Categories
Copyright Legislation

Senate IP Subcommittee Considers the Role of Private Agreements and Existing Technology in Curbing Online Piracy

The following post comes from Liz Velander, a recent graduate of Scalia Law and a Research Assistant at CPIP.

U.S. Capitol buildingBy Liz Velander

In mid-December, the Senate Intellectual Property Subcommittee, led by its Chairman, Senator Thom Tillis (R-NC), held a hearing entitled “The Role of Private Agreements and Existing Technology in Curbing Online Piracy.” The hearing came ahead of Sen. Tillis’s release of his first discussion draft of legislation to reform the Digital Millennium Copyright Act (DMCA). In his opening remarks, Sen. Tillis stated that reforming the DMCA is one of his top priorities in the 117th Congress, but it may take his entire second term to get a DMCA reform bill across the finish line. The purpose of the hearing was to identify voluntary steps that copyright owners and tech companies can take now to curb online infringement.

The hearing consisted of two panels. Panel I included: Ruth Vitale, CEO, CreativeFuture; Probir Mehta, Head of Global Intellectual Property and Trade Policy, Facebook, Inc.; Mitch Glazier, Chairman and CEO, Recording Industry Association of America (RIAA); and Joshua Lamel, Executive Director, Re:Create. Panel II included: Katherine Oyama, Global Director of Business Public Policy, YouTube; Keith Kupferschmid, CEO, Copyright Alliance; Noah Becker, President and Co-Founder, AdRev; and Dean Marks, Executive Director and Legal Counsel, Coalition for Online Accountability.

Sen. Tillis began the hearing by voicing his opinion on the matter, informed by a year-long series of hearings and months of feedback from creators, user groups, and technology companies. “There is absolutely more big tech can and should do to stop online piracy,” Sen. Tillis said. “Unfortunately, it seems that some in big tech aren’t serious about stopping online piracy, and I don’t know why that is. Maybe it isn’t a priority—or maybe some companies are actually profiting off the piracy on their site. It is clear as day to me that many multi-national, multi-billion-dollar companies simply aren’t using all the tools they have to stop theft from small creators. And that’s wrong.”

Mitch Glazier, Chairman and CEO of RIAA, stated that the problem is that big tech companies aren’t properly incentivized to take steps in combatting online piracy. Keith Kupferschmid, CEO of the Copyright Alliance, explained that Section 512 of the DMCA has been so misinterpreted by the courts that most service providers know that they have little risk of liability and need only do the absolute minimum required under the DMCA to avoid liability.

Mr. Glazier said that one of the most important things Congress can do is to provide the right incentives to encourage voluntary private agreements. He explained that there are two types of private agreements. First, there are individual agreements entered into by copyright owners and technology providers. These can be nimble and evolve with technology. Second, there are standards developed in the marketplace that eventually achieve broad enough consensus and use that they become required. In Mr. Glazier’s view, that is what the DMCA contemplated—a multi-stakeholder standard technical measure (STM) process where there was enough consensus and use that it would be unfair for outliers to compete without using them. Mr. Glazier said that a voluntary system only works if there exist the right incentives, which the DMCA does not currently provide.

The panelists disagreed as to whether Congress needs to reform the DMCA in order to incentivize voluntary agreements. The panelists representing big tech companies asserted that the process is working as the DMCA intended, pointing to the policies and procedures of their platforms and existing content protection technology. Probir Mehta, Head of Global IP and Trade Policy at Facebook, touted Facebook’s content management tool, Rights Manager. Katherine Oyama, Global Director of Business Public Policy at YouTube, pointed to Youtube’s Copyright Management Tools, which include a webform, Content ID, and Copyright Match. These panelists emphasized the significant amount of work their companies undertook to create these technologies, which they view as going above and beyond the requirements of the DMCA.

Members of the IP Subcommittee were very interested to hear how these tools work in practice. Ruth Vitale, CEO of CreativeFuture, testified that most individual creators are not given access to YouTube’s Content ID, nor are they given an explanation for why they are denied. Ms. Oyama stated that while Content ID has eligibility requirements, YouTube built an entirely new tool for smaller creators, Copyright Match, which runs on Content ID itself. She claimed that Content ID is such a powerful tool that, if used improperly, will erroneously take down content that is noninfringing.

