US Should Stay Committed to 12 Years Biologics Protection in TPP, Says Leading Innovation Group
U.S. negotiators should secure a final Trans-Pacific Partnership pact with “nothing less” than 12 years of data exclusivity for biologic medicines, said senior official at the Information Technology and Innovation Foundation, Stephen Ezell, in an op-ed in The Hill on…
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Aug. 17. That lifespan for data exclusivity has remained a sticking point through the final stages of TPP negotiations, experts have said in citing unresolved TPP issues following the Maui summit at the end of July (see 1508030024). “At stake in the TPP is the viability of a global innovation system that affords the necessary underlying IP protections that incentivize innovators to undertake the tremendous risk and expense associated with developing breakthrough new medicines, while also providing a pathway for generics competition,” said Ezell (here). “Twelve years of data exclusivity protection for biologics is the right standard.”