The following contribution to our gene patenting symposium comes from Dan L. Burk, Chancellor’s Professor and founding faculty member at the University of California, Irvine School of Law.
In April the Court will hear oral argument in Association for Molecular Pathology v. Myriad Genetics on the single question, “Are human genes patentable?” At issue in the case are nucleotide sequences that, in their native state, predispose the individuals carrying them to breast cancer. Myriad has isolated and patented the sequences for use in diagnostic testing.
The case is before the Court a second time, having been previously remanded to the U.S. Court of Appeals for the Federal Circuit for reconsideration in light of the Supreme Court’s 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories, which limited the availability of patents for medical diagnostic techniques claiming a new way to apply the laws of nature. In each instance, the Federal Circuit rendered virtually identical opinions that were divided as to whether the “product of nature” doctrine excludes genomic DNA sequences (gDNA) from patentable subject matter.
These fractured decisions of the Federal Circuit graphically demonstrate the vacuous character of the “product of nature” doctrine. Judge Lourie, writing for the majority, emphasized the molecular differences between the claimed sequences and the equivalent DNA existing in human cells, finding that the isolated molecules were not exactly the structures found in nature. Judge Moore, concurring, focused on the function of the isolated gDNA sequences. Although skeptical of the gDNA claims, she was willing to find them directed to patentable subject matter because of new utility – that is, she believed that the claimed molecules could be put to uses that were not necessarily those of the molecules in their native state. And Judge Bryson, dissenting, argued that the gDNA molecules, while structurally different, were not materially different from those found in their native environment, making them unpatentable.
In other words, each of the Federal Circuit judges relied on a different rationale in applying the “product of nature” doctrine to the claimed invention. The triptych of appellate opinions adopted legal tests resembling, respectively, the characteristic rationales of patent law’s novelty, utility, and non-obviousness doctrines, as found in Sections 101, 102, and 103 of the present statute. Much like Edward Lear’s invented all-purpose adjective “runcible” – which has no proper meaning except whatever readers choose to give it – the “product of nature” doctrine similarly appears to have no proper meaning except that infused from other provisions of patent law.
That three judges with vast experience in patent law could find no distinct provenance for the “product of nature” doctrine separate from the other patentability criteria of Title 35 should come as no surprise, given that the doctrine has been cobbled together from dicta in older cases decided before the current patent statute was codified in 1952. Those cases addressed the judicially created concept of “invention,” which we know today as distinct statutory requirements of novelty, utility, and non-obviousness. Such dicta first coalesced in the Court’s 1980 Diamond v. Chakrabarty decision, in which the Court held that a genetically modified bacterium constituted patentable subject matter. The Court distinguished the bacterium, which was living, from natural products such as “a mineral found in the earth” on the ground that it had been altered through human manipulation.
But the cases from which the “product of nature” dicta were drawn do not read on current statutory standards. For example, in one of the key cases now cited for the “product of nature” proposition, American Fruit Growers v. Brogdex, an accused infringer challenged the validity of a patent on the product and process of impregnating the rind of whole fruit with borax to deter mold spoilage. Both of the lower courts readily found that such an article constituted a “manufacture” under the pre-1952 patent statute. Drawing on definitions of “manufacture” from tariff and importation statutes, the Supreme Court disagreed, asserting that the treated fruit was still fruit, and not a “manufacture” for purposes of the former patent statute. According to the Court, a “manufacture” must have new and distinctive properties, and protecting the fruit by adding borax conferred no new or distinctive properties on it.
The opinion nowhere mentions a “product of nature” doctrine, but rather addresses itself to whether the claimed invention fit the statutory definition of “manufacture.” With regard to the present discussion over Myriad’s DNA patents, this holding probably has little relevance to the interpretation of the analogous term in the current statute. It seems plain that in a post-Chakrabarty world, in which the Court has found that Congress intended Section 101 to extend to “anything under the sun made by man[kind],” the altered fruit is likely an article of manufacture, or at the very least, certainly a composition of matter under the present statutory subject matter categories.
