Tagged as: AbbVie

AbbVie and Sandoz Settle Adalimumab Biosimilar Patent Disputes

On October 11, 2018, AbbVie and Sandoz announced that they reached a global resolution of all intellectual property-related litigation concerning Sandoz’s Hyrimoz™, a proposed biosimilar of Humira® (adalimumab).  According to the press releases, under the terms of the royalty-bearing settlement agreements, AbbVie is granting to Sandoz a non-exclusive license to…

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More Discovery Rulings in AbbVie v. BI

We previously reported on discovery disputes in the adalimumab litigation between AbbVie and Boehringer Ingelheim (BI) pending before the District of Delaware.  Earlier this month, Judge Lloret issued an order on additional discovery motions filed by the parties.  Taking into account standards under the Federal Rules, “that the amount in controversy…

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California Sues AbbVie Over Alleged Kickbacks for HUMIRA

In a complaint filed yesterday, the State of California sued AbbVie, Inc. based on an alleged kickback scheme in connection with AbbVie’s Humira® (adalimumab).  The complaint alleges that AbbVie violated the Insurance Frauds Prevention Act (“IFPA”) by providing kickbacks to health providers throughout California.  Specifically, AbbVie allegedly indirectly paid healthcare…

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New BPCIA Litigation: AbbVie Files Suit on Sandoz's HUMIRA (adalimumab) biosimilar

Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is directed to methods of administration of adalimumab for treatment of idiopathic inflammatory bowel diseases. The ‘808…

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Senators Ask FTC To Examine Biosimilar Patent Settlements For Antitrust Violations

United States Senators Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) recently sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the “FTC to examine global patent settlements relating to biosimilars to ensure they are not in violation of antitrust laws.”  According to the Senators, “biologics constitute a…

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Updates On Discovery Rulings in AbbVie v. BI Adalimumab Litigation

We have recently reported on multiple discovery rulings in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product.  On June 14, 2018, Magistrate Judge Lloret issued two additional opinions regarding discovery in the case. In the first opinion, the Court granted-in-part…

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Updates On Discovery Rulings in AbbVie v. BI Adalimumab Litigation

We have covered the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product, including the grant of a recent motion to compel discovery regarding BI’s unclean hands defense.  Magistrate Judge Lloret issued two additional orders regarding discovery in that case….

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AbbVie Reports Positive Phase 3 Results Showing Small Molecule Upadacitinib Is Superior To Adalimumab For RA

AbbVie recently announced positive results for upadacitinib, a small molecule Janus Kinase (JAK) inhibitor, in a phase 3 clinical trial of patients with rheumatoid arthritis (RA). According to AbbVie, upadacitinib met all primary and secondary endpoints in the study, including superiority versus adalimumab, the anti-TNFα antibody that Abbvie markets as…

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AbbVie and Samsung Bioepis Announce Global Settlement of Adalimumab Disputes

Today, AbbVie and Samsung Bioepis announced that they have reached a global resolution of all intellectual property-related litigation relating to Samsung Bioepis’ biosimilar of Humira® (adalimumab), SB5, clearing the way for its commercialization in all approved markets worldwide.  SB5 has already received marketing authorization from the European Commission (EC) as…

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