Medical Jurisprudence Commons^™

Can Dna Be Speech?, Jorge R. Roig

Jorge R Roig

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 …

Perkinelmer Inc. V. Intema Ltd. And Patent-Eligibility Of Diagnostic Screening Methods After Mayo V. Prometheus, John Ye

John Ye

In December 2011, the Supreme Court issued its ruling in Mayo v. Prometheus,[1] reversing the Federal Circuit based on unpatentable subject matter in a diagnostic method patent. In Mayo, the patent disclosed a method for determining the correct drug dosage based on the drug’s metabolite in a patient’s blood. The method was declared patent-ineligible because instead of teaching an application of laws of nature, the teachings only directed doctors to “apply it” - all disguised under the conventional steps such as “administering”, “measuring” and “determining” [2].

Following the Court’s holding, the Federal Circuit in November 2012 …

Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker

Chad I Brooker

Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

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 …

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 …

Energy And Environment Policy Case For A Global Project, Thomas A. Faunce

Thomas A Faunce

A policy case is made for a global project on artificial photosynthesis including its scientific justification, potential governance structure and funding mechanisms.

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.

The Alternative Forms Of Dispute Settlement And The Essential Difference Between These And Arbitration, Michael Diathesopoulos

Michael Diathesopoulos

The paper examines the characteristics of some common alternative forms of dispute settlement and their key differences from arbitration regarding their nature and scope. Its purpose is to explore each mechanism's suitability for specific types of disputes.

Could A Hub And Spoke, Homegrown Ceo Strategy Boost The Success Of University Start-Ups?, Brendan O. Baggot, Martin R. Graf Phd

Brendan O. Baggot

How can universities make more money with their spinout company (SpinCo)‐suitable technologies? By “growing” their own CEOs to improve both the quality and quantity of startup company leaders available, that’s how. Surprisingly, however, at most universities little or no effort is made to interweave this critical need into tech transfer efforts.

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 …

Governing Planetary Nanomedicine: Environmental Sustainability And A Unesco Universal Declaration On The Bioethics And Human Rights Of Natural And Artificial Photosynthesis (Global Solar Fuels And Foods)., Thomas A. Faunce

Thomas A Faunce

Environmental and public health-focused sciences are increasingly characterised as constituting an emerging discipline—planetary medicine. From a governance perspective, the ethical components of that discipline may usefully be viewed as bestowing upon our ailing natural environment the symbolic moral status of a patient. Such components emphasise, for example, the origins and content of professional and social virtues and related ethical principles needed to promote global governance systems and policies that reduce ecological stresses and pathologies derived from human overpopulation, selfishness and greed— such as pollution, loss of biodiversity, deforestation and greenhouse gas emissions, as well as provide necessary energy, water and …

A Bad Trip For Health-Related Human Rights: Implications Of Momcilovic V The Queen (2011) 85 Aljr 957, Tim Vines, Thomas A. Faunce

Thomas A Faunce

Momcilovic v The Queen (2011) 85 ALJR 957 [PDF] ; [2011] HCA 34 arose from a prosecution for drug trafficking brought under the Drugs, Poisons and Controlled Substances Act 1981 (Vic) . The Australian High Court held that the Charter of Human Rights and Responsibilities Act 2006 (Vic) (the Charter) validly conferred a power on the Victorian Supreme Court and Court of Appeal to interpret legislation in a manner consistent with a defined list of human rights. By a slim majority it also held that the Charter validly created a judicial power to "declare" a law inconsistent with one or …

Challenges To Australia’S National Health Policy From Trade And Investment Agreements, Thomas A. Faunce

Thomas A Faunce

Recent federal trade policy commitments concerning the Trans-Pacific Partnership Agreement (TPPA) negotiations (against changes to the Pharmaceutical Benefits Scheme (PBS) and against inclusion of an investor state provision) could protect Australia’s tobacco control legislation and Australia's sovereign capacity to regulate public health and environmental policy