Biomarin’s bid to block Ascendis from launching a competing drug for treating achondroplasia is nearing the merits. Biomarin started its campaign in the International Trade Commission (ITC), and in response, Ascendis filed two district court declaratory judgment actions. Ascendis withdrew the first DJ action, and the second one has been stayed. The ITC case is now scheduled to hear the parties’ claim construction disputes later this month. The outcome of that hearing, which will finally touch upon the merits of Biomarin’s infringement allegations, could prove to be a major inflection point in this dispute. What’s at stake in the upcoming Markman hearing?
Read MoreBiomarin Pharmaceutical sells Voxzogo, which is indicated for treatment of a genetic condition known as achondroplasia, which is the leading cause of short-limbed dwarfism. Ascendis Pharma has applied to the FDA for license to sell a competing drug, TransCon CNP. Hoping to stifle Ascendis’ path to the market, Biomarin has launched an ITC case seeking to block Ascendis from importing its drug into the US. For now, Ascendis is relying upon a safe harbor defense. Can Biomarin use its Orange Book patents to preemptively block a competing drug from Ascendis?
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I previously blogged about the patent tussle between iRobot and SharkNinja when the dispute originally erupted in late 2019. At the time, the prevalent concern was that iRobot would secure a quick injunction against SharkNinja’s sales in advance of the critical holiday shopping season. More than two years on, what started as a single pre-emptive suit commenced by Shark Ninja has ballooned into a multi-front war over whether SharkNinja is infringing iRobot’s patents. This has involved multiple litigations filed in district court, scores of invalidity proceedings filed at the Patent Office, and an investigation commenced before the International Trade Commission. What is the status of this ongoing patent war?
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