Science and Technology Law Commons^™

Diffusing New Technology Without Dissipating Rents: Some Historical Case Studies Of Knowledge Sharing, James Bessen, Alessandro Nuvolari

Faculty Scholarship

The diffusion of innovations is supposed to dissipate inventors’ rents. Yet in many documented cases, inventors freely shared knowledge with their competitors. Using a model and case studies, this article explores why sharing did not eliminate inventors’ incentives. Each new technology coexisted with an alternative for one or more decades. This allowed inventors to earn rents while sharing knowledge, attaining major productivity gains. The technology diffusion literature suggests that such circumstances are common during the early stages of a new technology.

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …

Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth

Marquette Intellectual Property Law Review

This Comment will address two primary issues. First, it will analyze the basis of sovereign immunity rights of tribes, with a focus on the relationship between intellectual property rights and sovereignty. Second, it will discuss whether this arrangement violates the antitrust laws of the United States. This Comment concludes that even if a claim of tribal sovereign immunity is legitimate, it is likely that such an arrangement still violates the relevant antitrust claims.

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

Marquette Intellectual Property Law Review

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 …

Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie

Marquette Intellectual Property Law Review

This paper will examine the challenges of international compulsory licensing by examining the issue historically and legally as well as offer possible solutions. Thus, this paper will explore the challenge of balancing corporate interests against the affordability and availability of pharmaceuticals by focusing on discrete situations in developing countries, the history of compulsory licensing, and how the World Health Organization (the “WHO”) and the WTO have attempted to tackle these challenges through compulsory licensing, and it will suggest a possible framework for use in arbitration, which balances equities through a Georgia-Pacific analysis.

Protecting Wisconsinites From Trolls: The Federal Circuit's "Bad Faith" Preemption And Its Restrictive Effect, Andrew Salomone

Marquette Intellectual Property Law Review

In this comment, I use Wis. Stat. Ann. § 100.197 (“Wisconsin’s anti-PAE statute”) to demonstrate the significant degree to which the Federal Circuit’s current preemption regime restricts states’ abilities to regulate the behavior of PAEs. In Part II, I summarize Wisconsin’s legislative response to PAEs. In Part III, I contrast the Federal Circuit’s preemption doctrine and the Supreme Court’s doctrine as it relates to state laws similar to anti-PAE statutes. Paying particular attention to Wisconsin’s patent notification statute, I provide a brief preemption analysis in Part IV. Finally, in Part V, I conclude by arguing that the severe consequences of …

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

Automation And Predictive Analytics In Patent Prosecution: Uspto Implications And Policy, Tabrez Y. Ebrahim

Faculty Scholarship

Artificial-intelligence technological advancements bring automation and predictive analytics into patent prosecution. The information asymmetry between inventors and patent examiners is expanded by artificial intelligence, which transforms the inventor-examiner interaction to machine-human interactions. In response to automated patent drafting, automated office-action responses, "cloems" (computer-generated word permutations) for defensive patenting, and machine-learning guidance (based on constantly updated patent-prosecution big data), the United States Patent and Trademark Office (USPTO) should reevaluate patent-examination policy from economic, fairness, time, and transparency perspectives. By conceptualizing the inventor-examiner relationship as a "patenting market," economic principles suggest stronger efficiencies if both inventors and the USPTO have better information …

Patent Clutter, Janet Freilich

Faculty Scholarship

Patent claims are supposed to clearly and succinctly describe the patented invention, and only the patented invention. This Article hypothesizes that a substantial amount of language in patent claims is in fact not about the core invention, which may contribute to well-documented problems with patent claims. I analyze the claims of 40,000 patents and applications, and document the proliferation of "clutter"-language in patent claims that is not about the invention. Although claims are supposed to be exclusively about the invention, clutter appears across industries and makes up approximately 25 % of claim language. Patent clutter may contribute several major problems …

Determining Enhanced Damages After Halo Electronics: Still A Struggle?, Veronica Corcoran

Marquette Intellectual Property Law Review

35 U.S.C. § 284 of the Patent Act allows district courts to use their discretion to award enhanced damages up to three times the amount found or assessed in the case of patent infringement. This Comment will consider how the Supreme court of the United States’ holding in Halo Electronics, Inc. v. Pulse electronics, Inc. changed the landscape of enhanced damages awards in light of willful infringement.

First, this Comment will examine the Federal Circuit’s approach that now embraces both an objective and subjective inquiry in determining enhanced damages, which may resolve the concern over the rigidity in the Seagate …

Patent Eligibility's Doctrinal Exclusions... Lately, A Scary Movie Too Difficult To Watch: Concrete Solutions And Suggestions, Kristy J. Downing

Marquette Intellectual Property Law Review

Patent eligible subject matter is defined by the legislature’s 35 U.S.C. § 101 to include “any new and useful process, machine, manufacture or composition of matter.” Since the nineteenth century, however, United States (U.S.) courts have considered certain otherwise eligible subject matter excludable from patent protection. The judiciary’s doctrinal exclusions’ purpose was to protect fundamental building blocks to science and useful arts ensuring that such information could not be monopolized by one entity. Presently, however, the judicial exclusions have been used to exclude fewer fundamental building blocks and more ordinary brick-and-mortar innovations after two U.S. supreme court decisions (Mayo …

