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Washington Monthly Cover Story Highlights Petition to Lower Price of Xtandi in U.S.


The November/December edition of the Washington Monthly cover story (available here) addresses executive actions to lower drug prices in the United States, in particular the use of march-in rights or royalty-free license rights in the Bayh-Dole Act. The story uses the case of Xtandi, a taxpayer-funded prostate cancer drug developed at UCLA with support from the National Institutes of Health and the U.S. Army, to highlight how those rights can be used by the executive branch to the lower the price of the drug. For more on Xtandi, see here:

Extending Bayh-Dole March-in rights

In a recent exchange with Senator Durbin, NIH Director Francis Collins expressed his concern that the NIH would alienate potential collaborators if the NIH applied the march-in remedy to address excessive prices of drugs.

Face time is policy: Appointment logs for USTR officials Froman, Holleyman and Punke, through July 2016

Attached below are the appointment calendars, with redactions by the USTR FOIA office, for USTR Ambassadors Froman, Holleyman and Punke.

Note: The files containing Ambassador Froman's calendar are arranged alphabetically by month.

KEI December 2, 2016 meeting on the delinkage of R&D costs from drug prices

KEI is holding a December 2, 2016 meeting on the delinkage of R&D costs from drug prices.

The venue will be US Senate Hearing Room SD-106, Dirksen Office Building. The meeting will take place from 9:00am to 2:00pm.

A copy of the agenda is available here.

For more information about delinkage, see:

To register for the event, please fill out this form:

2016: Kite Pharma, KEI Comments on NIH Proposed Exclusive License for Cancer Treatment

Today, KEI submitted comments to the Notice published in the Federal Register on October 5, 2016, entitled “Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers.” KEI's comments addressed issues with the NIH's processes for granting exclusive licenses, and transparency in those licenses, resulting data, trials, pricing, and revenue.

Kite Pharma Press Releases & News Stories Related to Relationship with National Cancer Institute

Kite Pharma is a California-based biopharmaceutical company working on various types of cell therapies for the treatment of cancer, in a bid to become the first pharmaceutical firm to gain successful FDA approval for this new class of cancer treatment.

Kite closely collaborates with the National Cancer Institute, which conducted significant early research into the forms of cell therapies that Kite is seeking to commercialize. NCI conducts clinical trials under Cooperative Research and Development Agreements (CRADAs) with Kite, and additionally has granted exclusive licenses on over a dozen patents to Kite on the same technologies.

Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments

Kite Pharma, Inc., which is racing Juno Therapeutics and Swiss pharmaceutical giant Novartis to successfully bring the first T-cell receptor (TCR) therapy to market, relies heavily on government support in the course of its research and development.

As noted previously by KEI, in various comments to the National Institutes of Health, the NIH rarely discloses detailed information on its connections with industry, raising concerns about how the NIH licenses out taxpayer-funded technologies without regard for future prices or access for U.S. residents.

For a selected bibliography of news stories on Kite's relationship with the National Cancer Institute, see here:

T-cell receptor therapy is the latest breakthrough in cancer treatment, and involves modifying a patient's own cells to better track and destroy cancer proteins, and then reintroducing them into the body. (The NIH has a concise description for non-scientists here.)

Dr. Steven Rosenberg
Dr. Steven A. Rosenberg is the Principal Investigator for the National Cancer Institute on Kite's 2012 CRADA. Dr. Rosenberg mentored Kite CEO and co-Founder Dr. Arie Belldegrun, and is also listed as a "Special Advisor" to Kite on their website. | Partnership for Public Service / Aaron Clamage

According to Kite’s filings with the Securities and Exchange Commission (SEC), Kite has secured three Cooperative Research and Development Agreements (CRADAs) with the National Cancer Institute (NCI). In exchange for quarterly cash payments, the NCI conducts clinical trials and laboratory work on many of its own patented technologies, with the understanding that Kite will have the rights to commercialize any successful products developed through the CRADA.

