Of possible interest

KEI requests that DHHS Inspector General investigate failure to disclose federal funding in Spinraza patents.

KEI objects to the U.S. Army grant of an exclusive license to Sanofi on U.S. Army-owned patents on a Zika Virus vaccine.

Research and testimony on transparency legislation.

Request to the NIH and U.S. Army to use government royalty free or march-in rights on the prostate cancer drug Xtandi.

Proposal for a WTO Agreement on the Supply of Public Goods.

Innovation inducement prizes as an alternative to IPR monopolies to reward successful innovation.

Now is a good time to donate money to KEI.

KEI timelines, on a variety of topics.

Poll

Governments can ration access to cancer drugs, or break patent monopolies. Why is rationing so popular?:

9 November 2016 - WTO TRIPS Council - EU's intervention on Intellectual Property and Innovation - Regional Innovation Models

Australia, the European Union, Japan, Switzerland, Chinese Taipei and the United States requested the Secretariat of the World Trade Organization (WTO) to place an item on the agenda of the November 2016 TRIPS Council agenda entitled - "Intellectual Property and Innovation: Regional Innovation Models. On 9 November 2016, the European Union delivered the following intervention on regional innovations models. Intellectual Property and Innovation have been on the agenda of the TRIPS Council since 2012.

IP AND INNOVATION: REGIONAL INNOVATION MODELS

9 November 2016 - WTO TRIPS Council - UNCTAD's statement on the Report of the UN High-Level Panel on Access to Medicines

On Wednesday, 9 November 2016, the United Nations Conference on Trade and Development (UNCTAD) delivered the following statement at the World Trade Organization's (WTO) TRIPS Council's discussions of the United Nations Secretary-General's High Level Panel Report on Access to Medicines. UNCTAD informed WTO members that the agency had recently recommended to Secretary-General Ban Ki-moon to consider endorsement of the Report of the High Level Panel.

The Report of the United Nations High Level Panel on Access to Medicine

SCCR 33: Argentina, Colombia and Mexico - Note on the Draft Treaty to Protect Broadcasting Organizations

On 8 November 2016, the World Intellectual Property Organization (WIPO) published a submission by Argentina, Colombia and Mexico entitled, "Note on the Draft Treaty to Protect Broadcasting Organizations" (SCCR/33/5). In their proposal, the proponents (Argentina, Colombia and Mexico) note that negotiations on a WIPO broadcast treaty have gone on for 18 years and 33 sessions of the Standing Committee on Copyright and Related Rights (SCCR).

India Patent Office denies patent for prostate cancer drug sold under brand name Xtandi, generic name enzalutamide

Updated
According to this story, the India Patent Office has denied a patent for the prostate cancer drug sold under the brand name Xtandi (generic name Enzalutamide). Opponents of the patent claimed it was a new form of a known substance, and not eligible in India under Section 3(d) of its patent act.

9 November 2016 - WTO TRIPS Council - India's intervention on the Report of the UN High-Level Panel on Access to Medicines

On Wednesday, 9 November 2016, India delivered the following statement at the World Trade Organization's (WTO) TRIPS Council's discussions of the United Nations Secretary-General's High Level Panel Report on Access to Medicines.

Agenda item 13: the United Nations Secretary-General’s High Level Panel Report on Access to Medicines

Statement by India.

Thank you Chairman.

At the outset, I would like to thank delegations of Brazil, China and South Africa who are also co-sponsors of this agenda item.

9 November 2016 - WTO TRIPS Council - WHO's intervention on the Report of the UN High-Level Panel on Access to Medicines

On Wednesday, 9 November 2016, the World Health Organization (WHO) delivered the following statement at the World Trade Organization's (WTO) TRIPS Council's discussions of the United Nations Secretary-General's High Level Panel Report on Access to Medicines.

COUNCIL FOR TRIPS

8-9 NOVEMBER 2016

WHO STATEMENT

13. THE UNITED NATIONS SECRETARY-GENERAL'S HIGH LEVEL PANEL REPORT ON ACCESS TO MEDICINES

Thank you very much for giving WHO the opportunity to share our feedback on the Report of the High-Level Panel on Access to Medicines.

9 November 2016 - WTO TRIPS Council - Brazil's intervention on the Report of the UN High-Level Panel on Access to Medicines

On 9 November 2016, the World Trade Organization's (WTO) TRIPS Council held discussions on the United Nations Secretary-General’s High-Level Panel Report on Access to Medicines (UN HLP). These timely WTO discussions on the UN HLP germinated from a 27 October 2016 request by Brazil, China, India and South Africa requesting the WTO Secretariat to place a dedicated agenda item for consideration at the 8-9 November 2016 session of the TRIPS Council entitled “the United Nations Secretary-General’s High-Level Panel Report on Access to Medicines.”

Lancet Commission on Essential Medicines Policies publishes 74 page report, endorses delinkage of R&D costs from drug prices

Today The Lancet Commission on Essential Medicines Policies published the 74 page report on "Essential Medicines for Universal Health Coverage." A copy is available here.

The report is rich in data, analysis and recommendations. The report endorses the delinking of R&D costs from drug prices:

Delinking R&D costs from the price of medicines

Some measures that a new President and/or Congress can take to lower drug prices in the near term

KEI and others working in the drug pricing space are frequently asked about measures that a new President or Congress can take to lower drug prices, in the relatively near term. The following is a list of such actions, including some that would require legislation and some that would not.

A comprehensive list of possible actions would be much longer, and this is not such a list. Our list does not include suggestions from several other groups working on drug pricing that deserve consideration, and there is nothing at this point on price spikes.

WTO TRIPS Council - Brazil, China, India and South Africa request discussion of the UN High-Level Panel on Access to Medicines

On Thursday, 27 October 2016, Brazil, China, India and South Africa submitted a communication (IP/C/W/619) to the World Trade Organization (WTO) requesting the WTO Secretariat to "place a dedicated agenda item for consideration at the 8-9 November 2016 session of the TRIPS Council entitled “the United Nations Secretary-General’s High-Level Panel Report on Access to Medicines.” In the WTO submission, Brazil, China, India and South Africa enclosed the entire Final Report of the UN Secretary-General's High-Level Panel on Access to

HIV revenues and industry investments in clinical trials for HIV

According to IMS, the global market for HIV antiviral drugs was $24.4 billion in 2015. Over the past three decades, drug companies have registered an average of one new molecular entity HIV ARV per year. This is a lot of money to spend on HIV drugs to induce just one new drug per year.

Today I took a look at data from the NIH clinicaltrials.gov database, to see what the industry was reporting in terms of trials.

Relative prices of brand and generic drugs

Part 1, and the GPhA report on cost savings from generics, and prices of generics relative to brand in 2015.

The US based Generic Pharmaceutical Association (GPhA) has issued its 8th annual survey of cost savings due to generic medicines. (Copy here). The data they present comes from QuintilesIMS Institute.

The leading shout-out from the report is that generic drugs saved U.S. consumers and third party payers $227 billion in 2015.

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

xtandi-cover-story.jpg

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: http://keionline.org/xtandi.

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.

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