Shrinking Territory: Patent Eligibility of Biotechological Inventions

Two recent Supreme Court decisions have changed how the Patent Office will determine patentability of biological inventions. Mayo v. Prometheus held that methods for administering drugs are not patent eligible under Section 101. Association for Molecular Pathology v. Myriad held that isolated DNA is not patent eligible under Section 101. The reasoning was the claims at issue merely recited laws of nature (Mayo) or claimed a natural product (Myriad).

The Federal Circuit recently interpreted Myriad as applicable to natural products other than nucleic acids. The PTO Guidance similarly applies Myriad broadly to all natural products, instructing that a claim for a naturally occurring product is not patent eligible unless it recites something “significantly different” than the naturally occurring product. The PTO Guidance provides that a “significant difference” can be shown if the product claimed is “markedly different in structure” from naturally occurring products.

The current uncertainty about criteria for patentability of biological inventions is having a measurable effect on biotechnological innovation, and it may in turn affect economic development in critical areas.

The PTO has said it intended to revise its Guidance to clarify some of the issues raised with respect to eligibility. Biotechnological innovators are very interested in the revisions, but the new guidelines will not be binding on the courts, and it may be some time before the courts clarify the scope of patent eligibility under Section 101 in light of Mayo and Myriad.