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Edwards Lifesciences has petitioned the full Federal Circuit to narrow its interpretation of a U.S. Food and Drug Administration safe harbor that essentially allows patent infringement during drug development, arguing that if Congress wanted the statute to be interpreted broadly, "it would have said exactly that."
A D.C. federal judge on Thursday found the U.S. Patent and Trademark Office has sufficiently proven that inventor Gilbert Hyatt forfeited the right to receive certain patents based on decades of delay, but made clear that his finding was the result of a Federal Circuit mandate, not how he thought the case should be approached.
U.S. Circuit Judge Alan Lourie has urged the Federal Circuit to reconsider its precedent over a safe harbor that allows infringement when companies are developing products regulated by the U.S. Food and Drug Administration, and many attorneys agreed with him that the appeals court has been improperly expanding the safe harbor for decades.
A D.C. federal judge may be allowing suspended U.S. Circuit Judge Pauline Newman to pursue a handful of arguments over the constitutionality of the Judicial Conduct and Disability Act, but attorneys told Law360 they aren't convinced those claims will fare any better than those already dismissed by the court.
In 2023, Fintiv—the precedential Order issued in 2020 that established a six-factor framework that the Patent Trial and Appeal Board (PTAB) applies when evaluating whether to exercise...