Law Commons^™

The Not-So-Standard Model: Reconsidering Agency-Head Review Of Administrative Adjudication Decisions, Rebecca S. Eisenberg, Nina A. Mendelson

Articles

The Supreme Court has invalidated multiple legislative design choices for independent agency structures in recent years, citing Article II and the need for political accountability through presidential control of agencies. In United States v. Arthrex, Inc., the Court turned to administrative adjudication, finding an Appointments Clause violation in the assignment of certain final patent adjudication decisions to appellate panels of unconfirmed administrative patent judges. As a remedy, a different majority declared unenforceable a statutory provision that had insulated Patent and Trademark Office (PTO) administrative adjudication decisions from political review for almost a century. The Court thereby enabled the politically appointed …

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, …

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

Michigan Law Review Online

In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …

The Cost Of Novelty, Will Nicholson Price Ii

Articles

Patent law tries to spur the development of new and better innova­tive technology. But it focuses much more on “new” than “better”—and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innova­tion”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not only …

Tell Me How It Ends: The Path To Nationalizing The U.S. Pharmaceutical Industry, Fran Quigley

University of Michigan Journal of Law Reform

The U.S. medicines system is broken. Millions of Americans suffer and some even die because they cannot afford medicines discovered by government-funded research. At the same time, corporations holding monopoly patent rights to those medicines collect some of the largest profits in modern capitalist history.

It does not have to be this way. The global legacy of treating essential medicines as a public good and the robust U.S. history of government seizure of private property for the public interest reveals a better path: the United States should nationalize its pharmaceutical industry.

U.S. statutory law already provides broad powers for the …

A Functional Approach To Judicial Review Of Ptab Rulings On Mixed Questions Of Law And Fact, Rebecca S. Eisenberg

Articles

The Court of Appeals for the Federal Circuit (“Federal Circuit”) has long relied on active appellate review to bring uniformity and clarity to patent law. It initially treated the PTO the same as the federal district courts, reviewing its factual findings for clear error and its legal conclusions de novo. Following reversal by the Supreme Court in Dickinson v. Zurko, the Federal Circuit began giving greater deference to PTO factual findings. But it continued to review the PTO’s legal conclusions de novo, while coding an expansive list of disputed issues in patent cases as legal conclusions, even when they …

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Articles

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

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 …

Intellectual Property: A Beacon For Reform Of Investor-State Dispute Settlement, Daniel Gervais

Michigan Journal of International Law

This Article attempts to resolve clashes between intellectual property and investor-state dispute settlement (“ISDS”). ISDS clauses contained in bilateral, plurilateral, or multilateral trade and investment agreements give multinational investors (corporations) a right to sue a state in a binding proceeding before an independent arbitral tribunal. This jurisgenerative right to file a claim against a state in an international tribunal with mandatory jurisdiction is exceptional; it is generally reserved to other states. Only multinational corporations can use ISDS to file claims against states in which they invest, provided the state is party to a bilateral investment treaty (“BIT”) or a trade …

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 …

Certiorari, Universality, And A Patent Puzzle, Tejas N. Narechania

Michigan Law Review

The most important determinant of a case’s chances for Supreme Court review is a circuit split: If two courts of appeals have decided the same issue differently, review is substantially more likely. But practically every appeal in a patent case makes its way to a single court—the Court of Appeals for the Federal Circuit. How, then, does the Supreme Court decide whether to grant certiorari in a patent case?

The petitions for certiorari in the Court’s patent docket suggest an answer: The Supreme Court looks for splits anyway. These splits, however, are of a different sort. Rather than consider whether …

Symbols, Systems, And Software As Intellectual Property: Time For Contu, Part Ii?, Timothy K. Armstrong

Michigan Telecommunications & Technology Law Review

The functional nature of computer software underlies two propositions that were, until recently, fairly well settled in intellectual property law: first, that software, like other utilitarian articles, may qualify for patent protection; and second, that the scope of copyright protection for software is comparatively limited. Both propositions have become considerably shakier as a result of recent court decisions. Following Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014), the lower courts have invalidated many software patents as unprotectable subject matter. Meanwhile, Oracle America v. Google Inc., 750 F.3d 1339 (Fed. Cir. 2014) extended far more expansive copyright protection …

The "Broadest Reasonable Interpretation" And Applying Issue Preclusion To Administrative Patent Claim Construction, Jonathan I. Tietz

Michigan Law Review

Inventions are tangible. Yet patents comprise words, and words are imprecise. Thus, disputes over patents involve a process known as “claim construction,” which formally clarifies the meaning of a patent claim’s words and, therefore, the scope of the underlying property right. Adversarial claim construction commonly occurs in various Article III and Article I settings, such as district courts or the Patent Trial and Appeal Board (PTAB). When these proceedings ignore each other’s claim constructions, a patent’s scope can become inconsistent and unpredictable. The doctrine of issue preclusion could help with this problem. The Supreme Court recently reemphasized in B & …

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 …

Understanding Nautilus's Reasonable-Certainty Standard: Requirements For Linguistic And Physical Definiteness Of Patent Claims, Gary M. Fox

Michigan Law Review

Patent applicants must satisfy a variety of requirements to obtain a patent from the U.S. Patent and Trademark Office (USPTO). The definiteness requirement forces applicants to describe their inventions in unambiguous terms so that other inventors will understand the scope of granted patent rights. Although the statutory provision for the definiteness requirement has been stable for many years, the Supreme Court’s decision in Nautilus v. Biosig Instruments altered the doctrine. The Court abrogated the Federal Circuit’s insoluble-ambiguity standard and replaced it with a new reasonable-certainty standard. Various district courts have applied the new standard in different ways, indicating the need …

