Supreme Court doesn't tip hand on biosimilars case

The Supreme Court did not show a clear preference for either party during oral arguments Wednesday in litigation between Amgen Inc. (NASDAQ:AMGN) and the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN). The case centers on whether branded biologics manufacturers can sue biosimilar applicants to compel them to comply with patent notification procedures in the Biologics Price Competition and Innovation Act (BPCIA), and if a 180-day premarket notification can be provided prior to FDA's approval of a biosimilar (see BioCentury, April 21).

Several justices suggested that FDA, rather than the courts, should try to resolve the questions. "We are being asked to interpret very technical provisions that I find somewhat ambiguous and [I] am operating in a field I know nothing about, but it's going to have huge implications for the future," Justice Stephen Breyer said. "So why isn't the way to go about this case to ask the agency to issue some regulations?"...