James Love's blog

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 am to 2 pm

For more information about delinkage, see:http://delinkage.org.

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

For more information about the event, contact claire.cassedy@keionline.org.

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).

Francis Gurry appoints Sylvie Forbin, lobbyist for Vivendi, as new head of copyright at WIPO

Francis Gurry has appointed the new Deputy Director General for the Copyright and Creative Industry Sector. She is Sylvie Forbin, a national of France, and most recently Senior Vice President for Public and European Affairs, for Vivendi. Here is the WIPO announcement: as PDF.

WIPO Marrakesh Treaty for the blind to come into force September 30, 2016, following ratification by Canada

On June 30, 2016, the WIPO Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled received its 20th ratification, from Canada, and this will bring the Treaty into force September 30, 2016. The WIPO announcement was here. WIPO Director General Francis Gurry made a statement about the Marrakesh Treaty's imminent entry into force in the video below:

US Chamber of Commerce defends Swiss drug company charging excessive prices in Colombia

David Hirschmann, US Chamber, claims efforts to curb high prices for cancer drugs are "a destructive course."

The US Chamber of Commerce might consider renaming itself the US/Swiss Chamber of Commerce, after their most recent attack on the Colombia Minister of Health (MoH) announcement that a "Declaration of Public Interest" would be issued for the patents on the cancer drug imatinib, held by the Swiss company Novartis. In the US Chamber's defense of the Swiss drug company, they don't mention the fact that Novartis has earned about $48 billion from sales of imatinib (sold by Novartis under the brand names Gleevec or Glivec) since the drug was put on the market, including more than $380 million per month in 2015.

Alfred Engelberg and Aaron Kesselheim in Nature on Bayh-Dole royalty free rights in patents, Xtandi case

Alfred Engelberg and Aaron Kesselheim have published an opinion article in Nature titled:

"Use the Bayh-Dole Act to lower drug prices for government healthcare programs," Nature Medicine 22, 576 (2016) doi:10.1038/nm0616-576, Published online 07 June 2016.

Letter from KEI, Public Citizen, Oxfam America and Health GAP to Senator Hatch, regarding Colombia Compulsory License

Attached is a letter that KEI, Public Citizen, Oxfam America and Health GAP have sent to Senator Hatch, via the Senate Finance Committee, objecting to the pressure his office has put on Colombia over a compulsory license on patents held by Novartis for the cancer drug Gleevec. This refers to the accounts of pressure from Hatch's office that are described in two letters from the Colombia Embassy in Washington, dated April 27 and April 28, which were recently leaked.

Fundación Karisma at WIPO SCCR32 on broadcast treaty


Good afternoon, and thank you very much, sir.
I wanted to refer to the rights to be granted in this proposed treaty and I would like to give you an example of something that has recently happened in Colombia and how sometimes the retransmission rights can be abused.

KEI comment on USTR's 2016 Special 301 report

The 2016 USTR Special 301 report is now available. (copy here). The report is 77 pages of complaints about intellectual property policies around the world, plus a number of other complaints, including those related to pricing and reimbursement of pharmaceutical drugs and medical devices, restrictions on data flows, standard setting, and government procurement.

On the one hand, USTR says it is supports "access to medicine for all."

2015 Oct 16 version: RCEP draft text for investment chapter

(More KEI RCEP leaks here: http://keionline.org/rcep)

Attached below is the October 16, 2015 version of the investment chapter for the proposed Regional Comprehensive Economic Partnership, known as RCEP. This text is made public for the first time by KEI.

Global pharmaceutical sales, by region, 2013-2015

These estimates are published by Statista, here.


Obama Administration memo: "Background on TPP Biopharma Provisions" describes how TPP will raise drug prices

[First reported by Politico] On April 9, 2016, the Obama Administration sent a document to Congress defending the TPP against criticism from the pharmaceutical industry that they did not get enough from the deal.

The 2016 Tufts estimates of the risk adjusted out-of-pocket costs to develop a new drug.

Draft, revised April 12, 2016.

2015:4 KEI Briefing Note: The Tufts estimates of the risk adjusted out-of-pocket costs to develop a new drug.
April 12, 2016
James Love

This is a briefing note on the 2016 Tufts study titled: Innovation in the pharmaceutical industry: New estimates of R&D costs, co-authored by three industry consultants, Joseph A. DiMasi, Henry G. Grabowski and Ronald W. Hansen. [J.A. DiMasi et al. Journal of Health Economics 47 (2016)].

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