Law Commons^™

Assessing Responses To The Pto’S 2021 Patent Eligibility Study, Jorge L. Contreras, Victoria T. Carrington

Utah Law Faculty Scholarship

In July 2021, the US Patent and Trademark Office (PTO) issued a public request for comments regarding the impact of recent patent eligibility jurisprudence on US businesses and markets. The PTO received 145 responses to its request by the October 2021 deadline. In this paper, we analyze the responses by industry sector and respondent type, assessing whether responses were generally positive, neutral or negative toward US patent eligibility jurisprudence, and also identifying those responses that cited international competitiveness of US businesses (particularly with respect to China) in their reasoning.

Pleasure Patents, Andrew Gilden, Sarah R. Wasserman Rajec

Faculty Publications

The United States Patent and Trademark Office has granted thousands of patents for inventions whose purpose is to facilitate the sexual pleasure of their users. These "pleasure patents" raise a range of novel questions about both patent theory and the relationship between law and sexuality more broadly. Given that "immoral" inventions were long excluded from the patent system, and that sexual devices were widely criminalized for much of the past 150 years, how have patentees successfully framed the contributions of their sexual inventions? If a patentable invention must be both new and useful, how have patentees described the utility of …

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

Utah Law Faculty Scholarship

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is part 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 Sec-tion 101 jurisprudence. Perhaps one of the most remarkable things about Myriad is that it meant so many different things to so many different …

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 …

Patenting The Unexplained, Sean B. Seymore

Vanderbilt Law School Faculty Publications

It is a bedrock principle of patent law that an inventor need not understand how or why an invention works. The patent statute simply requires that the inventor explain how to make and use the invention. But explaining how to make and use something without understanding how or why it works yields patents with uninformative disclosures. Their teaching function is limited; one who wants to understand or figure out the underlying scientific principles must turn elsewhere. This limited disclosure rule does not align with the norms of science and tends to make patent documents a less robust form of technical …

Computational Experimentation, Tabrez Y. Ebrahim

Faculty Scholarship

Experimentation conjures images of laboratories and equipment in biotechnology, chemistry, materials science, and pharmaceuticals. Yet modern day experimentation is not limited to only chemical synthesis, but is increasingly computational. Researchers in the unpredictable arts can experiment upon the functions, properties, reactions, and structures of chemical compounds with highly accurate computational techniques. These computational capabilities challenge the enablement and utility patentability requirements. The patent statute requires that the inventor explain how to make and use the invention without undue experimentation and that the invention have at least substantial and specific utility. These patentability requirements do not align with computational research capabilities, …

Three New Metrics For Patent Examiner Activity: Office Actions Per Grant Ratio (Ogr), Office Actions Per Disposal Ratio (Odr), And Grant To Examiner Ratio (Ger), Shine Tu

Law Faculty Scholarship

The current metric for examiner prosecution activity is allowance rate, which is calculated by dividing the total number of allowances by the sum of the allowances and abandonments (allowance rate = total allowance/(total allowances total abandonments)). Importantly, however, allowance rates do not consider an examiner’s pending docket. Specifically, allowance rates do not fully capture if the examiner is simply writing office actions thereby prolonging prosecution or allowing cases. This study rectifies this failure by creating and analyzing a dataset that captures every active examiner’s current docket. Calculating the Office Action per Grant Ratio (OGR = Total # of Office Actions/Total …

Bigger And Better Patent Examiner Statistics, Shine Tu

Faculty & Staff Scholarship

The American government charges the United States Patent and Trademark Office (USPTO) with reading and reviewing patent applications to determine what new or improved inventions, machines, and processes qualify for patent protection. Each application is reviewed by a specific patent examiner who theoretically applies the standards of patentability in an even, fair, unbiased and consistent manner. This task requires the examiner to not only be internally consistent with the applications she reviews but also consistent with the behavior of other examiners within the same technology center. I have conducted two studies based on data from hundreds of thousands of patents, …

Confusing Patent Eligibility, David O. Taylor

Faculty Journal Articles and Book Chapters

Patent law — and in particular the law governing patent eligibility — is in a state of crisis. This crisis is one of profound confusion. Confusion exists because the current approach to determining patent eligibility confuses the relevant policies underlying numerous discrete patent law doctrines, and because the current approach lacks administrability. Ironically, the result of all this confusion is seemingly clear: the result seems to be that, when challenged, patent applications and issued patents probably do not satisfy the requirement of eligibility. At least that is the perception. A resulting concern, therefore, is that the current environment substantially reduces …

