Patent claim limitations that are “negative”—that is, claim limitations specifying the absence of a particular element from the patent claim—can pose a dilemma in the written description context. How much of the specification should be devoted to something that is not supposed to be part of the claim? The answer may be none at all according to a recent Federal Circuit decision, Novartis Pharmaceuticals v. Accord Healthcare Inc. The key, according to the decision, is that the specification should not describe the negative limitation in a manner inconsistent with how it is used in the claim.
Gourdin W. Sirles is an associate in the Litigation Department, where he focuses on patent and intellectual property litigations. From large pharmaceutical litigations (including litigations related to the Biologics Price Competition and Innovation Act and Hatch-Waxman Act), to patent litigations related to electronics, software, Microelectromechanical systems and components thereof, and financial services products, Gourdin’s intellectual property litigation experience has covered a broad variety of technologies and specialties.
Gourdin has experience in all aspects of the litigation process, including trials, Markman hearings, fact and expert discovery, depositions, case preparation and strategy, motion practice, and settlement negotiation. Gourdin is also well-versed in e-discovery, including forensic document collections, e-discovery platforms, management of contract attorney teams, document review, and production.
In addition to patent and intellectual property litigations, Gourdin’s practice has also encompassed a variety of other legal matters, including pro bono immigration matters, bankruptcy law, toxic tort, employment litigation, commercial disputes, and campaign finance compliance and other election-related laws on the state and federal level.
Confronting a life sciences patentee with its statements to regulatory bodies (such as the FDA) is a textbook defense strategy in patent litigation. After all, communications with regulatory bodies are often performed by non-attorneys who may not appreciate the consequences of their statements in future litigation. And while in ideal circumstances the patentee’s attorneys will ensure accurate and consistent communications and try to put potentially inconsistent statements in context, it is not always possible to do so once the genie is out of the bottle. Belcher Pharmaceuticals, LLC v. Hospira, Inc., exemplifies the dire consequences that can result from inconsistent communications with regulators—particularly if a defendant can point to a single source for those communications.
Striking a blow to patent applicants seeking to assert inventorship by artificial intelligence (“AI”) systems, the U.S. District Court for the Eastern District of Virginia ruled on September 3, 2021 that an AI machine cannot qualify as an “inventor” under the Patent Act. The fight is now expected to move to the Federal Circuit on appeal.