Inventing DNA?

By Julie K. Staple

The first issue of Fish Tank this year (Volume 26, Issue 1) reviewed the question “Can a living organism be patented?” and concluded that U.S. patent law has evolved from “life is nature’s business” to “life can be patented if a human has invented something new.”

A recent case, REGENXBIO Inc. v. Sarepta Therapeutics, Inc., represents a new chapter in the continuing saga of a related issued, “can DNA be patented?”

The discovery of DNA as a molecular basis for genetic instructions is quite recent, and even now, our understanding of the role of particular genes, and genetic modification, in health and disease is still evolving.

Patent systems are designed to reward human ingenuity. New machines, processes, and compositions of matter are all considered patentable. Patent applications claiming exclusive rights to DNA sequences continue to raise questions about what can be patented. The idea that someone might “own” a piece of DNA raises a slightly uncomfortable question: can you really patent something that exists inside all of us?

For a while, perhaps surprisingly, the answer was yes. However, recognition that DNA can play a significant role in health, disease, and therapeutics creates an interesting tension. On one hand, isolating and characterizing specific genes, as well as developing methods for gene manipulation and therapeutic products, can require significant research investment, technical skill, and sophisticated effort. On the other hand, the underlying genetic material itself is not created by those processes, which presents a complicated question of where to draw a boundary between “ownership” of naturally occurring DNA sequences and genetically engineered DNA sequences.

As biotechnology evolves, legal systems have taken steps towards defining what qualifies a DNA sequence as an “invention” eligible for patent protection. A turning point in the debate over patentability of DNA sequences came in 2013, when the Supreme Court indicated that extensive effort alone is insufficient, and that groundbreaking, innovative, or even brilliant discovery does not by itself render a gene sequence patentable. (Assoc. for Molecular Pathology v. Myriad Genetics, Inc.) While this case limits patentability of naturally occurring DNA sequences, non-naturally occurring DNA sequences which are not a “product of nature” remained patentable.

For many people, the takeaway from that case is reassuring: no one can own your DNA but at the same time, genuinely new inventions which build on naturally occurring DNA are incentivized to help keep biotechnology moving forward.

A recent case reinforces the patentability of non-naturally occurring DNA sequences. In REGENXBIO case mentioned above, the United States Court of Appeals for the Federal Circuit considered whether genetically engineered cells could be patented. The technology used included splicing together two DNA sequences derived from two separate species into a single hybrid DNA molecule and producing a cell which contained the hybrid DNA. A lower court had initially said no, reasoning that the underlying DNA sequences inserted into the cells were naturally occurring. But the Federal Circuit reversed that decision, emphasizing that genetic engineering was used to create “a cell containing a molecule that could not form in nature on its own”.

In the end, patent law strikes a balance between encouraging innovation and keeping the building blocks of life open to all. The balance evolves as legal systems adapt when science drives entirely new kinds of questions.

Julie K. Staple is a partner at Fishman Stewart with over 20 years of experience working with scientists and biotech executives and entrepreneurs. She has written and prosecuted patent applications in diverse areas relating to biotechnology including molecular and cellular biology, biochemistry, pharmaceuticals, chemistry, cancer biology and bio-electrochemical systems. Prior to turning to the practice of intellectual property law, she received a Ph.D. in neuroscience from the University of Michigan in Ann Arbor. Her research interests included the mechanisms which regulate the molecular components of the neuromuscular junction and regulation of synaptic protein heterogeneity in CNS synapses.

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