Law Commons^™

What's Not Natural Phenomena? Let's Consider A Three-Step Innovative Concept Test For Composition Of Matter Claims, Sydney Hancock

IP Theory

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 …

Intellectual Property, Surrogate Licensing, And Precision Medicine, Jacob S. Sherkow, Jorge L. Contreras

IP Theory

The fruits of the biotechnology revolution are beginning to be harvested. Recent regulatory approvals of a variety of advanced therapies—Keytruda (pembrolizumab), Kymriah (tisagenlecleucel), and patisiran—have ushered in an age of “precision medicine” treatments that target patients’ specific genetic, physiological, and environmental profiles rather than generalized diagnoses of disease. Therapies like these may soon be supplemented by gene editing technologies such as CRISPR, which could enable the targeted eradication of deleterious genetic variants to improve human health. But the intellectual property (IP) surrounding precision therapies and their foundational technology remain controversial. Precision therapies ultimately rely—and are roughly congruent with—basic scientific information …