PDF of comments here)
Attn: Dan Correa, Office of Science and Technology Policy, Eisenhower Executive Office Building, 1650 Pennsylvania Ave NW., Washington, DC 20504.
Re: Strategy for American Innovation
Date: September 23, 2014
This just published by the US FDA:
The U.S. Food and Drug Administration is asking for potential breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.
The 2014 FDA Food Safety Challenge was developed under the America COMPETES Reauthorization Act of 2010, which grants all federal agencies broad authority to conduct prize competitions to spur innovation, solve tough problems, and advance their core missions. This challenge offers a total prize pool of $500,000.
Today we received news from Nina Mahmud that her father-in-law, Fathi Helmi Aboseda, has passed away in Egypt. Mr. Aboseda was suffering from liver cancer. Earlier this year, Nina Mahmud had contacted Bayer and KEI asking for help in finding affordable copies of sorafenib, a drug for liver and kidney cancer sold by Bayer under the trade name Nexavar, a drug that was extending and improving the quality of his life. The price of Nexavar in Egypt was $900 per week, and Mr. Aboseda had used his entire life savings to buy the drug.
On 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:
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 CommissionsSubmitted by James Love on 15. August 2014 - 8:58
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:
Attached are two annexes from our 2014 USTR Special 301 comments
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.
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.
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.
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
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 treatmentsSubmitted by James Love on 15. July 2014 - 5:43
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
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."