Zoo Animals

In Hanson-Young v Bauer Media Ltd [2013] NSWSC 1306 the New South Wales Supreme Court has granted leave to replead after striking out four imputations pleaded by Greens Senator Sarah Hanson-Young in defamation proceedings against Bauer Media Ltd.

The proceedings arose out of publication by Bauer's Zoo Weekly - a lad's magazine - of an article that  Hanson-Young claimed conveyed imputations that

• was not a politician to be taken seriously,
• her pro-asylum seeker stance was ridiculous,
• was not competent and
• was too immature to make a serious contribution to the political debate over asylum seekers.

The dispute's attracted most attention for a puerile Photoshopping of Hanson-Young's head onto a model's body as the cover image for the magazine.

Bauer argued that the matter complained of was incapable of being construed as other than a joke. The judgment notes that

The article appeared under the headline "Zoo's Asylum Seeker Bikini Plan". It was illustrated with a photograph which, as both parties agree, any reader would plainly have realised had been photo-shopped. The photograph shows Senator Hanson-Young's face superimposed on the body of a young woman in underwear standing at the open door of a motel room. In case the message was too subtle for some readers, the accompanying article was further illustrated with an inset close-up of the woman's breasts.

McCallum J notes that

The defendant objects to imputation 4A on the basis that it is incapable of arising and incapable of being defamatory. As the second point was developed in oral submissions, the objection appeared to extend to a complaint that the imputation is bad in form.

On the question of capacity Mr Richardson, who appears for the defendant, submitted that the article was clearly facetious and would not be taken literally. He submitted that it is not to the point that some readers may find the photograph offensive. It was submitted that, because the article was plainly intended as a joke, the imputation that the plaintiff is not a politician to be taken seriously can only be derived from it on a strained, forced or unnatural reading.

Those submissions assumed that there is a dichotomy between jokes and damaging statements. Implicitly, the proposition was that if a publication can be characterised as a joke (as opposed to a literal statement) it will be incapable of being defamatory, even if it is facetious or offensive.

I do not think a definitive statement of principle can be made in those terms. As noted by Ms Amato, who appears for Senator Hansen-Young, the critical question is what the joke says about a person and whether what is said is defamatory. Humour is notoriously subjective, a proposition captured in the quote attributed to the comedian, Mel Brooks:

Tragedy is when I cut my finger. Comedy is when you fall in an open sewer and die.

It may be doubted whether articles published in Zoo Weekly magazine reflect a sense of humour shared by the community as a whole but that is quintessentially a question for the jury. Whether any particular publication can be characterised as a joke which is incapable on that account of being understood in any defamatory sense is essentially an evaluative judgment and one very much informed by community values.

Officers

'‘Officers of the Commonwealth’ in the Private Sector: Can the High Court Review Outsourced Exercises of Power' by Janina Boughey and Greg Weeks in (2013) 36(1) University of New South Wales Law Journal analyses

the options available to the High Court in defining the phrase 'officer of the Commonwealth' in the context of modern mixed administration. The various tests used in Australian administrative law are explored, with a focus on the "public function" test developed in Datafin. We argue that these administrative law tests are largely unhelpful and inappropriate for defining the scope of section 75(v) of the Constitution. Instead, we suggest that the High Court could find inspiration for the most appropriate and adapted solution from an unlikely place: Canadian human rights law. We argue that by adapting the 'control' used by Canadian courts to determine the scope of Canadian Charter of Rights and Freedoms, the Australian High Court could find an appropriate balance for reviewing the actions of private sector actors, while simultaneously achieving consistency with existing precedent.

FDA

'Governance by the Backdoor: Administrative Law(lessness?) at the FDA' by Lars Noah in (2014) 93(1) Nebraska Law Review discusses

