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.

Technology Changes Drive Legal Changes For Antibody Patents: What Patent Examiners Can Teach Courts About The Written Description And Enablement Requirements., S. Sean Tu, Christopher M. Holman

Faculty Works

Antibody patents form the basis of some of the most valuable biotechnology products on the market. In 2020 alone, the sales of the top three drugs exceed 10 billion dollars. Two of those three drugs are monoclonal antibodies (Humira and Keytruda). In the past, patent law offered broad protection for monoclonal antibodies. As time has progressed, however, courts have narrowed the scope of antibody patents. However, very little research has been done to see how patent examiners are applying the rules of patentability to these valuable antibody patents.

We examine approximately two decades worth of antibody patents to determine how …

Patent Fake News, Jack M. Beermann

Faculty Scholarship

Complaints about the patent system are legion. Critics complain that it is too easy to get a patent, that it is too easy to challenge an existing patent, that many patent denials are rationally inexplicable, that aggressive enforcement of patents stifles innovation, that patent trolls abuse the system to extort money from innocent users of widespread technology, and that inventors leverage modest modifications of existing patents to extend the patent period beyond intended legislative limits. While Janet Freilich’s forthcoming article, Ignoring Information Quality, may not reveal the root of all patent evil, it illuminates an important problem in the …

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 …

Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, And The Economy, Jorge L. Contreras

Utah Law Faculty Scholarship

Because there is no practical way for patent examiners to verify that the inventions claimed in patent applications actually work, a surprising number of patents are issued for inventions that have turned out to be imaginary, fraudulent or otherwise non-existent. What's more, as illustrated by the recent attempt by Labrador Diagnostics to assert a patent acquired from now-defunct Theranos against firms developing testing kits for COVID-19, these patents present a genuine threat to businesses operating in important sectors of the economy. While it is unrealistic to expect patent examiners to verify the functionality of every claimed invention, there are a …

Patenting Fast And Slow: Examiner And Applicant Use Of Prior Art, Shine Tu

Law Faculty Scholarship

Previous studies have shown that an applicant's ability to obtain a patent is inexorably linked to the random assignment of a patent examiner. However, not all patent examiners are created equal. Some patent examiners allow patent applications quickly within just one or two Office Actions, resulting in only a few months of substantive patent prosecution. In contrast, other patent examiners constantly reject patents applications, which can result in unnecessarily delaying prosecution and years of substantive patent prosecution. This study focuses on how different examiners use prior art rejections to prolong or compact prosecution. Prior art rejections are one of the …

Brief For The R Street Institute As Amicus Curiae In Support Of Respondents, Charles Duan

Amicus Briefs

The government and its agencies should be treated as a “person” that may petition to institute post-issuance review proceedings under the America Invents Act, for two reasons. First, permitting the government to seek review of patents under these proceedings best realizes the intent of Congress to make those proceedings widely available. Second, compared to the government’s alternative option for administratively challenging patents, AIA post-issuance review better serves important norms of procedure and governance, including transparency, due process, and separation of functions.

Recent Pto Guidance Charts A New Course Through The Patent Eligibility Quagmire, Christopher M. Holman

Faculty Works

In a span of four years, 2010-2014, the U.S. Supreme Court issued four decisions that have dramatically altered patent eligibility jurisprudence: Bilski, Mayo, Myriad, and Alice. Ever since Bilski was decided, the PTO has struggled to apply the new patent eligibility jurisprudence in a consistent and predictable manner. The two part framework for assessing patent eligibility, as set for in Alice and Mayo, is stated at a high level of abstraction, and the Supreme Court has given little concrete guidance as to how it is to be applied beyond the specific claims at issue in its precedent. At times, the …

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 …

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 …

Amending Patent Claims, Gregory Reilly

All Faculty Scholarship

Patent claims traditionally have been freely amendable to overcome a finding of unpatentability. For that reason, the Patent Office’s restrictive approach to amendments in new post-issuance review proceedings created by the America Invents Act provoked strident criticism; generated administrative, statutory, and constitutional challenges; and fractured the Federal Circuit. This Article supplies the comprehensive evaluation of the costs and benefits of patent claimamendments, both in examination and post-issuance, surprisingly missing in the literature.The results are mixed. Amendments in initial examination are less clearly warranted than commonly thought, with the costs – primarily problematic drafting incentives – often overlooked and the benefits …

Patenting Around Failure, Sean B. Seymore

Vanderbilt Law School Faculty Publications

Many patents cover inventions that do not work as described. Fingers often point to the U.S. Patent and Trademark Office (Patent Office), which is criticized for doing a poor job of examining patents. But the story is more complicated for at least three reasons. First, from an information standpoint, the Patent Office is at a clear disadvantage because the inventor has little incentive to disclose failure because it might compromise patentability. Second, an inventor is not required to actually make everything that is claimed (or verify that everything that is claimed actually works) before filing a patent application. Third, inventors …

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 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 …

Ip Basics: Avoiding Patent, Trademark And Copyright Problems, Thomas G. Field Jr.

