Industry Rallies Around 12 Years Data Exclusivity for Biologics
The U.S. proposal for 12 years of certain data exclusivity in the Trans-Pacific Partnership is critical to ensuring U.S. companies continue to manufacture life-saving pharmaceutical medications, said a number of industry representatives on a March 9 conference call with reporters. U.S. law currently honors the 12-year level, and businesses and researchers will benefit from that consistency, said National Association of Manufacturers trade expert Linda Dempsey on the call. The Patient Protection and Affordable Care Act, the controversial healthcare overhaul, put that threshold into place in recent years (here).
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Extensive industry analysis produced that 12-year threshold, said the industry representatives. That threshold strikes the right balance between too much and too little financial incentives for producing biologics, they said. A weaker lifespan for protection would likely hurt profits and could discourage manufacturers from engaging in biologic production, said the representatives. “The U.S. market is dependent on private capital from investors as are really most other countries,” said McKenna Long & Aldridge senior counsel Alan Wolff on the call. The 12-year threshold is “not an arbitrary number. It’s what is deemed to be the incentive necessary to have private capital step up and create these new drugs. And the fact is we’re getting them, so why experiment with some lesser number.”
Many trade critics and opponents of that level of biologic protection rail against the U.S. proposal for preventing global consumer access to life-saving drugs (see 1502270018). The Office of the U.S. Trade Representative hasn’t commented recently on the status of intellectual property negotiations. In past months, trade observers have said the U.S. is alone among TPP parties in calling for such stringent intellectual property protections (see 14030520).