The US Orphan Drug Tax Credit


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From the FDA page on the Orphan Drug Tax Credit. Incentives TAX CREDIT (See Footnote 1 below) FOR TESTING EXPENSES FOR DRUGS FOR RARE DISEASES OR CONDITIONS Introduction Section 45C of the Internal Revenue Code of 1954 allows a credit…

Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs)


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(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…

Notes and data points for prices of orphan products


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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…

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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


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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…

Summary Report of WIPO’s expert group deliberations on a sui generis legal regime to protect folklore

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

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WIPO drafting groups release text for a possible legal instrument for the protection of traditional cultural expressions

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

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KEI interventions on a possible WIPO legal instrument for the protection of traditional cultural expressions

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

Luc Devigne’s role in ACTA negotiations

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.

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ACTA’s Article 2.3, on “Other Remedies”: the July 1, 2010 text

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.

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