Bad facts make bad law. The case of GlaxoSmithKline’s lawsuit over Teva’s generic Coreg® drug is a case-in-point. I previously blogged about the case here and here. Given that the Supreme Court declined to grant certiorari, we’re now stuck with Federal Circuit precedent holding that a generic can still face liability for induced infringement of a method-of-use patent covering a section viii carved-out indication. What will be the consequences of this?
Read MoreJust when you think the Amarin saga to keep out generic competition is over, something else happens. In the latest development, the Federal Circuit issued a precedential decision in an unrelated case (GlaxoSmithKline v. Teva) that suggests that a generic could potentially be liable for inducing infringement of a patented indication, even though that indication has been carved out of the generic’s label. Will this decision benefit Amarin?
Read MoreIn a slightly new wrinkle in Celgene’s recent Revlimid® saga, Celgene ($CELG) has commenced another suit against Dr. Reddy’s ($RDY). (This is the third patent lawsuit connected to Dr. Reddy’s proposed generic for Revlimid®.) In the most recent suit, Celgene asserts five new patents (the ‘720, ‘977, ‘784, ‘866 and ‘531). The suit was commenced on April 13, 2018 in the federal court in New Jersey, where the other Revlimid® suits are currently pending. What’s this suit all about?
Read MoreSandoz recently prevailed in court against Amgen by showing it does not infringe a patent covering two of Amgen’s drugs, Neulasta® and Neupogen®. No biosimilar has yet to receive FDA approval for Neulasata® within the U.S. Sandoz recently announced successful Phase 1 data indicating it may be getting closer. Further, other biosimilars for Neulasta® are in the works. Given that Neulasta® accounts for a third of Amgen’s sales, will Amgen’s recent loss in its case against Sandoz read-through to other biosimilars?
Read MoreThe biosimilar statute, Biologics Price Competition and Innovation Act (BPCIA, was passed in 2010. Since then, drug companies have been filing biosimilar applications with FDA. And even though, FDA has approved only nine biosimilar drugs today, an interesting trend may be emerging: biosimilars may be more willing to launch at-risk than small-molecule generics.
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