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Coronavirus/COVID-19 › Pharmaceutical Industry › Pharmaceutical Patents

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

Goodwin

Final Judgment of Non-Infringement Entered in Alnylam v. Pfizer Vaccine Patent Dispute

Goodwin on

​​​​​​​On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. (“Alnylam”) and Pfizer, Inc. (“Pfizer”)—concluding that Pfizer’s...more

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

mRNA/LNP Patent Litigation Update (Q1 2025)

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As we previously discussed, beginning in 2022, a series of patent infringement lawsuits were filed against Moderna and collaborators Pfizer+BioNTech seeking damages based on their respective sales of the Spikevax® and...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

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

[Webinar] The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape - September 27th, 2:00 pm ET

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

Partner Dan Shores will present a webinar titled "The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...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

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

Arbutus and Genevant Sue Moderna in First Significant Patent Infringement Lawsuit in the mRNA Space

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In the first major patent infringement lawsuit in the mRNA space, on February 28, 2022, Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences GmbH (“Genevant”) sued Moderna, Inc. and ModernaTX, Inc. (collectively...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

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

Health Canada TPD, BRDD and NNHPD Annual Performance Reports released

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The Therapeutic Products Directorate (TPD), the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), and the Natural and Non-Prescription Health Products Directorate (NNHPD) have released their Drug Submission...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

King & Spalding

Update on the Proposed TRIPS Waiver at the WTO: Where is it Headed, and What to Expect?

King & Spalding on

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

McDonnell Boehnen Hulbert & Berghoff LLP

GOP Legislators Write in Opposition to Proposed TRIPS Waiver

McDonnell Boehnen Hulbert & Berghoff LLP on

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

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

The mRNA IP and Competitive Landscape: Translate BIO; Arcturus; eTheRNA and Other Startups; and LNP Technology (Part II)

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

In Part I of this three-part series, we focused on three mRNA technology market players: BioNTech, Moderna and CureVac. In this second post, we will focus on Translate BIO, Arcturus Therapeutics, and eTheRNA and discuss...more

Akin Gump Strauss Hauer & Feld LLP

[Podcast] Vaccine IP Fight; Delicate Dem Dynamics; Deciphering CDC

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 public law and policy partners Ed Pagano and Clete Willems to talk federal health...more

Smart & Biggar

Transition measures released for Interim Order for COVID-19 drugs

Smart & Biggar on

As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...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

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