News & Analysis as of

Patent Litigation Medical Devices

A&O Shearman

District Court Denies Regeneron’s Motion For Preliminary Injunction To Block Amgen’s Eylea Biosimilar

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On September 23, 2024, Judge Kleeh of the Northern District of West Virginia denied Regeneron Pharmaceuticals, Inc.’s (“Regeneron”) motion for a preliminary injunction against Amgen Inc. (“Amgen”) related to Amgen’s filing of...more

Fish & Richardson

The Final Word on an Alleged Infringer’s Intent in a Hatch-Waxman Safe Harbor Analysis

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We have been monitoring the dispute between Edwards Lifesciences Corp. (“Edwards”) and Meril Life Sciences Pvt., Ltd. (“Meril”) before and after the initial Federal Circuit decision. The dispute focused on whether Meril’s...more

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

A&O Shearman

New Jersey District Court Orders Delisting Of Teva Inhaler Patents From The Orange Book

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On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more

Fenwick & West LLP

New Jersey Federal Court Weighs in on Orange Book Patent Listings

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In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade...more

Wolf, Greenfield & Sacks, P.C.

Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield

Meaghan Luster focuses her practice at Wolf Greenfield on patent litigation. Meaghan’s experience includes conducting pre-suit diligence, fact and expert discovery, claim construction, and motion practice in US district...more

Foley & Lardner LLP

Federal Circuit Applies Safe Harbor to Imported Medical Device Samples

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The “safe harbor” of 35 USC § 271(e)(1) shields certain acts from liability for patent infringement if they are conducted “solely for uses reasonably related” to obtaining U.S. Food and Drug Administration (FDA) approval to...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

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

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

Knobbe Martens

FDA Statements and Patent Disclosures

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Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve “indications for use” of their products–for use selling them in the U.S. Those same companies often seek U.S. patent protection so...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

Analogous Art Must Be Compared to the Challenged Patent

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In Sanofi-Aventis Deutschland GmbH v. Mylan Pharm. Inc., Case No. 2021-1981, the Federal Circuit reversed an obviousness determination by the PTAB. At issue was Sanofi’s reissued U.S. Patent No. RE47,614 (the ’614 patent),...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

AEON Law

Patent Poetry: Trade Show Demo Bars Patent

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The Federal Circuit has affirmed a grant of summary judgment that the asserted claims of a patent are barred because the device sought to be patented was demonstrated at a trade show. Minerva Surgical, Inc. v. Hologic,...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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2022 Design Patents Year in Review: Analysis and Trends: Federal Circuit Appeals: More Design Patent Case Reversals

In 2022, the Court of Appeals for the Federal Circuit issued six opinions regarding U.S. design patents: three precedential opinions and three unprecedential opinions. Unlike 2021 (where the two precedential opinions on...more

A&O Shearman

Federal Circuit Holds Surgical Patent Anticipated Under Pre-AIA 35 USC102b Public Use

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This is an appeal from a District of Delaware summary judgment order that held that the asserted claims of U.S. Patent No. 9,186,208 (the ’208 Patent) are anticipated under the public use bar of pre-AIA 35 U.S.C. § 102(b). ...more

Knobbe Martens

Jury Verdict Against Boston Scientific for $42 Million For Infringement of Patent on Biodegradable Drug-Releasing Implant

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On January 31st, 2023, a jury awarded $42 million to medical device company TissueGen in a patent infringement case against Boston Scientific for infringement of U.S. Patent No. 6,596,296, titled “Biodegradable Drug-Releasing...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

Morrison & Foerster LLP - Federal Circuitry

Last Week In The Federal Circuit (August 8 – August 12): Taking A Round Trip On The Assignor Estoppel Express

For most of us, we’re stuck in the August heat, on delayed European vacations, or hopefully just hanging out at the beach. But for the Court it still was work as usual, including a return trip to the Federal Circuit for the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Hologic, Inc. v. Minerva Surgical, Inc. (Fed. Cir. 2022)

Last year, the Supreme Court declined an invitation to abrogate the doctrine of assignor estoppel by an assignor sued for patent infringement in Minerva Surgical v. Hologic.  Nevertheless, the Court followed its proclivities...more

Smart & Biggar

2022 mid-year highlights in Canadian life sciences IP and regulatory law

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In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...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

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