AbbVie, Boehringer Settle Humira Patent Dispute in U.S.
Under the agreement, Boehringer will to pay AbbVie royalties for licensing its Humira patents and agreed to acknowledges the validity and enforceability of the patents, AbbVie said.
May 15, 2019 at 03:59 PM
3 minute read
AbbVie Inc. has settled its Delaware patent infringement suit against Boehringer Ingelheim, granting the German drugmaker a nonexclusive license to begin selling a biosimilar of its $20 billion immunosuppressant Humira in 2023.
The companies announced the settlement with a pair of press releases Tuesday. Under the agreement, Boehringer will to pay AbbVie royalties for licensing its Humira patents and agreed to acknowledges the validity and enforceability of the patents, AbbVie said.
The companies said the settlement applied only to the United States, though the specific terms of the agreement remained confidential.
“This is an important settlement as it resolves all Humira-related patent litigation in the U.S and provides access for another biosimilar manufacturer seeking to enter the U.S.,” Laura Schumacher, AbbVie's vice chairwoman of external affairs and chief legal officer, said in a statement.
“As an innovation-driven biopharmaceutical company, we will continue to develop novel cures for the toughest health challenges and rely on a robust patent system to protect that investment in innovation,” she said.
Boehringer said the license period for its biosimilar, Cyltezo, would begin July 1, 2023, making the company one of the first to market an alternative treatment option to Humira in the U.S.
“We are proud of the role we play in raising public awareness of biosimilars and being able to stimulate competition to bring more affordable treatment options to U.S. patients,” said Sheila Denton, senior vice president and U.S. general counsel at Boehringer. ”This resolution provides clarity regarding the availability of Cyltezo and allows us to focus on serving patients who need to manage their chronic disease.”
The settlement brought to a close AbbVie's 2017 suit under the Biologics Price Competition and Innovation Act, a federal law that provides for expedited regulatory approval of drugs that are exceptionally similar to innovative products already being sold in the U.S. The Chicago-based drugmaker claimed just eight patents in its complaint, but said it could assert dozens more if Boehringer, which had received regulatory approval, attempted to launch its copycat.
Boehringer responded with its own “unclean hands” defense, claiming that AbbVie had engaged in a “global effort” of pursuing overlapping and noninventive patents in order to create a “patent thicket” that would delay competition for its blockbuster drug. In February, U.S. Magistrate Judge Richard A. Lloret ordered AbbVie after a delay to quickly produce documents related to Boehringer's defense.
On Tuesday, AbbVie entered a stipulation of dismissal with the court, saying that all claims and defenses had been dismissed without prejudice and that each side would bear its own costs.
According to filings with the U.S. Securities and Exchange Commission, Humira accounted for 65% of AbbVie's total net revenues in 2017 and generated more than $18 billion in global sales, up 14.6% from 2016.
AbbVie was represented by William F. Lee, William G. McElwain and Amy K. Wigmore of Wilmer Cutler Pickering Hale and Dorr and Michael P. Kelly and Daniel M. Silver of McCarter & English.
Boehringer was represented by Bruce M. Wexler, Eric W. Dittmann, Isaac S. Ashkenazi, Chad Peterman, Young Park, Ashley Mays-Williams, Nicholas Tymoczko and Carl Minniti of Paul Hastings and James D. Taylor Jr., Selena E. Molina, Christopher R. Hall and Andrea P. Brockway of Saul Ewing Arnstein & Lehr.
The case was captioned AbbVie v. Boehringer Ingelheim Pharmaceuticals.
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
Not a Lexis Subscriber?
Subscribe Now
Not a Bloomberg Law Subscriber?
