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Following all of the latest IP developments in life sciences.

 

Federal Circuit Affirms As Obvious Suite of Patents Directed to Methods Of Treating Opioid Overdose

(Co-authored by Alexandra Kim)

Introduction

In February of 2022, the Federal Circuit affirmed a New Jersey District Court’s determination that four patents claiming methods of treating opioid overdose by intranasal administration of a naloxone formulation, as well as devices for intranasal administration, were invalid as obvious over two, three-reference, sets of prior art. A panel majority found that all of the individual components of the claimed methods were taught in the prior art and that a person of ordinary skill in the art (POSA) would have been motivated to combine such teachings because there was a strong desire in the prior art to improve upon existing but deficient methods for treating overdose.

In a 15-page dissent, Judge Newman criticized the majority’s logic, asserting that there was no evidence of “teaching or suggestion in the prior art” to make the claimed combination of ingredients for use in the claimed method so as to achieve the described beneficial results. She faulted the majority for relying on “the need for a better product” to provide motivation since “the artisan’s knowledge that the available products are deficient does not render the remedy obvious when it is eventually discovered.”

While the challenger here prevailed, this opinion—both the majority and the dissent—provides valuable guidance (and caution) for assembling multi-reference obviousness challenges.

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Kite Flies Away With CAR-T Patent Challenge Win Based on Written Description Battle

In Juno Therapeutics v. Kite Pharma, the Court of Appeals for the Federal Circuit (CAFC) reversed a $1.2 billion dollar judgment to Juno, finding that Juno’s asserted claims, which they alleged were infringed by Kite’s CAR-T therapy YESCARTA® (axicabtagene ciloleucel), lacked written description. The decision follows a line of cases involving antibodies and written description, extending recent antibody-related jurisprudence into the realm of cell-based immunotherapies, such as chimeric antigen receptor (CAR) T cells. The court determined that while the binding element of CARs (in this case, an scFv) and methods of making them were generally known in the art, the scope of the claimed CARs was too vast to be sufficiently supported by the limited number of exemplary binding elements in the specification, as well as the absence of common structural features defining the claimed genus. The decision means that those seeking claims that aim to broadly protect CARs with functional definitions will face significant challenges based on written description.

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Extending Ezra: Federal District Court Declines to “Cut Off” Patent Term Adjustment in View of Alleged Obviousness-Type Double Patenting in Mitsubishi v. Sandoz

(Co-authored by Anne Weeks)

In Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc., the District Court for the District of New Jersey considered whether a patent receiving patent term adjustment (PTA) may be invalidated for obviousness-type double patenting by a later-issuing, earlier-expiring patent in the same family.

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Poring Over Enablement: Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc.

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.

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Your IPR Petition Was Denied at Institution – What Next? The Federal Circuit Provides Insights on Petitioners’ Options

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.”

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The Federal Circuit Adds Color to Formulation Claims in Olaplex v. L’Oréal

(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.

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Finding the ‘Sweet Spot’ of Enablement in Amgen v. Sanofi: The Federal Circuit Provides Guidance on Enabling Antibody Claims

(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.

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2020 Year in Review: Patent Decisions Impacting the Life Sciences

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.

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Targeting Indefinite Claims: Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc.

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.

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Economic Considerations in Granting Injunctive Relief: Federal Circuit Partially Reverses Injunctive Relief in a Case of Willful Infringement

(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.

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