The rapid advancement from single-gene testing to whole genome sequencing has significantly broadened the type and amount of information available to researchers, physicians, patients, and the public in general. Much debate has ensued about whether genomic test results should be reported to research participants, patients and consumers, and at what stage we can be sure that existing evidence justifies their use in clinical settings. Courts and judges evaluating the utility of these results will not be immune to this uncertainty. As scholars increasingly explore the duty of care standards related to reporting genomic test results, it is timely to provide a framework for understanding how uncertainty about genetic and genomic tests influences evidentiary considerations in the court room. Here, we explore the subtleties and nuances of interpreting genetic data in an environment of substantial discord related to the value that individuals should place on genetic and genomic tests. In conjunction, we discuss the roles courts should play in qualifying experts, expert testimony, and genetic and genomic tests given the intricate and complex nature of genetic and genomic information.
14 June 2016
Genomic Evidence
'Genomic Test Results and the Courtroom: The Roles of Experts and Expert Testimony' by Edward Ramos, Shawneequa Callier, Peter Swann and Hosea Harvey in (2016) 44 The Journal of Law, Medicine and Ethics 205-215 comments
De-extinction
'Making De-Extinction Mundane?' by Friese and Marris in (2014) 12(3) PLoS Biology e1001825 argues
The use of new technologies to bring back extinct species has recently become a topic widely discussed in the media, partly as the result of a TEDx programme on de-extinction at the National Geographic Headquarters, timed to coincide with a National Geographic cover story in April 2013. Two weeks earlier, Stuart Brand, a key proponent of de-extinction, gave his own TED talk. These public events were followed by high-profile conferences at Cambridge (UK) and Stanford Universities. These events have begun to shape the contours of ‘de-extinction,’ by defining the relevant techniques (cloning, genome editing, back breeding, stem cell manipulation) and also the actors that can legitimately participate. Thus, de-extinction is currently crystalizing into a field that includes not only bioscientists but also, to varying degrees, the popular press, bioethicists, conservationists, and scientists from other fields (for example, synthetic biologists).
De-extinction has raised a number of ethical and political questions: Will it divert resources from other tried-and-tested measures for conservation? Will the resurrected animals be classified as members of the extinct species? Are conservationists too pessimistic and sceptical about cutting-edge science to embrace its potential? How will we ethically care for the animals used in and produced by these techniques? Are there hidden commercial interests at stake? What is striking, from our perspective, is that many of these debates have been held before: the tropes regarding de-extinction are remarkably similar to those used in debates regarding cloning endangered animals.
In this paper, we explore the relevance of previous debates and argue that important insights can be gleaned from them as de-extinction moves forward, and that there is another set of questions that has not yet been adequately addressed. In line with the arguments of Marris and Rose in the opening editorial for this series “Opening Engagement: Exploring Public Participation in the Biosciences,” we examine how, in the field of cloning endangered animals, the concerns of conservationists have in some cases been the basis for reformulating scientific practices in a way that can be interpreted as a form of ‘upstream’ public engagement. We argue that de-extinction could learn valuable lessons from these earlier projects regarding how to incorporate contributions from various publics; and demonstrate what a sociological approach can add to the exploration of these questions, in ways that traditional bioethics and ELSI (Ethical, Legal and Social Implications) approaches cannot.'From dinosaurs to dodos: who could and should we de-extinct?' by Kate Elizabeth Jones in (2014) 6(1) Frontiers of Biogeography comments
Reviving extinct species with new synthetic biology tools is as exciting an idea as it is controversial. Genomic manipulation of extinct species’ close relatives and/or cloning suitably preserved cells are the two main ways synthetic biology could be used to revive species. Discussions of where to target initial revival efforts have focused on species’ charisma (e.g. Woolly mammoth, Passenger pigeon) with less emphasis on feasibility or the ecological, ethical and legal considerations. Here I discuss who we could and should de-extinct, focussing on these latter criteria. Given the current devastating anthropogenic pressures on biodiversity, I suggest that a better use of de-extinction technologies would be to focus them on preventing species extinctions by restoring populations of critically endangered species. For example, this could be through increasing population numbers through cloning or genomic manipulation to better enable susceptible species to adapt to global change or by restoring genetic diversity by reviving extinct sub-species (e.g. Quagga, Barbary lion). This idea circumvents many of the criticisms of de-extinction from conservationists, whilst retaining public interest in de-extinction.'CRISPR Critters and CRISPR Cracks' by R. Alta Charo and Henry T. Greely in (2015) 15(12) The American Journal of Bioethics 11-17 comments on
