Elsevier – UA LAW IP

the word "inspiration" typed on a typewriter The 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.

Ever since the U.S. Copyright Office announced its study of the DMCA last December, the notice-and-staydown issue has become a particularly hot topic. Critics of notice-and-staydown have turned up the volume, repeating the same vague assertions about freedom, censorship, innovation, and creativity that routinely pop up whenever someone proposes practical solutions to curb online infringement. Worse still, many critics don’t even take the time to look at what proponents of notice-and-staydown are suggesting, choosing instead to knock down an extremist straw man that doesn’t reflect anyone’s view of how the internet should function. A closer look at what proponents of notice-and-staydown are actually proposing reveals that the two sides aren’t nearly as far apart as critics would have us believe. This is particularly true when it comes to the issue of how well notice-and-staydown would accommodate fair use.

For example, Joshua Lamel’s recent piece at The Huffington Post claims that “innovation and creativity are still under attack” by the “entertainment industry’s intense and well-financed lobbying campaign” pushing for notice-and-staydown. Lamel argues that the “content filtering proposed by advocates of a ‘notice and staydown’ system . . . would severely limit new and emerging forms of creativity.” And his parade of horribles is rather dramatic: “Parents can forget posting videos of their kids dancing to music and candidates would not be able to post campaign speeches because of the music that plays in the background. Remix culture and fan fiction would likely disappear from our creative discourse.” Scary stuff, if true. But Lamel fails to cite a single source showing that artists, creators, and other proponents of notice-and-staydown are asking for anything close to this.

Similarly, Elliot Harmon of the Electronic Frontier Foundation (EFF) argues that “a few powerful lobbyists” are pushing for notice-and-staydown such that “once a takedown notice goes uncontested, the platform should have to filter and block any future uploads of the same allegedly infringing content.” Harmon also assumes the worst: “Under the filter-everything approach, legitimate uses of works wouldn’t get the reasonable consideration they deserve,” and “computers would still not be able to consider a work’s fair use status.” Like Lamel, Harmon claims that “certain powerful content owners seek to brush aside the importance of fair use,” but he doesn’t actually mention what these supposed evildoers have to say about notice-and-staydown.

Harmon’s suggestion that the reliance on uncontested takedown notices gives inadequate consideration to fair use is particularly strange as it directly contradicts the position taken by the EFF. Back in October of 2007, copyright owners (including CBS and Fox) and service providers (including Myspace and Veoh) promulgated a list of Principles for User Generated Content Services. These Principles recommend that service providers should use fingerprinting technology to enact notice-and-staydown, with the general caveat that fair use should be accommodated. Two weeks later, the EFF published its own list of Fair Use Principles for User Generated Video Content suggesting in detail how notice-and-staydown should respect fair use.

The EFF’s Fair Use Principles include the following:

The use of “filtering” technology should not be used to automatically remove, prevent the uploading of, or block access to content unless the filtering mechanism is able to verify that the content has previously been removed pursuant to an undisputed DMCA takedown notice or that there are “three strikes” against it:

1. the video track matches the video track of a copyrighted work submitted by a content owner;
2. the audio track matches the audio track of that same copyrighted work; and
3. nearly the entirety (e.g., 90% or more) of the challenged content is comprised of a single copyrighted work (i.e., a “ratio test”).

If filtering technologies are not reliably able to establish these “three strikes,” further human review by the content owner should be required before content is taken down or blocked.

Though not explicitly endorsing notice-and-staydown, the EFF thinks it’s entirely consistent with fair use so long as (1) the content at issue has already been subject to one uncontested takedown notice, or (2) the content at issue is at least a 90% match to a copyrighted work. And the funny thing is that supporters of notice-and-staydown today are actually advocating for what the EFF recognized to be reasonable over eight years ago.

While Harmon never explicitly identifies the “powerful lobbyists” he accuses of wanting to trample on fair use, he does link to the Copyright Office’s recently-announced study of the DMCA and suggest that they can be found there. Reading through that announcement, I can only find three citations (in footnote 36) to people advocating for notice-and-staydown: (1) Professor Sean O’Connor of the University of Washington School of Law (and Senior Scholar at CPIP), (2) Paul Doda, Global Litigation Counsel at Elsevier, and (3) Maria Schneider, composer/conductor/producer. These three cites all point to testimonies given at the Section 512 of Title 17 hearing before the House Judiciary Committee in March of 2014, and they show that Harmon is attacking a straw man. In fact, all three of these advocates for notice-and-staydown seek a system that is entirely consistent with the EFF’s own Fair Use Principles.

Sean O’Connor seeks notice-and-staydown only for “reposted works,” that is, “ones that have already been taken down on notice” and that are “simply the original work reposted repeatedly by unauthorized persons.” His proposal only applies to works that “do not even purport to be transformative or non-infringing,” and he specifically excludes “mash-ups, remixes, covers, etc.” This not only comports with the EFF’s recommendations, it goes beyond them. Where the EFF would require either a previously uncontested notice or at least a 90% match, O’Connor thinks there should be both an uncontested notice and a 100% match.

The same is true for Paul Doda of Elsevier, who testifies that fingerprinting technology is “an appropriate and effective method to ensure that only copies that are complete or a substantially complete copy of a copyrighted work are prevented or removed by sites.” Doda explicitly notes that filtering is not suitable for “works that might require more detailed infringement analysis or ‘Fair Use’ analysis,” and he praises YouTube’s Content ID system “that can readily distinguish between complete copies of works and partial copies or clips.” Doda’s vision of notice-and-staydown is also more protective of fair use than the EFF’s Fair Use Principles. While the EFF suggests that a previously uncontested notice is sufficient, Doda instead only suggests that there be a substantial match.

Unlike O’Connor and Doda, Maria Schneider is not a lawyer. She’s instead a working musician, and her testimony reflects her own frustrations with the whack-a-mole problem under the DMCA’s current notice-and-takedown regime. As a solution, Schneider proposes that creators “should be able to prevent unauthorized uploading before infringement occurs,” and she points to YouTube’s Content ID as evidence that “it’s technically possible for companies to block unauthorized works.” While she doesn’t explicitly propose that there be a substantial match before content is filtered, Schneider gives the example of her “most recent album” being available “on numerous file sharing websites.” In other words, she’s concerned about verbatim copies of her works that aren’t possibly fair use, and nothing Schneider recommends contradicts the EFF’s own suggestions for accommodating fair use.

Lamel and Harmon paint a picture of powerful industry lobbyist boogeymen seeking an onerous system of notice-and-staydown that fails to adequately account for fair use, but neither produces any evidence to support their claims. Responses to the Copyright Office’s DMCA study are due on March 21st, and it will be interesting to see whether any of these supposed boogeymen really show up. There’s little doubt, though, that critics will continue attacking the notice-and-staydown straw man. And it’s really a shame, because advocates of notice-and-staydown are quite conscious of the importance of protecting fair use. This is easy to see, but first you have to look at what they’re really saying.

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