Expansion of the US 'safe harbour' provisions--an American perspective

Legal context. Since the mid-1980s, US patent law has exemptedcertain research activities in the pharmaceutical field fromliability for patent infringement. Recently, the US SupremeCourt expanded this exemption (‘safe harbour’) byholding that any type of research activity, regardless of itstiming or phase, may be exempt from liability for patent infringementwhere it can be shown that the such activity is reasonably relatedto the development and submission of drug approval informationunder a federal law. Key points. The timing or phase of research activities is immaterialto determining whether the safe harbour provisions apply. Thecritical inquiry in determining the applicability of the safeharbour provisions is whether the activity in question is reasonablyrelated to the submission of drug approval information to theUS Food and Drug Administration (FDA). A research activity is ‘reasonably related’ to thesubmission of drug approval information where it can be shownthat (i) a drug-maker has a reasonable basis for believing thata patented compound may work to produce a particular physiologicaleffect and (ii) the drug-maker uses that compound in researchwhich, if successful, would be appropriate for submission tothe FDA. The ultimate absence of experimental data from an FDAsubmission may not adversely impact the potential applicabilityof the safe harbour provisions. Mere intent to submit informationto the FDA is insufficient; rather, intent must be coupled withactual research activities. Practical significance. The safe harbour provisions of the USpatent law are not confined to specific types of research, norare they bounded by temporal limitations. Rather, any researchactivity, regardless of its timing or phase, may qualify forprotection. Importantly, industry researchers must take careto document actual research activities and be prepared to demonstratethat such activities are reasonably related to the submissionof information to the FDA.     

The "last vestiges of life"

On 4 June 2010, Deputy State Coroner Schapel of the Coroner's Court of South Australia ruled that he had jurisdiction to conduct an inquest into the death of Tate Spencer-Koch, who was declared deceased following complications during her home-birth. Coroner Schapel considered he had jurisdiction on the basis that Tate was a "person in the eyes of the law" under the born alive rule, as she had completely left her mother's body and she could be shown to have been alive after birth, evident from the PEA detected in her heart 10 minutes following her delivery. Close consideration of this ruling, however, reveals issues with the application of the born alive rule in the case.     

关于刑法溯及力的两个问题

我国刑法应支持建立溯及力可及于已生效判决的制度,即对"新法认为无罪且刑罚未执行完毕"的案件,即使已经作出生效裁判,仍然应当予以释放,不再执行;对由"罪重变为罪轻"的案件,只要还处在原判刑罚的执行过程中,也应允许依照新法予以改判。此外,刑罚溯及力中的"从轻"应理解为"最有利被告",当不同的有利被告人的情形分别出现于新旧刑法中时,应可以分别适用新旧刑法的有关规定,在行为时法和裁判时法之间存在中间法时,如中间法最轻,应适用中间法。     

Lawyers for God and Neighbor: The Emergence of “Law as a Calling” as a Mobilizing Frame for Christian Lawyers

Drawing on movement framing, collective identity, and mobilization scholarship, this article examines the emergence and potential effects of framing “law as a calling” for the Christian Lawyering community. The article finds that the term should have strong resonance and salience in the broader Christian community. It also finds that because of its interpretive malleability, “law as a calling” has been discussed and actualized in three related, but distinct, ways. That is, “law as a calling” has been conceptualized as requiring Christian Lawyers to turn inward, turn outward by pursuing social justice, and turn outward as a culture warrior. The article argues that while the different interpretations of “law as a calling” address a range of needs required to mobilize potential and existing Christian L/lawyers, the different ideological factions of self‐identifying Christian Lawyers emphasize different understandings of “law as a calling.”     

