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Pharmaceutical Industry AbbVie

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

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To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

WilmerHale

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

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Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more

Goodwin

Coherus and AbbVie File Dueling Motions for Injunctive Relief Relating to Coherus’s HUMIRA Biosimilar

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​​​​​​​Our readers may recall that nine HUMIRA biosimilars have been licensed to launch in July 2023, with Amgen’s AMJEVITA the only one to launch to date....more

Goodwin

AbbVie’s Q322 Earnings Call Highlights Oncoming Adalimumab Biosimilar Competition

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Last week, AbbVie held its third quarter 2022 earnings conference call, which included considerable discussion of forthcoming competition with biosimilars to HUMIRA (adalimumab) in 2023....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

Goodwin

AbbVie Moves to Strike Alvotech’s Final Invalidity and Unenforceability Contentions

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On February 18, 2022, in the first and second wave suits filed by AbbVie Inc. et al. (AbbVie) against Alvotech hf. (Alvotech) regarding an adalimumab biosimilar, AbbVie filed a motion to strike Alvotech’s Final Invalidity and...more

Goodwin

International Trade Commission Institutes Investigation of Alvotech’s Adalimumab Biosimilar

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As noted in our December 21, 2021 post, Complainants AbbVie Inc., AbbVie Biotechnology Ltd. and AbbVie Operations Singapore Pte. Ltd. filed a complaint at the International Trade Commission against Respondents Alvotech hf.,...more

Goodwin

AbbVie Inc. et al. v. Alvotech hf. Updates

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We have previously reported on AbbVie’s first and second wave suits against Alvotech hf. (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the second wave suit, on December 21, 2021,...more

Goodwin

Year in Review: Top Legal Developments of 2021 Impacting Biosimilars

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As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more

Haug Partners LLP

FDA Acting Commissioner of Food and Drugs Seeks Collaboration Between FDA and USPTO to Address Pharmaceutical Patent-Related...

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On September 10, 2021, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. Patent and Trademark Office (USPTO), which raised several of...more

Goodwin

AbbVie Files Second Suit Against Alvotech For Patent Infringement Under the BPCIA

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On May 28, AbbVie brought a second action in the Northern District of Illinois for patent infringement against Alvotech hf. under the BPCIA in connection with Alvotech’s proposed biosimilar version of HUMIRA® (adalimumab)....more

Goodwin

Study Concludes Two Adalimumab Biosimilars may be as Safe and Effective as Originator

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An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two...more

Goodwin

Alvotech Files Suit Against AbbVie to Invalidate Humira Patent Portfolio

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On May 11, 2021, Alvotech USA and Alvotech hf (jointly, Alvotech) filed a complaint seeking declaratory judgement against AbbVie Inc. and AbbVie Biotechnology Ltd (jointly, AbbVie) in the Eastern District of Virginia. As...more

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

7th Circuit Hears Oral Arguments in Humira “Patent Thicket” Antitrust Case

On February 25, 2021, the U.S. Court of Appeals for the Seventh Circuit heard oral arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc. (Case No. 20-2402), a case appealed from the U.S. District Court for the Northern...more

Goodwin

7th Circuit Evaluates the “Patent Thicket”

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Last week the 7th Circuit Court of Appeals heard arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402. The appeal concerns the United States District Court for the Northern District of Illinois’...more

Wiley Rein LLP

Third Circuit Sharply Limits FTC Authority to Obtain Monetary Relief as Supreme Court Prepares to Weigh In

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Last week, in FTC v. AbbVie et al., the Third Circuit joined the Seventh Circuit in holding that the Federal Trade Commission (FTC) was not authorized to seek disgorgement as a remedy under Section 13(b) of the FTC Act –...more

Hogan Lovells

AbbVie settlement seems to end period of intense scrutiny for manufacturer patient support programs

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Earlier this month, the California Insurance Commissioner announced that AbbVie had entered into a settlement agreement with the California Department of Insurance (CDOI) to resolve allegations that the pharmaceutical...more

Haug Partners LLP

INSIGHT: Abbvie Defeats Novel Antitrust Claims Against Humira Patent Estate—Lessons Learned

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A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an...more

McDonnell Boehnen Hulbert & Berghoff LLP

An Analysis of a Failed Biosimilar Antitrust Class Action

On June 10th, Judge Manish S. Shah, U.S. District Court Judge for the Northern District of Illinois, dismissed (without prejudice) a class action lawsuit against AbbVie and AbbVie Biotechnology Ltd. by consumer groups, drug...more

Goodwin

Judge Holds AbbVie Did Not Violate Antitrust Laws With Humira Patent Thicket

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We have previously reported on the class action suit against AbbVie alleging misconduct and antitrust violations in connection with AbbVie’s assertion of its patents against biosimilar manufacturers to prevent the sale of...more

Goodwin

Recent Developments in Humira (adalimumab) Antitrust Suit

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We have previously reported on the class action suit against AbbVie alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the...more

Goodwin

Biosimilar Buyouts: AbbVie Buyout of Allergan Receives Approval of Irish High Court; Gedeon Richter Buys Tocilizumab Biosimilar

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On May 8, 2020, AbbVie announced that it completed its acquisition of Allergan plc, having received approval by the Irish High Court. AbbVie and Allergan had previously announced, on May 5, 2020, that the U.S. Federal Trade...more

Goodwin

Federal Circuit Affirms Biosimilar-Related IPR Appeals; Bevacizumab Injunction Appeal Progresses

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Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein...more

Kramer Levin Naftalis & Frankel LLP

Biosimilars in 2020: What’s Ahead

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...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

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