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Agreement in Principle Reached on Biologic Drug Patents

A compromise was reached on patent protections for makers of biologic drugs in the 12-country Pacific-rim trade agreement. While the final language of the deal has not yet been released, the Trans-Pacific Partnership (TPP) negotiators settled on five years of data protection for biologics before other companies could start producing biosimilars.

The compromise was mainly brokered between the United States and Australia. The pharmaceutical industry had pushed for 12 years of protection for biologic medicines, as exists under current domestic law. This time period would help support medical innovation and the development of new cures and treatments. Australia and other countries, however, expressed concerns about the effect that a delay in biosimilar introduction could have on rising health care costs.

Some lawmakers have indicated that it will be difficult for them to support a deal without the 12 years of protection for biologics. Congress is expected to receive the agreement next year.