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Full-Text Articles in Law
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 …
Dilution At The Patent And Trademark Office, Jeremy N. Sheff
Dilution At The Patent And Trademark Office, Jeremy N. Sheff
Michigan Telecommunications & Technology Law Review
This Article undertakes the first systematic investigation of trademark dilution in registration practice before the US Patent and Trademark Office (PTO). The Article consists of three distinct descriptive empirical analyses. In the first, I present a new hand-coded dataset of all 453 Trademark Trial and Appeal Board (TTAB) dispositions of dilution claims through June 30, 2014, and report that dilution has been necessary to the PTO’s refusal of exactly three registrations in over a decade. In the second part, I apply algorithmic coding of the recently released PTO Casefiles Dataset to demonstrate that concurrent registration of identical marks to different …
Wireless Localism: Beyond The Shroud Of Objectivity In Federal Spectrum Administration, Olivier Sylvain
Wireless Localism: Beyond The Shroud Of Objectivity In Federal Spectrum Administration, Olivier Sylvain
Michigan Telecommunications & Technology Law Review
Recent innovations in mobile wireless technology have instigated a debate between two camps of legal scholars about federal administration of the electromagnetic spectrum. The first camp argues that the Federal Communications Commission (“FCC”) should define spectrum use rights more clearly and give spectrum licensees broad property rights in frequencies. The second camp argues that, rather than award exclusive licenses to the highest bidder, the FCC ought to open much, if not most, of the spectrum to unlicensed use by smartphones and tablets equipped with the newest spectrum administration technology. First, this Article shows that both of these camps comprise a …
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
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 …
Burying, Robert Brendan Taylor
Burying, Robert Brendan Taylor
Michigan Telecommunications & Technology Law Review
When applying for a patent, applicants must provide the examiner with all known material prior art. Those who fail to do so can be charged with inequitable conduct. But applicants can still effectively hide material prior art references by submitting them along with large quantities of immaterial prior art to the examiner. This deceptive practice, known as "burying," is generally not considered inequitable conduct. This Essay summarizes the current legal landscape concerning burying, discusses the costs associated with the practice, and suggests ways to deter and punish those who do it.
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Michigan Telecommunications & Technology Law Review
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 or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Michigan Telecommunications & Technology Law Review
Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a …
The Fcc Complaint Process And Increasing Public Unease: Toward An Apolitical Broadcast Indecency Regime, Kurt Hunt
Michigan Telecommunications & Technology Law Review
[...]I propose depoliticizing the broadcast indecency regime by utilizing polling to determine the average broadcast viewer's opinion, divorced from all the pressures inherent in relying on the complaint process as a proxy. In section II, I will discuss the background and development of the broadcast indecency doctrine from the days of the Federal Radio Commission in the 1920s through the present day. I will also explain why the apparent increasing public unease is misleading, and why valid First Amendment concerns are steamrolled by the fiery nature of the debate. In section III, I will explain why the FCC's reliance on …
Compulsory Patent Licensing: Is It A Viable Solution In The United States, Carol M. Nielsen, Michael R. Samardzija
Compulsory Patent Licensing: Is It A Viable Solution In The United States, Carol M. Nielsen, Michael R. Samardzija
Michigan Telecommunications & Technology Law Review
As technology continues to advance at a rapid pace, so do the number of patents that cover every aspect of making, using, and selling these innovations. In 1996, to compound the rapid change of technology, the U.S. Supreme Court affirmed that business methods are also patentable. Hence in the current environment, scores of patents, assigned to many different parties, may cover a single electronic device or software--making it increasingly impossible to manufacture an electronic device without receiving a cease and desist letter or other notice from a patentee demanding a large royalty or threatening an injunction. Companies, particularly those in …
The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh
The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh
Michigan Telecommunications & Technology Law Review
Gaps within the drug distribution system make it increasingly vulnerable to bad actors, such as counterfeiters and terrorists. Congress intended the Prescription Drug Marketing Act (PDMA) of 1987 to close these gaps, but the PDMA has not fully succeeded. Important PDMA provisions that require tracking of drugs throughout the distribution chain in the form of "pedigrees" were set to be implemented as of Dec. 1, 2006, although a recent court order has stayed complete implementation. However, these PDMA requirements do not apply uniformly to all drug distributors in the United States. Moreover, since paper pedigrees can be forged, the pedigree …
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
Michigan Telecommunications & Technology Law Review
This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Michigan Telecommunications & Technology Law Review
The government, particularly the Food and Drug Administration ("FDA"), heavily regulates the life sciences industry. FDA actions can have an extraordinary influence on the fortunes of biotechnology companies. Timely FDA approval of a drug or medical device can permit a company to exploit an inviting market window. FDA product approval is, in turn, tied to clinical test results which demonstrate "efficacy" and safety. Delayed approval, unfavorable test results, or the denial of an FDA application may ruin a company. Beyond the FDA product approval process and related testing lie FDA inspections and the possibility that the government will investigate charges …
Legacy Of Lost Opportunity: Designated Entities And The Federal Communications Commission's Broadband Pcs Spectrum Auction, A, Mark W. Munson
Legacy Of Lost Opportunity: Designated Entities And The Federal Communications Commission's Broadband Pcs Spectrum Auction, A, Mark W. Munson
Michigan Telecommunications & Technology Law Review
The Federal Communications Commission's ("FCC") designated entity policy has challenged the efficiency of the use of auctions to allocate spectrum licenses. As an alternative to comparative hearings and lotteries, auctions provide an effective solution to the costs, administrative burdens, and delays associated with apportioning spectrum. Congress required the FCC to allow firms to participate in the auctions even if they had difficulty in obtaining financing. The FCC gave these firms, known as "designated entities," set-asides and other preferences to assist them in the competitive bidding process. In the broadband Personal Communications Services ("PCS") auctions, however, designated entities frequently were unable …
Schizophrenia Among Carriers: How Common And Private Carriers Trade Places, Rob Frieden
Schizophrenia Among Carriers: How Common And Private Carriers Trade Places, Rob Frieden
Michigan Telecommunications & Technology Law Review
This article will examine court cases and actions by the Federal Communications Commission (FCC) that distort the traditional concepts of common and private carriage by establishing new rights and responsibilities previously applicable to the other category of carrier. This article will also consider the feasibility of (a) maintaining the traditional common carrier regulatory model and (b) continuing the application of that model to basic services provided by local exchange carriers (LECs). This is especially important as LECs qualify to become private carriers tapping new market opportunities, even within the same geographical region where they provide basic services. Finally, this article …
The Information Highway Must Pay Its Way Through Cities: A Discussion Of The Authority Of State And Local Governments To Be Compensated For The Use Of Public Rights-Of-Way, Clarence A. West
Michigan Telecommunications & Technology Law Review
In the ever-changing telecommunications industry there appears to be an enormous amount of confusion not only as to the appropriate amount of compensation chargeable to the users of public rights-of-way, but also as to the very authority of state and local governments to require compensation. This was not always the case. It has long been a well-settled legal principle that local governments may receive reasonable "rental" compensation from private commercial entities for their use of local public property for private economic gain, even where federal statutory law restricts local governments from denying access to rights-of-way for telecommunications services. For example, …