Hot Topics


Why is it a big mistake to link funding of R&D costs with drug prices?:

TPP: Senator Hatch to USTR, 12 years of IPR for Biologics test data, no restrictions on cross border data flows

In a December 2, 2013 letter, Senator Orrin Hatch wrote to USTR's Michael Froman, suggesting TPP exclude any countries that do not meet "high levels of ambition." According to Hatch, these high ambitions include agreeing to 12 years of exclusive rights for IPR in biologic drug test data, and the elimination of barriers to cross border data flows (a privacy issue). A copy of the Hatch letter is attached below.

The timing of the Hatch letter is designed to pressure countries meeting in Singapore on December 7-10 in the TPP negotiation, on these two contentious issues.

Aaron Cooper, leaves Leahy's staff to " help corporate clients on IP and antitrust issues"

I missed this news earlier. Here is a report from IP-Watch:

3-5 December 2013: WHO Global Technical Consultative Meeting of Experts on Identification of Health R&D Demonstration Projects

The World Health Organization (WHO) is convening a Global Technical Consultative Meeting of Experts on Identification of Health Research & Development Demonstration Projects from 3-5 December 2013.

The World Bank definition of "high income" has slipped, in relative terms, compared to high income countries in general

The United States has proposed that some (but no means all) IPR obligations involving medicines be modified for countries with incomes below the amount the World Bank defines as “high.” The threshold to be considered a high income country was $12,616 in per capita income for 2012, and is adjusted every year. In contrast, the US per capita income was $50,124 in 2012. (More data here)

USTR FOIA, 127 pages of emails between industry and USTR TPP negotiators

Earlier this year, IP-Watch submitted two FOIA requests to USTR about the TPP negotiation. I am attaching two letters from USTR to IP-Watch about the FOIAs, and a file with 127 pages of emails between USTR and various industry lobbyists. (USTR provided KEI with copies of the files provdied to IP-Watch as part a separate KEI FOIA to USTR regarding communications involving the TPP).

A lot has clearly been withheld by USTR. According to USTR's June 19, 2013 letter to IP-Watch

KEI proposal for Antibiotics Innovation Funding Mechanism (AIFM), shortlisted for demonstration project by WHO's EURO region

The WHO is considering potential projects that will demonstrate the feasibility and benefits of open innovation models, delinkage of R&D costs and product prices, and innovative finance mechanisms. The process for selection began at the regional level, as each of six WHO regions was allowed to shortlist four projects that will be considered at a December 3-4, 2013 meeting of experts in Geneva, where the list will be narrowed again, and then considered by the WHO Executive Board in January 2014 and the WHO World Health Assembly in May 2014.

TPP provisions on Injunctions, are the TRIPS exceptions in or out?


This note looks at the TPP, ACTA and TRIPS provisions on injunctions, and finds the TPP text unclear, as regards the possibility of exceptions to the obligation to make injunctions available in cases in of infringements. We have asked USTR and USPTO to clarify this issue.


The TRIPS text on injunctions reads as follows:

Section 2: civil and administrative procedures and remedies
Article 44 - Injunctions.

KEI TPP Note: Exceptions for regulatory test data

This is the short briefing note that KEI is sending to TPP negotiators, on the issue of regulatory test data, which is currently a monopoly without space for exceptions, in the TPP text:

Exceptions to rights in regulatory test data

KEI TPP Note: Damages language in IP Chapter conflicts with US copyright law, blocks Green Paper reforms

Subject: TPP, damages, US copyright law

KEI TPP Note: IP Chapter language on damages conflicts with US copyright law, and blocks reforms being considered by the USPTO Green Paper

20 November 2013

KEI: WIPO should update 1976 Tunis Model Law on Copyright for Developing Countries

The twelfth session of the WIPO's Committee on Development and Intellectual Property (CDIP) is taking place from 18 November 2013 to 21 November 2013. This Committee, squeezed into just four days of discussions, has a heavy workload.

Leaked TPP Text Versus the USPTO Green Paper: Cell Phone Unlocking

The USPTO’s green paper on “Copyright Policy, Creativity and Innovation in the Digital Economy” surveys current copyright law and notes that there are several areas where reform may be welcome. In many of these areas, the USPTO green paper demonstrates an openness to discussion on these issues or support existing efforts and proposals. Despite this support in some areas for reform and despite the USPTO’s involvement in the Trans-Pacific Partnership (TPP) negotiating process, there are several areas where the United States’ position in the TPP could hinder such reform.

TPP Negotiating Parties' Counterproposal to the US on Medicines Represents a More Flexible Approach

On November 13, 2013, Wikileaks obtained and published a copy of the consolidated IP negotiating chapter for the Trans-Pacific Partnership Agreement (TPP). This leak has allowed the public to learn what is in the text, including about the reported five country counterproposal to the United States' proposal on pharmaceuticals and medicines.

KEI analysis of Wikileaks leak of TPP IPR text, from August 30, 2013

KEI Comments on the August 30, 2013 version of the TPP IP Chapter

For more information, contact James Love,, mobile +1.202.361.3040.

NIH rejects March-In petition, also rejects proposed rules on pricing of and access to government funded inventions

In a decision dated November 1, 2013, and signed by NIH Director Francis Collins, the NIH has rejected the 2012 petition to the NIH to uses its powers under the Bayh-Dole Act to protect U.S. consumers from high prices and restrictive licensing of NIH funded inventions.

GE's Thaddeus Burns wrote to US Ambassador Betty King requesting US postpone Marrakesh Diplomatic Conference

Thaddeus Burns of GE spent months trying to derail the WIPO treaty for the blind negotiations

Syndicate content