Tag:pharmaceuticals

1
All Eyes on EYLEA–Sandoz Defeats Preliminary Injunction
2
Are Pre-Launch Statements Now Within the Range of the National Advertising Division?
3
ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

All Eyes on EYLEA–Sandoz Defeats Preliminary Injunction

The recent decision in Regeneron Pharmaceuticals, Inc v Sandoz shows how a strong noninfringement position can be powerful to resisting a preliminary injunction. The dismissal of the Regeneron Pharmaceuticals, Inc. (Regeneron) and Bayer Australia Ltd and Bayer Consumer Care AG (together Bayer) parties’ application for interlocutory relief aligns with the recent trend away from granting preliminary (interlocutory) injunctions in pharmaceutical patent cases. While the trend has primarily arisen from the court’s recognition that the calculation of damages for a new market entrant is likely to be more difficult than that for the patentee, this was a, but not the main driving, factor in this case.

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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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