Not all ideas are patentable. Patent applicants may obtain a patent for a new and useful process, machine, manufacture, or composition of matter, with some notable exceptions. The United States Patent and Trademark Office will not grant patents for abstract ideas, laws of nature, or natural phenomena. It’s worth noting that, at some level, all inventions embody abstract ideas, laws of nature, or natural phenomena, so the line between patent eligible and patent ineligible inventions may appear blurry.
Medicine-based patents may use laws of nature or natural phenomena. A patented invention claiming a method of preserving hepatocyte cells may rest upon an understanding that hepatocytes cells can survive multiple freeze-thaw cycles. A patented invention claiming a synthetic, complementary DNA (cDNA) may reflect an understanding of naturally occurring DNA segments. A patented invention claiming a method of treating schizophrenia patients by administering iloperidone based on genetic testing may apply an understanding of relationships between iloperidone, specific gene metabolism, and heart rhythm and electrical activity. These examples show that “patentable” inventing may start with “unpatentable” explaining of laws of nature or natural phenomena.
I spoke with Dr. Steven A. Fisher, a Principal Investigator with the University of Maryland School of Medicine. His research staff shown above includes Dr. Jeanine Ursitti, assistant professor, Dr. Mariam Meddeb, medical resident, and Dr. Myo Htet, post-doctoral fellow. He has spent decades researching and explaining human heart and vascular function. Dr. Fisher distinguishes between research scientists and clinical or translation scientists. For a research scientist, “The hope is that someday, something you discover will be useful to understanding and treating human disease.” Dr. Fisher further explains that “research is slow and grueling, and it is rare, and uncommon, to lead to a new therapy.” A research scientist may seek to understand a mechanism for disease, and ask, “What makes a cancer cell a cancer cell?” In contrast, a clinical or translation scientist may apply an understanding of the cancer cell to contemplate, ““How do I kill the cancer cell?”
The role separation between the research scientist and the clinical scientist may parallel the separation between patent ineligible subject matter and patent eligible subject matter. Similarly, the line separating the roles may appear blurry when, for example, understanding a new mechanism of disease leads to inventing a new method to address the disease. Dr. Fisher researches vascular smooth muscle function in the regulation of blood pressure. High blood pressure remains the leading treatable and thus preventable cause of death world-wide. He notes that “there has been an explosion of information” on this topic, particularly with respect to non-human subjects. While researching blood pressure mechanisms in non-human subjects, Dr. Fisher fluidly segued into researching how similar mechanisms function in human subjects. That research led to an invention. After 25 years as a research scientist, Dr. Fisher recently filed his first patent application based on his research of gene editing. I asked Dr. Fisher what prompted him to file a patent application at this point. He replied, ““This has a chance of being a successful therapy.”
Exploratory research may not lead to an issued patent, but many issued patents rely on exploratory research results. We would be hard-pressed to advance medicinal science without continuously improving our understanding of laws of nature and natural phenomena. I want to thank Dr. Fisher for sharing his story about researching and inventing. To learn more about Dr. Fisher’s research, please visit http://www.medschool.umaryland.edu/profiles/Fisher-Steven/.
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