Tag: Sean O’Connor

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CPIP Roundup

CPIP Roundup – April 30, 2020

Greetings from CPIP Executive Director Sean O’Connor

Sean O'Connor

As we move into another month of stay-at-home here in the DMV—and perhaps some re-openings—we here at CPIP hope that you and yours are staying safe and healthy while we weather this crisis.

We continue to move forward, however. Our biggest news this month is the addition of Joshua Kresh as our new Deputy Director. Most recently an IP attorney at DLA Piper, he has worked at other major firms and is active in policy and new lawyer training with AIPLA and the Giles Rich Inn of Court. Joshua brings with him a patent-rich legal background, and he’ll be a valuable asset to the CPIP team and mission. We look forward to working with him and hope you wish him the best as he takes up this new role.

Like many other schools and organizations, Scalia Law School and CPIP have moved online for the time being—but that doesn’t mean we’ve stopped forging ahead and navigating new challenges. Because all George Mason University onsite events have been cancelled through August 8, we’ve moved our much-anticipated Music Law Conference back to September 10-11, 2020. We greatly appreciate the flexibility and understanding of every single person involved, not least our special guest and keynote speaker, Rosanne Cash. We hope you can still join us for the event in the fall—and, if you were unable to make the April dates, we hope this postponement works to your benefit!

CPIP’s main event this summer, the WIPO-CPIP Summer School on Intellectual Property for this coming June 8-19, 2020, has moved online as a virtual program via WebEx. CPIP primarily will serve participants in the Americas, although we’ll also be welcoming a number of attendees from other parts of the world who have opted to stay with the U.S.A. program.

As of March, I joined the Board of Directors for The Circle Foundation, an organization in the Republic of Korea that supports innovation and entrepreneurship to strengthen the start-up ecosystem. This new role brings CPIP and Scalia Law School into another level of connection with Mason Korea’s excellent in-country campus and activities.

In April, I was a virtual guest speaker for CPIP Co-Founder—and now University of Akron Goodyear Tire & Rubber Chair of Intellectual Property—Mark Schultz’s WebEx event, Copyright and Social Justice: How the “Blurred Lines” Case Brought Overdue Recognition for African American Artist. The talk was co-sponsored by the Black Law Students Association and the Intellectual Property and Technology Law Association. Also in April, I gave a virtual presentation to admitted Scalia Law prospective students on Cannabis: Creating a New Regulated Economy.

CPIP and our colleagues have remained productive over these past weeks, from rescheduling events to publishing timely pieces. My article Distinguishing Different Kinds of Property in Patents and Copyrights—based on an early presentation at CPIP’s Annual Fall Conference—was published in the George Mason Law Review, and my recent op-ed, Avoiding Another Great Depression Through a Developmentally Layered Reopening of the Economy, appeared in The Hill. I was interviewed on WBAL for this piece as well. Finally, CPIP along with many other organizations from around the world signed onto an open letter to WIPO’s Director-General for World IP Day.

This past month and a half have undoubtedly been difficult. At CPIP, our thoughts go out especially to all creators and innovators who are facing new challenges as they strive to protect their livelihoods and intellectual property in this difficult time. We truly hope this May brings improvements, both locally and globally. Stay well, safe, and sane.

CPIP Welcomes Joshua Kresh as Deputy Director

Joshua Kresh

CPIP is proud to welcome Joshua Kresh to our leadership team! As Deputy Director, Joshua will report to CPIP Executive Director Sean O’Connor while managing and participating in CPIP’s day-to-day operations. Joshua will oversee CPIP’s academic research, policy, and fundraising efforts, working as well on planning and executing CPIP events such as conferences, meetings, fellowships, and roundtables. Joshua will also consult with Professor O’Connor and the other faculty directors to develop CPIP’s long-term academic and policy plans.

Before joining CPIP as Deputy Director, Joshua was an Associate with DLA Piper in Washington, D.C., where he practiced patent litigation. He received his law degree with honors from The George Washington University Law School, and he holds master’s and bachelor’s degrees in computer science from Brandeis University. Joshua is the Chair of AIPLA’s New Lawyers Committee and Co-Mentoring Chair of the Giles Rich American Inn of Court, and he is a registered patent attorney with the U.S. Patent and Trademark Office.

To read the rest of our announcement, please click here.

Music Law Conference with Rosanne Cash Moved to September 10-11, 2020

Rosanne Cash

We are excited to announce that the music law conference, The Evolving Music Ecosystem, which will be held at Antonin Scalia Law School in Arlington, Virginia, has now been moved to September 10-11, 2020. The keynote address will be given by Rosanne Cash, and it features two days of panel presentations from leading experts.

This unique conference continues a dialogue on the music ecosystem begun by CPIP Executive Director Sean O’Connor while at the University of Washington School of Law in Seattle. In its inaugural year in the D.C. area, the conference aims to bring together musicians, music fans, lawyers, artist advocates, business leaders, government policymakers, and anyone interested in supporting thriving music ecosystems in the U.S. and beyond.

For more information, and to register, please click here.

Registration Open for WIPO-CPIP Summer School on IP on June 8-19, 2020

WIPO Summer School flyer

CPIP has again partnered with the World Intellectual Property Organization (WIPO) to host the third iteration of the WIPO-CPIP Summer School on Intellectual Property from Antonin Scalia Law School in Arlington, Virginia, on June 8-19, 2020. Registration is now open, and we recommend that participants apply early, as we expect the program to be full. In order to accommodate the global response to COVID-19, we have moved the course online this year.

The course provides a unique opportunity for students, professionals, and government officials to work with leading experts to gain a deeper knowledge of IP to advance their careers. The course consists of lectures, case studies, simulation exercises, group discussions, and panel discussions on selected IP topics, with an orientation towards the interface between IP and other disciplines. U.S. law students can receive 3 hours of academic credit from Scalia Law!

For more information, and to register, please click here.

Spotlight on Scholarship

a pair of glasses, an apple, and a stack of books

Sean M. O’Connor, Distinguishing Different Kinds of Property in Patents and Copyrights, 27 Geo. Mason L. Rev. 205 (2019)

In this paper from our Annual Fall Conference, CPIP Executive Director Sean O’Connor explores the different meanings of “property” with respect to patents and copyrights. Prof. O’Connor explains that, contrary to the current conventional wisdom, the purpose of protection in early modern Europe was to incentivize public disclosure and commercialization, not private creation. To demonstrate this, he traverses the evolution of different kinds of property, including private knowledge, ad hoc grants of rights, rights in goods that embody intellectual property, and contractual assignments or licenses. Prof. O’Connor then describes how confusion over these different kinds of property has lead people to talk past each other in intellectual property debates, and he argues that a more nuanced understanding of the various property interests at stake might enable more constructive engagements going forward.

Charles Delmotte, The Case Against Tax Subsidies in Innovation Policy, 48 Fla. St. U. L. Rev. ___ (forthcoming)

In this paper from our Thomas Edison Innovation Fellowship, Charles Delmotte of NYU Law assesses the proposal for replacing intellectual property rights with tax subsidies for research and development (R&D) firms. Dr. Delmotte explains that innovation scholarship neglects economic insights on efficiencies, such as how information problems prevent the efficient operationalization of tax subsidies since innovation outcomes turn on unpredictable market processes that cannot be steered in advance. Turning to public choice theory, Dr. Delmotte points out that tax subsidies are particularly susceptible to diversion by the rent-seeking behavior of the politically affluent, and relying on economic realism, he argues that the best way to promote innovation is by securing stable intellectual property rights that undergird the background institutions that facilitate competition and entrepreneurship.

Activities, News, & Events

a lit lightbulb hanging next to unlit bulbs

In a new CPIP policy brief entitled The End of Patent Groupthink, CPIP Senior Fellow for Innovation Policy Jonathan Barnett highlights some cracks that have emerged in the recent policy consensus that the U.S. patent system is “broken” and it is necessary to “fix” it. Policymakers have long operated on the basis of mostly unquestioned assumptions about the supposed explosion of low quality patents and the concomitant patent litigation that purportedly threaten the foundation of the innovation ecosystem. These assumptions have led to real-world policy actions that have weakened patent rights. But as Prof. Barnett discusses in the policy brief, that “groupthink” is now eroding as empirical evidence shows that the rhetoric doesn’t quite match up to the reality. This has translated into incremental but significant movements away from the patent-skeptical trajectory that has prevailed at the Supreme Court, the USPTO, and the federal antitrust agencies.

We have several new posts on the CPIP blog, including the first installment of our new series on recent copyright law developments. In a post entitled Copyright Notebook: Observations on Copyright in the Time of COVID-19, CPIP Director of Copyright Research and Policy Sandra Aistars discusses several current copyright cases and issues, including how artists, authors, and copyright industries have taken unprecedented steps to bring enjoyment to our circumscribed lives. We published a similarly hopeful piece entitled IP Industries Step Up in This Time of Crisis on how bio-pharma industries and scientific publishers have made crucial information and materials available when they are needed the most. CPIP Director of Communications Devlin Hartline published a piece entitled Supreme Court Paves Way for Revoking State Sovereign Immunity for Copyright Infringement that looks at the Supreme Court’s decision in Allen v. Cooper. And CPIP Senior Fellow for Life Sciences Erika Lietzan published a piece entitled The Tradeoffs Involved in New Drug Approval, Expanded Access, and Right to Try on the various issues with approving new medicines.

