Law Commons^™

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 …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Ryan G. Vacca

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard

Vicki W Girard

Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals.

This article argues that …

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Fazal Khan

This article proposes a novel framework for more broadly securing the benefits of “off-label” drug usage while mitigating the harms inherent to this practice. Once the FDA approves a drug, doctors can prescribe for it any indication they think is reasonable, even uses that have not been thoroughly tested. The FDA bans the marketing or promotion for off-label uses by drug companies precisely because such uses have not been validated to be safe or effective through the regulatory process. Further, there are serious concerns with validity of industry-sponsored off-label research related to practices such as ghostwriting, gag-clauses on researchers, and …

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.

Is There An Efficient Antitrust Approach To Health Care?, Kathryn Ciano

Kathryn Ciano

As American states and the federal government wrestle to find a solution to health care reform, some regulators are looking towards antitrust laws in the international marketplace to govern domestic health care policy. Antitrust principles dictate that antitrust authorities must intervene only when pressures become so great as to interfere with the very operations of the market. Pharmaceutical and health care markets rely on free trade and competitive global cooperation, so there is no efficient antitrust approach to health care.

Intellectual Property As An ‘Investment’ In International Law: A Question Of Access To Medicines Vs Access To Justice, Christopher Wadlow

Christopher Wadlow

No abstract provided.

Cost-Effective Healthcare – How Patent Framework Can Be Re-Designed To Help Fulfil This Objective, Mian Atif Saeed

Mian Atif Saeed

The issue of prices of medicinal products is not only limited to third world countries alone and it is now becoming relevant in developed nations too. Governments all over the world are being pressurised to address the issue of providing better healthcare to every citizen. In order to address this issue the payers are becoming more and more cost conscious and the industry is being pressurised on reducing the cost of medicinal products. However, we have not seen any industry friendly developments in the legislative and business framework in which pharmaceuticals operate. Instead, the framework in which pharmaceuticals operate is …

The Adoption Of Intellectual Property Standards Beyond Trips – A Misguided Legal & Economic Obsession By Developing Countries?, Ferris K. Nesheiwat

Ferris K Nesheiwat

This paper looks at the effect intellectual property standards have had on technology transfers in Jordan, in light of the implementation of stricter intellectual property standards with the adoption of the Agreement on Trade Related Aspects of Intellectual Property (TRIPS)' and "TRIPS-plus" standards. Both the TRIPS and TRIPS-plus standards ushered in new legal requirements, which were justified and marketed under the theoretical assumption that greater protections of intellectual property rights are essential to both technology transfer and investment promotion. This paper intends to examine the level of technology transfer and the flow of intellectual property-related foreign direct investment into Jordan …

21st Century Healthcare - A New Scenario Needs New Rules Of The Game, Mian Atif Saeed

Mian Atif Saeed

We are witnessing a changing paradigm of healthcare sector in view increasing pressure on governments to provide free healthcare to citizens and increasing cost-consciousness of governments/payers to address this public issue. This changing paradigm in healthcare requirements requires a holistic review of the legislative framework in which industry operates. All stakeholders and all applicable regulatory and legal frameworks need to be appraised in order to address the requirements of 21st century healthcare. Drug development is very risky, costly and lengthy process and inventors and investor deserve financial gains for their efforts. Pharmaceutical industry requires the money to keep investing back …

The Great Pharmaceutical Patent Robbery, And The Curious Case Of The Chemical Foundation, Christopher Wadlow

Christopher Wadlow

In 1918, the United States confiscated virtually all German-owned intellectual property assets within its jurisdiction. Out of 6,000 patents in the chemical field, 4,500 were assigned for a very modest consideration to an newly-established entity, the Chemical Foundation, which was incorporated with the objective of licensing and managing them for the benefit of the United States chemical industry. This article describes the origins and activities of the Chemical Foundation, and considers whether it provides a useful model, or at least useful lessons, for the collective management of patents today.

These Statements Have Not Been Approved By The Fda: Improving The Post-Approval Regulation Of Prescription Drugs, Christopher R. Page

Christopher R. Page

The American public’s confidence in the FDA is waning in the midst of increased reporting of inefficiencies in the agency. The missteps by the FDA in the post-approval regulation of prescription drugs are magnified by the pervasive use of prescription drugs in the market. This article identifies these missteps. It also chronicles the response of the state attorneys general to this void in regulation, from the famous class action suit against the tobacco industry to the Oxycontin litigation to the recent Vioxx settlement.

This response to the public’s lack of confidence is accomplished through lawsuits against pharmaceutical companies under state …

Symposium Introduction: Contemporary Issues At The Intersection Of Public Health And Environmental Law, Patricia Ross Mccubbin

Patricia Ross McCubbin

This article serves as an introduction to the forthcoming symposium in the Southern Illinois University Law Journal, which presents the proceedings of a conference held at the SIU School of Law on February 27, 2009, on “Contemporary Issues at the Intersection of Public Health and Environmental Law.”

Improving Access To Medicines Doesn't Have To Mean More Patents, Luigi Palombi

Luigi Palombi

Access to medicines presupposes that there are medicines to access, but the development of medicines, especially those needed to treat diseases that inflict the poor and the disadvantaged, are especially difficult to access because of the pharmaceutical industry’s paradigm of medicines being inextricably linked to patents; meaning, without patents there is no incentive to undertake the necessary R&D to develop new medicines. This paper argues that this is a lie; told by pharmaceutical executives and spread by well meaning scientists. Uncontested by policymakers in the 1960’s it has become a truth that threatens scientific progress, the development of appropriate medicines …

Fda New Drug Review Times, Prescription Drug User Fee Acts, And R&D Spending, John Vernon

John Vernon

FDA approval times have declined significantly since the enactment of the Prescription Drug User Fee Act (PDUFA) in 1992. As a result, present value expected returns to pharmaceutical R&D have likely increased. In the current paper we employ a unique survey dataset, one which includes data from 1990 to 1999 on firm-level pharmaceutical R&D expenditures for 7 large, U.S.-based drug companies. We estimate the effect FDA approval times have on firm R&D spending. Controlling for other factors such as pharmaceutical profitability and cash flows, we estimate that a 10 percent decrease (increase) in FDA approval times leads to an increase …

Regulatory Data Protection Under Trips Article 39(3) And Article 10bis Of The Paris Convention: Is There A Doctor In The House?, Christopher Wadlow

Christopher Wadlow

Article 39 of the WTO TRIPs Agreement has attracted much attention for the protection its final paragraph affords for regulatory data in the pharmaceutical and agrochemical industries, but the literature has tended to treat Article 39(3) in individual isolation. This is to ignore one of the most striking features of Article 39, which is that in contrast to every other substantive provision of TRIPs, it expressly defines its entire scope of application by reference to a pre-existing treaty, the Paris Convention for the Protection of Industrial Property, and specifically Article 10bis of the latter, dealing with unfair competition. This article …

Data Exclusivity Regulations Explained, Jose R. Trigueros

Jose R. Trigueros

No abstract provided.

Health 2.0 Online Marketing: Attentio Blogs, Linda Margaret Broughton

Linda Margaret Broughton

Health 2.0 and online marketing for health and pharmaceuticals in the EU and the USA

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz

Ariel Katz

Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented and others have been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate …

El Registro De Nuevos Productos Químicos Conlleva Problemas De Protección De Información, Jose R. Trigueros

Jose R. Trigueros

No abstract provided.

Registering New Chemical Products Brings Data Protection Problems, Jose R. Trigueros

Jose R. Trigueros

No abstract provided.