Proof of causation in informed consent cases: establishing what the plaintiff would have done

A degree of judicial caution in accepting the assertion of a plaintiff as to what he or she would have done, if fully informed of risks, is clearly evident upon a review of decisions applying the common law. Civil liability legislation in some jurisdictions now precludes assertion evidence by a plaintiff. Although this legislative change was seen as creating a significant challenge for plaintiffs seeking to discharge the onus of proof of establishing causation in such cases, recent decisions suggest a more limited practical effect. While a plaintiff's ex post facto assertions as to what he or she would have done if fully informed of risks may now be inadmissible, objective and subjective evidence as to the surrounding facts and circumstances, in particular the plaintiff's prior attitudes and conduct, and the assertion evidence of others remains admissible. Given the court's reliance on both objective and subjective evidence, statistical evidence may be of increasing importance.     

Mega/City/Crime: Notes on the Cultural Significance of Reggio’s Koyaanisqatsi (1982)

In his “non-narrative” film Koyaanisqatsi (Hopi for ‘life in imbalance’) Godfrey Reggio documents the ecologically disastrous ‘imbalanced’ life in modern, industrialised mega-cities. In the film, he seems to mourn the loss of what he suggests was a more ‘balanced’ form of life, when Man was one with nature. This contribution draws on elements in Hopi culture and reads Reggio’s iconic film as part of a cultural trend in which submission, in all its guises, is no longer accepted. In this cultural trend submission always is submission to code (that is: to a certain structured solidity or ordered coherence), and therefore, to wasteful destruction and to ‘life in imbalance’. This trend has, however, in the course of the decades, also spawned a void of “Luciferian” desires of absolute sovereignty, and has done this to such an extent as to undermine the conditions of possibility for anything like a non-submissive life ‘in balance’ to endure.

     

A Christian or a Laïc Europe? Christian Values and European Identity

Abstract.  European constitutional traditions share a commitment to freedom of conscience and religion, but differ on their interpretation of whether such freedoms do or do not require a clear cut separation of state and church. Weiler has advocated that the writing of a Constitution for the European Union is a very apt moment to reconsider the conceptualization of freedom of conscience and religion. On constitutional and historical grounds, he has advocated that a reference to Christian values should be made in the preamble of the European fundamental law, and that this will be the alternative most respectful to the pluralistic national solutions, ranging from republican non-confessionality to the establishment of an official church. But contrary to what Weiler argues, the drafting of the constitution of the European Union is not bound by the present shape of European constitutional traditions; moreover, it is hard to conclude that the present common constitutional traditions require an explicit reference to Christianity to be included in the text. Furthermore, the claim that the individual and collective identities of Europeans are unavoidably shaped by Christian values is only tenable if we uphold a rather simplistic relation between history, memory, and identity. Finally, once one moves from law and history to practical reasoning, one finds that there are good substantive reasons why our collective identity should not contain reference to Christian values.     

Expulsion to Face Torture? Non-refoulement in International Law

Non-refoulement is a principle of international law that precludesstates from returning a person to a place where he or she mightbe tortured or face persecution. The principle, codified inArticle 33 of the 1951 Refugee Convention, is subject to a numberof exceptions. This article examines the status of non-refoulementin international law in respect to three key areas: refugeelaw, human rights law and international customary law. The findingssuggest that while a prohibition on refoulement is part of internationalhuman rights law and international customary law, the evidencethat non-refoulement has acquired the status of a jus cogensnorm is less than convincing.     

Moral theories of torts: Their scope and limits: Part I

One approach to legal theory is to provide some sort of rational reconstruction of all or of a large body of the common law. For philosophers of law this has usually meant trying to rationalize a body of law under one or another principle of justice. This paper explores the efforts of the leading tort theorists to provide a moral basis — for the law of torts. The paper is divided into two parts. In the first part I consider and reject the view that tort law is best understood as falling either within the ambit of the principle of retributive justice, a comprehensive theory of moral responsibility, or an ideal of fairness inherent in the idea that one should impose on others only those risks others impose on one. The second part of the paper distinguishes among various conceptions of corrective or compensatory justice and considers arguments — including previous arguments by the author himself — to the effect that tort law is best understood as rooted in principles of corrective justice. This paper argues that although the use of principles of justice may render defensible many (but by no means all) of the claims to repair and to liability recognized in torts, it cannot explain why we have adopted a tort system as the approach to vindicating those claims. Some other principle — probably not one of justice — is needed to explain why it is that the victims claims to repair is satisfied by having his losses shifted to his injurer — rather than through some other means of doing so. The paper concludes that the law of torts cannot be understood — in the sense of being given a rational reconstruction — under any one principle of morality.     

