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Articles 1 - 17 of 17
Full-Text Articles in Law
The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.
The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.
DePaul Journal of Health Care Law
This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …
That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn
That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn
Concordia Law Review
By their very nature, patents are exclusionary. A patent grants the right to exclude others from making use of an invention or process. But patents are also tools to promote innovation. However, when an invalid patent is granted, the patent becomes an exclusionary tool that also chills innovation. Invalid cannabis patents may be chilling innovation in the cannabis market, but they may not be the only thing. While the Controlled Substances Act continues to prohibit cannabis at a federal level, researchers and medical professionals will be unsure of the legality of their actions. This naturally leads to another chilling effect …
A Prescription For Biopharmaceutical Patents: A Cure For Inter Partes Review Ailments, Alex A. Jurisch
A Prescription For Biopharmaceutical Patents: A Cure For Inter Partes Review Ailments, Alex A. Jurisch
Seattle University Law Review
The patent system in the United States was forever changed with the introduction of the Leahy-Smith America Invents Act (AIA) in September of 2011. The AIA brought sweeping changes to American patent law in order to align the U.S. with much of the rest of the world by changing the invention priority from a “first to invent” to a “first to file” system. The first section of this note will provide a brief overview of the substance of inter partes reviews and some of the most critical negatives that have become apparent since 2013. The second section of this Note …
Adjustments, Extensions, Disclaimers, And Continuations: When Do Patent Term Adjustments Make Sense?, Stephanie Plamondon Bair
Adjustments, Extensions, Disclaimers, And Continuations: When Do Patent Term Adjustments Make Sense?, Stephanie Plamondon Bair
Stephanie Bair
The United States patent system represents a measured trade-off between two competing policy considerations: providing sufficient incentives to encourage the innovation and development of new and socially useful inventions; and ensuring that such inventions are readily available to the public at an affordable price. Although the default patent term is now twenty years from filing, various features of, and changes to, the patent system over the years have allowed patent owners to extend the duration of their patent monopolies, sometimes for several years. Such extensions, though seemingly insignificant when compared to the full patent term, have an enormous impact on …
Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini
Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini
Arbitration Law Review
No abstract provided.
Food Patents: The Unintended Consequences, Jay Dratler Jr.
Food Patents: The Unintended Consequences, Jay Dratler Jr.
Akron Intellectual Property Journal
This short paper explores the unintended consequences of this strong economic incentive. The underlying assumptions of patent law and its economic incentive are that innovation is good, and newer is better. But is that always so? Science and history suggest maybe not, for some very fundamental reasons. And there are reasons to believe that the risks of unintended consequences of innovation in food may be more hazardous than those in other fields of innovation.
Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier
Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier
Akron Intellectual Property Journal
Pharmaceutical product hopping is a relatively new phenomenon in which a brand-name pharmaceutical company tactically reformulates a drug and patents the reformulation in an attempt to avoid competition by a generic competitor. When viewed in the context of the HatchWaxman framework, product hopping can effectively eliminate generic competitors from the market, thereby implicating § 2 of the Sherman Act. In addressing antitrust liability, this Note advocates a per se legal approach to product hopping so long as the hop is supported by a valid patent. Although some have argued that deference to the United States Patent and Trademark Office and …
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.
The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson
The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson
Georgia Journal of International & Comparative Law
No abstract provided.
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.
Adjustments, Extensions, Disclaimers, And Continuations: When Do Patent Term Adjustments Make Sense?, Stephanie Plamondon Bair
Adjustments, Extensions, Disclaimers, And Continuations: When Do Patent Term Adjustments Make Sense?, Stephanie Plamondon Bair
Faculty Scholarship
The United States patent system represents a measured trade-off between two competing policy considerations: providing sufficient incentives to encourage the innovation and development of new and socially useful inventions; and ensuring that such inventions are readily available to the public at an affordable price. Although the default patent term is now twenty years from filing, various features of, and changes to, the patent system over the years have allowed patent owners to extend the duration of their patent monopolies, sometimes for several years. Such extensions, though seemingly insignificant when compared to the full patent term, have an enormous impact on …
The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely
The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely
Other Publications
The Supreme Court decision in Myriad Genetics struck down the patenting of human genomic DNA. What will this mean for genetic testing and medicine, more broadly?
Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz
Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz
Articles & Chapters
No abstract provided.
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 …
Pharmaceutical Innovation: Law & The Public's Health, Kevin Outterson
Pharmaceutical Innovation: Law & The Public's Health, Kevin Outterson
Faculty Scholarship
At last count, global pharmaceutical spending exceeded $750 billion. Unlike most medical products and services, many pharmaceuticals are sold at a price that greatly exceeds marginal cost. AIDS medicines that retail for over $10,000 per person per year in the United States can be produced generically at a marginal cost of less than $150. Patents and other related IP rights create these significant gaps between marginal cost and retail price, generating many billions of dollars in profits (patent rents) for companies.
Do Reverse Payment Settlements Violate The Antitrust Laws, Christopher M. Holman
Do Reverse Payment Settlements Violate The Antitrust Laws, Christopher M. Holman
Faculty Works
The term "reverse payment" has been used as shorthand to characterize a variety of diverse agreements between patent owners and alleged infringers that involve a transfer of consideration from the patent owner to the alleged infringer. Reverse payment settlements are particularly associated with drug patent challenges mounted by generic drug companies under the Hatch-Waxman Act. Many, including the Federal Trade Commission, would characterize these agreements as antitrust violations. However, courts have generally declined to find these agreements in violation of the antitrust laws based solely on the presence of a reverse payment.
This article begins in Section II with an …
Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer
Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer
Faculty Scholarship
Pharmacogenomics promises to revolutionize medicine by using genetic information to guide drug therapy. Genetic tests will help doctors improve drug safety and efficacy by better matching patients and drugs. This Article evaluates the effectiveness of patent-based incentives to create genetic tests, and the optimal mix of public and private sector pharmacogenomic R&D. Drug patent owners have a strong incentive to develop genetic tests that predict adverse drug reactions and allow them to market drugs that otherwise would be shelved. Incentives are also strong for genetic tests that are created as part of the drug development process. Incentives tend to be …