Law Commons^™

Post-Grant Adjudication Of Drug Patents: Agency And/Or Court?, Arti K. Rai, Saurabh Vishnubhakat, Jorge Lemus, Erik Hovenkamp

Faculty Scholarship

The America Invents Act of 2011 (AIA) created a robust administrative system—the Patent Trial and Appeal Board (PTAB)—that provides a route for challenging the validity of granted patents outside of district courts. Congress determined that administrative adjudication of the validity of initial patent grants could be cheaper and more scientifically accurate than district court adjudication of such validity.

For private economic value per patent, few areas of technology can match the biopharmaceutical industry. This is particularly true for small-molecule drugs. A billion-dollar drug monopoly may be protected from competition by a relatively small number of patents. Accordingly, the social cost …

Thank You For Not Publishing (Unexamined Patent Applications), Lidiya Mishchenko

Faculty Scholarship

Since 2000, the U.S. Patent & Trademark Office (“PTO”) has published nearly all patent applications as they are submitted by applicants. Scholars and practitioners have praised this practice for providing timely notice of the potential legal rights the application may eventually cover. But maximizing timeliness and transparency in this way can also create significant costs, which may chill innovation and deter the development and funding of new research areas. This Article explores these often-unrecognized costs of publishing unexamined patent applications and proposes solutions that balance the benefits of early notice with the costs of patent system uncertainty.

Published patent applications …

Justice Breyer And Patent Eligibility, David O. Taylor

Faculty Journal Articles and Book Chapters

Justice Breyer leaves the Supreme Court having left a significant mark on patent eligibility law. In Mayo Collaborative Services v. Prometheus Laboratories, he eliminated the ability to obtain patents on many useful applications of new (and even breakthrough) discoveries. The author discusses how Justice Breyer’s test for patent eligibility both contradicts the historical approach and has had pernicious impact on the patent system and investment in development of technology, including, and in particular, medical technologies.

Drugs, Patents, And Well-Being, Christopher Buccafusco, Jonathan S. Masur

Faculty Scholarship

The ultimate end of patent law should be to spur innovations that improve human welfare-innovations that make people better off. But firms will only invest resources in developing patentable inventions that will allow them to make money-that is, inventions that people will want to use and buy. This can gravely distort the types of incentives that firms face and the types of inventions they pursue. Nowhere is this truer than in the pharmaceutical field There is by now substantial evidence that treatments for diseases that primarily afflict poorer people-including the citizens of developing nations-are dramatically underproduced, compared with drugs that …

Patent Trial And Appeal Board's Consistency-Enhancing Function, Michael D. Frakes, Melissa F. Wasserman

Faculty Scholarship

Agency heads, who have the primary responsibility for setting an agency's policy preferences, have a variety of tools by which they attempt to minimize the discretion of their staff officials in an effort to ensure agency policy preferences are consistently applied. One such mechanism is subjecting agency official's determinations to higher-level agency review. While scholars have long surmised that judges seek to minimize reversal of their decisions by a higher-level court, how agency officials' decisions are influenced by higher-level agency reconsideration has mostly eluded analysis.

In this Essay, we begin to fill this gap by examining the extent to which …

Irrational Ignorance At The Patent Office, Michael D. Frakes, Melissa F. Wasserman

Faculty Scholarship

There is widespread belief that the Patent Office issues too many bad patents that impose significant harms on society. At first glance, the solution to the patent quality crisis seems straightforward: give patent examiners more time to review applications so they grant patents only to those inventions that deserve them. Yet the answer to the harms of invalid patents may not be that easy. It is possible that the Patent Office is, as Mark Lemley famously wrote, “rationally ignorant.” In Rational Ignorance at the Patent Office, Lemley argued that because so few patents are economically significant, it makes sense to …

The Design Patent Bar: An Occupational Licensing Failure, Christopher Buccafusco, Jeanne C. Curtis

Faculty Scholarship

Although any attorney can represent clients with complex property, tax, or administrative issues, only a certain class of attorneys can assist with obtaining and challenging patents before the United States Patent & Trademark Office (PTO). Only those who are members of the PTO 's patent bar can prosecute patents, and eligibility for the patent bar is only available to people with substantial scientific or engineering credentials. However much sense the eligibility rules make for utility patents-those based on novel scientific or technical inventions-they are completely irrational when applied to design patents-those based on ornamental or aesthetic industrial design. Nevertheless, the …

Fixing The Design Patent Bar: New Opportunities For Federal Lawyers, Christopher Buccafusco, Jeanne C. Curtis

Faculty Scholarship

No abstract provided.

