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.
TABLE OF CONTENTS INTRODUCTION I. THE ROLE OF PATENT LAW IN THE PHARMACEUTICAL INDUSTRY A. Patents' Importance to the Pharmaceutical Industry B. Patents as Part of a Broader Innovation Ecosystem for Pharmaceuticals II. THE EMERGING FIELD OF MICROBIOME RESEARCH A. Exploring the Microbiome B. Microbiome-Based Technologies as Pharmaceuticals III. OBSTACLES TO PATENTING MICROBIOME-BASED THERAPIES A. Analogizing Microbiome-Based Therapies to Traditional Pharmaceutical Products B. Doctrinal Barriers to Patenting C. Practical Barriers to Enforcement D. The Existing Patent Landscape IV. ALTERNATIVE APPROACHES TO MICROBIOME INNOVATION A. Industry Survey B. Interview Results V. RETHINKING THE CONVENTIONAL WISDOM A. Revising the Paradigm for Pharmaceutical Innovation B. Implications for Policy and Scholarship CONCLUSION INTRODUCTION
The pharmaceutical industry has long been held out as the paradigm example of the ability of patents to promote innovation. The process of developing new drugs is long, expensive, and risky, and scholars and policymakers argue that without the availability of patent protection, pharmaceutical companies would not make the investments needed to bring new drugs to market. (1) If anything, the prevailing scholarly debate is over whether patent protection for pharmaceuticals is too short, rather than too long, (2) as drugs have still not been developed for many diseases that are devastating to our healthcare system. (3)
An emerging new field of drug discovery now provides a test of the veracity of this conventional wisdom. Over the past decade, there has been an explosion of scientific interest in the microbiome: the community of microbes that lives within each of our bodies and exists in a symbiotic relationship with us. (4) Scientists and pharmaceutical companies have become interested in using the microbiome to fight and even prevent disease. If the conventional wisdom is to be believed, these companies must be applying for and utilizing robust patent portfolios as they traverse the FDA approval process. But they are not.
At one level, this Article presents a case study of the role of patent law in the emerging field of microbiome research. The dozens of companies already operating in this space are largely eschewing traditional patent protection, both because doctrinal barriers exist to obtaining patents and because practical barriers exist to their enforcement. Instead, these companies are relying on a range of other innovation incentives to protect their investments. Some of these incentives have been specifically designed to operate in the pharmaceutical space, such as FDA exclusivity periods, while others are more general, such as trade secrets. The picture is one of a growing, thriving sector of the biotechnology industry, operating largely without a tool that has long been viewed as an essential incentive mechanism.
Yet at another level, this Article challenges the conventional wisdom about the centrality of patents to the drug-development process. If patents are not necessary to encourage companies to move into this area of pharmaceutical investment, are they truly necessary to the industry as a whole? Over the last several decades, fears about insufficient investment in pharmaceuticals have led Congress, (5) the NIH, (6) and the FDA (7) to develop and implement a broad range of innovation incentives operating on different actors at different points in the development process. Many of these incentives have duplicated at least some of the functions of patent law itself. (8) Perhaps we should not be astonished that removing a single one of these incentives, patent law, does not disrupt the entire system.
Part I of this Article considers the role played by patent law in the pharmaceutical industry. It begins by explaining the ways in which patents are thought to operate to promote investment in pharmaceuticals before situating them within a broader context of innovation incentives operating in this area. Part II first provides a brief orientation to the emerging field of microbiome research, explaining how scientists have linked the microbiome to human disease and considering the many ways in which companies have begun using the microbiome to develop medical treatments. Part II goes on to consider the ways in which the innovation incentives described in Part I might play out in the microbiome context.
Part III then introduces a key problem: the microbiome can't be protected by patents in the way that other pharmaceutical technologies can. First, there are multiple doctrinal barriers preventing these companies from obtaining product patents covering their therapies. The patentable subject matter, written description, and enablement requirements will pose obstacles here. Second, even where companies have obtained less valuable method claims, they will confront enforcement difficulties that do not arise in the context of other pharmaceuticals. Difficulties surmounting the divided infringement bar and practical concerns involving detection and enforcement will create problems. Importantiy, these concerns are not merely doctrinal ones drawn from case law--they are supported by searches of granted patents.
Part IV goes on to present the results of a series of structured interviews I held with people in the field: scientists from both industry and academia, the IP attorneys advising them, and technology-transfer officers at universities. In short, companies are moving forward and developing microbiome-based therapies with thin, if any, patent protection. Instead of relying primarily on patent protection, companies are increasingly relying on other innovation incentives to fill the gap left behind. For example, companies are relying on trade secrecy to protect their manufacturing processes and donor information, and they are looking forward to the prospect of twelve years of biologic-drug exclusivity after FDA approval. Many deals have been executed between universities and small companies or between small companies and large companies without patents to facilitate them.
Part V revisits the conventional wisdom around pharmaceutical patents in light of this case study. The unpatentability of the microbiome presents an opportunity to evaluate whether patents are truly necessary for the development and commercialization of new treatments, not only in the microbiome context but also more generally. To the extent that the rest of the innovation ecosystem that policymakers have built up around pharmaceuticals is largely sufficient to entice drugs through the development process, scholars should reconsider our academic focus on patents as an irreplaceable driver of innovation incentives.
THE ROLE OF PATENT LAW IN THE PHARMACEUTICAL INDUSTRY
Patent scholars, industry representatives, and policymakers often debate the role our patent system plays in different technological sectors. However, there is general agreement on one thing: if there is any field where patent protection is critical, it is the pharmaceutical field. Due to the high costs of researching diseases, developing treatments, and traversing the FDA approval process, patents are thought to be necessary to encourage pharmaceutical companies to develop and commercialize new therapies. In this Part, I will first unpack this conventional wisdom, explaining why patents may be of special importance in this field relative to other technological areas. I will then situate patents within the broader innovation ecosystem surrounding pharmaceuticals, noting their similarities and differences to other special incentives created for these technologies.
Patents' Importance to the Pharmaceutical Industry
The patent statute is...