- KEI’s Initial Comments on the MPP/BMS license to patents and know-how for daclatasvir (DCV)
- 23 November 2015: Opening statement of Asia and the Pacific Group at Tenth Session of WIPO Advisory Committee on Enforcement
- US ITC notice for public comment, Jan 13, 2016 hearing, and Commission report on the TransPacific Partnership Agreement (TPP)
- My testimony this morning at the US ITC hearing on "Economic Impact of Trade Agreements"
- Seminars on Drug Pricing: Part 5 Kevin Outterson, Antibiotic Delinkage
- Tentative witness list for USITC hearing on Economic Impact of Trade Agreements
- Dr. Margaret Chan: TPP may "close access to affordable medicines"
- US Chamber of Commerce lauds USPTO for securing a time-bound LDC waiver for pharmaceutical products
- Economist Bhaven Sampat presents research on role of government funding in drug development
- Joint NGO Statement on TRIPS Council Decision On Extension of the Transition Period Concerning Pharmaceutical Products
The World Intellectual Property Organization's (WIPO) General Assembly is currently engaged five separate informal consultations on the following topics: 1) Lisbon Union, 2) the future of the Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore, 3) the work program of the Standing Committee on Copyright and Related Rights (SCCR), 4) the Design Law Treaty and 5) WIPO External Offices.
WTO TRIPS Council (October 2015) to discuss LDC extension for pharmaceuticals, non-violation, review of the Paragraph 6 systemSubmitted by thiru on 12. October 2015 - 11:56
The WTO TRIPS Council meets from Thursday, 15 October 2015 to Friday, 16 October 2015. The hot topics for consideration include agenda item 13 (Request from the LDC Group for an indefinite exemption from WTO IP obligations to provide patents for pharmaceutical products, agenda item 8 (non-violation and situation complaints), agenda item 7 (Review of the Paragraph 6 system) and agenda item 14 (a discussion item co-sponsored by Australia, the European Union and the United States on "Intellectual Property and Innovation: Entrepreneurialism and New Technologies).
Members of the World Trade Organization (WTO) meet this week in Geneva (15 October 2015 - 16 October 2015) to decide if the poorest countries on earth are exempt from WTO rules for pharmaceutical patents. The WTO's TRIPS Council is expected to make a decision in respect of the request of the LDC Group's request for indefinite exemption from TRIPS obligations on pharmaceutical patents.
This is a video explaining the request by the Coalition for Affordable T-DM1 to use the Crown Use provisions in the UK patents law, in order to grant compulsory licences on the patents relating to the cancer drug T-DM1, marketed by Roche under the brand name Kadcyla. The video was produced and edited by Zack Struver for KEI, and features narration by Merith Basey from UAEM.
Press Releases and Articles about the IP Chapter of the TPP
Leaked text can be found here.
On 9 October 2015, Wikileaks released the final text of the IP chapter in the Trans-Pacific Partnership. Jamie Love provided comments via twitter.
Updated: 9 October 2015
(In the order posted)
- Wikileaks has the October 5, 2015 version of the #TPP IP Chapter. https://wikileaks.org/tpp-ip3/WikiLeaks-TPP-IP-Chapter/WikiLeaks-TPP-IP-Chapter-051015.pdf
WIPO General Assembly 2015: Statement of United States on Broadcasting Treaty and Copyright Limitations and ExceptionsSubmitted by thiru on 8. October 2015 - 23:33
On Wednesday, 7 October 2015, the United States of America delivered the following statement on agenda item 12 (Report on the Standing Committee on Copyright and Related Rights). The US expressed support for a broadcasting treaty under a signal-based approach, focused on "unauthorized simultaneous or near-simultaneous retransmission of broadcast signals to the public over any type of platform, including the Internet."
On copyright limitations and exceptions, the US expressed support for
FDA enforcement discretion to allow unregistered generic Daraprim to be imported and sold at lower pricesSubmitted by James Love on 8. October 2015 - 19:09
In 2011, the FDA told the NIH it could use enforcement discretion to permit importation and sale of unregistered drugs
In 2011, in the context of a shortage of Fabrazyme, the FDA told the NIH if they could "in theory" allow Shire to import and sell Replagal, a drug approved for sale in Europe, but not in the United States, as an unregistered biologic substitute. The remedy explored for the Fabrazyme shortage may be the best way to address a different problem, the price gouging associated with the drug Daraprim (generic name: pyrimethamine).
Statement of KEI on announcement that there is a consensus on the Trans Pacific Partnership (TPP) trade agreement
October 5, 2015, 10am, EST
These comments by James Love, KEI Director
WIPO General Assembly 2015: Opening statement of Brazil on behalf of the Group of Latin and the Caribbean Group (GRULAC)Submitted by thiru on 5. October 2015 - 3:32
On Monday, 5 October 2015, Brazil delivered the following opening statement on behalf of the Group of Latin and the Caribbean Group (GRULAC) at the World Intellectual Property Organization's (WIPO) General Assembly.
Statement Delivered by the Delegation of Brazil on behalf of GRULAC
1. I have the honor to deliver this statement on behalf of the Latin American and the Caribbean Group (GRULAC).
Seven Members of House of Representatives Send Letter to USTR Calling For Waiver of WTO Patent Rules for LDCsSubmitted by Andrew Goldman on 2. October 2015 - 21:24
October 2, 2015
FOR IMMEDIATE RELEASE
CONTACT: Zack Struver
+1 (202) 332-2670
Seven House Members Push U.S. Trade Representative to Support Indefinite Waiver on Pharmaceutical Patents for Least Developed Countries (LDCs)
Press Release: Coalition for Affordable T-DM1 Asks UK Government to grant compulsory licenses on Roche breast cancer drugSubmitted by James Love on 30. September 2015 - 19:51
Press Release: Coalition for Affordable T-DM1 Asks the UK Government to Employ Crown Use Authority to Lower Price of Expensive Cancer Drug sold by Roche
Office: +1.202.332.2670 (between 2:00 PM and 10:00 PM BST)
Senator Bernie Sanders Asks USTR to Endorse Waiver of WTO Patent Rules for Least Developed CountriesSubmitted by Zack Struver on 28. September 2015 - 12:36
Knowledge Ecology International Press Release
28 September 2015
FOR IMMEDIATE RELEASE
CONTACT: Zack Struver
+1 (202) 332-2670
Senator Bernie Sanders asks USTR to endorse “indefinite waiver” of WTO requirements to grant drug patents for Least Developed Countries (LDCs)
KEI urges investigation of trade pressures on Least Developed Countries (LDCs) in light of Executive Order 13155Submitted by Zack Struver on 22. September 2015 - 7:43
Knowledge Ecology International sent letters today (attached to this release), September 21, 2015, to the Office of the General Counsel to the United States Trade Representative (USTR) and the Office of the Inspector General for the Department of Commerce, asking that they investigate USTR and the United States Patent and Trademark Office (USPTO) for the potential violation of an Executive Order issued by Bill Clinton — which prohibits the use of trade pressures to hinder polices related to access to HIV/AIDS medicines in sub-Saharan Africa — in their attempt to stop a request by Least Develop
On September 28, 2012, nearly three years ago, KEI submitted a FOIA request to USTR for "all documents relating to the World Health Organization (WHO) consideration of an agreement or treaty to support medical R&D."
Three years later USTR has released 89 pages of documents, with some redactions. But USTR also withheld 64 documents pursuant to FOIA exemption 552(b)(5) and three documents pursuant to FOIA exemption 552(b)(1).
- USTR Cover letter