CPIP Senior Scholar Kristen Osenga joined Professors Greg Dolin and Irina Manta in filing an amicus brief urging the Supreme Court to grant certiorari in Celgene v. Peter. The issue on appeal is one that was left unresolved in Oil States v. Greene’s Energy, namely, whether retrospective applications of inter partes review (IPR) proceedings under the 2011 American Invents Act are unconstitutional takings. The brief argues that, for several reasons, the Federal Circuit below reached the wrong conclusion in holding that they are not unconstitutional. First, IPRs are significantly different than ex parte and inter partes reexaminations, since patentees are not free to amend claims in order to resolve claim scope ambiguities. Second, empirical research shows that the economic impact of such IPRs is to devalue patents and chill investment. Finally, the cases relied on by the Federal Circuit to support its conclusion are inapposite or outdated. The amicus brief was featured in a recent article at IPWatchdog entitled Amici Urge Supreme Court to Grant Celgene’s Petition on Constitutionality of Retroactive IPRs.

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C-IP2 News

CPIP Welcomes Joshua Kresh as Deputy Director

Joshua KreshCPIP is proud to welcome Joshua Kresh to our leadership team! As Deputy Director, Joshua will report to CPIP Executive Director Sean O’Connor while managing and participating in CPIP’s day-to-day operations. Joshua will oversee CPIP’s academic research, policy, and fundraising efforts, working as well on planning and executing CPIP events such as conferences, meetings, fellowships, and roundtables. Joshua will also consult with Professor O’Connor and the other faculty directors to develop CPIP’s long-term academic and policy plans.

“We are thrilled that Joshua is joining us as we expand CPIP further into innovation and international policy. Joshua’s extensive background in IP, as well as in computer science and bioinformatics, position him ideally to strengthen our tech and patent research,” said Professor O’Connor. “We also expect to leverage his policy and outreach work with AIPLA and the Giles Rich American Inn of Court to connect with the new generation of IP lawyers,” he continued.

Before joining CPIP as Deputy Director, Joshua was an Associate with DLA Piper in Washington, D.C., where he practiced patent litigation. He received his law degree with honors from The George Washington University Law School, and he holds master’s and bachelor’s degrees in computer science from Brandeis University. Joshua is the Chair of AIPLA’s New Lawyers Committee and Co-Mentoring Chair of the Giles Rich American Inn of Court, and he is a registered patent attorney with the U.S. Patent and Trademark Office. He previously served on the Intellectual Property Committee for the U.S. Court of Federal Claims Advisory Council.

About CPIP

The Center for the Protection of Intellectual Property (CPIP) is dedicated to the scholarly analysis of intellectual property rights and the technological, commercial, and creative innovation they facilitate. CPIP explores how stable and effective property rights in innovation and creativity can foster successful and flourishing individual lives and national economies.

Through a wide array of academic and public policy programming, CPIP brings together scholars, industry leaders, inventors, creators, and policymakers to examine foundational questions and current controversies concerning patents, copyrights, and other intellectual property rights. Ultimately, CPIP seeks to promote a healthy academic discussion, grounded in rigorous scholarship, and a well-informed public policy debate about the importance of intellectual property.

For more information about CPIP, please visit our website at: https://cip2.gmu.edu

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C-IP2 News

CPIP Bids a Fond Farewell to Kevin Madigan and Seeks New Deputy Director

CPIP logoLongtime CPIP staff member Kevin Madigan is leaving the Center next week to become VP, Legal Policy and Copyright Counsel at the Copyright Alliance.

“I joined CPIP just over four years ago, and my time with the Center and Scalia Law has been rewarding on so many levels. The knowledge I’ve gained and the relationships I’ve cultivated are things that I’ll cherish for the rest of my life,” said Kevin Madigan. “I’m proud to have been a part of such a dynamic academic center, and I know CPIP will continue to thrive in my absence. I want to express my sincere gratitude to Sandra Aistars, Sean O’Connor, Adam Mossoff, Devlin Hartline, Matt Barblan, Mark Schultz, Kristina Pietro, and Mary Clare Durel,” he continued.

“We could not be happier for Kevin who has done impeccable work for us beginning as a Fellow and recently serving as Deputy Director. While we will miss him, we know that he will not be far away given our close relationship with CA,” said Sean O’Connor, Executive Director at CPIP.

As a result of Kevin’s departure, we are now seeking a new Deputy Director to join the CPIP team. This is an exciting position for an accomplished intellectual property professional seeking to advance their career at the interface of academia, industry, and public policy.

Reporting to CPIP’s faculty Executive Director, the Deputy Director manages and participates in CPIP’s day-to-day operations including academic and policy work as well as conferences, meetings, and other events. The Deputy Director also works with the Executive Director and other faculty directors to develop CPIP’s long-term academic and policy plans.

The position is designed for an individual with a J.D. degree and an interest in promoting innovation and creativity through CPIP’s academic and policy mission. The ideal candidate will have: strong experience in intellectual property law and policy; familiarity with the academic intellectual property community; and an understanding of government policy-making in Washington, D.C. and beyond. At least three years of IP law practice or IP policy experience are required.

The job listing is available at the following link: https://jobs.gmu.edu/postings/47630

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CPIP Roundup

CPIP Roundup – August 29, 2019

Greetings from CPIP Executive Director Sean O’Connor

Sean O'Connor

With a new academic year beginning at Antonin Scalia Law School, the CPIP team continues to build on a productive summer of scholarship, events, and more. Our WIPO-CPIP Summer School on Intellectual Property this past June boasted 70 students from 30 countries for a two-week crash course on the law and policy of IP in order to help advance their careers. And our Fifth Summer Institute in Beaver Creek, Colorado, this past July brought together IP scholars, policy analysts, and professionals in the innovation and creative industries to discuss the current state of affairs and to work on translating ideas into policy.

Looking ahead, we’re getting ready for our upcoming Seventh Annual Fall Conference, which will take place at Scalia Law on October 4. We’ll also be co-hosting the 31st Annual Intellectual Property Section Seminar with the IP Section of the Virginia State Bar on September 20-21 at Scalia Law. We’re thrilled as well that CPIP Director of Copyright Research and Policy Sandra Aistars will continue her work with the law school’s Arts & Entertainment Advocacy Clinic, while I will be focusing more on the patent side as I lead the law school’s new Innovation Law Practicum.

I hope you’ve had a wonderful summer, and I look forward to seeing you at our future events!

Registration Open for CPIP’s Seventh Annual Fall Conference on October 4

CPIP 2019 Fall Conference flyer

On October 4, 2019, CPIP will host its Seventh Annual Fall Conference at Antonin Scalia Law School in Arlington, Virginia. The theme of this year’s conference is The IP Bridge: Connecting the Lab & Studio, and it features keynote addresses by Professor Robert Merges, UC Berkeley, and Maria Pallante, President & CEO of AAP and former Register of Copyrights. 5 hours Virginia CLE, including 1.5 hours Ethics, available!

This unique conference will highlight how IP rights facilitate the creative and innovative processes and preserve the vibrant ecosystems that deliver innovative products and creative works to consumers. In addition to exploring how IP helps to improve and enrich the lives of creators, inventors, and the public, this conference will also discuss how various efforts to impose price controls in the creative and innovation industries threaten established markets and the creation of innovative products and artistic works.

Please click here to register. We look forward to seeing you in October!

Spotlight on Scholarship

a pair of glasses, an apple, and a stack of books

Kristen Osenga, Institutional Design for Innovation: A Radical Proposal for Addressing § 101 Patent-Eligible Subject Matter, 68 Am. U. L. Rev. 1191 (2019)

In this paper supported by a CPIP Leonardo da Vinci Fellowship Research Grant, CPIP Senior Scholar Kristen Osenga investigates the jumbled state of patent-eligible subject matter in the United States. Following an analysis of those entities currently wielding the power to make decisions on patent eligibility—and an assessment suggesting that other reforms will not solve the issue at its roots—Professor Osenga instead proposes and defends the revolutionary plan of turning over patent-eligibility decisionmaking authority to the courts.

Mark F. Schultz, The Market for Performance Rights in Sound Recordings: Bargaining in the Shadow of Compulsory Licensing (forthcoming)

In this forthcoming paper, CPIP Senior Scholar Mark Schultz discusses government regulations on licensing rights and rates for sound recordings, focusing on how their artificial nature divorces creators’ control and compensation from the marketplace. After exploring the negative impact of this arrangement on creators, consumers, and the market at large, Professor Schultz suggests policy changes for overhauling (and not merely recalibrating) the current, outdated system.

Jonathan M. Barnett, Antitrust Overreach: Undoing Cooperative Standardization in the Digital Economy, 25 Mich. Telecomm. & Tech. L. Rev. 163 (2019)

In this paper from our Sixth Annual Fall Conference, CPIP Senior Scholar Jonathan Barnett analyzes the benefits of standardization in ICT markets and the importance of IP rights and enforced contracts in keeping standardization relationships reciprocal rather than imposed by exterior monopolization. Professor Barnett looks at threats to cooperative standardization as posed by regulators and legislation—in particular, how implementation is favored over, and to the detriment of, innovation.

