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Articles 1 - 9 of 9
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 …
Cancer's Ip, Jacob S. Sherkow
Cancer's Ip, Jacob S. Sherkow
Articles & Chapters
The state of publicly funded science is in peril. Instead, new biomedical research efforts — in particular, the recent funding of a “Cancer Moonshot” — have focused on employing public-private partnerships, joint ventures between private industry and public agencies, as being more politically palatable. Yet, public-private partnerships like the Cancer Moonshot center on the production of public goods: scientific information. Using private incentives in this context presents numerous puzzles for both intellectual property law and information policy. This Article examines whether—and to what extent — intellectual property and information policy can be appropriately tailored to the goals of public-private partnerships. …
Use Of Mediation To Recover Rights To Our Genes, Rachel Albert
Use Of Mediation To Recover Rights To Our Genes, Rachel Albert
Pepperdine Dispute Resolution Law Journal
No abstract provided.
Patent Law's Reproducibility Paradox, Jacob S. Sherkow
Patent Law's Reproducibility Paradox, Jacob S. Sherkow
Articles & Chapters
Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties …
Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin
Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin
All Faculty Scholarship
As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …
Federal Trade Commission V. Actavis, Inc. And Reverse-Payment Or Pay-For-Delay Settlements, Jacob S. Sherkow
Federal Trade Commission V. Actavis, Inc. And Reverse-Payment Or Pay-For-Delay Settlements, Jacob S. Sherkow
Articles & Chapters
An imminent US Supreme Court ruling should resolve one of the thorniest legal issues facing pharmaceutical companies today.
Could A Hub And Spoke, Homegrown Ceo Strategy Boost The Success Of University Start-Ups?, Brendan O. Baggot, Martin R. Graf Phd
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.
Reverse Settlements As Patent Invalidity Signals, Gregory Dolin
Reverse Settlements As Patent Invalidity Signals, Gregory Dolin
All Faculty Scholarship
Over the last decade a new type of settlements, commonly referred to as “reversed payment settlements” or simply “reverse settlements,” emerged in litigation over patents covering pharmaceutical products. What differentiates these new settlements from their traditional counterparts is that whereas traditionally, the alleged trespasser on someone else's rights pays the rights-holder to settle the litigation, in these new settlements it is the rights holder that pays the alleged trespasser. These settlements are a direct consequence of the various incentives provided by the Hatch-Waxman Act - an Act designed to increase competition between brand name and generic manufactures of pharmaceutical products. …
The Patent Lottery: Exploiting Behavioral Economics For The Common Good, Dennis D. Crouch
The Patent Lottery: Exploiting Behavioral Economics For The Common Good, Dennis D. Crouch
Faculty Publications
Lotteries are immensely popular. Players are willing to give the organizer a large monetary cut of every ticket purchase in return for a chance at a jackpot. In some ways, our current patent system operates as a lottery as well. Most patents are relatively worthless, while a few are highly valuable. Reaching the major payout of a highly valuable patent takes perseverance in the face of tremendous uncertainty. Like lottery players, small entrepreneurial companies and individuals have shows signs of bounded rationality. In particular, what I call the patent lottery effect is associated with the phenomena of potential innovators overweighting …