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Less Is More — the Premise of the Biosimilar ‘Patent Thicket’ Bill

As part of a push to increase competition and lower drug prices, the U.S. Senate recently passed a bill that limits the number of patents that can be asserted in biosimilar litigation. The Affordable Prescriptions for...more

DC District Court Provides Guidance as to the Meaning of ‘Protein’ Under the BPCIA

In December 2020, the U.S. District Court for the District of Columbia issued a decision in Teva v. FDA, reviewing FDA’s definition of “protein” in connection with the agency’s determination that Teva’s Copaxone®, a...more

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