Activities, News, & Events

a lit lightbulb hanging next to unlit bulbs

CPIP Executive Director Sean O’Connor leads the law school’s new Innovation Law Practicum this fall. The Practicum will provide teams of students the opportunity to counsel entrepreneurs, creators, and inventors from the university’s internal and external communities. The course will teach students about entrepreneurship and commercializing innovation and creativity, as well as how to craft an overall legal strategy in the context of a client’s business, technology, and/or artistic vision. Anticipated projects include providing an initial assessment of legal issues and business planning, followed by specific legal services such as entity formation, securing IP, or drafting employment agreements upon mutual agreement with the client.

CPIP Director of Copyright Research and Policy Sandra Aistars heads the law school’s Arts & Entertainment Advocacy Clinic again this fall. The Clinic will continue its partnership with the U.S. Copyright Office by helping it and the World Intellectual Property Organization (WIPO) organize a conference on AI and copyright. The Clinic will also help mentor Native American musicians and promote cultural understanding via their music, work with a Grammy-nominated musician on a multi-disciplinary project, work with an author to register numerous books, advocate for the CASE Act, explore the intersection of copyright and constitutional law by representing parties interested in solving problems related to state sovereign immunity in cases of willful copyright infringement, and conduct an entertainment law education session and pop-up clinic with the Washington Area Lawyers for the Arts (WALA) during the DC Shorts Film Festival.

CPIP Executive Director Sean O’Connor joined Professors Lateef Mtima and Steve Jamar of the Institute for Intellectual Property and Social Justice (IIPSJ) in filing an amicus brief in Skidmore v. Led Zeppelin, a case currently before the en banc Ninth Circuit. The amicus brief argues that the courts should not improperly restrict composers to the “lead sheet” deposit copy for determining the scope of copyright protection for a musical composition. The brief explains how this position denies social justice to those whose backgrounds or musical styles preclude the use of traditional musical notation, and it argues that phonorecords or other contemporaneous documentation should be allowed as evidence of the scope of the copyrighted work.

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Biotech Patents Pharma

“No Combination Drug Patents Act” Stalls, but Threats to Innovation Remain

superimposed images from a chemistry labBy Kevin Madigan & Sean O’Connor

This week, the Senate Judiciary Committee was to mark up a bill limiting patent eligibility for combination drug patents—new forms, uses, and administrations of FDA approved medicines. While the impetus was to curb so-called “evergreening” of drug patents, the effect would have been to stifle life-saving therapeutic innovations. Though the “No Combination Drug Patents Act”—reportedly to be introduced by Senator Lindsey Graham (R-SC)—was wisely withdrawn at the last minute, it’s likely not the last time that such a misconceived legislative effort will be introduced.

An Exaggerated Response to a Disputed Theory

The bill would have established a presumption of obviousness for drug or biologic patent applications whose invention was a new: dosing regimen, method of delivery, method of treatment, or formulation. While there was a rebuttal provision where the claim covered a new treatment for a new indication or “increase[d] . . . efficacy,” the latter was almost certain to introduce years of uncertainty and litigation. Further, the bill would have covered a broader class than true combination drug patents, in which one active ingredient is combined with another or with a non-drug.

Like many recent legislative efforts, the amendment sought to address a perceived lack of affordability of prescription drugs. After praising the America Invents Act of 2011 and subsequent Supreme Court rulings for strengthening the US patent system, the bill claimed that rising drug prices have outpaced “spending on research and development with respect to those drugs.” In addition to applauding Supreme Court decisions that have injected unquestionable uncertainty into patentable subject matter standards, the amendment went on to blame high drug prices on continually overstated issues related to advanced drug patents.

According to critics, combination drug patents have granted drug makers unearned and extended protection over existing drugs or biological products. But, quite simply, when properly issued by the USPTO under existing patentability standards, these are new patents for new products or processes.

Combination patents have been maligned as anticompetitive, resulting in a “thicket” of patents that impedes innovation through transaction costs and other inefficiencies. Unfortunately, notwithstanding a lack of empirical evidence validating the harm of follow-on innovation patents, patent thicket rhetoric is now being echoed by the media, the academy, courts, and policy makers in a fraught attempt to fix drug pricing.

Reports (see here, here, here, and here) from leading antitrust experts and intellectual property scholars have detailed the value of incremental innovation and challenged the notion that patent thickets are a true threat to competition and innovation. These studies have exposed patent thicket claims—much like the “troll” narrative that for years infected patent law debates—as an empty strawman theory, the repetition of which has led to undue confidence in its accuracy. The reality is that what critics point to as problematic cases of combination patents are in fact infrequent outliers, strategically highlighted to discount evidence of the value of new and innovative drug uses and administrations.

A similar claim by those promoting the patent thicket narrative is that combination patents extend exclusivity on a drug for years beyond an initial patent term, thereby blocking generic entry in the market. But if an underlying drug has gone off patent, no follow-on or combination patent will prevent a generic drug company from producing the underlying formulation—it’s only the new formulation, use, or administration that is protected.

Vague, Yet Oddly Familiar Standards

The language of the Graham amendment asserted that because “numerous” combination patents “contain obvious product developments,” a restructuring of 35 USC 103 is necessary to combat patent thickets and achieve optimal drug pricing. Suggesting that 103 obvious standards for advanced drug development should include a presumption that the covered claimed invention and the prior art to which it relates would have been obvious, the legislation would have undermined a unitary system of patent law in favor of different standards for different fields of technology. It was a bold proposal, and it’s one that ignored the proven value of new drug formulations and methods of treatment.

While the amendment provided for a rebuttal to the presumption of obviousness, the language was ambiguous and likely to render the patent system even more unreliable than it already is. The proposed statute said that an applicant may rebut the presumption of obviousness if the covered claimed invention “results in a statistically significant increase in the efficacy of the drug or biological product that the covered claimed invention contains or uses.” It is unclear what would qualify as “statistically significant,” and proving this vague standard would be nearly impossible.

In order to show a “statistically significant increase in efficacy,” long and costly head-to-head clinical trials would be necessary. To be clear, this is not a standard required by the FDA for new drug approval, let alone patentability.

As if that wasn’t enough reason to reject the Graham amendment, the language was alarmingly similar to that of an Indian patent law statute that has been recognized by the US Trade Representative as a “major obstacle to innovators.” In 2005, in order to comply with the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, India adopted for the first time patent protection for pharmaceuticals. Despite its recognition of IP rights in pharmaceuticals, India’s Act contains a troubling ambiguity in its Section 3(d), which requires an “enhanced efficacy” for known drugs in addition to the standard novelty, inventive step, and industrial applicability requirements.

India’s Section 3(d) has been invoked to reject patent protection for life-saving drug innovations, including Novartis’ landmark leukemia drug, Gleevec. Drug companies, government agencies, and policy makers have all recognized the threat to innovation that India’s patent law poses. In 2013, not long after the Novartis ruling, a bipartisan group of 40 Senators signed a letter to then Secretary of State John Kerry urging the state department to take action against India’s “deteriorating IP environment,” citing its willingness to “break or revoke patents for nearly a dozen lifesaving medications.”

Despite the widespread condemnation of India’s Section 3(d), the Graham amendment proposed adopting similarly indefinable standards to US patent law. While the language differed slightly—replacing “enhanced efficacy” with “increase in the efficacy”—it was no clearer, and implementation of this type of standard would only cause more confusion.

Protecting and Incentivizing Medical Innovation

Like most forms of innovation, the development of medicines and therapeutics is a process by which one builds and improves upon previous discoveries and breakthroughs. Sometimes those improvements are major advancements, but often they are incremental steps forward. In the pharmaceutical field, incremental or follow-on innovation frequently results in new therapeutic uses for existing drugs, which address serious challenges related to adverse effects, delivery systems, and dosing schedules. While they might not sound like medical breakthroughs on par with the discovery of penicillin, these advancements in the administration and use of pharmaceuticals improve public health and save lives.

Additionally, follow-on innovations are—and should remain—subject to the same patentability standards as any other technologies. Patents reward advancements that are novel, useful, and nonobvious, and our patent system has long recognized that patent claims are to be presumed patentable and nonobvious. The Graham amendment would have turned this established standard on its head, creating a separate and ill-defined hurdle for certain advancements in medicine.

The benefits of incremental innovation to public health and patients cannot be overstated. New formulations of malaria drugs, dosing regimens and delivery systems for AIDS patients, more efficient administrations of insulin for the treatment of diabetes, and developments in the treatment of cognitive heart disease have all been possible because of incremental innovation.

Imposing unjustified restrictions on the patentability of advancements like these would be disastrous for drug development, as the incentives that come with patent protection would be all but eliminated. Without the assurance that their innovative labor would be supported by intellectual property protection, pioneering drug developers would shift resources away from improving drug formulations and uses. The development of more effective treatments of some of the most devastating diseases would stall, as innovators would be unable to commercialize their products, recoup losses, or fund future research and development.

As critics continue to target myopically the patent system for a broader issue of drug prices in the American health care system, it’s likely not the last time that language like this will be proposed. In order to avoid the implementation of such ill-conceived standards into our patent laws, understanding what’s at stake is critical. The future of medical innovation depends on it.

