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.
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 Continue Reading
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. Continue Reading
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. Continue Reading
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:
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.
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.
http://www.ice.gov/news/releases/1205/120518rochester.htm
News Releases
MAY 18, 2012
ROCHESTER, NY
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