The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
Addressing whether a party can waive a challenge to the constitutionality of Administrative Patent Judges’ (APJs’) appointment, the US Court of Appeals for the Federal Circuit found that the issue is non-jurisdictional and...more
In extraordinary times, sometimes the ordinary is comforting, so we want to bring you a short newsletter this month and provide some operating details for the major patent agencies in the US. First, we hope all our...more
THE CHAMBERLAIN GROUP, INC. v. ONE WORLD TECHNOLOGIES, INC. Before Dyk, Reyna, and Hughes. Appeal from the Patent Trial and Appeal Board. Summary: New arguments may be raised during PTAB oral hearings so long as they...more
The PTAB designated at least three more decisions as precedential. Of note, two of the cases rely on the Federal Circuit’s en banc decision in Click to Call, which is scheduled for argument at the Supreme Court on December 9,...more
Federal Circuit Determines Time-Barred Petitioner Joined to an IPR Has Appellate Standing - In Mylan Pharmaceuticals Inc. v. Research Corporation Tech., Appeal Nos. 2017-2088, -2089, -2091, the Federal Circuit held that a...more
Federal Circuit Summary - Before Lourie, Bryson, and Wallach. Appeal from the Patent Trial and Appeal Board. Summary: A party joined to an inter partes review has the right to appeal the Board’s final written decision...more
Federal Circuit Summary - Before Newman, Lourie, and Reyna. Appeals from the Patent Trial and Appeal Board. Summary: A party did not waive SAS-based relief in an IPR appeal when it requested remand for consideration of...more
Federal Circuit Sheds Some Light on How SAS May Impact Pending Appeals from the PTAB — Court Terminates Appeals of Partially-Instituted IPRs and Remands Back to the PTAB to Consider Non-Instituted “Claims and Grounds” in...more
Sovereign Immunity - Sovereign immunity exempts a sovereign from the jurisdiction of a court - States are entitled to sovereign immunity under the 11th amendment Seminole Tribe of Fla v. Florida, 517 U.S. 44 (1996) ...more
Federal Circuit Summaries - Before Newman, Dyk, and O’Malley. Appeal from the Patent Trial and Appeal Board. Summary: The PTAB may enter an adverse judgment against a patent owner where, before issuing an institution...more
On December 19, 2017, a seven-judge expanded PTAB panel ruled that the University of Minnesota (UM) waived its Eleventh Amendment immunity defense when it filed a patent infringement action in federal district court. ...more
The public version of ALJ Shaw’s Initial Determination (ID) in U.S. International Trade Commission (ITC) investigation Certain Magnetic Data Storage Tapes and Cartridges Containing the Same, Inv. No. 337-TA-1012 (1012...more
Less than four months after its decision in Covidien LP v. University of Florida Research Foundation Incorporated, finding that Eleventh Amendment sovereign immunity applies to PTAB proceedings, the Board has again dismissed...more
On May 23, 2017, the PTAB granted the University of Maryland’s (UM) motion to terminate inter partes review based on UM’s sovereign immunity in Neochord, Inc. v. Univ. of Maryland, Baltimore and Harpoon Medical, Inc.,...more