Categories
FTC Innovation

CPIP Scholars Join Comment Letter to FTC Supporting Evidence-Based Approach to IP Policymaking

a hand reaching for a hanging, shining keyOn December 21, 2018, CPIP Senior Scholars Jonathan Barnett, Chris Holman, Erika Lietzan, Adam Mossoff, Sean O’Connor, and Kristen Osenga joined a comment letter that was filed with the FTC as part of its ongoing hearings on Competition and Consumer Protection in the 21st Century. The comment letter was joined by 18 legal academics, economists, and former government officials—including former USPTO Director David Kappos and former Federal Circuit Chief Judge Paul Michel. The comment letter is copied below.

***

December 21, 2018

Via Electronic Submission

Mr. Donald S. Clark
Secretary of the Commission
Federal Trade Commission
600 Pennsylvania Avenue NW
Washington, DC 20580

Re: Competition and Consumer Protection in the 21st Century Hearings—
Public Comments Following Hearing #4 on Innovation and Intellectual Property Policy

Dear Secretary Clark,

As legal academics, economists, and former government officials who are experts in antitrust law and intellectual property law, we respectfully submit these comments and an Appendix in response to the request for public comments following the Federal Trade Commission’s Hearings on Innovation and Intellectual Property Policy held October 23-24, 2018, as part of the FTC’s Hearings on Competition and Consumer Protection in the 21st Century.

We support evidence-based policy-making by the FTC concerning all aspects of technological innovation, intellectual property (IP) rights, and the relationship between IP rights and innovation markets. It is imperative that the FTC ground any policy statements, investigations, or enforcement actions, not on academic theories about how IP rights might potentially be misused in stylized theoretical models, but on persuasive evidence of actual consumer harm from anti-competitive practices in real-world markets. Otherwise, regulatory overreach could undermine the economic incentives and resulting stream of innovative products and services that consumers enjoy in markets in which reliable and effective IP rights attract the private capital necessary to fund the high costs of R&D and the commercialization process.

Few economists and policymakers would question that reliable and effective property rights are a necessary predicate for supporting investment in conventional physical-goods markets. Logic holds that this economic principle applies for the innovators, investors, and entrepreneurs in the information technology and life sciences markets at the core of the US innovation economy.

Given reliable and effective IP rights, multiple empirical studies support the proposition that firms are more willing to incur substantial costs and bear significant risks in undertaking long-term R&D. Two well-known examples are the approximately $2.6 billion dollars required to bring a new drug to market or the billions in dollars required to develop new communications technologies like 5G. These and other long-term R&D investments occur in commercial environments in which courts and administrative agencies secure reliable and effective IP rights.

In recent years, antitrust agencies have sometimes taken policy actions in IP-intensive markets that overlook this fundamental connection between secure property rights, investment incentives, R&D, and commercialization activities. These regulatory actions have been based on academic theories and anecdotal reports that have not been put to thoroughgoing, rigorous empirical tests.

To illustrate the risks of making policy without firm empirical support, consider the smartphone industry. For over a decade, theoretical predictions have been made that comparatively high numbers of patents covering technologies used in a single multi-component consumer product—a smartphone—would create “patent thickets,” “royalty stacking,” and “patent holdup” that would increase prices, constrain output, and stunt innovation. Based on these conjectures, antitrust agencies around the world have issued policy statements, undertaken enforcement actions, and imposed billions of dollars in fines—often directed at the firms that had pioneered the fundamental technologies behind wireless communications. Yet those proposing this testable hypothesis never actually tested it. Empirical researchers who subsequently did so found little to no evidence of “patent holdup.” Contrary to theory, real-world market conditions in the smartphone industry are characterized by constant lower quality-adjusted prices, robust market entry by new producers, and continuously increasing performance standards. Consumers in the US and around the globe have benefited from the virtuous feedback effect between secure property rights in new technologies, strong investment flows, and robust R&D output. The evidentiary burden surely rests on those who propose taking policy actions that would erode the property-rights foundation behind this technological and economic success story.

The smartphone industry is just one of multiple innovation markets that exhibit a positive relationship between reliable and effective patent rights, increased innovation, and economic growth. This evidence demonstrates a close relationship in the biopharmaceutical, medical device and certain information technology markets between patent protection and startups’ ability to secure financing for R&D and to undertake the costly commercial task of translating R&D into new products and services for consumers. This relationship is especially powerful in the case of startups that are often the source of breakthrough innovation. One empirical study shows that a startup with a patent more than doubles its chances of obtaining venture capital funding compared to a startup without a patent. Without a secure IP portfolio, venture capital and other investors will decline to support startups that often have few other legal or commercial mechanisms by which to secure their products and services against imitation by larger incumbents. For similar reasons, larger firms that specialize in R&D but do not have downstream production and distribution capacities require a secure IP portfolio to support a licensing infrastructure that generates the returns necessary to fund continued R&D that ultimately benefits downstream companies in the value chain and end-users in the marketplace.

Antitrust policy has long followed an error-cost approach that takes into account the relative costs associated with overenforcement (false positive errors) and underenforcement (false negative errors) of the antitrust laws. Consistent with this approach, the FTC’s policymaking and enforcement actions in innovation markets should be based on valid empirical evidence that makes it possible to weigh the likely costs and benefits of the agency’s actions.

This concern is especially relevant in evaluating the likelihood of consumer harm and the impact on innovation from patent infringement litigation. Like any form of civil litigation, patent litigation can be used for either legitimate or opportunistic purposes. Based on a limited body of evidence that suffers from substantial methodological shortcomings, antitrust agencies have issued statements and taken actions supporting blanket denials of the availability of injunctive relief for all patent owners who primarily license their technologies (“non-practicing entities”).

A broader empirical literature has looked more closely with rigorous analysis and uncovered a far more nuanced market and legal reality. First, no empirical study has demonstrated that patent owners’ requests for injunctive relief after findings of defendants’ infringement of their property rights have resulted systematically either in consumer harm or in slowing down the pace of technological innovation. Second, researchers have found that the “non-practicing entities” or “patent assertion entities” rubric encompasses a large number of business models that generate social gains by providing licensing and other mechanisms for undercapitalized individual inventors, startups, small firms, and universities. These innovators lack the commercial means to extract revenue from R&D that can generate valuable new products and services for consumers. Painting all of these entities with the same rhetorical broad brush threatens to unravel a rich ecosystem of inventors, startups, and entrepreneurs that rely on the legal backstop of injunctive relief to support markets in intellectual assets. Abusive litigation practices by a limited number of patent owners could and should be targeted surgically through fee-shifting and other standard tools available in all civil litigation. Again, regulatory intervention without a firm evidentiary basis runs the risk of harming consumer welfare by undermining the reliable and effective patent rights on which innovators, venture capitalists, startups, and other market participants rely in creating and expanding the innovation markets that benefit everyone.

In support, we attach an Appendix of articles that provide rigorous empirical studies and evidence-based analyses of IP-driven innovation markets, patent licensing, and patent litigation.

In conclusion, the FTC should continue to develop policies and undertake enforcement actions only with evidence of proven harms to consumers and with proper consideration of the costs in undermining reliable and effective IP rights that have consumer-welfare enhancing effects in the US innovation economy. A balanced consideration of the evidence on both harms and benefits is necessary to ensure balanced protection of innovators and consumers. We are confident that a commitment by the FTC to a program of evidence-based policy-making will lead to a vibrant, dynamic innovation economy supported by a secure foundation of IP rights that will continue to benefit consumers in the US and around the world.

Sincerely,

Kristina M. L. Acri
Associate Professor of Economics
The Colorado College

Jonathan Barnett
Professor of Law
USC Gould School of Law

Andrew Beckerman-Rodau
Professor of Law
Suffolk University Law School

Ronald A. Cass
Dean Emeritus,
Boston University School of Law
Former Vice-Chairman and Commissioner,
United States International Trade Commission

The Honorable Douglas H. Ginsburg
Senior Circuit Judge,
United States Court of Appeals for the District of Columbia Circuit, and
Professor of Law,
Antonin Scalia Law School
George Mason University

Stephen Haber
A.A. and Jeanne Welch Milligan Professor
Stanford University

Christopher M. Holman
Professor of Law
UKMC School of Law

Keith N. Hylton
William Fairfield Warren Distinguished Professor
Boston University School of Law

David J. Kappos
Former Under Secretary of Commerce and Director
United States Patent & Trademark Office

Erika Lietzan
Associate Professor of Law
University of Missouri School of Law

The Honorable Paul Michel
Chief Judge (Ret.),
United States Court of Appeals for the Federal Circuit

Damon C. Matteo
Course Professor
Tsinghua University in Beijing

Adam Mossoff
Professor of Law
Antonin Scalia Law School
George Mason University

Sean M. O’Connor
Boeing International Professor of Law
University of Washington School of Law

Kristen Osenga
Professor of Law
University of Richmond School of Law

Matthew L. Spitzer
Howard and Elizabeth Chapman Professor of Law
Northwestern University School of Law

Saurabh Vishnubhakat
Associate Professor of Law
Texas A&M University School of Law

Joshua D. Wright
University Professor,
Antonin Scalia Law School
George Mason University
Former Commissioner,
Federal Trade Commission

APPENDIX

Kristina M. L. Acri, née Lybecker, Economic Growth and Prosperity Stem from Effective Intellectual Property Rights, 24 Geo. Mason L. Rev. 865 (2017), http://georgemasonlawreview.org/wp-content/uploads/2017/11/24_4_Lybecker.pdf