Noa V. Doa: Increasing Medical Diagnostic Patentability After Mayo, Karen Mckenzie

Marquette Intellectual Property Law Review

The medical diagnostics market is expected to reach 65 billion by 2018. In March 2012, in Mayo Collborative Services v. Prometheus Labs, Inc. , ("Mayo") the U.S. Supreme held that the Mayo Clinic (the "Clinic") had not infringed on Prometheus Labs’ (“Prometheus”) diagnostic patent because the Prometheus patent involved ineligible subject matter, and was therefore invalid. Section 101 of the Patent Act defines eligible subject matter an “any new and useful process, machine, manufacture, or composition of matter” as patentable subject matter. Courts have held that Section 101 contains an implicit exception, making laws of nature, natural phenomena, and abstract …

Ignorance Over Innovation: Why Misunderstanding Standard Setting Organizations Will Hinder Technological Progress, Kristen Osenga

Law Faculty Publications

On January 17, 2017, the Federal Trade Commission (FTC) sued Qualcomm Inc. in federal district court, alleging antitrust violations in the company's licensing of semiconductor chips used in cell phones and more. The suit alleges, in part, that Qualcomm refuses to license its patents that cover innovations incorporated in technology standards (standard-essential patents, or SEPs), in contradiction of the company's promise to license this intellectual property on fair, reasonable, and nondiscriminatory (FRAND) terms. According to the FTC, Qualcomm's behavior reduces competitors' ability to participate in the market, raises prices paid by consumers for products incorporating the standardized technology, and at …

From Alice To Bob: The Patent Eligibility Of Blockchain In A Post-Cls Bank World, Antonio M. Dinizo

Journal of Law, Technology, & the Internet

Every year the World Economic Forum publishes a list of the top ten emerging technologies. This list of breakthrough technologies has included 3-D printing, self-healing biomimicry materials, and human microbiome therapeutics. In 2016, the financial technology Blockchain dominated the list. Over $1 billion was invested into Blockchain technology and major financial firms are actively exploring Blockchain innovation.

As innovators enter the Blockchain space, they have pushed for patent protection. This Note examines whether Blockchain is patent eligible. Patent eligibility for business methods and software patents is determined under the Supreme Court’s holding in Alice v. CLS Bank. The first section …

Background Note: Standard Essential Patents, Innovation And Competition: Challenges In India, Arpan Banerjee

IP Theory

In September 2014, a few months after a landslide election victory, the Indian Prime Minister Narendra Modi announced the launch of “Make in India,” an ambitious program designed to turn India into a global manufacturing hub. One of the factors widely thought to be responsible for Modi’s victory was support from India’s “neo-middle class”—a young, newly- urbanized section of the electorate seeking employment and improved living standards but struggling amidst an economic downturn. In a speech inaugurating Make in India, Modi linked the program with the aspirations of this section of society. Modi stated the need to elevate the status …

A Virtue-Centered Approach To The Biotechnology Commons (Or, The Virtuous Penguin), David W. Opderbeck

Maine Law Review

The instrumentalist emphasis of the current biotechnology intellectual property rights (IPR) debate is not surprising. In the American tradition, intellectual property law has long been justified primarily by instrumentalist concerns. Thomas Jefferson famously acceded to the “embarrassment of patent and copyright monopolies because he believed a limited monopoly would encourage the production of new scholarship and inventions. The framers' willingness to allow this embarrassment for the greater good is enshrined in the Intellectual Property Clause of the U.S. Constitution. Countless judicial opinions refer to intellectual property law as a tool that provides necessary incentives to creators and innovators. Intellectual property …

Adoption Of The Bayh-Dolye Act In Developed Countries: Added Presure For A Broad Research Exemption In The United States?, Michael S. Mireles

Maine Law Review

Numerous developed countries, most if not all members of the Organization of Economic Cooperation and Development (OECD), including Japan, France, the United Kingdom, Germany, Austria, Denmark, Norway, Portugal, Spain, and Finland, have or are considering adopting legislation similar to the Bayh-Dole Act. These countries apparently believe that passage of legislation similar to the Bayh-Dole Act will lead to the transfer of government funded research results from the university laboratory to the marketplace and other economic activity. In the United States, the birthplace of the Bayh-Dole Act (the Act), it is not entirely clear whether its passage is the direct result …

The Supreme Court’S Devaluation Of U.S. Patents, Christopher M. Holman

Faculty Works

In a span of three weeks during the spring of 2017, the U.S. Supreme Court issued three patent decisions, bringing the total number of patent decisions for the 2016-2017 term to six. This means that the October 2016 term ties the previous record of six patent decisions in the October 2014 term. This represents a tremendous increase in the number of patent decisions compared to earlier times, and particularly the early days of the Federal Circuit. For reference, during the first quarter of a century the Federal Circuit was in existence, the Supreme Court heard on average less than one …

