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Conferences Copyright

C-IP2 2022 Fall Conference Panel Discusses Copyright Under Pressure

The following post comes from Cala Coffman, a 2L at Scalia Law and Research Assistant at C-IP2.

At the recent C-IP2 conference entitled IP on the Wane: IP on the Wane: Examining the Impacts as IP Rights Are Reduced, one panel discussed the current state of copyright law, the pressures it has come under in recent years, and their differing perspectives on how the digital world is shaping copyright. Topics of discussion included enforcement techniques, trends in fair use, and the impact of evolving technology on copyright.

Panelists were Clark Asay (Professor of Law at Brigham Young University J. Reuben Clark Law School), Orit Fischman-Afori (Professor of Law at The Haim Striks School of Law, College of Management Academic Studies (COLMAN)), Terry Hart (General Counsel, Association of American Publishers (AAP)), and Karyn A. Temple (Senior Executive Vice President & Global General Counsel, (Motion Picture Association)), and the session was moderated by Sandra Aistars (Clinical Professor, George Mason University, Antonin Scalia Law School; Senior Fellow for Copyright Research and Policy; and Senior Scholar at C-IP2).

Professor Fischman opened the panel by proposing a reconsideration of criminal enforcement for copyright claims. After reviewing current avenues for civil copyright enforcement, including the newly established Copyright Claims Board in the Copyright Office, Digital Millennium Copyright Act, and civil enforcement in federal court including the opportunity for statutory damages, Professor Fischman suggested that criminal copyright enforcement actions seem to be on the decline and should not be a focus of enforcement efforts. Rather, greater attention should be devoted to civil enforcement. Recently, the U.S. Sentencing Commission reported that criminal Copyright and Trademark cases have dropped from 475 cases in 2015 to 137 cases in 2021.

Over the past two decades, several enforcement mechanisms have been introduced to address the challenges authors face enforcing their copyrights in the digital world. These include the Digital Millennium Copyright Act in 1998, the Digital Theft Deterrence Act of 1999, and the Copyright Alternatives in Small-Claims Enforcement Act of 2020, which improved access to enforcement for small creators by creating a new administrative forum with simplified proceedings in the Copyright Office. Small copyright claims can be pursued there with or without the assistance of counsel. While these civil enforcement mechanisms are effective, they have not been without criticism.

Ultimately, Professor Fischman argued that the combination of civil and criminal enforcement frameworks creates a powerful enforcement mechanism for author’s rights. As we consider the current state of IP rights, criminal enforcement is becoming less meaningful overall, in her opinion.

Next, Professor Asay presented three recent empirical studies examining trends in copyright litigation.

The first study indexed fair use cases from 1991 to 2017. In this study, Professor Asay examines the scope of fair use analysis in copyright infringement cases and finds a “steady progression of both appellate and district courts adopting the transformative use paradigm, with modern courts relying on it nearly ninety percent of the time.” The study finds that at the Federal Circuit Court level, in cases where transformative use was asserted, 48% were found to be transformative, and 91% of transformative uses were found to be fair use. Professor Asay states that “fair use is copyright law’s most important defense to claims of copyright infringement,” but as courts increasingly apply transformative use doctrine, he finds that “it is, in fact, eating the world of fair use.”

The second study Professor Asay presented analyzed over 1000 court opinions from between 1978 and 2020 that used a substantial similarity analysis. In this study, Professor Asay finds first that courts rely on opinions from the Second and Ninth circuits “more than any other source in interpreting and applying the substantial similarity standard.” The study also breaks down trends within the two-step substantial similarity analysis. On the first step, Professor Asay finds that “courts mostly decide this first prong . . . as a matter of whether defendant’s had access to the plaintiff’s work, and they mostly favor plaintiffs.” On the second step, he finds “significant heterogeneity” in analyzing improper appropriation of a plaintiff’s work. He states that “no dominant means exist for resolving this question” and “the data also suggest that one of the keys to winning, for either defendants or plaintiffs, is the extent to which the court engages with and discusses copyright limitations.”

The third study, which is forthcoming, examines DMCA Section 1201 litigation. DMCA Section 1201 prohibits attempts to circumvent technological measures used to control access to a copyrighted work.17 U.S.C. § 1201. This study encompasses 205 cases and 209 opinions, and Professor Asay said during the panel that “the most interesting finding in this study is that there’s not much section 1201 litigation.” Although the DMCA has been in force for nearly twenty-five years, less than one appellate decision is made per year on average. The study also finds that “the most litigated subject matter” (over every other subject matter the study coded for) is software.

Ms. Temple discussed how new technologies, techniques, and distribution methods are constantly requiring courts to re-evaluate how authorship rights function in a digital landscape. She likewise commented on the challenges courts seem to face in appropriately drawing distinctions between derivative uses of copyrighted works that should require a license from the author, and transformative uses that are permissible under the affirmative defense of fair use.

