News & Analysis as of

Appeals Motion to Dismiss Food and Drug Administration (FDA)

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2024 Federal Circuit IP Appeals – Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., 104 F.4th 1370 (Fed. Cir. 2024) (Moore, Lourie,...

Amarin sells the drug icosapent ethyl under the brand name Vascepa. Vascepa is approved by the FDA for two indications: (i) to treat severe hypertriglyceridemia, a condition characterized by blood triglyceride levels greater...more

Knobbe Martens

Federal Circuit Review | June 2024

Knobbe Martens on

Reliably Determining Reasonable Royalty Rates from Lump Sum Licenses - In Ecofactor, Inc. V. Google LLC, Appeal No. 23-1101, The Federal Circuit held that license agreements containing a lump sum payment “based on” a royalty...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Reverses Motion to Dismiss—Generic Manufacturer’s Label Combined with its Expansive Public Statements Plausibly...

The Federal Circuit reversed a decision from the District of Delaware dismissing a case for failing to plead induced infringement because the totality of the evidence raised fact questions that could not be resolved on a...more

Schwabe, Williamson & Wyatt PC

‎Latest Federal Court Cases - August 2021 #2

Our Case of the Week this week is a re-write of our Case of the Week on October 5, 2020. The case involves a drug that could be used for multiple therapeutic purposes. A patent covered use of the product for a specific...more

Nutter McClennen & Fish LLP

Product Liability 2019 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

King & Spalding

Eleventh Circuit Rules That the Mere Purchase of Dietary Supplements Allegedly Sold in Violation of the FDCA Is Sufficient, by...

King & Spalding on

A recent Eleventh Circuit decision took a broad view of what type of economic injury is sufficient to confer Article III standing, concluding that two dietary supplement companies’ alleged violations of a federal statute...more

Nilan Johnson Lewis PA

Federal Courts Turn Away Challenges to FDA's e-Cig Regulations

Nilan Johnson Lewis PA on

On Monday, December 16, 2019, the U.S. District Court for the Southern District of Mississippi granted the U.S. Food and Drug Administration’s motion to dismiss a lawsuit filed by trade organization United States Vaping...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | January 2018 #3

House Panel Questions FDA Officials on Food-Recall Audit - One day after the U.S. Food and Drug Administration (FDA) issued draft guidance on proposals to expedite product warnings and recalls, FDA and other health officials...more

McDermott Will & Schulte

ANDA Update - Volume 2, Number 3

On-Sale Bar Is No Bar for Selling Manufacturing Services to the Inventor - Addressing what constitutes an invalidating “sale” under § 102(b), the US Court of Appeals for the Federal Circuit sitting en banc affirmed the...more

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