Patents and Pleistocene Park

'How to Permit Your Mammoth: Some Legal Implications of 'De-Extinction'' by Norman Carlin, Ilan Wurman and Tamara Zakim in (2013) 33 Stanford Environmental Law Journal comments

Extracting DNA from ancient specimens and using cloning technology to resurrect extinct species has become a staple plot device of wildly popular science fiction novels and films since Jurassic Park. But the prospect that extinct animals may live again no longer belongs solely to the realm of science fiction. “De-extinction” is coming closer to reality, as scientists now are experimenting with a number of methods for resurrecting extinct species. No method will bring back the dinosaurs; it has been too long since the Jurassic era for their DNA to survive. It may well be possible to “resurrect” more recently extinct species, however, such as the Pyrenean ibex, the passenger pigeon, or possibly even the awe-inspiring woolly mammoth, in the not too distant future.

While some discussion of these exciting developments has appeared in the scientific and popular press, most articles focus on technical and ethical issues: can we do this, and should we? For purposes of this Article, we treat de-extinction, in some form, as a scientifically reasonable future prospect whose legal implications should be considered in a practical manner. For the most part, we assume that if de-extinction can feasibly be accomplished, someone will undertake the effort if for no other reason than because it would be irresistibly thrilling to do so. Jurassic Park itself may be unattainable, but a somewhat more plausible Pleistocene Park, populated with mammoths and aurochs, would generate nearly as much popular excitement. Other motivations for pursuing de-extinction might include the reintroduction of “keystone” species for purposes of reviving whole ecosystems, with substantial environmental benefits.

Therefore, this Article explores the implications of de-extinction under existing law. Part I introduces the current science of de-extinction and the different methods its proponents are pursuing. The methods are worth reviewing in some detail, since the implications of those methods are significant for legal outcomes. Part II discusses the ESA, whether it would apply to de-extinct species, and how it should be applied. Part III addresses permitting and evaluation of environmental impacts under NEPA for projects to reintroduce de-extinct species into the wild, by analogy to EISs for reintroductions of living but locally extirpated species into regions that they formerly inhabited and EISs for releases into the environment of genetically modified organisms (GMOs). Part IV explores the regulation of resurrected species as GMOs, given that two of the three de-extinction methods being pursued would result in GMOs. Part V considers the patentability of such GMOs. Part VI summarizes our conclusions.

The authors ask would "resurrected species be patentable"

This is no minor issue. Even where the ultimate goal is release and re-establishment of the species (or facsimiles) in the wild, projects could generate considerable revenue—which could be used to recover past costs or fund de-extinction efforts for additional species—from exclusive rights to exhibit resurrected species in a Jurassic or Pleistocene Park. Moreover, there could be a market for resurrected species as pets, not unlike the market for exotic animals, though as noted above no de-extinction project proponent has yet announced an attempt to exploit this potential opportunity. As facsimiles rather than exact recreations of extinct species, at least some resurrected species arguably should be patentable. Contrary arguments are possible, however. The leading American case on patenting living organisms is Diamond v. Chakrabarty. In that case, Chakrabarty, a microbiologist, genetically engineered bacteria to break down components of crude oil. While the patent office allowed claims to a process for creating the bacteria, it denied claims for the bacterium itself on grounds that microorganisms are “products of nature” and that living things are not patentable.

The Supreme Court disagreed. The Court began by citing 35 U.S.C. § 101, the statutory authority for granting patents: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” Citing precedent, the Court then defined “manufacture” as “the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery” and further defined “composition of matter” to include “all compositions of two or more substances and . . . all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids.”

Finally, the Court noted that “Congress plainly contemplated that the patent laws would be given wide scope” and that the Committee Reports accompanying the statute indicated that Congress intended to include within this scope “anything under the sun that is made by man.” Not included within the statute’s scope, however, were the “laws of nature, physical phenomena, and abstract ideas.” Thus, a natural phenomenon that is merely discovered, such as a new plant found in a rainforest (or, for that matter, the Franciscan manzanita rediscovered in San Francisco), is not patentable. By contrast, Chakrabarty had not merely discovered a natural phenomenon; he had created a bacterium that was a “nonnaturally occurring manufacture or composition of matter—a product of human ingenuity ‘having a distinctive name, character, [and] use’” which therefore could be patented.

