Note on use of Orphan Drug Act to increase price of hydroxyprogesterone caproate from $10 to $1,500 per dose

(Following discussions with Ed Silverman of Pharmalot, this blog was updated at 12 pm on March 22, to add some suggestions as to how to reform the Orphan Drug Act).

This note concerns an increase in the price of hydroxyprogesterone caproate, from $10 to $20 per dose to $1,500 per dose. (Several injections are needed). Long used off label to prevent premature births, the drug will be sold by KV Pharmaceuticals, under a newly granted right under a statutory monopoly, at 150 times the price of the generic product using the trade name Makena.

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United States Patent and Trademark Office’s “Humanitarian Pilot Proposal.” Comments by KEI, MSF, Oxfam, PC and UAEM

The USPTO is considering a pilot program to consider the benefits of providing a voucher for certain accelerated reviews of patent applications, as a reward for licensing patents for humanitarian uses. On March 2, 2011, Anne Guha provided a very useful summary of public comments on the proposal, which is available here: https://www.keionline.org/node/1074

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Seven being considered for new US Register of Copyrights

Apparently it is now down to seven final candidates to be the new US Register of Copyrights. These include two employees of the Copyright Office (Carson and Kasunic), a lawyer in private practice (Fries), a full time professor (Brauneis), a professor/USPTO negotiator (Hughes), a trade negotiator (McCoy), and a representative of a trade association (Perlmutter). By gender, the finalists are two women, and five men.

They are, in alphabetical order:

Robert Brauneis
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WBU suspends participation in WIPO & EU Stakeholder discussions, pending agreement at WIPO on legal framework

On February 26, 2011, the World Blind Union issued a statement announcing it would “suspend participation in the WIPO Stakeholder Platform and EU Stakeholder Dialogue projects, pending agreement at WIPO on a proper binding legal framework.” [See full statement below]. The WBU statement is expected to dramatically change the environment for considering a new WIPO treaty for persons who are blind or have other disabilities.

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Greens/EFA MEPs Engström, Sargentini, Beliér, Albrecht ask question on ACTA and Vienna Convention

Four Green/EFA MEPs (from four parties and four countries) have asked a follow-up question on ACTA and the Vienna Connection, trying to get at the “is the US bound?” issue.

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Greens/EFA MEPs Christian Engström, Judith Sargentini, Sandrine Beliér and Jan Albrecht have asked the European Commission this follow-up question on ACTA and Vienna Convention:

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Judit Rius takes position as U.S. Manager of MSF’s Campaign for Access to Essential Medicines

At the end of the month, Judit Rius will be leaving KEI and joining MSF in New York as U.S. Manager of MSF’s Campaign for Access to Essential Medicines. Judit has been with KEI since 2006, and from the beginning, contributed greatly to nearly every aspect of KEI’s work. We will miss her a lot. At MSF, Judit will work closely with another talented former KEI lawyer, Michelle Childs. We wish Judit well in her new position, and congratulate MSF on the appointment.

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