is an attorney with Fenwick & West LLP. She focuses her practice on patent litigation and trade secret matters across a wide variety of industries, including pharmaceuticals, chemicals, hardware, and software. She has experience drafting various motions in both federal and state court, working with experts to draft reports and declarations, managing discovery, handling claim construction issues, and taking and defending depositions. As a member of an on-site member of trial team in a patent infringement matter, she prepared both fact witnesses and technical experts for testimony, prepared graphics for trial to explain the technology at issue, and drafted various trial motions. Amy has also represented both petitioners and patent owners in inter partes review (IPR) proceedings before the USPTO. She additionally has an active Federal Circuit practice, with experience in briefing appeals from both district courts and the PTAB. For more information, or to contact Amy, please see her firm bio 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.