Expired Patents, Trade Secrets, And Stymied Competition, W. Nicholson Price Ii

Articles

Patents and trade secrecy have long been considered substitute incentives for innovation. When inventors create a new invention, they traditionally must choose between the two. And if inventors choose to patent their invention, society provides strong legal protection in exchange for disclosure, with the understanding that the protection has a limit: it expires twenty years from the date of filing. At that time, the invention is opened to the public and exposed to competition. This story is incomplete. Patent disclosure is weak and focuses on one technical piece of an invention—but that piece is often only a part of the …

Patent Privateers And Antitrust Fears, Matthew Sipe

Michigan Telecommunications & Technology Law Review

Patent trolls are categorically demonized as threatening American innovation and industry. But whether they are a threat that antitrust law is equipped to deal with is a complex question that depends on the particular type of patent troll and activities they engage in. This Article looks specifically at privateer patent trolls: entities that acquire their patents from operating entities and assert them against other industry members. In the particular context of privateering, antitrust law is almost certainly not the proper legal solution. Privateering does raise significant issues: circumventing litigation constraints, evading licensing obligations, and raising the cost and frequency of …

Rent-Seeking And Inter Partes Review: An Analysis Of Invalidity Assertion Entities In Patent Law, W. Michael Schuster

Michigan Telecommunications & Technology Law Review

This Essay is the first analysis of a recent entrant on the patent landscape: the Invalidity Assertion Entity (IAE). IAEs engage in rent-seeking by demanding payment from patent holders in exchange for not attempting to invalidate their patents through administrative action before the U.S. Patent and Trademark Office. The response to IAEs has been uniformly negative. Reflexive proposals have been raised in Congress (unsurprisingly) to terminate the IAE business model. In contrast to the common response to IAEs, this Essay discusses how profit-driven IAEs may generate socially beneficial externalities and why legislating to end the IAE business model is imprudent.

Plausible Pleading In Patent Suits: Predicting The Effects Of The Abrogation Of Form 18, Kyle R. Williams

Michigan Telecommunications & Technology Law Review

On December 1, 2015, amendments to the Federal Rules of Civil Procedure took effect. The changes included, among other things, the abrogation of the Appendix of Forms, which contained templates for summons, complaints, answers, and other litigation documents. Prior to its abrogation, Form 18—a template for a “Complaint for Patent Infringement”—was widely utilized by patent plaintiffs in crafting infringement complaints. Form 18 was created during the Conley pleading regime, when conclusory allegations were generally sufficient to survive a motion to dismiss. Accordingly, the sample allegations in Form 18 were conclusory and bare-bones in nature. Under Conley, plaintiffs who followed this …

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 …

The Supreme Assimilation Of Patent Law, Peter Lee

Michigan Law Review

Although tensions between universality and exceptionalism apply throughout law, they are particularly pronounced in patent law, a field that deals with highly technical subject matter. This Article explores these tensions by investigating an underappreciated descriptive theory of Supreme Court patent jurisprudence. Significantly extending previous scholarship, it argues that the Court’s recent decisions reflect a project of eliminating “patent exceptionalism” and assimilating patent doctrine to general legal principles (or, more precisely, to what the Court frames as general legal principles). Among other motivations, this trend responds to rather exceptional patent doctrine emanating from the Federal Circuit in areas as varied as …

From Incentive To Commodity To Asset: How International Law Is Reconceptualizing Intellectual Property, Rochelle Dreyfuss, Susy Frankel

Michigan Journal of International Law

The intellectual property landscape is changing. As Jerry Reichman once observed, intellectual property rights were islands in a sea of the public domain until domestic laws expanded to include such “innovations” as business methods, software, scents, and sounds and turned the public domain into a pond surrounded by a continent of rights. Reichman spoke towards the end of the 20th century, and whatever problems accompanied this change, in truth (to paraphrase Voltaire’s view of the Holy Roman Empire), the concept of “intellectual property rights” was predominantly about neither “property” nor “rights” (nor was it always “intellectual”). Rather, copyright, patent, and …

An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel

Michigan Law Review

Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …

Forcing Patent Claims, Tun-Jen Chiang

Michigan Law Review

An enormous literature has criticized patent claims for being ambiguous. In this Article, I explain that this literature misunderstands the real problem: the fundamental concern is not that patent claims are ambiguous but that they are drafted by patentees with self-serving incentives to write claims in an overbroad manner. No one has asked why the patent system gives self-interested patentees the leading role in delineating the scope of their own patents. This Article makes two contributions to the literature. First, it explicitly frames the problem with patent claims as one of patentee self-interest rather than the intrinsic ambiguity of claim …

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 …

Reinventing Copyright And Patent, Abraham Bell, Gideon Parchomovsky

Michigan Law Review

Intellectual property systems all over the world are modeled on a one-size-fitsall principle. However important or unimportant, inventions and original works receive the same scope of protection, for the same period of time, backed by the same variety of legal remedies. Essentially, all intellectual property is equal under the law. This equality comes at a heavy price, however. The equality principle gives all creators access to the same remedies, even when those remedies create perverse litigation incentives. Moreover, society overpays for innovation through more monopoly losses than are strictly necessary to incentivize production. In this Article, we propose a solution …