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Pharmaceuticals

2016

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Institution
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Articles 1 - 19 of 19

Full-Text Articles in Law

Correlative Obligation In Patent Law: The Role Of Public Good In Defining The Limits Of Patent Exclusivity, Srividhya Ragavan Dec 2016

Correlative Obligation In Patent Law: The Role Of Public Good In Defining The Limits Of Patent Exclusivity, Srividhya Ragavan

Srividhya Ragavan

In light of the recent outrageous price-spiking of pharmaceuticals, this Article questions the underlying justifications for exclusive rights conferred by the grant of a patent. Traditionally, patents are defined as property rights granted to encourage desirable innovation. This definition is a misfit as treating patents as property rights does a poor job of defining the limits of the patent rights as well as the public benefit goals of the system. This misfit gradually caused an imbalance in the rights versus duties construct within patent law. After a thorough analysis of the historical and philosophical perspectives of patent exclusivity, this Article …


The New York Pharmaceutical Cost Transparency Act: How A Narrow View Of The Prescription Drug Pricing Puzzle Renders A Well-Intentioned Bill Irrational, John G. Curran Dec 2016

The New York Pharmaceutical Cost Transparency Act: How A Narrow View Of The Prescription Drug Pricing Puzzle Renders A Well-Intentioned Bill Irrational, John G. Curran

Brooklyn Law Review

Pricing prescription pharmaceuticals is a complex process that entails the consideration of a multitude of factors, not the least of which is the research and development expenditure exhausted by drug makers to gain FDA approval. While public sentiment has increasingly turned against the pharmaceutical industry due to its perceived greed as manifested in the high cost of its drugs, the intricacies of pricing such unique products is rarely discussed. A recently proposed New York state bill, the Pharmaceutical Cost Transparency Act (the NYPCTA), continues this unfortunate trend, by requiring companies to disclose the R&D costs of newly approved drugs in …


How Do The Social Benefits And Costs Of The Patent System Stack Up In Pharmaceuticals?, Daniel J. Gifford Oct 2016

How Do The Social Benefits And Costs Of The Patent System Stack Up In Pharmaceuticals?, Daniel J. Gifford

Journal of Intellectual Property Law

This paper explores the workings of the patent system in the context of the generation of new pharmaceutical products. First it identifies the relevant characteristics of the patent system and its relation to the market. The paper concedes that, in general, the patent system is probably the best way of generating new technology, in substantial part because that system uses the market to provide both incentives and rewards. The paper also identifies downsides of this patent/market system: deadweight loss and the unresponsiveness of that patent/market system to the needs of the poor. The paper then explores the social costs and …


Correlative Obligation In Patent Law: The Role Of Public Good In Defining The Limits Of Patent Exclusivity, Srividhya Ragavan Oct 2016

Correlative Obligation In Patent Law: The Role Of Public Good In Defining The Limits Of Patent Exclusivity, Srividhya Ragavan

Faculty Scholarship

In light of the recent outrageous price-spiking of pharmaceuticals, this Article questions the underlying justifications for exclusive rights conferred by the grant of a patent. Traditionally, patents are defined as property rights granted to encourage desirable innovation. This definition is a misfit as treating patents as property rights does a poor job of defining the limits of the patent rights as well as the public benefit goals of the system. This misfit gradually caused an imbalance in the rights versus duties construct within patent law. After a thorough analysis of the historical and philosophical perspectives of patent exclusivity, this Article …


Modernizing The Canada Health Act, Colleen M. Flood, Bryan Thomas Oct 2016

Modernizing The Canada Health Act, Colleen M. Flood, Bryan Thomas

Dalhousie Law Journal

The Canada Health Act (CHA) was adopted in 1984, to shore up a health-care system conceptualized in the 1960s. Under the CHA, universal coverage is limited to "medicallynecessary" hospital and physician services, to the exclusion of vital goods and services such as outpatient pharmaceuticals, dental care, long-term care, and many mental health services. Inequities resulting from these gaps in public coverage are partly to blame for pushing Canada's health system to the bottom ofrecent international rankings. But there is more to modernizing Canada s health care system, we argue, than filling these gaps in universal coverage. Every major health system …


The Future Of Health Law: How Can Law Meet Emerging Health Challenges?, Colleen M. Flood, Lorian Hardcastle Oct 2016

The Future Of Health Law: How Can Law Meet Emerging Health Challenges?, Colleen M. Flood, Lorian Hardcastle

Dalhousie Law Journal

Canadians have often prided themselves on having one of the best health-care systems in the world, but in recent years our system has fallen to the bottom of relevant international comparisons. Incremental attempts to improve the system have not resulted in significant improvements and the reality is that our most pressing challenges can be addressed only through ambitious, systemic reforms. For example, it is well established that Canada's patchwork scheme for providing long-term care will not scale to meet growing needs as a quarter ofthe population enters retirement age over the next two decades.' As yet further examples, the Canadian …


Corporate Power Unbound: Investorstate Arbitration Of Ip Monopolies On Medicines—Eli Lilly V. Canada And The Trans-Pacific Partnership Agreement, Brook K. Baker, Katrina Geddes Apr 2016

Corporate Power Unbound: Investorstate Arbitration Of Ip Monopolies On Medicines—Eli Lilly V. Canada And The Trans-Pacific Partnership Agreement, Brook K. Baker, Katrina Geddes

Journal of Intellectual Property Law

No abstract provided.