possible nonhuman applications of CRISPR/Cas9 that are likely to be widely overlooked because they are unexpected and, in some cases, perhaps even “frivolous.” We look at five uses for “CRISPR Critters”: wild de-extinction, domestic de-extinction, personal whim, art, and novel forms of disease prevention. We then discuss the current regulatory framework and its possible limitations in those contexts. We end with questions about some deeper issues raised by the increased human control over life on earth offered by genome editing.'The Woolly-Mammoth in the Room: The Patentability of Animals Brought Back From Extinction Through Cloning and Genetic Engineering' by Miriam R. Swedlow in (2015) 11(3) Washington Journal of Law, Technology and Arts 185 comments
Advances and success in cloning and genetic engineering may mean passenger pigeons, dodos, gastric- brooding frogs, thylacines, woolly mammoths, and other extinct species will once again grace this planet. As de-extinction becomes a reality, it is uncertain whether these animals are patent eligible. Diamond v. Chakrabarty opened the door to cloning multicellular organisms. Since then, the U.S. Patent Office’s Board of Patent Appeals and Interferences has found “non-naturally occurring, man- made organisms including animals” to be patentable subject matter under 35 U.S.C. § 101. Because the initial case challenging this decision failed on procedural grounds, the underlying legal issue has not been addressed in a federal court. Congress forbids patents directed at, or encompassing, human organisms, but has been silent with respect to animals. The Supreme Court holds that sections of naturally occurring DNA are not patent eligible, while non-naturally occurring synthetic strands are. But the Court has not considered organisms created from both naturally occurring and synthetic DNA, as would be the case in de-extinction. The Federal Circuit upheld a decision denying a patent for Dolly the cloned sheep, yet left room for successful patents of other cloned animals. The Federal Circuit’s distinction may lie between patenting the clone of an animal that already exists and patenting an animal that does not or no longer exists. In light of ever- changing science and technology, there are few clear boundaries of what organisms can or cannot be patented. Practitioners need to be aware of the boundaries and the gray areas in the existing law to navigate a path towards patentability of de-extinct species.'Going the Way of the Dodo: De-Extinction, Dualisms, and Reframing Conservation' by Alejandro E. Camacho in (2015) 92 Washington University Law Review 849 comments
De-extinction, a suite of selective breeding or biotechnological processes for reviving and releasing into the environment members or facsimiles of an extinct species, has been the subject of a recent surge of analysis in popular, scientific, and legal literature. Yet de-extinction raises more fundamental questions about the relationship between humans and nature and about the more and less useful ways that the law serves to navigate that relationship. Unfortunately, the endangered species, invasive species, and public land management laws likely to govern the revival and introduction of de-extinct species largely remain premised on an understanding of nature as static and easily divisible from human activity. In these contexts, the law habitually privileges and even actively promotes what it identifies as natural and native over the unnatural and exotic.
Through the example of de-extinction, this article illustrates the limitations of the law’s reliance on these crude dualisms. Currently, de- extinct species will often be obstructed as non-native and introduced (evenif they might promote ecological function in a particular area) and may be allowed or promoted in locations they used to exist (even if likely to cause ecological damage). De-extinction illustrates how policymakers need to reformulate natural resources law to be less dependent on these strict dualities. Instead, the article argues in favor of cautious risk assessment that acknowledges the dynamism of nature and humanity’s indivisibility from it.'De-extinction and precision conservation' by William M. Adams in (2016) Progress in Human Geography argues
Extinction has long been a central concern in biodiversity conservation. Today, de-extinction offers interesting possibilities of restoring charismatic species and ecosystem function, but also risks and costs. Most de-extinction depends on genetic engineering and synthetic biology. These technologies are also proposed for use in ‘gene tweaking’ in wild species to enhance their chance of survival. Within conservation, the resulting debates pit an optimistic world of high-tech ‘precision conservation’ against a more conventional vision of biodiversity conservation achieved primarily through protected areas. De-extinction is a fashionable idea that brings the complex debates about the ethics and wisdom of genetic engineering to a central position within conservation science.