Ranking Member Senator Chris Coons (D-DE) wanted to know what the panelists viewed as the path forward. Mr. Kupferschmid said that while voluntary agreements have a role, they cannot address everything. He emphasized that legislative action is appropriate in this circumstance because service providers are not being cooperative. Noah Becker, President and Co-Founder of AdRev, a digital rights management and media technology company, agreed with Mr. Kupferschmid. He explained his business’ revenue-sharing proposition is a better fit for copyright owners that do not want to use YouTube’s monetization tools. In addition to legislation, he explained that there should be some sort of support for the concept of a list of approved vendors, like AdRev, to be able to access copyright APIs on massive platforms. He urged that this would reduce the large cost and technology burden of accessing APIs, making takedowns more affordable for creators.

Sen. Tillis closed the hearing by stating that the parties need to engage with one another in order to avoid a potential legislative overreach. He said that the hearing showed that tech companies must do more to combat online piracy. Sen. Tillis stressed that they have the tools and resources but must find ways to get greater engagement and create voluntary paths to prevent Congress from paving less voluntary ones.

Categories
Antitrust Patent Law Pharma

USPTO-DOJ Workshop on Promoting Innovation in the Life Science Sector: Day Two Recap

The following post comes from Austin Shaffer, a 2L at Scalia Law and a Research Assistant at CPIP. 

night view of Washington, D.C.By Austin Shaffer

This past fall, the Department of Justice (DOJ) and U.S. Patent and Trademark Office (USPTO) hosted day two of their public workshop to discuss the importance of intellectual property rights and pro-competitive collaborations for life sciences companies, research institutions, and American consumers. While day one focused on how patents and copyrights impact collaboration and innovation for business development in life science technologies, day two concentrated on competition, collaboration, and licensing, and how those tools can promote access to therapeutics, diagnostics, and vaccines. Video of day two of the workshop is available here, and our summary of day one is available here.

Welcome Remarks, Fireside Chat, and Program Overview

Makan Delrahim, Assistant Attorney General for the DOJ Antitrust Division, kicked off day two with some opening remarks, emphasizing the significant role that IP and antitrust play to encourage innovation and healthy competition as entities around the globe race to find a COVID vaccine.

Mr. Delrahim was then joined by USPTO Director Andrei Iancu for a fireside chat, moderated by Judge Kathleen O’Malley of the U.S. Court of Appeals for the Federal Circuit. Mr. Iancu spoke to the critical pro-competitive role of patents at this time, as they incentivize innovation and disclosure and create transferrable financial instruments. Indeed, obtaining a patent boosts viability and employment growth, particularly for small companies. Additionally, Mr. Iancu highlighted some of the measures that the USPTO is taking to foster innovation and collaboration in the life science sector. One such measure, the Patents 4 Partnerships program, provides the public with a user-friendly, searchable repository of patents and published applications related to the COVID pandemic that are available for licensing. Additionally, the USPTO has extended deadlines and discounted application fees pursuant to the CARES Act.

Following the fireside chat, David Lawrence, Chief, Competition Policy & Advocacy Section at the DOJ, gave a brief overview of the day’s program. Mr. Lawrence noted that the life science sector relies on both competition and collaboration—the key question throughout the upcoming panels is where to draw the line at the cross-section of those factors to promote efficiency and effectiveness.

Session V: Collaboration and Licensing Strategies

Partnerships can serve as a key tool in the development of therapeutics and vaccines from initial research, through product development and clinical trials, and into the market-ready stage. These partnerships and various licensing strategies are particularly relevant to addressing the current pandemic. This panel focused on public-private partnerships, private partnerships, exclusive versus non-exclusive licensing, ownership rights, and information pooling.

