Navigating The Isolated DNA Patent Eligibility Jungle

Article by Debora Plehn-Dujowich and Roy Isaac

Introduction

For over 150 years the Supreme Court has provided three categories of exceptions to patent eligibility under 35 U.S.C §101: abstract ideas, laws of nature, and physical phenomena, since these are the basic tools of scientific and technological work.1 The Roberts Court has revised the standard for review of "abstract ideas" and "laws of nature" in Bilski v. Kappos and Mayo v. Prometheus, respectively. The Court's much awaited decision in AMP v. Myriad addressed the "physical phenomena" exception with respect to patents claiming isolated DNA.2

The recent decision in Myriad will have an impact reaching far beyond the patentability of isolated DNA. Patent eligibility for isolated DNA is crucial for the continued growth of the biotechnology and diagnostics industries. The decision, disallowing patenting of isolated DNA, will have a chilling effect on these industries. Furthermore, the decision casts a cloud on the validity of thousands of issued patents and pending applications. In contrast. the application of the holding by the lower courts broadening the exception for natural products in general would have had an even wider impact in industries such as those involving petroleum products and natural product-derived pharmaceuticals. While the unanimous decision by the Supreme Court carefully avoided a broad new directive, its application by the lower courts and the Patent and Trademark Office is yet to be resolved. The decision, which will be discussed in more detail below, disallowed the patenting of "isolated DNA" while finding that cDNA is patent eligible. The decision is an implicit rejection of obviousness-type analysis in patent eligibility determination for products of nature.

The significance of the issues raised in the Myriad case is evident from the number of amicus briefs submitted in the case and the diversity of the parties submitting them.3 Many amici expressed concern about reduced investment and research in the biotechnology industry that may result from lack of patent protection for isolated DNA and other biological products, while others expressed public policy concerns about increased cost and impediments to research.4 Some of the amici were concerned about the ethical issues involved in patenting genetic code.5 This review focuses on the legal principles involved in the patent eligibility question and the procedural history of the case.

A review of the significant cases as well the history of AMP v. Myriad will provide the necessary background to understanding the evolution of the "products of nature" doctrine. The recent decisions in Bilski and Prometheus have addressed the patentability of business methods and method of treatment claims.

In Bilski, the Court rejected the use of the "machine-or-transformation" test as the sole analytical tool for determining patentability of method patents. In rejecting the "machine-or-transformation" test, the Court stated that, "[it] is unaware of any ordinary, contemporary, common meaning of "process" that would require it to be tied to a machine or the transformation of an article." While the Court's ruling allows for patenting of business methods without tying the methods to a machine or transforming an article, the claimed method in Bilski was rejected as being directed to patenting an abstract idea. The Court concluded that the claims were directed to patenting both the concept of hedging risk and the application of that concept to energy markets. In the Court's view, the claims merely explained the basic concept of hedging by reducing it to a mathematical formula which it considered as an unpatentable abstract idea. Claims that included limitations to energy markets were considered token post-solution activity that were not significant enough to render the unpatentable abstract idea of hedging patentable.6 With respect to claims directed to hedging that were limited to the energy market, the Court looked at the claim elements apart from the abstract idea to determine if the additional elements were merely post-solution activity. The "use of well-known random analysis techniques to establish some of the inputs into the equation" was found not significant enough to render the claims patent eligible.7 The Court's decision in Bilski was followed by its unanimous decision in Mayo v. Prometheus.8 The claims in Prometheus were directed to processes that help doctors determine whether the used concentrations of thiopurine drugs were too low or too high. In the Court's view, the relationship between the concentration of thiopurine metabolites in the blood and the likelihood that the drug dosage will be ineffective or harmful represented a natural law, and additional steps in the claims did not transform the natural law to a patent-eligible process. The Court held that the additional steps apart from the natural laws themselves need to be more than "well-understood, routine, conventional activity previously engaged in by researches in the filed" to render the claims patent eligible.9 The Court further stated that, "simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable."10

While Bilski and Promethus involved process patents, the claims at issue in Myriad are directed to product claims. There are several seminal cases in Supreme Court jurisprudence that set out a framework for analyzing product claims for patent eligibility. The most significant of these cases is Diamond v. Chakrabarty, decided by the Supreme Court in 1980. In Chakrabarty, the researchers discovered a process by which four different plasmids, capable of degrading four different oil components, could be transferred to and maintained stably in a single Pseudomonas bacterium, which itself has no capacity for degrading oil.11 The Court held that the claims were directed "not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter—a product of human ingenuity "having a distinctive name, character and use.'"12 The presence of new characteristics was the distinguishing factor in comparison with the mixture of bacteria that were held ineligible in Funk Brothers v. Kalo.13. In contrast, the bacterium in Chakrabarty exhibited markedly different characteristics from those found in nature, and thus, meeting the threshold standard for patent eligibility.

The question of whether isolated natural products were patent eligible was considered in several lower court decisions.14 In a decision by Judge Learned Hand, Parke-Davis, a purified form of adrenaline was held patentable since the purification results in a product with such distinct characteristics that it becomes for every practical purpose a new thing commercially and therapeutically.15 The decision in Parke-Davis was followed by the Court in Merck v. Olin in finding a purified form of Vitamin-B12 patentable. Referring to the concentrated purified form, the Court stated that "it did not exist in nature in the form in which the patentee produced it and was produced by them only after lengthy experiments." Furthermore, "every step in the purification of a product is not a patentable advance, except, perhaps, as to the process, if the new product differs from the old 'merely in degree, and not in kind.'"16 In the case of...