Medical Fiduciaries
'Breaching The Sexual Boundaries In The Doctor-Patient Relationship: Should English Law Recognise Fiduciary Duties?' by Suzanne Ost in (2016) 24(2) Medical Law Review 206-233 considers whether sexual exploitation in the doctor–patient
relationship would be dealt with more appropriately by the law in England and Wales on the basis of a breach of fiduciary duty. Three different types of sexual boundary breaches are discussed, with a focus is on breaches where the patient's consent is obtained through inducement. Ost argues that current avenues of redress do not clearly catch this behaviour, failing to capture the essence of the wrong committed by the doctor—the knowing breach of trust for self-gain—and the calculated way in which consent is induced.
Ost comments
Ost comments
The central argument presented in this article is that doctors' breaches of sexual boundaries would be most appropriately responded to through the recognition of fiduciary obligations. Whilst the argument has previously been made that sexual exploitation in certain relationships may be dealt with more fittingly at law on the basis of a breach of fiduciary duty, this claim has been made in the broader context of all professional relationships in which one party ‘has responsibility for the [other's] emotional or psychological well-being’. My concern is more specific. It is centred on the doctor–patient relationship for three reasons.
First, this professional relationship, which is so fundamental in our society, offers a considerable exploitative opportunity for the unscrupulous doctor. This is due to not merely the significant imbalance of power, but also the unique way in which the relationship will readily furnish opportunities for sexual exploitation. Other professional relationships—such as social worker–client or solicitor–client—will seldom if ever do likewise, for as Archard explains, ‘[a] patient … must open herself up, lay herself bare, share significant confidences with her doctor’. In such a relationship that is so dependent on trust, there is clear evidence that the sexual exploitation of patients has a deleterious effect on their mental well-being. Moreover, the sexual nature of the exploitation in the unequal relationship between the doctor and patient serves to render especially egregious the abuse of trust. Secondly, as I will demonstrate, a fiduciary duty not to breach the sexual boundaries can be grounded in the doctor's professional responsibilities not to breach trust or to act out of self-interest, and is compatible with the contemporary pro-patient autonomy model of the doctor–patient relationship.
Thirdly, although the ethical obligation on doctors to refrain from breaching sexual boundaries with their patients is far from new, being traceable to the Hippocratic Oath, medical professionals’ adherence to this ethical imperative has been raising growing concern. Over the past 20 or so years, there has been a series of well-publicised cases in which doctors were alleged to have behaved in a sexualised way towards their patients. Initially, there was the Department of Health's inquiry concerning GP Clifford Ayling, who was alleged to have committed indecent assaults on female patients over a period of 30 years. This was followed by a second inquiry into sexual abuse allegations made by female psychiatric patients against two male psychiatrists, and media coverage of allegations against GPs Oladapo Idowu and Benjamin Deodhar. More recently, a tribunal upheld a Primary Care Trust's decision to bar GP Navin Zala from working in its area in 2012 following allegations that he had sexually abused patients over a 20-year period. He was subsequently convicted of 10 counts of indecent assault and sentenced to 11 years imprisonment. And, at the beginning of 2014, the Fitness to Practice of the Medical Practitioners Tribunal Service suspended Dr Srinivas Yenugula, having ruled that he had provided ‘sexually motivated’ treatment to numerous female patients.
This article's unique contribution lies in its detailed critical scrutiny of the synergy between fiduciary duties, the obligation to maintain sexual boundaries, and (the nature of) the doctor–patient relationship. The case for dealing with a doctor's sexual misconduct through recognising fiduciary duties has previously been made by Tan. However, whilst I reach broadly the same conclusion regarding the appropriateness of fiduciary law to tackle this behaviour, this article takes forward Tan's briefer analysis in a number of important respects. First, I consider the issue of prevalence to demonstrate the significance of the problem. Secondly, whilst Tan focusses on battery as an alternative cause of action for the patient, I consider the suitability of both battery and negligence. Thirdly, I subject the question of whether the case for fiduciary obligations is made out to greater critical and analytical scrutiny. Finally, I draw important connections between fiduciary obligations and the contemporary model of the doctor–patient relationship.
