​​​​Inventing Life?

By Julie K. Staple

Advances in molecular biology have an uncanny knack of doing two things at once: saving lives and giving U.S. patent law a persistent headache. As basic science grows more sophisticated, human genomes are sequenced before lunch and viral genes are edited by dinner time. Meanwhile, patent law must continually evolve in step with the new techniques to determine: What, exactly, counts as an invention? Can a living organism be patented?

For much of U.S. history, patent law considered living things as “nature’s handiwork” and therefore unpatentable. You could patent a machine, a process, or maybe a clever mouse trap, but a plant or animal? Absolutely not. If it grew, breathed or photosynthesized, it was off-limits.

Plants enter the chat (1930)

Plant breeders advocated for exclusive rights for their novel plants that were grafted or otherwise propagated by hand since their innovations were often replicated and sold by others without authorization. The Plant Patent Act of 1930 provided limited rights based on the rationale that the work of the plant breeder “in aid of nature” produced a patentable invention. This was the first official acknowledgement that some living things, when sufficiently shaped by human ingenuity, might qualify for patent protection.

Microbes Break the Rules (1980)

A turning point came in 1980 with the Supreme Court’s decision in Diamond v Chakrabarty. The case involved patentability of a genetically engineered bacterium capable of breaking down oil spills.

The Court observed that the engineered bacteria are “a result of human ingenuity” and not merely products of nature. In one of the most quoted lines in patent law, the Court decision referred to “anything under the sun that is made by man” as patentable subject matter.

OncoMouse (1988)- The First Animal Patented in the U.S.

The OncoMouse was genetically modified to include a gene which increased the probability of cancer in the mouse. The development of cancer in a predictable way allowed for improvements in the safety and efficiency of anti-cancer research and faster development of anti-cancer therapies.

The Supreme Court Defines Boundaries

More recently, patents on genetically modified organisms, isolated DNA sequences, and biotechnology inventions more generally became common. However, the courts continue to refine boundaries around what counts as a natural product versus a human-made invention.

In recent decades, Supreme Court cases like Mayo (Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) and Myriad (Association for Molecular Pathology v. Myriad Genetics (2013) reined things in, clarifying that naturally occurring genes and biological relationships cannot be patented, even if they are isolated. However, for modified or engineered versions, patents may still be obtained.

U.S. patent law has evolved from “life is nature’s business” to “life can be patented if a human has invented something new”. It’s a balance between encouraging innovation and making sure no one ends up owning biology itself.