Law Commons^™

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 …

The Inherent Monetary Incentive Of Intellectual Property Rights And The Failure Of Intellectual Property Waivers To Recognize This Motive, Ellaheh D. Sims

Barry Law Review

No abstract provided.

Renewing Faith In Antitrust: Unveiling The Hidden Network Behind Pharmaceutical Product Hopping, Victoria Field

Fordham Journal of Corporate & Financial Law

Patents grant time-limited market exclusivity to drug manufacturers, meaning that other companies are prohibited from copying and selling the patented pharmaceutical. This allows manufacturers to lawfully charge monopoly prices. Generic competition starts at the expiration of the patent. To maintain coveted monopoly power, manufacturers often release an alternative formulation of the drug with a fresh patent that enjoys continued market exclusivity. Manufacturers who can convert their consumer base to the new formulation can continue charging peak prices. This process, called “product hopping,” has been the target of significant antitrust inquiry, with mixed results.

A product hop may be the result …

Does Size Matter? Nanoscale Particle Size As An Indicator Of Inherency In Nanopharmaceutical Patent Validity, Kirsten Fehlan

Georgia State University Law Review

Scientific and technological advances in nanopharmaceuticals bring the doctrine of inherent obviousness to a head. On the one hand, nanotechnology promises to offer novel ways to target and treat traditionally incurable diseases by operating at a scale that is comparable to the scales that most biological systems use. On the other hand, nanotechnology inventions that result in improved pharmacokinetic properties are susceptible to validity challenges based on inherent obviousness.

Inherency and obviousness are two independently recognized and well-understood principles in United States patent law. Inherency refers to a claimed limitation or feature that is either necessarily present in, or the …

International Rights Affecting The Covid–19 Vaccine Race, Samantha Johnson

University of Miami Inter-American Law Review

The impact of the COVID–19 pandemic has been felt world-wide, and despite having several vaccines in the market at this point, there are still issues of accessibility for certain countries. International intellectual property law has been a breeding ground for the exploration of intellectual curiosity and creation as it provides strong protections to creators. These strong protections have allowed for the monopolization of certain goods, such as vaccines, under the concept of patents. While patents are important to incentivize pharmaceutical companies to create life–saving medicines, these protections have also become a barrier for access to medicines, especially in less–developed countries. …

Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous

Saint Louis University Journal of Health Law & Policy

Biologics are a growing class of pharmaceutical drugs and are associated with a significant portion of major medical breakthroughs over the past fifty years. However, in comparison with traditional small-molecule drugs, biologics are vastly more complex, more difficult to manufacture, and extremely expensive. Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in an effort to increase the availability of biosimilars—the generic versions of biologic drugs—but the BPCIA has been largely ineffective. This is due, in part, to the lack of a standard regarding initial information disclosures required at the outset of the BPCIA process, leading to a cumbersome …

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 …

Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini

Arbitration Law Review

No abstract provided.

The Experiences Of Trips-Compliant Patent Law Reforms In Brazil, India, And South Africa And Lessons For Bangladesh, M. Monirul Azam

Akron Intellectual Property Journal

This study analyzes the policy options used by Brazil, India, and South Africa in their transitions to a TRIPS-compliant patent law and their introduction of pharmaceutical patents. This comparative review can be used to explore possible policy options that can also be utilized by LDCs, including Bangladesh.

Finders Keepers, Or Finders Weepers? A Proposed Answer To A Question Raised By Myriad Genetics, Jingshi Shi

Journal of Intellectual Property Law

No abstract provided.

Trade Secret Rising: Protecting Equivalency Test Research And Development Investments After Momenta V. Amphastar, Hannah-Alise Rogers

Journal of Intellectual Property Law

No abstract provided.

Renewing Healthy Competition: Compulsory Licenses And Why Abuses Of The Trips Article 31 Standards Are Most Damaging To The United States Healthcare Industry, Jon Matthews

The Journal of Business, Entrepreneurship & the Law

No abstract provided.

To The Front Of The Line: Spurring Biotech Collaboration Through Patent Fast-Track Examination Vouchers, Scott E. Yackey

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Bayer Schering Pharma Ag V. Barr Laboratories, Inc., Joshua Zarabi

NYLS Law Review

No abstract provided.

Doctrine Of Equivalents: Is Festo The Right Decision For The Biomedical Industry., Faith S. Fillman

St. Mary's Law Journal

The doctrine of equivalents, which Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. threatens to overturn, is an equitable doctrine and should therefore provide patentees and competitors equal and fair protection. Prior to Festo, the Federal Circuit used two approaches: the complete bar rule and the flexible bar rule. Under the complete bar rule, the author must completely copy the patented art for infringement to occur, this is otherwise known as literal infringement. In contrast, under the flexible bar rule, infringement can occur if the product is closely related to the prior art. Federal Circuits have officially adopted the complete …

First-To-Invent: A Superior System For The United States., Ned L. Conley

St. Mary's Law Journal

The United States uses the first-to-invent patent system, which is a time-honored system not worth abandoning in pursuit of harmonization. First-to-invent and first-to-file patent systems incentivize different approaches to obtaining a patent. However, a first-to-invent approach is, in part, what has allowed the United States to lead the world in innovation and it should not abandon this approach. The United States patent system is unique when compared to most other patent systems used by democratic, capitalistic, developed nations. A first-to-invent system provides incentive to invent, particularly to inventors who are less well financed. The incentive to innovate is in the …