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Methods of treating a subset of patients are likely nonobvious if the subset exhibits unexpected results

In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., a recent decision involving methods of treating a specific subset of patients, the Court of Appeals for the Federal Circuit (“Federal Circuit”) ruled that,...more

A Split Decision Remains Split; No en banc Review of Amgen v. Sandoz

On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for...

On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar...more

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