Law Commons^™

The Case Of The Missing Device Patents, Or: Why Device Patents Matter, Erika Lietzan, Kristina M. L. Acri, Evan Weidner

Faculty Publications

A company that earns premarket approval of its medical device is entitled to an extension of one patent claiming the device, to make up for some of the time it spent doing premarket research. Yet, surprisingly, a mere thirteen percent of those eligible for this extension (also known as patent term "restoration") ask for one. In contrast, most drug companies entitled to this same patent extension ask for one.

In this Article, we attribute the imbalance largely to differences between the two regulatory frameworks. In brief, because the FDA classifies and regulates devices based on what they do and how …

Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri

Faculty Publications

For years pharmaceutical policymaking discussions have been revolving around allegations of supposed “evergreening” by pharmaceutical companies, and policymakers have considered a range of significant policy reforms — including to antitrust law and drug regulatory law — to address this purported problem. This paper evaluates empirical data offered to substantiate “evergreening” and explains that these data — though mostly accurate — do not support proposed policy changes.

The “evergreening” claim is that by securing additional patents and FDA-related exclusivities after approval of their new drugs, brand drug companies enjoy a period of exclusivity in the market that is longer than the …

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 …

Diversity In Innovation Best Practices Guide, Laura Norris, Mary Fuller, Joy Peacock, Sydney Yazzolino

Faculty Publications

In 2020, the USPTO collaborated with the HTLI to propose a study designed to increase diversity in the patenting process, specifically targeted to in-house legal / IP department and their practices. The goal of the study was simple - harvesting the collective knowledge of nationwide IP professionals and producing an “insanely practical” guide to expand inventorship to a more diverse inventor population. By “diverse” we mean underrepresented or historically marginalized groups in the United States patent system. The term "diversity" can be interpreted differently in different countries. The HTLI research team collected this extensive list of over 90 best practice …

Comments To The National Strategy For Expanding American Innovation, Colleen Chien, Ernest Fok

Faculty Publications

The United States Patent and Trademark Office (USPTO) sought input for its National Strategy for Expanding American Innovation to build a more demographically, geographically, and economically inclusive innovation ecosystem. Students in Professor Colleen Chien’s Patent Law course submitted 13 comments on how to make innovation more representative of the United States. This document contains 13 comments that draw heavily from personal and professional experience, and highlights the diversity in Santa Clara Law’s patent course. Here are excerpts:

• Erik Perez and Grant Wanderscheid, drawing from their own undergraduate and graduate experiences in science and engineering, recommend a “shift towards achievement …

The Aia At Ten - How Much Do The Pre-Aia Prior Art Rules Still Matter?, Colleen Chien, Janelle Barbier, Obie Reynolds

Faculty Publications

As the America Invents Act (AIA) turns 10, patent students across the
country may ask: if the law is already a decade old, why am I spending so much
time studying pre-AIA law? Though patents filed before the transition date will
remain in force up through March 2033, a good 10+ years away, teachers may also
be wondering which regime to emphasize and for how long the pre-AIA rules will
be considered fundamental rather than footnote material.

Parsing The Impact Of Alice And The Peg, Colleen Chien, Nicholas Halkowski, Maria He, Rodney Swartz

Faculty Publications

Almost two years have passed since the USPTO issued its January 2019 Patent Eligibility Guidance (PEG), itself a response to the Supreme Court’s Alice decision, and what many perceived as its destabilizing impact on the certainty of patent prosecutions. Leveraging new data releases, we report on trends in prosecution following the USPTO’s PEG and the Guidance on 112, finding 1) a decline in subject matter rejections and stabilization of subject matter appeals, 2) no discernable increase in 112 rejections, 3) no evidence that small entities were being left behind in Alice-impacted art units by forum shopping by large entities, …

