[author: Leslie Fischer*]
Recently, I had the privilege of speaking at the annual meeting of the American Society of Pharmacognosy in Colorado. Members of this scientific association are dedicated to identifying and isolating natural products from various sources, and finding use for these isolated compositions as medicines, cosmetics, food additives, etc. I don't imagine this group would normally be particularly excited to hear a patent attorney speak for an hour, but these are troubled times for natural products, and these folks were, indeed, troubled. Unfortunately, by the end of the evening, no one was feeling more positive about the patent eligibility of natural products in the United States. I don't relish going back next year with the news that the patent eligibility of claims reciting natural products has gotten even worse, which it has -- thanks to Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015).
In subject matter eligibility (SME) cases, "natural products" traditionally fall within the judicial exception (JE) to 35 U.S.C. §101 referred to as a "natural phenomenon," the other two JEs being "abstract ideas" and "laws of nature." When we look to historical and modern court decisions addressing the eligibility of natural products, we find that product claims have been at issue, e.g., American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1 (1931) (claims to oranges), Parke‐Davis & Co. v. H. K. Mulford Co., 189 F. 95, 103 (S.D.N.Y. 1911) (claims to adrenalin), Diamond v. Chakrabarty, 447 U.S. 303 (1980) (claims to genetically-modified bacteria), Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013) (claims to DNA), In Re Roslin, 750 F.3d 1333 (Fed. Cir. 2014) (claims to cloned sheep). The SME analysis used for product claims is quite different than the SME analysis used for process claims, and this makes sense -- natural products are tangible and concrete things, whereas abstract ideas and laws of nature are intangible concepts. For product claims reciting natural products, courts have asked (in one way or another) whether the composition or manufacture has some meaningful difference from its naturally‐occurring counterpart, whereas for process claims reciting abstract ideas or laws of nature, courts have asked (in one way or another) whether the idea or law recited therein is applied in a meaningful way. Ariosa is the first case that I am aware of in which an application test is used to analyze the SME of a process claim simply because it recites a natural product.
The process claims at issue in Ariosa relate to methods of detecting fetal DNA in maternal plasma, and, in some claims (e.g., claim 21 and 25), using that detected fetal DNA to provide a diagnosis. The Federal Circuit explains in the decision that the claimed processes begin and end with a natural phenomenon, and then nonchalantly concludes that the process claims are directed to naturally-occurring phenomenon (also called a "naturally‐occurring thing" by the panel). The panel is fairly clear that the alleged ending natural phenomenon is paternally‐inherited fetal DNA derived from maternal plasma (given the moniker "cell free fetal DNA" or "cffDNA" in the decision). But the panel is less clear as to what, exactly, is the beginning natural phenomenon, at one point identifying it as the existence of cffDNA in maternal blood ("It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon.") but in other passages suggesting that cffDNA itself is both the beginning and ending natural phenomenon ("Thus, the claims at issue, as informed by the specification, are generally directed to detecting the presence of a naturally occurring thing or a natural phenomenon, cffDNA in maternal plasma or serum. As we noted above, the claimed method begins and ends with a naturally occurring phenomenon.").
Having identified a natural phenomenon (or two)? in Sequenom's method claims, the panel was faced with a significant decision -- what relevant precedent to apply? cffDNA is, after all, a natural product, but historical and modern SME decisions related to natural products (e.g., American Fruit, Chakrabarty, Myriad, Roslin) analyze product claims, not process claims. And, historical and modern SME court decisions that analyze process claims (e.g., Parker v. Flook, 437 U.S. 584 (1978), Diamond v. Diehr, 450 U.S. 175 (1981), Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. __, 132 S. Ct. 1289 (2012), Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S.__, 134 S. Ct. 2347 (2014)) deal with very different JEs, i.e., abstract ideas and laws of nature. Each of these lines of cases is readily distinguishable. Undaunted, the Ariosa panel creates an entirely new rule of law, ostensibly derived from Mayo, but sounding rather like Flook. The Ariosa SME test may be broadly stated as follows: for process claims that encompass a natural product, the process steps themselves must be new and useful. While this SME test closely resembles Flook in that the process steps themselves must be inventive, it has a significant difference -- Flook's inventive application test has never been triggered by anything other than intangible JEs, i.e., abstract ideas and laws of nature. In contrast, Sequenom's claims recite only a tangible natural product.
Why is this extension of Flook problematic? First, the Flook (and Mayo) application‐based tests were designed to ensure that an intangible JE is meaningfully applied. Yet...
