Law Commons^™

A Comparative Analysis Of The Prevention Of Pharmaceutical Patenting Abuse In The United States, Japan, And France, Kristen Coan

Cybaris®

No abstract provided.

Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii

IP Theory

Part I of this Article investigates the development of pharmaceuticals and clinical trial data with a focus on patent and data protection. Part II evaluates the effects of protection and the challenges it poses to widespread public pharmaceutical access. Part III discusses two scholarly approaches to the public access issue that focus on clinical data protection and their associated challenges. In light of these scholarly works, Part IV suggests a new approach to clinical trial data protection that aims to improve public pharmaceutical access while maintaining the incentives to invent for drug developers.

Beefing Up Skinny Labels: Induced Infringement As A Question Of Law, Garrett T. Potter

Notre Dame Law Review

This Note proposes a novel argument for improving the application of induced infringement by splitting its elements into separate questions of fact and law, incorporating the relevant perception and reasoning of both judge and jury. Part I provides a primer of the Hatch-Waxman Act and interactions (and lack thereof) between the USPTO and FDA in regulating pharmaceutical compositions. Part II assesses the historical landscape that led to the codification of induced infringement. Part III concludes by proposing an alternate approach by treating an element of induced infringement as a question of law, rather than a question of fact, and sets …

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

Michigan Law Review Online

In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …

Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth

Marquette Intellectual Property Law Review

This Comment will address two primary issues. First, it will analyze the basis of sovereign immunity rights of tribes, with a focus on the relationship between intellectual property rights and sovereignty. Second, it will discuss whether this arrangement violates the antitrust laws of the United States. This Comment concludes that even if a claim of tribal sovereign immunity is legitimate, it is likely that such an arrangement still violates the relevant antitrust claims.

Update On Antitrust And Pay-For-Delay: Evaluating “No Authorized Generic” And “Exclusive License” Provisions In Hatch-Waxman Settlements, Saami Zain

San Diego Law Review

In Federal Trade Commission v. Actavis, the United States Supreme Court held that a patent litigation settlement where a branded drug company pays a generic drug company to end the litigation and delay launching its generic may violate the antitrust laws. Although the decision ended years of controversy over whether such settlements were subject to antitrust scrutiny, many issues remain unresolved concerning the lawfulness of these settlements. In particular, courts have struggled in assessing the legality of patent settlements between branded and generic drug manufacturers involving non-cash compensation or benefits. This article discusses one type of non-cash compensation that is …

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

How Do The Social Benefits And Costs Of The Patent System Stack Up In Pharmaceuticals?, Daniel J. Gifford

Journal of Intellectual Property Law

This paper explores the workings of the patent system in the context of the generation of new pharmaceutical products. First it identifies the relevant characteristics of the patent system and its relation to the market. The paper concedes that, in general, the patent system is probably the best way of generating new technology, in substantial part because that system uses the market to provide both incentives and rewards. The paper also identifies downsides of this patent/market system: deadweight loss and the unresponsiveness of that patent/market system to the needs of the poor. The paper then explores the social costs and …

Corporate Power Unbound: Investorstate Arbitration Of Ip Monopolies On Medicines—Eli Lilly V. Canada And The Trans-Pacific Partnership Agreement, Brook K. Baker, Katrina Geddes

Journal of Intellectual Property Law

No abstract provided.

The Health Impact Fund Proposal: Application In The United States' Era Of Comparative Effectiveness, Katherine Jeanne Racz

Journal of Intellectual Property Law

No abstract provided.

History, Trips, And Common Sense: Curbing The Counterfeit Drug Market In Sub-Saharan Africa, Hannah Elizabeth Jarrells

Georgia Journal of International & Comparative Law

No abstract provided.

A Pharmaceutical Park Place: Why The Supreme Court Should Modify The Scope Of The Patent Test For Reverse Payment Deals, David Ernest Balajthy

Journal of Intellectual Property Law

No abstract provided.

Test Data Protection: Different Approaches And Implementation In Pharmaceuticals, Wael Armouti, Mohammad F. A. Nsour

Marquette Intellectual Property Law Review

None

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 …

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 …

Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff

Michigan Telecommunications & Technology Law Review

“Pay-for-delay” settlements, also known as reverse payments, arise when a generic manufacturer pursues FDA approval of a generic version of a brand-name drug. If a patent protects the brand-name drug, the generic manufacturer has the option of contesting the validity of the patent or arguing that its product does not infringe the patent covering the brand-name drug. If the generic manufacturer prevails on either of these claims, the FDA will approve its generic version for sale. Approval of a generic version of a brand-name drug reduces the profitability of the brand-name drug by forcing the brand-name manufacturer to price its …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litigation, Kenneth C. Louis

