Health Law and Policy 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 …

Trazos Y Reflexiones En Torno A La Marca Farmacéutica, Javier André Murillo Chávez

Javier André Murillo Chávez

No abstract provided.

The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah W. Brennan

Hannah W Brennan

The United States spends nearly $1,000 per person annually on drugs—40 percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, the crucial role that intellectual property laws play in inhibiting access to cheaper, generic medications is among one of the best documented. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different exclusivity—trademark law. New …

The Plain Packaging Of Tobacco Products: A Submission To The New Zealand Parliament, Matthew Rimmer Dr

Matthew Rimmer

RECOMMENDATIONSRecommendation 1 New Zealand should introduce the plain packaging of tobacco products in order to implement the World Health Organization Framework Convention on Tobacco Control 2003 – in particular, Articles 11 and 13 of the agreement, and the accompanying guidelines.Recommendation 2 New Zealand should implement plain packaging of tobacco products, without delay or hesitation. There is no good reason to wait for the resolution of the five disputes between Australia and other countries in the World Trade Organization. Australian Government has a strong case. Its opponents have been seeking to stall and delay the disputes.Recommendation 3 In my expert opinion, …

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 Empire Of Cancer: Gene Patents And Cancer Voices, Matthew Rimmer

Matthew Rimmer

In his book, The Emperor of All Maladies, Siddhartha Mukherjee writes a history of cancer — ‘It is a chronicle of an ancient disease — once a clandestine, “whispered-about” illness — that has metamorphosed into a lethal shape-shifting entity imbued with such penetrating metaphorical, medical, scientific, and political potency that cancer is often described as the defining plague of our generation’.Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned …

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.

A Submission To The House Of Representatives Standing Committee On Social Policy And Legal Affairs On The Intellectual Property Laws Amendment Bill 2013 (Cth), Matthew Rimmer

Matthew Rimmer

The amendments contained in the Intellectual Property Laws Amendment Bill 2013 (Cth) are designed to provide safeguards in relation to patent law and the public interest.In the 2012 case on plain packaging, the Chief Justice of the High Court of Australia, Robert French, emphasized that the role of intellectual property law is to promote public objectives. His Honour observed: ‘There are and always have been purposive elements reflecting public policy considerations which inform the statutory creation of intellectual property rights.’ Discussing the role of patent law, Chief Justice Robert French commented:The Patents Act 1990 (Cth) provides that a patent gives …

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, …

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 …

Can Incentives To Generic Manufacturers Save The Doha Declaration's Paragraph 6?, Stacey B. Lee

Stacey B. Lee

A primary objective of the DOHA Declaration was to create a process for member countries with insufficient manufacturing capabilities to access generic versions of patented drugs without violating TRIPS intellectual property standards. This year marks the 10^th anniversary of the process. Referred to as the “Paragraph 6 compulsory licenses provisions,” this first and only amendment to TRIPS was intended to ensure developing countries access to affordable medicines. Over the past decade, these provisions have failed to provide the gains initially anticipated. This article explores the reasons for this failure and suggests that an under-examined approach to reaching the DOHA …

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 …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Ryan G. Vacca

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

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 …

An Assessment Of The Effects Of Desertification In Yobe State, Nigeria, Jibril Musa Phd

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

Desertification is one of the most serious environmental and socio-economic problems of our time. Desertification describes circumstances of land degradation in arid, semi-arid and dry sub-humid regions resulting from the climatic variation and human activities. The fundamental goal of this thesis was to assess the effects of desertification in Yobe State, Nigeria. The present threat of desertification in the sahel has reached an alarming stage where crops cultivation and animal rearing/grazing are no more productive, soil has lost its nutrient/fertility, various infrastructure had given way because of windstorm from the neighbouring Niger Republic and sand dunes had taken over. The …

Using Remote Sensing Data To Improve Rice Production In Kutigi, Niger State, Nigeria, Jibril Musa Phd, M B. Yunusa

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

This research work looked in the used of Remote Sensing to improve Agricultural production in Kutigi, Niger State. The aim of the study is to use remote sensing to improve rice farming activities in Kutigi, Niger State. It is very important to identify such methods to improve Agricultural production because experts are always interested in new researches and findings to better the standard of living in any environment. In view of this, Remotely-sensed data could be used or employed to elevate most of these agricultural problems in Kutigi through the following objectives: Using Landsat imagery to assess the present landuse …

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 …

Variations In Climatic Parameters And Food Crop Yields: Implications On Food Security In Benue State, Nigeria., Emmanuel Adamgbe, Fanan Ujoh

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

Agricultural production in Nigeria like in other developing countries is highly vulnerable to variations in climatic parameters which may have inverse or direct effect on the performance of food crops. This paper examines the patterns and trends of the variations in the climatic parameters and the implications of such variations on efficient yield rates of some food crops in Benue State using data on climatic variables (rainfall, temperature, sunshine) and the yield of some crops per hectare for 25 years (1986-2010). Data on the climatic variables were collected from the Nigerian Meteorological Agency, AirForce Base, Makurdi while the data on …

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 …