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
Imagine that your company has just been sued by a competitor for patent infringement, deceptive advertising, unfair competition, or any number of other business torts. The news of the lawsuit has been reported in various...more
Over a year after the world shut down from the COVID-19 pandemic, many countries are beginning to see the light at the end of the tunnel that is a return to normalcy. Unfortunately, other countries are still deep in the...more
This 27th edition of Unprecedented, our weekly update on COVID-19-related litigation, sees us start with a discussion of a trend toward class actions, with later discussions on two key areas -- insurance coverage disputes and...more
A few weeks back, as remote working and social distancing were becoming the order of the day (and interesting phrase, given what quickly became the norm in many US states and cities, as executive orders abounded), my son...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 Prost, Moore, and Wallach. Appeal from the Northern District of Florida. Summary: When a state entity sues for patent infringement, it waives sovereign immunity as to all defenses,...more
Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more
The US Court of Appeals for the Federal Circuit concluded venue was improper under the patent venue statute as interpreted by the Supreme Court of the United States, finding that the accused infringer did not waive or forfeit...more
Federal Circuit Summary - Before Dyk, Reyna, and Taranto, per curiam. Petition for Writ of Mandamus from the District Court for the Eastern District of New York. Summary: In a case pending before TC Heartland was...more
Federal Circuit Summary - Before Reyna, Bryson, and Hughes. Appeal from the Northern District of California. Summary: Breach of a duty of disclosure to a standards-setting organization may constitute implied waiver,...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
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
Claims Directed to Methods for Streaming Audiovisual Data Held Unpatentable Under § 101 - In Two-Way Media Ltd v. Comcast Cable Communications, Appeal Nos. 2016-2531, 2016-2532, the Federal Circuit affirmed the district...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
The United States Supreme Court decided earlier this year that a 1957 opinion is still valid and still limits venue choices for patent infringement actions under 28 U.S.C. § 1400. See TC Heartland LLC v. Kraft Foods Group...more
The Supreme Court’s decision five months ago in TC Heartland v. Kraft Food Group Brands was a sea change in the way courts interpret venue for patent infringement cases. Since the Federal Circuit’s decision in VE Holding...more
The Supreme Court’s recent holding in TC Heartland settled several points of law: first, 28 U.S.C. § 1400(b) is the “sole and exclusive provision controlling venue in patent infringement actions; second, the broader venue...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
In a lengthy litigation between Akamai Technologies, Inc. (“Akamai”) and Limelight Networks, Inc. (“Limelight”), the District of Massachusetts recently addressed whether Limelight waived issues presented in its Renewed Motion...more
When considering an inter partes review in conjunction with a pending patent infringement suit, defendants must time the filing of their petition to beat the one-year-from-service bar imposed by 35 U.S.C. § 315(b). ...more