Ashish Arora & Robert P. Merges, Specialized Supply Firms, Property Rights and Firm Boundaries, 14 Ind. & Corp. Change 451 (2005)

Jonathan H. Ashtor, Does Patented Information Promote Progress? (June 22, 2017), https://ssrn.com/abstract=2857697

Jonathan H. Ashtor, Opening Pandora’s Box: Analyzing the Complexity of U.S. Patent Litigation, 18 Yale J. L. & Tech. 217 (2016), https://ssrn.com/abstract=2736556

Jonathan M. Barnett, Antitrust Overreach: Undoing Cooperative Standardization in the Digital Economy (Nov. 2018), https://ssrn.com/abstract=3277667

Jonathan M. Barnett, Has the Academy Led Patent Law Astray?, 32 Berk. Tech. L. J. 1313 (2017), http://btlj.org/data/articles2017/vol32/32_4/Barnett_web.pdf

Jonathan M. Barnett, From Patent Thickets to Patent Networks: The Legal Infrastructure of the Digital Economy, 55 Jurimetrics J. 1 (2014), https://ssrn.com/abstract=2431917

Jonathan M. Barnett, Three Quasi-Fallacies in the Conventional Understanding of Intellectual Property, 12 Journal of Law, Econ. and Pol. 1 (2016), https://ssrn.com/abstract=265636

Christopher A. Cotropia, Jay P. Kesan & David L. Schwartz, Unpacking Patent Assertion Entities (PAEs), 99 Minn. L. Rev. 649 (2014), https://ssrn.com/abstract=2346381

Richard Epstein, F. Scott Kieff & Daniel F. Spulber, The FTC, IP, and SSOs: Government Hold-Up Replacing Private Coordination, 8 J. Comp. L. & Econ. 1 (2012), https://ssrn.com/abstract=1907450

Richard A. Epstein & Kayvan Noroozi, Why Incentives for Patent Hold Out Threaten to Dismantle FRAND and Why It Matters, 32 Berkeley Tech. L. J. (2018), https://ssrn.com/abstract=2913105

Joan Farre-Mensa, Deepak Hegde, & Alexander Ljungqvist, What Is a Patent Worth? Evidence from the U.S. Patent ‘Lottery’ (USPTO Econ. Working Paper No. 2015-5, Mar. 2017), https://ssrn.com/abstract=2704028

Alexander Galetovic & Stephen Haber, The Fallacies of Patent Holdup Theory, 13 J. Comp. L. & Econ. 1 (2017), https://academic.oup.com/jcle/article/13/1/1/3060409

Alexander Galetovic, Stephen Haber, & Lew Zaretzki, An Estimate of the Average Cumulative Royalty Yield in the World Mobile Phone Industry: Theory, Measurement and Results (Feb. 7, 2018), https://hooverip2.org/working-paper/wp18005

Alexander Galetovic, Stephen Haber, & Ross Levine, An Empirical Examination of Patent Hold Up, 11 J. Comp. L. & Econ. 549 (2015), https://academic.oup.com/jcle/article/11/3/549/800066

Douglas H. Ginsburg, Koren W. Wong-Ervin, & Joshua Wright, The Troubling Use of Antitrust to Regulate FRAND Licensing, CPI Antitrust Chronicle (Oct. 2015), https://www.competitionpolicyinternational.com/assets/Uploads/GinsburgetalOct-151.pdf

Douglas H. Ginsburg, Taylor M. Ownings, & Joshua D. Wright, Enjoining Injunctions: The Case Against Antitrust Liability for Standard Essential Patent Holders Who Seek Injunctions, The Antitrust Source (Oct. 2014), https://ssrn.com/abstract=2515949

Stuart J.H. Graham & Ted Sichelman, Why Do Start-Ups Patent?, 23 Berk. Tech. L. J. 1063 (2008), https://ssrn.com/abstract=1121224

Stuart J.H. Graham & Saurabh Vishnubhakat, Of Smart Phone Wars and Software Patents, 27 J. Econ. Persp. 67 (2013), http://ssrn.com/abstract=2291603

Kirti Gupta, Technology Standards and Competition in the Mobile Wireless Industry, 22 Geo. Mason L. Rev. 865 (2015), http://www.georgemasonlawreview.org/wp-content/uploads/2015/06/GuptaTechStandards.pdf

Stephen Haber, Patents and the Wealth of Nations, 23 George Mason L. Rev. 811 (2016), https://ssrn.com/abstract=2776773

Christopher M. Holman, The Critical Role of Patents in the Development, Commercialization and Utilization of Innovative Genetic Diagnostic Tests and Personalized Medicine, 21 B.U. J. Sci. & Tech. L. 297 (2015), http://www.bu.edu/jostl/files/2015/12/HOLMAN_ART_FINALweb.pdf

Ryan T. Holte, Trolls or Great Inventors: Case Studies of Patent Assertion Entities, 59 St. Louis U. L.J. 1 (2014), https://ssrn.com/abstract=2426444

Albert G.Z. Hu and I.P.L. Png, Patent Rights and Economic Growth: Evidence from Cross-Country Panels of Manufacturing Industries, 65 Oxford Econ. Papers 675 (2013), https://academic.oup.com/oep/article-abstract/65/3/675/2362113

Keith N. Hylton, Patent Uncertainty: Toward a Framework with Applications, 96 B.U. L. Rev. 1117 (2016), https://ssrn.com/abstract=2714434

Zorina Khan, Trolls and Other Patent Inventions: Economic History and the Patent Controversy in the Twenty-First Century, 21 Geo. Mason L. Rev. 825 (2014), http://www.georgemasonlawreview.org/wp-content/uploads/2014/06/Khan-WebsiteVersion.pdf

Scott Kieff & Anne Layne-Farrar, Incentive Effects from Different Approaches to Holdup Mitigation Surrounding Patent Remedies and Standard-Setting Organizations, 9 J. Comp. L. & Econ. 1091 (2013), https://www.researchgate.net/publication/274522003_Incentive_effects_from_different_approaches_to_holdup_mitigation_surrounding_patent_remedies_and_standard-setting_organizations

Bruce H. Koboyashi & Joshua D. Wright, Federalism, Substantive Preemption, and Limits on Antitrust: An Application to Patent Holdup, 5 J. Comp. L. & Econ. 1 (2009), https://ssrn.com/abstract=1143602

Bruce H. Koboyashi & Joshua D. Wright, The Limits of Antitrust and Patent Holdup: A Reply to Cary et al., 78 Antitrust L.J. 505 (2012), https://ssrn.com/abstract=2704591

Anne Layne-Farrar, Why Patent Holdout is Not Just a Fancy Name for Plain Old Patent Infringement, CPI North American Column (Feb. 2016), https://www.competitionpolicyinternational.com/wp-content/uploads/2016/02/NorthAmerica-Column-February-Full.pdf

Anne Layne-Farrar, Patent Holdup and Royalty Stacking Theory and Evidence: Where Do We Stand After 15 Years of History?, OECD Intellectual Property and Standard Setting (Nov. 18, 2014), http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=DAF/COMP/WD%282014%2984&doclanguage=en

Anne Layne-Farrar, Moving Past the SEP RAND Obsession: Some Thoughts on the Economic Implications of Unilateral Commitments and the Complexities of Patent Licensing, 21 Geo. Mason L. Rev. 1093 (2014), http://www.georgemasonlawreview.org/wpcontent/uploads/2014/06/Layne-Farrar-Website-Version.pdf

Gerard Llobet & Jorge Padilla, The Optimal Scope of the Royalty Base in Patent Licensing, 59 J. L. & Econ. 45 (2016), https://ssrn.com/abstract=2417216

Alan C. Marco & Saurabh Vishnubhakat, Certain Patents, 16 Yale J.L. & Tech. 103 (2013), http://ssrn.com/abstract=2324538

Kevin R. Madigan & Adam Mossoff, Turning Gold to Lead: How Patent Eligibility Doctrine is Undermining U.S. Leadership in Innovation, 24 Geo. Mason L. Rev. 939 (2017), http://georgemasonlawreview.org/wpcontent/uploads/2017/11/24_4_Madigan_Mossoff_2.pdf

Keith Mallinson, Don’t Fix What Isn’t Broken: The Extraordinary Record of Innovation and Success in the Cellular Industry under Existing Licensing Practices, 23 Geo. Mason L. Rev. 967 (2016), http://www.georgemasonlawreview.org/wp-content/uploads/Mallinson-FINAL.pdf

Keith Mallinson, Theories of Harm with SEP Licensing Do Not Stack Up, IP Fin. Blog (May 24, 2013), http://www.ip.finance/2013/05/theories-of-harm-with-sep-licensing-do.html

Ronald J. Mann, Do Patents Facilitate Financing in the Software Industry?, 83 Tex. L. Rev. 961 (2005), https://ssrn.com/abstract=510103

Jorge Padilla & Koren W. Wong-Ervin, Portfolio Licensing to Makers of Downstream End-User Devices: Analyzing Refusals to License FRAND-Assured Standard-Essential Patents at the Component Level, 62 The Antitrust Bulletin 494 (2017), https://doi.org/10.1177/0003603X17719762

