- 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
India's Department of Industrial Policy and Promotion creates IPR Think Tank to Draft National IPR PolicySubmitted by thiru on 24. October 2014 - 6:05
On Friday, 24 October 2014, India's Department of Industrial Policy and Promotion (DIPP) announced the creation of an IPR Think Tank to Draft National Intellectual Property Rights Policy.
The composition of the think tank follows:
Justice Prabha Sridevan, Chairperson, IPR Think Tank;
Ms. Pratibha Singh, Advocate, Singh & Singh Associates, Member;
Ms. Punita Bhargava, Advocate, Inventure IP, Member;
Dr. Unnat Pandit, Cadila Pharmaceuticals Limited, Member;
|Ambassador Michael Froman wants to block compulsory licenses on drug patents in India|
New leak of TPP consolidated text on intellectual property provides details of pandering to drug companies and publishersSubmitted by James Love on 16. October 2014 - 5:03
For more information:
James Love, Knowledge Ecology International
email: email@example.com, +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.
UPDATE: TRIPS Council (Oct. 2014): Ukraine requests discussion on compatibility of tobacco plain packaging measures with TRIPSSubmitted by thiru on 6. October 2014 - 0:05
UPDATE: On 17 October 2014, the Secretariat of the World Trade Organization (WTO) circulated an updated WTO airgram WTO/AIR/4358 REV. 1 to its Members following a request by Ukraine. Ukraine requested the addition of an item on "Concerns with Respect to Measures Related to Plain Packaging of Tobacco Products and their Compatibility with the TRIPS Agreement." This will be discussed under agenda item 13.
From the TTIP Stakeholder Forum.
The 7th Round of the negotiations of the Transatlantic Trade and Investment Partnership (TTIP) Agreement began Monday September 29, 2014 in the United States. This round's paltry effort at transparency, the TTIP Stakeholder Engagement Day, was held at the suburban 4-H conference center in Chevy Chase, MD. Although the information packet for the event included public transport instructions, the location was difficult to access for any attendees without a car, and even then, parking was extremely limited.
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.
|Brazil asks delegates to embrace work on copyright exceptions|
During intense plenary discussions regarding WIPO's future work program on the protection of broadcasting organizations and copyright limitations and exceptions, Brazil made the following proposal to reproduce language from the General Assembly decision of 2013. Brazil proposed,
On 30 September 2014, the WIPO secretariat handed the following text relating to the "Consideration of the Convening of a Diplomatic Conference for the Adoption of a Design Law Treaty (DLT)."
Consideration of the Convening of a Diplomatic Conference for the Adoption of a Design Law Treaty (DLT)
Agenda item 14 Decision Paragraph
The WIPO General Assembly:
Will at its session in September 2015 decide on whether to convene a diplomatic conference for the adoption of a Design Law Treaty as soon as practicable."
WIPO General Assembly 2014: Draft decision on item 16 (IGC on genetic resources, traditional knowledge & folklore)Submitted by thiru on 30. September 2014 - 12:04
On 30 September 2014, the WIPO secretariat handed the following draft decision relating to the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC).
Draft decision on item 16
The WIPO General Assembly:
(1)) took note of the information contained in document WO/GA/46/6;
(2) took note of the statements made by delegations at the Forty-Sixth Session of the WIPO General Assembly in 2014; and
WIPO General Assembly 2014: No Decision Reached on the Work of the Standing Committee on Copyright and Related Rights (SCCR)Submitted by thiru on 30. September 2014 - 11:53
On Tuesday, 30 September 2014, the Secretariat handed out the following text:
Matters relating to the Standing Committee on Copyright and Related Rights (SCCR) Agenda item 15 Decision Paragraph
The WIPO General Assembly
(i) took note of the information contained in document WO/GA/46/5; and
(ii) took note of the statements made by delegations at the 46th session of the WIPO General Assembly in 2014.
European Medicines Agency (EMA) recommends approval of Harvoni, Gilead's all oral HCV combination productSubmitted by James Love on 26. September 2014 - 8:37
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."