Publications and Announcements

Taking Biologics for Granted? Takings, Trade Secrets, and Off-Patent Biological Products

Health & Biotechnology

By: Andrew Wasson Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind’s worst diseases. Not surprisingly, generic companies want a part of the biologic market. The FDA believes that it has the authority to approve off-patent versions of biologics that were originally regulated under the Food, Drug & Cosmetic Act, but in order to effectively do so the FDA would have to rely on findings based on data produced by the brand name companies. This iBrief examines whether the FDA’s reliance on previous findings would give rise to a valid claim under the Takings Clause of the U.S. Constitution. In the end, it concludes that the FDA’s proposed action likely would not constitute a taking. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0004

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Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored

Health & Biotechnology

By: Janene Boyce Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ensure their ability to profit from their own research. In the wake of the controversy over antidepressant use in children, both the public and Congress have called for the disclosure of all clinical trial data. However, rather than taking an all-or-nothing approach that could harm the development of new drugs, this iBrief argues that Congress should address the issue of trial data disclosure by restoring the proper balance to Exemption 4 of the Freedom of Information Act. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0003

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Patent Damage Strategies and the Enterprise License: Constructive Notice, Actual Notice, No Notice

Patents & Technology

By: James W. Soong For the patent owner, early provision of patent notice can help maximize recoverable infringement damages during subsequent litigation. This iBrief recognizes a growing trend of infringement suits predicated on patented enterprise software technology, and analyzes application of patent notice principles against industry convention. This iBrief examines the licensing paradigm of enterprise software and questions whether mechanical compliance with the marking statute should qualify as constructive notice. Borrowing from analogous Federal Circuit principles, this iBrief concludes by proposing alternate notice theories that would empower patentees to seek increased remedies consistent with industry reality, case law, and fundamental statutory purpose. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0002

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Regulating Innovative Medicine: Fitting Square Pegs in Round Holes

Health & Biotechnology

By: Mark Lavender Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration (“FDA”) because they often transcend the FDA’s traditional categorical approach to regulating medical products. In a recent attempt to simplify this process, the FDA has proposed a new rule for regulating “combination products.” This iBrief discusses the FDA’s current approach and analyzes the possible affects of the proposed regulation. Because of the many shortcomings of both systems, this iBrief concludes that the FDA should instead stop assigning center jurisdiction based on a product’s “primary mode of action,” and give the Office of Combination Products internal agency jurisdiction over combination products. This alternative approach would increase consistency and efficiency while maintaining the FDA’s high standards for medical product safety and efficacy. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0001

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Canning Spam: Consumer Protection or a Lid on Free Speech?

eCommerce

By: Grant C. Yang The United States Congress recently passed the first federal legislation to curb the influx of spam. However, the Controlling the Assault of Non-Solicited Pornography and Marketing Act (“CAN-SPAM Act”) left some measures to be enacted by the Federal Trade Commission (“FTC”), and some consumers are calling for the Act to have a broader reach and for the creation of a Do-Not-E-Mail registry. Conversely, the FTC decided to delay the creation of a registry and opted to assist in the development of a new technological authentication system. This iBrief looks at the current state of spam and explains that it is too early to tell whether the effects of the CAN-SPAM Act warrant new anti-spam measures. In addition, it points out that it is questionable whether the FTC’s current authentication approach will be effective, and, thus, considers the possible First Amendment challenges to a Do-Not-Call registry as well as other possible anti-spam solutions. In the end, this iBrief postulates that the most effective option might be for the FTC to implement both a Do-Not-Email registry and an authentication system. Download Full Article (PDF) Cite: 2004 Duke L. & Tech. Rev. 0016

