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Discovery Patent Litigation Pharmaceutical Patents

Herbert Smith Freehills Kramer

The UPC – Two Years On

The Unified Patent Court – a one-stop-shop for European patent litigation – is now two years old. As it enters its third year of operation, we look at the approach that is becoming established in the new system, drawing out...more

Goodwin

Third Circuit Holds That Granting Discovery Under Section 1782 Is Not a “Final” Judgment

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The U.S. Court of Appeals for the Third Circuit recently issued an opinion holding that when a district court has ordered discovery under 28 U.S.C. § 1782, but has not yet conclusively defined the scope of that discovery, the...more

Goodwin

HyClone Seeks to Quash Amgen’s Subpoena Issued in Amgen/Accord Denosumab BPCIA Litigation

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On May 14, 2025, HyClone Laboratories, LLC (“HyClone”) filed a Motion to Quash in the U.S. District Court for the District of Utah, seeking to quash Amgen Inc.’s (“Amgen”) subpoena to HyClone issued in Amgen’s denosumab BPCIA...more

Goodwin

HyClone Seeks to Quash Amgen’s Subpoena Issued in Denosumab BPCIA Litigation Against Fresenius

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On February 4, 2025, HyClone Laboratories, LLC (“HyClone”), a cell culture media supplier, filed a Motion to Quash a subpoena issued by Amgen, Inc. (“Amgen”). The underlying subpoena was issued in Amgen’s ongoing denosumab...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2021 #5

MLC Intellectual Property, LLC v. Micron Technology, Inc., Appeal No. 2020-1413 (Fed. Cir. Aug. 26, 2021) - For those interested in an important Section 112 written description case, we recommend reading the Juno...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #3

C.R. Bard Inc. v. AngioDynamics, Inc., Appeal No. 2019-1756, -1934 (Fed. Cir. Nov. 10, 2020) - Our Case of the Week is one of two cases decided this week in which the Federal Circuit finds that a district court jumped the...more

American Conference Institute (ACI)

[Virtual Event] Paragraph IV on Virtual Trial - COVID-19 Edition - August 20th, 8:45 am - 6:00 pm EDT

Join us for a one-day virtual event for Counsel for Hatch-Waxman Litigators. While COVID-19 prevented us from meeting in person this April in NYC, we are pleased to announce a special one-day virtual event Paragraph IV on...more

Goodwin

District Court Postpones Trial in Amgen v. Hospira Filgrastim Biosimilar Litigation

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As we previously reported, Amgen sued Pfizer and its affiliate Hospira in July 2018 based on Hospira’s submission of an aBLA for a biosimilar of NEULASTA (filgrastim). That same month, Pfizer obtained FDA-approval and, in...more

Goodwin

Immunex and Samsung Bioepis Seek to Stay Etanercept Biosimilar Litigation

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This week, in the Immunex v. Samsung Bioepis BPCIA litigation regarding ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL, the New Jersey district court entered a Consent Injunction Order that prohibits...more

Goodwin

More Discovery Rulings in AbbVie v. BI

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We previously reported on discovery disputes in the adalimumab litigation between AbbVie and Boehringer Ingelheim (BI) pending before the District of Delaware. Earlier this month, Judge Lloret issued an order on additional...more

Goodwin

Scheduling Order Entered in Amgen v. Adello Filgrastim Biosimilar Litigation

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Today, the district court entered a scheduling order in the Amgen v. Adello BPCIA litigation concerning Adello’s aBLA for a biosimilar of Neupogen® (filgrastim). The scheduling order is generally consistent with the joint...more

Goodwin

Updates On Discovery Rulings in AbbVie v. BI Adalimumab Litigation

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We have recently reported on multiple discovery rulings in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of...more

Jones Day

High Court of Australia Settles Principles for Preliminary Discovery

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The Situation: Pfizer, a pharmaceutical manufacturer, brought an application for preliminary discovery of certain confidential documents belonging to Samsung Bioepis ("SB"), a competitor, believing those documents would...more

Jones Day

Additional Discovery: Must Be More Than Mere Possibility

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The PTAB recently denied a motion for additional discovery that sought the production of documents argued to be relevant to inventorship. In Watson Laboratories, Inc. v. United Therapeutics, Corp., Case IPR2017-01621 and...more

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Jones Day

PTAB Revokes Filing Privileges For Repeated Rules Violations

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In September 2017, Saint Regis Mohawk Tribe moved to dismiss six instituted trials on petitions filed by Mylan Pharmaceuticals Inc. Those petitions challenged six patents that, at the time the petitions were filed, belonged...more

Goodwin

Janssen v. Celltrion: CAFC & District Court Litigation Update

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As we previously reported last year, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Janssen appealed the district court’s partial final...more

Goodwin

Amgen v. Coherus: Coherus Files Reply in Support of Motion to Stay

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As we have previously reported, on July 25th, Coherus filed a motion to stay discovery pending the result of its motion to dismiss in its litigation against Amgen regarding pegfilgrastim, and Amgen filed an opposition on...more

BakerHostetler

Federal Circuit Suggests Solution to Patent Owner’s Dilemma When Applicant for Biosimilar Product Refuses Discovery

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In Amgen, Inc. v. Hospira, Inc., Appeal No. 2016-2179 (Fed. Cir. Aug. 10, 2017), the Federal Circuit suggested what an owner of a reference product suing an applicant for a biosimilar under the Biologics Price Competition and...more

Goodwin

Update: Coherus’ Motion to Stay Discovery in Amgen v. Coherus

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Earlier this week Coherus filed a motion to stay the BPICA litigation brought by Amgen in the District of Delaware, arguing that in light of the FDA’s complete response letter delaying the launch of Coherus’ pegfilgrastim...more

WilmerHale

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

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Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more

Perkins Coie

Inter Partes Review Proceedings: A Third Anniversary Report

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When inter partes review (IPR) proceedings became effective in September 2012, few people would have predicted the transformative effect it would have on patents and the litigation landscape. Three years in, IPR has become...more

Akin Gump Strauss Hauer & Feld LLP

IP Newsflash - December 2014

Federal Circuit Vacates Lower Court’s Obviousness Finding Based on Incorrect Application of Inherency Doctrine - In Par Pharmaceutical, the Federal Circuit vacated an obviousness ruling by the district court, finding...more

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