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Settlement Agreements Pharmaceutical Patents

Saul Ewing LLP

FTC Supports Proposed PTO Rule Mandating Disclosure of Agreements Between Litigants in Disputes Before the Patent Trial and Appeal...

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Introduction - On June 18, 2024, the Federal Trade Commission (“FTC”) unanimously agreed to submit a comment supporting a recent proposed U.S. Patent and Trademark Office (“PTO”) rule that would mandate the disclosure of all...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - April 2024

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This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more

Goodwin

Biocon Settles with Janssen, Securing U.S. Market Entry Date for Ustekinumab Biosimilar

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​​​​​​​On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA....more

Goodwin

Biocon Settles with Bayer and Regeneron, Securing Canada Market Entry Date for Aflibercept Biosimilar

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On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept)....more

Goodwin

Alvotech Announces More Settlements and Expected Launch Dates Regarding Biosimilar to STELARA (ustekinumab), AVT04

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On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and...more

Goodwin

Ustekinumab Antitrust Litigation

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On December 7, 2023, a group of health insurers and health insurance administrators filed a class action complaint against Johnson & Johnson and Janssen Biotech, Inc. (collectively “J&J”) in the Eastern District of Virginia...more

Smart & Biggar

Competition Bureau closes two investigations into pharmaceutical patent litigation settlements

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On May 20, 2022, the Competition Bureau announced that it closed two investigations into pharmaceutical patent litigation settlement agreements as evidence gathered during the two investigations suggested the agreements did...more

Goodwin

Alvotech and AbbVie Resolve Disputes Relating to Alvotech’s Adalimumab Biosimilar in Europe

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Alvotech Holdings S.A. (“Alvotech”) announced today that it has resolved all intellectual property disputes with AbbVie in Europe related to Alvotech’s AVT02 (adalimumab) biosimilar candidate. This announcement follows...more

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

Humira’s End of Reign

On March 8, 2022, Alvotech announced that it has executed a U.S. settlement agreement with Abbvie that grants Alvotech non-exclusive rights to market AVT02 (adalimumab) in the U.S starting July 1, 2023. AbbVie confirmed the...more

Goodwin

Alvotech and AbbVie Settle Patent Dispute

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Alvotech Holdings S.A. (“Alvotech”) has announced that they have settled all pending disputes between AbbVie and Alvotech related to AVT02 (100mg/mL), Alvotech’s high-concentration, citrate-free biosimilar candidate for...more

Jones Day

Board Requires Settlement Agreement to Dismiss Pre-Institution Proceeding

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Biofrontera AG (“Petitioner”) filed an unopposed motion to dismiss the petition during the preliminary phase of the proceedings.  Here, DUSA Pharmaceuticals, Inc. (“Patent Owner”) had not yet filed a Preliminary Response, and...more

WilmerHale

District Court Enjoins California's Unprecedented "Reverse Payment" Law

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On December 8, 2021, a federal district court granted a preliminary injunction temporarily enjoining enforcement of the California state law Preserving Access to Affordable Drugs, which attempts to sanction reverse-payment...more

Haug Partners LLP

Xryem: Pharmaceutical Settlement Acceleration Clause Found Anticompetitive Due To Risk Of “Profit Crushing Competition”

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On August 13, 2021, in a decision that largely flew under antitrust and patent practitioners’ radars, U.S. District Judge Lucy H. Koh mostly denied a motion to dismiss in the alleged “reverse payment” case, In Re Xyrem...more

A&O Shearman

Beyond “pay-for-delay” – the EU-Commission’s investigation into patent filing practices and communication measures

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On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the...more

McDermott Will & Emery

‘Pay-for-Delay’ Agreements can be Restrictions of Competition by their very Nature

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On 25 March 2021 the European Court of Justice (ECJ) dismissed all the appeals brought by Danish pharmaceutical company H. Lundbeck A/S (Lundbeck) and five generic manufacturers against the judgments of the General Court of...more

White & Case LLP

The ECJ’s Lundbeck judgment offers little new on patent settlements but gives birth to an interesting principle: sector inquiries...

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On 25 March 2021, the European Court of Justice ("ECJ") dismissed all the appeals against the European Commission's decision to fine Lundbeck and several other companies for entering into anti-competitive patent settlement...more

Robins Kaplan LLP

ANDA Litigation Settlements - Fall 2020

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Reported settlements in federal district court cases - This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed...more

Robins Kaplan LLP

Somaxon Pharma, Inc. v. Actavis Elizabeth LLC

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THE COURT GRANTED DEFENDANT’S MOTION TO ENFORCE ITS SETTLEMENT AGREEMENT, FINDING THAT THE AGREEMENT WAS NOT ANTICOMPETITIVE AND IN VIOLATION OF ANTITRUST LAW. Case Name: Somaxon Pharma, Inc. v. Actavis Elizabeth LLC, No....more

Robins Kaplan LLP

ANDA Litigation Settlements - Summer 2020

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Goodwin

Genentech v. JHL case schedule extended

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As we previously reported, Genentech and JHL Biotech reached a settlement agreement resolving the parties’ lawsuit regarding JHL’s alleged misappropriation of trade secrets relating to Genentech’s Rituxan® (rituximab),...more

A&O Shearman

EU’s top court clarifies when a patent settlement agreement can infringe EU antitrust rules

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The Court of Justice of the EU (ECJ) has for the first time ruled on the issue of settlement agreements involving a value transfer (monetary or otherwise) between the holder of a pharmaceutical patent and generic drug...more

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

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On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

Goodwin

FDA and FTC Announce Collaboration to Support Biosimilars Market

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The U.S. Food and Drug Administration and the Federal Trade Commission today released a joint statement regarding collaboration to advance competition in the market for biologic products. According to the FDA press release,...more

Kramer Levin Naftalis & Frankel LLP

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Robins Kaplan LLP

Amgen Inc. v. Amneal Pharms. LLC

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The Court Denied Defendant’s Motion To Enforce Its Settlement Agreement With Plaintiff After The At-risk Launch And Subsequent Settlement Of Another Defendant. ...more

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