The panel included Laura Coruzzi of Regenxbio, Lauren Foster from MIT, Prof. Sheridan Miyamoto from Penn State University, Mita Mukherjee of Emergent BioSolutions, Mark Rohrbaugh of the NIH, and Dick Wilder of the Coalition for Epidemic Preparedness Innovations, and it was moderated by DOJ Deputy Associate Attorney General Brian Pandya.

Each panelist took a turn discussing the role of collaboration in the development of therapeutics and vaccines. Ms. Coruzzi said that while collaboration is important throughout product development, it is particularly critical in the early research stage. Gene therapy research is precariously risky, and investors tend to stay away from those endeavors. Collaboration between multiple entities leads to a higher success rate, thereby providing a greater incentive for investors to get on board. Ms. Mukherjee explained that while big pharma has the expertise in researching and developing a marketable product, the initial work is often more appropriate for smaller, niche companies.

Ms. Foster explained that at MIT, the mission is to make technology broadly available, and by prudently engaging in a collaborative relationship, they can better ensure advancement. While the NIH approaches licensing in a similar manner to MIT, Mr. Rohrbaugh noted some of the statutory requirements and regulations that govern the NIH’s ability to license, such as the requirement to post on the Federal Register for comment. Mr. Wilder argued that the key to successful collaboration is to manage projects on a collective basis to ensuring that the resulting IP is used properly.

Turning to recent developments in licensing structures, Mr. Pandya noted the recent increase in invalidation of IP rights and posed the question: How has this negatively impacted licensing? Ms. Coruzzi cited Mayo v. Prometheus, a 2012 Supreme Court case which held that a natural phenomenon must be sufficiently added upon or transformed in order to make an idea, formula, mechanism, or test patentable. That decision, she argued, has squandered tax-funded university research and placed the U.S. at a competitive disadvantage with other countries that protect purified or engineered natural products. She called on the legislature to fix a decision that “knocked the legs out of patents.”

Session VI: How do Regulation and Antitrust Enforcement Impact Competition and Incentives for Innovation?

The extent to which regulation and antitrust enforcement are necessary to maintain competition is a contested issue, and the answer can have a significant impact on the incentives for innovation. The panelists in this session considered the tradeoffs between the two and the resulting consequences, especially within the context of a pandemic.

The panel included Alden Abbott of the FTC, Prof. Ernst Berndt from MIT, David Kappos of Cravath, Swaine & Moore, Prof. William Kovacic from George Washington University Law School, and Dick Wilder of the Coalition for Epidemic Preparedness Innovations, and it was moderated by Deputy Assistant Attorney General Alexander Okuliar.

Mr. Kappos argued that the patent system has been disabled and marginalized in its role of incentivizing innovation and bringing ideas from the university level to the marketplace for a variety of reasons. Mentioning a host of companies that agree, Mr. Kappos deemed the patent system broken, calling on congressional reform of 35 U.S.C. § 101. From his observations, our restricted statutory scheme has caused investment to flee elsewhere, recent Supreme Court decisions have resulted in decreased overall investment, and venture capital funding is decreasing in patent-reliant sectors.

Pertinent to regulation and antitrust enforcement concerns, several of the panelists pointed to the March 2020 FTC-DOJ Joint Statement as a positive step forward. The statement outlined ways that firms, including competitors, can engage in collaboration for the purpose of public health and safety protection without violating the antitrust laws. Mr. Kovacic called on further FTC and DOJ action, explicating that those agencies have the capacity to analyze the effects of previous policymaking on the life science sector that can provide useful guidance moving forward.

Session VII: Competition and Collaboration: Examining Competitive Effects and Antitrust Risks Associated with Collaborations

In this session, the panelists discussed what makes a collaboration or partnership successful and procompetitive, antitrust concerns that can arise, and potential safeguards that can reduce antitrust risk.

The panel included William Diaz of Amgen, Andrew Finch of Paul Weiss, Prof. Luba Greenwood from Harvard University, and Chuck Loughlin of Hogan Lovells, and it was moderated by the DOJ’s Jennifer Dixton, Special Counsel for Policy & Intellectual Property, Antitrust Division.

