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AbbVie Pharmaceutical Patents BPCIA

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

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

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

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On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

Goodwin

Biosimilar Legal Decisions to Keep an Eye out for in 2019

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Here are our picks of some legal developments to keep an eye out for in the new year: 1. Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s...more

Goodwin

AbbVie Answers BI’s Counterclaims in Adalimumab Litigation

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As we previously reported, on August 2, 2017, AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira®...more

McDonnell Boehnen Hulbert & Berghoff LLP

HUMIRA® Biosimilar Update -- Settlement in AbbVie v. Amgen Case Announced and AbbVie v. Boehringer Ingelheim Litigation Begins

On September 28, 2017, both parties to the AbbVie v. Amgen litigation announced a settlement that resolves all intellectual property-related litigation over Amgen's FDA-approved adalimumab biosimilar AMGEVITA™/AMJEVITA™. ...more

Goodwin

Amgen and AbbVie Settle Adalimumab BPCIA Litigation

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Amgen has announced that it has settled all pending patent litigation regarding AMJEVITA, its biosimilar version of AbbVie’s Humira® (adalimumab). Amgen reports that AbbVie will grant patent licenses for the use and sale of...more

Goodwin

BPCIA Litigation Roundup (Summer 2017)

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Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

Patterson Belknap Webb & Tyler LLP

New Biosimilar Litigation Reflects Benefits of Complying with BPCIA

On August 2, AbbVie sued Boehringer in the District of Delaware, alleging infringement of multiple patents related to AbbVie’s blockbuster biologic Humira (adalimumab). Though AbbVie has “more than 100 issued United States...more

Goodwin

New BPCIA Litigaton: AbbVie Sues Boehringer Ingelheim Regarding Proposed Biosimilar to Humira (adalimumab)

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Today, AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira (adalimumab) product. The complaint...more

Foley & Lardner LLP

Coherus Challenges One AbbVie Humira Patent In Four PTAB Proceedings

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I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same...more

Goodwin

AbbVie’s Response Regarding Amgen’s Third-Party Patent Dance Discovery Request

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As we previously posted, Amgen seeks discovery from AbbVie regarding its “patent dance” exchanges with other adalimumab biosimilar applicants under the BPCIA. Last Friday, AbbVie filed its response, arguing that the BPCIA...more

Goodwin

Amgen Seeks Discovery Regarding AbbVie’s Patent Dance with Other Biosimilar Applicants

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In the ongoing litigation between AbbVie and Amgen regarding Amgen’s proposed biosimilar for Humira® (adalimumab), Amgen is seeking discovery from AbbVie regarding its exchanges with other adalimumab biosimilar applicants...more

Goodwin

BPCIA Litigation Roundup (Spring 2017)

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Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

Goodwin

Abbvie Files Amicus Brief in Amgen V. Sandoz Supreme Court Case

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On February 17, 2016, we reported that Amgen and Sandoz had both petitioned the U.S. Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz, each seeking to advance their respective positions on whether...more

Goodwin

BPCIA Litigation Roundup (Midwinter 2017)

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Below is our midwinter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

Fish & Richardson

New Developments in AbbVie’s BPCIA Suit Targeting Amgen’s Humira® Biosimilar

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On August 4, 2016, AbbVie filed a complaint against Amgen alleging that Amgen’s Humira® biosimilar Amjevita® infringes ten AbbVie patents. Humira® received FDA approval in 2002 to treat rheumatoid arthritis, juvenile...more

Patterson Belknap Webb & Tyler LLP

Biosimilar Litigation Update

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

Patterson Belknap Webb & Tyler LLP

Humira Biosimilar Approved As Litigation Gets Going

The FDA on Friday approved the first U.S. biosimilar of Humira (adalimumab), AbbVie’s best-selling biologic for treatment of inflammatory conditions. The biosimilar, Amgen’s Amjevita (adalimumab-atto), received approval for...more

Goodwin

BPCIA Litigation Roundup (Summer 2016)

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Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product....more

Foley & Lardner LLP

AbbVie Sues Amgen On 10 Of 100 Humira Patents

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On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more

Goodwin

AbbVie Sues Amgen to Prevent Launch of Humira Biosimilar

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As we reported last week, on Thursday, August 4, AbbVie sued Amgen seeking an injunction to prevent Amgen from launching its biosimilar version of AbbVie’s Humira. The complaint alleges that Amgen’s biosimilar infringes 61...more

Foley & Lardner LLP

Amicus Briefs on Biosimilar Patent Litigation

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Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more

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