Patent Law Challenges For The Internet Of Things, W. Keith Robinson

Faculty Journal Articles and Book Chapters

In the near future, emerging technologies will allow billions of everyday devices to be connected via the Internet. This increasingly popular phenomenon is referred to as the Internet of Things (“IoT”). The IoT is broadly defined as technology that allows everyday devices to (1) become “smart” and (2) communicate with other smart devices. Estimates indicate that the market for smart devices, such as wearables, will grow to $70 billion dollars in the next ten years. Like many other emerging technologies, the entrepreneurs and companies developing these applications will seek patent protection for their inventions. In turn, the current U.S. patent …

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 …

Genes 101: Are Human Genes Patentable Subject Matter?, Andrew Bowman

Law Student Publications

This comment proposes a totality-of-the-circumstances approach to analyzing biological molecules under § 101 such that both the structure and its information is examined. Part II of this note reviews relevant precedent in patent law. Part III analyzes the Federal Circuit's Myriad decision, and Part IV explains the potential effects of the recent Supreme Court decision Mayo Collaborative Services v. Prometheus Laboratories. Finally, in Part V, the patent eligibility of human genes is examined. Analyzing this issue under the proposed totality-of-the-circumstances approach, this article concludes that isolated human genes are not patentable.

What Do America's First Patents Have To Do With Today's?, Kristen Jakobsen Osenga

Law Faculty Publications

In an invited response to an article by Prof. Michael Risch, Prof. Osenga reexamines some of the conclusions drawn by his study of early American Patents and what they suggested about inventors' perceptions of patentability.

The Technological Edge, Elizabeth I. Winston

Scholarly Articles

To grant a patent to natural phenomena hinders innovation, taking back from the public that which the public has a right to possess. To deny a patent to man’s manufacture undercuts the fundamental bargain of the patent system. All inventions, at their core, may be deemed natural, rendering it difficult to distinguish between man’s manufacture and natural phenomena. Determining whether the innovative aspect of the product is a technological one, rather than a natural one, can clarify whether the patent grant promotes the progress of science and the useful arts. The higher the level of skill in the art required …

Patent Law's Audience, Mark D. Janis, Timothy R. Holbrook

Articles by Maurer Faculty

Many rules of patent law rest on a false premise about their target audience. Rules of patentability purport to provide subtle incentives to innovators. However, innovators typically encounter these rules only indirectly, through intermediaries such as lawyers, venture capitalists, managers, and others. Rules of patent scope strive to provide notice of the boundaries of the patent right to anyone whose activities might approach those boundaries, including, in theory, any member of the general public. But the rules of patent scope are practically incomprehensible to the general public. In this Article, we argue that rules of patent law should be designed …

Better Mistakes In Patent Law, Andres Sawicki

Articles

This Article analyzes patent mistakes-that is, mistakes made by the patent system when it decides whether a particular invention has met the patentability requirements. These mistakes are inevitable. Given resource constraints, some might even be desirable. This Article evaluates the relative costs of patent mistakes, so that we can make better ones.

Three characteristics drive the costs of mistakes: their type (false positive or false negative), timing (early or late), and doctrinal basis (utility, novelty, nonobviousness, and so on). These characteristics make some mistakes more troubling than others.

This Article compares the costs of making mistakes of different types, at …

Tuning The Obviousness Inquiry After Ksr, Mark D. Janis

Articles by Maurer Faculty

One of the most important and delicate judicial tasks in patent law is to keep the obviousness doctrine in reasonable working order. There are several reasons why the obviousness doctrine has been the subject of frequent judicial tinkering. First, patentability doctrines interact with each other, so doctrinal alterations that seem to be entirely external to the obviousness doctrine frequently have ripple effects on obviousness. The interaction between the utility and obviousness doctrines provides one good example. Second, the obviousness doctrine is internally complex. Cases in the chemical and biotechnology areas over the past several decades have amply illustrated this point. …