the U.S. Food and Drug Administration’s growing - and in some respects peculiar - reliance on guidance documents. Although only offered as a case study, it poses (without necessarily answering) a number of broader questions that may interest administrative law scholars. For instance, when Congress demanded that the FDA use an abbreviated notice-and-comment process to formulate major guidance documents, did this reflect a throwback to informal legislative rulemaking as originally conceived (and will this new variant also become ossified over time)? Along those lines, if a final nonbinding guidance is no more authoritative than a draft version of that same guidance, then what motivates agencies to abide by this hybridized procedure? Separately, when OMB treats a guidance document as likely to have a significant impact on the economy, might such a finding influence courts when agencies interpose ripeness objections in response to challenges to these purportedly nonlegislative rules? In addition, when Congress specifically has required (sometimes with strict deadlines) or invited an agency to issue guidance, should courts accord interpretations of that statutory provision greater deference than normally granted announcements lacking the force of law? Conversely, in areas where Congress has not specifically called for guidance-making, what does one make of the fact that large and important swaths of the FDA’s activities (e.g., genetically modified foods and prescription drug advertising) depend almost entirely on technically nonbinding announcements, or the fact that a number of the agency’s legislative rules governing other subjects incorporate by reference guidance that it has (or will in the future) issue? Finally, in what respect do threats and offers (in enforcement and licensing contexts) allow agencies to secure “voluntary” adherence to nonbinding guidance (and is this at least preferable to tolerating the use of such informal means of leverage to pursue entirely unannounced policies)?

Niqaab

Past posts in this blog have noted controversy about facial covering, for example Cory Bernardi's characterisation of the burqa as "unaustralian", comment by Ray King (exponent of sniper rifles to inject satellite-tracked microchips into crime suspects) that the burqa had no place in Australian society and disagreement about the Criminal Investigation (Identifying People) Amendment Bill 2013 (WA).

Murphy J in The Queen v D (R) in the Crown Court at Blackfriars (UK) has considered the wearing of the Niqaab by a defendant in criminal proceedings.

The judgment [PDF] indicates that

he defendant, to whom I shall refer in this judgment as D, is a woman who has been charged on indictment at this court with a single count of witness intimidation. The facts alleged are not relevant for the purposes of this judgment, except for the fact that the defendant is alleged to have committed the offence while wearing the burq’a and niqaab, and no issue of visual identification will arise at trial.

The question now before me was initially raised by the Court of its own motion, and not by the prosecution or the defence. The case was listed before me for a plea and case management hearing on 22 August 2013. A person, who both the prosecution and the defence agreed was D, appeared and surrendered to the dock. D was wearing a burq’a and niqaab. (I understand that burq’a is the term applied to the black loose shroud which covers the head and body, and that niqaab is the term applied to the black veil which covers the entire face, except for the eyes. In case my understanding is wrong, and so that there is no doubt, my concern is with the covering of the face, by whatever means that may be achieved. I am not concerned with any  other aspect of D’s dress or appearance.) When I refer to the niqaab in this judgement, I refer to a covering of the face.

Through her counsel, I conveyed to D the court’s request that she reveal her face (but no other part of her body) for the purpose of identification. After conferring with D, counsel said that D declined to comply with my request because her Muslim faith requires that she may not reveal her face in the presence of men. It may be that this refers to men who are not members of her immediate family.

I decided to take time to consider the matter. I adjourned the hearing until 12 September 2013, to be listed before me for further proceedings including legal argument, and extended the defendant’s bail until that date. It became clear to me that, because the issue of the niqaab was bound to recur during the proceedings, it would be desirable to deal with it on a broader basis during the plea and case management hearing. I asked counsel to submit skeleton arguments dealing with the way in which the Court should approach the matter. I received skeleton arguments from both parties, and heard oral argument on the adjourned date. I am extremely grateful to both counsel for their clear, well-judged, and helpful submissions. I also received an expert report from Professor Susan Edwards, an expert witness on Gender and Islamic Dress, which was prepared on behalf of D.

At the hearing on 12 September 2013, I allowed the defendant to be identified by means of evidence from P.C. Hughes, a female police officer who knows D, and who observed D in private without her niqaab during a short adjournment for that purpose, and was able to say that she was certain that the person before the Court was in fact D. D was arraigned and pleaded not guilty to the sole count of the indictment. I conducted a general plea and case management hearing and heard argument about what further directions, if any, should be given about the wearing of the niqaab during the proceedings. Having heard argument, I adjourned the case further until 16 September 2013, to prepare this judgment.

After a consideration of UK and other precedent, along with discussion of principles Murphy J states

I propose to adopt the least restrictive approach consistent with what I see as the necessity of enabling the Court to conduct the proceedings fairly and effectively in the interests of all parties. In my judgment, the following principles should be applied when a defendant in the Crown Court asserts the right to wear the niqaab during the proceedings.

