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

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Oct 11, 2018, 16:32 ET

NORTH CHICAGO, Ill., Oct. 11, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today a global resolution of all intellectual property-related litigation with Sandoz over its proposed biosimilar adalimumab product.

Under the terms of the settlement agreements, AbbVie will grant to Sandoz 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. The license period will begin on September 30, 2023 in the U.S., and will not be accelerated by the entry of companies who have already taken a license. The license will begin on October 16, 2018 in most countries in the European Union, and on other dates in various countries in which AbbVie has intellectual property.

Sandoz will pay royalties to AbbVie for licensing its HUMIRA patents and acknowledges the validity of the licensed patents. AbbVie will make no payments to Sandoz. The precise terms are confidential between the parties. All litigation pending between the parties will be dismissed.

"AbbVie's HUMIRA patents reflect the groundbreaking work of AbbVie scientists in the field of fully-human biologics and our investment in patient-focused innovation," 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."

On September 28, 2017, AbbVie announced a global resolution with Amgen to enter the U.S. on January 31, 2023, and on April 5, 2018, AbbVie announced a similar resolution with Samsung Bioepis to enter the U.S. on June 30, 2023. On July 17, 2018, AbbVie announced resolution with Mylan to enter the U.S. on July 31, 2023.

About AbbVie

AbbVie is a global, research and development-based 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, LinkedIn or Instagram.

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