- Xtandi patient on Medicare — with supplement — pays $441.97 per month
- 2016: NIH FOIA office withholds all records related to exclusive license on HER2+ breast cancer treatment technology
- WHO CEWG 2016: Statement of Health Action International, Knowledge Ecology International and STOPAIDS
- Rep. Lloyd Doggett keynote address at CAP drug pricing event highlights Xtandi, federal funding of pharmaceutical R&D
- China: as PCT patent filings increase, GDP growth has decreased
- Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countries
- KEI comment on USTR's 2016 Special 301 report
- Transparency of patents on medicines and other technologies
- WHO releases program of work and progress report in advance of Consultative Expert Working Group on R&D (2-4 May 2016)
- 2015 Oct 16 version: RCEP draft text for investment chapter
Obama Administration memo: "Background on TPP Biopharma Provisions" describes how TPP will raise drug pricesSubmitted by James Love on 12. April 2016 - 9:18
[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.
CDIP 17: Asia Pacific and African Group raise concerns re: WIPO's position on the UN High-Level Panel on Access to MedicinesSubmitted by thiru on 11. April 2016 - 4:04
The World Intellectual Property Organization (WIPO) is convening its 17th session of the Committee on Intellectual Property and Development (CDIP17) from 11 April 2016 to 15 April 2016. The mandate of the Committee is to "develop a work-program for implementing the 45 adopted Development Agenda recommendations" and "monitor, assess, discuss and report on the implementation of all recommendations adopted" (Source: WIPO page on the Committee on Development And Intellectual Property).
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
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)].
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:
7 April 2016: Keynote address of Minister Rob Davies (South Africa) to WIPO International Conference on IP and DevelopmentSubmitted by thiru on 7. April 2016 - 6:36
On Thursday, 7 April 2016, Dr. Rob Davies, Minister of Trade and Industry of South Africa, delivered a keynote address at the World Intellectual Property Organization's (WIPO) International Conference on Intellectual Property and Development.
On compulsory licensing, in relation to voluntary licensing, the Minister remarked:
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.
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.
BIO, PhRMA and US Chamber of Commerce express fear of UN High-Level Panel on Access to Medicines in letter to Senator HatchSubmitted by thiru on 31. March 2016 - 10:11
In a sternly worded letter dated 18 February 2016, the Biotechnology Innovation Organization (BIO), the National Association of Manufacturers (NAM), the National Foreign Trade Council (NFTC), the Pharmaceutical Research and Manufacturers of America (PhRMA), the U.S. Chamber of Commerce (the Chamber) and the United States Council for International Business (USCIB) wrote Senator Orrin Hatch (Republican - Utah) expressing serious reservations with the United Nations High-Level Panel on Access to Medicines (UN HLP).
GSK has made a major announcement of new policies to expand access to its patented medicines. A copy of the press statement is here.
11 Groups Urge NIH to Lower Price of Xtandi, NIH/Army-Funded Prostate Cancer Drug With $129k/Year Price TagSubmitted by Zack Struver on 21. March 2016 - 12:34
+1 (914) 582-1428
FOR RELEASE: MARCH 21, 2016
Non-Profit Groups Urge Obama Administration, NIH to Lower Price of Government-Funded, $129,000 Per Year Prostate Cancer Drug
The groups asked the National Institutes of Health to “take this opportunity to act” to lower the price of the prostate cancer drug Xtandi and show leadership on deterring discriminatory pricing practices.
TDR releases report on a Health Product Research & Development Fund: A Proposal for Financing and OperationSubmitted by thiru on 17. March 2016 - 4:28
On 17 March 2016, the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) released a 76-page report entitled, Health Product Research & Development Fund: A Proposal for Financing and Operation.
I have provided an update on our work on US government owned patents here:
On Monday, March 7, 2016, from 1:45 P.M. to 2:45 P.M., the US Patent and Trademark Office (USPTO) met with invited stakeholders in a briefing at the White House on the Beijing Treaty on Audiovisual Performances and the implementation package that was sent to Congress on February 29, 2016. The package was submitted for review to the Senate Foreign Relations and Judiciary Committees.
2016: KEI and MSF comments to the NIH on the licensing of patents on Attenuated Respiratory Syncytial Virus VaccinesSubmitted by James Love on 9. March 2016 - 8:04
Other KEI comments on NIH licenses can be found here: http://keionline.org/nih-licenses
On Monday, March 7, 2016, Congressman Lloyd Doggett, D-Texas, issued a statement in support of the recent Knowledge Ecology International (KEI) and Union for Affordable Cancer Treatment (UACT) request that the National Institutes of Health (NIH) authorize the generic production of an expensive prostate cancer drug in order to curb an excessive and discriminatory price in the United States.