The modern world is full of unexpected discoveries that touch every aspect of our lives. Nylon, Velcro, Teflon, SuperGlue, and Corn Flakes are familiar examples of “serendipitous” discovery. Serendipity can occur in several ways – for example, when an experiment with an expected outcome produces something unexpected, or an experiment with an uncertain outcome produces something valuable.
Another common way to discover the unexpected is to determine a new use for an old thing. This happens frequently in the pharmaceutical industry, when firms seek new indications for drugs facing soon-to-expire patents. Examples of successful repurposed drugs include Viagra (originally purposed for angina), Rogaine (hypertension), and Ozempic (diabetes management). New-use drug patents stem from these serendipitous moments.
But new-use drug patents have weaknesses. Patent claims are often avoided because they’re often narrow in scope. Drugs still covered by a patent for an old use will dominate the new-use patent until the earlier one expires. Off-patent drugs can be sold, prescribed, and administered for an older, unpatented use. Generics can avoid infringement if the patented use is off-label, and enforcement can be tricky, because drug firms rarely sue patients, doctors, and pharmacists.
Moreover, as patent law expert Sean Seymore details in his article “Patenting the Unexpected,” serendipitous discovery of a new use for an old drug should often fail patent law’s novelty requirement. He argues that the unanticipated, beneficial side effects which constitute the new use are inherent characteristics of the original drug. The inherent characteristic has always existed, even if doctors and patients were unaware. While inventors often do not face such novelty challenges today, the possibility remains.
“Serendipitous discoveries involving repurposed drugs should face a novelty hurdle under current patent theory and doctrine,” he writes. Seymore also argues, quite controversially, that serendipitous discoveries are not conceived. Conception—the formation of the complete invention in the inventor’s mind before it is made—is a bedrock principle of patent law. “It’s now time to reexamine serendipitous discoveries in patent law,” he writes. “They don’t align with traditional invention theory.”
“Patenting the Unexpected” examines how serendipitous discoveries are currently patented and the novelty issue they face, with a particular focus on repurposed drugs. He then proposes an alternative theory of patentability for such discoveries that aligns with his broader effort to “realign patent law with the realities of invention in modern science.”
Seymore’s alternative theory achieves two central goals. The first is to treat serendipitous discoveries as inventions (and the discoverers as inventors), which removes the conception issue while remaining true to the “heart” of patent law: invention. The second addresses the novelty problem by creating a path to patentability for some newly discovered uses of repurposed drugs.
“Given the importance of serendipity in drug discovery and other fields that are highly dependent on patenting, hopefully this article will help focus attention on the need for patent law and policy to better accommodate serendipitous discoveries,” Seymore concludes.
“Patenting the Unexpected” is forthcoming in the Federal Circuit issue of Volume 75 of the American University Law Review. Sean Seymore is the Centennial Professor of Law at Vanderbilt Law School.
