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Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Shire v. Blackburn: Drawing the Line Between FDA Drug Labeling Regulations and State Law on Product Liability

On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC (collectively, “Shire”) asked the Supreme Court to review an Eleventh Circuit ruling involving the interplay between state tort law and FDA...more

Teva v. GSK: The “Skinny” Label Case Pending Before the Supreme Court

On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva...more

The Supreme Court Holds that Non-Public Sales May Trigger the On Sale Bar Under the America Invents Act

On Tuesday, January 22, 2019, the U.S. Supreme Court held in a unanimous decision that, even where the details of the invention are kept confidential, a commercial sale may place the invention “on sale” under the Leahy-Smith...more

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