US, AU and CA try to block WTO LDC drug patent waiver because PhRMA's not happy enough with the TPP

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.

Video: Coalition for Affordable T-DM1 Crown Use Request (in UK, for patents on cancer drug Kadcyla)

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.

Commentary on TPP IP Chapter Leak

Press Releases and Articles about the IP Chapter of the TPP

Leaked text can be found here.

Some KEI Tweets regarding TPP IP Chapter

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)

WIPO General Assembly 2015: Statement of United States on Broadcasting Treaty and Copyright Limitations and Exceptions

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 prices

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 of consensus on Trans Pacific Partnership (TPP) trade agreement

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)

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

"Mr President,

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 LDCs

October 2, 2015
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 drug

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


Diarmaid McDonald

Susannah Markandya

Zack Struver
Cell: +1.914.582.1428
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 Countries

Knowledge Ecology International Press Release
28 September 2015

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 13155

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

USTR releases documents from 2012 R&D treaty negotiations

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).

Senator Bernie Sanders proposal to expand Veterans access to patented medical inventions

This is a video by Zack Struver about Senator Bernie Sander's proposal to expand Veterans access to patented medical inventions. The video discusses both the proposal by Senator Sanders to give the U.S. Department of Veterans Affairs the authority to use compulsory licenses on patents on medical inventions, including drugs, and the history of "government use" provisions in current U.S. statutes, including 28 U.S.C. 1498, which Sanders proposes modifying.

Joint NGO letter to USTR and USPTO: What is the US Position on LDC Pharmaceutical Extension of TRIPS Transition Period?

On Friday, 11 September 2015 five public interest groups (Health GAP, Knowledge Ecology International, Médecins Sans Frontières, Oxfam America and Public Citizen) sent a letter to Ambassador Michael Froman (United States Trade Representative) and Michelle Lee, (Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office) requesting that the Obama administration disclose its position on the LDC request for an extension of their pharmaceutical production transition period under the WTO TRIPS Agreement.

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