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Derivation Proceeding Patents Food and Drug Administration (FDA)

Jones Day

Confidential FDA Communications as Prior Art in Hatch-Waxman Litigation

Jones Day on

The Situation: In a Hatch-Waxman litigation, the claims recite oxymorphone with less than 0.001% of an impurity called 14-hydroxymorphinone. The prior art includes confidential communications from the FDA to oxymorphone...more

Locke Lord LLP

All Claim Limitations Must be Shown for Derivation Under 35 U.S.C. § 102(f) And Obviousness

Locke Lord LLP on

Introduction - In proving a patent invalid (or infringed), all claim limitations must be considered. A recent case illustrates this maxim for both derivation under 35 U.S.C. § 102(f) and obviousness under 35 U.S.C. §...more

Foley & Lardner LLP

Court Rejects Theory Of Derivation Based On FDA Requirement

Foley & Lardner LLP on

The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision...more

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