Internet Law Commons^™

3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom

Evan R. Youngstrom

Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must be …

Bridging The Gap Between Intent And Status: A New Framework For Modern Parentage, Yehezkel Margalit

Hezi Margalit

The last few decades have witnessed dramatic changes in the conceptualization and methodologies of determining legal parentage in the U.S. and other countries in the western world. Through various sociological shifts, growing social openness and bio-medical innovations, the traditional definitions of family and parenthood have been dramatically transformed. This transformation has led to an acute and urgent need for legal and social frameworks to regulate the process of determining legal parentage. Moreover, instead of progressing in a piecemeal, ad-hoc manner, the framework for determining legal parentage should be comprehensive. Only a comprehensive solution will address the differing needs of today’s …

From Baby M To Baby M(Anji): Regulating International Surrogacy Agreements, Yehezkel Margalit

Hezi Margalit

In 1985, when Kim Cotton became Britain’s first commercial surrogate mother, Europe was exposed to the issue of surrogacy for the first time on a large scale. Three years later, in 1988, the famous case of Baby M drew the attention of the American public to surrogacy as well. These two cases implicated fundamental ethical and legal issues regarding domestic surrogacy and triggered a fierce debate about motherhood, child-bearing, and the relationship between procreation, science and commerce. These two cases exemplified the debate regarding domestic surrogacy - a debate that has now been raging for decades. Contrary to the well-known …

The "Uberization" Of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology's Impact On The Medical Profession, Fazal Khan

Fazal Khan

The nascent field of mobile health technology is still very small but is predicted to grow exponentially as major technology companies such as Apple, Google, Samsung, and even Facebook have announced mobile health initiatives alongside influential healthcare provider networks. Given the highly regulated nature of healthcare, significant legal barriers stand in the way of mobile health’s potential ascension. I contend that the most difficult legal challenges facing this industry will be restrictive professional licensing and scope of practice laws. The primary reason is that mobile health threatens to disrupt historical power dynamics within the healthcare profession that have legally enshrined …

Defining Death: A Call For The Reformation Of The Standard For Declaration Of Death In The Modern Era, Jayme M. Reisler

Jayme M Reisler

Prior to the mid 20th century, a declaration of death was a relatively definite determination because the functioning of each vital organ was inextricably linked to the other. With the advent of the positive-pressure mechanical ventilator, however, came the loss of integration among these organ systems. The ability to maintain metabolic functioning of a patient as well as the ability to successfully transplant viable organs have given rise to a host of legal issues revolving around the determination of death. The main issue that arises is two fold. On one hand, such medical technology can prolong an individual’s life even …

Foreseeability Decoded, Meiring De Villiers

Meiring de Villiers

The Article reviews the conceptual and doctrinal roles of the foreseeability doctrine in negligence law, and analyzes its application in cases where a new technology or unexplored scientific principle contributed to a plaintiff’s harm. It adopts the common law definition of foreseeability as a systematic relationship between a defendant’s wrongdoing and the plaintiff’s harm, and demonstrates translation of the concept into the language of science so that the common law meaning of the foreseeability doctrine is preserved. An analysis of the foreseeability of HIV/AIDS as a blood-borne risk illustrates application of the concept to contemporary issues in medical science.

Ivf And The Law: How Legal And Regulatory Neglect Compromised A Medical Breakthrough, Steve Calandrillo

Steve P. Calandrillo

The rise of assisted reproductive technology like in vitro fertilization (IVF) as a method of human reproduction represents a remarkable medical achievement. It has allowed millions of infertile and same-sex couples to have children who were previously only the subject of their unrequited dreams. Live births and success rates have increased dramatically in the past decade, so much so that many fertility clinics “guarantee” a baby to clients who sign up. But with success comes inevitable downsides. Everyone knows that the price tag is steep, but given the demand, that obstacle seems to deter relatively few determined individuals. More insidious …

Rebuttable Presumption Of Public Interest In Protecting The Public Health—The Necessity For Denying Injunctive Relief In Medically Related Patent Infringement Cases After Ebay V. Mercexchange, Lance E. Wyatt Jr.

Lance E Wyatt Jr.

