Law Commons^™

Enabling Science Fiction, Camilla A. Hrdy, Daniel H. Brean

Michigan Technology Law Review

Patent law promotes innovation by giving inventors 20-year-long exclusive rights to their inventions. To be patented, however, an invention must be “enabled,” meaning the inventor must describe it in enough detail to teach others how to make and use the invention at the time the patent is filed. When inventions are not enabled, like a perpetual motion machine or a time travel device, they are derided as “mere science fiction”—products of the human mind, or the daydreams of armchair scientists, that are not suitable for the patent system.

This Article argues that, in fact, the literary genre of science fiction …

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

Saliency, Anchors & Frames: A Multicomponent Damages Experiment, Bernard Chao

Michigan Technology Law Review

Modern technology products contain thousands, sometimes hundreds of thousands, of different features. Nonetheless, when electronics manufacturers are sued for patent infringement, these suits typically accuse only one feature, or in more complex suits, a handful of features, of actual patent infringement. But damages verdicts often do not reflect the relatively small contribution an individual patent makes to an infringing product. One study observed that verdicts in these types of cases average 9.98% of the price of the entire product. While both courts and commentators have blamed the law of patent damages, the role cognitive biases play in these outsized damages …

Patents For Sharing, Toshiko Takenaka

Michigan Technology Law Review

Spurred by the Internet, emerging technologies have changed the way commercial firms innovate and have made it possible for individuals to play an important role in that innovation. Producers in the Information Communication Technologies (ICT), and other sectors dealing with complex technologies with many separately patentable components, find it increasingly difficult to make products without infringing on patents held by others. Numerous overlapping patents often cover such products. Producers have developed a new way to use patents: as inclusive rights for sharing their technologies with others through cross-licensing and other private ordering arrangements in order to ensure the freedom to …

Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan

Articles

The Bayh-Dole Act of 1980 established a new default rule that allowed nonprofit organizations and small businesses to own, as a routine matter, patents on inventions resulting from research sponsored by the federal government. Although universities helped get the Bayh-Dole Act through Congress, the primary goal, as reflected in the recitals at the beginning of the new statute, was not to benefit universities but to promote the commercial development and utilization of federally funded inventions. In the years since the passage of the Bayh-Dole Act, universities seem to have lost sight of this distinction. Their behavior as patent seekers, patent …

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii

Articles

Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in medicine, including …

Connect The Dots: Patents And Interdisciplinarity, Michal Shur-Ofry

University of Michigan Journal of Law Reform

This Article unravels a troubling paradox in the ecosystem of innovation. Interdisciplinarity is widely recognized as a source of valuable innovation and a trigger for technological breakthroughs. Yet, patent law, a principal legal tool for promoting innovation, fails to acknowledge it in an explicit, consistent manner. Moreover, although the scientific understanding of the significance of interdisciplinarity for innovation increasingly relies on big data analyses of patent databases, patent law practically ignores patent data as a source of information about interdisciplinary innovation. This Article argues that patent law should connect the dots—explicitly recognize interdisciplinarity as a positive indication when deciding whether …

Beyond Eureka: What Creators Want (Freedom, Credit, And Audiences) And How Intellectual Property Can Better Give It To Them (By Supporting, Sharing, Licensing, And Attribution), Colleen Chien

Michigan Law Review

In the theater of the courtroom or the rough and tumble arena of intellectual property policymaking, the day-to-day lives of creators are rarely presented. We often instead see one-dimensional vignettes, for example, “the new artist or band that has just released their [sic] first single and will not be paid for its success,” described on Taylor Swift’s Tumblr last summer when she initially withdrew from Apple’s music streaming service. While instructive, this description leaves out that Swift and other artists have long relied on “free play” mediums like radio and, more recently, YouTube to develop, not cannibalize, their audiences and …