Subscribe Now
NOT FOR REPRINT
© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
You Might Like
View AllWilson Sonsini Knocks Out Claims Against Inhibrx Biosciences in Trade Secrets Verdict
Chancery Again Rules in Plaintiff's Favor in Earnout Provision Dispute
3 minute readNovo Nordisk Files Patent Claims to Fend off Generic Rivals of Wegovy
3 minute readTrending Stories
- 1Gibson Dunn Sued By Crypto Client After Lateral Hire Causes Conflict of Interest
- 2Trump's Solicitor General Expected to 'Flip' Prelogar's Positions at Supreme Court
- 3Pharmacy Lawyers See Promise in NY Regulator's Curbs on PBM Industry
- 4Outgoing USPTO Director Kathi Vidal: ‘We All Want the Country to Be in a Better Place’
- 5Supreme Court Will Review Constitutionality Of FCC's Universal Service Fund
Who Got The Work
Michael G. Bongiorno, Andrew Scott Dulberg and Elizabeth E. Driscoll from Wilmer Cutler Pickering Hale and Dorr have stepped in to represent Symbotic Inc., an A.I.-enabled technology platform that focuses on increasing supply chain efficiency, and other defendants in a pending shareholder derivative lawsuit. The case, filed Oct. 2 in Massachusetts District Court by the Brown Law Firm on behalf of Stephen Austen, accuses certain officers and directors of misleading investors in regard to Symbotic's potential for margin growth by failing to disclose that the company was not equipped to timely deploy its systems or manage expenses through project delays. The case, assigned to U.S. District Judge Nathaniel M. Gorton, is 1:24-cv-12522, Austen v. Cohen et al.
Who Got The Work
Edmund Polubinski and Marie Killmond of Davis Polk & Wardwell have entered appearances for data platform software development company MongoDB and other defendants in a pending shareholder derivative lawsuit. The action, filed Oct. 7 in New York Southern District Court by the Brown Law Firm, accuses the company's directors and/or officers of falsely expressing confidence in the company’s restructuring of its sales incentive plan and downplaying the severity of decreases in its upfront commitments. The case is 1:24-cv-07594, Roy v. Ittycheria et al.
Who Got The Work
Amy O. Bruchs and Kurt F. Ellison of Michael Best & Friedrich have entered appearances for Epic Systems Corp. in a pending employment discrimination lawsuit. The suit was filed Sept. 7 in Wisconsin Western District Court by Levine Eisberner LLC and Siri & Glimstad on behalf of a project manager who claims that he was wrongfully terminated after applying for a religious exemption to the defendant's COVID-19 vaccine mandate. The case, assigned to U.S. Magistrate Judge Anita Marie Boor, is 3:24-cv-00630, Secker, Nathan v. Epic Systems Corporation.
Who Got The Work
David X. Sullivan, Thomas J. Finn and Gregory A. Hall from McCarter & English have entered appearances for Sunrun Installation Services in a pending civil rights lawsuit. The complaint was filed Sept. 4 in Connecticut District Court by attorney Robert M. Berke on behalf of former employee George Edward Steins, who was arrested and charged with employing an unregistered home improvement salesperson. The complaint alleges that had Sunrun informed the Connecticut Department of Consumer Protection that the plaintiff's employment had ended in 2017 and that he no longer held Sunrun's home improvement contractor license, he would not have been hit with charges, which were dismissed in May 2024. The case, assigned to U.S. District Judge Jeffrey A. Meyer, is 3:24-cv-01423, Steins v. Sunrun, Inc. et al.
Who Got The Work
Greenberg Traurig shareholder Joshua L. Raskin has entered an appearance for boohoo.com UK Ltd. in a pending patent infringement lawsuit. The suit, filed Sept. 3 in Texas Eastern District Court by Rozier Hardt McDonough on behalf of Alto Dynamics, asserts five patents related to an online shopping platform. The case, assigned to U.S. District Judge Rodney Gilstrap, is 2:24-cv-00719, Alto Dynamics, LLC v. boohoo.com UK Limited.
Featured Firms
Law Offices of Gary Martin Hays & Associates, P.C.
(470) 294-1674
Law Offices of Mark E. Salomone
(857) 444-6468
Smith & Hassler
(713) 739-1250