Of possible interest

Recent blogs about the World Intellectual Property Organization (WIPO) meetings are available at http://keionline.org/wipo.

The UN Secretary General High Level Panel on Access to Medicine. KEI submissions.

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

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

Prices and patents on drugs, vaccines and diagnosis of hepatitis.

Innovation inducement prizes, possibly 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?:

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.

KEI Comments on NIH Proposed Exclusive License to Kite Pharma 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: http://keionline.org/node/2644.

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, zack.struver@keionline.org, +1-202-332-2670, or Paul Davis, pdavis@keionline.org, +1-202-332-2670

Note: Letter from Biolyse to HHS here: http://keionline.org/sites/default/files/28-sept-2016-biolyse-to-hhs-letter.pdf
Letter from NGOs to HHS here: http://keionline.org/sites/default/files/17-oct-2016-civil-society-letter-xtandi.pdf

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 2013 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.

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