News & Analysis as of

Pharmaceutical Patents Vaccinations Coronavirus/COVID-19

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

Sheppard Mullin Richter & Hampton LLP

Lexicography: Clear And Unequivocal

This Federal Circuit opinion analyzes lexicography in the context of claim construction. Alnylam Pharmaceuticals owns U.S. Patent Nos. 11,246,933 (parent) and 11,382,979 (child). These patents relate to biodegradable...more

Ballard Spahr LLP

Comments Deadline Looms for Proposed TRIPS Waiver Expansion

Ballard Spahr LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

"Zero Draft" of WHO CA+ Released

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

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

Knobbe Martens

WTO Agrees to Partial Patent Waiver for COVID-19 Vaccines

Knobbe Martens on

On June 16, 2022, the World Trade Organization (WTO) agreed to a partial waiver of intellectual property rights related to COVID-19 vaccines. The agreement came on the heels of an all-night negotiating session. The agreement...more

A&O Shearman

Potential compromise on COVID-19 IPR waiver: deadlock resolved?

A&O Shearman on

Last month, a leaked document regarding the TRIPS Waiver revealed a breakthrough between the EU, South Africa, India and the United States. After 18 months of negotiations, the four parties now have reached a high-level...more

Kilpatrick

WTO’s COVID-19 Waiver Negotiations

Kilpatrick on

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

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

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

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

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

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

Polsinelli

During a Global Health Crisis, IP Rights Are Getting a Bad Rap

Polsinelli on

Four months ago, the U.S. became one of 100 countries supporting the proposal presented a year ago to the World Trade Organization (WTO) by India and South Africa that intellectual property protection for COVID-19 vaccines be...more

Akin Gump Strauss Hauer & Feld LLP

[Podcast] Onshoring Drug Manufacturing and TRIPS Waiver Part II

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

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

Neal, Gerber & Eisenberg LLP

NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi

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

McDonnell Boehnen Hulbert & Berghoff LLP

GOP Legislators Write in Opposition to Proposed TRIPS Waiver

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

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

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

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

Kilpatrick

Patents on COVID-19 Vaccines Feel free to infringe

Kilpatrick on

There was big news from the Biden administration yesterday regarding patent protection for COVID-19 vaccines. Katherine Tai, United States Trade Representative, announced in an official statement dated May 5, 2021 that the...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)

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

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

JAMS

Is ADR the Cure for COVID-19-Related Litigation? - The benefits of having a neutral with life sciences experience to resolve your...

JAMS on

As we continue our battle against COVID-19, one of the successes is the speed with which pharmaceutical companies have developed vaccines. For those not familiar with the science and the process of getting new drugs to...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

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