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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. ....
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. ....
In Hatch-Waxman litigation, method of treatment patents present unique infringement issues. Because generic drug manufacturers typically do not treat patients, patentees frequently. ....
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. ....
Over-the-counter (“OTC”) drugs are protected from civil liability by an express preemption provision that is even stronger than the medical device… ....