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 …

Level Of Skill And Long-Felt Need: Notes On A Forgotten Future, Joe Miller

Scholarly Works

The Supreme Court's KSR decision transforms the way we think about patent law's ordinary artisan. The ordinary artisan, the Supreme Court states, is also a person of ordinary creativity, not an automaton. This transformation, which sweeps aside a contrary precept that had informed the Federal Circuit's nonobviousness jurisprudence for a generation, raises a key question: How do we fill out the rest of our conception, in a given case, of the ordinary artisan's level of skill at the time the invention was made? Reaching back to a large vein of case law typified by Judge Learned Hand's decisions about nonobviousness, …

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 …

Patents On Legal Methods? No Way!, Andrew A. Schwartz

Publications

An “invention,” as used in the United States patent laws, refers to anything made by man that employs or harnesses a law of nature or a naturally occurring substance for human benefit. A watermill, for instance, harnesses the power of gravity to run machinery. But legal methods, such as tax strategies, are not inventions in this sense, because they employ “laws of man” — not laws of nature to produce a useful result.

The Patent Office Meets The Poison Pill: Why Legal Methods Cannot Be Patented, Andrew A. Schwartz

Publications

In 2003, for the first time in its 170-year history, the United States Patent Office began awarding patents for novel legal innovations, in addition to traditional inventions such as the telephone or airplane. Commentators have accepted the Patent Office's power to grant legal method patents, but at the same time have criticized this new type of patent on policy grounds. But no one has suggested that the Patent Office exceeded its authority by awarding patents for legal methods, until now.

In the Patent Act of 1952, which is still in effect today, Congress established certain requirements for patentability, including a …

Tax Strategies Are Not Patentable Inventions, Andrew A. Schwartz

Publications

No abstract provided.

Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg

Articles

In this Article, I consider the possibility of giving the USPTO input from currently active technological practitioners in evaluating the obviousness of claimed inventions. Such input could potentially serve three useful functions. First, it could improve the accuracy of USPTO decisionmaking by providing access to the perspective of actual practitioners as to the obviousness of inventions from the perspective of the hypothetical PHOSITA. Second, it could help the USPTO document the evidentiary basis for rejections that rest in part upon tacit knowledge within technological communities. Third, it could provide a quality control mechanism that would improve the credibility of USPTO …

Reaching Through The Genome, Rebecca S. Eisenberg

Book Chapters

The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg

Articles

Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.

The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg

Book Chapters

The sequencing of the human genome is a great scientific accomplishment that opens the door to further scientific inquiry of a sort that would otherwise be impossible. In addition to being passionately interested in the patent issues this research presents, as a legal scholar I have a long-standing interest in the role of intellectual property in interactions between the public and private senators and between universities and private firms in research science, with a focus on biomedial research. However, although the Human Genome Project has provided a rich terrain for exploring these issues, I am puzzled that intellectual property issues …

Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg

Articles

As public and private sector initiatives race to complete the sequence of the human genome, patent issues have played a prominent role in speculations about the significance of this achievement. How much of the genome will be subject to the control of patent holders, and what will this mean for future research and the development of products for the improvement of human health? Is a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claims to the genome on behalf of the many sequential innovators who elucidate its sequence …

The Promise And Perils Of Strategic Publication To Create Prior Art: A Response To Professor Parchomovsky, Rebecca S. Eisenberg

Articles

In a provocative recent article in the Michigan Law Review, Professor Gideon Parchomovsky observes that a firm racing with a competitor to make a patentable invention might find it strategically advantageous to publish interim research results rather than risk losing a patent race. This strategy exploits legal rules limiting patent protection to technological advances that are new and "nonobvious" in light of the "prior art" or preexisting knowledge in the field. By publishing research results, a firm adds to the prior art and thereby limits what may be patented in the future. Parchomovsky posits that, before it is able to …

Analyze This: A Law And Economics Agenda For The Patent System, Rebecca S. Eisenberg

Articles

Legal scholars and economists might enhance the value and impact of their work by making more effective use of each other's knowledge and capabilities. Legal scholars can offer a more nuanced understanding of the legal rules that underlie the patent system and the doctrinal levers that might be manipulated in furtherance of public policy goals. Economists bring to bear a set of analytical and methodological tools that could shed considerable light on what these doctrinal levers are doing and which of them we ought to be manipulating. Together, we have a better chance of asking the right questions and thinking …