Moral theories of torts: Their scope and limits: Part II

One approach to legal theory is to provide some sort of rational reconstruction of all or of a large body of the common law. For philosophers of law this has usually meant trying to rationalize a body of law under one or another principle of justice. This paper explores the efforts of the leading tort theorists to provide a moral basis - in the sense of rational reconstruction based on alleged moral principles - for the law of torts. The paper is divided into two parts. In the first part I consider and reject the view that tort law is best understood as falling either within the ambit of the principle of retributive justice, a comprehensive theory of moral responsibility, or an ideal of fairness inherent in the idea that one should impose on others only those risks others impose on one. The second part of the paper distinguishes among various conceptions of corrective or compensatory justice and considers arguments — including previous ones by the author himself — to the effect that tort law is best understood as rooted in principles of corrective justice. This paper argues that although the principles of justice may render defensible many (but by no means all) of the claims to repair and to liability recognized in torts, it cannot explain why we have adopted a tort system as the approach to vindicating those claims. Some other principle — probably not one of justice — is needed to explain why it is that the victim's claim to repair is satisfied by having his losses shifted to his injurer — rather than through some other means of doing so. The paper concludes that the law of torts cannot be understood — in the sense of being given a rational reconstruction — under any one principle of morality.     

Self-Mediated Risk in Criminal Law

The paper addresses the question whether ‘self-mediated risk’ – risk whose coming-to-fruition depends on future volitional conduct by the actor himself – bears on the wrongfulness of an actor's present conduct. Moral philosophers have long been divided on this question. ‘Actualists’ take the view that an actor's present moral obligations do, in fact, depend on what he or she actually is likely to do in the future. In contrast, ‘possibilists’ take the view that an actor's present obligations depend only on what he or she will have the capacity to do in the future. This paper argues that actualism better captures the morality that underlies the criminal law. The paper also explores actualism's implications for criminal law. Among these is the implication that the locus of moral fault in criminal cases sometimes is temporally removed from the conduct that triggers the assignment of blame.     

Outsiders’ Responsibility to Answer for Crime

R. A. Duff has revived the tradition of “answerability” for crime. In this philosophical and jurisprudential tradition, a person is answerable to the criminal law of a state and the process of that state’s courts only if there is some appropriate relationship between the state and the person. Duff’s great contribution has been to develop the idea of accountability of persons to a state or other polity as a philosophical notion which, he argues, underlies all just implementations of criminal law. Duff has centered his views around the relationship between the citizen and the polity (in today’s world, the state) to which the citizen belongs. His focus has been on insiders, rather than outsiders. This article argues that, in the current world, the relationship among cocitizens, outsiders, and the state is based in part on the moral idea that the state exists to protect citizens from evil acts, specifically those that we call public and criminal wrongs, wherever the acts originate. Outsiders understand this, and understand that states other than their own use criminal law to protect their citizens. Duff’s writings contain an idea which turns out to be very useful in cases of outside acts, even though he does not apply it directly to them. Some states or other entities may have only an incomplete relationship with an accused person (compared with the relationship of citizen and state), but nonetheless may have the moral and political authority to try her for crime. This paper extends this notion to show that such incomplete relationships exist in a great many common cases of outsiders (noncitizens who act outside the territory of a state) who commit crime. These relationships support criminal prosecution of outsiders, so long as we admit that protection of persons from crime is a legitimate goal of the criminal law.     

