Ever since Therasense made it more difficult to plea and prove inequitable conduct (IC), I feel that practitioners and litigators have pushed this defense to patent infringement out of the front lines of infringement attacks. In fact, I know of only a handful of cases in the pharma space in which an inequitable conduct defense was successful. In a sense, it has been replaced by pleas for enhanced damages, sanctions for misbehavior during litigation, and even anti-trust violations. This despite invalidations of a variety of patents post-Therasense in decisions such as GS Cleantech v. Adkins Energy, Appeal No. 2016-2231, 2017-1838 (Fed. Cir., March 2, 2020), Apotex v. UCV, 763 F.3d 354 (Fed. Cir. 2019) and Aventis Pharma. v. Hospira, 675 F.3d 1324 (Fed. Cir. 2012).
[The USPTO’s] webpage houses useful information regarding the implementation of an interim Director review process in Patent Trial and Appeal Board (PTAB) proceedings following Arthrex.
On June 21, 2021, the U.S. Supreme Court issued a decision in United States v. Arthrex, Inc., Nos. 19-1434, 19-1452, 19-1458, 2021 WL 2519433, addressing the Constitution’s appointments clause as it relates to PTAB administrative patent judges (APJs). The court considered whether APJs are “principal officers” who must be appointed by the President with the Senate’s advice and consent, or, as the United States Patent and Trademark Office (USPTO) and the U.S. government argued, whether they are “inferior officers” who can be appointed by the Secretary of Commerce.