Tag Archives: FDA

The Court Can Wait; The Patent Office Cannot

In a set of astonishing identical Director Review decisions, the Acting USPTO Director discretionarily denied five IPR petitions whose proceedings would have concluded over seven months before the underlying patent infringement suit would have gone to trial. The Acting Director reasoned that the petitioner waited too long to file its IPR petitions because, even though … Continue Reading

FDA Proudly Announces Its First Approval of an Interchangeable Biosimilar

On July 28, 2021, the Food and Drug Administration (FDA) announced the approval of the first “interchangeable biosimilar”—in this case Mylan Pharmaceticals Inc.’s Semglee® (insulin glargine-yfgn), which is both biosimilar to, and interchangeable with, its reference product Lantus® (insulin glargine), a long-acting insulin analog. Acting FDA Commissioner Janet Woodcock, M.D. called it a “momentous day.”… Continue Reading

False Advertising Dangers Lurk in the Age of COVID-19 – Redux

As we previewed in our earlier post, the COVID-19 pandemic raises new and heightened false advertising concerns for companies seeking to capitalize through mentions of the virus in marketing or consumer outreach efforts. During this harried time, both the unwary – and the well-informed – advertiser should navigate carefully to avoid the trap of consumer … Continue Reading
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