Of possible interest

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

The US 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.


Governments can ration access to cancer drugs, or break patent monopolies. Why is rationing so popular?:

September 2011: Spotlight on India at the WTO Trade Policy Review

On 14 September 2011 and 16 September 2011, the World Trade Organization (WTO) undertook a trade policy review of India. All members of the WTO are subject to review under the Trade Policy Review Mechanism (TPRM). The TPRM takes place in the "Trade Policy Review Body which is actually the WTO General Council — comprising the WTO’s full membership — operating under special rules and procedures" (Source: WTO, Trade Policy Reviews: Brief Introduction).

Birch Bayh's competing interests and evolving views

The 1980 Bayh-Dole Act is named after two former US Senators, Birch Bayh and Bob Dole. In 2002 both claimed the Bayh-Dole Act march-in provisions were not intended to address cases where prices for inventions are unreasonable, and Senator Bayh repeated this view during a 2004 march-in case involving Abbott patents on ritonavir.

Among the provisions of the Act that suggest otherwise are the following:

Federal Circuit decision again results in three-way split in reasoning in AMP v. USPTO; 2-1 ruling upholds DNA patents

On Thursday, 16 August 2012, the Court of Appeals for the Federal Circuit issued its opinion in the case Association for Molecular Pathology v. US Patent and Trademark Office, again rejecting the plaintiffs' contentions that isolated DNA is not eligible for patent protection. This case surrounds the patent eligibility of isolated DNA, particularly the BRCA1 and BRCA2 genes known to be associated with an individual's susceptibility to breast and ovarian cancer.

Geneva Fall/Winter 2012: What's in store at the WHO, WIPO and WTO

As Geneva awakes from its summer slumber post-Jeûne genevois (6 September 2012), the following conferences and negotiations are expected to shape the knowledge governance landscape in the second semester of 2012 at WHO, WIPO and WTO.

World Health Organization

Here are upcoming meetings of the WHO in 2012 of relevance to public heath, innovation and access.

ISP sources defend USTR proposals in TPP on copyright limitations: undermine opposition to USTR proposal

A story today by Adam Behsudi in the trade publication, Inside U.S. Trade, quotes from ISP industry sources who basically defend the USTR position, which is the worst among the TPP negotiating countries. Taken as a whole, we read the ISP positions as both weak and incredibly damaging, as they are undercutting real opposition to the USTR proposal by non-US governments in the TPP negotiations.

Copyright exception for U.S. libraries and archives when works not available at reasonable price

Interesting exception in US copyright law tied to pricing of works, and year of copyright term.

Berne Convention revisions, and the evolution of its limitations and exceptions to copyright

Revised August 11, 2012

Table of Contents

I. The text of revisions of the Berne Convention
II. Notes on the evolution of exceptions (revised Aug 10)

  1. News reporting
  2. The Article 2bis power to exclude certain works from protection, including speeches, addresses and lectures
  3. The quotation right
  4. Teaching
  5. Legal Texts
  6. Developing country protocols
  7. Exceptions to the reproduction right (the 3-step test)
  8. Compulsory licensing for music
  9. Translations

Berne Exceptions not subject to 3-step test

When politicians and trade officials tell you they want to impose a restrictive 3-step test to narrow the copyright limitations and exceptions permitted under the Berne Convention, take a minute to review what the Berne exceptions cover, and ask yourself, why would anyone want to further limit these exceptions?

[The related rights in the Rome Convention, the rights in the WCT, WPPT and Beijing treaties, and the flexabilities in the WTO TRIPS Agreement require a separate discussion].

Article 2(4,7 and 8) - Protected Works:

Dmitry Medvedev's Nov 2011 message to the G20 leaders on call for new copyright treaty

In 2011, Russia made a very important proposal to the G20 regarding the need for new global norms on copyright. Just a few parts of the message illustrate its ambition.

  • to expand the opportunities of right holders to manage and exercise the rights to the results of intellectual activities on the Internet;
  • to amend the way of obtaining a right holder's consent

TPP IP text would restore right to sue surgeons and other medical professionals for patent infringement. Why?

Kista Cox on a provision in the TPP trade negotiation that would restore right to sue surgeons and other medical professionals for patent infringement. The US law (35 USC 287(c)) was changed after lawsuits were filed against surgeons performing certain procedures in eye surgery. USTR and USPTO have been asked to protect this exception in the TPP Intellectual Property Chapter, but have not done so.

Which U.S. public official is LEAST likely to favor a treaty on copyright exceptions for blind people?

David Kappos, Under Secretary of Commerce for Intellectual Property and Director of the USPTO
12% (16 votes)
Ambassador Ronald Kirk, United States Trade Representative
20% (26 votes)
Maria Pallante, Register of Copyrights in the United States
17% (22 votes)
Robert D. Hormats, Under Secretary of State for Economic Growth, Energy, and the Environment
5% (6 votes)
Michael Froman, White House Deputy National Security Adviser for International Economic Affairs
5% (7 votes)
Vice President Joe Biden
40% (52 votes)
Total votes: 129

2012: NIH case: exclusive rights in regulatory test data are absolute, even where there are drug shortages

In August 2, 2010, the National Institutes of Health (NIH) was asked to grant an open license to permit manufacture of Fabrazyme, a drug used to treat Fabry disease (more on the march-in case here: http://www.keionline.org/fabrazyme). On December 1, 2010, Francis S. Collins, Director of the NIH issued a determination in the case, rejecting the petition for the NIH to exercise its march-in rights, citing as support for the denial that granting march-in rights would not overcome other barriers, including the exclusive rights in test data.

DG-Enterprise - data exclusivity prevents access to life saving drugs (in the EU), even in an emergency situation

On February 20, 2006, Martin Terberger, the Head of Unit for Pharmaceuticals in the European Commission Directorate-General for Enterprise and Industry, wrote to Greg Perry of the European Generic medicines Association (EGA). The letter was a follow-up to an inquiry from the EGA regarding "the question of data exclusivity under the European pharmaceutical legislation," in cases where a government overrode the exclusive rights of a patent and granted a compulsory license, and/or in a case of a medical emergency.

AIDS 2012: Former President Clinton and House Minority Leader Nancy Pelosi Speak at Closing Ceremony

The XIX International AIDS Conference, which saw over 24,000 participants, came to a close on Friday, July 27, 2012. A number of people living with HIV/AIDS, activists, the immediate past president and current president of the International AIDS Society (and 2008 Nobel Prize Winner in Medicine), House Minority Leader Nancy Pelosi (D-CA), and former President Bill Clinton were among the speakers.

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