AbbVie Announces Global Resolution of HUMIRA® (adalimumab) Patent Disputes with Samsung Bioepis

- Agreements Provide Non-Exclusive License to Samsung Bioepis for HUMIRA-Related Intellectual Property in the U.S. Effective June 30, 2023, and in Other Markets on Different Dates

- Samsung Bioepis Acknowledges Validity of AbbVie's Intellectual Property for HUMIRA

News provided by

AbbVie

Apr 05, 2018, 08:05 ET

NORTH CHICAGO, Illinois, April 5, 2018 /PRNewswire/ – AbbVie (NYSE: ABBV) announced today global resolution of all intellectual property-related litigation with Samsung Bioepis over its proposed biosimilar adalimumab product. Under the terms of the settlement agreements, AbbVie will grant to Samsung Bioepis a non-exclusive license to AbbVie's intellectual property relating to HUMIRA beginning on certain dates in certain countries in which AbbVie has intellectual property:

In the U.S., Samsung Bioepis' license period will begin on June 30, 2023. In most countries in the European Union, the license period will begin on October 16, 2018.
On September 28, 2017, AbbVie announced a global resolution with Amgen to enter the U.S. market on January 31, 2023. Samsung Bioepis' U.S. license date will not be accelerated upon Amgen's entry.

Under the terms of the agreement, Samsung Bioepis will pay royalties to AbbVie for licensing its HUMIRA patents once its adalimumab biosimilar product is launched. As with the prior Amgen resolution, AbbVie will make no payments to Samsung Bioepis. All litigation pending between the parties, as well as all litigation with Samsung Bioepis' European partner, Biogen, will be dismissed. The precise terms of the agreements are confidential.

"The Samsung Bioepis settlement reflects the strength and breadth of AbbVie's intellectual property," said Laura Schumacher, executive vice president, external affairs, general counsel and corporate secretary, AbbVie. "We continue to believe biosimilars will play an important role in our healthcare system, but we also believe it is important to protect our investment in innovation. This agreement accomplishes both objectives."

About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SOURCE AbbVie