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Pharmaceutical Patents Life Sciences Medical Devices

Hudnell Law Group

Federal Circuit Rejects Formalistic Shield to Prosecution History Estoppel

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On July 18, 2025, the U.S. Court of Appeals for the Federal Circuit reversed a $106 million jury verdict in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No. 2023-2153, finding that Colibri’s infringement claim under...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - December 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more

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

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

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As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Smart & Biggar

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

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Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...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

Fish & Richardson

Federal Circuit to Consider the Relevance of an Alleged Infringer’s “Intent” in a Hatch-Waxman Safe Harbor Analysis

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The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...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

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

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

Quarles & Brady LLP

Junker v. Medical Components, Inc.: Pre-filing Offers for Sale Trigger Patent “On-Sale Bar”

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A recent Federal Circuit decision, Junker v. Med. Components, Inc., No. 2021-1649 (Feb. 10, 2022), serves as a warning to prospective filers that making pre-filing offers for sale, or engaging in discussions for future sales,...more

Rothwell, Figg, Ernst & Manbeck, P.C.

PTAB Agrees to Review Novartis’ Patent for an Ophthalmic Injection Syringe

On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled...more

Knobbe Martens

Medical Device Trade Secret Not Publicly Disclosed via Patenting, Displaying, and Selling Covered Product, 7th Cir. Affirms

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Can certain specific medical device details remain company know-how or protected trade secrets even if patents are pursued on the medical device? Consider the Seventh Circuit’s commentary in its August 9, 2021 decision...more

Proskauer - The Patent Playbook

Federal Circuit Invalidates Device Patent As Directed to an Abstract Idea

Nearly seven years after the landmark Supreme Court decision in Alice Corp. v. CLS Bank Int’l, subject matter eligibility for patent claims under 35 U.S.C § 101 remains a moving target. In Alice, the Court found claims for a...more

MoFo Life Sciences

Bill Proposes 10 Additional Years for COVID-19 Inventions

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A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Life Sciences Report - February 2020

About the PTAB Life Sciences Report:  We will periodically report on developments at the PTAB involving life sciences patents. Abbott Laboratories v. Edwards Lifesciences Corp. PTAB Petition:  IPR2020-00480; filed January...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

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Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for December 2018?

This month we highlight two Federal Circuit obviousness-type double patenting decisions. CASES - Federal Circuit - Section 156 Patent Term Extension and Obviousness-Type Double Patenting - Novartis AG v. Ezra...more

Knobbe Martens

Patent Law Update for Medical Device Companies 2018 (Presentation)

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Knobbe Martens Partners Paul Conover, Irfan Lateef, and Curtis Huffmire presented "Patent Law Update for Medical Device Companies 2018" at the MedTech Innovation Summit in San Francisco, CA on November 28, 2018. This session...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Fall/Winter 2018

Interview with Dr. Daniel Burnett of Theranova LLC - Wilson Sonsini Goodrich & Rosati partner James Huie recently interviewed Dr. Daniel Burnett, president and CEO of TheraNova. TheraNova is an experienced medical device...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for August 2018?

This month we highlight a district court opinion from Judge Dyk, sitting by designation, denying a preliminary injunction in a brand-vs-brand litigation, and a lengthy district court opinion from Judge Bryson, sitting by...more

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