Jay J. Cho, Ph.D.

Jay J. Cho, Ph.D., Associate

Biologics Blog

Visit the Full Blog

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.

FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability

Jay J. Cho | Jordan M. Engelhardt
November 30, 2020

FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” 

The draft guidance supplements two prior documents concerning biosimilar interchangeability published in December 2018.  This new guidance, in particular, has some useful information for prospective applicants who seek licensure of an “interchangeable” biosimilar product.

Categories: Biosimilars
Go

No Antitrust Violations for Creating and Enforcing Humira Patent Thicket

Jay J. Cho | Jordan M. Engelhardt
July 6, 2020

Last month, Judge Manish Shah of the United States District Court of the Northern District of Illinois dismissed an antitrust complaint brought by indirect purchasers of AbbVie’s blockbuster rheumatoid arthritis drug, Humira®.  The suit alleged antitrust violations under a novel “patent thicket” theory, citing § 2 of the Sherman Act, and “pay-for-delay” and “market allocation” theories under § 1 of the Sherman Act.  Mem. Op. and Order (Dkt. 170), In Re: Humira (Adalimumab)Antitrust Litigation, No. 19-cv-1873 (N.D. Ill. June 8, 2020).

Categories: Biosimilars
Go

FDA Finalizes New Definition of Biological Product

Jay J. Cho | Jordan M. Engelhardt
February 27, 2020

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”). 

Categories: Biosimilars, BPCIA
Go

Federal Circuit Walks Back Its “Exceptional” Stance on the Doctrine of Equivalents in the Latest Amgen v. Sandoz Decision

Jay J. Cho | Andrew D. Cohen | Jordan M. Engelhardt
September 6, 2019

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. 

Categories: Biosimilars, BPCIA, Patent Litigation
Go

Prosecution History Estoppel Bars Amgen’s Doctrine-of-Equivalents Infringement Claim Against Neulasta (Pegfilgrastim) Biosimilar Maker Coherus

Jay J. Cho | Jordan M. Engelhardt
July 31, 2019

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.

Categories: Biosimilars, Patent Litigation
Go

Federal Circuit Invalidates Polynucleotide-Labeling Claims for Lack of Enablement

Jay J. Cho | Jordan M. Engelhardt
July 16, 2019

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.

Categories: Patent Litigation
Go