(Cite as Molly Redfield Ward, Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs), KEI Research Note 2010:3) A PDF version of this document is available here. Notes on the 2004… Continue Reading
February 22, 2010., Matthew Herper, “The World’s Most Expensive Drugs,” Forbes. Genzyme’s web page on the cost of treatment. Some data points on Fabrazyme prices. 2004 prices for Replagal 2001 prices for Cerezyme. Myozyme/Lumizyme A 2007 Canadian analysis of (50… Continue Reading
Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures, On the topic of Direct funding, subsidies and incentives for the development… Continue Reading
WIPO’s First Intersessional Working Group (IWG 1) concluded its five days of deliberations on Friday, 23 July 2010 substantially closer to its goal of establishing a sui generis legal regime for the protection of traditional cultural expressions/expressions of folklore. On Friday, the WIPO secretariat distributed a summary report of the first IWG (attached below). Continue Reading
As mentioned in two previous KEI blogs, the WIPO’s First Intersessional Working Group received its mandate from the 16th WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) to ‘provide legal and technical advice and analysis, including, where appropriate, options and scenarios for consideration of the IGC’ including the outcomes, recommendations and texts relating to the discussion specifically on a working document containing draft provisions for a possible instrument for the protection of traditional cultural expressions/e Continue Reading
As mentioned in a previous piece entitled WIPO expert committee deliberates on road map to protect traditional cultural expressions, WIPO has convened an intersessional working group (IWG) comprised of experts from countries and observer organizations to examine draft provisions of a document prepared by the WIPO secretariat on ‘The Protection of Traditional Cultural Expressions/Expressions of Folklore: Revised Objectives and Principles‘. The IWG runs from July 19-23, 2010. Continue Reading
On Saturday, July 17, 2010, I said on twitter, “Apparently Luc Devigne is out as head #acta negotiator for EU.” There were a number of sources for this inside the European Union and also among other trade bodies or governments following or participating in the ACTA negotiations.
This was re-tweeted extensively, and resulted in various commentary and reporting on LucDevigne’s rule in ACTA, including speculation on the reasons for the change.
Article 2.3 of the July 1, 2010 version of the ACTA text provides for “Other Remedies” for infringement. The Japan, Switzerland and EU versions of the text appear to be overreaching, including for example by directly conflicting with explicit TRIPS provisions and provisions in the laws of ACTA negotiating countries, including several European Countries.
From 19-23 July 2010, WIPO has convened an Intersessional Working Group to examine a WIPO document on ‘Revised Provisions for the Protection of Traditional Cultural Expressions/Expressions of Folklore’ (WIPO/GRTKF/IC/17/4). Continue Reading
The July 1, 2010 ACTA text includes several provisions that would set global norms for damages, including most importantly, on pages 6 and 7, Article 2.2 on Damages. Also relevant are the provisions in Article 2.X on General Obligations with Respect to Enforcement, on page 5.