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Following all of the latest IP developments in life sciences.

 

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.

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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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Lessons on Inherency Challenges After Hospira v. Fresenius Kabi USA

The Federal Circuit’s recent decision in Hospira v. Fresenius Kabi USA is the latest to show how the court handles allegations of inherency in life sciences patent litigation. Jonathan Roses dissects the case, addresses whether the court created a new burden-shifting framework for such challenges and summarizes lessons that parties on both sides on an inherency argument can take away from the decision. To read the full article, which was published in Westlaw Journal, click here.

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Strategies for Patenting Artificial Intelligence Innovations in the Life Sciences

(Co-authored by Dan Rudoy)

Today, companies are developing artificial intelligence (AI) systems to meaningfully analyze the deluge of biomedical data. A substantial investment in building and deploying machine learning (ML) technology—the most active area of AI technology being developed today—warrants carefully considering how to protect the resulting intellectual property (IP), but there are challenges to doing so. In this post, we explore strategies of protecting IP for ML technology, including what aspects to consider patenting given current and ongoing changes to US patent law, and when to consider trade secret protection.

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