Mr. Finch started off the penultimate panel by identifying the hallmarks of a successful joint venture: mechanisms that enable participants in the venture to increase output, clear boundaries as to the scope of the venture, and safeguards to make sure the venture stays “on the rails.” He proposed a “red-yellow-green” system that lawyers can articulate to business clients to let them know what can and cannot be shared, and when to seek advice from counsel for further guidance. Mr. Diaz echoed those sentiments, adding that ventures need a clear charter from the onset of the relationship that provides comprehensive plans for what to do in a variety of scenarios. Also, he continued, it is imperative to keep detailed meeting agendas to avoid members straying into discussions that might raise antitrust concerns.

The panelists went on to commend the usefulness of the DOJ’s Business Review Letters, which provide unusually expedited advisory guidance to firms wondering whether their collaborations will pass antitrust muster. Ms. Dixton, fielding those comments as moderator and in her capacity at the DOJ, then posed a final question to the panel: What else could the Department be doing? The panelists called for updates to the FTC-DOJ Antitrust Guidelines for Collaborations Among Competitors. While still useful, the Guidelines have not been updated in twenty years, leaving many gray areas in today’s world.

Keynote Speech

The keynote speech was delivered by Dr. Elias Zerhouni, Emeritus Professor of Radiology and Biomedical Engineering and Senior Advisor at Johns Hopkins Medicine.

Dr. Zerhouni shared his wealth of life science knowledge and experience in the day’s keynote speech. He made a key point when it comes to the need for collaboration to combat COVID: no single university, single company, or even single country is able to address modern biological issues by themselves—the amount of data generated in the life science sector is simply beyond the capabilities of one player.

Dr. Zerhouni agreed with some of the previous panelists that developments in the patent system have changed the structure of innovation and created a difficult market to negotiate in. He argued for statutory reform that will allow US innovators to pool their IP together to operate more effectively. Although there are many contributing factors to the current state of the patent system, Dr. Zerhouni referred to the Federal Circuit’s 2002 decision in Madey v. Duke University as an inhibitor to pre-competitive innovation. (Madey held that the experimental use defense applied only to acts taken for amusement, to satisfy curiosity, or for strictly philosophical inquiry).

Session VIII: Academics’ and Economists’ Views on Collaboration and Competition

The final panel featured the perspectives of experts from academia and the field of economics, including Prof. Rena Conti from Boston University, Prof. Scott Hemphill from NYU School of Law, Richard Manning of Bates White Economic Consulting, and Prof. Joanna Shepherd from Emory Law School, and it was moderated by Patrick Greenlee, Economist with the DOJ’s Antitrust Division.

Mr. Greenlee asked one question of the final panel: Are the current prices for life sector IP too high? That question fielded diverse opinions and evaluations. Mr. Manning said there is no cause for worry because the profit margins “aren’t that big.” Prof. Shepherd agreed, citing historically low lifetime revenues for new drugs, resulting in decreasing returns on R&D for pharmaceutical companies. Prof. Hemphill took a step back, arguing that our economic knowledge is still too limited to know the optimal level for the collaboration-competition tradeoff. Prof. Conti contended that we may be looking at the system entirely wrong—when evaluating mergers and the value of IP assets, the value of labor and manufacturing assets and access to raw materials is often overlooked.

Conclusion

Overall, the second day of the DOJ-USPTO workshop on promoting innovation in the life science sector left us with a lot to consider in the coming months as COVID vaccinations continue to be developed and distributed. What is the optimal level of antitrust enforcement? How can firms effectively, and legally, take advantage of licensing strategies and collaboration to expedite development? Does our patent system need to be reformed in the wake of the pandemic? These are questions of the upmost importance for our industry leaders and policymakers to consider and solve.