Distorted Drug Patents, Erika Lietzan

Faculty Publications

Drug patents are distorted. Unlike most other inventors, drug inventors must complete years of testing to the government’s specifications and seek government approval to commercialize their inventions. All the while, the patent term runs. When a drug inventor finally launches a medicine that embodies the invention, only a fraction of the patent life remains. And yet, conventional wisdom holds — and empirical studies show — that patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other inventive industry. Congress tried to do something about this in 1984, authorizing the Patent and Trademark Office to …

Third-Party Interests And The Property Law Misfit In Patent Law, Sarah Rajec

Faculty Publications

Courts and scholars have long parsed the characteristics of patent grants and likened them, alternately, to real or personal property law, monopolies, public franchises and other regulatory grants, or a hybrid of these. The characterizations matter, because they can determine how patents are treated for the purposes of administrative review, limitations, and remedies, inter alia. And these varied treatments in turn affect incentives to innovate. Patents are often likened to real property in an effort to maximize rights and allow inventors to internalize all of the benefits from their activities. And courts often turn first to real property analogies when …

Right On Time: A Reply To Professors Allen, Claeys, Epstein, Gordon, Holbrook, Mossoff, Rose, And Van Houweling, Dotan Oliar, James Y. Stern

Faculty Publications

A simple observation started us off in writing Right on Time. Studying and teaching intellectual property law, we noticed striking parallels between traditional first possession rules in property law and analagous rules governing the acquisition of patent, copyright, and trademark rights. We thought that established first possession principles could illuminate the workings of IP law. As we dug in, however, it became increasingly clear that our premise wasn’t quite right. While many penetrating commentators had said many penetrating things about first possession, the leading treatments tended to focus on significant individual aspects of the overall issue. What we could …

The Harmonization Myth In International Intellectual Property Law, Sarah R. Wasserman Rajec

Faculty Publications

There is a dominant narrative in international intellectual property ("IP") law of ever-increasing harmonization. This narrative has been deployed in ways descriptive, prescriptive, and instrumental: approximating the historical trend, providing justification, and establishing the path forward. Appeals to harmonization are attractive. They evoke a worldwide partnership and shared sacrifice to meet the goals of innovation and access to technology through certainty, efficiency, and increased competition through lowered trade barriers. Countries with strong IP protections consistently and successfully tout the importance of certainty and lower trade barriers when seeking new and stronger protections from countries with lower levels of protection. Yet …

How Can Congress Prevent The Issuance Of Poor Quality Patents? Questions For The Record For Colleen V. Chien, Colleen V. Chien

Faculty Publications

This is a submission of responses by Prof. Colleen Chien to questions for the record posed by Sen. Thom Tillis (R-N.C.) and Chris Coons (D-Del.) at a October 30th hearing of the Senate Judiciary Committee’s Subcommittee on Intellectual Property, entitled, "Promoting the Useful Arts: How can Congress prevent the issuance of poor quality patents?"

Right On Time: First Possession In Property And Intellectual Property, Dotan Oliar, James Y. Stern

Faculty Publications

How should we allocate property rights in unowned tangible and intangible resources? This Article develops a model of original acquisition that draws together common law doctrines of first possession with original acquisition doctrines in patent, copyright, and trademark law. The common denominator is time: in each context, doctrine involves a trade-off between assigning entitlements to resources earlier or later in the process of their development and use. Early awards risk granting exclusivity to parties who may not be capable of putting resources to their best use. Late awards prolong contests for ownership, which may generate waste or discourage acquisition efforts …

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 …

Paper Promises For Drug Innovation, Erika Lietzan

Faculty Publications

Innovation does not stop when a new medicine is launched. Development of new uses for already approved drugs, in particular, can make profound contributions to the public health. Whether a new use is suspected during the initial premarket trials, identified through focused research after approval, or discovered serendipitously by physicians treating patients, however, it requires extensive clinical testing before it can be approved by FDA. This testing takes time and money — three to five years on average, and as much as $300 million. This Article considers the incentives that federal law offers to companies to make this investment: patent …

