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Radius Health sued Orbicular Pharmaceutical and three related entities, asserting that an Abbreviated New Drug Application ("ANDA") for a generic version of Tymlos® infringed its U.S. 11,977,067 patent. Tymlos® reduces the risk of bone fractures in patients at high risk of fractures, such as post-menopausal women and patients with osteoporosis. Radius says that Orbicular, an India-based company, had submitted the subject ANDA and intended to have the U.S.-based co-defendants actually market and sell the generic in the United States.
Judge Stearns granted Orbicular's motion to stay pending the outcome of an appeal in a different litigation involving the validity of two family members of the '067 patent being asserted in this case. He found that a stay would not unduly prejudice either party, because even if the other decision were reversed and the other patents were deemed invalid, Orbicular still could not market their ANDA product until 2031, by which point the appeal and the present litigation should be resolved on the merits. Further, a decision invalidating the other patents would potentially resolve the instant litigation, as it would likely result in an invalidity following here. While the case was relatively far along, with a Markman order having already issued, the other factors outweighed this one.
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