Department of Health and Human Services (DHHS) FOIA Requests

  • On October 2, 2009, KEI submitted the following request to CDC, regarding IP aspects of pandemics:

    ——– Forwarded Message ——–
    From: James Love
    To: FOIARequests@cdc.gov
    Subject: FOIA Request, IP aspects of pandemics
    Date: Fri, 02 Oct 2009 16:36:44 -0400

    CDC/ATSDR FOIA Officer:
    Lynn Armstrong

    CDC/ATSDR
    Attn: FOIA Office, MS-D54
    1600 Clifton Road, N.E.
    Atlanta, GA 30333

    Dear CDC FOIA officer:

    Knowledge Ecology International (KEI) is a non-profit organization that deals with public health issues. KEI is currently undertaking research on issues relating to possible pandemics and intellectual property rights.

    As a member of the TransAtlantic Consumer Dialogue (TACD), KEI is also interested in the implementation of resolution IP 07-09, on the topic of IP Aspects of Pandemics (adopted May 2009). A copy of this resolution is available here:

    http://tacd.org/index2.php?option=com_docman&task=doc_view&gid=234&Itemid=40

    KEI requests documents under FOIA relating the following items:

    1.CDC documents relating to patent barriers to the development of new vaccines and drugs for possible pandemics, including but not limited to influenza.

    (a)Included in this request would be any documents including but not limited to memorandum, power point presentations, or communications including email to or from anyone related to patents on reverse genetics technology in human influenza vaccines. Among the documents particularly likely to exist and be relevant to this request would be:

    i.communications or memorandum which address the possibility of the exercise of U.S. government rights in patents under provisions of the Bayh-Dole Act, including but not limited to federal royalty free licenses or March-in rights for patents that benefited from federally funded research. KEI is aware that such discussions have taken place.

    ii.Analysis of the patent barriers to the making or distribution of new vaccines or drugs.

    2.Documents relating to intellectual property aspects of the World Health Organization negotiations on pandemic preparedness.

    3.CDC communications with private companies that manufacture drugs or vaccines, or Universities or others that hold relevant patent rights,
    that address any issue concerning intellectual property rights relevant to possible pandemics.

    4.CDC communications with the White House, USTR, DHHS, State or other federal agencies that address any issue concerning intellectual property rights.

    5.CDC communications with members of Congress or their staff, on any issue concerning intellectual property rights.

    The period for this request is January 1, 2004 to October 2, 2009.

    KEI is a non-profit organization under Section 501(c)(3) of the International Revenue Code. I personally have written about the topic of intellectual property aspects of pandemics in the Financial Times and in several academic and policy journals, and will be using this information to publish articles and papers that will further inform the public and policy makers and the management of intellectual property issues, as they related pandemics. We request a waiver of fees for this request.

    Sincerely,

    James Love
    Knowledge Ecology International

  • On October 9, 2009, KEI sent requests to DHHS, CDC, NIH, and FDA regarding the Bayh Dole Act, with the following request:

    “In order to conduct our investigation and serve the public interest, KEI requests all documents, including email, letters, faxes and other communications, memorandums, power point presentations, and any other information which addresses the use, request to use or the possibility of using U.S. government rights in patents under provisions of the Bayh-Dole Act, including but not limited to possible or actual exercise of the right to a nonexclusive royalty-free license to use an invention, or the exercise March-in rights. This request also includes any cases where the agency has used or considered using the process laid out in the Commerce Regulations 37 C.F.R. 401 to resolve a dispute about the use of the invention. The time period of our request dates from 12 December 1980 to the present.”

    On November 19, 2009 the Office of General Counsel (OGC) sent us a letter where they informed us that NIH will sent us a CD will the information found. OGC claimed they have found no additional responsive records. On November 4, 2009, NIH sent us CD and documentation concerning the Cellpro case.
    On December 22, 2009, KEI received a letter from the FDA where they claim that “the FDA did not find any emails, letters, faxes, memos, or other communications that address the above. None of the power point presentations that I have on file address the request above”.

  • On June 2010, KEI filed the following request under the Freedom of Information Act with the FDA.

The request asked for documents and communications prepared or received by the FDA regarding the Partnership for Safe Medicines (PSM) India Collaboration Summit held at the Imperial Hotel in Delhi, India, on May 11th, 2010 and called “Empowering Indian Patients, Healthcare Professionals and Policymakers Against Unsafe Drugs”. The request is available here.