Lindis Biotech, Gmbh V. Amgen Inc.

Case Background

Lindis Biotech, GmbH filed a patent infringement lawsuit against Amgen Inc. for the willful infringement of its patented immunotherapy regimen for cancer treatment. The case was filed in the United States District Court, Delaware (Wilmington). Judge Gregory B. Williams presided over this case. [Case number: 1:22cv35]

Cause

Lindis Biotech, GmbH (“Lindis”) developed a patented immunotherapy regimen to address major challenges in cancer treatment. This innovative approach uses bispecific antibodies to target cancer cells, minimize harm to healthy tissue, and prevent excessive immune responses. Unlike traditional therapies like chemotherapy and radiation, which often damage healthy cells and suppress immunity, Lindis’s regimen offers a safer and more effective alternative.

Dr. Horst Lindhofer and Dr. Marcus M. Heiss, the inventors behind Lindis’s patents, devised a groundbreaking method to enhance immunotherapy. Their regimen pairs glucocorticoids with bispecific antibodies. Administering glucocorticoids before antibodies reduces the risk of cytokine storms—dangerous immune reactions—while preserving the antibodies’ cancer-fighting properties. This method allows higher antibody doses without compromising safety.

Lindis holds U.S. and European patents, including U.S. Patent Nos. 8,709,421 and 10,071,158, for its regimen. These patents cover the use of bispecific antibodies targeting CD19 (a tumor antigen) and CD3 (a T-cell marker), combined with glucocorticoid premedication like dexamethasone or prednisone.

Amgen Inc., a pharmaceutical company, markets Blincyto (blinatumomab), an immunotherapy for leukemia that uses bispecific antibodies targeting the same antigens as Lindis’s regimen. Amgen’s prescribing information recommends glucocorticoids to reduce cytokine release, mirroring Lindis’s patented methods.

Lindis claims that Amgen’s use of glucocorticoids in its Blincyto regimen infringes on Lindis’s patents. Despite warnings on Blincyto’s packaging about cytokine release, Amgen’s methods reportedly replicate Lindis’s patented approach. Lindis seeks legal action to protect its intellectual property, asserting that Amgen knowingly adopted its innovative methods. Amgen’s continued marketing and distribution of Blincyto demonstrate willful infringement, reinforcing Lindis’s allegations.

Damages

Amgen’s actions resulted in significant harm to Lindis, prompting the company to seek remedies. Lindis requested a judgment confirming that Amgen either contributed to or induced others to infringe claims of the ’421 and ’158 Patents. It also sought a declaration that Amgen’s patent infringement was willful and intentional. Lindis pursued compensation for actual damages, including interest and costs, under 35 U.S.C. § 284. Additionally, Lindis sought a determination that the case qualified as exceptional under 35 U.S.C. § 285, justifying an award of attorneys’ fees and related expenses. Finally, Lindis requested any further relief the Court deemed appropriate to address the ongoing harm.

Key Arguments and Proceedings

Legal Representation

  • Plaintiff(s): Lindis Biotech, GmbH
    • Counsel for Plaintiff(s): James Taylor | Jessica Jones | Henry Platt | Robert Gill | Matthew Antonelli | Alireza Behrooz | Dennis Ostrovsky | Courtland Merrill
  • Defendant(s): Amgen Inc.
    • Counsel for Defendant(s): Michael Wise | Joseph Hamilton | Lara Dueppen | Courtney Prochnow | Alisha Burgin of Perkins Coie | Lisa Pensabene | Hassen Sayeed | Carolyn Wall | Luann Simmons | Sorin Zaharia

Claims

Lindis claimed that Amgen infringed on its ’421 and ’158 Patents through the manufacturing, marketing, and sale of Blincyto. Amgen produced and distributed Blincyto in the United States for domestic use and export to other countries. Upon information, Amgen shipped Blincyto internationally with accompanying prescribing information, further enabling its use. These actions directly infringed on claims of both patents. Moreover, Amgen’s instructions for using Blincyto induced and contributed to the infringement of Lindis’s patented methods.

Defense

Amgen in its answer denied the allegations of patent infringement and asserted affirmative defenses. It also presented counter-claims in its answer.

Amgen counterclaimed that the ’421 and ’158 Patents are invalid, unenforceable, and not infringed. It argued that the patents fail to meet conditions for patentability, such as novelty and non-obviousness, and accused the patent holder of inequitable conduct by misrepresenting inventorship and withholding critical information. Amgen sought declarations confirming non-infringement, invalidity, and unenforceability of both patents.

Jury Verdict

On December 17, 2024, the jury unanimously determined that Amgen infringed Lindis’s ’421 and ’158 Patents, which protect key immunotherapy innovations. The verdict stated that Amgen’s infringement was willful and actively induced. The jury dismissed Amgen’s argument that the patents were invalid. It awarded Lindis $50,306,120 in damages for past infringement, calculated using a royalty rate. However, the jury found that Amgen’s Blincyto sales outside the United States were not caused by its active inducement of U.S. healthcare providers to use the patented methods.

An Amgen spokesperson expressed disappointment with the verdict and stated that the company planned to challenge the decision.

Court Documents:

Documents are available for purchase upon request at jurimatic@exlitem.com

Press Release:

Thomas Reuters