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Natural Alternatives International v. Creative Compounds (BIO Brief as Amicus Curiae)

The Biotechnology Innovation Organization (“BIO”) (formerly: Biotechnology Industry Organization) is the principal trade association representing the biotechnology industry domestically and abroad. BIO has more than 1,000 members, which span the for-profit and non-profit sectors and range from small start-up companies and biotechnology centers to research universities and Fortune 500 companies. Approximately 90% of BIO’s corporate members are small or midsize businesses that have annual revenues of under $25 million. 

BIO’s members are concerned that, six years after the Supreme Court decided Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), increasing uncertainty exists about the patent-eligibility of biotechnological products that incorporate naturally-occurring substances, and of methods of using such products in therapeutic, diagnostic, or industrial processes. The unstable state of patent-eligibility jurisprudence affects modern biotechnologies ranging from biomarker-assisted methods of drug treatment to companion diagnostic tests, fermentation products, industrial enzyme technology, and marker-assisted methods of plant breeding. As developers of, and investors in, such advanced technologies, BIO members have a strong interest in clear and predictable rules of patent-eligibility. Amicus BIO submits this brief in the hope that it will assist the Court in the orderly development of the law in this important area. 

 

Natural Alternatives International v. Creative Compounds (BIO Brief as Amicus Curiae)