Kristen Osenga, Formerly Manufacturing Entities: Piercing the “Patent Troll” Rhetoric, 47 Conn. L. Rev. 435 (2014), https://ssrn.com/abstract=2476556

Kristen Osenga, Ignorance Over Innovation: Why Misunderstanding Standard Setting Operations Will Hinder Technological Progress, 56 U. Louisville L. Rev. 159 (2018). https://scholarship.richmond.edu/law-faculty-publications/1502/

Kristen Osenga, Sticks and Stones: How the FTC’s Name-Calling Misses the Complexity of Licensing-Based Business Models, 22 Geo. Mason L. Rev. 1001 (2015), https://ssrn.com/abstract=2834140

Jonathan D. Putnam & Tim A. Williams, The Smallest Salable Patent-Practicing Unit (SSPPU): Theory and Evidence (Sept. 2016), https://ssrn.com/abstract=2835617

David L. Schwartz & Jay P. Kesan, Analyzing the Role of Non-Practicing Entities in the Patent System, 99 Cornell L. Rev. 425 (2014), https://ssrn.com/abstract=2117421

Gregory Sidak, What Aggregate Royalty Do Manufacturers of Mobile Phones Pay to License Standard-Essential Patents?, 1 Criterion J. Innovation 701 (2016), https://www.criterioninnovation.com/articles/sidak-aggregate-royalty-to-license-standard-essential-patents.pdf

Gregory Sidak, The Antitrust Division’s Devaluation of Standard-Essential Patents, 104 Geo. L.J. Online 48 (2015), https://georgetownlawjournal.org/articles/161/antitrust-division-sdevaluation-of/pdf

Gregory Sidak, Testing for Bias to Suppress Royalties for Standard-Essential Patents, 1 Criterion J. on Innovation 301 (2016), https://www.criterioninnovation.com/articles/sidak-bias-to-suppress-sep-royalties.pdf

Matthew Spitzer, Patent Trolls, Nuisance Suits, and the Federal Trade Commission, 20 N.C. J.L. & Tech. 75 (2018), https://scholarship.law.unc.edu/ncjolt/vol20/iss1/2

Daniel F. Spulber, Standard Setting Organizations and Standard Essential Patents: Voting and Markets, Econ. J. (2018), https://doi.org/10.1111/ecoj.12606

Daniel F. Spulber, Patent Licensing and Bargaining with Innovative Complements and Substitutes (June 2018), https://ssrn.com/abstract=2818008

Daniel F. Spulber, How Patents Provide the Foundation of the Market for Inventions, 11 J. Comp. L. & Econ. 271 (2015), https://ssrn.com/abstract=2487564

David J. Teece, Competing Through Innovation: Technology Strategy and Antitrust Policies (Edward Elgar, 2013), https://www.e-elgar.com/shop/competing-through-innovation

David J. Teece, Edward F. Sherry, & Peter Grindley, Patents and ‘Patent Wars’ in Wireless Communications: An Economic Assessment, 95 Comm. & Strat. 85 (2014), https://ssrn.com/abstract=2603751

David J. Teece & Edward F. Sherry, On Patent ‘Monopolies’: An Economic Re-Appraisal, CPI Antitrust Chronicle (Apr. 2017), https://ssrn.com/abstract=2962208

Joanna Tsai & Joshua D. Wright, Standard Setting, Intellectual Property Rights, and the Role of Antitrust in Regulating Incomplete Contracts, 80 Antitrust L.J. 157 (2015), https://ssrn.com/abstract=2467939

Gregory J. Werden & Luke M. Froeb, Why Patent Hold-Up Does Not Violate Antitrust Law (Sep. 24, 2018), https://ssrn.com/abstract=3244425

Joshua D. Wright, SSOs, FRAND, and Antitrust: Lessons from the Economics of Incomplete Contracts, 21 Geo. Mason L. Rev. 791 (2014), http://www.georgemasonlawreview.org/wpcontent/uploads/2014/06/Wright-Website-Version.pdf

Ziedonis, Rosemarie H. and Bronwyn H. Hall, The Effects of Strengthening Patent Rights on Firms Engaged in Cumulative Innovation: Insights from the Semiconductor Industry, in Gary D. Libecap (ed.), Entrepreneurial Inputs and Outcomes: New Studies of Entrepreneurship in the United States (2001).

Categories
Patent Law Patent Theory

Proposed Misuse of Section 1498 Relies on the False Claim that Patents Are Not Property

hand under a lightbulb drawn on a chalkboardBy Kathleen Wills*

The question whether patents are property rights is a continuing and hotly debated topic in IP law. Despite an abundance of scholarship (see here, here, here, here, and here) detailing how intellectual property (“IP”) rights have long been equated with property rights in land and other tangible assets, critics often claim that this “propertarian” view of IP is a recent development. Misconceptions and false claims about patents as property rights have been perpetuated in an echo chamber of recent scholarship, despite a lack of evidentiary support.

Unfortunately, these misleading arguments are now influencing important pharmaceutical patent debates. Specifically, a new push to devalue patent rights through the misapplication of an allegedly obscure and misunderstood statute, Section 1498 in Title 28 of the U.S. Code (“Section 1498”), is now being used to promote price controls. Arguments for this push have gained traction through a recent article whose flawed analysis has subsequently been promoted by popular media outposts. A better understanding of the nature of patents as property reveals the problems in this argument.

The history of Section 1498 clearly contemplates that patents are property subject to the Takings Clause, which reflects a long-standing foundation of patent law as a whole: Patents are private property. In an influential paper, Professor Adam Mossoff established that from the founding of the United States, patents have been grounded in property law theories. While some scholars today argue that the perception of patents began as monopoly privileges, this is only partially correct.

The arguments usually revolve around certain stated views of Thomas Jefferson, but they ignore that his position was actually a minority view at the time. Even when the term “privilege” was used, it reflected the natural rights theory of property that a person owns those things in which he invests labor to create, including labors of the mind. The term did not reflect a discretionary grant revocable at the will of the government. Thus, an issued patent was a person’s property, as good against the government as against anyone else.

To understand the majority perspective of courts in the nineteenth century, it is important to note that James Madison, the author of the Takings Clause, wrote that the “[g]overnment is instituted to protect property of every sort.” What types of property? Courts often used real property rhetoric in patent infringement cases, as seen in Gray v. James. By 1831, the Supreme Court believed that patent rights were protected just like real property in land was protected. In Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., the Court established that patent rights represent legitimate expectations similar to property rights in land, which, in turn, are rights secured under the Takings Clause of the Constitution.

This understanding of patents reflected a stark break from the traditions in English law from which American law developed. In England, the “crown-right” granted the government the right to practice a patented invention wherever and however it pleased. In 1843, the Supreme Court in McClurg v. Kingsland explained that while England viewed a patent as “a grant” issued as a “royal favor,” which could not be excluded from the Crown’s use, the American system was intentionally different and patent rights were good against the government. This meant that Congress had to treat patents as vested property rights in the patent owner.

Justice Bradley enumerated this difference between the United States and England in James v. Campbell:

The United States has no such prerogative as that which is claimed by the sovereigns of England, by which it can reserve to itself, either expressly or by implication, a superior dominion and use in that which it grants by letters-patent to those who entitle themselves to such grants. The government of the United States, as well as the citizen, is subject to the Constitution; and when it grants a patent the grantee is entitled to it as a matter of right, and does not receive it, as was originally supposed to be the case in England, as a matter of grace and favor.

As an article by Professor Sean O’Connor explains, this change occasionally caused confusion in American courts when it came to patent owners seeking redress against unauthorized government use. The problem was that there was no single clear mechanism for suing the federal government for injunctive or monetary relief—in fact under sovereign immunity principles, in many cases the plaintiff could not sue the government. Various mechanisms such as implied or quasi contracts were used, but the varying nature of patentees—had they received some government funding leading to their invention or developed it purely outside of government support—complicated things further.

To provide a venue where citizens could sue the government for patent infringement and other claims, Congress created the Court of Claims in 1855. In 1878, the Court of Claims in McKeever v. United States explained that in the United States, patent rights secured the “mind-work which we term inventions,” authorized under the Copyright and Patent Clause in the Constitution. By explaining that patent rights derived from Article I in the Constitution, the Court of Claims suggested that patents were as important as other property rights and thus different from grants. Prof. O’Connor shows that the status of patents as property, and the recognition of this fact by the courts, solved much of the confusion over the history of American patent law.

The Supreme Court went on to affirm the Court of Claims’ decision to award damages to a patentee for an unauthorized governmental use of his patented invention. In United States v. Burns, the Court said that “[t]he government cannot, after the patent is issued, make use of the improvement any more than a private individual, without license of the inventor or making compensation to him.” In James v. Campbell, the Supreme Court echoed this idea when it held that patents confer owners an exclusive property in their invention, and that the government cannot use such an invention without just compensation any more than the government could appropriate land without compensation.

By 1881, it was clear that the courts recognized patents as property rights under constitutional protection from government takings, just like real property. With a strong historical record showing that the Supreme Court equated patents as protected property rights, a question remains: Where does the confusion today stem from?

