As previously posted, President Trump has stated that he planned to issue a notification of intent to withdraw from the Trans-Pacific Partnership (TPP), which is a proposed trade agreement between several pacific countries concerning (among other things) intellectual property and pharmaceutical products. While President Obama had approved a deal on the TPP, Congress has not ratified it yet. Today, President Trump acted on that plan and formally abandoned the TPP.
One of the most contentious issues in the TPP is the data exclusivity period that member states must provide for biologics. While the U.S.’s BPCIA provides for 12-years of data exclusivity, some TPP-member countries provide much less (e.g., Australia provides for 5 years of data exclusivity). The deal approved by President Obama had provided a compromise under which biologics data will be protected for at least five years.
It’s unclear if the TPP will be replaced with another trade agreement. Stay tuned to the Big Molecule Watch for developments.