James Love's blog

KEI comment on USTR's 2016 Special 301 report

The 2016 USTR Special 301 report is now available. (copy here). The report is 77 pages of complaints about intellectual property policies around the world, plus a number of other complaints, including those related to pricing and reimbursement of pharmaceutical drugs and medical devices, restrictions on data flows, standard setting, and government procurement.

On the one hand, USTR says it is supports "access to medicine for all."

2015 Oct 16 version: RCEP draft text for investment chapter

(More KEI RCEP leaks here: http://keionline.org/rcep)

Attached below is the October 16, 2015 version of the investment chapter for the proposed Regional Comprehensive Economic Partnership, known as RCEP. This text is made public for the first time by KEI.

Global pharmaceutical sales, by region, 2013-2015

These estimates are published by Statista, here.

Statista-Global-Sales-2013-2015.png

Obama Administration memo: "Background on TPP Biopharma Provisions" describes how TPP will raise drug prices

[First reported by Politico] On April 9, 2016, the Obama Administration sent a document to Congress defending the TPP against criticism from the pharmaceutical industry that they did not get enough from the deal.

The 2016 Tufts estimates of the risk adjusted out-of-pocket costs to develop a new drug.

Draft, revised April 12, 2016.

2015:4 KEI Briefing Note: The Tufts estimates of the risk adjusted out-of-pocket costs to develop a new drug.
April 12, 2016
James Love

This is a briefing note on the 2016 Tufts study titled: Innovation in the pharmaceutical industry: New estimates of R&D costs, co-authored by three industry consultants, Joseph A. DiMasi, Henry G. Grabowski and Ronald W. Hansen. [J.A. DiMasi et al. Journal of Health Economics 47 (2016)].

2016: Great Lakes Neuroscience and NIH exclusive license on MS/ALS patent

The following is the KEI comment to the NIH proposed exclusive license to Great Lakes Neuroscience for a patent on Multiple Sclerosis, Amyotrophic Lateral Sclerosis and certain other CNS Disorders. (PDF version here). KEI asks the NIH for certain information about the proposed license, and also asks the NIH to include provisions in the license that protect consumers in both the United States and developing countries.

For the United States, KEI asks that prices be:

Incentives for R&D on new uses of existing drugs

The Fordham international IP conference just concluded a panel on patents for second uses of medical inventions, and the discussions illustrated once more the degree to which the patent system is poorly designed to address this issue.

Notes for the talk at Fordham on TPP/TTIP.

These were my notes from my talk on Thursday morning at the annual Fordham International IP conference, which is organized by Professor Hugh Hansen. The panel was titled "Examination of TPP & TTIP."


What is wrong with the TransPacific Partnership (TPP)?

The TPP was negotiated with asymmetric secrecy. Not from industry, but from the public. Nearly all of the real experts in IP policy were in the dark over the actual language of the texts. We delegated too much power to government trade negotiators and to lobbyists.

KEI statement on GSK's announcement of policies to expand access to patented medicines

GSK has made a major announcement of new policies to expand access to its patented medicines. A copy of the press statement is here.

The WSJ on Doha Declaration on TRIPS and Public Health, in 2001

This was the Wall Street Journal's take on the Doha Declaration on TRIPS and Public Health, two days after the agreement was reached:

Update on our work on US government owned patents

I have provided an update on our work on US government owned patents here:

KEI's March 4, 2016 submission to USTR regarding the Special 301 list

This is a slightly expanded version of the testimony we provided at the March 1, 2016 USTR Special 301 hearing. I had some trouble uploading to Regulations.Gov, but emailed a copy to Christine R. Peterson, the Director for Intellectual Property and Innovation. One addition was this data:

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.

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