As Prof. Mossoff explains, the confusion could come from misconstrued inferences of legislative intent regarding the Tucker Act (“Act”). The 1887 version of the Act did not address patents when giving the Court of Claims jurisdiction to hear claims arising from Constitution. This was used by the Federal Circuit in Zoltek Corp. v. United States to deny patents security under the Takings Clause. The Federal Circuit reasoned that patents weren’t constitutional private property. Judge Newman, however, dissented from the petition for rehearing en banc. She highlighted that “[a]lmost a century of precedent has implemented the right of patentees to the remedies afforded to private property taken for public use. There is no basis today to reject this principle.” (The Takings Clause analysis was subsequently vacated when the Federal Circuit eventually took the case en banc.)

An investigation of the Act’s legislative history also leads to a 1910 committee report (H.R. Rep. No. 61-1288), stating that the government’s unauthorized use of patents qualified as a taking. A few years after, the 1918 amendment adjusted the Act’s language to specifically allow patentees to sue the government for unauthorized uses of their property. Thus, the Tucker Act included patent claims in the kind of suits where the government’s unauthorized use was a constitutional issue, appropriately within the Court of Claims’ jurisdiction. Towards the end of the twentieth century, courts continued to hold that patents were constitutionally protected private property.

Modern cases have also confirmed that patents are property protected by the Takings Clause. Chief Justice Roberts, in Horne v. Department of Agriculture, used a patent case for the proposition that the Takings Clause extends to all forms of property, not just real property. Even in Oil States v Greene’s Energy, Justice Thomas went out of his way to assert that the Takings Clause still applies to patents, citing the same case cited by the Chief Justice in Horne.

There has always been a continuous understanding that patents are property, and thus, that Section 1498 is the eminent domain mechanism for the use of patents for the government’s own purposes. Popular media has recently misunderstood Section 1498, but the statute is not a price control statute as detailed in a previous post in this series. Additionally, forthcoming posts in this series will address other such misconceptions surrounding Section 1498.

*Kathleen Wills is a 2L at Antonin Scalia Law School, and she works as a Research Assistant at CPIP

Categories
Innovation Patent Law

Proposal for Drug Price Controls is Legally Unprecedented and Threatens Medical Innovation

dictionary entry for the word "innovate"By Adam Mossoff, Sean O’Connor, & Evan Moore*

The price of the miracle drugs everyone uses today is cause for concern among people today. The President has commented on it. Some academics, lawyers, and policymakers have routinely called for the government to “do something” to lower prices. The high prices are unsurprising: cutting-edge medical treatments are the result of billions of dollars spent by pharmaceutical companies over decades of research and development with additional lengthy testing trials required by the Food & Drug Administration. Earlier this year, though, the New York Times called for the government to use a federal law in forcing the sale of patented drugs by any private company to consumers in the healthcare market, effectively creating government-set prices for these drugs.

The New York Times proposal was prompted by an article in the Yale Journal of Law and Technology, which asserts that this law (known as § 1498) has been used by the federal government in the past to provide the public with lower-cost drugs. This claim—repeated as allegedly undisputed by the New York Times—is false. In fact, the proposal to use § 1498 for the government to set drug prices charged by private companies in the healthcare market would represent an unprecedented use of a law that was not written for this purpose.

Let’s first get clear on the law that the New York Times has invoked as the centerpiece of its proposal: § 1498 was first passed by Congress over a hundred years ago. It was a solution to a highly technical legal issue of how patent owners could overcome the government’s immunity from lawsuits when the government used their property without authorization. What ultimately became today’s § 1498 waived the federal government’s sovereign immunity against lawsuits, securing to patent owners the right to sue in federal court for reasonable compensation for unauthorized uses of their property.

This law resolved vexing legal questions about standing and jurisdiction, securing to patent owners the same right to constitutional protection of their property from a “taking” of their property by the government under the Fifth Amendment as all other property owners. This short summary makes clear that § 1498 is solely to provide compensation for government use of patented invention; it is neither a price control statute nor a general license for government agencies to intervene in private markets.

This is confirmed by the text of § 1498, which provides that when a patented invention is “used or manufactured by” the government, the patent owner is owed a “reasonable and entire compensation.” Thus, § 1498 acknowledges that the government has the power to use a patent for government use as long as it pays reasonable compensation to the patent owner. The predecessor statute was initially limited to direct government use of the invention. But in 1918 it was amended to cover government contractors as well. The issue was that patentees were suing and obtaining injunctions for infringement by private contractors, which slowed important production of war materials during World War One.

Just as the initial statute precluded an injunction against the government—providing only for “reasonable and entire compensation” as the sole remedy—the amended statute further shielded government contractors by placing the sole remedy for the latter’s infringement on the government as well. This makes sense given that the private company was working at the behest of the government itself. Thus, central to any such defense was that the contractor needed to show that it was infringing the patent on the “authorization and consent” of the government. And, just as for the government’s direct infringement, the contractor’s infringement was covered only to the extent it was for legitimate government use. Any private market use by the private company placed its infringing uses outside the statute and thus the company was fully liable for regular patent remedies, including injunctive relief.

The article published in the student-edited law journal that precipitated the New York Times proposal misconstrues § 1498 because it engages in an economic sleight of hand, characterizing pharmaceutical patents as an unwarranted tax paid by the public. The underlying argument is that drugs are expensive due to monopoly pricing and any drug sold above its basic cost of production represents economic deadweight loss. This argument ignores one of the key economic functions of the patent system, which is to secure the opportunity for innovators to recoup extensive costs in R&D expenditures and which are not reflected in costs of production themselves, such as the more than $2 billion in R&D spent by innovative pharmaceutical companies in creating a new drug.

The argument by the journal article thus applies to any patent (and has been made against all patents by other critics of the patent system), but the authors limit their proposal to cases of “excessive” prices for certain drugs, such as the cutting-edge, groundbreaking Hepatitis C treatment that ranges from $20,000-$90,000 for a 12-week treatment plan. Section 1498, they argue, should be used not just for the government’s own use of patented drugs for military personnel or other public employees, but for any infringement of the patent approved by the government in the name of providing lower prices to the public.

If the article authors and the New York Times had their way, the federal government would simply declare that a drug is too expensive and thus it would preemptively authorize any private company to make and sell the drug more cheaply. The pharmaceutical company would sue the companies for patent infringement, and the government would intervene under § 1498, claiming that these companies are essentially contractors acting at the behest of the government. Under the legal rules governing payment of “reasonable compensation” under § 1498 and payment of “just compensation” under the Fifth Amendment, the property owner receives the “fair market value” for the unauthorized use.

To the article authors and the New York Times this means a minimal royalty based off the mistaken premise that the price comparison would be retail price of the drug if it were not covered by a patent (like a generic). But instead, § 1498 procedures routinely rule that the government must compensate the patent owner the full measure of patent damages as would have been awarded in a regular patent infringement trial. Section 1498 does not provide a back door, cheaper “compulsory license” even for appropriate government use. The article authors and the New York Times would like to ignore the innovating pharmaceutical company’s R&D expenditures incurred beforehand and have the government compensate the company at significantly less than what it would receive under normal circumstances.

Aside from the flawed economic and legal argument underlying this price-control proposal, it represents an unprecedented use of § 1498, despite the claims by the article authors to the contrary. In the article, the authors assert that § 1498 was used exactly in this way in the 1950s and 1960s. But this is false: the federal government has never used § 1498 to authorize private companies to sell drugs to private consumers in the healthcare market in the United States. In these cases, the Department of Defense (“DoD”) relied on § 1498 to purchase military medical supplies from drug companies that infringed patents. Statements from agency heads during congressional hearings at the time confirm that the DoD, NASA, and the Comptroller General all understood the law as applying to procurement of goods for government use.

In other words, the government has never relied on or argued that § 1498 applies outside of the federal government procuring patented goods and services for its own use by its own agencies or officials. This is also true for government contractors: § 1498 shields a contractor’s infringement only while it is working directly for the federal government, and thus the private company cannot deliver the goods or services directly to private markets. If the contractor does this, its infringement falls outside the scope of § 1498, and it can be sued as a matter of private right directly for patent infringement under the patent laws.

Despite this significant commercial and legal difference between private companies working as contractors for the federal government and private companies selling products in the marketplace, the article authors (and thus the New York Times) claim otherwise. The New York Times, for instance, asserts that “In the late 1950s and 1960s, the federal government routinely used 1498 to obtain vital medications at a discount.” The New York Times further asserts that § 1498 “fell out of use” due mainly to the lobbying efforts of pharmaceutical companies. This is false. The historical record is absolutely clear that government agencies and courts have all applied § 1498 only to situations of government procurement and its own direct use. It has never been used to authorize private companies infringing patents for the sole purpose of selling the patented innovation to consumers in the free market.

The question then becomes whether § 1498 permits the federal government to simply declare certain patented products to be “too expensive” and this then justifies the government to indemnify private companies under its sovereign immunity to infringe the patent in selling the drug in the private healthcare market on the basis of this allegedly public purpose. Section 1498 has never been used in this way before, including when the government purchased drugs in the 1950s and 1960s. The authors of the article in the Yale Journal of Law and Technology claim they “recover this history and show how § 1498 can once again be used to increase access to life-saving medicines.” But § 1498 was never used in this way historically—the federal government has never used this law to permit private companies to sell drugs to private consumers in the private healthcare market. This proposal is an unprecedented use of a law in direct contradiction to its text and its 100+ years of application by federal agencies and courts.

