False Claims Act Insights - How a Marine Fisheries Dispute Opened an FCA Can of Worms
False Claims Act Insights - If Everything Matters, Nothing Does: Parsing Materiality in FCA Disputes
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
On August 20, 2025, the U.S. District Court for the District of Delaware (court) found inequitable conduct when Applicant, Lindis Biotech, GMBH (Lindis), relied on data from hastily performed experiments to obtain a patent...more
Properly pleading inequitable conduct claims is a challenge, a challenge that can be met with early due diligence and attention to detail in your pleading....more
In a 38 page decision with a 19 page dissent by Judge Newman, the Federal Circuit determined that Regeneron’s transgenic mouse patent is unenforceable due to inequitable conduct. The decision was rendered in Regeneron...more
In Regeneron v. Merus, a divided panel affirms a determination of unenforceability for violation of the duty of disclosure. What is interesting about the case is that neither the district court nor the majority reviewed...more
More than five years after the Federal Circuit’s en banc decision in Therasense and its first proposed rulemaking under that decision, the USPTO has issued a new proposed rulemaking to adapt its duty of disclosure rule (37...more
Am. Calcar, Inc. v. Am. Honda Motor Co., Inc. - In a post-Therasense decision, addressing the issue of inequitable conduct the U.S. Court of Appeals for the Federal Circuit upheld a district court’s finding that the...more
Today, the Federal Circuit upheld the District Court’s inequitable conduct verdict based on the submission of false affidavits to the United States Patent & Trademark Office (“PTO”). Intellect Wireless, Inc. v. HTC Corp.,...more