Ms. Temple cited the numerous briefs in Andy Warhol Foundation for the Visual Arts, Inc. v. Goldsmith (including the Motion Picture Association’s) that note that the transformative use test is becoming the sole criteria courts use to determine fair use. Indeed, the MPA’s brief cited to Professor Asay’s study on transformative use (Is Transformative Use Eating the World?) to support the petitioner’s assertion that “in practice, the transformativeness inquiry is virtually always dispositive of the fair use question.” In closing, Ms. Temple stated that although we may be “waning” in how courts see fair use, Warhol presents a chance to correct the fair use analysis and steer it away from infringing on the derivative work rights of authors.

Finally, Mr. Hart presented on potential threats to authorship rights and the concomitant harms to consumer interests in the e-book arena. Mr. Hart’s perspective was that as businesses, copyright industries legitimately have profit-motivated goals, but happily, their ability to meet these goals is directly tied to the “ultimate goal” of promoting science and the useful arts and thus is beneficial to society as a whole. Mr. Hart stated that “the good news, if we think copyright [protections are] waxing, is that . . . the legal framework both in the United States and internationally recognizes [the] principles” that allow copyright owners to take advantage of and divide their exclusive rights. However, digitization may pose a threat to the ability to license rights as the copyright owner desires, as digital copying and transmission greatly increases risk of infringement of e-books.

The e-book market is unique, according to Mr. Hart, in that authors may be particularly vulnerable to digital threats when “digital copies are completely indistinguishable from the originals, and so they would be competing directly with the copyright owner’s primary markets.” Furthermore, he stated that “threats to the ability of copyright owners . . . to pursue rational choices in how they market and distribute their works can be just as harmful as straight up piracy.”

Mr. Hart characterized the e-book market as a thriving, sustainable economy. E-books have been popular for over a decade now, and there are a “variety of licensing models [available] . . . that continue to evolve to meet both the needs of publishers and libraries.” Mr. Hart stated, “the evidence shows that this is a well-functioning market.” He said that “Overdrive, which is the largest e-book aggregator, reported that in 2021 there was over half a billion check-outs of library e-books worldwide, and the pricing is, in my view, fair and sustainable.” Additionally, Mr. Hart said, “Overdrive also reported . . .  that the average cost per title for libraries declined in 2021, and libraries have been able to significantly grow their e-book collections . . . with collection budgets that, when you’ve adjusted for inflation, have essentially been flat the entire time.”

One of the major threats to authorship rights in the e-book market, in Mr. Hart’s view, is the rise of Controlled Digital Lending (CDL). While this theory is currently being litigated in Hachette Book Group v. Internet Archive, Mr. Hart posits that we are only a few steps from a full-blown digital first-sale doctrine, which could have widespread harms throughout copyright for many types of authors. Many amicus briefs in the Internet Archive case have identified this potential harm, as well. According to Hart, the Copyright Alliance brief, for example, stated that a ruling in favor of CDL would have extremely widespread economic harms for authors.

The second threat Mr. Hart identified comes from recent propositions at the state level that would introduce compulsory licenses for e-books. These proposed laws would outlaw limitations on e-book licenses offered to libraries and allow states to dictate what states believe are “reasonable” pricing for e-book licenses. A flaw in both the arguments for CDL and for compulsory e-book licensing, as Mr. Hart sees it, is that both approaches treat the mere exercise of a copyright owner’s exclusive right as unfair and, if accepted, would be dangerous encroachments on authorship rights.

Ultimately, while the panelists identified significant concerns in the existing copyright regime, they were hopeful about the future of authorship rights, reflecting that even if the protections for copyright law had “waned” in certain respects in recent years, and certain rights remain in peril, there are opportunities for education as courts confront the significant changes that accompany an increasingly digital landscape.

Categories
Copyright Innovation Patents Pharma

IP Industries Step Up in This Time of Crisis

the word "inspiration" typed on a typewriterThe global COVID-19 pandemic has challenged multiple aspects of modern society in a short time. Health and public safety, education, commerce, research, arts, and even basic government functions have had to change dramatically in the space of a couple months. Some good news in all this is the response of many companies in the intellectual property (IP) industries: they are stepping up to make sure crucial information and materials are available to speed research and development (R&D) towards vaccines, therapeutics, and medical devices. This blog post gives a sampling of the current initiatives facilitating the best innovative work the world has to offer.

Bio-pharmaceutical companies

Bio-pharmaceutical (bio-pharma) companies have been leading the charge, collaborating with academic and government partners to advance vaccine and therapy candidates on a fast track. While there have been isolated stories of some IP-related issues for rapid deployment and use of medical devices such as ventilators, the overall message is clear that research, development, and deployment have not been hindered by IP rightsholders. In fact, problems for distribution of medicines, personal protective equipment, and medical devices have little to do with IP rights but rather with hoarding and nationalistic impulses by governments.

