Cancer Immunotherapy Drugmaker Lindis Biotech Sues Amgen for Patent Infringement

On Monday, Lindis Biotech, GmbH filed a complaint in the District of Delaware against Amgen Inc. for allegedly infringing upon their patents for an immunotherapy regimen that is more effective, and less harmful to the human body, than chemotherapy or radiation treatments.

Lindis Biotech holds several patents for an immunotherapy regimen, of which three have allegedly been infringed upon. The plaintiffs’ regimen directs the body to only kill harmful cancer cells – and not healthy cells – and to “modulat[e] the body’s cell-killing response so that it does not overwhelm the body and kill other healthy cells and/or cause a dangerous inflammatory response.” This form of cancer therapy is purportedly more effective than chemotherapy and radiation, as those methods can be ineffective against certain types of cancer and can damage healthy tissues.

Lindis’ therapy uses bispecific antibodies that “bind to the target antigen on the surface of cancer cells, and also bind to T-cells.” They also discovered a method to effectively target the cancer cells while preserving other tissue in a novel way. The plaintiff had a patent approved on September 15, 2004 in Europe and an American patent on April 26, 2005, and had their patent opposed in Europe on January 17, 2014 by Amgen.

In December 2014, Amgen announced a drug, Blincyto, which they marketed as “the first and only Bispecific CD 19 Directed CD3 T-Cell Engager (BITE®) Immunotherapy to be Approved by the FDA,” despite Lindis having patents for a very similar form of immunotherapy. According to the complaint, this drug uses the same type of bispecific antibody as Lindis does and contains ingredients and processes that Lindis had already patented across their ‘421, ‘158 and ‘149 patents and marketed their product as the first of its kind.

The plaintiffs are seeking a declaration that Amgen infringed upon the ‘421, ‘158 and ‘149 patents, actual damages, interest, attorney’s fees and costs, and other relief.

Lindis Biotech is represented by Saul Ewing Arnstein & Lehr, LLP.