All Bark and No Bite: Notes on the Federal Constitutional Court's 'Banana Decision'

The Federal Constitutional Court's banana decision of 7 June 2000 continues the complex theme of national fundamental‐rights control over Community law. Whereas in the ‘Solange II’ decision (BVerfGE 73, 339) the Federal Constitutional Court had lowered its standard of review to the general guarantee of the constitutionally mandatorily required minimum, the Maastricht judgment (BVerfGE 89, 155) had raised doubts as to the continued validity of this case law. In the banana decision, which was based on the submission of the EC banana market regulation by the Frankfurt‐am‐Main administrative court for constitutional review, the Federal Constitutional Court has now confirmed the ‘Solange II’decision and restrictively specified the admissibility conditions for constitutional review of Community law as follows. Constitutional complaints and judicial applications for review of European legislation alleging fundamental‐rights infringements are inadmissible unless they show that the development of European law including Court of Justice case law has since the ‘Solange II’ decision generally fallen below the mandatorily required fundamental‐rights standard of the Basic Law in a given field. This would require a comprehensive comparison of European and national fundamental‐rights protection. This paper criticises this formula as being logically problematic and scarcely compatible with the Basic Law. Starting from the position that national constitutional courts active even in European matters should be among the essential vertical ‘checks and balances’ in the European multi‐level system, a practical alternative to the Federal Constitutional Court's retreat is developed. This involves at the first stage a submission by the Federal Constitutional Court to the Court of Justice, something that in the banana case might have taken up questions on the method of fundamental‐rights review and the internal Community effect of WTO dispute settlement decisions. Should national constitutional identity not be upheld even by this, then at a second stage, as ultima ratio taking recourse to general international law, the call is made for the decision of constitutional conflicts by an independent mediating body.     

法官能动性与公正再论

法院的判决宣示着法的精神,引导着民众的行为.诉诸于法院各种诉讼请求,即是将各种矛盾呈现在法官面前.法官必须判断何种诉求为正当,只有当案件事实符合法律规范的构成要件,且案件事实中蕴涵的法律价值和所适用的法律规范的价值取向相一致时,才可以依据该法律规范对案件事实作出判决.法官在运用国家的制定法以回应民众的要求时,将一些明显不当的有违民意的规定加以过滤,能动地对制定法加以填充修正.刘荣军教授亦言:"处于社会与国家立法机关之间的司法,应当以并不完整的法律作为基本的支撑,寻找制定法之外的法源,将社会的正义、公平的观念和价值导入司法程序之中,创造出能够解压、还原法律本意的规则,以作为裁判的依据."     

Criminal and Procedural Fairness: Some Challenges to the Presumption of Innocence

The presumption of innocence (POI) requires all judges, juries, and other officials in a trial, to presume and treat any accused of criminal wrongdoing as innocent, until he or she is proven guilty. Although a POI lacks an authoritative definition, this overarching principle of procedural fairness is so robust and vital for the exercise of legal power in matters of criminal law that one rarely finds anyone questioning its standing. In this article I examine the rationale behind the POI from a different perspective. The basic assumption is that this procedural standard captures the tenor of a broader principle which seeks to ensure fairness in criminal proceedings as well as in criminal law doctrine. I argue that honouring a principle of fairness is not exclusively a matter of criminal procedural law but also something that is deeply rooted in other areas of criminal law doctrine. Hence: not maintaining a principle of fairness in criminal law doctrine could lead to the POI being compromised or even undermined. In the article, I draw attention to three areas in which I believe that criminal law policies threaten a principle of fairness: criminalising remote harm, doctrine of ignorance of law and inversed presumptions of guilt. My conclusion is that some solutions to so called doctrinal problems in criminal law, are questionable and their practical consequences (on a general level) are, at least partially, equal to treating an individual (in a trial) as guilty for something for which he or she ought not to be accountable. Hence: gaining the support of a POI could thus work as principle for keeping the use of criminal law moderate and in accordance with a principle of fairness.     

