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
The ever-changing landscape of state government requires businesses across all industries to stay informed on the happenings in Madison. Welcome to the November issue of the Capitol Connection....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
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
The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...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
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
As 2021 comes to an end, the White House and the Department of State have announced: 1.South African Travel Restrictions Lifted. The 14-day travel restrictions on southern African countries will be lifted as of...more
Applicants for Adjustment of Status to Permanent Residence will have more than 60 days after completing their medical examinations to file their Forms I-485 Adjustment of Status applications, USCIS has announced...more
Key Points- •HF 902 was signed into law on October 28, 2021 and requires employers to issue vaccine waivers to employees who: 1) refuse to receive a COVID-19 vaccine requirement and 2) submit a statement that the vaccine...more
On October 29, 2021, Iowa Governor Kim Reynolds signed into law legislation affecting the interplay between Iowa employers, employees, and COVID-19 vaccine requirements. Iowa’s new law, HF 902, sets up questions regarding...more
All applicants for lawful permanent residency in the United States are required to submit to a medical examination to ensure that they are not carrying any communicable diseases of public health significance, and that they...more
The U.S. Centers for Disease Control and Prevention (CDC) have recently added vaccination against COVID-19 to its list of required vaccinations for individuals seeking lawful permanent resident status - colloquially known as...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
On May 26, SBA Administrator Isabella Casillas Guzman began a series of hearings on the Hill that will continue through May 28. On May 26, she testified before the House Committee on Small Business in a hearing titled “An...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
This is the latest in a series of articles discussing selected updates to the Department of Consumer Affairs’ (DCA) waivers issued in response to Governor Newsom’s March 30, 2020 Executive Order N-39-20, which authorized the...more