BRIEF—Court rules against Amgen in bid for Sensipar patent extension

The District Court for the District of Columbia has rejected a bid from Amgen to secure a six-month boost to US exclusivity for Sensipar (cinacalcet).

Amgen argued that the US Food and Drug Administration had applied different standards unfairly when it granted pediatric exclusivity for J&J’s Ortho Tri-Cyclen (ethinyl estradiol and norgestimate).

For the second time, the court ruled against that view, saying that: “Amgen has not met its burden of demonstrating that the FDA applied different standards,” and that the court was “now satisfied that the FDA has offered a reasoned—and reasonable—basis for distinguishing the Ortho Tri-Cyclen precedent.”