The practice of patenting genetic material is currently under sharp attack. Recent litigation has forced the courts to grapple with the doctrinal basis for patenting DNA sequences identical to those found in nature. Faced with conflicting authorities and difficult policy questions, courts have leaned heavily on history to guide — or at least to justify — their decisions.
This article explores the history in question. It traces the patent law’s changing treatment of “products of nature” in an attempt to untangle the origins of present-day patentability arguments. The evidence suggests that the historical foundations of the bar on patenting products of nature are surprisingly shaky. The article also reveals how isolated biological materials first came to be patented. This task, I argue, requires looking not only to court decisions, but also to the history of patent practice. My principal vehicle for doing so is the case of Parke-Davis & Co. v. H. K. Mulford Co, a century-old decision by Judge Learned Hand, which now stands as a central (and much disputed) precedent for the patenting of DNA sequences. Parke-Davis arose at a key moment in the sociology of intellectual property, when the American pharmaceutical industry first learned to embrace the power of patents.
The article shows how Parke-Davis came to prominence in half-understood form during the biotechnology era, and how the decision’s original rationale suddenly seems poised to control the Federal Circuit’s latest thinking on gene patentability.Beauchamp concludes -
Anyone looking for a historical “right” answer on the product-of-nature question will be disappointed. For all the spirited attempts to impose consistency on the case law of natural subject matter, it remains a kaleidoscope of doctrine: cases come at the question from different angles, in different historical contexts, with premises ranging from pragmatic to formalist and from patent-friendly to fiercely patent-skeptical. The same applies to the history of patent practice. Based on the evidence gathered above, we can say that patents for isolated (and/or barely modified) products of nature have been issued at some times, disdained at others, and have in some instances, such as the hormone patents of the 1930s, issued from the Patent Office even as the judicial climate turned against them.
Even so, there are a few lessons we can draw from the history. Two stand out. One is that the historical foundations of the bar on patenting products of nature are surprisingly shaky. The prohibition on patenting laws of nature represented a separate set of concerns about scope and abstract claiming, which failed to supply either clear authority or a clear nature/application-of-nature guiding line for product patentees. Meanwhile, before the twentieth century, there was no jurisprudential category of “natural” products, only a set of rules about novelty and distinctiveness from the prior art that applied across technologies, without regard to natural origin. The purported great exception, Ex parte Latimer, was surprisingly marginal: unknown to the courts, it may have presented occasional claim-drafting challenges for patentees such as Takamine, but did not effectively block the patenting of broadly natural subject-matter, either in its own time or later. Only in the 1920s did a clutch of stronger product-of-nature statements emerge from the federal circuit courts, staking out categorical language against patenting products of nature, but giving no indication that they had a precedential basis to rest on. By that time, of course, the law had opened up a space for patenting isolated natural substances. Again, this development emerged without a natural/non-natural distinction being made; instead, the doctrine of “useful difference” arose in the chemical sector, was duly applied by Learned Hand in the Parke-Davis case, and proved to be a legal gateway for isolated biological compounds that could demonstrate sufficient practical usefulness to constitute patentable difference over the prior art. As a historical matter, the traditional understanding of the doctrine is backwards: rather than appearing as an “isolation and purification exception to the ban on patenting products of nature,” the isolation-and- purification patents came first, and the case law against patenting natural products arrived only later.
Time will tell if the useful difference test becomes the framework for DNA patenting in the future. As I have suggested, the idea that great enough new utility can convey sufficient novelty on an isolated natural product is not a major feature of the two cases (Funk and Chakrabarty) allegedly guiding the Federal Circuit’s Myriad opinions. Reading those cases that way, as Judges Moore and Bryson arguably do, depends on imbuing them with the spirit of Judge Hand’s Parke-Davis ruling. This approach allows for a highly pragmatic rule of patentability, focused on rewarding valuable inventions if the circumstances warrant, and deployable (as Judge Moore’s opinion shows) to avoid the disruption and recrimination that would accompany mass invalidation of isolated DNA patents. Such pragmatism would be much in the tradition of Learned Hand. Whether it is the best course or not, the courts will have to decide.
Finally, the history tells a story about how patent law and its wider context change each other. Formal legal doctrine aside, the events of the adrenalin battle left their mark on the medical and scientific world in which they arose. Patenting in the life sciences became an un-ignorable fact of life in the twentieth century, and—whatever the outcome of Myriad—will continue to be in the twenty-first. From where we stand now, it is striking to look back to the point when the American pharmaceutical industry and the medical profession turned away from patent-skepticism and embraced the propriety of patent rights. Standing at the threshold of these events, the Parke-Davis story reminds us that an intellectual property culture is not inevitable, but develops piece by piece. Learned Hand’s decision a century ago was another brick in the wall.