The Court in Chakrabarty distinguished another leading case, Funk Brothers Seed Co. v. Kalo Inoculant Co. There, the patentee had merely discovered the existence in nature of a group of bacteria that could inoculate seeds of certain plants, enabling them to fix nitrogen from the air. The bacteria infect specific plant species and generally inhibit one another, so they cannot be combined. However, the patentee discovered a set of bacteria that were not mutually inhibitory and could be used with a wider range of plants. The Court concluded that his discovery was a product of nature, reasoning that:

No species [of the bacteria] acquires a different use. The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee.

In contrast, Chakrabarty had “produced a new bacterium with markedly different characteristics from any found in nature,” and his discovery “is not nature’s handiwork, but his own.”

Although Chakrabarty itself applied to microorganisms, in 1987 the Board of Patent Appeals reversed an examiner’s decision not to issue a patent on oysters genetically engineered to be polyploid (rather than diploid), so that they could be harvested and edible year-round. The Federal Circuit affirmed this decision, on the grounds that the Chakrabarty Court had upheld the patenting of living organisms created by man. Following this case, the Patent and Trademark Office (PTO) issued a notice that henceforth the office would examine “claims to multicellular living organisms, including animals.” The PTO stated, “To the extent that the claimed subject matter is directed to a non-human ‘nonnaturally occurring manufacture or composition of matter—a product of human ingenuity’ (Diamond v. Chakrabarty), such claims will not be rejected under 35 U.S.C. 101 as being directed to nonstatutory subject matter.”

Applying Chakrabarty’s reasoning to facsimiles of resurrected species, it seems clear that, in at least some cases, the facsimiles are not products of nature but are manmade in the strictest sense, thus falling within Congress’s intent to include “anything under the sun that is made by man” in the scope of patent law. A resurrected species—that is, the species itself, not just the process of creating it—is the “result of human ingenuity and research” rather than a natural phenomenon. Moreover, even species resurrected by the SCNT method would not be exact copies or recreations of the extinct species donating the nuclear genome, since the mitochondrial genome would be that of the living species donating the egg. Perhaps a court might conclude that this distinction would not suffice for SCNTresurrected species to satisfy the standard of “markedly different characteristics from any found in nature” as expressed in Chakrabarty. Facsimiles produced by genetic engineering, however, would be still more “markedly different” products of human ingenuity, whose nuclear genome would be neither that of the extinct species nor the living egg donor species, but a human-created combination of the two, never before found in nature. Moreover, they would be distinctive compared to any existing product of nature, because the products of nature which they superficially resemble are extinct. By contrast, facsimiles of extinct species produced by artificial selection are no different in principle from any other domestic breed, e.g., of cattle or dogs. While genetic techniques and gene markers utilized in animal breeding can be patented, it does not appear that modification by conventional selective breeding, utilizing genetic variation that exists in nature, is generally considered sufficiently “non-naturally occurring” to be patentable.

Alternatively, opponents of patenting resurrected species (or competing sellers of Carolina parakeets) might focus on the intent to recreate a naturally-occurring phenomenon, the original extinct species, as closely as possible. The whole point of the exercise is to produce a semblance of nature that is not too visibly distinctive in character. In rebuttal, proponents of patenting resurrected species would reply, their resemblance to the extinct species is, literally, skin-deep (while at the same time those proponents would be emphasizing the surface similarities in announcing that they had succeeded in “bringing back” an extinct species). Thus, a court would have to decide whether the surface similarity or underlying genetic distinctiveness is more fundamental to determining whether the resurrected species is naturally occurring or the product of human ingenuity.

The Chakrabarty decision was revisited in a recent and high-profile case on the patent eligibility of isolated DNA sequences. In the decision below, the Federal Circuit discussed how “markedly” different a product must be from that found in nature to be patentable. The court held that the isolated DNA sequences (consisting of a specific sequence of nucleotides, removed from the chromosome in which that sequence is naturally found) are not found in nature and are patentable. That the sequences ultimately derived from nature was not determinative, because all compositions of matter are derived from nature. The Supreme Court disagreed, however, holding that “the claims understandably focus on the genetic information encoded” in the isolated sequences, and simply severing them from other sequences to which they normally are attached does not make them inventions. Thus, the Court found the isolated sequences were not different from those in nature.

