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Articles 1 - 10 of 10
Full-Text Articles in Law
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan
Michigan Telecommunications & Technology Law Review
The United States spends nearly $1,000 per person annually on drugs—forty 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, intellectual property law plays a crucial and well-documented role in inhibiting access to cheaper, generic medications. 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 avenue of exclusivity—trademark law. New studies suggest that pharmaceutical …
An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel
Michigan Law Review
Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …
New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson
New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson
Faculty Scholarship
As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn't mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product's risks as well. Since it's not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a …
International Intellectual Property, Access To Health Care, And Human Rights: South Africa V. United States, Winston Nagan
International Intellectual Property, Access To Health Care, And Human Rights: South Africa V. United States, Winston Nagan
Winston P Nagan
This Article examines the question of access to patented medicines in international law. It analyzes the extent to which international agreements may lawfully limit affordable versions of these medicines that may be available through parallel imports or compulsory licensing procedures. It considers the concept of intellectual property rights from a national and international perspective to determine how these rights must be sensitive to matters of national sovereignty when extraordinary, life-threatening diseases afflict societies in catastrophic ways. This Article suggests that viewing property (including intellectual property) as a human right requires that its scope be delimited and understood in the context …
Pharmaceuticals And Biopiracy: How The Aia May Inadvertently Reduce The Misappropriation Of Traditional Medicine, Ryan D. Levy, Spencer Green
Pharmaceuticals And Biopiracy: How The Aia May Inadvertently Reduce The Misappropriation Of Traditional Medicine, Ryan D. Levy, Spencer Green
University of Miami Business Law Review
For decades, Eastern traditional medicine has been misappropriated by others who claim it as their own and attempt to obtain patent protection for it. As long this practice has existed, the international community has pushed back against it. Several countries and international bodies have created databases of traditional knowledge, hoping to preclude the issuance of patents on that knowledge. Other countries, like Thailand, have extended intellectual property protection to the traditional knowledge stakeholders themselves. However, a recent change to US patent law may have the unintended consequence of helping resolve the issue of biopiracy
The Actavis Inference: Theory And Practice, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro
The Actavis Inference: Theory And Practice, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro
All Faculty Scholarship
In FTC v. Actavis, Inc., the Supreme Court considered "reverse payment" settlements of patent infringement litigation. In such a settlement, a patentee pays the alleged infringer to settle, and the alleged infringer agrees not to enter the market for a period of time. The Court held that a reverse payment settlement violates antitrust law if the patentee is paying to avoid competition. The core insight of Actavis is the Actavis Inference: a large and otherwise unexplained payment, combined with delayed entry, supports a reasonable inference of harm to consumers from lessened competition.
This paper is an effort to assist courts …
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 …
Off-Label Drug Advertising And The First Amendment, Rodney Smolla
Off-Label Drug Advertising And The First Amendment, Rodney Smolla
Rod Smolla
No abstract provided.
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Michigan Telecommunications & Technology Law Review
Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …
Biosimilar Naming: A Call For Uniformity In A Complex Field, Jacqueline Genovese
Biosimilar Naming: A Call For Uniformity In A Complex Field, Jacqueline Genovese
Brooklyn Journal of International Law
Recombinant technology has opened a pathway for a means of producing a variety of therapeutic proteins and generating the growth of the biopharmaceutical industry. Further, due the patent expirations of a number of biologics in the coming years, there has been an increased interest in the development of generic biologics, also known as biosimilars, and a widespread push for biosimilar FDA approval in the United States. While the pressure for the expansion of biosimilar approval is warranted, the FDA must be cautious when implementing regulatory guidelines. Since biologics differ greatly from small-molecule drugs, biologics have a distinct approval process. The …