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

Attached 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). The second is a table of inconsistencies between the TPP and US law (Copy here).

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.

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.

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.

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.

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.