Author: James Love

The NIH has a notice for comments on proposed licenses of several patents relating to the “Production of Attenuated Respiratory Syncytial Virus Vaccines”. See: https://federalregister.gov/a/2016-03486

We asked Peter Soukas, a Senior Technology Licensing Specialist in the Technology Transfer and Intellectual Property Office, at the National Institute of Allergy and Infectious Diseases (NIAID), these questions:

1. What provisions exist in the license to protect US residents against excessive or unreasonable pricing?

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This is the announcement.

For Immediate Release February 10, 2016

TO THE SENATE OF THE UNITED STATES:

With a view to receiving the advice and consent of the Senate to ratification, I transmit herewith the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired, or Otherwise Print Disabled, done at Marrakesh on June 27, 2013 (Marrakesh Treaty). I also transmit, for the information of the Senate, a report of the Secretary of State with respect to the Marrakesh Treaty that includes a summary of its provisions.

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In calendar year 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel drugs, approved as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). This is a large number of approvals.

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Attached here is a KEI submission to the US ITC for the January hearing of the

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, DC
Investigation No. TPA-105-001
Trans-Pacific Partnership Agreement: Likely Impact on the U.S. Economy and on Specific Industry Sectors

Our earlier, related testimony on trade agreements was here: /node/2370

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Under the UK’s Pharmaceutical Price Regulation Scheme (PPRS), drug companies will make rebates of about £550 million in 2016, according to this story.

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WIPO SCCR 31 is having a text based discussion of the language for a proposed broadcasting treaty. The meeting is open to NGOs, instant transcripts are streamed over the Internet, and the proceedings are webcast. I was allowed to make to technical interventions this afternoon on the definitions. This is a slightly edited version of my second intervention, on the question of whether or not to have separate definitions for broadcasting and cable casting.

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KEI’s Initial Comments on the MPP/BMS license to patents and know-how for daclatasvir (DCV)

November 23, 2015

FYI: Contact: Andrew Goldman (andrew.goldman@keionline.org) or Zack Struver (zack.struver@keionline.org)

Knowledge Ecology International (KEI) notes the successful conclusion of negotiations between Bristol-Myers Squibb (BMS) and the Medicines Patent Pool (MPP) for a royalty-free license and technology transfer agreement on daclatasvir (DCV), an important new medicine for the treatment of the hepatitis C virus (HCV), and offers comments on the agreement.

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Attached is a PDF file with my testimony this morning for the United States International Trade Commission (USITC) hearing on
“Economic Impact of Trade Agreements Implemented Under Trade Authorities Procedure”, 2016 Report. Inv. No.: 332­555 November 17, 2015

Manon Ress also provided testimony at this hearing, for the Union for Affordable Cancer Treatment (UACT). A copy of her testimony is available here.
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