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Advanced IP Considerations for Cell-and-Gene Therapeutic Companies Utilizing Lipid Nanoparticle Delivery Systems

As I have written about previously, the IP and competitive landscape for mRNA and lipid nanoparticles is complex. Pioneers, mid-stage, and new market entrants must take careful consideration of this landscape and develop a...more

The Current mRNA/LNP Patent Litigation Landscape

Several patent litigations have been filed involving mRNA pioneers such as Moderna, Inc. and BioNTech, Inc. (with Pfizer) over the past year relating to sales of the Moderna and BioNTech/Pfizer COVID-19 vaccine products...more

Delaware Judge Denies Sarepta Protection Under Hatch-Waxman “Safe Harbor”

On January 4, 2022, Judge Andrews from the United States District Court for the District of Delaware denied Sarepta Therapeutics, Inc.’s (“Sarepta”) Rule 12(b)(6) motion to dismiss a complaint for infringement of U.S. Patent...more

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

Three (3) Initial Considerations for Entrepreneurial Faculty, Researchers, Post-Docs, and Graduate Students

Universities and certain colleges in the United States (US) spend billions of dollars on research and development (R&D) each year to advance knowledge across the gamut of Arts, Humanities, and Science, Technology,...more

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

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

IP Assignment Considerations for Emerging Companies

Founders of an emerging company must decide early on in its growth cycle whether to require employees to assign their inventions (including rights to patent and patent applications –collectively “patent rights”) to the...more

COVID-19 Vaccine Leader Moderna “Not Aware of Any Significant Intellectual Property Impediments” in Development of its Vaccine...

Moderna, one of the global leaders in developing a safe and effective vaccine to combat COVID-19, appears poised to get through clinical trials with a vaccine that is based on mRNA technology. As was recently announced,...more

Breaking Down Moderna’s COVID-19 Patent Pledge: Why Did They Do It?

Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine, made the following statement regarding enforcement of its patents: We feel a special obligation under the current...more

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