56 NGOs ask US Government enable export of low cost generic versions Xtandi to developing countries

17 OCTOBER 2016

CONTACT: Zack Struver,, +1-202-332-2670, or Paul Davis,, +1-202-332-2670

Note: Letter from Biolyse to HHS here:
Letter from NGOs to HHS here:

Washington, DC — Today, over 50 patient, senior citizen, global health, development, social justice, and faith groups urged the United States Government to use its rights in a federally funded patented invention, and accept the request by a Canadian generic drug manufacturer (Biolyse Pharma) to enter into an agreement to manufacture and export an affordable version of the taxpayer-funded prostate cancer drug enzalutamide to South Africa and other countries with low per-capita incomes relative to the United States.

5 October 2016: Statement of Knowledge Ecology International at inaugural Marrakesh Treaty Assembly

On Wednesday, 5 October 2016, Knowledge Ecology International (KEI) delivered the following intervention at the inaugural Marrakesh Treaty Assembly.

5 October 2016

It is an important achievement for WIPO to have embraced the Marrakesh Treaty, and addressed and corrected the barriers that copyright presented for access to culture and knowledge, for persons who are blind or have other disabilities.

KEI statement at WIPO GA 2016 on the Inter-governmental Committee (IGC) on genetic resources, traditional knowledge

KEI is interested in how regimes proposed in the IGC impact the economics of stewardship, curation and sharing of Traditional Knowledge (TK) and Genetic Resources (GR).

KEI generally opposes the creation of exclusive rights that can block innovations and access to knowledge and materials, in the context of Traditional Knowledge or Generic Resources.

However, benefit sharing does not require the granting of exclusive rights. Liability rule approaches seem to offer a better model.

WIPO GA 2016: Statement by India on behalf of Asia Pacific Group - Report on the IGC

On Thursday, 6 October 2016, India delivered the following statement on behalf of the Asia Pacific Group in relation to the General Assembly's deliberations on WIPO's work on genetic resources, traditional knowledge and traditional cultural expressions.

Position Statement by India on behalf of Asia- Pacific Group on Agenda Item 16 - Report on the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), delivered by Dr. Sumit Seth, First Secretary(Economic Affairs)

Thank you Mr. Chairman

WIPO General Assembly 2016: Statement of Knowledge Ecology International on the Report of the SCCR

On Wednesday, 5 October 2016, Knowledge Ecology International delivered the following intervention on the agenda item concerning the Report of the Standing Committee on Copyright and Related Rights (SCCR).

Agenda item 11: Report on the SCCR

244 words

Thank you Chair.

Congratulations to Sylvie Forbin, the highly qualified new DDG for the Copyright and Creative Industries Sector.

KEI welcomes the entry into force of the Marrakesh Treaty, and look forward to additional work at WPO to expand access to knowledge and knowledge based goods.

WIPO General Assembly 2016: Opening Statement of Knowledge Ecology International

On October 4th, 2016, Knowledge Ecology International (KEI) delivered this opening statement on the occasion of the Fifty-Sixth Series of Meetings of the Assemblies of the Member States of the World Intellectual Property Organization (WIPO).

KEI General Statement - WIPO General Assembly - 2016

October 4th, 2016

Thank you Chair for providing Knowledge Ecology International (KEI) the opportunity to speak today.

General Assembly 2016 - Opening Statement of Bangladesh on behalf of the LDC Group

On Monday, 3 October 2016, Bangladesh delivered the following opening statement on behalf of the LDC Group at the World Intellectual Property Organization's (WIPO) General Assembly.

General Statement on behalf of the LDC Group at the 56th Session of the Assemblies of the Member states of WIPO
[3 October 2016]
Delivered by Ambassador H.E. Mr. M Shameem Ahsan,
Permanent Representative of Bangladesh to the United Nations
( Suggested time: 5 minutes)

Mr. President,
Director General,
Distinguished representatives,
Good morning.

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