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March 2011

Rx for the Defense: Dominic Campodonico Authors Article on "Innovator Liability for a Consumer's Use of Follow-On Biologics"

San Francisco Partner Dominic Campodonico authored an article in the March 2011 issue of Rx for the Defense, the newsletter of the Drug and Medical Device Committee of the Defense Research Institute. The article explains the scientific, legal and regulatory differences governing pharmaceuticals (brand and generic) verses biopharmaceuticals (reference products and follow-on biologics). Dominic also provided legal arguments and suggestions for the development of upcoming FDA rules that will help protect biopharmaceutical innovators from potential liability arising from the use of a competitor's follow-on biologic product.

"In February, 2011, FDA Commissioner Margaret Hamburg expressed her agency's fast-track focus on providing guidelines for a regulatory pathway for follow-on biologics. The legal framework and regulatory approval process for follow-on biologics is about to dramatically change. All participants in the biopharmaceutical industry need to gain as much knowledge as possible and be proactively involved in shaping their own destiny," said George Ng, Co-Chair of the Life Sciences practice at Gordon & Rees and a former General Counsel of a publicly-traded, global biotechnology company.

The First Appellate District of California alarmed the drug and medical device defense bar when the Conte court held that a brand-name manufacturer may be liable for alleged injuries sustained by consumers of competitors' generic products. Conte v. Wyeth, Inc., 85 Cal.Rptr.3d 299 (Cal. App. 1st Dist. 2008). In December 2010, the U.S. Supreme Court granted certiorari in Pliva, Inc., et al. v. Gladys Mensing, a case that could expand Conte to other jurisdictions. While follow-on biologics are different from traditional generic pharmaceuticals, it is imperative that biopharmaceutical companies understand Conte and Mensing because those decisions may impact the emerging legal field of follow-on biologic products.

Please click here to read "Innovator Liability for a Consumer's Use of Follow-On Biologics: the Combined Threat of Conte and New FDA Regulations" by Dominic Campodonico.

J. Dominic Campodonico