ABSTRACT
Biotechnology innovation is rapidly growing, especially in the realm of biotech. This growth leads to questions about patent subject matter eligibility of natural phenomena. For example, currently the human genome and microbiome are being extensively studied, bacteriophages are being edited, animals are being cloned, and CRISPR is widespread. Additionally, composition of matter patent claims give the most protection to patent holders. Therefore, knowing when a natural phenomenon veers into human innovation is important for courts, lawyers, and innovators in the era of biotechnology and genetic engineering.
Part I discusses the history of Supreme Court cases on natural phenomena subject matter eligibility, highlighting the important laws set forth by the Supreme Court. Part II discusses how the Federal Circuit has applied five-factor and two-step tests established in Diamond v Chakrabarty and Mayo Collaborative Services v Prometheus Laboratories, Inc, respectively. In addition, Part II discusses the lack of clarity the courts have when applying the second step of the test established in Mayo. Lastly, Part III proposes a three-step innovative concept test specifically for composition of matter claims directed toward natural phenomena and applies the innovative concept test to the claims directed at cloned animals in In Re Roslin (Edinburgh).
Importantly, this paper focuses solely on composition of matter claims for natural phenomena. However, in Part I and Part II, some cases revolving around methods on laws of nature, natural phenomena, and abstract ideas are discussed.
Hancock, Sydney, What’s Not Natural Phenomena? Let’s Consider a Three-Step Innovative Concept Test for Composition of Matter Claims, IP Theory, volume 13, issue 1, article 4 (2023).
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