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Full-Text Articles in Law
Expired Patents, Trade Secrets, And Stymied Competition, W. Nicholson Price Ii
Expired Patents, Trade Secrets, And Stymied Competition, W. Nicholson Price Ii
Articles
Patents and trade secrecy have long been considered substitute incentives for innovation. When inventors create a new invention, they traditionally must choose between the two. And if inventors choose to patent their invention, society provides strong legal protection in exchange for disclosure, with the understanding that the protection has a limit: it expires twenty years from the date of filing. At that time, the invention is opened to the public and exposed to competition. This story is incomplete. Patent disclosure is weak and focuses on one technical piece of an invention—but that piece is often only a part of the …
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
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
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 …
District Courts Versus The Usitc: Considering Exclusionary Relief For F/Rand-Encumbered Standard-Essential Patents, Helen H. Ji
District Courts Versus The Usitc: Considering Exclusionary Relief For F/Rand-Encumbered Standard-Essential Patents, Helen H. Ji
Michigan Telecommunications & Technology Law Review
Technological standards allow manufacturers and consumers to rely upon these agreed-upon basic systems to facilitate sales and further invention. However, where these standards involved patented technology, the process of standard-setting raises many concerns at the intersection of antitrust and patent law. As patent holders advocate for their patents to become part of technological standards, how should courts police this activity to prevent patent holdup and other anti-competitive practices? This Note explores the differing approaches to remedies employed by the United States International Trade Commission and the United States District Courts where standard-essential patents are infringed. This Note further proposes that …
Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane
Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane
Articles
The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …
Antitrust Rulemaking As A Solution To Abuse On The Standard-Setting Process, Adam Speegle
Antitrust Rulemaking As A Solution To Abuse On The Standard-Setting Process, Adam Speegle
Michigan Law Review
While many recognize the critical role that technology plays in modern life, few appreciate the role that standards play in contributing to its success. Devices as prevalent as the modern laptop computer for example, may be governed by over 500 interoperability standards, regulating everything from the USB drive to the memory chip. To facilitate adoption of such standards, firms are increasingly turning to standard-setting organizations. These organizations consist of members of an industry who agree to abide by the organization's bylaws, which typically regard topics such as patent disclosure and reasonable licensing. Problems arise, however, when members violate these bylaws …
Innovative Copyright, Greg Lastowka
Innovative Copyright, Greg Lastowka
Michigan Law Review
For over a decade, Michael Carrier has been exploring the intersection of antitrust and intellectual property ("IP") law, contributing many articles that offer new solutions and approaches to the vexing problems confronting the law of innovation. Carrier's academic writing is situated in a voluminous scholarly discourse about the appropriate rules and goals of the laws of copyright, patent, and antitrust. While Carrier easily could have written an "insider" tome for specialists in this area, his new book, Innovation for the 21st Century, is targeted at a broader audience. Carrier's book is directed at legislators, jurists, and opinion makers-as well as …
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
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 …
Pioneers Versus Improvers: Enabling Optimal Patent Claim Scope, Timothy Chen Saulsbury
Pioneers Versus Improvers: Enabling Optimal Patent Claim Scope, Timothy Chen Saulsbury
Michigan Telecommunications & Technology Law Review
Arising most commonly as a defense to an infringement claim, enablement requires a patent to describe the claimed invention in sufficient detail to permit a person having ordinary skill in the relevant field to replicate and use the invention without needing to engage in "undue experimentation." If a patent claim is not "enabled"--i.e., if a person having ordinary skill in the art (PHOSITA) who studied the patent cannot make or use the invention without undue experimentation--the claim is invalid and can no longer be asserted. This penalty deters patent applicants from claiming more than they invented and allows others to …
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Articles
This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …
Trolling For Trolls: The Pitfalls Of The Emerging Market Competition Requirement For Permanent Injunctions In Patent Cases Post-Ebay, Benjamin H. Diessel
Trolling For Trolls: The Pitfalls Of The Emerging Market Competition Requirement For Permanent Injunctions In Patent Cases Post-Ebay, Benjamin H. Diessel
Michigan Law Review