Will Delaware Be Different? An Empirical Study Of Tc Heartland And The Shift To Defendant Choice Of Venue, Ofer Eldar, Neel U. Sukhatme

Faculty Scholarship

Why do some venues evolve into litigation havens while others do not? Venues might compete for litigation for various reasons, such as enhancing their judges’ prestige and increasing revenues for the local bar. This competition is framed by the party that chooses the venue. Whether plaintiffs or defendants primarily choose venue is crucial because, we argue, the two scenarios are not symmetrical.

The Supreme Court’s recent decision in TC Heartland v. Kraft Foods illustrates this dynamic. There, the Court effectively shifted venue choice in many patent infringement cases from plaintiffs to corporate defendants. We use TC Heartland to empirically measure …

Risk Regulation And Innovation: The Case Of Rights-Encumbered Biomedical Data Silos, Arti K. Rai

Faculty Scholarship

Recent Supreme Court cases on patent-eligible subject matter are likely to exacerbate the longstanding problem of biomedical data fragmentation. For each data silo, multiple overlapping legal claims and claimants must be addressed to achieve the benefits of pooling.

Commentators who have discussed the data aggregation challenge have generally focused on possibilities created through public funding, through collective action by research participants, or through pressure by payers. This Article emphasizes the important role of risk regulators, most notably the precedent offered by risk regulation in the area of clinical trial data.

While U.S. risk regulators have taken some positive steps, the …

Functionality Screens, Christopher Buccafusco, Mark A. Lemley

Faculty Scholarship

Among intellectual property (IP) doctrines, only utility patents should protect function. Utility patents offer strong rights that place constraints on competition, but they only arise when inventors can demonstrate substantial novelty after a costly examination. Copyrights, trademarks, and design patents are much easier to obtain than utility patents, and they often last much longer. Accordingly, to prevent claimants from obtaining “backdoor patents,” the other IP doctrines must screen out functionality. As yet, however, courts and scholars have paid little systematic attention to the ways in which these functionality screens operate across and within IP law.

We have four tasks in …

Patent Institutions: Shifting Interactions Between Legal Actors, Arti K. Rai

Faculty Scholarship

This contribution to the Research Handbook on Economics of Intellectual Property Rights (Vol. 1 Theory) addresses interactions between the principal legal institutions of the U.S. patent system. It considers legal, strategic, and normative perspectives on these interactions as they have evolved over the last 35 years. Early centralization of power by the U.S. Court of Appeals for the Federal Circuit, newly created in 1982, established a regime dominated by the appellate court's bright-line rules. More recently, aggressive Supreme Court and Congressional intervention have respectively reinvigorated patent law standards and led to significant devolution of power to inferior tribunals, including newly …

Brief Of Amici Curiae 56 Professors Of Law And Economics In Support Of Petition Of Writ Of Certiorari, John R. Allison, Margo Bagley, James Bessen, Jeremy Bock, Daniel H. Brean, Michael A. Carrier, Michael W. Carroll, Bernard Chao, Tun-Jen Chiang, Colleen V. Chien, Andrew Chin, Robert Cook-Deegan, Md, Rochelle Dreyfuss, Dr. Dieter Ernst, Samuel F. Ernst, Robin C. Feldman, Lee Fleming, Brian Frye, William Gallagher, Shubha Ghosh, Eric Goldman, Bronwyn H. Hall, Yaniv Heled, Christian Helmers, Joachim Henkel, Susan Helper, Tim Holbrook, Herbert Hovenkamp, William Hubbard, Dr. Xavier Jaravel, Dennis S. Karjala, Peter Lee, Mark A. Lemley, David K. Levine, David S. Levine, Doug Lichtman, Yvette Joy Liebesman, Orly Lobel, Brian Love, Phil Malone, Michael J. Meurer, Dr. Shawn Miller, Matthew Mitchell, Susan Barbieri Montgomery, Sean Pager, Arti K. Rai, Jacob H. Rooksby, Jorge R. Roig, Matthew Sag, Pamela Samuelson, Ana Santos Rutschman, Lea Bishop Shaver, Toshiko Takenaka, John L. Turner, Jennifer Urban, Eric Von Hippel

