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Brief of the Biotechnology Industry Organization as Amicus Curiae supporting neither party in Rapid Litigation Management Ltd.v. Cellzdirect Inc. (Appeal from the US District Court for the Northern District of Illinois)


The Biotechnology Industry Organization (BIO) is the world's largest biotechnology trade association, providing advocacy, development, and communications services for over 1,100 members worldwide. BIO members - many of whom are small, emerging companies-involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

BIO has no direct stake in the result of this appeal, nor does BIO take a position on the ultimate validity or infringement of the claims to a method of obtaining viable hepatocytes for medical uses. No counsel for a party authored this brief in whole or in part, and no such counsel or party, nor any person other than the amicus curiae or its counsel, made a monetary contribution intended to fund the preparation or submission of this brief. This brief is solely the work of BIO and its counsel and reflects BIO's consensus view, but not necessarily the view of any individual member or client. BIO and its members are concerned that the development and commercialization of a diverse array of biotechnologies, including diagnostic testing and personalized medicine, will be hampered, if not precluded, if this Court does not address the mounting uncertainty currently afflicting patentable subject matter jurisprudence.

Unfortunately, the District Court’s decision has done nothing to alleviate that uncertainty, but instead has exacerbated doubts as to whether meaningful patent protection remains available in the United States for many biotechnology inventions, and if so, the extent of that protection and the means to draft commercially meaningful method claims that meet the newly heightened standard for patent eligibility. The invention in this case would traditionally have been deemed eligible subject matter for patenting under 35 U.S.C. §101. It provides an excellent opportunity for the court to provide timely clarification on issues of critical concern to BIO and its members.