James Love's blog
Deputy USPTO Director Teresa Stanek Rea has issued a retraction of her statement regarding Administration support for 12 years of exclusive rights in test data for biologic drugs, and moderated somewhat her statement on the India compulsory license for Nexavar. USTR also issued a statement on the issue of biologic test data in response to Rea's earlier comments.
[update: See: Leak of TPP text on copyright Limitations and Exceptions]
On June 27, 2012, Teresa Stanek Rea, the Deputy Under Secretary of Commerce for Intellectual Property and the Deputy Director of the United States Patent and Trademark Office (USPTO), testified at a hearing on: "International IP Enforcement: Protecting Patents, Trade Secrets and Market Access", before the US House of Representatives, Judicary Committee, Subcommittee on Intellectual Property, Competition, and the
The governments of Brunei, Chile, New Zealand, Singapore, Australia, Malaysia, Peru, Vietnam and the United States are negotiating a multilateral free trade agreement known as the Trans-Pacific Partnership Agreement (TPP). The negotiations are being conducted with considerable secrecy, even though they address many issues of great interest to the general public. The Agreement will cover many topics, including intellectual property rights, the pricing of pharmaceutical drugs, and the rights of investors to sue states over policies and actions that impact their investments.
The language in S. 3187, calling for National Academies evaluation of Medical Innovation inducement prizesSubmitted by James Love on 12. June 2012 - 9:07
SEC. 906. INDEPENDENT STUDY ON MEDICAL INNOVATION INDUCEMENT MODEL.
I recently sent the following letter to Andrew Bast, the editor of Foreign Affairs. The letter responds to a May 24, 2012 article by Devi Sridhar, Lawrence O.
The USPTO/DOC's liberal and misleading definition of IP-Intensive industries is designed to influence policy debatesSubmitted by James Love on 6. June 2012 - 7:07
At yesterday's TACD event, USPTO and KEI discussed the report by the Department of Commerce's Economics and Statistics Administration and the United States Patent and Trademark Office on Intellectual Property and employment. The report, titled: Intellectual Property and the U.S. Economy: Industries in Focus, has been widely quoted, including these bullets from its executive summary:
- IP-intensive industries accounted for about $5.06 trillion in value added, or 34.8 percent of U.S. gross domestic product (GDP), in 2010.
This is a rough list of the recent ICE press releases mentioning counterfeit and pharmaceutical. It is quite clear that the overwhelming majority of counterfeit busts involve Viagra and other erectile dysfunction drugs, a problem that will probably resolve itself once the Pfizer patents on Viagra expire.
In my quick read of the ICE press releases, I found just 12 pharmaceutical counterfeiting cases in the ICE press releases from 2009 to May 2012, with 14 defendants.
- 13 of the 14 defendants were men.
Despite very tough laws on the books in the US for counterfeiting, which include possible life sentences for some offenses, and the very aggressive federal PR campaign against counterfeit drugs, the US is not always that tough on the trade in counterfeit drugs. In this recent case, Curtis Henry was sentenced to three years probation.
MAY 18, 2012
Upstate New York man sentenced for importing counterfeit pharmaceuticals
Donald McNeil has an article in the New York Times that appeared in print on May 22, 2012 (page D6 of the New York edition) with the headline: "Malaria: Fake and Substandard Drugs Grow as Threat to Fight Disease." A web version is available here: http://www.nytimes.com/2012/05/22/health/policy/fake-and-substandard-drugs-grow-as-threat-to-fight-malaria.html
KEI Statement on WHA resolution on Consultative Expert Working Group on Research and Development: Financing and CoordinationSubmitted by James Love on 26. May 2012 - 4:51
KEI Statement on World Health Assembly resolution on Consultative Expert Working Group on Research and Development: Financing and Coordination
A number of developing countries worked together to push the World Health Assembly to create a member state process to consider the implementation of the CEWG. The most important CEWG recommendations are to begin work on a new WHO Convention on R&D financing, and to de-link R&D costs from drug prices.
Here is the resolution that was adopted.
Among the key parts of the 2 page resolution are the following:
1. WELCOMES the analysis of the CEWG report and expresses its appreciation to the Chair, Vice Chair and all the members of the Working Group for their work;
2. URGES Member States:2
(1) to hold national level consultations among all relevant stakeholders in order to discuss the CEWG report and other relevant analyses resulting in concrete proposals and actions;
Open letter to those who collectively produced the May 23, 2012 statement to the WIPO SCP on the topics of patents and healthSubmitted by James Love on 25. May 2012 - 5:58
Open letter to those who collectively produced the May 23, 2012 statement to the WIPO SCP on the topics of patents and health (Copy of US statement available here: http://www.keionline.org/node/1416).
May 25, 2012
To each and everyone who worked on the SCP submission:
This letter outlines our concerns to the May 23, 2012 statement to the 18th Session of the World Intellectual Property Organization (WIPO) Standing Committee on the Law of Patents (SCP), on the agenda for patents and health.
In its opening, the USPTO said the following:
This is a brief note regarding the WHA negotiations on the proposed treaty for medical R&D, and in particular, the elements which deal with financing R&D. I'll skip the history and earlier context of the negotiations, and focus on the main issues in play this week.