The Health Impact Fund Proposal: Application In The United States' Era Of Comparative Effectiveness, Katherine Jeanne Racz Mar 2016

The Health Impact Fund Proposal: Application In The United States' Era Of Comparative Effectiveness, Katherine Jeanne Racz

Journal of Intellectual Property Law

No abstract provided.


History, Trips, And Common Sense: Curbing The Counterfeit Drug Market In Sub-Saharan Africa, Hannah Elizabeth Jarrells Mar 2016

History, Trips, And Common Sense: Curbing The Counterfeit Drug Market In Sub-Saharan Africa, Hannah Elizabeth Jarrells

Georgia Journal of International & Comparative Law

No abstract provided.


A Pharmaceutical Park Place: Why The Supreme Court Should Modify The Scope Of The Patent Test For Reverse Payment Deals, David Ernest Balajthy Feb 2016

A Pharmaceutical Park Place: Why The Supreme Court Should Modify The Scope Of The Patent Test For Reverse Payment Deals, David Ernest Balajthy

Journal of Intellectual Property Law

No abstract provided.


Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd Jan 2016

Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd

Faculty Articles

This Article examines a relatively new business strategy in the pharmaceutical market -- "product hopping" or "product replacement" -- in which brand pharmaceutical companies shift their marketing efforts from a drug nearing the end of its patent period to a new, substitute drug with a longer patent life. In July 2015, the Second Circuit issued an opinion in the first appellate case addressing pharmaceutical product replacement, New York ex rel. Schneiderman v. Actavis PLC. This Article explains that product replacement is the predictable business response to the incentives created by patent law and state substitution laws, and withdrawing an …


A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise Jan 2016

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.


Test Data Protection: Different Approaches And Implementation In Pharmaceuticals, Wael Armouti, Mohammad F. A. Nsour Jan 2016

Test Data Protection: Different Approaches And Implementation In Pharmaceuticals, Wael Armouti, Mohammad F. A. Nsour

Marquette Intellectual Property Law Review

None


Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow Jan 2016

Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow

Articles & Chapters

Profs. Allison and Ouellette’s Article, How Courts Adjudicate Patent Definiteness and Disclosure, 65 Duke L.J.609 (2015), on courts’ adjudication of certain patent disputes presents some surprising data: pharmaceutical patents litigated to judgment fare substantially worse on written-description analyses if they are not part of traditional pioneer-generic litigation. This Response engages in several hypotheses for this disparity and examines the cases that make up Allison and Ouellette’s dataset. An analysis of these cases finds that the disparity can be best explained by technological and judicial idiosyncrasies in each case, rather than larger differences among pharmaceutical patent cases. This finding contextualizes …


The Myths Of Data Exclusivity, Erika Lietzan Jan 2016

The Myths Of Data Exclusivity, Erika Lietzan

Faculty Publications

This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: …


Nanotechnology, Environmental Risks, And Regulatory Options, Vincent R. Johnson Jan 2016

Nanotechnology, Environmental Risks, And Regulatory Options, Vincent R. Johnson

Faculty Articles

Nanotechnology today is viewed by many as a great advance in the quest for stronger and lighter materials, more effective pharmaceuticals, and better medicine. The critical question—largely unanswered—is whether this kind of science harbors destructive powers which, if fully understood, would call for restrictions or a ban on the use of certain types of nanotechnology. Current regulations in the United States and Europe cover chemicals that may be produced in nanoform. However, those regimes are not well designed to detect the risks posed by nanotechnology because they often fail to appreciate what is unique about nanomaterials. It is unlikely that …


Aids Activists, Fda Regulation, And The Amendment Of America's Drug Constitution, Lewis Grossman Jan 2016

Aids Activists, Fda Regulation, And The Amendment Of America's Drug Constitution, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

This Article explores how AIDS activists, desperate for access to potentially life-saving pharmaceuticals, permanently transformed America’s “drug constitution.” Their advocacy altered the FDA’s interpretation and application of the federal Food, Drug, and Cosmetic Act (FDCA) so as to expedite the availability of new, unproven drugs for critical illnesses, thus enhancing individual patients’ autonomy to make therapeutic choices without government interference.The FDCA is more than simple set of instructions to a federal agency — it is a source of vitally important and deeply entrenched institutional and normative frameworks. Like major civil rights, antitrust, and environmental statutes, the FDCA should be viewed …


Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova Dec 2015

Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova

Robin C Feldman

The FDA’s citizen petition process was created in the 1970s as part of an effort to fashion more participatory regimes, in which ordinary citizens could access the administrative process. The theoretical underpinnings hypothesize that a participatory structure will prevent regulatory agencies from being captured by the very industries they were intended to police. Anecdotal evidence suggests, however, that the FDA’s citizen petition process may have taken a different turn. This empirical study explores whether pharmaceutical companies are systematically using citizen petitions to try to delay the approval of generic competitors. Delaying generic entry of a drug — even by a …


Regulatory Property: The New Ip, Robin C. Feldman Dec 2015

Regulatory Property: The New Ip, Robin C. Feldman

Robin C Feldman

For thirty years, a new form of intellectual property has grown up quietly beneath the surface of societal observation. It is a set of government-granted rights that have the quintessential characteristic of intellectual property and other forms of property — that is, the right to exclude others from the territory. 

The impact of this form of IP on the US health care system, in particular, is enormous. In 2014, more than 40% of all new drugs approved by the FDA came through just one of these portals, with the companies collecting regulatory property rights along the way. 

Some forms of …