Law Faculty Scholarship

Patents, copyrights and trademarks, as well as trade secrets and related rights, can be used to exclude free riders. These rights are collectively called "intellectual property" or IP.

Ip Basics: Trademarks And Business Goodwill, Thomas G. Field Jr.

Law Faculty Scholarship

This is information all business owners need if they wish to preserve their hard-won goodwill. It discusses, for example, the important differences between strong and weak marks for products and services, the value of state and federal registrations and the importance of searches (to avoid wasting money).

Administering Patent Litigation, Jacob S. Sherkow

Articles & Chapters

Recent patent litigation reform efforts have focused on every branch of government — Congress, the President, and the federal courts — save the fourth: administrative agencies. Agencies, however, possess a variety of functions in patent litigation: they serve as “gatekeepers” to litigation in federal court; they provide scientific and technical expertise to patent disputes; they review patent litigation to fulfill their own mandates; and they serve, in several instances, as entirely alternative fora to federal litigation. Understanding administrative agencies’ functions in managing or directing, i.e., “administrating,” patent litigation sheds both descriptive and normative insight on several aspects of patent reform. …

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.

Administrating Patent Litigation, Jacob S. Sherkow

Articles & Chapters

Recent patent litigation reform efforts have focused on every branch of govemment-Congress, the President, and the federal courts-save the fourth: administrative agencies. Agencies, however, possess a variety of functions in patent litigation: they serve as "gatekeepers" to litigation in federal court; they provide scientific and technical expertise to patent disputes; they review patent litigation to fulfill their own mandates; and they serve, in several instances, as entirely alternative fora to federal litigation.

Understanding administrative agencies' functions in managing or directing, i.e., "administrating," patent litigation sheds both descriptive and normative insight on several aspects of patent reform. These include several problems …

Still Aiming At The Wrong Target: A Case For Business Method And Software Patents From A Business Perspective, Kristen Jakobsen Osenga

Law Faculty Publications

In Part I, I briefly discuss the rise and recent fall of business method patents. Part II covers the scholarly literature discussing business method and software patents. In Part III, I explain the proxy argument that I have made elsewhere and show how it plays in the recent decisions surrounding the patent eligibility of business method and software inventions. I then explain why the analysis of business method and software patents in the literature uses the same proxy-type arguments to avoid more difficult questions of patentability and policy. Finally, I conclude by explaining how business method and software patents, if …

Saving The Federal Circuit, Paul Gugliuzza

Faculty Scholarship

In a recent, attention-grabbing speech, the Chief Judge of the Seventh Circuit, Diane Wood, argued that Congress should abolish the Federal Circuit’s exclusive jurisdiction over patent cases. Exclusive jurisdiction, she said, provides too much legal uniformity, which harms the patent system. In this response to Judge Wood’s thoughtful speech, I seek to highlight two important premises underlying her argument, neither of which is indisputably true.

The first premise is that the Federal Circuit actually provides legal uniformity. Judge Wood suggests that, due to the Federal Circuit’s exclusive jurisdiction, patent doctrine is insufficiently “percolated,” meaning that it lacks mechanisms through which …

Dilution At The Patent And Trademark Office, Jeremy N. Sheff

Faculty Publications

This Article undertakes the first systematic investigation of trademark dilution in registration practice before the US Patent and Trademark Office (PTO). The Article consists of three distinct descriptive empirical analyses. In the first, I present a new hand-coded dataset of all 453 Trademark Trial and Appeal Board (TTAB) dispositions of dilution claims through June 30, 2014, and report that dilution has been necessary to the PTO’s refusal of exactly three registrations in over a decade. In the second part, I apply algorithmic coding of the recently released PTO Casefiles Dataset to demonstrate that concurrent registration of identical marks to different …

