2016: KEI comments to NIST on Bayh-Dole Act Regulations

In November, NIST proposed to amend the regulations implementing the Bayh-Dole Act, 35 U.S.C. 200 et seq., which concerns intellectual property arising from federally-funded research, including 37 CFR sections 401 and 404. There were 15 comments, including a letter from KEI on December 9, 2016. EFF also provided comments. The other 13 comments to NIST were from Universities, associations or individuals taking the side of right-holders.

The KEI comments are available here.

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SCCR 33, KEI’s intervention on legal protection for technological protection measures

This was our intervention at SCCR 33 on the topics of exceptions to the legal protection for technological protection measures.

TPMs are an legitimate and important measure to protect certain works, data and technologies from unauthorized uses.

The issues raised by libraries and archives concern the legal protection that one gives the technological protection.

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SCCR 33: Notes from KEI NGO statement on WIPO broadcast treaty negotiations, November 16, 2016

Today, after two and a half days of negotiations, mostly off the record in informals, NGOs were given a few minutes to make statements on the broadcasters treaty. We were asked to keep things short, and focus on discussions this week. These are the notes from our intervention.

Notes from KEI NGO statement on Broadcast treaty
November 16, 2016

Right to prohibit

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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

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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.

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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.

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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.

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