Intellectual Property Rights and the Trans-Pacific Partnership

Provision on Biologic Medicines Could Slow Innovation

The Obama Administration’s Industry Trade Advisory Committee on Intellectual Property Rights (ITAC) has just released a new report on the status of the Trans-Pacific Partnership (TPP), a new trade agreement between the United States. and 11 other countries around the Pacific Rim.

The TPP agreement is set to lower intellectual property protections for promising new biologic medicines by setting the minimum period for data protection at eight years—down from the current 12 year standard in the U.S. where many biologic manufacturers are located.

While the ITAC report states that this shortened period will create uncertainty for the inventors of innovative new medicines, it does not address the bigger issue of the reduced length of data protection.

It is important to note that producing critical new medicines for patients is far from an easy, or cheap, endeavor. The average medicine takes more a decade and over $2 billion to take from lab to pharmacy. Success for developers of these medicines depends not merely on producing a single medicine, but on a commitment to constantly re-investing in Research and Development that lead to medical improvements that ultimately help patients in need.

Diminishing the length of protection for biologic medicines disincentivizes the production of biologic medicines by making huge R&D expenses less worthwhile, which threatens progress on treatments that hold great promise to combat rheumatoid arthritis, asthma, type 2 diabetes, leukemia, and other diseases.

This was a missed opportunity to forge agreement behind a modern standard in this area—one that is critical to safeguarding public health for generations to come. Unfortunately, the ITAC analysis largely misses this point on this important component of the TPP agreement.