On Tuesday October 20, 2015, Representative Anna Eshoo (D-CA), one of the principal authors of the Biologic Price Competition and Innovation Act (BPCIA), sent a letter to the United States Trade Representative requesting timely clarification regarding the Trans-Pacific Partnership’s impact “on existing U.S. laws that limit damages for infringement of intellectual property (IP) rights, and on the potential ISDS ramifications for those conflicts.”
The BPCIA, as the letter points out, provides that, “…in some cases the ‘sole and exclusive’ remedy for patent infringement pertaining to biologics is a ‘reasonable royalty.'”
As Representative Eshoo states, “I’m concerned that the TPP agreement’s language on damages in the IP Chapter provides no room for statutory limitations on damages, and thus conflicts with the Affordable Care Act’s provisions regarding biologic drugs under 35 U.S.C. § 271(e)(6)(B)….”
The letter goes on to suggest that if the TPP’s language on damages conflicts with the BPCIA and other laws that similarly provide for statutory limitations on damages, the conflict “would leave the U.S. vulnerable to costly private sector actions under the TPP’s ISDS mechanism which only exempts intellectual property rights to the extent they are consistent with the TPP and [TRIPS]…[and] could potentially limit the ability of Congress to provide statutory limitations on damages for other important intellectual property infringement problems.”