USTR Hits Back at Hatch Criticism on TPP Biologics Outcome
The Trans-Pacific Partnership will ensure intellectual property for U.S. biologics by requiring “an extended term of effective market protection” on the products for the first time in a U.S. free trade agreement, said Deputy U.S. Trade Representative Robert Holleyman during a recent speech to the Chamber of Commerce. His remarks (here) come on the heels of fierce criticism from Senate Finance Chairman Orrin Hatch, R-Utah, against the outcome on biologics (see 1511060028).
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The pact’s intellectual property chapter (here) lays out a dual-track system for biologic data exclusivity. TPP members must provide exclusivity for at least eight years or “provide effective market protection” through five years of exclusivity, on top of “other measures” that “deliver a comparable outcome in the market." The text doesn’t elaborate on the measures, but Holleyman said they’d be “regulatory procedures or other administrative actions.”
Despite Hatch’s call earlier in the week, also at the Chamber of Commerce, for USTR to potentially revisit the terms of the pact over the biologics outcome, Holleyman said the terms benefit U.S. industry and meet congressional demands laid out in Trade Promotion Authority. “There are many ways to provide effective market protection that are strong and meaningful,” said Holleyman on Nov. 6. “Japan does this through their post-marketing surveillance process, which gives effectively more than 8 years of protection for these drugs.”
TPP will boost intellectual property across the spectrum, from a range of patent and copyright terms to trade secret protection, Holleyman said. He, however, mentioned a set of ongoing intellectual property concerns the U.S. has with other trading partners, namely China and India. Roughly 50-80 percent of all IP theft globally originates in China, he said.