Faculty Scholarship

28 U.S.C. § 1400(b) provides that a defendant in a patent case may be sued where the defendant is incorporated or has a regular and established place of business and has infringed the patent. This Court made clear in Fourco Glass Co. v. Transmirra Prods. Corp., 353 U.S. 222, 223 (1957), that those were the only permissible venues for a patent case. But the Federal Circuit has rejected Fourco and the plain meaning of § 1400(b), instead permitting a patent plaintiff to file suit against a defendant anywhere there is personal jurisdiction over that defendant. The result has been rampant …

Empirical Scholarship On The Prosecution Process At The Pto, Michael D. Frakes, Melissa F. Wasserman

Faculty Scholarship

In this book chapter, we summarize empirical scholarship examining the patent prosecution process at the United States Patent and Trademark Office.

Strategic Decision Making In Dual Ptab And District Court Proceedings, Saurabh Vishnubhakat, Arti K. Rai, Jay P. Kesan

Faculty Scholarship

The post-grant review proceedings set up at the U.S. Patent and Trademark Office’s Patent and Trial Appeal Board by the America Invents Act of 2011 have transformed the relationship between Article III patent litigation and the administrative state. Not surprisingly, such dramatic change has itself yielded additional litigation possibilities: Cuozzo Speed Technologies v. Lee, a case addressing divergence between the manner in which the PTAB and Article III courts construe patent claims, will soon be argued at the U.S. Supreme Court.

Of the three major new PTAB proceedings, two have proven to be popular as well as controversial: inter partes …

Comment To The Sec In Support Of The Enhanced Disclosure Of Patent And Technology License Information, Colleen V. Chien, Jorge Contreras, Carol Corrado, Stuart Graham, Deepak Hedge, Arti K. Rai, Saurabh Vishnubhakat

Faculty Scholarship

Intangible assets like IP constitute a large share of the value of firms, and the US economy generally. Accurate information on the intellectual property (IP) holdings and transactions of publicly-traded firms facilitates price discovery in the market and reduces transaction costs. While public understanding of the innovation economy has been expanded by a large stream of empirical research using patent data, and more recently trademark information this research is only as good as the accuracy and completeness of the data it builds upon. In contrast with information about patents and trademarks, good information about IP licensing is much less publicly …

Does The U.S. Patent And Trademark Office Grant Too Many Bad Patents?: Evidence From A Quasi-Experiment, Michael D. Frakes, Melissa F. Wasserman

Faculty Scholarship

Many believe the root cause of the patent system’s dysfunction is that the U.S. Patent and Trademark Office (PTO or Agency) is issuing too many invalid patents that unnecessarily drain consumer welfare. Concerns regarding the Agency’s overgranting tendencies have recently spurred the Supreme Court to take a renewed interest in substantive patent law and have driven Congress to enact the first major patent reform act in over sixty years. Policymakers, however, have been modifying the system in an effort to increase patent quality in the dark. As there exists little to no compelling empirical evidence the PTO is actually overgranting …

Brief Of Professors Peter S. Menell, J. Jonas Anderson, And Arti K. Rai As Amici Curiae In Support Of Neither Party, J. Jonas Anderson, Peter S. Menell, Arti K. Rai

Faculty Scholarship

No abstract provided.

The Failed Promise Of User Fees: Empirical Evidence From The United States Patent And Trademark Office, Michael D. Frakes, Melissa F. Wasserman

Faculty Scholarship

In an attempt to shed light on the impact of user-fee financing structures on the behavior of administrative agencies, we explore the relationship between the funding structure of the Patent and Trademark Office (PTO) and its examination practices. We suggest that the PTO’s reliance on prior grantees to subsidize current applicants exposes the Agency to a risk that its obligatory costs will surpass incoming fee collections. When such risks materialize, we hypothesize, and thereafter document, that the PTO will restore financial balance by extending preferential examination treatment—i.e., higher granting propensities and/or shorter wait times—to some technologies over others.