The public’s interest in medicine and good health is substantial. However, this interest is harmed when important medical devices or pharmaceuticals, although infringing on valid patents, are suddenly taken off the market after a court grants a permanent injunction. While permanent injunctions were automatically granted by the Federal Circuit before the Supreme Court’s holding in eBay v. MercExchange, courts now have more discretion to deny injunctive relief. Now that courts have this newfound discretion after eBay, the public should no longer expect to be harmed by the sudden removal of medical supplies. Unfortunately, this has not been the course that …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis

Kenneth C. Louis

No abstract provided.

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

Pirates Of The Australian Election, Matthew Rimmer

Matthew Rimmer

“Pirate parties” have proliferated across Europe and North America in the past decade, championing issues such as intellectual property (IP), freedom of speech, and the protection of privacy and anonymity.This year, the movement hit Australian shores: The Pirate Party Australia was officially registered by the Australian Electoral Commission in January 2013. (You can read its principles and platform here.)“More than ever before, there is a necessity in Australia for a party that holds empowerment, participation, free culture and openness as its central tenets”, Pirate Party founder Rodney Serkowski said in a press release announcing the group’s successful registration. Their first …

An Elegy For Greg Ham: Copyright Law, The Kookaburra Case, And Remix Culture, Matthew Rimmer

Matthew Rimmer

The ‘Kookaburra’ case was a tragic and controversial copyright dispute, highlighting the need for copyright law reform by the Australian Parliament. In the Kookaburra case, a copyright action was brought by Larrikin Records against Men at Work’s song ‘Down Under’, alleging copyright infringement of the ‘Kookaburra’ song composed by Marion Sinclair. The dispute raised a host of doctrinal matters. There was disquiet over the length of the copyright term. There were fierce contests as to the copyright ownership of the ‘Kookaburra’ song. The litigation raised questions about copyright infringement and substantiality – particularly in relation to musical works. The ‘Kookaburra’ …

23andme Inc.: Patent Law And Lifestyle Genetics, Matthew Rimmer

Matthew Rimmer

The venture, 23andMe Inc., raises a host of issues in respect of patent law, policy, and practice in respect of lifestyle genetics and personalised medicine. The company observes: ‘We recognize that the availability of personal genetic information raises important issues at the nexus of ethics, law, and public policy’. 23andMe Inc. has tested the boundaries of patent law, with its patent applications, which cut across information technology, medicine, and biotechnology. The company’s research raises fundamental issues about patentability, especially in light of the litigation in Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories Inc. and Association for Molecular Pathology …

A Submission To The Australian Law Reform Commission On Copyright And The Digital Economy: Remix Culture, Matthew Rimmer

Matthew Rimmer

RECOMMENDATIONSIn its issues paper, the Australian Law Reform Commission asks a number of inter-connected questions about transformative use, fair dealing, and fair use:Transformative useQuestion 14. How are copyright materials being used in transformative and collaborative ways—for example, in ‘sampling’, ‘remixes’ and ‘mashups’. For what purposes—for example, commercial purposes, in creating cultural works or as individual self-expression?Question 15. Should the use of copyright materials in transformative uses be more freely permitted? Should the Copyright Act 1968 (Cth) be amended to provide that transformative use does not constitute an infringement of copyright? If so, how should such an exception be framed?Question 16. …

A Submission To The Australian Law Reform Commission On Copyright And The Digital Economy: 3d Printing, Matthew Rimmer

Matthew Rimmer

RECOMMENDATIONSThe Australian Law Reform Commission poses a number of questions on the defence of fair use in Copyright and the Digital Economy.Question 52. Should the Copyright Act 1968 (Cth) be amended to include a broad, flexible exception? If so, how should this exception be framed? For example, should such an exception be based on ‘fairness’, ‘reasonableness’ or something else? Question 53. Should such a new exception replace all or some existing exceptions or should it be in addition to existing exceptions?The case study of 3D printing highlights how Australia would benefit from a defence of fair use.Recommendation 1 The narrow, …

A Submission To The Australian Law Reform Commission On Copyright And The Digital Economy: Disability Rights, Matthew Rimmer Dr

Matthew Rimmer

RECOMMENDATIONS

Recommendation 1 The Australian Government should take legislative action to implement Article 30 (3) of the United Nations Convention on the Rights of Persons with Disabilities 2006, which provides that ‘States Parties shall take all appropriate steps, in accordance with international law, to ensure that laws protecting intellectual property rights do not constitute an unreasonable or discriminatory barrier to access by persons with disabilities to cultural materials’. This will involve revising the Copyright Act 1968 (Cth) – and addressing any direct or indirect disability discrimination.

