News & Analysis as of

Medical Devices Pharmaceutical Industry Intellectual Property Protection

Jones Day

FTC Weighs In on Orange Book Listing of Drug-Device Patents

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On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more

Seyfarth Shaw LLP

Medical Device Companies Settle Trade Secrets Dispute for $8,000,000

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Aegis Spine Inc. has agreed to pay $8,000,000 to fellow spinal implant manufacturer Life Spine Inc., following Life Spine’s suit in the Northern District of Illinois alleging Aegis had misappropriated Life Spine’s trade...more

Knobbe Martens

Middle District of North Carolina Grants Preliminary Injunction in Natera, Inc. v. NeoGenomics Laboratories, Inc.

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(December 27, 2023) Natera Inc. succeeded in obtaining a preliminary injunction against NeoGenomics Laboratories, Inc.’s medical assay test. Natera’s ongoing federal lawsuit alleges that NeoGenomics’ product “RaDaR,” a tumor...more

Knobbe Martens

Recent Developments in Medical Casts

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On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin.  Cast21’s device seeks...more

Knobbe Martens

PREVAIL Act Proposes Significant Changes PTAB Proceedings

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IP rights can be vital to the success of medical device companies.  Significant legislative changes governing some of these rights may be on the horizon.  Senators Coons (Delaware), Durbin (Illinois), Hirono (Hawaii), and...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

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Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

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Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

Knobbe Martens

Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device

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Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Knobbe Martens

Federal Circuit Review - June 2023

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Objective Evidence in Determining Obviousness - In Medtronic, Inc. v. Teleflex Innovations, Appeal No. 21-2357, the Federal Circuit held that a close prima facie case of obviousness can be overcome by strong evidence of...more

Knobbe Martens

Objective Evidence in Determining Obviousness

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MEDTRONIC, INC. v. TELEFLEX INNOVATIONS - Before Moore, Lourie, and Dyk.  Appeal from the Patent Trial and Appeal Board. Summary: A close prima facie case of obviousness can be overcome by strong evidence of objective...more

McDermott Will & Emery

[Event] Life Sciences Boot Camp For In-House Counsel 2023 - April 4th, South San Francisco, CA

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McDermott is pleased to bring our Life Sciences Boot Camp for In-House Counsel back to the Bay Area! Amid turbulent economic forces, life sciences companies continue to grapple with increasingly complex legal and business...more

Irwin IP LLP

No Handling Necessary: Industry Demo Was A Public Use: Minerva Surgical, Inc. v. Hologic, Inc., 2023 WL 1999900 (Fed. Cir. Feb....

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Be careful of showing your claimed inventions at tradeshows.  On February 15, 2023, the Federal Circuit (“CAFC”) affirmed a summary judgment ruling that, by merely showcasing an embodying device at an industry event (the...more

Smart & Biggar

2022 Highlights in Canadian Life Sciences IP and Regulatory Law

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Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more

Smart & Biggar

Health Canada releases its Health Product Highlights, Annual Drug Submission Performance Reports and OPML Statistical Report

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Health Canada released a number of reports over the summer: - Annual Health Product Highlights for 2021, which provides an overview of new health products, including drugs and medical devices, that Health Canada approved...more

Gardner Law

Are you Submission Ready? FDA Medical Device Submission Tips & Tricks

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Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time and effort that truly goes...more

Knobbe Martens

USPTO Issues Notice Regarding Patent Examinations and FDA Submissions

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On July 29, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice by Director Kathy Vidal that may be relevant to those seeking or holding patents on medical devices that require Food and Drug...more

Knobbe Martens

Medical Device Patentee Petitions Supreme Court Regarding On-Sale Bar and Price Quotes

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A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention...more

McDermott Will & Emery

Intellectual Property & Health | News To Know – June 2022

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RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more

Knobbe Martens

Niazi’s Patent Survives on Appeal: Federal Circuit Reverses In Part Lower Court’s Decision

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On April 11, 2022, Niazi Licensing Corporation (“Niazi”) succeeded in part in its appeal at the Federal Circuit in Niazi Licensing Corporation v. St. Jude Medical S.C. Inc. Niazi’s lawsuit alleged that St. Jude Medical S.C....more

Knobbe Martens

“Pliable” Language Results in “Resilient” Patent Claims

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NIAZI LICENSING CORPORATION v. ST. JUDE MEDICAL S.C., INC. Before Taranto, Bryson, and Stoll. Appeal from the U.S. District Court for the District of Minnesota. Summary: Providing examples in the claim language and...more

Knobbe Martens

Becton Dickinson’s PureWick Wins Patent Infringement Suit Against Stryker’s Sage Products Related To Female External Catheters

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PureWick Corp., a Becton Dickinson company, succeeded in its infringement lawsuit PureWick Corp. v. Sage Products LLC. PureWick’s lawsuit alleged that Sage Products infringed U.S. Patent Nos. 10,226,376; 10,390,989;...more

Knobbe Martens

Federal Circuit Reverses District Court’s Decision Based on On-Sale Bar (Junker v. Medical Components, Inc.)

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On February 10, 2022, in Junker v. Medical Components, Inc., the U.S. Court of Appeals for the Federal Circuit reversed the Eastern District of Pennsylvania’s grant of summary judgment of no invalidity under the “on-sale bar”...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – January 2022

Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an interview with Foresight Diagnostics co-founder and CEO Jake Chabon conducted by Matthew Meyer, the firm’s Chief...more

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