In eBay v. MercExchange, a unanimous Supreme Court announced that a new four-factor test should be employed by district courts in determining whether to award an injunction or damages to an aggrieved party whose intellectual property has been infringed. In the context of permanent injunctions in patent cases, district courts have distorted the four-factor test resulting in a "market competition requirement." Under the new market competition requirement, success at obtaining an injunction is contingent upon a party demonstrating that it is a market competitor After consistent application in the first twenty-five district court cases post-eBay, the market competition requirement …
Knowledge, Competition And The Innovation: Is Stronger Ipr Protection Really Needed For More And Better Innovations, Giovanni Dosi, Luigi Marengo, Corrado Pasquali
Knowledge, Competition And The Innovation: Is Stronger Ipr Protection Really Needed For More And Better Innovations, Giovanni Dosi, Luigi Marengo, Corrado Pasquali
Michigan Telecommunications & Technology Law Review
The main questions addressed in this Article are thus: given that growth is a highly desirable phenomenon and that it is primarily spurred by technological innovation, how should society solve the problem of favoring a sufficient level of investments in R&D? In particular, is it necessarily true and always desirable that, independent of any other consideration, society should protect innovators from competition and shelter them in a legally protected and enforced monopoly? Is it true that the real source of economic value of new recipes is only found in the blueprints of ideas that those recipes implement? Is it necessarily …
The Problem Of New Uses, Rebecca S. Eisenberg
The Problem Of New Uses, Rebecca S. Eisenberg
Articles
Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …
Copyright's Communications Policy, Timothy Wu
Copyright's Communications Policy, Timothy Wu
Michigan Law Review
There is something for everyone to dislike about early twenty-first century copyright. Owners of content say that newer and better technologies have made it too easy to be a pirate. Easy copying, they say, threatens the basic incentive to create new works; new rights and remedies are needed to restore the balance. Academic critics instead complain that a growing copyright gives content owners dangerous levels of control over expressive works. In one version of this argument, this growth threatens the creativity and progress that copyright is supposed to foster; in another, it represents an "enclosure movement" that threatens basic freedoms …
Gaining Momentum: A Review Of Recent Developments Surrounding The Expansion Of The Copyright Misuse Doctrine And Analylsis Of The Doctrine In Its Current Form, Neal Hartzog
Michigan Telecommunications & Technology Law Review
The United States intellectual property ("IP") system is the foundation for incentives for authors and inventors to create and invent so that their work will be distributed to the public for the betterment of society. These incentives, in the form of limited monopolies over creations via patents, copyrights, and trademarks, are becoming increasingly important as the United States depends upon intellectual property to sustain its economy. As the intellectual property industry grows, it becomes vital to preserve the impetus behind its creation: the public good, or more specifically, the public's ability to make use of and enjoy new ideas and …
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …
The Promise And Perils Of Strategic Publication To Create Prior Art: A Response To Professor Parchomovsky, Rebecca S. Eisenberg
The Promise And Perils Of Strategic Publication To Create Prior Art: A Response To Professor Parchomovsky, Rebecca S. Eisenberg
Articles
In a provocative recent article in the Michigan Law Review, Professor Gideon Parchomovsky observes that a firm racing with a competitor to make a patentable invention might find it strategically advantageous to publish interim research results rather than risk losing a patent race. This strategy exploits legal rules limiting patent protection to technological advances that are new and "nonobvious" in light of the "prior art" or preexisting knowledge in the field. By publishing research results, a firm adds to the prior art and thereby limits what may be patented in the future. Parchomovsky posits that, before it is able to …
To Innovate Or Not To Innovate, That Is The Question: The Functions, Failures, And Foibles Of The Reward Function Theory Of Patent Law In Relation To Computer Software Platforms , Seth A. Cohen
Michigan Telecommunications & Technology Law Review
The patent system has traditionally been viewed as having two primary functions: the reward function and the prospect function. Although these theories do explain some behavior which results from the practical applications of the patent system, they also overlook some behavior of the patent system which indicates a failure of these functions. In order to properly prevent such failure, this paper proposes that the patent system adopt an orientation that will lead to increased innovative rivalry and competition. In Part I, using the computer operating system software market as an example, I propose a framework for reconceptualizing patent protection as …
Personal Jurisdiction Over Aliens In Patent Infringement Actions: A Uniform Approach Toward The Situs Of The Tort, David Wille
Personal Jurisdiction Over Aliens In Patent Infringement Actions: A Uniform Approach Toward The Situs Of The Tort, David Wille
Michigan Law Review
