Court Rejects Theory Of Derivation Based On FDA Requirement

The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision for pharmaceutical companies who need to innovate in order to satisfy FDA requirements. Continue reading this entry

Federal Circuit Finds Infringement Under Akamai Of Two-Step Method Of Treatment

In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court decision finding infringement under Akamai of a two-step method of treatment when the prescribing information for the prescription drug component required coadministration of the other active agent. The appeal arose from ANDA litigation surrounding Eli Lilly’s ALIMTA® product, which is to be taken with folic acid and vitamin B12 to reduce side effects. Although pharmaceutical companies may welcome this decision, they should be aware of the emphasis the court place on the specific guidance and instructions provided in the product labeling.  Continue reading this entry

Supreme Court Will Judge Biosimilar Patent Dance

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz, where the Federal Circuit decided that the biosimilar patent dance provisions are optional, but pre-marketing notice always is required.

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