The article unfolds as follows. I begin by exploring what sexual boundary breaches within the doctor–patient relationship are and consider also their prevalence, before explaining why such breaches of sexual boundaries can be harmful and exploitative. I then differentiate between three different types of sexual boundary breaches. My particular focus is on breaches involving inducement. I do not address cases of rape or sexual assault, which would ordinarily be dealt with by the criminal law. Rather, I am concerned with instances where doctors engage in sexual behaviour with their patients when patients acquiesce, but whilst their consent might be questioned because they have been induced into sexual activity by the doctor, the question of whether their consent is invalid at law is not clear cut. Take, for instance, the case of cosmetic surgeon, Fabian Baez, who offered to provide a botox procedure for free to a patient in exchange for sexual favours. In such a case, the patient consents to the sexual activity; however, her only reason for so doing is to obtain the surgery she desires. The surgeon takes advantage of the patient, knowing that offering her the procedure is likely to be sufficient inducement to gain her acquiescence to sexual activity. Considering such wrongful and harmful breaching of the sexual boundaries by doctors, I explore what is available in terms of legal redress. I contend that the current avenues of redress do not lend themselves well to such sexual exploitation because it is not clear that they catch this behaviour. Moreover, they fail to capture the essence of the wrong committed by the doctor—his knowing breach of trust for self-gain, having allowed a conflict to arise between his duty to the patient and his self-interest—and the calculated way in which consent is induced. I thus argue that these cases would be more appropriately dealt with if the law recognised a doctor's liability for breach of fiduciary duty. Finally, I proceed to elucidate the way in which the fiduciary approach can be synthesised with the contemporary pro-patient autonomy model of the doctor–patient relationship.
Euthanasia
'Permitting Voluntary Euthanasia and Assisted Suicide: Law Reform Pathways for Common Law Jurisdictions' by Jocelyn Downie in (2016) 16(1) QUT Law Review comments
End-of-life law and policy reform is the subject of much discussion around the world. This paper explores the pathways to permissive legal regimes that have been tried in various common law jurisdictions. These include legislation, prosecutorial charging guidelines, court challenges, jury nullification, the exercise of prosecutorial discretion in the absence of offence-specific charging guidelines, and the exercise of judicial discretion in sentencing. In this paper, I describe these pathways as taken (or attempted) in five common law jurisdictions (USA, UK, Australia, New Zealand, and Canada) and reflect briefly on lessons that can be drawn from the recent experiences with law reform in Canada. Through its bird’s eye view, it highlights the remarkable number and variable nature of past attempts at law reform and suggests a shifting tide. It debunks some common myths that have either limited or stymied reform in the past. Finally, it illuminates jurisdictional similarities and differences and lessons learned by those who have gone before so as to inform choices about pathways to pursue for those who will seek to advance a law reform agenda in the future.Downie states
End-of-life law and policy reform is the subject of much discussion around the world. Many jurisdictions, including Canada, have beenactively exploring the issue of whether to move to more permissive regimes with respect to voluntary euthanasia and assisted suicide. However, this is not a paper on that well-travelled terrain. Rather, it explores the pathways to permissive legal regimes that have been tried in various common law jurisdictions. There are, of course, a number of pathways to permissive legal regimes with respect to voluntary euthanasia and assisted suicide. These include legislation, prosecutorial charging guidelines, court challenges, jury nullification, the exercise of prosecutorial discretion in the absence of offence-specific charging guidelines, and the exercise of judicial discretion in sentencing. In this paper, I describe these pathways as taken (or attempted) in five common law jurisdictions (USA, UK, Australia, New Zealand, and Canada) and reflect briefly on lessons that can be drawn from the recent experiences with law reform in Canada. I seek to gather into one place descriptions of law reform initiatives across a significant set of jurisdictions. This consolidation providesa useful resource for those simply seeking a record of past activities in order to do further comparative work across jurisdictions or across spans of time. Through its bird’s eye view, it highlights the remarkable number and variable nature of past attempts at law reform and suggests a shifting tide. It debunks some common myths that have either limitedor stymied reform in the past. Finally, it illuminates jurisdictional similarities and differencesand lessons learned by those who have gone before so as to inform choices about pathways to pursue for those who will seek to advance a law reform agenda in the future.'Terminal Sedation - Good Medicine? Good Ethics? Good Law?' by Sheila McLean in (2016) 16(1) QUT Law Review 113-124 comments
The use of sedation at the end of life is becoming increasingly common, yet its ethics and lawfulness have not been as widely discussed as might have been expected. In this article, the primary focus is on what is known as ‘terminal sedation’, with particular reference to the use of sedation without the provision of assisted nutrition and hydration (‘ANH’). It is argued that, where ANH is not contraindicated by patient wellbeing itself, close scrutiny of the practice is required. There are both ethical and legal reasons why a move towards appropriate regulation is appropriate. The urgency of doing this is evidenced by the variety in practices throughout the world, with some commentators suggesting that the decision whether or not to instigate terminal sedation may be influenced by more than clinical indications for its use (in which case, it may be perilously close to a form of euthanasia). Indeed, it may be argued that there is little that differentiates terminal sedation from a form of euthanasia. Moreover, the relatively common exclusion of existential suffering as an indication for terminal sedation is questioned. Were this also to be accepted as a valid indicator for terminal sedation (without the provision of ANH) it becomes even more urgent that anadequate regulatory framework is developed and that the ethics of the practice are appropriately explored and clarified.McLean indicates that
The purpose of this article is to address the implications – medical, legal and ethical – of the use of terminal sedation, particularly where it is combined with the removal or withholding of assisted nutrition and hydration (‘ANH’). My aim is to both evaluate the status of this increasingly common practice against principles that inform other end of life decisions, and to robustly analyse it for consistency and clarity.
