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
Our newsletter reflects the focus of Akin’s cross-practice autonomous systems and advanced mobility team on developments in the regulatory, policy, trade, intellectual property, and cybersecurity and privacy spaces....more
A Céspedes for the Rest of Us! Ex-New York Met Has Himself a Day, Winning a Critical Preliminary Injunction, as Chandler Bats Founder Finds Himself in a Pickle - The companies of ex-MLB player Yoenis Céspedes—La Potencia,...more
It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more
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
Strike 3 Holding, LLC is a prolific filer of federal copyright infringement actions. They have filed thousands of lawsuits across the United States in states like Illinois, Pennsylvania, New Jersey, New York, Florida, Texas...more
Summary - The U.S. International Trade Commission (USITC) is soliciting public comment on the proposed expansion of a June 2022 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property...more
On February 1, 2023, the U.S. International Trade Commission (the “ITC”) initiated an investigation into the impact of intellectual property (“IP”) rights on the production, supply, and availability of diagnostics and...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
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
While over 48% of the U.S. population is fully vaccinated, only about 15% of the world is. Such disparities have caused members of the World Trade Organization (WTO), such as India and South Africa, to call for a waiver of...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
The news cycle remains dominated by COVID-19 issues. One thing we’re watching is whether and to what extent the World Trade Organization (WTO) will waive intellectual property (IP) protections for vaccines in an attempted...more
On June 8-9, 2021, the World Trade Organization’s (WTO) TRIPS Council will hold their first meeting in the wake of the U.S. Trade Representative (USTR) announcing “the Biden-Harris Administration’s support for waiving...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
Companies holding intellectual property in medical products used in the fight against COVID-19 should be aware of formal efforts by a group of nearly 60 developing countries, led by India and South Africa, to obtain a waiver...more
The director of the United States Patent and Trademark Office (USPTO) announced on March 31, 2020, a 30-day extension of statutory deadlines for filing certain patent-related documents and paying associated fees so long as...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
Yesterday, March 31, 2020, the USPTO issued a Notice of Waiver of Patent-Related Timing Deadlines under the CARES Act. The Waiver concerns a limited set of deadlines for patent-related documents or fees that are otherwise due...more
Recognizing the disruptions caused by COVID-19, the United States Patent and Trademark Office (“USPTO”) is providing fee waivers for certain applicants that cannot meet filing deadlines to maintain their intellectual property...more
The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and...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