Perhaps the most surprising aspect of the New York Times proposal is that it refers to § 1498 as an “obscure” provision of the patent law. First, it is not a statutory provision in the Patent Act, but rather is part of the federal statutes authorizing the judiciary to hear lawsuits. This underscores the early point that § 1498 was merely a technical fix to an unintended loophole existing since the 19th century that prevented, or at least complicated, patent owners suing the government for unauthorized uses by officials or agencies—even as the courts routinely opined that patents are property and that government should have to pay for their use. Second, while § 1498 may be “obscure” to the public at large, patent lawyers and government lawyers know this law very well. It is the bread and butter of government contract work and the legal basis of hundreds, if not thousands, of lawsuits against the federal government for over a century.

As the courts have long recognized, § 1498 is an eminent domain law. It provides a court with the authority to hear a lawsuit and award just compensation when the federal government or a person acting directly at its behest as its agent or contractor uses a patent without authorization. Section 1498 does not grant the government a new power to authorize infringement of a patent for the sole purpose of a company selling a product at a lower price in the market, effectively imposing de facto government price controls on drugs. The proposal in an academic journal and repeated by the New York Times to use § 1498 in this way is unprecedented. Even worse, it threatens the legal foundation of the incredible medical innovation in this country created by the promise to pharmaceutical companies of reliable and effective patent rights as a way to secure to them the fruits of their innovative labors.

*Evan Moore is a 2L at Antonin Scalia Law School, and he works as a Research Assistant at CPIP.

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Press Release

CPIP Announces Leadership Transitions

CPIP logoARLINGTON, Virginia – August 22, 2018 – The Center for the Protection of Intellectual Property (CPIP) announced today that Matthew Barblan, CPIP’s Executive Director, will leave the center this month to join the Association of American Publishers (AAP) as Vice President, Public Policy. “It has been an amazing journey working with such wonderful colleagues to build CPIP from the ground up over the past five years,” said Barblan. “I’m deeply grateful to my friends at CPIP and Scalia Law for making the center’s success possible, and I look forward to following CPIP’s growth and influence for years to come.”

Beginning on August 27, 2018, CPIP founder Adam Mossoff will become Executive Director of the center. “As a founding member of CPIP’s leadership team, Matt was absolutely essential to the success of the center over the last five years,” said Mossoff. “I will miss very much my day-to-day interactions with Matt at Scalia Law, but I’m looking forward to continuing to engage with him at future CPIP events on IP policy in his new role in representing the publishing industry.”

As part of the transition, longtime CPIP friend and senior scholar Sean O’Connor has joined CPIP as Director of International Innovation Policy. O’Connor will be an integral part of CPIP’s leadership team, focusing on law and policy issues regarding innovation and entrepreneurship, with a particular focus on international contexts.

“I’m excited about the future of CPIP, and it is a great pleasure to welcome Sean to the team,” said Henry N. Butler, Dean of Antonin Scalia Law School. “On behalf of the Scalia Law community, I also want to thank Matt for everything he has done over the past five years to take CPIP from idea to reality and build it into the successful center that it is today. Matt has been a great colleague and friend to the law school, and we wish him all the best in his new role at AAP.”

About the Center for the Protection of Intellectual Property

The Center for the Protection of Intellectual Property (CPIP) at Antonin Scalia Law School is dedicated to the scholarly analysis of intellectual property rights and the technological, commercial, and creative innovation they facilitate.

CONTACT:
Devlin Hartline
jhartli2@gmu.edu
703-993-8086

Categories
Copyright Copyright Licensing Copyright Theory Infringement Intellectual Property Theory Internet Reasonable Royalty Uncategorized

Despite What You Hear, Notice and Takedown is Failing Creators and Copyright Owners

cameraIn a recent op-ed in the LA Times, Professors Chris Sprigman and Mark Lemley praise the notice and takedown provisions of the Digital Millennium Copyright Act (DMCA) as “a bit of copyright law worth saving.” They argue that Section 512 of the DMCA continues to serve its purpose of balancing the rights of copyright owners and creators with those of Internet service providers (ISPs), while leaving both sides only “slightly disappointed.” Satisfying these two groups is indeed a difficult charge, but it’s simply disingenuous to suggest that creators and copyright owners are satisfied with a system so clearly in need of an overhaul.

As the Copyright Office embarks on its review of the DMCA, supporters and critics of the nearly twenty-year-old doctrine are weighing in on its effectiveness in addressing online infringement. Sprigman and Lemley claim that the “process has worked well for years,” and that the result of shifting more enforcement burden to ISPs “could be a broken Internet.” But for those creators and copyright owners who have their works resurface online just minutes after they are taken down, the Internet is already “broken.” The fact that piracy continues to intensify, despite incredible efforts to have infringing content taken down, shows that notice and takedown is largely ineffective.

As CPIP Senior Scholar Sean O’Connor testified before Congress, the notice and takedown system is not working for any of its intended beneficiaries. The constant game of whack-a-mole renders the system essentially futile for copyright owners and creators, and it creates significant burdens for ISPs that want to comply—especially small to mid-level companies that can’t afford compliance staff. Worse still, by shielding service providers from liability, the DMCA creates perverse incentives where there’s little downside to ignoring infringing content. In fact, reviewing content could lead to an ISP having knowledge of infringement and losing its safe harbor.

Now that the Copyright Office’s review is underway, it’s somewhat strange to see some supporters claim that all is well. But has anything actually changed since the Office announced its study?  Of course not. The whack-a-mole problem remains, and the knowledge standards are still interpreted broadly to disproportionately favor ISPs. When one side says the system is working and the other side says it’s broken, the truth is that the system is not working well for everyone. Sprigman and Lemley can claim that the DMCA is “worth saving” only by downplaying the true plight of creators and copyright owners.

A concrete example of this struggle comes from the comments filed by Universal Music Group (UMG) as part of the Copyright Office’s study. UMG describes the painstaking efforts devoted to protect just one artist’s creative work. In October of 2014, UMG and Big Machine Records launched a joint offensive to protect Taylor Swift’s “1989.” A staff of UMG employees dedicated 100% of their time and resources to manually search for infringements on YouTube, SoundCloud, and Tumblr, and through March of 2016, they had sent over 66,000 DMCA takedown notices. Despite their considerable efforts, over 500,000 links to the album were identified, and “1989” was illegally downloaded nearly 1.4 million times from torrent sites.

Of course, this type of effort would be impossible to replicate for any works other than those that attract such massive attention. For most artists, the burden of monitoring the Internet and sending takedown notices would fall entirely on their shoulders, with no guarantee of putting a stop to the theft of their works. Sprigman and Lemley ignore these problems, instead claiming that since copyright owners sent “more than 500 million takedown requests just to Google last year,” we know that the “system is a powerful tool against pirated content.” That would be great, if true, but the reality is that those notices barely made a dent.

Sprigman and Lemley claim that the “genius of the DMCA” is that it “enables entertainment companies to turn piracy into legitimate revenue.” They give the example of “YouTube’s Content ID system,” which “gives copyright owners the opportunity to ‘claim’ their work and share in any advertising revenue rather than pull it off the site.” From the perspective of creators and copyright owners, the only “genius” of this system is that YouTube can legally present them with an unfair choice—suffer infringement and get nothing or monetize and get next to nothing.

While Sprigman and Lemley praise the “more than $1 billion” paid out by YouTube, the real question is how much more copyright owners and creators would have been paid in a properly functioning market. YouTube is consistently teeming with infringing videos—one recent report revealed that over 180 million infringing videos had been removed in 2014 alone. And the artists that YouTube’s largess supposedly benefits are loudly complaining about their exploitation. If Content ID is so great, why are so many creators and copyright owners upset with the arrangement? The monetization Google offers to copyright owners and artists is less than half of the royalties paid out by streaming services like Pandora, an amount that artists have denounced as already inequitable.

In her excellent piece on the fictions of the Content ID system, Grammy-winning artist Maria Schneider exposes Content ID as a way for Google to cash in by actually legitimizing and perpetuating piracy. She explains that a majority of creators that opt for monetization realize miserable percentages of ad revenue, and the continued illegal uploading of their music and content drives billions of users to YouTube’s platform. YouTube has turned the weakness of the DMCA into a system that exploits artists while offering embarrassingly lower royalty rates than what would be negotiated in a free market.

The current situation is untenable, and if change means “breaking” the Internet, then we should pull out the pickaxes and get to work. A system of notice and staydown, rather than just takedown, would help alleviate the constant and seemingly ineffectual vigilance required by the current system. By removing all copies of a protected work and blocking inevitable re-postings, ISPs would honor the original purpose of the DMCA while actually doing their part to earn the protection of the safe harbor provisions. Only by ensuring that targeted works do not resurface will ISPs respect the rights of those without whose content they would cease to exist.

How anyone can honestly say that the current notice and takedown system is working for copyright owners and creators is mystifying given the constant calls for reform from creators and the numerous critical comments filed with the Copyright Office. The incredible magnitude of takedown notices sent and the seemingly unstoppable reappearance of infringing works online are a clear signal that the system is completely failing those it was meant to protect. Creators and copyright owners deserve a better chance at protecting the fruits of their labors, and the DMCA needs to be changed so that it truly is a system “worth saving.”