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
Key Points - On July 28, 2023, President Biden signed EO 14104, “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs,” which aims to increase domestic manufacturing and...more
Protesters and other litigants before the U.S. Court of Federal Claims have long encountered the complexities of jurisdiction under the Tucker Act. The Tucker Act, 28 U.S.C. § 1491, is the statute granting jurisdiction to the...more
Key Points - On December 6, days before a deadline for WTO members to decide whether to expand the TRIPS waiver for COVID-19 vaccines to cover COVID-19 diagnostics and therapeutics as well, the Office of the USTR...more
It is often observed (or asserted) that a fair compromise in a dispute has likely been reached when both sides are not particularly happy about it. This is not always the case, of course, and is more likely not to be the...more
We first posted about a potential waiver of patent rights related to COVID-19 medical tools on May 6, 2021 (Patents on COVID-19 Vaccines Feel free to infringe (kilpatricktownsend.com)). A recent version of the waiver released...more
In this new episode of OnAir: Health Care, Akin Gump health care senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Akin Gump public law and policy partner Clete Willems and Centrient...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
Recently, the U.S.’s changed position on IP Waiver for patent protection of the COVID-19 vaccines and technology grabbed the headlines. It was an about-face from its previous stance. But what does it all mean? From Facebook...more
Dennis Crouch, our colleague at Patently-O, tweeted last week that there have Dennis Crouch, our colleague at Patently-O, tweeted last week that there have been 148 U.S. patents granted having disclosure related to (COVID-19...more
On Friday, Dr. Albert Bourla, the Chairman and Chief Executive Officer of Pfizer, sent an open letter to Pfizer employees regarding the U.S. Trade Representative's announcement last week that the Biden-Harris Administration...more
On Wednesday, May 7, 2021, the United States officially endorsed waiving intellectual property protections for COVID-19 vaccines. While the United States has taken the opposite position in recent months, the administration...more
The US Court of Appeals for the Federal Circuit rejected a biotechnology company’s argument that assignment provisions in its employment agreements granted ownership rights in post-employment inventions. Bio-Rad Laboratories,...more
Last year, the global COVID-19 pandemic created unprecedented challenges for American courts. By making several changes, however, the U.S. Court of Appeals for the Federal Circuit was able to largely continue its operations....more
Last month, the United States Patent and Trademark Office’s (USPTO) began an initiative to expedite the review of, and waive the fees related to, trademark applications for marks used to identify qualifying Covid-19 products...more
On May 27, 2020, the U.S. Patent and Trademark Office issued a further extension of certain deadlines that were about to expire on May 31. The latest order provides until July 1, 2020 for certain actions delayed due to...more
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
The Director of the U.S. Patent and Trademark Office on March 31, 2020 signed a notice waiving certain deadlines for patent-related filings, if the missed deadline resulted from situations relating to COVID-19. Due dates...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 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
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
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