This Note examines current approaches to the question of personal jurisdiction over alien patent infringers. Part I describes personal jurisdiction requirements in the context of patent infringement suits against aliens. The leading case addressing these requirements has been interpreted differently by several courts, thus resulting in conflicting outcomes. Part II explains the current controversy over the locus of the tort of patent infringement. The three different modes of reasoning currently used by courts to determine the locus of the tort would allow immunity from suit for the alien in at least two hypothetical cases. This Part concludes that in order …
Proprietary Rights And The Norms Of Science In Biotechnology Research, Rebecca S. Eisenberg
Proprietary Rights And The Norms Of Science In Biotechnology Research, Rebecca S. Eisenberg
Articles
As basic research in biotechnology yields increasing commercial applications, scientists and their research sponsors have become more eager to protect the commercial value of research discoveries through intellectual property law. Some scientists fear that these commercial incentives will weaken or even undermine the norms that have traditionally governed scientific research. In this Article, Professor Eisenberg examines the interaction of proprietary rights in inventions with these traditional scientific norms. Trade secrecy, she argues, is an undesirable strategy for protection of basic research discoveries because it impedes dissemination of new knowledge to the scientific community. She finds that patent law is in …
Abuse Of Trademarks: A Proposal For Ompulsory Licensing, Mara L. Babin
Abuse Of Trademarks: A Proposal For Ompulsory Licensing, Mara L. Babin
University of Michigan Journal of Law Reform
This article neither deals with the propriety of the Federal Trade Commission's (FTC) proposed order nor evaluates the effectiveness of compulsory trademark licensing as a remedy for unfair trade practices.8 Rather, the pending cereal industry case is used as a point of departure for an examination of the problem of trademark abuse and the responses of the courts, the Congress, and the FTC to it. Acknowledging the legality of compulsory licensing of trademarks, the article suggests legislation which will incorporate licensing and standards for its application. Such legislation would make licensing an accessible remedy for trademark abuse while accommodating both …
Antitrust-Patents-Licenses-Regulation Of Patent License Royalty Rates Under The Antitrust Laws, Michigan Law Review
Antitrust-Patents-Licenses-Regulation Of Patent License Royalty Rates Under The Antitrust Laws, Michigan Law Review
Michigan Law Review
Neither the Constitution nor federal legislation defines a patentee's licensing rights; consequently, it has devolved upon the courts to control patent marketing practices. A patentee is entitled to a limited monopoly on his invention, and proper use of this grant is not a violation of any law regulating trade practices. Yet licensing affords an opportunity to enlarge the scope of this monopoly, and courts using various rationales have declared illegal different forms of patent licensing arrangements found to be outside the protective coverage of the patent grant. Until recently, however, the courts have not dealt with the problem of whether …
Know-How Licensing And The Antitrust Laws, David R. Macdonald
Know-How Licensing And The Antitrust Laws, David R. Macdonald
Michigan Law Review
The purpose of this article is to re-analyze the present antitrust status of know-how licensing for the purpose of clarifying the extent of the protection which the exploiter of know-how may accord himself without abusing the public interest in unfettered competition.
Regulation Of Business-Resale Price Maintenance-Constitutionality Of Non-Signer Provion In Michigan Fair Trade Act, Richard D. Rohr S.Ed.
Regulation Of Business-Resale Price Maintenance-Constitutionality Of Non-Signer Provion In Michigan Fair Trade Act, Richard D. Rohr S.Ed.
Michigan Law Review
Plaintiff, a manufacturer of trade-marked products, brought a bill to restrain defendant-retailer from selling plaintiff's products at prices below the minimum prices established by plaintiff in contracts made pursuant to the Michigan Fair Trade Act. Defendant admitted such sales; but contended that because it had not signed a fair trade agreement with plaintiff, enforcement of the Michigan act against defendant would violate its rights under the due process clause of the state constitution. The trial court, treating the transactions involved as being exclusively in intrastate commerce, held the Michigan Fair Trade Act, as applied to non-signers of fair trade agreements, …
Patents-Exclusive Licenses-Licensor And Licensee Relationship- Llicensee's Obligations, Gordon W. Hueschen S. Ed.
Patents-Exclusive Licenses-Licensor And Licensee Relationship- Llicensee's Obligations, Gordon W. Hueschen S. Ed.
Michigan Law Review
Patent licensing is today, as always, a very significant part of patent law. Since royalty licenses allow a patentee to realize pecuniary benefits from his invention without yielding ownership, as he would by an assignment, they are especially attractive to an inventor who anticipates considerable commercial success for his contribution, and who does not desire to lose all control of the invention for a lump sum, the adequacy of which must be, at best, speculative. From the licensee's standpoint, it is usually advantageous to be free of competition from others also operating under the same patent monopoly, at least within …