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1984 Is Still Fiction: Electronic Monitoring in the Workplace and U.S. Privacy Law

eCommerce

By: Christopher Pearson Fazekas Electronic monitoring in the workplace has been the subject of relentless public criticism. Privacy advocates argue that technological advancements have given overbearing employers powerful tools to abuse employee dignity in the name of productivity and that new legislation should bolster workplace privacy rights. This iBrief contends that current U.S. legal doctrine governing electronic monitoring in the workplace is fair given the nature and purpose of the workplace, and potential employer liability for employee misconduct. Download Full Article (PDF) Cite: 2004 Duke L. & Tech. Rev. 0015

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Crossed Signals in a Wireless World: The Seventh Circuit’s Misapplication of the Complete Preemption Doctrine

Media & Communications

By: Matthew J. Kleiman As the number of wireless telephone users continues to proliferate, so does the number of lawsuits against wireless service providers. While consumers seek to utilize various consumer-friendly state law causes of action, the wireless industry continues to push for a uniform federal regulatory regime. Ambiguous language in the Federal Communications Act of 1934 (“FCA”) and disagreement among the federal circuits has led to much confusion over whether state law claims affecting wireless rates and market entry are removable to federal court by way of “complete preemption.” This iBrief argues that FCA’s preemption power is limited by its savings clause, failure to establish a comprehensive regulatory scheme, and provision of a significant role for state regulation. Accordingly, the Seventh Circuit erred in Bastien v. AT&T Wireless Services, Inc. when it concluded that the FCA completely preempts certain state law claims against wireless service providers and thereby requires their removal to federal court. Download Full Article (PDF) Cite: 2004 Duke L. & Tech. Rev. 0014

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The Trade of Cross-Border Gambling and Betting: The WTO Dispute Between Antigua and the United States

International

By: James D. Thayer The first ecommerce dispute to come before the World Trade Organization (“WTO”) was billed to be one of David and Goliath proportion. The tiny twin-island nation-state of Antigua and Barbuda challenged the United States’ ban on cross-border Internet gambling and betting. As a result of the dispute, the WTO issued a private final report against the United States finding that the ban violates the United States’ commitments under the WTO. Shortly before the public release of the final report, both parties petitioned the WTO to indefinitely postpone its release so that the parties could engage in private negotiations. The final report is said to uphold the Panel’s interim report that found against the United States by, among other things, rejecting the United States’ claim that its ban on cross-border Internet gambling and betting does not violate its WTO obligations because the ban protects public morals. On October 28, 2004, the United States announced that the negotiations had broken down, and that it planned to appeal the Panel’s decision to the WTO Appellate Body. This iBrief sets forth the basic background of the dispute and argues that the Appellate Body will have to make at least three

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Privacy, Free Speech & the Garden Grove Cyber Café Experiment

eCommerce

By: Brett Stohs In response to gang violence at local “cyber cafés,” the City Council of Garden Grove, California, passed an ordinance requiring cyber cafés to install video surveillance systems. The constitutionality of the provision was subsequently challenged, and a California Court of Appeal determined that the video surveillance requirement did not violate free speech or privacy protections under either the federal or California Constitutions. This decision was immediately challenged, by commentators and a dissenting judge, as opening the door to Orwellian-type, government intrusions into individuals’ personal lives. This iBrief analyzes the appellate court’s decision and concludes that not only did the majority reach the correct conclusion, but that there is no merit to the dissent’s Orwellian fears. Download Full Article (PDF) Cite: 2004 Duke L. & Tech. Rev. 0012

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The Medicare Prescription Drug, Improvement, & Modernization Act of 2003: Are We Playing the Lottery With Healthcare Reform?

Health & Biotechnology

By: Melissa Ganz With millions of Americans unable to cope with the rising costs of prescription drugs, and many even forced to go without health insurance, the mounting pressure on Congress to enact major healthcare reform culminated in the Medicare Prescription Drug, Improvement, & Modernization Act of 2003. This iBrief examines this legislation, and concludes that it provides elusive benefits for seniors and merely creates a windfall for the pharmaceutical and insurance industries. Download Full Article (PDF) Cite: 2004 Duke L. & Tech. Rev. 0011

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