Youth Justice and Mandatory Reporting
The Youth Justice and Other Legislation Amendment Bill 2016 (Qld) seeks to
- Close the Childrens Magistrates Court when hearing all youth justice matters under the Childrens Court Act 1992 (Qld) and provide for victims or their representatives to be present in closed court;
- Increase the age at which children and young people subject to periods of detention under the Youth Justice Act 1992 (Qld) are to be transferred to adult corrections from 17 to 18 and empower a court on application, to delay a young person’s transfer for up to six months; and
- Reinstate a court-referred youth justice conferencing program and expand the program to allow for increased flexibility in the delivery of restorative justice interventions as part of police-referred and court-referred conferencing.
current provisions in the YJ Act were based on a non-evidenced policy rationale that stronger penalties and other negative consequences which hold repeat offenders more accountable for their actions will deter further offending by the small cohort of recidivist offenders responsible for a significant proportion of youth offending.
During the 2015 general election, the Government committed to repealing reforms made to the CC Act and YJ Act in 2014 (the 2014 amendments) as introduced by the former Government and effected by the Youth Justice and Other Legislation Amendment Act 2014 (the 2014 Amendment Act). The 2014 amendments, amongst other things, opened the Childrens Magistrates Court when hearing youth justice matters involving repeat offenders and provided for the automatic transfer to adult correctional facilities of 17 year olds who had at least six months left to serve in detention.
In the lead up to the 2015 general election, the elected Government also committed to reinstate court-referred youth justice conferencing, removed by the previous Government in 2012 through the Youth Justice (Boot Camp Orders) and Other Legislation Amendment Act 2012 (the Boot Camp Act).
The Government’s commitment to repeal the 2014 amendments and reinstate court- referred youth justice conferencing is based on a substantial body of international criminological evidence which indicates that increasing the severity of punishment is a poor means of reducing recidivism. Criminological evidence shows that it is the likelihood of being apprehended and punished for an offence, rather than the severity of that punishment, which exhibits the greatest deterrent effect on offending behaviour.
This is particularly the case with children and young people, whose neurological and cognitive development remains incomplete while they are within the age range to which the YJ Act applies. Children and young people’s cognitive immaturity significantly impedes their capacity to rationally consider the long term consequences of their actions, meaning their behaviour is likely to be more impulsive and marked by poorer decision making and greater risk taking than that of adults. This places children and young people at a heightened risk of opportunistic offending, notwithstanding increases in applicable tariffs and more onerous forms of accountability for that offending. The 2014 amendments were viewed as unduly punitive and inappropriate by the majority of stakeholders. The Legal Affairs and Community Safety Committee (LACSC) consulted widely on the 2014 amendments during its examination of the 2014 Bill. The measures implemented were not supported by any of the submitters to the Parliamentary inquiry, including the Queensland Law Society (the QLS), Bar Association of Queensland, Anti-Discrimination Commission Queensland, Queensland Council for Civil Liberties, leading church and research organisations and Amnesty International. Stakeholders, instead, urged implementation of measures to divert children and address the causes of offending. The amendments proposed in the Bill address the concerns of key stakeholders.
In reinstating youth justice conferencing, the Bill gives effect to a key restorative justice process and an effective diversionary strategy to reducing youth offending.
Evidence shows conferencing can, having regard to the right cohorts of offenders and circumstances, have a positive impact on a child or young person’s likelihood of reoffending. Critically, evidence also strongly shows there are direct benefits to victims from being involved in a restorative justice process. These include a reduction in post-traumatic stress symptoms, reduction in the desire for violent revenge and a heightened level of satisfaction when compared to conventional criminal justice practices.