Holding Up And Holding Out, Colleen V. Chien

Michigan Telecommunications & Technology Law Review

Patent “hold-up” and patent “hold-out” present important, alternative theories for what ails the patent system. Patent “hold-up” occurs when a patent owner sues a company when it is most vulnerable—after it has implemented a technology—and is able wrest a settlement because it is too late for the company to change course. Patent “hold-out” is the practice of companies routinely ignoring patents and resisting patent owner demands because the odds of getting caught are small. Hold-up has arguably predicted the current patent crises, and the ex ante assertion of technology patents whether in the smartphone war, standards, or patent “troll” context. …

After Myriad: Reconsidering The Incentives For Innovation In The Biotech Industry, Daniel K. Yarbrough

Michigan Telecommunications & Technology Law Review

35 U.S.C. § 101 allows a patent for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Recently, the Supreme Court issued several key decisions affecting the doctrine of patentable subject matter under § 101. Starting with Bilski v. Kappos (2011), and continuing with Mayo Collaborative Services, Inc. v. Prometheus Laboratories (2012), Association for Molecular Pathology v. Myriad Genetics (2013) and, most recently, Alice Corporation Pty. Ltd. v. CLS Bank International (2014), every year has brought another major change to the way in which the Court assesses patentability. In Myriad, the …

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 …

Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg

Articles

The Supreme Court’s decision last Term in Mayo v. Prometheus left considerable uncertainty as to the boundaries of patentable subject matter for molecular diagnostic inventions. First, the Court took an expansive approach to what counts as an unpatentable natural law by applying that term to the relationship set forth in the challenged patent between a patient’s levels of a drug metabolite and the indication of a need to adjust the patient’s drug dosage. And second, in evaluating whether the patent claims add enough to this unpatentable natural law to be patent eligible, the Court did not consult precedents concerning the …

Student Intellectual Property Issues On The Entrepreneurial Campus, Bryce C. Pilz

Michigan Business & Entrepreneurial Law Review

This article examines issues that are more frequently arising for universities concerning intellectual property in student inventions. It seeks to identify the issue, explain the underlying law, identify actual and proposed solutions to these issues, and explain the legal ramifications of these potential solutions.

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Michigan Telecommunications & Technology Law Review

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …

Res Or Rules - Patents And The (Uncertain) Rules Of The Game, Emily Michiko Morris

Michigan Telecommunications & Technology Law Review

The Article proceeds as follows. Part I reviews the basics of patent claiming, the traditional view of claims as real property deeds, and why uncertainty as to the boundaries of those deeds is considered undesirable. Part II critiques the analogy between real property deeds and patent claims, highlighting in particular the requisite novelty and conceptual nature of the patent res, the differences between the purposes of the patent system and real property regimes, and the effect of these different purposes on the expected predictability of patent boundaries. Part III then changes the analogy from patent claims as property deeds to …

Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg

Articles

In 1980, the Supreme Court gave a reassuring signal to the then-nascent biotechnology industry about the availability of patent protection for the fruits of its research when it upheld the patentability of a genetically modified living organism in Diamond v. Chakrabarty. Twenty-five years later, the Court seemed poised to reexamine the limits of patentable subject matter for advances in the life sciences when it granted certiorari in Laboratory Corporation v. Metabolite. But the Federal Circuit had not addressed the patentable subject matter issue in Laboratory Corporation, and the Court ultimately dismissed the certiorari p etition as improvidently granted. Five years …

Not So Technical: An Analysis Of Federal Circuit Patent Decisions Appealed From The Itc, Holly Lance

Michigan Telecommunications & Technology Law Review

A widespread perception among the patent law community is that the patent system would be more effective if judges with technical backgrounds and patent law experience decided patent disputes. Proponents believe that if judges all had similar baseline knowledge of technological analysis, there would be more consistency in decision-making, leading to more predictability for parties. Some district courts have unofficially become semi-specialized in patent law disputes, and Congress is debating whether to institute a more formalized Patent Pilot Program in which district court judges specialize in patent law cases. This Note joins the debate and examines patent law cases at …

Patenting By Entrepreneurs: An Empirical Study, Ted Sichelman, Stuart J.H. Graham

