The Association of American Universities, a coalition of 60 research universities, has written a letter to Reps. Anna G. Eshoo, D-Calif., and Joe L. Barton, R-Texas, in support of the lawmakers’ legislation that would create an approval pathway for follow-on biologics (HR 5629). The letter highlights the bill’s proposed data exclusivity period as essential to funding the creation of new biologic products.

“Universities conduct basic research that yields early-stage discoveries. To ensure that discoveries will benefit the public, innovator companies and venture capitalists must have sufficient economic incentives to commit the substantial investments necessary to conduct clinical trials and develop such discoveries into new, breakthrough biologic treatments,” Association of American Universities President Robert Berdahl said in his letter. “Your bill accomplishes this objective by providing innovators 12 years of data exclusivity,” Berdahl wrote.

Berdahl also commended Eshoo and Barton for including a provision that permits third-party patent holders to defend biologic patents in disputes raised by makers of potential follow-on biologic products. Many universities hold biologic patents, and would be categorized as third-party patent holders.

Generic industry groups object to the market exclusivity period included in the Eshoo and Barton legislation.

“Unfortunately, this new proposal contains just such barriers including an unjustifiable 14.5 years of market exclusivity beyond the years companies already have under their existing patents. This is in stark contrast to the current system which works exceedingly well in bringing generics to the markets while fostering innovation,” said Generic Pharmaceutical Association President and CEO Kathleen Jaeger.

Legislation (HR 1038) sponsored by Rep. Henry A. Waxman, D-Calif., would create an abbreviated pathway for follow-on biologics with no period of data exclusivity and no stipulation that third-party patent holders could participate in patent disputes.

• From CQ TopDocs: AAU Letter (pdf)2894821