White House Pushes 12-Year Exclusivity For Biologics In Trade Talks


As the latest round of the Trans Pacific Partnership ended in Salt Lake City, the US Trade Representative has been circulating documents that show the US is pushing for an agreement that would include 12 years of product for new , according to sources.

The move contradicts budget proposals over the past three years that called for shrinking the 12-year exclusivity period, which was created by Biologics Price Competition and Innovation Act of 2009, to seven years. In doing so, the House articulated hopes of saving $ 3 billion over 10 years for various federal health programs, including Medicare and Medicaid (see this and page 40 here).

The pharmaceutical industry, though, has long been active in pushing for the 12-year exclusivity period. Brand-name drugmakers argue that 12 years is needed to recover R&D investments and to protect patents. They have noted that biosimilars do not have to be identical and, as a result, patents may be circumvented because these are not technically the same as the original drugs.

Toward that end, the pharmaceutical industry convinced dozens of members of Congress to write the White House shortly after the Trans Pacific Partnership talks got under way to urge that 12 years of exclusivity is obtained. The take-away message they have conveyed is that the US would be at a disadvantage because foreign countries do not provide the same level of patent protection (back story).

However, more than a dozen consumer advocacy groups have simultaneously urged the White House not to push for a 12-year exclusivity period, because such a provision would lock US into the same terms. They argue this would cause…Read more

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