Research suggests restorative justice is most effectively taken up when it is legislated as a required consideration rather than on an optional basis.The Queensland Government has also introduced the Child Protection (Mandatory Reporting-Mason’s Law) Amendment Bill 2016 (Qld), described in the Explanatory Memo as follows
Mandatory reporting laws are enacted in each Australian jurisdiction. It is broadly accepted that these laws are an important component of the broader child protection system.
Currently in Queensland the Child Protection Act 1999 (the Act) identifies the following groups as mandatory reporters:
• a doctor
• a registered nurse;
• a teacher; • a police officer who works in child protection; and
• a person engaged to perform a child advocate function under the Public Guardian Act 2014 (Qld).
Queensland and Western Australia are the only two Australian jurisdictions that do not extend mandatory reporting to the Early Childhood Education and Care sector (ECEC sector).
Whilst previous reviews into the child protection system in Queensland have looked at the mandatory reporting provisions they have not recommended that they be expanded to include the ECEC sector. The most recent inquiry1 recommended that mandatory reporting requirements be consolidated into one provision and that a consistent approach to reporting child protection concerns be established. These changes commenced after a period of training and education on 1 January 2015.
On 6 November 2014, the Queensland Law Reform Commission (the Commission) was requested by the then Government to review child protection mandatory reporting laws for the ECEC sector.
The overwhelming majority of submissions received by the Commission supported extending the mandatory reporting obligation under the Act to apply to the ECEC sector. The Commission recognised ‘the protective role of the ECEC sector in relation to children aged 0–5 years, who are particularly vulnerable. Staff employed in ECEC services are in regular and direct contact with children and their families, and are well-placed to observe and report concerns that children are at risk of significant harm, thereby enabling timely intervention and the protection of children from harm’.
It also noted that ECEC services are already subject to child protection obligations, have internal policies and procedures in place and can, and do, voluntarily report concerns to Child Safety. The Commission considered that the expansion of the mandatory reporting obligation to the ECEC sector aligned with these existing obligations. It also aligned with the increasing regulation of ECEC services and professionalisation of the workforce that has taken place in recent years.
The Commission’s report titled ‘Review of Child Protection Mandatory Reporting Laws for the Early Childhood Education and Care Sector’ was presented to Government in December 2015. It made a key recommendation that the mandatory reporting provisions in Queensland be expanded to apply to the ECEC sector.
In accordance with the Commission’s recommendation, the objective of this Bill is to ensure that mandatory reporting obligations apply to the ECEC sector individuals identified by the Commission.
The Commission found that extending the mandatory reporting obligation to certain individuals in the ECEC sector could be adequately addressed through appropriate training and education about the scope and content of the reporting obligation, and the provision of adequate support and resourcing to the ECEC sector to fulfil the obligation.
US Surveillance History
The short 'Laird v. Tatum and Article III Standing in Surveillance Cases' by Jeffrey L. Vagle in (2016) 18 University of Pennsylvania Journal of Constitutional Law comments
Plaintiffs seeking to challenge government surveillance programs have faced long odds in federal courts, due mainly to a line of Supreme Court cases that have set a very high bar to Article III standing in these cases. The origins of this jurisprudence can be directly traced to Laird v. Tatum, a 1972 case where the Supreme Court considered the question of who could sue the government over a surveillance program, holding in a 5-4 decision that chilling effects arising “merely from the individual’s knowledge” of likely government surveillance did not constitute adequate injury to meet Article III standing requirements.
Patent Metrics
'Patent Quantity' by Jeremy Bock in (2016) University of Hawaii Law Review comments
Much of the academic commentary on the patent system’s dysfunctions has focused on patent quality. The considerable attention paid to quality issues, while necessary, overlooks a much larger problem — one of patent quantity. The generation, examination, management, and monetization of an ever-increasing number of patents and applications exert distortionary effects on the patent system, such as the U.S. Patent and Trademark Office’s prioritization of application processing over patent quality; the growth of patent thickets; the “anticommons” that impede innovation; and the rise of patent assertion entities.
In a departure from the literature, this Article argues that the patent quantity problem must be solved first in order to solve the quality problem. Solving the quantity problem may also mitigate the other distortions in the patent system. Based on a situational analysis of the behavior of the patentees’ agents — who have been largely overlooked in the patent reform literature — this Article proposes that a mechanism for mitigating the patent quantity problem (and its effects) may lie in a judicially-developed de facto working requirement for patent assertions.
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