Recommendation 2 The Australian Law Reform Commission should consider revising the Copyright Act 1968 …

A Submission To The Australian Law Reform Commission On Copyright And The Digital Economy: International Law, Matthew Rimmer Dr

Matthew Rimmer

The Australian Law Reform Commission poses a question in respect of international law in the issues paper on Copyright and the Digital Economy.Question 1. The ALRC is interested in evidence of how Australia’s copyright law is affecting participation in the digital economy. For example, is there evidence about how copyright law: a. affects the ability of creators to earn a living, including through access to new revenue streams and new digital goods and services; b. affects the introduction of new or innovative business models; c. imposes unnecessary costs or inefficiencies on creators or those wanting to access or make use …

A Submission To The Australian Law Reform Commission On Copyright And The Digital Economy: Consumer Rights, Matthew Rimmer

Matthew Rimmer

RECOMMENDATIONSThe Australian Law Reform Commission poses a number of inter-related questions about copyright law, personal use, consumer rights, and cloud computing:Cloud computingQuestion 5. Is Australian copyright law impeding the development or delivery of cloud computing services?Question 6. Should exceptions in the Copyright Act 1968 (Cth) be amended, or new exceptions created, to account for new cloud computing services, and if so, how?Copying for private useQuestion 7. Should the copying of legally acquired copyright material, including broadcast material, for private and domestic use be more freely permitted?Question 8. The format shifting exceptions in the Copyright Act 1968 (Cth) allow users to …

A Submission To The Australian Law Reform Commission On Copyright And The Digital Economy: Moral Rights, Matthew Rimmer

Matthew Rimmer

RECOMMENDATIONSThe Australian Law Reform Commission poses a question in respect of moral rights in the issues paper on Copyright and the Digital Economy.Question 18. The Copyright Act 1968 (Cth) provides authors with three ‘moral rights’: a right of attribution; a right against false attribution; and a right of integrity. What amendments to provisions of the Act dealing with moral rights may be desirable to respond to new exceptions allowing transformative or collaborative uses of copyright material?In response, I would emphasize a number of themes in respect of moral rights.Recommendation 1 There is a need for the Australian Law Reform Commission …

A Submission To The Australian Law Reform Commission On Copyright And The Digital Economy: The Copyright Term And Orphan Works, Matthew Rimmer

Matthew Rimmer

RECOMMENDATIONSThe Australian Law Reform Commission asks a number of questions in respect of copyright law and orphan works:Question 23. How does the legal treatment of orphan works affect the use, access to and dissemination of copyright works in Australia?Question 24. Should the Copyright Act 1968 (Cth) be amended to create a new exception or collective licensing scheme for use of orphan works? How should such an exception or collective licensing scheme be framed?In response, I would make the following recommendations on copyright term and copyright duration; old copyright works; orphan works; and copyfraud:Recommendation 1 The Australian Government should withdraw from …

A Submission To The Australian Law Reform Commission On Copyright And The Digital Economy: The Progress Of Science, Matthew Rimmer

Matthew Rimmer

RECOMMENDATIONSThe Australian Law Reform Commission poses a number of questions about copyright law and databases in its issues paper on Copyright and the Digital Economy:Data and text miningQuestion 25. Are uses of data and text mining tools being impeded by the Copyright Act 1968 (Cth)? What evidence, if any, is there of the value of data mining to the digital economy?Question 26. Should the Copyright Act 1968 (Cth) be amended to provide for an exception for the use of copyright material for text, data mining and other analytical software? If so, how should this exception be framed?Question 27. Are there …

Patents For Humanity, Matthew Rimmer

Matthew Rimmer

This article evaluates two policy initiatives by the United States Government to address access to essential medicines—Priority Review vouchers and “Patents for Humanity”. Such proposals are aimed at speeding up the regulatory review of inventions with humanitarian uses and applications by the United States Food and Drug Administration, and the United States Patent and Trademark Office. It is argued that such measures fall short of international standards and norms established by the World Intellectual Property Organization Development Agenda 2007; the World Trade Organization’s Doha Declaration on the TRIPS Agreement and Public Health 2001 and the WTO General Council Decision of …