Categories
Copyright Patent Law Pharma

USPTO-DOJ Workshop on Promoting Innovation in the Life Science Sector: Day One Recap

The following post comes from Colin Kreutzer, a 2E at Scalia Law and a Research Assistant at CPIP.

night view of Washington, D.C.By Colin Kreutzer

This past fall, the United States Patent and Trademark Office (USPTO) hosted a joint workshop with the Department of Justice (DOJ) entitled Promoting Innovation in the Life Sciences Sector and Supporting Pro-Competitive Collaborations: The Role of Intellectual Property. Nyeemah Grazier and Brian Yeh (USPTO Office of Policy and International Affairs (OPIA)) emceed the day’s events, which focused on the impact of patents and copyrights on collaboration and innovation in the life sciences sector. The goal was to promote dialogue between members of the innovation and legal communities working in the life sciences sector to combat the COVID-19 pandemic. Video of day one of the workshop is available here, and our summary of day two is available here.

Opening Remarks

In his opening remarks, Andrei Iancu (USPTO Director and Under Secretary of Commerce for Intellectual Property ) discussed the main purpose of the workshop—to find ways of accelerating American innovation in the life sciences. “Our goal is to enhance collaboration among innovative companies and researchers to solve one of the most vexing health problems we have faced as a country in the past century.” He highlighted the ongoing collaboration between the USPTO and DOJ as “truly innovative.”

Director Iancu also emphasized the positive impact of the patent system on our economy and quality of life throughout American history. He cited the discovery and development of insulin treatments as an example of how innovations have alleviated suffering and helped treat diseases. As an economic example, he noted the massive biopharmaceutical company Amgen, whose co-founder Dr. Marvin Caruthers had once told him that patents are so critical to life sciences development that, without them, the U.S. “would not have a serious biotechnology industry.” Finally, Director Iancu pointed out a number of pandemic-era efforts that the USPTO has undertaken to keep innovation moving forward.

Session I: The role of patents in research and development of therapeutics, diagnostics, and vaccines, particularly during pandemics

In the first session of the day, Ms. Genia Long (Senior Advisor, Analysis Group) gave a presentation on the relationship between patents and innovation, and the value of innovation in improving the diagnostic and therapeutic arena of public health.

Ms. Long explained that technological innovation is a key determinant of economic and public health progress. Disease and morbidity rates have consistently declined over the last thirty years for many serious illnesses such as heart disease, cancer, HIV, and hepatitis. Much of the overall increase in life expectancy in the United States is attributable to pharmaceutical developments. These sorts of improvements are expected to continue into the future, so long as we continue to incentivize and support development in cutting-edge technologies such as gene and cell therapies.

Ms. Long built on Director Iancu’s comments about the core reason that patents are essential in drug development. The cost of developing a drug is extremely high, while the cost of copying a successful drug is very low. Without granting pharmaceutical companies a limited period of exclusivity in which their costs may be recovered, those massive R&D investments are guaranteed to be a losing bet. Realizing this in advance, of course, companies would choose not to make such investments in the first place. And we would have to do without many of the life-enhancing treatments that we now enjoy.

Ms. Long also discussed the importance of collaboration between all government actors who play a role in this innovation ecosystem. In addition to the patenting process, FDA approval takes a large part of the time and money in bringing a drug to market. The Hatch-Waxman Act provided a patent restoration period, adding time to the end of a patent life to compensate for time lost while seeking approval. But the market exclusivity period has remained steady at about 12 to 13 years. Meanwhile, patent challenges from generic drug makers have increased dramatically. Collaboration is important because pharmaceutical patents are “embedded within a larger and somewhat complex system of rules and incentives which act together to yield market results.”

Session II: Update on USPTO guidance on patentability of life science inventions

Next, Ali R. Salimi (Senior Legal Advisor, Office of Patent Legal Administration (OPLA), USPTO) gave an overview of the most recent USPTO guidance to examiners on disclosure and subject matter eligibility analysis.

Mr. Salimi first discussed the rather convoluted history of patent eligibility under 35 U.S.C. § 101. In brief, the Supreme Court has developed a set of judicial exceptions to the four statutory categories of patent-eligible subject matter: process, machine, manufacture, and composition of matter. The Court views these exceptions as necessary to prevent the basic tools of scientific and technical work from becoming inaccessible. As currently written, those exceptions are laws of nature, natural phenomena, and abstract ideas.

