An overview of a recent court challenge to the protection of biomarkers as intellectual property

Background: We present an intellectual property case in the United States to demonstrate the recent developments concerning patenting novel biomarker discoveries. A court struck down several patents owned by Myriad Genetics, which were related to breast cancer (BRCA1 and BRCA2). This decision can affect patent eligibility for inventions related to biomarkers, particularly genetic biomarkers. Methods: The court proceedings for the Myriad Genetics case were reviewed by two patent attorneys (SCH and JMT). Relevant discussions applicable to the scientist involved with biomarker discovery were also prepared. Results: In this case, the Plaintiff had argued that the analysis and comparison of various gene mutations merely involved natural phenomena, and, therefore, could not be eligible for patent protection. The patent holder (Myriad) argued that the claimed gene compositions did not exist in nature, and that the claimed methods provided practical utility for science and medicine. The Court held that the patent claims did not meet patent eligibility requirements under United States patent law. It held that the patent claims at issue were merely abstract mental processes of analyzing and comparing gene sequences, and that such abstract mental processes are not patentable. On June 22. 2010, Myriad appealed the ruling. Conclusions: This case provides guidance to inventors in the biomarker field who may be interested in obtaining intellectual property protection for their inventive work, as well as their patent counsel. However, the case also presented unique factors that may not be present in all situations involving biomarker patents. (C) 2011 Elsevier B.V. All rights reserved.