The question of identification must be dealt with in open court whenever it arises. The defendant should be asked to remove the niqaab for this purpose. If she refuses to do so, the Court should adjourn briefly to allow an officer or other reliable female witness to examine the defendant’s face in private, and to give positive evidence of identification in open court. This procedure must be followed on every occasion when identification is needed, especially before arraignment, the return of the verdict, and sentence, if the defendant is convicted. There may be cases where this procedure is insufficient, and where the niqaab must be removed, for example when there is an issue of visual identification, or suspicion of impersonation.

In general, the defendant is free to wear the niqaab during trial. The judge should, nonetheless, in the absence of the jury, advise the defendant of the possible consequences of so doing, and make it clear that she will not be free to do so while giving evidence. She should be invited to remove the niqaab during trial, and given time to reflect and take advice if she wishes to do so. Again, if there is an issue of visual identification to be decided by the jury, it may necessary to order that the niqaab be removed, at least while evidence relevant to that issue is given.

If the defendant gives evidence, she must remove the niqaab throughout her evidence. The Court may use its inherent powers to do what it can to alleviate any discomfort, for example by allowing the use of screens or allowing her to give evidence by live link. Again, the judge should, in the absence of the jury, advise the defendant of the possible consequences of refusing to remove the niqaab. She should be invited to remove the niqaab and given time to reflect and take advice if she wishes to do so. If she refuses, the judge should not allow her to give evidence, and must give the jury a clear direction in the terms suggested in the Bench Book, with appropriate modifications, about the defendant’s failure to give evidence.

I recognise that particular circumstances may arise in other cases which may lead a judge, having considered the matters which must be considered, to make a different order. I cannot, and do not attempt to enumerate such situations, but they may include cases in which the evidence is effectively agreed; or where the defendant’s evidence would be purely formal, or would not be challenged. This must be a matter for the judge to decide on the facts of each case.

Though I have made much use of the feminine form in this judgment, everything I have said is to be taken to apply to male defendants in equal measure, should an analogous situation arise; and it applies alike to both male and female defendants of any, or no, religious faith.

Accordingly

Accordingly, before this plea and case management hearing ends, I give the following directions -

(1) The defendant must comply with all directions given by the Court to enable her to be properly identified at any stage of the proceedings.

(2) The defendant is free to wear the niqaab during trial, except while giving evidence.

(3) The defendant may not give evidence wearing the niqaab.

(4) The defendant may give evidence from behind a screen shielding her from public view, but not from the view of the judge, the jury, and counsel; or by mean of a live TV link.

(5) Photographs and filming are never permitted in court. But in this case, I also order that no drawing, sketch or other image of any kind of the defendant while her face is uncovered be made in court, or disseminated, or published outside court.

GMO Regulation in New Zealand

'An overview of genetic modification in New Zealand 1973-2013: the first forty years' [PDF] by Wendy McGuinness and Renata Mokena-Lodge of the McGuinness Institute (2013) argues that

strategically, New Zealand is no further ahead on public policy regarding outdoor use of GMOs than it was when the Royal Commission on Genetic Modification reported its findings in 2001. It considers New Zealand is less equipped to make a strategic decision to release GMOs in the outdoors in 2013 than it was a decade ago.The report forms part of the Institute’s flagship project, Project 2058. Forty years since the development of genetic modification, the Institute believes it is timely to reassess New Zealand’s approach to managing the benefits, costs and risks.

The report provides a comprehensive overview of policy development through four key eras: (1) the journey towards the 2001 Royal Commission on Genetic Modification; (2) the Royal Commission and its findings, (3) the response to the Royal Commission, and (4) the era of institutional change from 2008 – 2013.

The Institute’s report makes 12 recommendations on how the current system could be strengthened, stressing the need for transparency, accountability, and consideration of the interests of all New Zealanders.

The report concludes by reflecting on the proposal that ‘the most risk-adverse solution is to close down New Zealand’s only two GM outdoor experiments on the basis that they create unnecessary public risk, with little or no public benefit, and to use those funds elsewhere. Currently the only two outdoor field tests are being operated by two Crown Research Institutes, AgResearch and Scion, and could therefore be closed down by government.

