Last week, the U.S. Food and Drug Administration (“FDA”) issued a final rule to amend its regulation that defines the term “biological product” in line with the definition set by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), as amended by the Further Consolidated Appropriations Act, 2020, enacted on December 20, 2019 (“FCA Act”).
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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.
Federal Circuit Walks Back Its “Exceptional” Stance on the Doctrine of Equivalents in the Latest Amgen v. Sandoz Decision
In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment of no literal infringement and no infringement under the doctrine of equivalents. Amgen Inc. v. Sandoz Inc., 923 F.3d 1023 (Fed. Cir. May 8, 2019). In so holding, the panel stated that “the doctrine of equivalents applies only in exceptional cases.” Amgen petitioned for rehearing en banc, arguing that the Federal Circuit had overstated the law. According to Amgen’s petition, “[s]uch a rule is contrary to Supreme Court precedent and [Federal Circuit] precedent.” This week, the Federal Circuit course-corrected, granting Amgen’s petition without explanation for the limited purposes of removing the “exceptional” language from its prior decision.
Prosecution History Estoppel Bars Amgen’s Doctrine-of-Equivalents Infringement Claim Against Neulasta (Pegfilgrastim) Biosimilar Maker Coherus
Amgen Inc. v. Coherus Biosciences Inc., No. 2018-1993, Slip op. at 6 (Fed. Cir. July 29, 2019) stems from a Biologics Price Competition and Innovation Act action brought by Amgen against Coherus seeking FDA approval to market a biosimilar version of Amgen’s pegfilgrastim product Neulasta.
In Enzo Life Sciences v. Roche Molecular Systems, No. 2017-2498, 2017-2499, 2017-2545, 2017-2546, Slip op. (Fed. Cir. July 5, 2019), the Federal Circuit affirmed summary judgment of invalidity for lack of enablement of Enzo’s two patents relating to non-radioactive labeling of polynucleotides. The decision highlights non-enablement issues that may arise with respect to broad functional claims in an unpredictable field.