Following all of the latest IP developments in life sciences.

Overview

In a recent case analyzing enablement and the weight of remarks made at trial about a technology’s relevance to COVID-19, the Federal Circuit affirmed a United States District Court for the District of Delaware jury’s determination that claims asserted by Pacific Biosciences of California, Inc. (PacBio) against Oxford Nanopore Technologies, Ltd. (Oxford) were invalid for lack of enablement. PacBio had sued Oxford in district court, accusing Oxford of infringing several DNA sequencing methodology patents, including U.S. Patent Nos. 9,546,400 (‘400 patent) and 9,772,323 (‘323 patent). The jury found that all claims were infringed, but the claims were invalid for lack of enablement. PacBio moved for judgment as a matter of law and for a new trial, arguing that the jury erred in finding lack of enablement, and that the jury was prejudiced by remarks made regarding COVID-19 treatments during Oxford’s opening statement. The district court denied PacBio’s motion, and the Federal Circuit affirmed.

Mylan v. Janssen considers a topic IPR petitioners may be concerned about when institution of their petition is denied by the PTAB – is there any way to appeal the decision? The Federal Circuit held that while there is an avenue for relief, it is reserved for “extraordinary circumstances.”

(as published in the May 2021 issue of the American Chemical Society's Northeast Section publication of The Nucleus)

Olaplex v. L’Oréal involves a particular problem that can arise when claiming pharmaceutical and consumer product formulations. In particular, a chemical compound, such as maleic acid as recited in the asserted claims, may be converted to different forms (e.g., salts, such as maleate or hydrogen maleate) once added to a formulation. Claim limitations that aim to specify the amounts or concentrations of such compounds in claimed formulations can be problematic when it is unclear how they are to be calculated.

(Co-authored by Gabe McCool)

On February 11, 2021 the Federal Circuit upheld a United States District Court for the District of Delaware decision finding that Amgen’s function-only anti-PCSK9 monoclonal antibody claims were not enabled under 35 U.S.C. § 112. This highly anticipated decision involved a suit between the makers of the LDL-cholesterol-lowering drugs, Repatha® (Amgen) and Praluent® (Sanofi/Regeneron), filed nearly seven years ago by Amgen. Amgen had argued that patents for its cholesterol drug, RepathaⓇ, which cover a genus of antibodies that bind to a protein known as PCSK9, were sufficiently specific to allow one “skilled in the art” to “make and use” the patented invention without “undue experimentation” under the Wands factors.

Authors: Jason Balich, K. Blake Chancellor, Sam Estabrooks, Eric Greenwald, Chelsea Loughran, Gabe McCool, Marie McKiernan, Kevin Mosier, Jonathan Roses, Claire Schuster, Charlie Steenburg, Patrick Waller, Andrew Williams

Editors: Sam Estabrooks, Gabe McCool, Patrick Waller

In the midst of many significant challenges in 2020, the year managed to see the first increase in the total annual number of patent cases in some time. In particular, the federal judiciary produced a string of biotech-related patent decisions impacting a range of issues, including enablement, written description, indefiniteness, novelty, obviousness, patent eligibility, safe harbor, and doctrine of equivalents.

Overview

On December 11, 2020, the PTAB issued a Final Written Decision in Illumina, Inc. v. Natera, Inc., IPR2019-01201, upholding the validity of Natera Inc.’s patent for determining genetic data from fragmentary DNA. Illumina, Inc. (“Illumina”) filed its petition, challenging claims 1-27 of Natera Inc.’s (“Natera” or “Patent Owner”) U.S. Patent No. 8,682,592 B2 (“’592”). The PTAB instituted inter partes review of all the challenged claims on obviousness grounds. While Illumina carried its burden at the institution stage, it failed to prove the unpatentability of the challenged claims by a preponderance of the evidence as required by 35 U.S.C. § 316(e). The PTAB determined that the challenged claims were not unpatentable, and also denied Illumina’s Motion to Exclude Evidence. Central to the PTAB’s decision were the expert declarations submitted by the parties, and the noted failure by Illumina to include all of its expert’s declarations in its petition.

Summary

Agreeing with the district court’s decision to invalidate two drug patents for indefiniteness, the Federal Circuit reasoned that two terms (“target” versus “produce”) used in the alternative in similar specification contexts were not implicitly interchangeable in meaning, affirmed a district court’s judgment that the claims were indefinite, and affirmed that conclusory, non-factual expert testimony was not persuasive either in construing the claims during a Markman hearing or in establishing an issue of fact to prevent summary judgment.

(Co-authored by Eric Greenwald)

Overview

On August 3, 2020, the United States Court of Appeals for the Federal Circuit partially reversed a District Court’s decision for a permanent injunction against 10X Genomics. Bio-Rad Laboratories had sued 10X Genomics (“10X”) for infringing three patents directed to a microfluidic system that enables researchers to encapsulate biological materials in oil partitions, or plugs, for high-throughput biochemical reactions and genomics. During trial in the District Court for the District of Delaware, a jury found the patents-in-suit to be valid and willfully infringed and awarded Bio-Rad $24 million in damages based on 10X’s sale of five product lines. After denying 10X’s motion for judgment as a matter of law to overturn the verdict, the district court granted Bio-Rad’s motion for a permanent injunction prohibiting 10X from selling the five infringing product lines. 10X appealed these decisions.

(Co-authored by Chelsea Loughran)

Scores of lawyers and stakeholders in the biologics industry had been eagerly awaiting guidance from a federal district court in the In re Humira (Adalimumab) Antitrust Litigation, which was filed in March 2019 by indirect purchasers of Humira^® alleging anticompetitive behavior on the part of Humira^® manufacturer, AbbVie Inc. (AbbVie). On June 10, 2020, Northern District of Illinois Judge Manish Shah granted AbbVie’s motion to dismiss the complaint, finding that the plaintiffs’ antitrust allegations were too speculative and therefore insufficient to state a claim upon which relief could be granted. The decision suggests that patent “evergreening” practices akin to those the plaintiffs allege AbbVie has exercised will still be available to innovators who wish to find ways to increase patent term on their marketed reference biologics and maintain a dominant position in the market.

(Co-authored by Suresh Rav, Summer Associate)

Overview

On July 6, 2020, the Federal Circuit affirmed denial of Genentech’s motions to enjoin Amgen from marketing MVASI™ (bevacizumab-awwb), a biosimilar version of Genentech’s AVASTIN® (bevacizumab), an anti-angiogenic agent indicated for treating metastatic colorectal cancer in combination with certain other chemotherapies. The Federal Circuit held that filing a supplement to a previous biosimilar application does not trigger new notice requirements unless the biologic itself has changed. Both the district court and the Federal Circuit focused on the statutory language of the Biologics Price Competition and Innovation Act (“BPCIA”), particularly the relationship between § 262 (l)(8)(A) “Notice of Commercial Marketing” (“subsection (l)(8)(A)”) and § 262 (k) “Licensure” (“subsection (k)”). The Federal Circuit concluded that changes made under subsection (k) that do not alter the biosimilar’s chemical or biological structure do not require new notice under subsection (l)(8)(A).