Publications and Announcements

The Resurrection of the Duty to Inquire After Therasense, Inc. v. Becton, Dickinson & Co.

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By: Brandee N. Woolard Balancing a duty to a tribunal and a duty to a client can paralyze a lawyer. The task raises difficult questions about how to reconcile competing obligations as an advocate and as an officer of the court. Individuals licensed to prosecute patent applications must decide how to honor both their obligations to the Patent and Trademark Office (PTO) and their obligation to successfully prosecute patent applications. This burden can result in willful blindness, where the patent attorney or patent agent (“patent practitioner”) limits inquiry into information that may bar a patent application. The recent Federal Circuit opinion in Therasense may have eliminated the judicial “duty to inquire” doctrine that kept these obligations in balance. This Issue Brief argues that there is a need to protect against willful blindness and proposes a resurrection of the eliminated doctrines. Download Full Article (PDF) Cite: 12 Duke L. & Tech. Rev. 41

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Carbons Into Bytes: Patented Chemical Compound Protection in the Virtual World

Health & Biotechnology, Patents & Technology Leave a comment

By: B. Thomas Watson “Virtual” molecular compounds, created in molecular modeling software, are increasingly useful in the process of rational drug design. When a physical compound is patented, however, virtual use of the compound allows researchers to circumvent the protection granted to the patentee. To acquire protection from unauthorized use of compounds in their virtual form, patentees must directly claim the virtual compound. But Supreme Court decisions such as Bilski v. Kappos and Mayo Collaborative Services v. Prometheus Laboratories, Inc. call into question whether virtual compound claims are patentable subject matter under § 101. Using the guidance offered by the Supreme Court and Federal Circuit, this Issue Brief argues that virtual compound claims are not abstract ideas and therefore, consistent with patent policy, qualify as patentable subject matter. Download Full Article (PDF) Cite: 12 Duke L. & Tech. Rev. 25

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In Ambiguous Battle: The Promise (And Pathos) of Public Domain Day, 2014

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By: Jennifer Jenkins On the first day of each year, Public Domain Day celebrates the moment when copyrights expire, and books, films, songs, and other creative works enter the public domain, where they become, in Justice Brandeis’s words, “free as the air to common use.” Educators, students, artists, and fans can use them with neither permission nor payment. Online archives can digitize and make them fully available without the threat of lawsuits or licensing demands. Sadly, in the United States, as a result of copyright term extensions, not a single published work will enter the public domain in 2014. In fact, almost no works created during most readers’ lifetimes will become completely free for them to redistribute and reuse, unless the rights holders affirmatively decide otherwise. In this Article, I will briefly trace the history and consequences of this legally imposed impoverishment of the public domain. But, I argue, this is only part of the story. Increasingly, private initiatives are trying to build zones of legal freedom that simulate some attributes of the public domain. At the same time, there are global copyright reform efforts to limit the negative effects of term extension, at least with regard to “orphan works”—those

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After Prometheus, Are Human Genes Patentable Subject Matter?

Health & Biotechnology, Patents & Technology Leave a comment

By: Douglas L. Rogers On April 15, 2013, the U.S. Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. on the question, “Are human genes patentable?” This article argues that human genes are not patentable and that isolating a gene from its surroundings in a human body—or creating synthetically what exists in nature as DNA—does not cause the DNA to become patentable subject matter. The isolated DNA segments of claim 1 have the identical nucleotide sequence and the same function as native DNA, and the isolated DNA of claim 1 do not reflect the marked changes required under Chakrabarty, or the inventive step required under Prometheus, to change an unpatentable product of nature into patentable subject matter. Claim 2 describes those nucleotides in the DNA sequence that code for the polypeptide identified in the Myriad Genetics patent specification and simply reflects the genetic code, an unpatentable law of nature. Since no inventive step has been added to the law of nature, claim 2 constitutes unpatentable subject matter under Prometheus. The Federal Circuit’s contrary decision in Myriad Genetics disregards 150 years of Supreme Court cases that physical phenomena found in nature and laws of nature are

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Lack of Transparency in the Premarket Approval Process for Aquadvantage Salmon

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By: Michael P. McEvilly After a lengthy premarket approval process, the Food and Drug Administration (FDA) is soon likely to deem AquAdvantage Salmon, a fast-growing, genetically engineered salmon, safe for human consumption. If approved, AquAdvantage Salmon will be the first genetically engineered animal designed for human consumption to go to market in the United States. Because there have been no significant changes to the statutory or regulatory framework governing agricultural biotechnology since it was established in the 1980s, the FDA reviews applications of genetically engineered animals under the New Animal Drug Application (NADA) provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA’s treatment of genetically engineered food as a new animal drug has been criticized due to potential environmental and human health risks, and because of a lack of transparency throughout the regulatory process. After providing an overview of the premarket approval process, this Issue Brief argues that even under the NADA provisions, the FDA’s premarket approval risk assessment should be more transparent. In particular, the justification for trade secret status of relevant biotechnology is undermined, if not extinguished, by the need for public consideration of the biotechnology’s safety and effectiveness after a certain time in the

