On November 13, 2025, the U.S. District Court for the District of Massachusetts (court) found that patent applicant, Inline Plastics Corp. (Inline), engaged in inequitable conduct when it failed to disclose two inventors from...more
The U.S. Court of Appeals for the Federal Circuit (the court) issued its first precedential opinion to an appeal from a derivation proceeding at the Patent Trial and Appeal Board (PTAB) under the Leahy-Smith America Invents...more
In an unprecedented move, starting in July 2025, the U.S. Food and Drug Administration (FDA) released communications that have previously remained unpublished and confidential to the public. Specifically, Complete Response...more
9/26/2025
/ Disclosure Requirements ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Trade Secrets ,
USPTO
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
On August 8, 2025, the U.S. Department of Commerce notified Harvard University (Harvard) that it has initiated a comprehensive review of Harvard’s federally funded research programs to assure compliance with the Bayh-Dole...more
8/15/2025
/ Bayh-Dole Act ,
Corporate Counsel ,
Disclosure Requirements ,
Enforcement Actions ,
Federal Funding ,
Government Agencies ,
Intellectual Property Protection ,
March-in Rights ,
Patents ,
U.S. Commerce Department ,
Universities
On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit issued a decision in the case of In Re: Xencor, Inc. In this Appeal from the Appeals Review Panel of the Patent Trial and Appeal Board (ARP), with regard to...more
On October 21, 2024, the U.S. Department of Justice (DOJ) issued a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117, which authorizes the Attorney General to prohibit or restrict transactions by U.S....more
The Inflation Reduction Act (the Act) of 2022 was controversial at the time the Act was signed into law and remains so. To date, multiple legal challenges have been asserted against the Act, with more expected in the future....more
In a precedential decision issued on August 13, 2024, the U.S. Court of Appeals for the Federal Circuit held that a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued,...more
On May 10, 2024, the United States Patent and Trademark Office (USPTO) issued a notice of proposed rulemaking to add a new requirement for terminal disclaimers filed to obviate nonstatutory double patenting rejections to the...more
The United States Patent and Trademark Office (USPTO) is requesting public comment on how they can accelerate and incentivize the commercialization of innovative technologies. Public comments can be submitted via this...more
The U.S. patent system is based upon a quid pro quo balance that incentivizes innovation via a time-limited patent exclusivity, while encouraging the dissemination of new ideas for public benefit and use upon expiration of...more
On December 8, 2023, the National Institute of Standards and Technology (NIST) released the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (guidance) to the public for comment. The...more
Amgen Inc. et al. v. Sanofi et al., No. 22-157 (U.S. 2023) -
The U.S. Supreme Court, in a unanimous decision, has affirmed the Federal Circuit’s decision invalidating Amgen’s patent claims covering a genus of antibodies...more