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Articles 1 - 23 of 23
Full-Text Articles in Law
Pay-For-Delay: How Brand-Name And Generic Pharmaceutical Drug Companies Collude And Cost Consumer Billions, Raymond J. Prince
Pay-For-Delay: How Brand-Name And Generic Pharmaceutical Drug Companies Collude And Cost Consumer Billions, Raymond J. Prince
South Carolina Law Review
No abstract provided.
3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom
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 …
It’S The End Of The Biological Patent World As We Know It, And Consumer Watchdog Feels Fine: How Consumer Watchdog Is Attempting To Kill The Future Of Horticultural Research, George R. Holton
George R Holton
No abstract provided.
Promoting “Academic Entrepreurship” In Europe And The United States: Creating An Intellectual Property Regime To Facilitate The Efficient Transfer Of Knowledge From The Lab To The Patient, Constance Bagley, Christina Tvarno
Promoting “Academic Entrepreurship” In Europe And The United States: Creating An Intellectual Property Regime To Facilitate The Efficient Transfer Of Knowledge From The Lab To The Patient, Constance Bagley, Christina Tvarno
Constance E. Bagley
In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the EU needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (PPPPs) …
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah W. Brennan
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 Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq
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
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
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.
Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker
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
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, Ag-Biotech And The Right To Adequate Food: A Critical African Perspective, Chidi Oguamanam
Intellectual Property, Ag-Biotech And The Right To Adequate Food: A Critical African Perspective, Chidi Oguamanam
Chidi Oguamanam
Recent transformations in agricultural innovations have resulted in the consolidation of intellectual property rights in the agricultural arena resulting in an ongoing struggle for the control of plant genetic resources. For many developing countries, especially in Africa, traditional and communal-based artisanal farmers are the producers of over three quarters of regional food supply. But contemporary techno-legal transformations in agriculture undermine the critical role of these informal actors in a manner that aggravates the state of regional food insecurity in Africa. The aspirations of African countries to implement their obligations in regard to the right to adequate food under the International …
Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower
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 …
One Size Does Not Fit All, David Spratt
One Size Does Not Fit All, David Spratt
Articles in Law Reviews & Other Academic Journals
No abstract provided.
Special 301 Of The Trade Act Of 1974 And Global Access To Medicine, Sean Flynn
Special 301 Of The Trade Act Of 1974 And Global Access To Medicine, Sean Flynn
Articles in Law Reviews & Other Academic Journals
Since its inception in 1988, the United States Trade Representative’s “Special 301” adjudication of foreign intellectual property law standards has been used to promote policies restricting access to affordable medications around the world. President-elect Obama released a platform promising to “break the stranglehold that a few big drug and insurance companies have on these life-saving drugs” and pledged support for “the rights of sovereign nations to access quality-assured, low-cost generic medication to meet their pressing public health needs.” The 2009 and 2010 Special 301 reports, however, indicate that the Obama Administration has not yet implemented this pledge into administration trade …
An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo
An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo
Articles in Law Reviews & Other Academic Journals
This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …
A Complete Property Right Amendment, John H. Ryskamp
A Complete Property Right Amendment, John H. Ryskamp
ExpressO
The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.
On The Legal Consequence Of Sauces: Should Thomas Keller's Recipes Be Per Se Copyrightable, Christopher J. Buccafusco
On The Legal Consequence Of Sauces: Should Thomas Keller's Recipes Be Per Se Copyrightable, Christopher J. Buccafusco
ExpressO
This article is devoted to copyright protection for one of the restaurant industry’s most valuable assets – original recipes. The two most recent appellate courts to consider the issue have been hostile to the notion that recipes are copyrightable, but given the enormous amount of money at stake, litigation in this area is likely about to expand. The article begins by critiquing the courts’ conclusions. Following an analogy to musical composition, I argue that recipes are simply the means of fixation for culinary works of authorship, i.e, dishes. Next, based on interviews with some of America’s leading chefs, including Thomas …
Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu
Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu
ExpressO
The constitutional purpose of intellectual property is to “promote the progress of science and useful arts.” Given the utilitarian basis of patents, it is critical that policies and laws must be continually adjusted to reflect the needs of new technologies. When the law tries to shield itself from rather than confront the realities of underlying technologies, patents end up actually subverting rather than promote technological progress. This paper explores why the natural extracts doctrine belongs to the class of doctrines that subvert progress. The doctrine, established over a century ago to enable the patenting of purified compounds for use as …
Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp
Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp
ExpressO
This brief comment suggests where the anti-eminent domain movement might be heading next.
Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson
Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson
ExpressO
This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …
Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson
Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson
ExpressO
This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …
Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor
Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor
ExpressO
No abstract provided.
Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland
Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland
ExpressO
This article discusses the recent passage of the Medicare Prescription Drug, Modernization and Improvement Act of 2003, and the executive and judicial decisions affecting the ability of the general public to access foreign pharmaceutical markets. The article examines the recent actions taken by the U.S. government, explore various state movements within the United States aimed at reducing pharmaceutical drug prices, outline the process of pharmaceutical drug prices in foreign countries, and advocate for a workable integration of all available mechanisms to feasibly reduce prescription drug prices for the benefit of both U.S. consumers and U.S. drug companies. As avenues to …