Dolly and Alice

摘要

All of the cases considered here struggle with long-standing uncertainties in the law of patentable subject matter. Section 101 of the American patent statute sets forth four categories of patent eligible subject matter: processes, machines, articles of manufacture, and compositions of matter.12 These categories have been read by the Supreme Court as broad, inclusive, and representative.13 The statute is silent as to what does not constitute patentable subject matter;14 presumably we can infer that inventions that lie outside the four broad and inclusive categories fail the requirements for subject matter. But, given that the explicit categories are highly inclusive, relatively little should fall outside their scope. Some excluded categories have over the years been supplied by the courts as a judicial gloss on the statute: abstract ideas, laws of nature, products of nature, and perhaps one or two related categories such as mental processes, are deemed to fall outside even the broadest reading of the statutory language.15Myriad's relationship to the Supreme Court's other subject matter cases is also a bit of a muddle. The Myriad opinion is sandwiched in time between the Supreme Court's previous opinion in Mayo v. Prometheus and the later Alice Corp. opinion. Alice skips backwards over Myriad to draw on Mayo for its analysis, attempting to distill the logic of Mayo into a workable standard. But Alice makes only a passing mention of Myriad, just as Myriad make little mention of Mayo.26 This could perhaps be attributed to the difference in the inventions at issue in the cases. Like the majority of the Court's subject matter decisions, whether contemporary or classical, both Alice and Mayo concern process claims, where the prohibited subject matter is either an abstract idea or a law of nature. The two categories are themselves sufficiently abstract that it is often hard to tell which is which, or which is being invoked in a given instance to exclude an invention from Section 101.27The remainder of the opinion relies on cases of greater relevance, although much of the reasoning remains problematic. The Federal Circuit panel looks to Myriad primarily for a dubious comparison between Dolly's nuclear genetic material and the ineligible genomic DNA sequences claimed in the earlier case.38 Dolly's primary claim to fame was that her cellular nuclei were derived from an existing adult sheep.39 Mammalian cells can be divided into somatic cells that are constituent of the body and have a full genetic complement, and gametes such as oocytes or spermatozoa that conjoin for reproduction and have only half the genetic complement of mature somatic cells.40 Dolly was created by a process of transferring the nuclear material of a somatic cell into an enucleated oocyte, which then developed into an embryo and gestated under the direction of the transferred genes.41In addition to the rather strained analogies to Myriad, the Roslin opinion offers some strained analogies to other Supreme Court opinions dealing with patents on biological inventions. The Federal Circuit panel compares the claimed clones to the inventions considered by the Supreme Court in Funk Brothers v. Kalo Inoculant66 and in Diamond v. Chakrabarty.67 The former decision concerned a mixture of agriculturally beneficial bacteria, which was held unpatentable under the pre-1952 patent statute.68 The Chakrabarty case concerned a modified microorganism, capable of digesting petroleum, which was held patentable under the current statute.69 Although often cited with regard to patentable subject matter, neither of these decisions is an especially good guide to determining the relevant exceptions to patent eligibility under Section 101. As I have pointed out elsewhere, Funk Bros. was decided prior to the enactment of the current statute, under a different standard,70 and Chakrabarty held that living organisms are patentable subject matter, not that the claimed invention was (or was not) a product of nature.71One might nonetheless expect that, had the Federal Circuit panel in Roslin applied the Alice test to the clones, the claims would have failed the first prong. The panel seemed determined to analogize the clones to the Myriad gDNAs rather than the Myriad cDNAs, and given that the Myriad opinion offers little in the way of principled distinction between its gDNA and cDNA holdings, the Federal Circuit panel may have felt compelled to force the Roslin clones into the first prong's products of nature box. In some senses, the Roslin panel's analysis might be viewed as encompassing only the first prong of the Alice test; the analysis looks for a product of nature and then stops. To the extent that Roslin follows Myriad, this might be expected; as I have indicated above, the Myriad outcome seems to res