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Posts Tagged: "TTP"

The Need for Regulatory Data Protection in the TPP: Why Australia’s Got it All Wrong

While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe and effective. Regulatory data protection safeguards this data for a limited period of time, preventing competing firms from free-riding on the data that was generated at great expense. Specifically, biosimilar firms seeking regulatory approval are required to produce their own preclinical and clinical trial data to establish safety and efficacy, or wait the set period of time after which they are able to utilize the innovator’s prior approval in an abbreviated regulatory approval, eliminating the need for independently generated data.

A 2015 Trade Policy Outlook

With Republicans in control of both Chambers, the Administration may finally get TPA, fast- track negotiating authority for trade agreements that allows the President to negotiate international agreements that Congress can approve or disapprove but cannot amend or filibuster. Senator Hatch will likely have an ally in incoming Senate Majority Leader Mitch McConnell (R- KY), who has signaled that TPA is a pro-business measure that could pass Congress and have the support of the President.