James Love's blog

New leak of TPP consolidated text on intellectual property provides details of pandering to drug companies and publishers

For more information:
James Love, Knowledge Ecology International
email: james.love@keionline.org, +1.202.361.3040

The May 16, 2014 version of the consolidated negotiating text for the Intellectual Property Chapter for the Trans-Pacific Partnership (TPP) agreement is a long, complex document that taken as a whole is designed to expand and extend monopolies on knowledge goods, including in particular publisher-owned copyrights, patents on inventions, and monopoly rights in data used to register new drugs, vaccines and agricultural chemical products.

Matrix of Export Possibilities under Gilead HCV Licence

KEI was asked to make a presentation on Hepatitis C, on September 30, 2014, at a lunch seminar at UNITAID. I am attaching a PDF of the slides I used, as well as an eight page memo that takes a look at the recent Gilead license. The memo on the license was last edited on September 30, 2014, and is presented as a draft that may be revised in the future.

WIPO General Assembly: Worst ever?

brazilIMG_20140930_234549887_1024.jpg
Brazil asks delegates to embrace work on copyright exceptions

European Medicines Agency (EMA) recommends approval of Harvoni, Gilead's all oral HCV combination product

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 Innovation

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.
Email: innovationstrategy@ostp.gov.
Re: Strategy for American Innovation
Date: September 23, 2014

FDA creates $500k prize for technology to improve detection of Salmonella

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.

Bayer's rejection of request for affordable Nexavar for Fathi Helmi Aboseda (Egypt)

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.

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

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