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H. Lundbeck A/S v. Lupin Ltd. (Fed. Cir. 2023)* | McDonnell Boehnen Hulbert & Berghoff LLP

The provisions of U.S. regulatory law regarding FDA approval for less than all the indications for which an innovator drug was approved under 21 U.S.C. § 355(j)(2)(A)(viii) (the. ....

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The Federal Circuit Weighs in On Hatch-Waxman "Skinny" Label Infringement Dispute | Fish & Richardson

The Hatch-Waxman Act allows a generic drugmaker to rely on a branded drugmaker’s Food and Drug Administration-approved New Drug Application if the generic drugmaker can show that the. ....

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The Skinny On Infringement Of Method Of Treatment Claims - Patent

In Hatch-Waxman litigation, method of treatment patents present unique infringement issues. Because generic drug manufacturers typically do not treat patients, patentees frequently. ....

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Is the United States' Nonobviousness Test 'Plausibly' Similar to the EPO/UK Inventive Step Standard?

Recent cases in the European Patent Office (EPO), the UK, and United States illustrate substantive differences between these jurisdictions as they continue to develop their inventive step/nonobviousness frameworks. ....

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Trying To Make Some Sense Out of OTC Economic Loss Decisions

Over-the-counter (“OTC”) drugs are protected from civil liability by an express preemption provision that is even stronger than the medical device… ....

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