In Defense Of Secondary Pharmaceutical Patents: Response To The Un's Guidelines For Pharmaceutical Patent Examination, Christopher M. Holman

Faculty Works

In 2015 the United Nations Development Programme issued a document entitled Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective (the “Guidelines”). The heart of the Guidelines is a category-by-category examination of eight types of “secondary” pharmaceutical patent claims: Markush claims; selection patents; polymorphs; enantiomers; salts; ethers and esters; compositions; doses; combinations; prodrugs; metabolites; and new medical uses. The Guidelines advise patent offices to apply heightened patentability requirements to these claims in a manner that would effectively deny patent protection to important pharmaceutical innovations currently afforded patent protection. In particular, the Guidelines postulate that many forms …

Towards Patent Standardization, Janet Freilich, Jay P. Kesan

Faculty Scholarship

Among the most important purposes of patents are to provide clear notice to third parties of the patent's boundaries and to disclose helpful information to researchers seeking to replicate or further develop the patented invention. Unfortunately, patents often fail at both of these tasks, in part because of lack of uniformity of language and format.' Use of idiosyncratic language in patent claims renders it difficult to find relevant patents and, once a patent is found, to interpret its claims. As there is no customary set of information that must always be included in a patent, researchers often find reading a …

University Ip: The University As Coordinator Of The Team Production Process, Samuel Estreicher, Kristina A. Yost

Indiana Law Journal

This Article focuses on intellectual property (IP) issues in the university setting. Often, universities require faculty who have been hired in whole or in part to invent to assign inventions created within the scope of their employment to the university. In addition, the most effective way to secure compliance with the Bayh-Dole Act, which deals with ownership of inventions involving federally funded research, is for the university to take title to such inventions. Failure to specify who has title can result in title passing to the government. Once the university asserts ownership, it then decides whether to process a patent …

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …

Make America Innovate Again: Construing Patent Box Proposals In View Of A Policy Mix Approach, Adam E. Szymanski

Cybaris®

No abstract provided.

Protecting Products Versus Platforms, Jacob S. Sherkow

Articles & Chapters

Patents have long been the most important legal assets of biotech companies. Increasingly, however, biotech firms find themselves on one side of a divide: as either traditional product companies or platform companies. Given the differences between these two types of business models, the merits of intellectual property (IP) protection vary between them. This article explores how those differences relate to biotech startups and entrepreneurs seeking to protect their inventions.

The Changing Life Science Patent Landscape, Arti K. Rai, Jacob S. Sherkow

Articles & Chapters

Over the past two decades, patent law in the life sciences has been buffeted by numerous controversies. With courts, legislatures and patent offices all responding, one could be forgiven for believing that the main constant has been change. In the following article, we look back at some of the major events in life science intellectual property (IP) law and business practice over the past 20 years and then suggest where IP practice in the life sciences may be heading in the coming years.

Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow

Articles & Chapters

Profs. Allison and Ouellette’s Article, How Courts Adjudicate Patent Definiteness and Disclosure, 65 Duke L.J.609 (2015), on courts’ adjudication of certain patent disputes presents some surprising data: pharmaceutical patents litigated to judgment fare substantially worse on written-description analyses if they are not part of traditional pioneer-generic litigation. This Response engages in several hypotheses for this disparity and examines the cases that make up Allison and Ouellette’s dataset. An analysis of these cases finds that the disparity can be best explained by technological and judicial idiosyncrasies in each case, rather than larger differences among pharmaceutical patent cases. This finding contextualizes …

The Uniformed Topograhy Of Patent Scope, Janet Freilich

Faculty Scholarship

Setting and ascertaining patent scope are among the most important questions in patent law. However, we cannot accurately set patent scope. This is because patent scope has a sequence-of- information problem. Patent scope is set at the time that a patent is granted, while the information necessary to set and measure patent scope is not obtained until many years later. In consequence, the scope of any given patent is very likely to contain significant "error," meaning that the scope is broader or narrower than the theoretical ideal (the minimum amount of scope necessary to incentivize innovation). Deviation from the theoretical …

Researching The Early History Of The Patent Policy: Getting Started, Robert Berry

Librarian Publications

There are a lot of reasons to research the early history of American patent policy. It is an inherently interesting history that provides a framework making contemporary patent policy more comprehensible and a foundation for interpreting historic patent records. For students it provides an opportunity to become familiar with some of basic primary sources that are a staple of research into American history. Also, of course, questions may arise from time to time that can only be authoritatively answered by researching this history.

The approach described below seeks to balance comprehensiveness with feasibility, and emphasizes the importance of creating a …

Stem Cell Patents After The America Invents Act, Jacob S. Sherkow, Christopher Scott

Articles & Chapters

Under the newly passed Leahy-Smith America Invents Act (AIA), the U.S. Patent and Trademark Office may hear new challenges to stem cell patents. Here, we explore how the new law affects challenges to stem cell patents, focusing on two recent cases, and discuss the future of stem cell patent disputes.

The History Of Patenting Genetic Material, Jacob S. Sherkow, Henry T. Greely

Articles & Chapters

The US Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, “products of nature” were not eligible to be patented unless they were “isolated and purified” from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply …