USPTO “clarifies” June 27, 2012 testimony on biologics exclusivity and India compulsory license

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.

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US Congress

Hearings on intellectual property rights, 112th Congress

House of Representatives

  • April 26, 2012. Hearing on: “International Patent Issues: Promoting a Level Playing Field for American Industry Abroad” Subcommittee on Intellectual Property, Competition and the Internet. http://judiciary.edgeboss.net/wmedia/judiciary/ip/ip04262012.wvx
  • May 26, 2012. Hearing on: Implementation of the Leahy-Smith America Invents Act, Full Judiciary Committee Hearing. http://judiciary.edgeboss.net/wmedia/judiciary/full/fullcomm05162012.wvx

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USPTO and Congress bash India over the Nexavar compulsory license

Teresa Stanek Rea 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

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Update: Global Fund responds to Report on William Steiger

The Global Fund just sent an email, which says that “your website which inaccurately reports that Mr Steiger will run VPP.” Here is the Global Fund email:

From: Andrew Hurst
Date: June 20, 2012 5:36:49 PM GMT+02:00
To: Thirukumaran Balasubramaniam Subject: RE: Question on the Global Fund’s Voluntary Pooled Procurement?

Dear Thiru

Further to our conversation this week, here is our statement:

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Recent ICE Press regarding counterfeit of pharmaceutical drugs

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.

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What’s a counterfeit? And how many counterfeit drugs are there?

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

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