Lauren Baker is a Partner with Barnes & Thornburg. A proactive problem-solver, Lauren has significant experience defending her clients’ intellectual property rights in district court proceedings and in inter partes review (IPR) and post grant review proceedings before the U.S. Patent and Trademark Office on both the patentee and patent challenger side. With her excellent writing and critical thinking skills, Lauren has obtained preliminary injunctive relief for her clients in district court and defeated challenges to patent validity at the USPTO.
Lauren has been involved in virtually all phases of intellectual property litigation, including at the appellate level, where she has helped her clients achieve favorable decisions from the U.S. Court of Appeals for the Federal Circuit.
Prior to joining Barnes & Thornburg, she practiced at two large Atlanta law firms, where she represented clients in district court proceedings and in proceedings before the USPTO. She has handled litigation matters in numerous jurisdictions across the United States, including in the patent-heavy Western and Eastern Districts of Texas, the District of Colorado, the Northern District of Georgia, the Eastern and Middle Districts of North Carolina, Southern and Central Districts of California, and Middle District of Florida, among others.
Lauren has also participated in a number of pro bono matters, including four grandparent-relative adoption proceedings, throughout her career.
As part of her master’s program at the Bloomberg School of Public Health at Johns Hopkins University, Lauren worked at the Agency for Toxic Substances and Disease Registry, where she conducted a systematic review of the adverse reproductive effects of polychlorinated biphenyls (PCBs), culminating in her master’s thesis.
While in law school, Lauren was an extern in the U.S. Attorney’s Office for the Northern District of Georgia’s Civil Division and at Emory University’s Office of Technology Transfer.
In several previous articles (1, 2a, 2b), we reviewed key cases on the common law experimental use exemption and the statutory safe harbor under the Hatch Waxman Act. In this last installment, we will provide practical advice on what it takes to successfully invoke the exemptions during litigation or (where possible) avoid litigation entirely. We thus conclude our series of with some practical tips for both patentees and defendants dealing with (A) the common law research exemption and (B) activities “reasonably related” to the development and submission of information under the Hatch-Waxman Act, including an update from the Federal Circuit’s § 271(e)(1) safe harbor jurisprudence.
In a previous article, we analyzed the contours of the common law experimental use exemption. Now, we will explore the application of the exemption to common research activities, including those at universities and research institutions, in cases spanning recent decades. These cases illustrate the narrow confines of the experimental use exemption and its limited applicability in scenarios involving activities with direct or indirect commercial or business-related objectives. As a result, researchers should tread carefully and not count on the exemption to shield them from liability for patent infringement.
When exploring exemptions to patent infringement, there are several key U.S. Court of Appeals for the Federal Circuit cases to be aware of. First, we will examine a number of cases that have shaped the contours of the common law experimental use exemption, which applies to all industries, and secondly, we will look at recent decisions evaluating activities under the safe harbor of 35 U.S.C. § 271(e)(1) for products requiring U.S. Food and Drug Administration (“FDA”) approval.
On June 29, 2021, the Supreme Court issued its long-awaited decision in Minerva Surgical, Inc. v. Hologic, Inc. in which it clarified the proper limits of the centuries-old doctrine of assignor estoppel, which operates to prevent an inventor who assigns a patent to another for value from later claiming that the patent assigned is invalid during litigation, holding that the doctrine only applies when “the assignor’s claim of invalidity contradicts explicit or implicit representations he made in assigning the patent.” The decision underscores the need to keep in mind a number of factors when preparing and executing patent assignments.