Pace Intellectual Property, Sports & Entertainment Law Forum

This Article examines the preliminary injunction standard in pharmaceutical patent infringement actions pursuant to the Hatch-Waxman Act. Prior to Supreme Court’s decision in eBay v. MercExchange, L.L.C. in 2006, federal courts applied a presumption of irreparable harm when a patent holder established a likelihood of success on the merits. While the eBay Court abrogated the presumption of irreparable harm in permanent injunctions, courts have been unclear as to application of eBay on preliminary in-junctions. This Article will further examine preliminary injunctions in Hatch-Waxman actions in the District of New Jersey since eBay in 2006 and argue that courts still tacitly …

The Case For Flexible Intellectual Property Protections In The Trans-Pacific Partnership , Matthew E. Silverman

Journal of Law and Health

The United States and eleven other countries are currently in the end stages of negotiating the Trans-Pacific Partnership (TPP)—the largest free trade agreement (FTA) in U.S. history—which incorporates a range of trade topics, including the protection and enforcement of intellectual property rights (IPRs). Although the negotiations have been highly secretive, negotiating texts of the agreement leaked as recently as November 2013 have suggested that the United States is proposing IPR provisions, specifically relating to patent protection, that are stronger and less flexible than IPR provisions included within three of the four most recent U.S. FTAs. This paper addresses and analyzes …

Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork

Michigan Telecommunications & Technology Law Review

Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval …

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Michigan Telecommunications & Technology Law Review

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …

Breaking Patents, Daniel R. Cahoy

Michigan Journal of International Law

In the 1970s and 1980s, the Boeing aircraft company worked to address the rising cost of jet fuel by inventing lighter metal alloys for use in aerospace materials. Among its discoveries was a method of producing aluminum-lithium alloys with high "fracture toughness," and in 1989, Boeing received a patent for the process. Five years later, another aerospace company working as a National Aeronautics and Space Administration (NASA) contractor, Lockheed Martin, was attempting to solve a similar problem related to materials used in the space shuttle. Lighter materials were necessary for future shuttle missions to transport components of the International Space …

Public Non-Commercial Use' Compulsory Licensing For Pharmaceutical Drugs In Government Health Care Programs, Pier Deroo

Michigan Journal of International Law

Suppose a relatively prosperous nation with universal public health coverage faces an HIV/AIDS crisis. It refuses to negotiate with the patent-holding manufacturers of the best antiretrovirals (ARVs) available, instead issuing compulsory licenses. Compulsory licenses permit the generic drug manufacturers designated in the compulsory licenses to make, use, import, and sell the patented ARVs without the permission of the patent owners, increasing competition and lowering prices. Realizing that drugs are much cheaper without patents, the nation decides to issue another round of compulsory licenses for an extensive list of patented drugs for its universal health care program. While improving public access …

Hatch-Waxmanizing Copyright, Michal Shur-Ofry

Michigan Telecommunications & Technology Law Review

This Essay presents a novel proposal for counter balancing "copyright overspills." In the background of the discussion is the common reality of users succumbing to rights holders' attempts to license uses which are most likely fair uses or completely free of copyright protection. These practices have attracted considerable attention in recent literature. Most scholarly proposals in this context emphasize the need to clarify the contours of the fair use doctrine and to remove doctrinal ambiguities. Yet these initiatives are probably insufficient to overcome users' risk aversion in copyright markets due to an inherent structural imbalance within copyright law. While the …

Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook

Michigan Telecommunications & Technology Law Review

Should a branded pharmaceutical company be allowed to pay a generic competitor to stay out of the market for a drug? Antitrust policy implies that such a deal should be prohibited, but the answer becomes less clear when the transaction is packaged as a patent-litigation settlement. Since Congress passed the Hatch-Waxman Act, which encourages generic manufacturers to challenge pharmaceutical patent validity, settlements of this kind have been on the rise. Congress, the Department of Justice, and the Federal Trade Commission have condemned these agreements as anticompetitive and costly to American consumers, but none of these bodies has been able to …

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

The 2009 H1n1 Swine Flu Pandemic: Reconciling Goals Of Patents And Public Health Initiatives, Michelle Kaplan

Fordham Intellectual Property, Media and Entertainment Law Journal

No abstract provided.

How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette

Michigan Telecommunications & Technology Law Review

As described by Professors Dan Burk and Mark Lemley, drugs are[...] special because of the low number of patents per product: "In some industries, such as chemistry and pharmaceuticals, a single patent normally covers a single product. Much conventional wisdom in the patent system is built on the unstated assumption of such a one-to-one correspondence." Although many have repeated this one-patent, one-drug assumption, there has been little empirical analysis of how many patents actually protect each drug. In fact, most small-molecule drugs are protected by multiple patents. The average was nearly 3.5 patents per drug in 2005, with over five …

It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü

Michigan Telecommunications & Technology Law Review

Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …