News & Analysis as of

Doctrine of Equivalents Biosimilars

Robins Kaplan LLP

Alcon Inc. v. Padagis Israel Pharms. Ltd.

Robins Kaplan LLP on

Simbrinza® (brinzolamide / brimonidine) - Case Name: Alcon Inc. v. Padagis Israel Pharms. Ltd., Civ. No. 22-1422-WCB, 2025 WL 457119 (D. Del. Feb. 5, 2025) (Bryson, C.J.)  Drug Product and Patent(s)-in-Suit:  Simbrinza®...more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Issues Order Clarifying Status of Doctrine of Equivalents

The late Gilda Radner's character, Emily Latella, would consistently misapprehend something ("violins on television," "saving Soviet jewelry"), give a guest editorial on Weekend Update, and when corrected would say "Never...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Walks Back Its “Exceptional” Stance on the Doctrine of Equivalents in the Latest Amgen v. Sandoz Decision

In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Cautions Against Rigid Approach to Prosecution History Estoppel in Fourth Appeal from ALIMTA® Litigations

On August 9, 2019, the United States Court of Appeals for the Federal Circuit, in Eli Lilly & Co. v. Hospira, Inc., Nos. 2018-2126, 2127, 2128, reversed in-part and affirmed in-part a district court’s determination of...more

Akin Gump Strauss Hauer & Feld LLP

Prosecution History Estoppel Bars Amgen’s Infringement Claim Under the Doctrine of Equivalents

The Federal Circuit affirmed a district court decision barring Amgen from asserting an infringement claim under the doctrine of equivalents against Coherus Biosciences because Amgen disclaimed all combinations not identified...more

McDermott Will & Emery

Maintaining Order in Process Claims

The US Court of Appeals for the Federal Circuit affirmed a summary judgment non-infringement ruling, finding that where both the claim language and the specification require that the disclosed steps be performed in the order...more

Akin Gump Strauss Hauer & Feld LLP

Delaware Court Recommends Dismissal with Prejudice of Biosimilar Neulasta Suit

In a Report and Recommendation issued December 7, 2017, Magistrate Judge Burke in the District of Delaware recommended that Amgen’s BPCIA complaint for infringement against Coherus Biosciences Inc. be dismissed with prejudice...more

Goodwin

UPDATE Janssen v. HyClone: HyClone files a motion for injunctive relief to dismiss and to stay

Goodwin on

As we previously reported, on June 17, Janssen filed two complaints alleging infringement of claims in U.S. Patent No. 7,598,083, one against Celltrion and Hospira, and one against HyClone Laboratories, Celltrion’s supplier...more

McDonnell Boehnen Hulbert & Berghoff LLP

An Inflectra Update: Janssen Requests an Expedited Trial

As we reported last week, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-a antibody. On Tuesday, April 12,...more

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