is a partner with Fenwick & West LLP. He is a trial lawyer focusing on cases involving biotechnology, pharmaceuticals, polymer chemistry, and medical devices, primarily patent, trade secret, and licensing disputes. In addition to his trial work, he also consults on technology strategy, opinions, and due diligence. David is a frequent writer and lecturer in areas of patent law and patent litigation. He has been selected as a Washington “Super Lawyer” in the area of Intellectual Property Litigation each year since 2008. He has also been recognized as one of the top Intellectual Property Litigation lawyers in Washington by Chambers USA. From 2012-2014, Intellectual Asset Management magazine named David to the IAM Patent 1000: The World’s Leading Patent Practitioners. He is also included in the list of IP Stars by Managing Intellectual Property ?for 2014 and 2015. For more information, or to contact David, please visit his firm profile page.
The Supreme Court is currently considering whether to review Amgen Inc. v. Sandoz Inc., the Federal Circuit’s first decision regarding the Biologics Price Competition and Innovation Act (BPCIA). Although the Federal Circuit does not technically have any input into the Supreme Court’s grant or denial of certiorari, it nonetheless took the opportunity last week to bolster one of the challenged holdings: that a biosimilar applicant cannot provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product until that product is licensed. Specifically, in the course of ruling in Amgen Inc. v. Apotex Inc. that a biosimilar applicant must provide such notice even if it participated in the BPCIA’s so-called “patent dance,” the Federal Circuit addressed a primary criticism of its earlier decision, namely, that permitting only post-licensure notice effectively extends by 180 days the twelve-year exclusivity term of the biologic product. The solution suggested by the panel, however, is far from a legal certainty.