WASHINGTON, D.C.—In a letter dated Aug. 4, CaliforniaDemocrat Rep. Henry Waxman and half a dozen Democratic colleagues imploredPresident Barack Obama to exclude the 12-year data exclusivity perioddelineated in the biosimilar approval pathway of the nation's healthcare reformlaw, the Patient Protection and Affordable Care Act, from the intellectualproperty provisions of the Trans-Pacific Partnership (TPP) agreement.
The TPP is a shorthand name for the Trans-Pacific StrategicEconomic Partnership Agreement, a free trade agreement that is currently beingnegotiated. It is expected that the agreement will be on paper by November ofthis year. Current participating nations include Australia, Brunei, Chile,Malaysia, New Zealand, Peru, Singapore, the United States and Vietnam.
In the future, Canada, Japan, the Philippines, South Koreaand Taiwan may participate in the group.
The United States is preparing to propose language onintellectual property for the agreement, and Waxman is pushing hard to ensurethat the new language won't include biologics. The TPP partners met in Vietnamin June, and the partners are now gearing up for two meetings scheduled forAmerican soil in September.
The healthcare reform law created an approval pathway forgeneric versions of biologic drugs, or biosimilars. The brand-name biologicdrugs were provided with 12 years of patent protection from generic counterpartswith that legislation.
Waxman has long been a supporter of shorter time limits onexclusivity. In the brief letter, Waxman took issue with the administration'sproposal to include the 12-year protection provision on biologics in the tradeagreement, pointing out that that would run counter to its own proposal to tryto shorten the protection period on U.S. soil.
"Were the TPP to ultimately contain a 12-year biologicsexclusivity provision, it would impede the ability of Congress to achieve theadministration's proposed seven-year change without running afoul of U.S. tradeobligations," the letter states. "We see no reason for the UnitedStates to agree to such a provision, much less propose it."
On July 27, 40 members of Congress from both parties sent thepresident their own missive, supporting the 12-year provision. The coalitionthat signed the letter was an almost even split among political parties, with19 of the signers from the Democratic party. The bipartisan letter says thatAmerica's knowledge-based economy is the "envy of the world," and is so becauseof a history of carefully crafted policies that foster growth in that sector.
"The United States Trade Representative should ensure thatthe TPP agreement respects strong intellectual property standards for allsectors, especially the intellectual property-intensive sectors critical to thesuccess of the American economy and our nation's global competitiveness," theletter says.
The letter continues: "In the course of the TPP negotiationson intellectual property rights issues, we urge you to support current U.S. lawon biologics, which provides for 12 years of protection. The U.S.-ledbiopharmaceutical industry would be disadvantaged if the U.S. does not ensureconsistency with U.S. law as part of the TPP, because foreign countries do notprovide the same type of protection rules. This provision is critical tokeeping and expanding high-value U.S. jobs offered by America's biotech sectorand spurring the R&D investment needed to seize extraordinary opportunitiesfor medical advances to combat our most costly and challenging diseases."
One of the signatories of the letter is Rep. Anna Eshoo, aDemocrat from California and a proponent of the biotechnology industry. As ddn reported last fall, Eshoo had been key in thehealthcare reform law debate in advancing the issue of the biosimilar approvalprocess and the 12-year exclusivity provision.