A Submission To The New Zealand Government On The Plain Packaging Of Tobacco Products, Matthew Rimmer

Matthew Rimmer

EXECUTIVE SUMMARYThis submission draws upon a number of pieces of research and policy papers on the plain packaging of tobacco products including:1. Becky Freeman, Simon Chapman, and Matthew Rimmer, 'The Case for the Plain Packaging of Tobacco Products' (2008) 103 (4) Addiction 580-590.2. Matthew Rimmer, 'A Submission to the Senate Legal and Constitutional Committee on the Trade Marks Amendment (Tobacco Plain Packaging) Bill (Cth)', September 2011, https://senate.aph.gov.au/submissions/comittees/viewdocument.aspx?id=dabfcd75-9807-493f-bc99-4a7506bf493b3A. Matthew Rimmer, 'Tobacco's Mad Men Threaten Public Health', The Conversation, 23 September 2011, http://theconversation.edu.au/tobaccos-mad-men-threaten-public-health-34503B. Matthew Rimmer, 'Big Tobacco's Box Fetish: Plain Packaging at the High Court', The Conversation, 20 April 2012, https://theconversation.edu.au/big-tobaccos-box-fetish-plain-packaging-at-the-high-court-65183C. Matthew …

It Pricing: Copyright Law, Consumer Rights, And Competition Policy. A Submission To The House Of Representatives Standing Committee On Infrastructure And Communications Inquiry Into It Pricing, Matthew Rimmer

Matthew Rimmer

Justice Lionel Murphy‘Copyright is being used to manipulate the Australian market.’Justice Michael Kirby‘In effect, and apparently intentionally, those [technological] restrictions reduce global market competition. They inhibit rights ordinarily acquired by Australian owners of chattels to use and adapt the same, once acquired, to their advantage and for their use as they see fit.’US Attorney-General Eric Holder‘As a result of this alleged conspiracy, we believe that consumers paid millions of dollars more for some of the most popular titles.’Justice Denise Coates‘There can be no denying the importance of books and authors in the quest for human knowledge and creative expression, and …

This Sporting Life: Copyright Law And Consumer Rights, Matthew Rimmer

Matthew Rimmer

When too much sport is not enoughH.G. Nelson and Roy SlavenSport occupies an anomalous position under Australian copyright law. A footballer like Gary Ablett Junior is not an author under copyright law. A sporting spectacle like the AFL Grand Final or the State of Origin is not a dramatic work. Sporting events are protected somewhat peripherally as television broadcasts under Australian copyright law. Nonetheless, sports organizations have engaged in special pleading in respect of intellectual property law. This has been particularly evident in the litigation between Optus, the National Rugby League, and the Australian Football League.

La Transparencia En La Protección De Datos Personales, Bruno L. Costantini García

Bruno L. Costantini García

La Transparencia en la Protección de Datos Personales, ponencia elaborada dentro de los trabajos del VII Congreso Nacional de Organismos Públicos Autónomos (OPAM)

Sorting Out The Green From The Greenwash, Matthew Rimmer

Matthew Rimmer

Greenwashing is corporate spin which involves making misleading or deceptive claims that a company’s products or services are environmentally sustainable or friendly.The problem of greenwashing requires a robust, integrated approach to law reform to discourage the practice that makes it harder for legitimate voices to be heard.The consultancy group, TerraChoice, had identified seven sins of greenwashing – including claims involving hidden trade-offs; lack of proof; vagueness; false labelling; irrelevant claims; false comparisons; and false statements. Such conduct is putting consumers at a disadvantage and giving some businesses an unfair advantage in a market increasingly concerned about the environment and climate …

Aspectos Generales Dela Publicidad En México. "La Publicidad De Productos, Servicios, Y Actividades Reguladas Por La Ley General De Salud", Bruno L. Costantini García

Bruno L. Costantini García

Introducción a las generalidades de la regulación en materia de publicidad de insumos para el consumo humano (salud) en México.