WolfTracks Logo (15)

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.

Read More »

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.

Read More »

Expert Declarations in Inter Partes Review Proceedings Must Do More Than Create Noise:  PTAB Silences Challenge to Patented Method for Cleaning “Noisy” Genetic Data

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.

Read More »

Uphill Challenges for Parties Seeking Attorney Fees in Federal Circuit Appeals of PTAB Decisions

As any involved party can confirm, patent litigation is often not the most economical method of resolving a dispute. Typically, the “American Rule” is that each party must pay for its own litigation costs, but 35 U.S.C. § 285 allows for a court to award attorney fees to the prevailing party in “exceptional” cases. The question before the court in Amneal v. Almirall was whether this statute is broad enough to cover those fees incurred by the prevailing party for work done before the PTAB. Under the facts of the case, the Federal Circuit concluded that it is not.

Read More »