AbbVie Announces Global Resolution of HUMIRA Patent Disputes with Sandoz

AbbVie, a research-based global biopharmaceutical company, announced 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 US, 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 US on January 31, 2023, and on April 5, 2018, AbbVie announced a similar resolution with Samsung Bioepis to enter the US on June 30, 2023. On July 17, 2018, AbbVie announced resolution with Mylan to enter the US on July 31, 2023. – Medical Buyer Bureau