BIO Calls for 14-Year Data-Exclusivity Period for Biologics

Washington, DC (May 3)-The Biotechnology Industry Organization (BIO, www.bio.org) published a position paper stating that any legislation establishing a regulatory pathway for follow-on biologics should grant pioneering products 14 years of data exclusivity. The organization defines data exclusivity as the time period after the innovator’s product is approved during which the US Food and Drug Administration (Rockville, MD, www.fda.gov) may not approve a follow-on biologic (FOB) product that relies on the innovator product’s safety and effectiveness.

“For biologics to receive the same length of effective market protection that small- molecule drugs receive under the Hatch-Waxman Act, the period of data exclusivity in any FOBs framework must be no less than 14 years,” said Jim Greenwood, BIO’s president and CEO in a prepared statement. “Anything less could skew investment away from biologics research and development, jeopardizing the development of future pioneering biomedical advances.”   

BIO asserts that a FOBs regime would create a “patent protection gap” that would allow a follow-on manufacturer to elude an innovator’s patents while still relying on the innovator’s product to bypass the full regulatory process because of two factors not present in the Hatch-Waxman construct for small-molecule drugs. First, unlike a generic drug, which must be the same as an innovator product, a follow-on biologic may be only “similar” to the corresponding innovator product. Second, because biologic products are large molecules produced by living cells, patent protection for such products is often narrower and easier to “design around,” than that of small-molecules drugs.

Greenwood remarked that a 14-year exclusivity period for biologics would be consistent with previous Congressional efforts to protect the pharmaceutical industry. “Given that Congress has previously concluded that up to 14 years of patent protection is appropriate for drugs and biologic products, any statutory formula that allows for follow-on biologics should allow for at least the same degree of effective market protection,” Greenwood said in a prepared statement.

Data exclusivity is particularly important for the biotechnology industry, BIO observes, because the industry is composed mainly of small companies with unstable funding. The organization notes that these companies would be vulnerable to follow-on biologics legislation that could change the investment incentives.

Click here for the full text of BIO’s data-exclusivity justification paper.