News & Analysis as of

AbbVie

Wells Fargo Analyst: Humira® Price Increase Could Add $1.2 Billion to U.S. Healthcare Market

by Goodwin on

It has been reported that manufacturer AbbVie will increase the price of Humira® (adalimumab) by 9.7% in 2018. According to Wells Fargo analyst David Maris, this price increase could add an additional $1.2 billion to the U.S....more

Year in Review: Top 5 Biosimilars Deals of 2017

by Goodwin on

Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017...more

Year in Review: The Top-Five U.S. Market Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

IPR Updates

by Goodwin on

Here are some updates since our last IPR update: HUMIRA - On November 6, 2017, Sandoz filed an IPR Petition challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156). ...more

Biosimilar Litigation Updates

by Goodwin on

Below is an update on recent developments in several litigations involving biosimilar products. AbbVie v. Boehringer Ingelheim (adalimumab): On October 23, the parties filed a joint status report. ...more

Federal Jury Returns $140 Million Punitive Verdict Against AbbVie In Second AndroGel Trial

As my colleague Andy Frey and I reported in an earlier post, an Illinois federal jury in July returned a $150 million punitive verdict against AbbVie without awarding the plaintiff any compensatory damages. That verdict is...more

AbbVie Answers BI’s Counterclaims in Adalimumab Litigation

by Goodwin on

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

Sandoz Files Petition for IPR on Abbvie Adalimumab Patent

by Goodwin on

Today Sandoz filed IPR2018-00002, directed to AbbVie’s U.S. Patent No. 9,512,216. According to the petition, the ’216 patent claims a subcutaneously-administered dosing regimen for the anti-TNF-a antibody adalimumab, the...more

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

Amgen and AbbVie Settle Adalimumab BPCIA Litigation

by Goodwin on

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

Recent IPR Updates

by Goodwin on

The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more

BI Files Answer to AbbVie’s Complaint in Adalimumab Litigation

by Goodwin on

As we previously reported, last month 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

News from Abroad -- No Pharmaceutical Extension of Patent Term for Swiss Type Claims in Australia

The Australian Full Federal Court's recent decision in Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 confirms that an extension of patent term for pharmaceutical substances does not extend to Swiss type...more

BPCIA Litigation Roundup (Summer 2017)

by Goodwin on

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

Federal Jury Returns $150 Million Punitive Verdict Against AbbVie—Without Awarding Any Compensatory Damages For The Plaintiff’s...

You’ve likely seen by now media reports about an Illinois federal jury’s $150 million punitive award against AbbVie in a case brought by a plaintiff who alleged that AbbVie’s low-T medication AndroGel caused his heart attack....more

FDA Approves Boehringer Ingelheim’s Adalimumab Biosimilar

by Goodwin on

Today, Boehringer Ingelheim received FDA approval for Cyltezo®, its biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic...more

Patent Extension for Humira® Denied by Australian Court

by Goodwin on

The Australian Federal Court recently ruled that to be eligible for an extension, a patent must cover a “product” rather than a “method of use.” AbbVie Biotechnology Ltd (AbbVie) filed requests to extend Australian patents...more

Sandoz Files Petitions for IPR on Two Abbvie Adalimumab Patents

by Goodwin on

Sandoz has filed two petitions for IPR challenging Abbvie patents related to use of an antibody identified in the petitions as Humira® (adalimumab): IPR2017-01987 challenging U.S. Patent 8,911,737, directed to methods of...more

Q2 Earnings Round-Up

by Goodwin on

Below are some highlights from second quarter earnings reports recently released by biologics and biosimilar companies. ..Coherus reported that it has cash and cash equivalents of $118.3 million as of June 30, 2017 and...more

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

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

by Goodwin on

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

Abbvie v. Amgen (Adalimumab) Reassigned to Judge Goldberg

by Goodwin on

Today, the District of Delaware reassigned the AbbVie v. Amgen (adalimumab) litigation from retiring Senior Judge Sue L. Robinson to a visiting judge, Judge Mitchell S. Goldberg of the Eastern District of Pennsylvania. Judge...more

Sandoz Files Two Petitions for IPR of Two AbbVie Patents Related to Humira

by Goodwin on

Sandoz has filed a petition for inter partes review of AbbVie’s U.S. Patent No. 8,802,100 (IPR2017-01823), which claims stable formulations of an anti-TNFa antibody identified in the petition as Humira® (adalimumab). Sandoz...more

Coherus Challenges One AbbVie Humira Patent In Four PTAB Proceedings

by Foley & Lardner LLP on

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

Method-of-Treatment Claims That Did Not Require a Specific Level of Efficacy Held Unpatentable as Obvious in Light Of References...

The Patent Trial and Appeal Board (the “Board”) issued a final written decision in an inter partes review determining Claims 1-5 of U.S. Patent No. 8,889,135 owned by Abbvie Biotechnology Ltd. unpatentable as obvious...more

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