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Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms... more +
Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -
Goodwin

UK Court of Appeal Upholds Moderna mRNA Patent Against Pfizer/BioNTech

Goodwin on

On August 1, 2025, a UK Court of Appeal upheld the validity of Moderna’s European Patent No. 3,590,949 (“EP’949”) in a dispute with Pfizer and BioNTech. The decision affirmed a July 2024 UK High Court ruling finding that...more

McDonnell Boehnen Hulbert & Berghoff LLP

Five Years Ago Today . . .

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On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear."  At...more

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

Ballard Spahr LLP

Life Sciences Landscape: 2023 Mid-Year Industry Update

Ballard Spahr LLP on

The Inflation Reduction Act (IRA), signed into law in August 2022, impacted a wide range of tax laws and touched many aspects of government. Significantly, part of the IRA provides Medicare with the ability to negotiate the...more

Venable LLP

The State of Biosimilars in 2023

Venable LLP on

It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market. While there have been challenges over this time, the U.S. biosimilar...more

McDonnell Boehnen Hulbert & Berghoff LLP

"Zero Draft" of WHO CA+ Released

McDonnell Boehnen Hulbert & Berghoff LLP on

On February 1, the World Health Organization (WHO) released a "zero draft" of a WHO convention, agreement, or other international instrument on pandemic prevention, preparedness, and response (or "WHO CA+") for the...more

Akin Gump Strauss Hauer & Feld LLP

USTR Announces Support for Extending TRIPS Waiver Expansion Discussions and Launches USITC Investigation

Akin Gump Strauss Hauer & Feld LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

Status of Proposed Extension of TRIPS Waiver in WTO

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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

McDonnell Boehnen Hulbert & Berghoff LLP

The Proposed WTO IP Waiver: Just What Good Can It Do? -- An Analysis

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As posted Monday, BIO (the Biotechnology Innovation Organization) provided a link to the supposed compromise agreement reached recently to permit WTO member states to waive patent protection for "subject matter required for...more

Rothwell, Figg, Ernst & Manbeck, P.C.

mRNA Patent and Competitive Landscape: 2021 Year in Review and 2022 Outlook

Rothwell, Figg, Ernst & Manbeck, P.C. on

In April of 2021, we provided a three-part series relating to the IP and Competitive Landscape for the mRNA market. In this post we provide a 2021 year in review update on mRNA pioneers and key players and offer additional...more

Spilman Thomas & Battle, PLLC

What was Fascinating in 2021 for Biotech

Spilman Thomas & Battle, PLLC on

2021 was a fascinating year in biotech, especially for legal issues. Of course, 2021, as the second year of a global pandemic, must be viewed in context with 2020....more

Akin Gump Strauss Hauer & Feld LLP

[Podcast] Onshoring Drug Manufacturing and TRIPS Waiver Part II

Akin Gump Strauss Hauer & Feld LLP on

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

Smart & Biggar

2021 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In the first half of 2021, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more

Porter Hedges LLP

Anticipating President Biden’s Intellectual Property Policy in an Historical Context

Porter Hedges LLP on

Presidential administrations have affected intellectual property (IP) policy since the very beginning of United States history. In his first State of the Union address in 1790, President George Washington addressed patents....more

McDonnell Boehnen Hulbert & Berghoff LLP

GOP Legislators Write in Opposition to Proposed TRIPS Waiver

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Earlier this month, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines."  One day prior to Ambassador...more

McDonnell Boehnen Hulbert & Berghoff LLP

Population of Patents at Risk from Proposed WTO Patent Waiver

McDonnell Boehnen Hulbert & Berghoff LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver

McDonnell Boehnen Hulbert & Berghoff LLP on

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

Sheppard Mullin Richter & Hampton LLP

Waiver Of Intellectual Property Protections For COVID-19 Vaccine Unlikely To Have Meaningful Impact In Short Term

Sheppard Mullin Richter & Hampton LLP on

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

Rothwell, Figg, Ernst & Manbeck, P.C.

The mRNA Patent and Competitive Landscape: Pioneers, Litigation Outlook and Big Pharma’s Next Moves (Part III)

Rothwell, Figg, Ernst & Manbeck, P.C. on

In Part I of this series providing a summary of the mRNA IP and competitive landscape through one year of the COVID-19 pandemic, we focused on market players BioNTech, Moderna and CureVac; in Part II, we discussed Translate...more

McDonnell Boehnen Hulbert & Berghoff LLP

The Road to Hell Is Paved with What Everybody Knows

McDonnell Boehnen Hulbert & Berghoff LLP on

And everybody knows that suspending patent rights is necessary to provide sufficient vaccine to stem the global pandemic caused by the SARS-CoV-2 virus known as COVID-19.  It is always a sign of intellectual weakness and pack...more

McDermott Will & Schulte

International News: Healthcare - Spotlight on the Industry - May 2021

McDermott Will & Schulte on

Sovereign Wealth Fund Investment in the Global Healthcare Industry - Sovereign Wealth Funds (SWF) seek out investments that are resilient, conducive to their aims and objectives, and reasonably free from market...more

Weintraub Tobin

Pfizer And BioNTech Claim Immunity From COVID-19 Vaccine Testing IP Claim

Weintraub Tobin on

Pfizer and BioNTech recently asked the Southern District of California to dismiss a patent infringement claim from Allele Biotechnology related to Pfizer and BioNTech’s Covid-19 vaccine. Allele holds a patent for a...more

McDonnell Boehnen Hulbert & Berghoff LLP

BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver

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One year ago today, World Health Organization Director-General Tedros Adhanom declared the COVID-19 outbreak to be a pandemic.  At the time of the announcement, the WHO noted that there were 118,000 cases reported globally,...more

MoFo Life Sciences

Rare Disease: Sustained Progress In Development Regardless Of The Pandemic

MoFo Life Sciences on

Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In...more

Smart & Biggar

2020 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more

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