In Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014), the Supreme Court rejected the Federal Circuit’s “insolubly ambiguous” standard for determining whether a patent claim meets the definiteness requirement under 35 U.S.C. §112, ¶ 2, and that “a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” In the ensuing one and a half years, the Federal Circuit and several trial courts have applied the Nautilus standard in the biotechnology and pharmaceutical contexts. We discuss three notable decisions.
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Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes. Our team includes highly experienced trial attorneys with extensive technical knowledge, many of whom have advanced scientific degrees and industry experience in fields such as molecular biology, biochemistry, chemistry, statistics and nuclear engineering.
Defendants in Hatch-Waxman cases continue to contest personal jurisdiction outside of their "home" state, in reliance on the Supreme Court's decision in Daimler AG v. Bauman. Most district courts have rejected such arguments, and found that jurisdiction is proper in the patent owner's preferred forum based on consent-by-registration jurisdiction or specific jurisdiction. Both theories of personal jurisdiction are on appeal before the Federal Circuit, and oral argument is likely to occur early in 2016. The lessons learned in the Hatch-Waxman context will provide guidance for litigation under the BPCIA.
In the wake of the Supreme Court’s decision in Daimler AG v. Bauman, some defendants in Hatch-Waxman litigation have contested personal jurisdiction anywhere outside their “home” state. District courts have universally rejected such arguments, finding personal jurisdiction in the patent owner’s chosen forum on the basis of consent or specific jurisdiction. The Federal Circuit will consider two of these cases this summer. The lessons learned will be equally applicable to litigation under the BPCIA.
Protective orders preventing litigation counsel from participating in the prosecution of litigation-related patents are commonplace. These restrictions, however, could prejudice brand companies in light of the increasing trend among generic and biosimilar applicants to file IPR proceedings on the same patents that are at issue in litigation. In such cases where “the PTO and district court are just two fronts in the same battle,” courts have been liberal in allowing litigation counsel to participate in IPR proceedings, post-grant proceedings, and reexaminations.