Examples of rapid response are abundant. In February, the Department of Health and Human Services and its Biomedical Advanced Research and Development Authority (BARDA) partnered with the Janssen Research & Development unit of Johnson & Johnson to investigate a promising vaccine candidate. Janssen also committed to invest in the scale-up of production and manufacturing capacities to produce the vaccine candidate if it succeeds through clinical trials. By mid-March, 50 drugs that might fight the virus had been identified by collaborations of hundreds of scientists. Research continues apace and 80 clinical trials are proceeding, some on fast track status including a potential vaccine.

Beyond its core R&D, regulatory, manufacturing, and distribution mission, the bio-pharma industry is providing direct support to many places in need. This includes donations of medical supplies and personal protective equipment (PPE), existing treatments and medicines, and monetary and in-kind support.

At the same time, private incentives are more important than ever to get novel vaccines, drugs, and devices out to the world in safe, efficacious form and at scale. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, has long recognized that exclusive licenses of IP to bio-pharma industry partners are necessary to get innovative vaccines and drugs to the public:

“We always need a pharmaceutical partner,” [Fauci] told CQ Roll Call in October 2017. “I can’t think of a vaccine, even one in which we’ve put substantial intellectual and resource input, that was brought to the goal line without a partnership with industry. So this is a very natural process that we’re doing right now.”

He argued that for vaccines like Zika, which might predominantly be used in low-income countries, drugmakers don’t see a lot of financial incentive to get involved, which is why the NIH needs to grant exclusive licenses. But he argued that the process hasn’t had an impact on vaccine affordability.

“I have not seen in my experience situations in which we were involved in the development of a vaccine, particularly for low- and middle-income countries that really needed it, where the pharmaceutical companies priced it out of their reach,” Fauci said.

Likewise, as noted innovation scholars Daniel J. Hemel and Lisa Larrimore Ouellette point out in a recent article, Innovation Policy Pluralism, multiple vectors of public and private incentives and resources work together to advance pioneering innovation. Even in countries with a national health or single payer system, the government health program does not manufacture vaccines, drugs, or devices. Instead, it relies on private firms that in turn work closely and well with public and academic researchers to identify pressing problems, locate relevant basic science advances, and then translate those into actual vaccines, therapies, or devices.

The myth of patients and the public “paying twice” for bio-pharma innovation arising from public-private partnerships is pernicious. It conflates the distinction between basic science research and drug or vaccine candidates, on the one hand, with compounds that can be produced at scale, distributed safely, and that have passed arduous clinical trials to demonstrate safety and efficacy. In the United States, private companies must foot the entire bill for these clinical trials, which run into hundreds of millions of dollars over three phases that enroll thousands of subjects. Simply stated, publicly funded research does not result in a substance or compound that can be manufactured and distributed as is with no further R&D or clinical trials.

A related myth is that governments should use compulsory licenses and similar mechanisms to bypass IP rights holders in an effort to speed research and delivery of drugs and vaccines—when they emerge—to the public at low to no cost. First, there are important distinctions between compulsory licenses, U.S. Bayh-Dole style march-in rights, and government use under statutory provisions like 28 USC 1498, which we have outlined here. But across all of them, IP rights holders must still be compensated at a fair market license rate. Thus, there are no “savings” of IP royalties that could lower the price of vaccines or drugs. This makes sense as we don’t force manufacturers to produce drugs or vaccines for free. Even the Defense Production Act merely directs production, it does not require manufacturers to produce goods for free.

Finally, even if patents could be disregarded, we should be careful about encouraging “open source” or amateur production of regulated devices like ventilators. While the FDA has authorized some limited modifications of approved ventilators to accommodate the exigencies of COVID-19, this does not create a free-for-all in which wholesale changes or entirely new designs of the device or its components can be used. We need to take care that these modifications or new designs are actually safe and efficacious. Thus, while innovation like that of famed inventor James Dyson is most welcome, it does not actually solve the immediate problem of a shortage of ventilators as national regulators must still test and approve these untested devices for medical use. And at any rate, Dyson is not offering their new ventilators for free, even as they are designed to be produced at lower costs and sell at a lower point price in the market.

Thus, we need the bio-pharma industry more than ever to get through this pandemic. Large established firms and nimble start-ups have the resources and expertise to innovate and produce vaccines, drugs, and devices that will pass regulatory muster for safety and efficacy. Now is not the time to attack the patent system and weaken incentives for full-steam-ahead bio-pharma and medical device R&D.

