is a partner in Venable Fitzpatrick’s Intellectual Property Litigation Practice in New York. He practices complex patent litigation in the areas of pharmaceuticals, biotechnology, and chemistry. As lead or co-counsel, Chris has litigated patent cases involving oncology therapies, anti-HIV therapies, anti-hepatitis drugs, antidepressants, and statins. He has argued before numerous federal district courts and the United States Court of Appeals for the Federal Circuit, and has won in inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB), on behalf of patent owners.
For more information or to contact Christopher, please visit his Firm Profile Page.
Innovator (or “reference”) biologic drug makers and small-molecule drug makers face differing legal obligations with respect to public patent disclosures. Under the Hatch-Waxman Act, reference small-molecule drug makers are required to provide to the U.S. Food and Drug Administration (FDA) a list of the patents covering the active ingredients, compositions, formulations, and methods of treatment for their approved reference drug products, which the FDA in turn is required to publish in its “Orange Book.” 21 U.S.C. § 355(b)(1), (c)(2). The publication of such patents in the FDA Orange Book thus gives all generic drug applicants advance notice of the patents to be asserted by a reference drug maker in future Hatch-Waxman litigation.
Earlier this year, the Patent Trial and Appeal Board (PTAB) established a two-part framework for applying 35 U.S.C. § 325(d), under which the PTAB may deny institution of an inter partes review (IPR) if substantially the same art or arguments previously were presented to the U.S. Patent and Trademark Office (USPTO). This framework injects a degree of rigor into the PTAB’s discretionary Section 325(d) determinations and suggests ways that IPR participants may more effectively raise or resist Section 325(d) arguments. The framework and its practical implications are discussed below.