James Love's blog

2016: Did Army do analysis to determine if public is better off with exclusive license to patent?

We sent this brief note to the Army today regarding this federal register note: https://federalregister.gov/a/2016-04494



From: Jamie Love
Date: Sat, Mar 5, 2016
To: Phoebe.E.Lenear@usace.army.mil
Subject: Digital Optical Method patents

I am writing about the notice of intent for an exclusive license to patents on the Digital Optical Method (DOMTM ), United States Patent No. 7,495,767.

KEI comments to the Senate Finance Committee Report on the Price of Sovaldi

On March 4, 2016, KEI provided comments to the US Senate Committee on Finance on a report prepared by staff for Senators Grassley and Wyden that was issued by the committee on December 2015, titled “The Price of Sovaldi and Its Impact on the U.S. Health Care System.” Senators Grassley and Wyden asked the public to comment on various issues raised in the report. The comments we filed on March 4 included three major sections.

Colombia takes an important step in defining the public interest in compulsory licensing case

(More on Colombia here: http://keionline.org/colombia)

Andrea Carolina Reyes Rojas informs us that a committee appointed to consider a request for a compulsory license on the leukemia drug Imatinib has decided that there are public interest reasons to do so.

A copy of the decision is available here. Andrew Goldman shares some thoughts and context here.

KEI submissions to the UN Secretary General's High Level Panel on Access to Medicine

Attached below are the four submissions for which KEI was the lead author to the UN Secretary General's High Level Panel (HLP) on Access to Medicine.

  1. "The Need for Global Negotiations on Agreements to Fund R&D within the Context of a Progressive De-linking of R&D Costs from Product Prices". Supported by 12 organizations; 1 individual; 3 Members of European Parliament.
  2. "Increasing the Transparency of Markets for Drugs, Vaccines, Diagnostics and other Medical Technologies". Supported by 17 organizations; 2 individuals; 3 Members of European Parliament.

DHHS Declared public health emergency for Zika virus

DHHS has declared a public health emergency over the Zika viru, and authorized emergency use of diagnostic tests. (Copy here)

Notes from KEI's testimony at today's USTR Special 301 hearing

(An expanded, edited and better version of this is available in our March 4, 2016 reply comment to USTR, available here: http://www.keionline.org/node/2440)

These were my notes from my testimony for KEI at today's USTR Special 301 hearing

Big market puts countries on the #special301 watch list

Schedule for the March 1, 2016 USTR Special 301 Hearing

KEI is one of the non-government entities speaking at the USTR Special 301 hearing on Tuesday. We each get 7 minutes of testimony and 3 minutes of questions. (The schedule is here).

Equitable Access Initiative (EAI), 1st intervention

I am in a meeting of the Equitable Access Initiative (EAI), which is considering new ways of measuring development and/or health needs, in the context of the priority setting by donors. I am a member of the Expert Panel, and this was my intervention in the morning session:

The presentations by John McArthur and Dominik Zotti were excellent, and the work of the four expert groups is a very useful contribution for those struggling with the challenge of setting priorities for aid.

5 questions about NIH licenses to patents on Production of Attenuated Respiratory Syncytial Virus Vaccines

The NIH has a notice for comments on proposed licenses of several patents relating to the "Production of Attenuated Respiratory Syncytial Virus Vaccines". See: https://federalregister.gov/a/2016-03486

We asked Peter Soukas, a Senior Technology Licensing Specialist in the Technology Transfer and Intellectual Property Office, at the National Institute of Allergy and Infectious Diseases (NIAID), these questions:

  1. What provisions exist in the license to protect US residents against excessive or unreasonable pricing?

Obama asks the Senate to ratify the Marrakesh treaty for the blind

This is the announcement.

For Immediate Release February 10, 2016

TO THE SENATE OF THE UNITED STATES:

With a view to receiving the advice and consent of the Senate to ratification, I transmit herewith the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired, or Otherwise Print Disabled, done at Marrakesh on June 27, 2013 (Marrakesh Treaty). I also transmit, for the information of the Senate, a report of the Secretary of State with respect to the Marrakesh Treaty that includes a summary of its provisions.

Xtandi 2016 March-In Request

Today Knowledge Ecology International and the Union for Affordable Cancer Treatment (UACT) petitioned the Department of Health and Human Services, the Department of Defense, and the National Institutes of Health, asking that they exercise either their royalty-free, non-exclusive license or federal "march-in" rights to end the monopoly on an expensive prostate cancer drug, enzalutamide, marketed as Xtandi by Astellas, a Japanese pharmaceutical company.

Xtandi was invented at UCLA on federal grants from the NIH and DoD.

51 members of Congress have asked the NIH to use March-In rights to rein in high drug prices

This was the release from Representative Doggett's office:

FOR IMMEDIATE RELEASE
January 11, 2016

Contact:
Leslie Tisdale, (202) 225-4865
Over 50 Members of Congress to Obama Administration:
Help End Drug Price Gouging Now

FDA approves 45 new drugs. 47 percent qualify for 50 percent Orphan Drug tax credit

In calendar year 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel drugs, approved as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). This is a large number of approvals.

KEI's December 19, 2015 submission to the US ITC regarding the TPP

Attached here is a KEI submission to the US ITC for the January hearing of the

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, DC
Investigation No. TPA-105-001
Trans-Pacific Partnership Agreement: Likely Impact on the U.S. Economy and on Specific Industry Sectors

Our earlier, related testimony on trade agreements was here: http://keionline.org/node/2370

The UK's rebates on drug sales, and introducing the budget constraint into pricing models

Under the UK's Pharmaceutical Price Regulation Scheme (PPRS), drug companies will make rebates of about £550 million in 2016, according to this story.

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