Sex crime legislation: Proactive and anti-therapeutic effects

Therapeutic jurisprudence may have its major role within law practice, but analysis of the law from a therapeutic perspective is a task that should not be neglected; how a piece of legislation is designed and formulated certainly influences the therapeutic outcome of a legal process. This article uses sex legislation as an example to demonstrate how the old rape law based on coercion has anti-therapeutic effects on rape victims. If the law requires resistance, it implies that a woman is sexually available until she resists physically, resulting in an attitude that a woman reporting rape without injuries should be mistrusted. This mistrust of the victim and the victim's attendant feelings of self-blame aggravate the victim's trauma. On the other hand, a modern rape law based on lack of consent gives the signal that a woman is not available until she has given her consent, resulting in a different starting position for the investigation. Since the will of the victim must be respected, the victim herself must be respected in the legal process. Furthermore, being able to tell one's story in a respectful atmosphere can be more important for the well-being of the victim than the outcome of the reported case.     

The Hysterical Attorney: The Legal Advocate Within Lacanian Discourse Theory

In this essay, I apply Jacques Lacan'sfour discourses to the legal profession. A lawyer –i.e. a legal expert – engages in the Master'sdiscourse when he writes the law; he engages in theUniversity discourse when he interprets or attempts tojustify the law. In contrast, an attorney – i.e. a legal advisor – engages in the Analyst'sdiscourse when she counsel's her client; she engagesin the Hysteric's discourse when she represents herclient. From a Lacanian perspective, the two lawyer'sdiscourses are masculine, while the two attorney'sdiscourses are feminine. I divergefrom Lacan's view that the Analyst's is the mostradical discourse. The insight gained throughanalysis can only challenge and change the law iftranslated through the Hysteric's discourse. Consequently, despite dominant sexual stereotypes tothe contrary, to be an effective advocate should takeon a radically hysteric femininity.     

Christian Wolff on Subsidiarity, the Division of Labor, and Social Welfare

In more than one way Christian Wolff (1679-1754) has provided the grammar for modern social sciences in general, but economics in particular. Next to his path-breaking contributions to philosophy and international law, which are generally recognized, he has also pioneered the social sciences and provided the notions with which modern economics is still largely working. This is important also for modern law and economics research, since Wolff conceived of both law and economics still largely as one discipline and therefore was able to integrate naturally what has today to be integrated conscientiously, and with effort.     

Law, Finance, and Politics: The Case of India

The liberalization of India's economy since 1991 has brought with it considerable development of its financial markets and supporting legal institutions. An influential body of economic scholarship asserts that a country's "legal origin"—as a civilian or common law jurisdiction—plays an important part in determining the development of its investor protection regulations, and consequently its financial development. An alternative theory claims that the determinants of investor protection are political, rather than legal. We use the case of India to test these theories. We find little support for the idea that India's legal heritage as a common law country has been influential in speeding the path of regulatory reforms and financial development. Rather, we suggest there are complementarities between (1) India's relative success in services and software; (2) the relative strength of its financial markets for outside equity, as opposed to outside debt; and (3) the relative success of stock market regulation, as opposed to reforms of creditor rights. We conclude that political economy explanations have more traction in explaining the case of India than do theories based on "legal origins."     

Xenotransplantation: consent, public health and charter issues

There is a growing body of literature and commentary analyzing the ethical and public policy concerns associated with xenotransplantation. While this technology holds great promise to provide an almost limitless supply of organs for transplantation, there remains grave concern about possible public health ramifications. As a result, it has been recommended that patients who undergo xenotransplantations will need to agree, inter alia, to a lifetime of close health monitoring, participation in an international database and autopsy upon death. It has been suggested that this agreement would transform the nature of informed consent into a "binding contract." Though such draconian measures are understandable given the magnitude of the risks involved, would existing common law and legislation allow their implementation? This paper analyzes relevant Canadian consent and public health law in the context of the xenotransplantation. Canada is a country with a particularly rich body of informed consent jurisprudence--jurisprudence firmly rooted (rightly or not) in the ethical principle of autonomy. In this climate, many of the suggested monitoring strategies would find little support from Canadian law. Before xenotransplantations proceed, policy makers must be sensitive to the legal barriers which exist to the implementation [of] effective public health measures. Effective surveillance programs will require novel approaches to consent and the enactment of specific public health laws.