The authors comment that

It is now 12 years since the report of the Royal Commission on Genetic Modification was released. After considering the options available to New Zealand, the Commissioners endorsed a compromise: a strategy to preserve opportunities and proceed with caution. It is timely to review what has essentially been an expensive and time-consuming exercise in public policy-making. The issue of genetic modification (GM) has provided a particularly interesting case study for policy development in relation to assessing and developing strategies for new technologies where the benefits and risks are uncertain.

The purpose of this report is two-fold. On the one hand it seeks to chronicle the history of GM in New Zealand and provide a record of the available data. On the other, it seeks to consider gaps in the current policy framework and provide a meaningful contribution to the continuing debate. The report consists of seven sections and is split into two main parts; the first part, comprising Sections 1 to 5, describes the historical landscape from the beginnings of the technology in the 1970s to the present day, while the second part, comprising Sections 6 and 7, looks at the Crown Research Institute (CRI) system and suggests principles to guide its future, and concludes with a set of observations, recommendations and narrative on future strategy for GM in New Zealand. Importantly the focus of this report is on public policy, it does not aim to report on scientific developments in any detail.

The context of the report and its limitations are outlined in Section 1. Sections 2–5 document the history of GM in New Zealand, breaking it into four eras: the journey to the Royal Commission; the Royal Commission’s inquiry; the response to the inquiry, and the current era of institutional change. These sections are supported by the 16 appendices and seek to collate the available data on the topic to provide a factual overview and historical commentary. The journey toward the Royal Commission (see Section 2) started in the mid-1970s with the emergence and adoption of ground-breaking new technology. As a tool it offered benefits, but arguably it came with considerable risks to an agriculture-based economy. Public concern developed accordingly, and the result was the establishment of the Royal Commission on Genetic Modification in 2000.

The Commission was charged with considering the strategic options available to New Zealand to manage genetic modification, and its conclusions were published in a report in 2001 (see Section 3). During this time a pause was put on the outdoor use of genetically modified organisms (GMOs) while a deeper understanding of the risks and opportunities was developed. The Commission’s report included 49 recommendations conceptualised to allow New Zealand to ‘preserve opportunities’ and retain optionality. In Section 4 we present an overview of the response to the report of the Royal Commission and consider the subsequent implementation of the Commissioners’ recommendations. This era saw both government acceptance of and public protest at the Commission’s findings.

The most recent era spans the last five years, during which we have witnessed unprecedented institutional change in New Zealand (see Section 5). As of 2013 only two GM field tests are in operation in New Zealand, but there have been 57 since 1988. Not one of these has resulted in any commercial benefit or tangible return on the public’s investment, while all experiments have presented a constant risk. Debates on this subject are often framed as a matter of balancing environmental protection and economic development. Could it be that in this case we have compromised environmental protection for promises of economic development and received neither?

Sections 6 and 7 are the only area of the report to draw conclusions and make suggestions going forward. In Section 6 we take a closer look at the three CRIs that have conducted the majority of GM research in the outdoors since the Royal Commission: AgResearch; Scion, and Plant & Food Research. In this section we also present five principles to drive the current system in order to deliver more effective public investment in the future. These five principles are:

1. Value for money

2. Robust assessment, decisionmaking and monitoring by regulators

3. Ethics should drive practice

4. Timely reporting on controversial experiments is essential

5. A culture of due diligence is vital across science.

The overall goal of Section 7 is to assess whether the system fulfils its purpose, and if not, what the government must do to develop a better policy landscape and operational system to manage the benefits, costs and risks of GM in the outdoors. Section 7.1 identifies ten observations that can be made about the current operational framework. Section 7.2 provides our conclusions on the policy process thus far and provides 12 recommendations in response to perceived gaps in the current framework. Lastly, Section 7.3 presents a strategic reflection, bringing the report to a close by providing a narrative and context for future debate.

We found that many initiatives put in place after the Royal Commission have since been disestablished or not progressed. Since 2001, New Zealand has significantly reduced its ability to collect strategic information to make informed decisions on GM. For example, New Zealand has disestablished the Bioethics Council (2009); discontinued Futurewatch, a work programme of the Ministry of Research, Science and Technology (MoRST) (2011); discontinued the Bioscience Survey, a survey undertaken by Statistics NZ (2013); and have not reviewed or updated the Biotechnology Strategy, published in 2003 and due to expire this year.

