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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
On November 7, Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) approved QLETLI®, a biosimilar to AbbVie’s HUMIRA® (adalimumab). QLETLI® is the first adalimumab biosimilar...more
Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’...more
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
Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer’s proposed biosimilar adalimumab. According to the press releases, AbbVie has granted...more
Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira®...more