A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan

Faculty Publications

This short paper comments on Professor Carrier's new article, Biologics: The New Antitrust Frontier. His article makes a profound initial contribution to a new area of scholarship, based on a large body of prior work considering antitrust issues relating to small molecule drugs. But Professor Carrier’s article, like my own forthcoming piece on innovation and competition in the biologics marketplace, is inherently speculative. We are making our best judgments about the nature of a still emerging marketplace and likely conduct in that marketplace, based on our understandings of a new regulatory framework that is itself still emerging, the broader legal …

The History And Political Economy Of The Hatch-Waxman Amendments, Erika Lietzan

Faculty Publications

Reform of the Hatch–Waxman generic drug framework is in the air. Scholars, consumer advocacy groups, regulated industry, and policymakers are engaged in heated debate about perceived shortcomings in the scheme, flaws, and unexpected loopholes. Changes in how the U.S. Food and Drug Administration (FDA) implements the law, as well as changes to the law itself, are under serious consideration. These policymaking discussions take place against a backdrop of shared assumptions about the origins and nature of the original Hatch–Waxman legislation — assumptions that this Article claims are wrong. Convention wisdom holds that the Hatch–Waxman legislation was a delicate compromise privately …

Design Patent Infringement Needs A Free Expression Defense (La Infracción De Patentes De Diseño Necesita Una Defensa De Libre Expresión), Richard J. Peltz-Steele, Ralph D. Clifford

Faculty Publications

English Abstract: As elsewhere in the world, design patents are propagating copiously in U.S. intellectual property law. Notwithstanding their fertility, design patents face potentially prohibitive and as yet unexplored legal challenges. One possibility is that the U.S. Congress might lack the very power to authorize design patents. Another possibility – our subject here, with implications for design patents in Europe and around the world – is that design patents violate fundamental rights if there is not a defense to infringement founded in the freedom of expression.

Spanish Abstract: Las patentes de diseño se propagan en abundancia en el derecho de …

The Market For Software Innovation Through The Lens Of Patent Licenses And Sales, Colleen V. Chien

Faculty Publications

Software innovation is transforming the US economy. Yet our understanding of how patents and patent transactions support this innovation is limited, in part because of a lack of public information about patent licenses and sales. Claims about the patent marketplace, for example, extolling the virtues of intermediaries like non-practicing entities, or questioning the social utility of ex post patent licenses, tend not to be grounded in empirical evidence. This article brings much-needed data to the policy debate by analyzing transactional data from several proprietary databases of patent licenses and transfers, and reporting several novel findings. First I find that, despite …

The Uncharted Waters Of Competition And Innovation In Biological Medicines, Erika Lietzan

Faculty Publications

In 2010, Congress fundamentally changed how federal law encourages the discovery and development of certain new medicines and for the first time authorized less expensive “duplicates” of these medicines to be approved and compete in the marketplace. The medicines at issue are biological medicines, generally made from, or grown in, living systems. Many of the world’s most important and most expensive medicines for serious and life–threatening diseases are biological medicines.

We have a profound interest in understanding and evaluating the impact of this legislation on innovation and competition. Scholars and courts considering this question may be tempted to reason from, …

Comparative Patent Quality, Colleen Chien

Faculty Publications

One of the most urgent problems with the US patent system is that there are too many patents of poor quality. Most blame the US Patent and Trademark Office (USPTO) – its mistakes, overly generous grant rate, and lack of consistency. But, the quality and quantity of patents in force is the product of three sets of decisions: to submit an application of certain quality (by the applicant), to grant the patent (by the patent office), and to renew a patent and keep it in force (by the applicant/patentee). Startling, there is no consensus way to measure patent quality. This …