We also found considerable evidence that the system is showing symptoms of fatigue. Largely due to the significant institutional change that has occurred in the last five years, information is not well collected or reported (see Section 7.2.5 for examples) and institutional knowledge and therefore analytical capability and linkages are likely to be significantly reduced (see in particular Figure 2 and Appendix 16). Strategically, New Zealand is no further ahead on public policy regarding outdoor use of GMOs than it was when the Commissioners reported their findings in 2001. Indeed, we consider New Zealand is less equipped to make a strategic decision to release GMOs in the outdoors in 2013 than it was a decade ago. We also identified a number of emerging issues that add to this sense of urgency:

1. Community concerns over the use of GM in food production are growing, that is now putting pressure on councils to address benefits, risks and costs in local plans. This is in line with overseas trends, particularly the European Union (see discussion in Section 7.2.6 and 7.2.11).

2. Food Standards Australia New Zealand (FSANZ) is continuing to approve increasing numbers of GM foods, raising issues over labelling and traceability (FSANZ provides a list of approved GM ingredients, but there is currently no list of food for sale in New Zealand containing those ingredients). Further, an application for conditional or full release may not necessarily trigger a ‘call-in’ by the Minister if it is a FSANZ approved GM food.

3. If the Minister did decide to ‘call-in’ an application (see s 68 of the HSNO Act 1996), the resulting process is unclear. We suggest that the government is not ready to make such a strategic decision on the first release of a GM crop or fibre.

4. There are a range of emerging molecular plant breeding technologies on the horizon that may not come under the HSNO legislation. One that local developers AgResearch and Scion have expressed interest in is zinc finger nuclease (ZFN-1). In April 2013 a decisionmaking committee of the Environmental Protection Authority (EPA), in response to an application by Scion, reached a decision that ZFN-1 was outside of HSNO regulation (despite EPA staff recommending that these techniques should be considered similar to GM techniques, and not exempt from the regulations) (EPA, 2013: 3). This decision may be appealed but, as it currently stands, there would be no assessment of the public benefits, costs and risks as required under the HSNO legislation; nor would outdoor use of food or fibre crops generated by the tecnique be subject to any controls.

5. The upcoming Trans Pacific Partnership Agreement means New Zealand needs to think deeply about its position of GM crops and other uses.

The Royal Commission purposefully created a strategic pathway for New Zealand to follow. Twelve years later, with little evidence that significant commercial benefits exist for New Zealand through outdoor research, it seems timely to revisit the Commission’s recommendation of preserving opportunities, and ask whether New Zealand would not be better to remain a GM-free food and fibre producer.

Our approach to GM crops in the outdoors would be threefold:

1. Buy time: Put in place a moratorium or require a field test before any GMO release

2 Undertake a systemic review: ensure the current system is 'fit for purpose' by implementing the Institute's 12 recommendations

3 Think strategically: revisit the original question - should NZ commit to becoming a dedicated GM-free food and fibre producer?

In the closing section of the report, Section 7.3, we reflect on the way forward. We discuss New Zealand’s current position, and argue that we have one foot in and one foot out of GM. We argue that this is a risky position, particularly when combined with the fact that there appears to be a prevailing belief that we operate the most robust regulatory system in the world. Are we putting at risk our global reputation simply because we are failing to critique our own systems? It is crucial that as a country we reflect on what is the best outcome for New Zealand and ensure we create durable public policy to deliver on that outcome. Reactive public policy delivers uncertainty to all stakeholders, creates unnecessary stress within the system for regulators, and is more likely to lead to systemic failure.

Our view is that the most risk-averse solution is to close down New Zealand’s only two GM experiments (AgResearch and Scion) on the basis that they create unnecessary public risk at little to no public benefit; the science research funds would be better spent elsewhere. In regard to GM crops and other uses, we suggest retaining optionality through buying time, undertaking a systemic review of the current system and thinking strategically about the best way forward. Most importantly we think it is timely to have a conversation about the future of GM crops and other uses; as indicated by the Royal Commission recommendations, this issue remains unresolved but has always been believed to be a necessary consideration sometime in the future, when more information was available. The time for reflection is now.