Competing With The “Patent Court”: A Newly Robust Ecosystem, Arti K. Rai

Faculty Scholarship

In a provocative address, Chief Judge Wood of the Seventh Circuit Court of Appeals suggests exposing the Court of Appeals for the Federal Circuit, created in 1982 to hear all appeals from patent cases, to competition from sister appellate courts. This response, published as part of a Symposium on Chief Judge Wood's address, argues that competition is indeed desirable. Whether such competition is best provided by other appellate courts is unclear, however. The more tractable approach is to improve competitive input from sources that have already emerged. These include dissenting Federal Circuit judges, parties and amici who are not "patent …

Compliance Of Canada’S Utility Doctrine With International Minimum Standards Of Patent Protection, Jerome H. Reichman

Faculty Scholarship

This article analyzes the Canadian court case of Eli Lilly v. Novopharm and the "utility" doctrine in Canada, and international standards of patent protection including TRIPS and NAFTA. The ‘‘promise of the patent’’ doctrine in Canada seeks to ensure that firms do not obtain a legal monopoly on the basis of speculative claims about increased utility — especially claims about therapeutic efficacy — that were unsubstantiated at the time of filing. Under this test, some of Eli Lilly’s patented pharmaceutical products have been invalidated retroactively.

Experimental Tests Of Intellectual Property Laws' Creativity Thresholds, Christopher Buccafusco, Zachary C. Burns, Jeanne C. Fromer, Christopher Jon Sprigman

Faculty Scholarship

No abstract provided.

Innovation, Inequality, And The Commercialization Of Academic Research, Walter Valdivia

Brookings Scholar Lecture Series

Patent policy is rarely debated in relation to its distributive consequences. In particular, the Bayh-Dole Act has been discussed in terms of its effects on the pace of innovation or the organization of science. However, this lecture re-assesses this policy from the perspective of a fair distribution of resources, both those committed to and those created by research-based innovation. Specifically, examining the management of university’s intellectual property, Valdivia will identify the institutional arrangements that reinforce a very asymmetric distribution of political and economic resources among universities and then characterize subtle but important links between these inequalities and the social distribution …

Does Agency Funding Affect Decisionmaking?: An Empirical Assessment Of The Pto’S Granting Patterns, Michael D. Frakes, Melissa F. Wasserman

Faculty Scholarship

No abstract provided.

Making Sense Of Intellectual Property Law, Christopher Buccafusco

Faculty Scholarship

Intellectual property (IP) scholars have long struggled to explain the boundaries of and differences between copyright and patent law. This Article proposes a novel explanation: copyright and patent can be fruitfully understood as establishing a dichotomy between the different human senses. Copyright has bracketed works addressed to the senses of sight and hearing, and it treats products appealing to touch, taste, and smell as functional and, thus, uncopyrightable. To the extent the latter receive IP protection, it is through the utility patent regime. The Article begins by establishing this descriptive proposition, and it shows how some of the most contested …

How Trade Secrecy Law Generates A Natural Semicommons Of Innovative Know-How, Jerome H. Reichman

Faculty Scholarship

No abstract provided.

Pharmaceutical Patent Litigation Settlements: Implications For Competition And Innovation, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Although brand-name pharmaceutical companies routinely procure patents on their innovative medications, such rights are not self-enforcing. Brand-name firms that wish to enforce their patents against generic competitors must commence litigation in the federal courts. Such litigation ordinarily terminates in either a judgment of infringement, which typically blocks generic competition until such time as the patent expires, or a judgment that the patent is invalid or not infringed, which typically opens the market to generic entry. As with other sorts of commercial litigation, however, the parties to pharmaceutical patent litigation may choose to settle their case. Certain of these settlements have …

University Software Ownership And Litigation: A First Examination, Arti K. Rai, John R. Allison, Bhaven N. Sampat, Colin Crossman

Faculty Scholarship

Software patents and university-owned patents represent two of the most controversial intellectual property developments of the last twenty-five years. Despite this reality, and concerns that universities act as "patent trolls" when they assert software patents in litigation against successful commercializers, no scholar has systematically examined the ownership and litigation of university software patents. In this Article, we present the first such examination. Our empirical research reveals that software patents represent a significant and growing proportion of university patent holdings. Additionally, the most important determinant of the number of software patents a university owns is not its research and development ("R&D") …

Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman

Faculty Scholarship

This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …

Process Patents: Hearing Before The S. Comm. On The Judiciary, 110th Cong., May 1, 2007 (Statement Of John R. Thomas, Geo. U. L. Center), John R. Thomas

Testimony Before Congress

No abstract provided.