Scientific publishing

Similar to the bio-pharma companies, publishers have been leading the way in making crucial scientific and technological information widely available in order to help fight the global coronavirus pandemic. An open letter from Kelvin Droegemeier, Director of the White House Office of Science and Technology Policy (OSTP) and member of President Trump’s Coronavirus Task Force, issued the call to arms last month (for example, see here, here, and here). Joined by government science leaders from eleven other countries—Australia, Brazil, Canada, Germany, India, Italy, Japan, Republic of Korea, New Zealand, Singapore, and United Kingdom—the letter called for publishers to make all research and data related to the coronavirus available immediately to the public. Publishers were quick to respond positively to the letter, pointing out that many journals had already been opened up to the public in an effort to support the dissemination of important scientific research and data when it is needed the most.

In the letter, the government science leaders stated: “To assist efforts to contain and mitigate the rapidly evolving COVID-19 pandemic, basic science research and innovation will be vital to addressing this global crisis. Given the urgency of the situation, it is particularly important that scientists and the public can access research outcomes as soon as possible.” The leaders asked the publishers to voluntarily agree to make their coronavirus-related publications, and the data supporting them, immediately accessible in PubMed Central and other public repositories. PubMed Central refers to the digital archive of biomedical and life sciences journal literature at the U.S. National Institutes of Health’s National Library of Medicine. The leaders also requested that the information be made available in both human and machine-readable format to allow for text and data mining using artificial intelligence.

The same day that the government science leaders sent their letter, Maria Pallante, President and CEO of the Association of American Publishers (AAP), issued a statement noting that the organization and its members would be happy to continue doing their part in making the research and data available to the public:

Publishers purposefully and continuously contribute to the advancement of science and medicine by investing billions of dollars in producing and disseminating high-quality, peer-reviewed journal articles. In this urgent and serious environment, we are grateful to the many publishers who are doing their part to communicate valuable discoveries, analyses, and data as quickly as possible, including by making their copyrighted articles pertaining to the virus freely available for public use during this crisis, in both text and machine-readable formats. Many publishers – both commercial companies and nonprofit societies – have been doing so for weeks.

 

Likewise, Elsevier, which specializes in publishing global information on science and health, has taken the lead in ensuring that relevant scientific information is available to the public. Back in January, Elsevier set up its Novel Coronavirus Information Center, offering free health and medical research information on the coronavirus and COVID-19, the disease that is causes. The Information Center is updated daily with the latest research information, including links to nearly 20,000 peer-reviewed journal articles on its ScienceDirect platform that are curated by clinicians and other experts. The information is intended for use by practitioners, such as nurses and doctors, as well by patients and their families. In response to the letter from the government science leaders, Elsevier announced in a press release that same day that the information would be made available to PubMed Central and other publicly funded repositories, including in machine-readable format that could be used for full text and data mining.

Kumsal Bayazit, the CEO of Elsevier, also released a statement that day underscoring Elsevier’s continued leadership on this front and concluding:

In working with the White House to improve the discoverability and utility of this important body of knowledge, we are now making it available to PubMed Central and other publicly funded repositories such as the WHO COVID database for full text and data mining and without any limitations for as long as needed while the public health emergency is ongoing. Through this partnership we hope to help researchers to keep up with the rapidly growing body of literature and identify trends as countries around the world address this global health crisis.

 

Numerous other publishers have stepped up as well. Wiley announced that it “is making all current and future research content and data on the COVID-19 Resource Site available to PubMed Central” and “other publicly funded repositories, such as the World Health Organization (WHO) COVID-19 database and Wellcome Trust.” The Resource Site was set up by Wiley in February in order to ensure rapid, public access to COVID-19 research, and in response to the request of the government science leaders, Wiley is now inputting that information into PubMed Central and other publicly-accessible databases. Likewise, Springer Nature stated: “We have made available, for free, all relevant research we have published and continue to publish, [and] are strongly urging our authors submitting articles related to this emergency to share underlying datasets relating to the outbreak as rapidly and widely as possible.” Other publishers, such as American Chemical Society, PLOS, STM Publishing, IOP Publishing, Emerald Group Publishing, F1000 Research, and eLife Research, have committed themselves to the cause of making their coronavirus research and data available publicly.

It is not just scientific research that is being freely shared by publishers. Textbooks for students affected by the pandemic have been made available as well. Wiley recognized the need “to ensure instructors who need to teach remotely have the necessary tools to help their students,” and it opened up its online textbooks so that instructors “can receive free access for their students for the remainder of the Spring 2020 term.” Barnes & Noble announced that it was joining VitalSource and other leading publishers to provide free online textbooks for students at schools where it operates a campus bookstore. Michael P. Huseby, CEO and Chairman of Barnes & Noble Education, said: “Our top priority remains providing schools and students with solutions during this time of unprecedented disruption, while simultaneously protecting the health and safety of our employees and customers.” Other textbook publishers, including Cengage, Gale, Cambridge University Press, among many others, have done the same in order to make the transition to online learning as smooth as possible by ensuring that students have online access to the textbooks that they need.

Categories
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