[Ip-health] ​Money speaks: USTR releases letters from Congress backing PhRMA on exclusive rights biologic test data in TPP

Elizabeth Rajasingh elizabeth.rajasingh at keionline.org
Mon Aug 4 13:49:36 PDT 2014

Updated with a list of the letters and link to the letters.

*Money speaks: USTR releases letters from Congress backing PhRMA on
exclusive rights biologic test data in TPP*


4 August 2014

As part of a partial response to FOIA request, USTR has provided KEI with
copies of 13 letters sent by members of Congress, from July 27, 2011 to
August 8, 2013, on the topic of biologic drug test data provisions in the
TPP negotiation. We had obtained several but not all of these letters
earlier from a variety of sources, including from PhRMA's web page -- where
some had been proudly displayed. (See link below).

Were there letters on the other side? Yes, three. (see below).

With the FOIA request, we have also obtained the responses to the letters.

Most of the 13 letters include multiple signatures from Members of Congress
from both parties, such as the 37 US Senators signing a September 12, 2011
letter circulated by Senators Orin Hatch and John Kerry, or the 40 members
of Congress signing a letter to President Obama on July 27, 2011.

The letters were provided to KEI as part of a FOIA request we filed last
year. We received only two letters from 2013, including a March 22, 2013
letter from Senators Baucus and Hatch to acting USTR Marantis, and an
August 8, 2013 letter from Hakeem Jeffries and ten other members of the
House of Representatives to the recently confirmed USTR Michael Froman. All
of the other letters were from 2011 to 2012, and were letters sent either
to then USTR Ron Kirk or to President Obama, and cc'd to Ron Kirk.

PhRMA had managed the letters so some were organized by state delegations,
such as the letter from Delaware Senators Carper and Coons, the letter from
Texas Senators Hutchison and Cornyn, the letter from Washington State
Senators Murray and Cantwell, the letter from Oklahoma Senators Inhofe and
Coburn, and the letter signed by eight members of the House of
Representatives representing Massachusetts.

It is doubtful that we have obtained a complete set of letters from
Congress on this topic, but this collection is already an impressive
illustration of PhRMA's power with both political parties.

Note that all consumer groups working on these issues, including AARP,
Public Citizen, PIRG, KEI, and several labor unions and State legislators
have opposed the 12 year term for biologic test data, and the President's
own budget has long called for a rollback in the US law from 12 years to 7

Those supporting an obligation in the TPP for 12 years of exclusive rights
in test data want to make it nearly impossible to reduce the term in the US
domestic legislation. On this issue, like many others these days, PhRMA has
support from the right, center and left of both parties. None of the
Senators or Representatives pushing for the 12 years term for test data
rights have expressed any interest in safeguards for the predictable (and
frequent) cases where a company selling a biologic drug charges too much
money (pick any standard for what constitutes an excessive or unreasonable
price), as if drug prices are a non-issue for the United States health care
system, and our only interest is in promoting higher prices around the
world. This is what unlimited private funding of campaigns leads to --
government for those who fund the campaigns.

Note: KEI's September 5, 2012 blog on this topic reports on some but not
all of these letters.

See also: Members of Congress and Governors backing PhRMA/BIO, calling for
12 years data protection for biologic drugs in TPP. September 5, 2012.
http://keionline.org/node/1544 [2]


Here are the 13 letters expressing support for 12 years of protection for

July 27, 2011. Letter [3] from 40 members of the United States Congress
urging President Obama to support current U.S. law on biologics, which
provides for 12 years of protection, during TPP negotiations.
September 12, 2011. Letter [4] from 37 members of the United States Senate
to Ambassador Ron Kirk, urging for a 12-year term of regulatory data
protection for biologics consistent with U.S. law. USTR response here [5].
September 12, 2011. Letter [6] from Senator Mark Udall and Senator Michael
F. Bennet to Ambassador Ron Kirk, stressing the importance of proposing a
high standard of intellectual property rights for biologics, which is
consistent with the 12 years of exclusivity under U.S. law. USTR response
to Udall here [7] and to Bennet here [8].
May 3, 2012. Letter [9] from Senator Tom Carper and Senator Christopher A.
Coons urging President Obama to ensure high intellectual property standards
in any TPP agreement, including a 12-year data protection for biologics.
USTR response here [10].
May 4, 2012. Letter [11] from Senator Kay Hutchison and Senator John Cornyn
to Ambassador Ron Kirk, stressing the importance of proposing intellectual
property protection for biologic drugs that reflects the 12 years of
exclusivity consistent with U.S. law. USTR response here [12].
May 11, 2012. Letter [13] from Senator Robert Menendez to President Obama,
emphasizing the importance of securing robust intellectual property rights
for biologics, including 12 years of data protection as found in U.S. law.
USTR response here [14].
July 12, 2012. Letter [15] from Senator Patty Murray and Maria Cantwell to
President Obama, stressing the importance of robust intellectual property
rights for biologics, including 12 years of data protection as found in
U.S. law. USTR response here [16].
July 13, 2012. Letter [17] from 8 members of the House of Representatives
from Massachusetts to President Obama, calling for 12 years of exclusive
rights in biological drug test data. USTR response here[18].
August 6, 2012. Letter [19] from Senator Claire McCaskill to President
Obama, supporting 12 years of exclusivity for biological medical products.
USTR response here [20].
September 10, 2012, Letter [21] from Senators James Inhofe and Tom Coburn,
the two Republican Senators from Oklahoma, supporting 12 years of exclusive
rights for biological drug drug test data. USTR response to Inhofe here
[22] and to Coburn here [23].
November 29, 2012. Letter [24] from Senators Toomey and Casey. USTR
response to Casey here [25] and to Toomey here [26].
March 22, 2013. Letter [27] from Senators Baucus and Hatch to acting USTR
August 8, 2013. Letter [28] from 11 members of the United States Congress
urging Ambassador Michael Froman to ensure the TPP trade agreement contains
a high standard of protection for intellectual property, specifically
robust measures to protect copyrights, patents, trademarks and trade


Three letters that take positions in opposition to PhRMA on the test data

There were two letters that, while not specifically referring to biologic
test data, called for flexibility on the test data issue. There was one
letter, from Representative Waxman and six other members of Congress, that
specifically opposed 12 years of exclusive rights in biologics test data,
while endorsing 7 years of exclusive rights.

August 4, 2011. Letter [29] from Congressman Waxman and six others
recommending that the United States refrain from negotiating a 12 year
biologics exclusivity provision.
December 1, 2011. Letter [30] from Senator Sanders expressing strong
objections to the reversal of U.S. trade policy during negotiations on the
TPP Agreement with respect to flexibility on test data.
September 8, 2011. Letter [31] from Congressman John Lewis and four others
expressing support of move flexible test data protections

[1] http://keionline.org/user/8
[2] http://keionline.org/node/1544
Elizabeth Rajasingh
Perls Fellow, Knowledge Ecology International
1621 Connecticut Ave. NW, Suite 500
Washington, DC 20009
*elizabeth.rajasingh at keionline.org <elizabeth.rajasingh at keionline.org>* |

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