Mr. Salimi outlined the 2012-2014 decisions in Mayo v. Prometheus, AMP v. Myriad Genetics, and Alice Corp. v. CLS Bank, as well as the responses by the USPTO in updating its guidance to examiners. The final result was the 2019 updated patent eligibility guidance (PEG) version of the Alice-Mayo test.

The current form of the test is given in a flow chart shown at 42:50 of the video presentation. Step One of the test asks whether the claim is directed to a statutory category. If so, Step Two then asks if a judicial exception renders the claim ineligible—if the claim does recite a judicial exception, it will still satisfy §101 so long as it integrates the exception into a practical application and recites “additional elements that amount to significantly more” than the exception.

Mr. Salimi finished by briefly discussing the three disclosure requirements under § 112: written description (whether the disclosure demonstrates that the inventor actually had possession of the invention), enablement (whether the description enables a person of ordinary skill to make and use the invention), and best mode (whether the inventor knows and discloses the best mode of carrying out the invention).

Overall, he says the 2019 PEG has been well received by both examiners and practitioners, and it has done much to further the goals of clarity and certainty in patent prosecution.

Session III: Life science patents in practice

In this session, two speakers shared their own experiences with how the patent system protects inventions in the life sciences, promotes innovation and facilitates collaboration in life sciences.

David E. Korn (VP of Intellectual Property and Law at PhRMA) spoke first. As a representative of a trade association of leading biotech firms, he elaborated on the concerns about recovering large investments made in the prior remarks of Director Iancu and Ms. Long.

Mr. Korn explained that not only is the drug development process lengthy and costly, but it is also uncertain. Discovery of an active compound is just the beginning. It is followed by initial laboratory and animal testing. If successful, the developer may file an Investigational New Drug (IND) application and begin phase I and phase II clinical trials. This is followed by larger and longer phase III trials involving thousands of patients. If that is successful, the developer may file a new drug application (NDA) to the FDA and seek approval. Only after this process is the drug ready, and drugs can fail at every step along the way. Mr. Korn said the cost of developing a successful drug can be as much as $2.6 billion when accounting for unsuccessful candidates. He likened the process to a rocket mission in which “everything needs to work perfectly at each stage.”

Moreover, Mr. Korn continued, R&D doesn’t stop after FDA approval. There is ongoing research into new forms, new indications, methods of delivery, and multiple therapies. All of these innovations require additional investment and further FDA approval. He credited a number of laws with supporting pharma innovation and collaboration, including the Hatch-Waxman Act, the Orphan Drug Act, and the Bayh-Dole Act.

Next, Dr. Gaby Longsworth (Director, Sterne Kessler Goldstein & Fox) discussed life sciences patents from the perspective of a practicing patent attorney. Patents do more than allow drug developers to recoup their investments. By offering an alternative to holding information as a trade secret, they allow for more open collaboration and licensing in order to “build a common innovation instead of battling it out in litigation.” Patents can also be sold or used as collateral for a bank loan, providing research incentives and support to smaller companies.

First, Dr. Longsworth gave an overview of the three main forms of small molecule drug applications under the Federal Food, Drug, and Cosmetic Act. An NDA can be filed under § 505(b)(1) for new drug compounds, as well as new formulations or indications of an existing drug. A second type is found under § 505(b)(2), known as the paper NDA, for modifications of previously approved drugs based on safety and effectiveness data of the prior drug. Finally, there is the Abbreviated NDA (ANDA) under § 505(j). This is a duplicate application used by generic manufacturers, and it relies on studies provided in the NDA for the original drug.

Next, Dr. Longsworth discussed the general protection strategies of drug innovators. One goal is to build a strong blocking patent. She explained the importance of understanding the different types of patents available when drafting the application in order to obtain claims that will not be easily designed around. Another goal is to create a patent thicket to deter competition. It can become very difficult and expensive for generic competitors to file an ANDA when there are many patents to analyze, and it becomes more difficult for competing innovators to mount successful attacks at the Patent Trial and Appeal Board.

Panel Discussion I: Are changes to U.S. patent law needed to better support innovation in life sciences and the development of COVID-19 solutions?