Recommendation 1: Investment programmes should be evaluated as a matter of good practice

Recommendation 2: Risk management requires a whole-of-government approach

Recommendation 3: Compliance costs should be fully recovered from applicants

Recommendation 4: Legal liability should be reviewed as coexistence with zero contamination is not possible and definitions of new organisms have become increasingly unclear

Recommendation 5: Data management requires urgent attention

Recommendation 6: Allow local authorities to regulate GMOs or amend the HSNO framework accordingly

Recommendation 7: Before the conditional release of any GMO, a field test should first be undertaken

Recommendation 8: Reviews should be tactical and regular

Recommendation 9: Memoranda of Understanding should be urgently reviewed and updated

Recommendation 10: Strategy should be revisited

Recommendation 11: A high-level foresight unit should be established

Recommendation 12: Decouple hazardous substances from new organisms, creating separate legislation for both

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.

Unintended Consequences

'Tales of the Unintended in Copyright Law' by Peter K. Yu in (2014) Studies in Law, Politics, and Society comments

Having unintended consequences is an oft-cited defect of copyright reform. Whether it is the Digital Millennium Copyright Act, the recently adopted Anti-Counterfeiting Trade Agreement, the still-under-negotiation Trans-Pacific Partnership Agreement, or such highly controversial copyright legislation as the PROTECT IP ACT or the Stop Online Piracy Act, critics of copyright-strengthening measures have lamented their potential for creating collateral damage. As critics have reasoned, the collateral damage caused by these proposed measures outweigh their intended benefits, and policymakers should refrain from adopting these measures.

While undertaking cost-benefit analyses is commonsensical and useful, adopting laws that have unintended consequences is nothing new. In the copyright area alone, one could find many examples featuring laws that result in unintended consequences. Indeed, many of the ill-advised copyright laws were adopted long before the active lobbying by the existing entertainment industries. A better and deeper understanding of the "disconnect" between law and its intended consequences is therefore in order.

To help us grasp the complex reasons behind the unintended consequences of copyright law, and the role legal scholars could play in alleviating these consequences, this Article retells three "tales of the unintended." All of them concern the 1976 Copyright Act, the present U.S. copyright statute. The first tale focuses on fair use, the second on statutory damages, and the third on formalities. From these three tales, the Article draws five different morals that provide insights into the ongoing process of copyright reform. These insights will enable policymakers and commentators to rethink the ongoing and future development of copyright law.

'The Levy Runs Dry: A Legal and Economic Analysis of EU Private Copying Levies' by Joost Poort and João Pedro Quintais in (2013) 4(3) JIPITEC offers

a legal and economic analysis of private copying levies in the EU, against the background of the Copyright Directive (2001/29), a number of recent rulings by the European Court of Justice and the recommendations presented by mediator Vitorino earlier this year. It concludes that notwithstanding these rulings and recommendations, there remains a lack of concordance on the relevance of contractual stipulations and digital rights management technologies (DRM) for setting levies, and the concept of harm. While Mr. Vitorino and AG Sharpston (in the Opinion preceding VG Wort v Kyocera) use different lines of reasoning to argue that levies raised on authorized copies would lead to double payment, the Court of Justice’s decision in VG Wort v Kyocera seems to conclude that such copies should nonetheless be levied. If levies are to provide fair compensation for harm resulting from acts of private copying, economic analysis suggests one should distinguish between various kinds of private copies and take account of the extent to which the value said copies have for consumers can be priced into the purchase. Given the availability of DRM (including technical protection measures), the possibility of such indirect appropriation leads to the conclusion that the harm from most kinds of private copies is de minimis and gives no cause for levies. The user value of copies from unauthorised sources (e.g. from torrent networks or cyber lockers), on the other hand, cannot be appropriated indirectly by rightholders. It is however an open question in references for preliminary rulings pending at the Court of Justice whether these copies are included in the scope of the private copying exception or limitation and can thus be be levied for. If they are not, as currently happens in several EU Member States, legal and economic analysis leads to the conclusion that the scope of private copying acts giving rise to harm susceptible of justifying levies is gradually diminishing.