On February 16, 2012, the USPTO held a public hearing on genetic diagnostic testing, permitting stakeholders to present their views relating to DNA patents, exclusive licensing, patient health and genetic testing, particularly as they relate to secondary or confirmatory genetic diagnostic testing. Notes from the hearing and speaker statements are included below. KEI's oral statement can be found here.

On February 16, 2012, the USPTO held a public hearing on genetic diagnostic testing, pursuant to a Congressional mandate that was part of the America Invents Act. This mandate directed the USPTO to evaluate several questions related to genetic diagnostic testing, particularly with regard to second opinion or confirmatory genetic testing. USPTO will deliver its final report to Congress in June. Notes from the public hearing are available in a separate blog post.

On January 26, 2012, KEI sent a letter to Senator Patrick Leahy (D-VT), Chairman of the Judiciary Committee, calling for greater transparency in the Trans-Pacific Partnership Agreement (TPPA). The letter highlights the fact that the general public is kept in the dark regarding negotiating positions and the actual text while "cleared advisers" and corporate lobbyists have unequal access to information. It calls for Senator Leahy to urge the Obama Administration to release the negotiating text in order to allow full and effective public participation in our democratic society.

Since May 2009, the ACLU and Public Patent Foundation (PUBPAT) have been litigating a case involving the patent eligibility of two human genes, BRCA1 and BRCA2, associated with ovarian and breast cancer. ACLU and PUBPAT, representing the petitioners, Association for Molecular Pathology, among others, have argued that human genes are not patentable and that patents on such objects stifle diagnostic testing and further research.

For call-in details for today's event, contact Krista Cox.

On January 27, 2012, KEI will host a brown bag lunch with Shira Perlmutter. Shira was recently appointed the Administrator for Policy and External Affairs of USPTO. This position was most recently held by Albert Tramposch, who replaced Arti Rai, the first Obama appointee.

On December 7, 2011, USTR issued Federal Register Notice 76480-76481 requesting comments on "Canada's Expression of Interest in the Proposed Trans-Pacific Partnership Trade Agreement." USTR issued similar requests for comments regarding Japan's (Notice 76478-76479) and Mexico's (Notice 76479-76480) expression of interest in the TPPA.

KEI has submitted a response to this notice available for download here.

On Wednesday, December 14, 2011 the Subcommittee on Trade of the Committee on Ways and Means held a hearing on the Trans-Pacific Partnership Agreement (TPPA). Oral testimony was accepted only from invited witnesses. These witnesses included: Ambassador Demetrios Marantis (Deputy U.S. Trade Representative), Devry S. Boughner (Director, Intenrational Business Relations on behalf of Cargill Inc. and U.S. Business Coalition for TPP), Angela Marshall Hofmann (Vice President for Global Integrated Sourcing on Trade, Wal-Mart Stores), and Michael Wessel (President of The Wessel Group).

On December 1, 2011, Senator Sanders (I-VT) sent a letter to United States Trade Representative, Ambassador Kirk, objecting to USTR's position with regard to access to medicines in the Trans-Pacific Partnership Agreement (TPPA) and the apparent retreat from the May 10th Agreement. Senator Sanders also objects to the secrecy of the negotiations and calls for the public release of the TPPA negotiating texts.

Next week, the WIPO Standing Committee on Copyright and Related Rights (SCCR 23) will meet beginning on 21 November and continue through 2 December 2011. One issue that will be discussed is a possible treaty for copyright limitations and exceptions for persons who are visually impaired or have other disabilities. A treaty is necessary to provide minimum standards for limitations and exceptions to permit the creation of accessible format works and also to facilitate cross-border sharing of these works.

The ninth round of negotiations for the Trans-Pacific Partnership Agreement (TPPA) took place in Lima, Peru from 19-28 October 2011. Stakeholders were given the opportunity to present at the stakeholder platform on 23 October, attend the stakeholder briefing on 25 October and the reception on 25 October.

Intellectual Property

On 4-5 October 2011, UNITAID held its third Consultative Forum giving stakeholders the opportunity to view UNITAID's achievements to date as well as provide input on UNITAID's activities moving forward. Attendees at the forum included civil society, NGOs, implementing partners, representatives from the pharmaceutical industry and private foundations, and governmental officials. Several of the presentations from the IP workshop as well as the recommendations from the IP workshop are attached below.

Today, on the eve of discussions on the Standing Committee on Copyright and Related Rights (SCCR) at the WIPO General Assembly, Senators Harkin (D-IA) and Sanders (I-VT) submitted a letter to Director David Kappos of the US Patent and Trademark Office. This letter recommended USPTO's support for the timely consideration of a treaty for the benefit of persons who are visually impaired or have other disabilities.

Krista Cox wrote these notes on September 13, 2011, reporting on the eighth round of negotiations for the Trans-Pacific Partnership Agreement (TPPA).

The United States and the European Union are using a United Nations High Level Meeting on Non-Communicable Diseases (NCDs) to effectively renegotiate a landmark agreement on intellectual property rights and public health.

As KEI has discussed previously, USTR's proposal for the IP chapter of the Trans-Pacific Partnership Agreement (TPPA) raises numerous concerns for human rights, access to medicines, and access to information, among other issues.