USTR will host two public hearings regarding the Trans-Pacific Partnership Agreement (TPPA). The first, to be held on Friday, 21 September 2012, will cover Mexico's participation in the TPPA. The second hearing will be held on Monday, 24 September 2012, and will address Canada's participation in the TPPA.

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).

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:

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.

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.

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.

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

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

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].

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

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.

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.

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.