[Ip-health] Mylan criticisms of the TPP provisions as regards generic medicines, warns USTR on "lazy drafting"

Claire Cassedy claire.cassedy at keionline.org
Mon Jul 20 12:22:38 PDT 2015


Mylan criticisms of the TPP provisions as regards generic medicines, warns
USTR on "lazy drafting"

Submitted by James Love on 20. July 2015 - 14:45

Attached below are two documents from Mylan regarding their concerns about
the TPP. The first is an April 13, 2015 10 page letter from Heather Bresch,
the CEO of Mylan, to USTR head Michael Froman. (Copy here [1]). The second
is a table of inconsistencies between the TPP and US law (Copy here [2]).

The letter from Heather Bresch, the CEO of Mylan, to Ambassador Froman, was
cc'd to Senators Orrin Hatch and Ron Wyden, and to Representatives Paul
Ryan and Sander Levin, as well as Ralph G. Neas, the President and CEO,
Generic Pharmaceutical Association.

The Mylan letter uses the Wikileaks version of the text in its analysis.

---Begin quote---
I would now like to take this opportunity to address the IP provisions in
TPP specifically and outline in detail the basis for our concern. While I
must rely on leaked texts of the IP Chapter in TPP, as I am not a cleared
advisor, I trust that to the extent this language is the same as or similar
to the actual text, that our concerns will be considered. I have attached
the leaked text here as an Appendix for common reference.
---End quote---

The letter focuses on (a) patent linkage, (b) linkage for biologics, and
(c) other IP provisions, including provisions regarding test data, patent
extensions and standards for granting patents, and a general concern that
"lazy drafting" will lead to significant and consequential delays in the
entry of lower cost generic drugs.

---Begin quote---
I raise these issues here (and there are others) because in the U.S., some
of this type of “lazy drafting” has resulted in extensive delays for
generic companies. These essential provisions have the potential to
dramatically alter whether, when, and how Mylan and other U.S. companies
will be able to have timely access for our products in TPP countries, in
addition to being inconsistent with U.S. law.
---End quote---

Mylan is a drug company that develops, licenses, manufactures, markets and
distributes generic, branded generic and specialty pharmaceuticals. They
operate in more than 140 countries and territories and have about 25,000
employees. The company is currently fighting a hostile takeover from Teva.
Heather Bresch, the CEO, has been with Mylan for about 20 years.

[2] http://keionline.org/sites/default/files/Mylan-GPHA-July

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