Conversely, the Court determined, a sequence consisting only of the functional coding portions of an isolated gene, with the non-coding “intron” sequences removed, was a patentable invention because intron-less sequences are not naturally occurring. Thus even the modest modification of removing the introns—without in any way altering the coding portions of the gene—was sufficient to establish patent eligibility. Inserting genetically functional, appearance-altering sequences from an extinct species into a living one would be a more extensive manipulation than merely deleting the introns, clearly qualifying as an invention under this standard.

By contrast, under Canadian patent law, resurrected species would not be patentable. In Harvard College v. Canada, the Canadian Supreme Court held that higher life forms, including those that have been genetically engineered, cannot be patented. Section 2 of Canada’s Patent Act defines an invention in terms almost identical to those of U.S. law: an invention “means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.” However, the Canadian Supreme Court held that the “Harvard oncomouse”—genetically engineered to carry cancer genes for the purpose of medical studies—could not be patented because it was a higher life form. While acknowledging that the patenting of lower life forms such as bacteria is accepted in Canada, the court concluded that higher life forms are not mere “compositions of matter,” because they are “generally regarded as possessing qualities and characteristics that transcend the particular genetic material of which [they are] composed.” The court distinguished between higher and lower life forms on the basis that, as is already widely acknowledged, human beings cannot be patented (the same is true in U.S. law); therefore, courts already make this distinction. The Canadian decision is, however, of limited utility to a U.S. court, not only because it is outside the jurisdiction but the oncomouse itself, notwithstanding its “higher” status, was patented in the United States in 1988 and has been patented in dozens of other countries.

Before concluding this section, it should be noted, even if a subject matter is patentable, that does not mean a patent will be granted. An invention or creation must also be new and nonobvious to be patented. Because the issues already discussed arise under this topic as well, we touch on them only briefly. First, the requirement for nonobviousness is laid out in 35 U.S.C. § 103: “A patent for a claimed invention may not be obtained . . . if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.” Given the effort necessary to create facsimiles of extinct species in the laboratory, not to mention the novelty of the attempt in the first place, it seems reasonably obvious that they are nonobvious.

Second, the requirement for novelty is laid out in 35 U.S.C. § 102: “A person shall be entitled to a patent unless the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” In other words, one cannot patent something that existed as part of the “prior art.” This is the obverse of the distinctiveness issue: if resurrected species were exact replicas of extinct originals, those originals might be considered as a form of “prior art.” However, to the extent that its genetic distinctiveness from the extinct original qualifies the resurrected species as a non-naturally occurring human invention, it seems reasonable to consider it as novel as well.

Other authors have addressed the novelty issue, on the assumption that resurrected species would be identical to the (formerly) naturally occurring extinct originals. An extinct species would have been “available to the public” before extinction, and therefore a genetically identical clone of that species would not be novel. Nevertheless, two authors have argued, the doctrine of “lost arts” could apply to restore the necessary element of novelty. Since the extinct species has been completely lost, the creation of new copies using genetic technology would constitute an independent invention, in that knowledge of the “prior art” would not “permit one with ordinary skill in the art to reproduce the living animal, by way of breeding for instance, without reliance on the ingenuity embodied in the second invention.” Another author argues that the lost arts doctrine would not apply, because the extinct species’ DNA was never lost and its identical copy is not “independent from nature, the first inventor.” As discussed above, however, resurrected species would be facsimiles, rather than exact copies, of the extinct originals. It is their underlying distinctiveness that constitutes the “novelty” of the facsimile, in which case the “lost arts” issue would not arise.

Finally, there seems to be little policy reason to deny a patent to those who have devoted considerable resources to research and development of cutting-edge genetic technology for the recreation of extinct species, whether intended to produce (facsimiles of) lost biodiversity or domestic pets. Rather, it seems reasonable that de-extinction project proponents, in most cases, should be rewarded for their human ingenuity and investment in bringing back extinct species which otherwise would no longer exist on earth, and which are not unpatentably exact replicas of what is or was found in nature. That said, there may be at least one policy reason to deny exclusive patents to private proponents of de-extinction projects— where doing so would be inconsistent with re-establishing the species in the wild. An exclusive patent would deny the federal government the opportunity to create more of the species in order to propagate, reintroduce and manage them. Inasmuch as this approach would be consistent with the public benefit purpose of de-extinction and the environmental laws discussed above, it would seem reasonable for any patents issued to private parties for resurrected species to permit the federal government, and perhaps other public agencies and nongovernmental organizations, to undertake such activities without requiring a license from the patentee.