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’ dismissal of a proposed class action alleging that AbbVie, Inc. created a “patent thicket”…
On July 6, 2020, the U.S. FDA approved Mylan’s aBLA for HULIO (adalimumab-fkjp), a biosimilar of AbbVie’s HUMIRA. HULIO is indicated for treating certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HUMIRA, in contrast, is additionally approved for…
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 United States. AbbVie had moved to dismiss the lawsuit. On May 15, 2020, the plaintiffs filed…
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 purification method IPR appeal Today, the Federal Circuit issued a 2-1 opinion affirming a 2018…
On November 15, the FDA approved Pfizer’s Humira® biosimilar, ABRILADA (adalimumab-afzb). The acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, Sarah Yim, M.D., announced the approval as one of nine new biosimilar products the FDA “has taken action on…
As we previously reported, AbbVie had appealed the PTAB’s final written decisions that the challenged claims of U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987, directed to methods of using adalimumab, are unpatentable on obviousness grounds. These final written decisions stemmed from IPR petitions filed by Coherus against all three patents,…
U.S.-based AbbVie, Inc. has reached a deal to acquire Irish pharmaceutical company Allergan PLC for about $63 billion, according to an AbbVie press release from Tuesday. The “definitive transaction agreement” includes both cash and stock. According to the press release, it is expected that, immediately after the closing of the…
Today, AbbVie and Boehringer Ingelheim (“BI”) announced that they reached a resolution of all intellectual property-related litigation concerning BI’s proposed biosimilar Cyltezo® (adalimumab-adbm). According to the press releases, AbbVie has granted BI a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States. All U.S. litigation pending between the parties…
April has seen a flurry of biosimilar-related appellate activity before the Federal Circuit. Below are some highlights. The parties in the Amgen v. Hospira BPCIA litigation concerning Hospira’s RETACRIT (epoetin alfa-epbx) biosimilar concluded appellate briefing this month. As we previously reported, Hospira is appealing the district court’s adverse judgment that…
On March 18, 2019, UFCW Local 1500 Welfare Fund, a New-York based grocery union, filed a putative class-action lawsuit against AbbVie and seven adalimumab biosimilar manufacturers alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the United States….