Publications and Announcements

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

Health & Biotechnology Leave a comment

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

Health & Biotechnology Leave a comment

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

Patents & Technology Leave a comment

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

Patents & Technology 2 comments

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

eDiscovery Leave a comment

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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The Greatest Book You Will Never Read: Public Access Rights and the Orphan Works Dilemma

Copyrights & Trademarks Leave a comment

By: Libby Greismann Copyright law aims to promote the dual goals of incentivizing production of literary and artistic works, and promoting public access and free speech. To achieve these goals, Congress has implemented a policy that acknowledges the rights of both the copyright holder and the public, which vest with the fixation of the work. However, as Congressional action has strengthened copyright protection, the rights of the public have been narrowed. Orphan works – works to which the copyright owner cannot be located or identified – present a unique problem, in that achieving free access and use of the works is often impossible. This note argues that the public has a recognizable right in both gaining access to and using orphan works – a right which emanates from, but is tangential to, the First Amendment right to free speech. Download Full Article (PDF) Cite: 11 Duke L. & Tech. Rev. 193

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Beta-Testing the “Particular Machine”: The Machine-or-Transformation Test in Peril and Its Impact on Cloud Computing

Patents & Technology Leave a comment

By: Richard M. Lee This Issue Brief examines recent cases addressing the patent eligibility of computer-implemented method claims and their implications for the development of cloud computing technologies. Despite the Supreme Court’s refusal to endorse the machine-or-transformation test as the exclusive patent eligibility inquiry, lower courts have continued to invalidate method claims using a stringent “particular machine” requirement alongside the requisite abstract ideas analysis. This Issue Brief argues that 1) post-Bilski v. Kappos cases have failed to elucidate what constitutes a particular machine for computer-implemented methods; 2) in light of substantial variance among Federal Circuit judges’ Section 101 jurisprudence, the application of the particular machine requirement has become subject to a high degree of panel-dependency, such that its relevance for analyzing software method claims has come under question; 3) notwithstanding the unease expressed by practitioners and scholars for the future of cloud computing patents, the courts’ hardening stance toward computer-implemented method claims will do little to deter patenting in the cloud computing context. Instead, clouds delivering platform and software services will remain capable of satisfying the particular machine requirement and supporting patent eligibility, especially given the possible dilution of the particular machine requirement itself. Download Full Article (PDF) Cite: 11

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Cloud Computing, Clickwrap Agreements, and Limitation on Liability Clauses: A Perfect Storm?

eCommerce Leave a comment

By: Timothy J. Calloway “To the cloud!” trumpets a commercial by Microsoft, whose aim is to herd customers, and their checkbooks, into the cloud computing fold. But Microsoft, and other cloud providers like Amazon and Google, might inadvertently be doing just the opposite. It is not for lack of security or even early adopter apprehension that potential customers might turn away. Nor is it a lack of fantastic, cost-saving applications of cloud technology. Rather, the problem is buried deep within these tech giants’ clickwrap agreements—the ones that customers rarely read and to which they invariably click “I Agree.” Hidden in these agreements are limitation on liability clauses, veritable safe harbors for cloud providers and submerged icebergs for the unwary cloud customer. Often, these clauses wholly abrogate a customer’s right to recover damages for his provider’s wrongful acts. In other words, a provider could purposefully delete its customers’ data or shut down its users’ websites, leaving the aggrieved customers with no cause of action and no right to recover. While limitation on liability clauses are not new to the contract law vernacular, their inclusion in cloud computing agreements is particularly troublesome. The amount of potential liability that customers may waive through

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