Data Protection for Biologics – Should the Data Exclusivity Period Be Increased to 12 Years?

Abstract

A question was left open following the conclusion of the recent Trans-Pacific Partnership Trade Agreement – whether there is justification in extending the data exclusivity period for biologics beyond the current 5 year period. Using various lines of independent evidence, including company financial reports and statistical data from patent application filings, this essay will demonstrate that sales and profits from biologics are not significantly impacted by biosimilar competition and that research, development and innovation have continued to improve notwithstanding the length of data exclusivity. Accordingly, there is no compelling reason, at present, to justify an increase in the data exclusivity period for biologics.

Keywords: Law, intellectual property, biologics