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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

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

Smart & Biggar

Amended PMNOC Regulations: First Anniversary Update

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As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...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

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

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

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

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

Goodwin

Amgen v. Hospira: Court Considers Issues Regarding the Scope of Discovery and the RPS’s Ability to Assert Additional Patents in...

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In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: - ..Whether a reference product sponsor (“RPS”) can compel a...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

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