Tag: pharmaceuticals

1
Are Pre-Launch Statements Now Within the Range of the National Advertising Division?
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ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

Are Pre-Launch Statements Now Within the Range of the National Advertising Division?

In a bold departure from its focus on allegedly misleading and deceptive statements in commerce, the National Advertising Division’s (“NAD”) decision in PLx Pharma, Inc. (Vazalore), Report #6912, NAD/CARU Case Reports (December 2020), arguably stretches its jurisdictional scope to include certain pre-national launch investor statements.

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ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

By: Trevor M. Gates, Theodore J. Angelis, and Peter Giunta

The Federal Circuit recently held that filing an abbreviated new drug application with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including Delaware), subjected Mylan to specific personal jurisdiction in Delaware.

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