Patent Reform And Best Mode: A Signal To The Patent Office Or A Step Toward Elimination?, Ryan G. Vacca

Law Faculty Scholarship

On September 16, 2011, President Obama signed the America Invents Act (AIA), the first major overhaul of the patent system in nearly sixty years. This article analyzes the recent change to patent law's best mode requirement under the AIA. Before the AIA, patent applicants were required, at the time of submitting their application, to disclose the best mode of carrying out the invention as contemplated by the inventor. A failure to disclose the best mode was a basis for a finding of invalidity of the relevant claims or could render the entire patent unenforceable under the doctrine of inequitable conduct. …

Open Letter To Director David Kappos Of The United States Patent And Trademark Office, Kenneth L. Port

Faculty Scholarship

I appreciate the opportunity to respond to the Request for Comments on the extent to which small businesses may be harmed by litigation tactics by corporations‟ attempts to enforce trademark rights beyond a reasonable interpretation of the scope of the rights granted to the trademark owner; the best use of Government services to protect trademarks and prevent counterfeiting; and appropriate policy recommendations.

The PTO should be commended for considering whether the use of trademark litigation as a form of “bullying” is a problem for the U.S. trademark system. While some consider trademark litigation as a justifiable effort to police marks …

Patent Amicus Briefs: What The Courts’ Friends Can Teach Us About The Patent System, Colleen Chien

Faculty Publications

Over the last two decades, more than a thousand amici, representing hundreds of organizations, companies, and individuals, have signed onto amicus briefs in over a hundred patent cases, many of them landmark decisions. This paper turns the spotlight on these “behind-the-scenes” actors in the patent system, combining theoretical insights with an empirical study of amicus briefs filed in patent cases over the last 20 years in an examination of patent interest groups, the positions they have advocated, and the effectiveness of their advocacy. Amicus filers appear to have been instrumental in shaping the courts’ agenda; the Supreme Court was seven …

The Ptos Fast Track Takes Us In The Wrong Direction, Kristen Jakobsen Osenga

Law Faculty Publications

On June 3, 2010, the Patent Office issued a press release touting an initiative to reduce patent pendency by allowing patent applicants to pick the speed at which their applications are examined. Patent pendency has been an increasing problem in the Patent Office, jumping to 34.6 months last year from 26.7 months in 2003. The proposal has two main prongs: first, provide three paths to patent examination, and second, rely more heavily on foreign patent office efforts. While the press release provides some preliminary details about the proposal, further information is expected to be published in the Federal Register on …

The Unreasonableness Of The Patent Office's 'Broadest Reasonable Interpretation' Standard, Christopher A. Cotropia

Law Faculty Publications

This article does what is long overdue: it fully explores the validity of the BRI standard. The previously articulated rationales behind the BRI standard are severely lacking. Not only does the BRI standard fail to provide the advantages touted by the courts that created the standard, the standard is contrary to both the patent statutes and the concept of a unitary patent system. It allows examiners to avoid difficult claim interpretation issues; it leads to improper and uncorrectable denials of patent protection; and it is incurably ambiguous. Given that the BRI standard is severely lacking, the courts and the USPTO …

Heightened Enablement In The Unpredictable Arts, Sean B. Seymore

Vanderbilt Law School Faculty Publications

A bedrock principle of patent law is that an applicant must sufficiently disclose the invention in exchange for the right to exclude. The essential facet of the disclosure requirement is enablement, which compels a patent applicant to enable a person having ordinary skill in the art (PHOSITA) how to make and use the full scope of the claimed invention without undue experimentation. Enablement problems may arise when the applicant claims an invention broadly with a dearth of supporting data or examples. This is problematic in unpredictable fields like chemistry because a PHOSITA often needs a specific and detailed teaching in …

To Live In In-‘Fame’-Y: Reconceiving Scandalous Marks As Analogous To Famous Marks, Jasmine C. Abdel-Khalik

Faculty Works

In 1905, Congress enacted a revised trademark registration act, which included a prohibition on registering marks containing or consisting of scandalous or immoral material. Because Congress failed to provide any further guidance either in legislative history or in the statutory language, administrative bodies and the courts have struggled to define this standard. Over the past century, decisions applying this prohibition have been inconsistent. The general public and potential trademark owners are unable to predict accurately if a mark will be accepted or refused for federal registration, which has some significant benefits. Perhaps because of this uncertainty, some estimate that hundreds …