- NIH rulemaking on transparency of clinical trials
- UACT sends letter to Tufts President, Chairman of Trustees, asking questions about R&D cost study
- The Winning Bet
- KEI comment on the new Tufts Study on Drug Development Costs
- What to look for in the new Tufts study on drug development costs. 10 issues.
- Research note on oncology drugs, including trial size and orphan drug status
- KEI Research Note: Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
- Former WTO Director-General, Pascal Lamy, mooted to chair Global Fund's Equitable Access Initiative
- WIPO patent committee engaged in heated talks on work sharing, limitations & exceptions, client confidentiality
- WIPO patent committee (SCP21): Intervention of KEI on Patents and Health
SCCR27: UK proposal on the Proposed WIPO treaty on the protection of broadcasting organizations (the BBC experience)Submitted by thiru on 14. April 2014 - 6:28
On 8 April 2014, the United Kingdom of Great Britain and Northern Ireland submitted a paper to the 27th session of WIPO's Standing Committee on Copyright and Related Rights (SCCR) on the Proposed WIPO treaty on the protection of broadcasting organizations (SCCR/27/3). In its proposal, the UK endeavors to "shed light on a number of different technologies already being used by broadcasters from around the world" including the deployment of the BBC iPlayer and the BBC Red Button services.
32 Members of US House of Representatives ask USTR to sanction Canada for not granting patents on drugsSubmitted by James Love on 11. April 2014 - 14:21
The attached letter, dated April 10, 2014 and signed by a bipartisan group of 32 members of the House of Representatives, asks USTR to elevate Canada to the Special 301 "priority watch list," for "violation of their international obligations" for not granting enough patents on "innovative medicines." According to the members of Congress signing the letter, Canada is in violation of its WTO TRIPS obligations.
On the Table for the next Standing Committee on Copyright and Related Rights (SCCR27) April 28 to May 2Submitted by Manon Ress on 9. April 2014 - 11:06
What is on the table for the next Standing Committee on Copyright and Related Rights: Twenty-Seventh Session (SCCR/27) April 28 to May 2, 2014 (Geneva, Switzerland)?
On April 1, 2014, ViiV, a consortium of Pfizer and GSK, and the Medicines Patent Pool (MPP), announced two new licensing agreements that expand generic competition for dolutegravir (DTG), and integrase inhibitor used for the treatment of adult and pediatric HIV infection. (MPP press release here.) Dolutegravir is a new drug, approved for marketing by the US FDA on August 12, 2013.
Below is a two page excerpt from a March 20, 2014 EU analysis of the TransAtlantic Trade and Investment Partnership (TTIP) negotiations on intellectual property rights, including geographical indications. The memo summarizes in a sentence or two the negotiations in eight types of intellectual property, patents, copyrights, designs, pharmaceutical regulatory test data, plant varieties, trademarks, trade secrets, geographical indications (GIs), as well as negotiations on enforcement, voluntary best practices, and cooperation on third country and multilateral IPR negotiations.
Comments of KEI, regarding USTR Request For Comments From The Public On The Creation Of The Public Interest Trade Advisory Committee And Request For Nominees To That Committee.
Submitted to Regulations.gov on March 25, 2014, under docket number USTR-2014-0005.
Intellectual property issues are an important element of US trade agreements, and according to a recent study by Open Secrets, the most intensively lobbied issue, by far.
17 March 2014: The African Group highlights the hidden costs of implementing the Design Law Formalities TreatySubmitted by thiru on 22. March 2014 - 13:35
On 17 March 2014, the African Group delivered the following opening statement at the Thirty-First Session of the WIPO Standing Committee on the Law of Trademarks, Industrial Designs and Geographical Indications (SCT) highlighting the need for an inclusion of an article on technical assistance (with legally binding effect) in the proposed design law treaty. The African Group noted,
On 17 March 2014, the European Union and its Member States issued the following clarion call to the Thirty-First Session of the WIPO Standing Committee on the Law of Trademarks, Industrial Designs and Geographical Indications (SCT) urging the committee to "make a clear and unambiguous recommendation to convene a diplomatic conference to the upcoming Extraordinary General Assembly" for a Design Law Formalities Treaty.
Geographical indications, country names and the domain name system: Czech Rep, Germany, Hungary, Italy, Moldova and SwitzerlandSubmitted by thiru on 20. March 2014 - 4:59
On 18 March 2014, the delegations of the Czech Republic, Germany, Hungary, Italy, Republic of Moldova and Switzerland submitted the following proposal (SCT/31/8 Rev.) on the Protection of Geographical Indications and Country Names in the Domain Name System for consideration by the WIPO Standing Committee on the Law of Trademarks, Industrial Designs and Geographical Indications (SCT).
The US Copyright Office held a two day roundtable event on the topic, "Orphan Works and Mass Digitization." The two days were split into ten sessions, with extensive panels convened for each roundtable discussion. The meetings were held in the Montpelier Room at the Madison building of the Library of Congress, with the exception of the afternoon panels on the second day, which was held downstairs in the hearing room of the Copyright Office.
Resurrecting the Ghost of Høsbjør Past: Global Fund seeks to establish global framework on tiered pricing enforced by WTO rulesSubmitted by thiru on 14. March 2014 - 4:07
Informed sources have revealed that Mark Dybul, Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, is the brains behind an initiative to create global framework for the tiered pricing or in the Global Fund's own words, "Equitable Access to Essential Medicines and Vaccines: Developing a Framework for Success", enforced by the rules of the World Trade Organization. KEI has obtained this internal concept note prepared by the Global Fund which we understand is a work in progress.
Protection for geographical indications is an issue that divides the generally united front that Australia, Canada, the European Union, Japan, Switzerland, New Zealand and the United States maintain at WIPO and WTO negotiations on setting rules for the enforcement of patents, copyright, trademarks and industrial designs. In a 12 March 2014 piece, Europe wants its Parmesan back, seeks name change, the Associated Press reported that,
KEI’s Additional Comments Special 301
March 7, 2014
James Love, Knowledge Ecology International
Docket # USTR-2013-0040
These comments supplement KEI’s February 7, 2014 written submission (Also available here: http://www.keionline.org/ustr/special301, and http://keionline.org/node/1927), and our February 24, 2014 oral testimony, and provide also comment or reply to the written or oral submissions by others.
1. India is an important source of affordable medicines.
Among the comments that KEI filed today in the 2014 Special 301 Review process were comments regarding pharmaceutical companies' donation and patient assistance programs. An oft-cited claim by pharmaceutical companies and those lobbying on their behalf is that donations and patient assistance programs fully provide for those that cannot afford the high priced medications offered by the companies.
KEI Comments on the IIPA oral and written submission to 2014 Special 301 regarding education and researchSubmitted by Manon Ress on 7. March 2014 - 15:12
Manon Ress, Knowledge Ecology International, Comments on the IIPA oral and written submission to 2014 Special 301
March 7, 2014
Docket ID: USTR-2013-0040
In 2014, the International Intellectual Property Alliance (IIPA) submission for the Special 301 failed to propose constructive policies by the USTR regarding copyright, as regards to access to knowledge and copyright related issues, in the context of education or research.