Partner Kristin Connarn and counsel Richard Bone will speak at the 256th American Chemical Society National Meeting, hosted in Boston on August 20, 2018.
Kristin will discuss 'Extensions to Patent Term in the US & Worldwide', and PTE's valuable benefit to developers of patented small molecule pharmaceutical products that exists within the Hatch Waxman framework. Nevertheless, the PTE statute, 35 U.S.C. § 156, embodies limitations that are quite stringent and mean that most patent holders need to strategize carefully in order to maximize the potential extension to term that can be afforded. Although there has been only a small amount of litigation to test the language of 35 U.S.C. § 156, the cases that have been decided have had an important impact on defining the scope of the extension
Richard will speak on 'Patent Term Adjustment in the US', which will address methods of obtaining patent terms that extend beyond the normal 20-year terms afforded by most countries. The Hatch-Waxman regime in the US provides a system for awarding extensions to patent term for drug products that have been subjected to a regulatory approval process. Patent Term Adjustment is now also a key component of a strategy to extend US patent term. Other countries worldwide offer Supplementary Protection Certificates to provide patentees with extended coverage for products that have received marketing authorization. These provisions, when coupled with data exclusivity possibilities, provide a valuable extension of rights for approved drug products.