Recalibrarting Patent Venue, Colleen V. Chien, Michael Risch

Faculty Publications

For most of patent law’s 200-year plus history, the rule has been that patentholders are permitted to sue defendants only in the district they inhabit. In 1990, the Federal Circuit changed this by enlarging the scope of permissible venue to all districts with personal jurisdiction over the defendant. Since then, patentees have flocked to fewer districts, and in 2015, brought more than 40% of their cases in a single rural district with 1% of the US population, the Eastern District of Texas. Fueled in particular by concerns that non-practicing entities (NPEs), who bring the majority of cases in the Eastern …

The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post

Faculty Publications

In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section …

The Myths Of Data Exclusivity, Erika Lietzan

Faculty Publications

This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: …

Exclusionary And Diffusionary Levers In Patent Law, Colleen Chien

Faculty Publications

The patent system is built on the premise that exclusion leads to innovation. But a mounting body of evidence calls into question the assumption that “innovation by exclusion” – innovation based on excluding rivals– is the only, or even primary, way innovation happens today: nearly 50% of manufacturers got the idea for their most important new product from an outside source that shared it with them, 45-60% of patentees acquire patents to access the technology of others, and over 1,300 companies, including five of the ten top holders of patents, have pledged to share their patents with others. But because …

The History And Future Of E-Commerce Patents, Dennis D. Crouch, Mitchell L. Terry

Faculty Publications

The past two decades have seen a great rise in the patenting of e-commerce inventions. Now, those same patents are taking an equally great fall. In a series of four recent cases, the U.S. Supreme Court has shifted the doctrine of patent eligibility and, in the process, raised the bar for e-commerce and software patents - making it more difficult to obtain and enforce those types of patents.

The Standard For Awarding Attorney Fees Under 35 U.S.C. Section 285 To Prevailing Parties In Patent Litigation - Octane Fitness, Llc V. Icon Health & Fitness, Inc. And Highmark, Inc. V. Allcare Health Management Systems, Dennis D. Crouch, Jafon Fearson

Faculty Publications

The Supreme Court granted certiorari in two patent infringement cases that both concern shifting of attorney fees under the “exceptional case” standard of 35 U.S.C. § 285. The Federal Circuit has traditionally been resistant to fee shifting awards—especially in cases where an accused infringer is the prevailing party. In Octane Fitness, petitioner asks the Court to lower the standard for proving an exceptional case. In Highmark, petitioner asks for deference to lower court exceptional case findings.

Evaluating Flexibility In International Patent Law, Sarah R. Wasserman Rajec

Faculty Publications

Global patent law has raced toward harmonization over the past decades. Countries with vastly different industries, values, and levels of development now offer robust patent rights with similar contours through membership in the World Trade Organization and consequent adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”). However, patent law is still far from harmonized among countries or static within countries. Jurisdictions tailor their patent laws to accommodate differences between industries, unforeseen inefficiencies, and diverse views of the costs and benefits associated with offering patent rights to stimulate innovation. Prior scholarly work consists of either doctrinal analyses …

Why Technology Customers Are Being Sued En Masse For Patent Infringement & What Can Be Done, Colleen Chien, Edward Reines

Faculty Publications

Last year, the Children’s Hospital of Philadelphia and the AIDS Healthcare Foundation were accused of patent infringement. Their alleged wrongdoing? Purchasing routers and using them to provide wireless services. A small Atlanta-based company called Bluewave, along with hundreds to thousands of small businesses, received demands for royalties for alleged patent infringement. The accusation? Using an off-the-shelf PDF machine. As incredible as they might seem, these mass patent assertions and the harm they cause are real – six out of the top ten patent litigation campaigns have exclusively named technology customers, not suppliers. This has drawn attention from state attorneys generals, …

'Holding Up' And 'Holding Out', Colleen Chien

Faculty Publications

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’s most vulnerable – after it has implemented a technology – and is able wrest a settlement because it’s too late for the company to change course. Patent “hold-out” is a term I use to describe 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 – the smartphone wars, standards patents, or trolls all involve …