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The Promise of Priority Review Vouchers as a Legislative Tool to Encourage Drugs for Neglected Diseases

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By: Lesley Hamming Despite the intellectual property system’s success in promoting the economic well-being of the United States, this system has not achieved all socially valuable ends. Insufficient treatments are applied both to diseases endemic in developing countries, such as malaria, and rare diseases, such as rare childhood cancers. This Issue Brief reviews the existing legislative tools for promoting socially valuable drugs and biologics through market incentives. The priority review voucher (PRV) program is the latest and most unique of these legislative tools aimed at encouraging the development of drugs for neglected diseases without burdening taxpayers. The Creating Hope Act—recently signed into law as part of the Food & Drug Administration Safety & Innovation Act—extends the PRV program to rare pediatric diseases. This Issue Brief argues that some provisions in this new legislation may result in undesirable collateral effects that could prevent the legislation from fulfilling its objective of encouraging investment in treatments for rare pediatric diseases. Download Full Article (PDF) Cite: 11 Duke L. & Tech. Rev. 390

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The America Invents Act 500: Effects of Patent Monetization Entities on US Litigation

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By: Sara Jeruss, Robin Feldman, & Joshua Walker Any discussion of flaws in the United States patent system inevitably turns to the system’s modern villain: non-practicing entities, known more colorfully as patent trolls. For many years, however, discussions about non-practicing entities have been long on speculation and short on data. In 2011 Congress directed the nonpartisan Government Accountability Office to study the effects of non-practicing entities on patent litigation. At the request of the GAO, we collected and coded a set of patent lawsuits filed over the past five years. This article presents our analysis of the data and its implications. The data confirm in a dramatic fashion what many scholars and commentators have suspected: patent monetization entities play a role in a substantial portion of the lawsuits filed today. Based on our sample, lawsuits filed by patent monetizers have increased from 22% of the cases filed five years ago to almost 40% of the cases filed in the most recent year. In addition, of the five parties in the sample who filed the greatest number of lawsuits during the period studied, four were monetizers and only one was an operating company. Download Full Article (PDF) Cite: 11 Duke L.

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Cooking Protestors Alive: The Excessive-Force Implications of the Active Denial System

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By: Brad Turner The Active Denial System (ADS) is unlike any other nonviolent weapon: instead of incapacitating its targets, it forces them to flee, and it does so without being seen or heard. Though it is a promising new crowd-control tool for law-enforcement, excessive-force claims involving the ADS will create a Fourth Amendment jurisprudential paradox. Moreover, the resolution of that paradox could undermine other constitutional principles—like equality, fairness, and free speech. Ultimately, the ADS serves as a warning that without legislation, American jurisprudence may not be ready for the next generation of law-enforcement technology and the novel excessive-force claims sure to follow. Download Full Article (PDF) Cite: 11 Duke L. & Tech. Rev. 332

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A Comparative Critique to U.S. Courts’ Approach to E-Discovery in Foreign Trials

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By: Lauren Ann Ross This Issue Brief explores an oft-neglected irony in international e-discovery: the rationales used by courts to compel discovery against foreign parties embroiled in litigation in U.S. courts may contradict courts’ reasoning when compelling discovery against U.S. parties engaged in litigation overseas. U.S. courts often grant petitions for discovery, increasingly electronic in form, both against a foreign party in the U.S. and against a domestic party abroad. Although allowing discovery in both scenarios appears consistent, it actually ignores important counterconsiderations like fairness and reciprocity in different legal systems. Because the rise of technology has exacerbated the existing problem, making discovery more expensive and time-consuming, this Brief proposes that, when examining 28 U.S.C. § 1782 claims, courts adopt a more conservative approach to foreign-discoverability and a comparative approach to the balancing test set forth in Intel Corp. v. Advanced Micro Devices, Inc. Download Full Article (PDF) Cite: 11 Duke L. & Tech. Rev. 313

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The Myth and Reality of Dilution

Copyrights & Trademarks Leave a comment

By: Sandra L. Rierson Statutory dilution claims are traditionally justified on the theory that even non-confusing uses of a famous trademark (or similar mark) can nonetheless minutely dilute the source-identifying capacity of the targeted trademark. This Article challenges that theory. The evidence that this phenomenon occurs is weak and has been subject to substantial empirical challenge. The true foundation for dilution claims lies not in alleged economic harms, but rather the misplaced fiction of corporate personality. We do not require trademark holders to prove actual economic injury in the context of a dilution claim because, at least in the vast majority of cases, there is none. Instead, we have granted the holders of famous trademarks the equivalent of a “moral” right to these marks, analogous to the rights granted to a creator of an expressive work in the copyright context. The parameters of that right have recently expanded in numerous ways that have increasingly burdened both competition and free speech. Recasting dilution law in a moral rights framework allows us to more accurately assess its costs and benefits, with normative implications for its continued existence and scope. In particular, the federal dilution statute should be repealed, amended, or, at the

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