Michigan Telecommunications & Technology Law Review

[T]he Ewing Marion Kauffman Foundation--an organization that studies and promotes entrepreneurship in the United States--funded an effort at the University of California, Berkeley School of Law, to undertake the first comprehensive survey of the relationship between patenting and entrepreneurship in the United States. The authors, along with other investigators, administered the survey in 2008 to approximately 15,000 startup and early-stage companies in the biotechnology, medical device, information technology (IT) hardware, and software and Internet sectors. A portion of the survey examined why entrepreneurs, startups, and early-stage companies do (and do not) seek patents. This Article reports and analyzes results from …

Noncompliance, Nonenforcement, Nonproblem? Rethinking The Anticommons In Biomedical Research, Rebecca S. Eisenberg

Articles

A decade ago the biomedical research community was sounding alarm bells about the impact of intellectual property (IP) rights on the ability of scientists to do their work. Controversies and delays in negotiating terms of access to patented mice and genes, databases of scientific information, and tangible research materials all pointed toward the same conclusion: that IP claims were undermining traditional sharing norms to the detriment of science. Michael Heller and I highlighted one dimension of this concern: that too many IP rights in "upstream" research results could paradoxically restrict "downstream" research and product development by making it too costly …

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 …

Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann

Michigan Telecommunications & Technology Law Review

In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied …

Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm

Michigan Telecommunications & Technology Law Review

Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to a …

Biopiracy And Beyond: A Consideration Of Socio-Cultural Conflicts With Global Patent Policies, Cynthia M. Ho

University of Michigan Journal of Law Reform

This Article provides afresh and multi-dimensioned approach to a long-standing claim of biopiracy patents made by developing countries and communities. The basic principles of patent law and policy are first established to provide a foundation from which to evaluate the claim that genetic resources and traditional knowledge from developing countries are being misappropriated in a variety of ways that are loosely referred to as biopiracy. The Article distinguishes rhetoric from reality in examining biopiracy allegations from the perspective of national patent laws, as well as international agreements. In addition, the Article explains the underlying conflicts, misconceptions, and historical biases that …

Harnessing And Sharing The Benefits Of State-Sponsored Research: Intellectual Property Rights And Data Sharing In California's Stem Cell Initiative, Rebecca S. Eisenberg, Arti K. Rai

Articles

This Article discusses data sharing in California's stem cell initiative against the background of other data sharing efforts and in light of the competing interests that CIRM is directed to balance. We begin by considering how IP law affects data sharing. We then assess the strategic considerations that guide the IP and data policies and strategies of federal, state, and private research sponsors. With this background, we discuss four specific sets of issues that public sponsors of data-rich research, including CIRM, are likely to confront: (1) how to motivate researchers to contribute data; (2) who should have access to the …

Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde

Michigan Telecommunications & Technology Law Review

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …

Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg

Articles

Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …

The Experimental Purpose Doctrine And Biomedical Research, Tao Huang

Michigan Telecommunications & Technology Law Review

The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose …

Better, Faster, Cheaper - Later: What Happens When Technologies Are Suppressed, Kurt M. Saunders, Linda Levine

Michigan Telecommunications & Technology Law Review

Some inventions never see the light of day. Others enter the spotlight after long delays and the factors that slowed the arrival of that innovation are ignored. Technology suppression is a real occurrence involving well known and widely used products. In this Article, we examine the topic of technology suppression, seeking to reveal the tactics of suppression and the patterns and conditions under which it occurs. Current examples of US technologies are used to highlight the significance of this phenomenon. We consider related factors, including market and innovation forces, and we identify suppressive tactics, using illustrative cases where patent nonuse …

An Examination Of Patents, Licensing, Research Tools, And The Tragedy Of The Anticommons In Biotechnology Innovation, Michael S. Mireles

University of Michigan Journal of Law Reform

The continued development of and affordable access to potentially life saving pharmaceuticals, gene therapies and diagnostics is unquestionably a socially important issue. However, crafting government policy to encourage the development of and allowing affordable access to those services and products is difficult. On one hand, the development of those services and products requires a large investment of funds because of the complexity, collaborative nature, and uncertainty of the development of those products and services. Accordingly, investors require the safety of strong and stable patent rights to ensure a return on their investment in the development of a commercial end-product or …