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Groups Object to Army Proposal to Give Sanofi a Monopoly on Patents for Taxpayer-Funded Zika Vaccine

12 JANUARY 2017

CONTACT: Zack Struver, zack.struver@keionline.org, +1 (202) 332-2670

Groups Object to Army Proposal to Give Sanofi a Monopoly on Patents for Taxpayer-Funded Zika Vaccine

KEI Dec 9, 2016 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 provide 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.

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.

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

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

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.

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.

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.

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: http://delinkage.org.

To register for the event, please fill out this form: https://goo.gl/forms/AbP2npqLRLYneLjk1.

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.

USPTO publishes new estimates of "IP-Intensive" industries, spin results

USPTO has just published its new estimates of "IP-intensive" jobs for the US economy. The report is titled: Intellectual Property and the U.S. Economy: 2016 Update, and is available as a PDF file here. USPTO press release here:

I took a quick look at the report, and below are some initial bullet points:

Differences between the march-in, royalty free right, and government use options

I wanted to post a brief note about three separate mechanism to overcome patent monopolies in current US law. All are useful, in the right context, and all have some limits.

1. The Bayh-Dole March-In rights under 35 U.S.C. 203, as defined by 35 U.S.C. 201(f).

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