Brinckerhoff Discusses Recent Federal Circuit Decision on Biosimilar with Bloomberg Law
15 December 2017
Partner Courtenay Brinckerhoff was quoted in a Bloomberg Law Patent, Trademark & Copyright Journal – Daily Edition article, “Biosimilars Statute Trumps State Law, Appeals Court Rules,” about a recent U.S. Court of Appeals for the Federal Circuit ruling on the Biologics Price Competition and Innovation Act.
The court, in a December 14, 2017, ruling, held that the statute, which provides a relatively quick path for biosimilar makers to get new drug products to market, supersedes state law claims. The ruling was the second big win for biosimilar applicants this year. Earlier the U.S. Supreme Court allowed a biosimilar applicant to skip a notice period to a biologic owner before marketing its biosimilar product.
“The decision favors biosimilar applicants in that it forecloses a state law remedy for failing to comply with the BPCIA information exchange procedures, and thereby confirms that doing so is completely optional,” Brinckerhoff said. “Since the field of biosimilar litigation is relatively new, the decision does not upset any long-settled practices, although existing cases may include similar state law claims that may not survive this decision.”
The court, in a December 14, 2017, ruling, held that the statute, which provides a relatively quick path for biosimilar makers to get new drug products to market, supersedes state law claims. The ruling was the second big win for biosimilar applicants this year. Earlier the U.S. Supreme Court allowed a biosimilar applicant to skip a notice period to a biologic owner before marketing its biosimilar product.
“The decision favors biosimilar applicants in that it forecloses a state law remedy for failing to comply with the BPCIA information exchange procedures, and thereby confirms that doing so is completely optional,” Brinckerhoff said. “Since the field of biosimilar litigation is relatively new, the decision does not upset any long-settled practices, although existing cases may include similar state law claims that may not survive this decision.”
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