摘要：Mr. X suffers from recurrent glioblastoma, a type of deadly brain cancer. One of his physicians reads a study reporting a novel immunotherapy, which uses the chimeric antigen receptor T cell (CAR-T) technology, leading to regression of glioblastoma in a small number of patients. Although the therapy has recently been approved by the U.S. Food and Drug Administration (FDA) and is now offered by two major pharmaceutical companies, it is only approved for certain hematological cancers. In addition, Mr. X’s cancer does not express the biomarker that is necessary for the CAR-T therapy used in the published glioblastoma trial. Fortunately, the physicians are aware of a research laboratory at the university associated with the medical center that has expertise on the technologies associated with the CAR-T immunotherapy as well as certain biomarkers associated with Mr. X’s cancer. In collaboration with the laboratory’s researchers, Mr. X’s physicians conduct a small clinical trial administering an experimental CAR-T therapy to Mr. X and other glioblastoma patients, for whom this clinical trial was their only remaining hope. Later, one of the pharmaceutical companies holding multiple CAR-T patents sues the physicians, researchers, and academic institution for patent infringement. This hypothetical scenario involving the first FDA-approved gene therapy, CAR-T therapy, illustrates a potential patent infringement lawsuit that might occur more frequently as we enter the new era of personalized and precision medicine. The beauty and power of personalized medicine is that it is inherently experimental and innovative. Naturally, therapies in personalized medicine are built upon many patented technologies. Thus, underlying these novel therapies is the potential for alleged patent infringement by the physicians and researchers who experiment with and personalize the therapy in order to cure patients and save their lives. This Note uses the CAR-T therapy as a case study to examine the unique challenges that patent law faces in the dawn of the personalized medicine era, particularly regarding patent infringement. Specifically, this Note inquires whether a use of patented medical therapy related to a clinical experiment or trial by physicians, researchers, and academic institutions for the purpose of patient treatment renders them liable for patent infringement. Patent law confers exclusive rights to inventors and allows them to enforce those rights associated with a specific patent by bringing a patent infringement claim against the alleged infringer. At the same time, however, patent law also permits certain unauthorized uses of patented inventions to be exempted from
关键词：Patent law; Patent Infringement; Personalized Medicine; Food and Drug Administration; FDA; USFDA; chimeric antigen receptor T cell; CAR-T; technology; immunotherapy; biomarkers; therapy; precision medicine; medical procedure exemption; experimental use exemption; biotechnology; 21st Century Cures Act of 2016; Precision Medicine Initiative; Gene Therapy; 35 U.S.C. § 287(c); 35 U.S.C. § 271(e)(1)
