Biologics Exclusivity Still Central in Trade Talk Debate

Regulatory NewsRegulatory News | 05 June 2015 |  By 

The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history.

While the US Trade Representative (USTR) and the biopharmaceutical industry have publicly called for a 12-year exclusivity period, Politico reports that some industry lobbyists are tempering their expectations.


Among the 12 parties to TPP, the United States is the only country to offer a greater level of data exclusivity for biologics.

Data exclusivity, also known as "regulatory data protection," is the period of time during which other products cannot be approved using the data generated by an innovator company. This protects innovator companies from generic competition for a set period of time after receiving regulatory approval. Data exclusivity should not be confused with marketing exclusivity, which prevents other products from being approved for a given indication until the marketing exclusivity period expires.

Pharmaceuticals, including biologics, are given this additional protection to account for the lengthy and expensive development times, which make patent protection on its own less effective than for other technologies.

Tempering Expectations

The push for a 12-year period of data exclusivity has been criticized internationally by advocacy groups such as Médecins Sans Frontières and domestically by many Democratic lawmakers who favor a shorter period of five or seven years.

The pharmaceutical industry has been very vocal in its support of maintaining the 12-year data exclusivity period in TPP. However, Politico reports some in the industry may be softening their stance in view of the broader benefits TPP would bring to pharmaceutical companies.

Mark Grayson, a representative for the Pharmaceutical Research and Manufacturers of America (PhRMA) told Politico, "I think potentially at the end of the day, we have to look at the totality of the agreement … Are we at a better or worse place?" Additionally, Politico says two unnamed lobbyists said "an eight- or nine-year period may be the most that the industry can realistically expect" in the face of mounting pressure from Democrats and nongovernmental groups who oppose the 12-year period.




© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy