A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.
This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of the role of patents in the emerging field of microbiome research. Scientists have recently begun to appreciate the important role played by the human microbiome, the community of microbes that lives within each of our bodies, in preventing and treating disease. The microbiome has been linked to autoimmune disorders, mental health conditions, and a range of conditions affecting our intestinal systems. Put simply, research involving the microbiome has the potential to change the future of medicine.
There’s just one problem: the microbiome can’t meaningfully be patented. Several doctrines within patent law will make it extremely difficult for companies to obtain and enforce patents like the ones that are so readily available in most areas of medicine. Drawing on patent doctrine, patent searches, and interviews with scientists and lawyers, this Article demonstrates that companies are developing microbiome-based therapies largely in the absence of patent protection. Instead, the companies are relying on other innovation incentives to fill the gap.
The microbiome’s unpatentability presents an opportunity to evaluate whether patents are truly necessary for the development of new drugs. Congress, the NIH, and the FDA have implemented many innovation incentives throughout the development process, and we should not be astonished that removing a single such incentive, patent law, does not disrupt the entire system. Perhaps scholars should reconsider, if only selectively, our focus on patents as an irreplaceable driver of pharmaceutical innovation.
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