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One of the many changes introduced into U.S. patent law by the Leahy-Smith America Invents Act were provisions for post-grant review (PGR) and inter partes review (IPR). There have.
Not surprisingly, the Federal Circuit visited upon Plaintiff/Appellant PureCircle two of the Four Horsemen of the Biotech Patent Apocalypse in a decision affirming the District Court's.
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.