Such fruit might not have been “inventive” at common law, but it seems to fit current statutory subject matter. Certainly fruit impregnated with borax is a human artifact that does not occur in nature. It may be that the borax in fruit rinds behaves exactly as it does “naturally,” but this is true of all components of human artifacts. On such reductionist logic, Chakrabarty’s genetically modified bacterium should have been a product of nature: he drew all the elements of the organism from nature, and each element – genes, the bacterial plasmid, and so on – behaved as they did in their natural state, since that is what molecules do. We nonetheless recognize that the combination constitutes something novel, useful, non-obvious, and patentable.
Similarly, Funk Bros. Seed Co. v. Kalo Inoculant Co. is another pre-1952 case, dealing with inventiveness, that is routinely cited as a key “product of nature” opinion. At issue in Funk Bros. was a mixture of six nitrogen-fixing bacteria that could be beneficially used by farmers to populate the root nodules of certain agricultural crops such as legumes. Before the patentee created the mixture of inoculants, the bacteria had been sold separately; indeed, until then the conventional wisdom was that they must be used separately because they would inhibit one another. The Supreme Court reasoned that the patent essentially concerned a new and perhaps more convenient form of packaging for known agricultural supplements that could have been purchased separately and easily combined by the purchaser. As part of that reasoning, the Court noted that there was nothing new or different about the bacteria, only the convenience of purchasing them mixed together.
Perhaps the simplest way to view such cases is to acknowledge that they were just wrongly decided, and have been replaced or overruled sub silentio by more recent opinions. The American Fruit Growers opinion seems plainly mistaken on its own terms: treating the fruit with borax manifestly conferred on it a new property that it did not have before, which was resistance to mold, and which fruit off a tree does not possess. Similarly, the bacterial mixture in Funk Bros. constituted a surprising and unexpected advance over the prior art – combining six species not found together in nature, allowing a single inoculum to be used for many crops even though it was previously believed that the properties of the different bacteria, if mixed, would cancel one another out.
But the most sensible way to avoid imputing the standards of novelty, utility, or non-obviousness to the subject matter inquiry is to simply follow the current statute as written, as the late Judge Giles Rich advocated in his response to the Supreme Court in In re Bergy. When Bergy was remanded to the Federal Circuit for reconsideration in light of the Supreme Court’s subject matter decision in Parker v. Flook, Rich chided the Supreme Court for the mess it had made by co-mingling the concepts of novelty, utility, non-obviousness, and subject matter. He noted that the Section 101 subject matter provision simply requires the claimed invention to fit into the categories of machine, process, manufacture, or composition. Questions of novelty, utility, or obviousness are addressed by other sections.
The difference between the current statute and the pre-1952 inventiveness cases has been raised in the Myriad litigation, at the trial court level. There, Judge Sweet correctly noted that this is not how the Supreme Court has treated these cases, relying on them as subject matter opinions. A district court judge might understandably not feel himself in a position to reorient from the trial bench the Supreme Court’s proof-texting of its own decisions. On the other hand, the Supreme Court could certainly correct course, and Myriad is an opportunity to do so.
However, if the Court’s recent subject matter opinions in Bilski v. Kappos and Mayo v. Prometheus are any indication, the Court is likely in the Myriad case to dig itself deeper into the hole it has been excavating in the subject matter area. When something resembling Judge Rich’s approach was proposed to the Court by the Solicitor General’s office in Prometheus, the Court responded with a bizarrely circular justification for rejecting this approach, pointing out that neither Section 102 nor Section 103 speak to natural law as part of the prior art. In other words, because neither section was crafted to perpetuate the mistake the Court had been making in Section 101, the Court was unwilling to rely on them to correct the mistake, preferring to continue down the same wrong road it has been taking for some decades.