After hearing several presentations on the effect of economic incentives on innovation, a panel discussion addressed the question of whether changes are needed to improve innovation, collaboration, or access to medicines. Moderated by Director Iancu, the panel featured: The Honorable Paul R. Michel (Chief Judge, U.S. Court of Appeals for the Federal Circuit (CAFC) (Ret.)), Steven Caltrider (VP and General Patent Counsel, Eli Lilly & Co.), Karin Hessler (Assistant General Counsel, Association for Accessible Medicines (AAM)), Arti Rai (Elvin R. Latty Professor of Law and Director, Center for Innovation Policy, Duke University School of Law), Corey Salsberg (VP, Global Head IP Affairs, Novartis), Hans Sauer (Deputy General Counsel and VP, Biotechnology Innovation Organization), and Hiba Zarour (Head of IP Department, Hikma Pharmaceuticals).

Judge Michel noted the problems with uncertainty in § 101 eligibility of patent claims, which he referred to as a “systemic failure” of the courts. If businesses and venture capitalists cannot reliably predict whether a claim will survive § 101, there is less appetite for investment in R&D, less commercialization, and ultimately fewer new medicines. He credited the 2019 USPTO guidance as an improvement but lamented that the Federal Circuit had not gone along with it. The best hope for clarity would not come from the courts, he said, but through new legislation.

Mr. Salsberg noted that from a medical standpoint, the two most important elements for getting through the pandemic are innovation and collaboration. He said the patent system is the reason we entered this pandemic with “libraries of millions of novel compounds that are ready to test right now.” Likewise, it is why we have the tools to sort through these compounds and identify those that can help with COVID-19.

Speaking for generic manufacturers, Ms. Zarour argued that innovation is not solely dependent upon IP protection: “Innovation will happen.” And while previous speakers had argued that it increases innovation, she cited a study from the Swiss Federal Institute of Intellectual Property that found an upper limit on the benefits of patent protection. At a certain point, the stifling effects of IP protection outweigh the benefits of incentivizing investments. She proposed a solution in which the initial patent for a drug would grant the inventor a period of exclusivity (e.g., 15 years) but subsequent or ancillary patents to the same drug would go into a pool that could be voluntarily licensed. This would strike a balance between the need for innovation with the need for access, and it could prevent the “evergreening” of drug patents.

Ms. Hessler also advocated for such a balance. She agreed that strong innovation incentives are responsible for the thousands of COVID-19 compounds that are already in late-stage clinical trials. At the same time, she used an example previously cited by Dr. Longsworth—a 1,000-patent thicket for a biologic manufacturing process—to argue that excessive protection can unduly impede medical access. She mentioned a proposal to cap the number of patents that can be inserted into the biologics patent dance as being a potential solution.

Ms. Hessler also said that settlement of patent litigation is becoming increasingly difficult due to “a patchwork of inconsistent regulations” and disagreement between state and federal laws. Legal settlements can expedite access of generic and biosimilar drugs by over a decade. Mr. Caltrider agreed that the settlement issue is of great importance, and that states such as California are creating laws that interfere with the federal world of patents.

Mr. Sauer said that collaboration is important in biotech because many companies in that field are small. Licensing and technology transfer are critical to the proper function of our biotech ecosystem. The small innovators must have a secure means of profitably transferring their technology to the larger manufacturers who are better equipped to fully develop and deliver the product to the public.

Mr. Caltrider pointed out that the USPTO has remained open for business since the very beginning of the COVID pandemic. Touching on the initiatives that Director Iancu had mentioned in the opening remarks, he praised the certainty and reliability of our patent system as essential to keep “the machinery working” to promote collaboration and innovation.

Prof. Rai pointed to a recent DOJ business review letter which declined to raise antitrust issues over a collaboration between large manufacturers of monoclonal antibodies. She said that from a COVID perspective, the patent system has been doing great. But she echoed Judge Michel’s remarks about § 101, calling the situation a “mess that needs to be fixed.” Finally, she described a forthcoming study on biologics litigation and a proposal regarding manufacturing process patents that are filed after FDA approval.

Session IV: Copyright and innovation in the life sciences

The final sessions of the day shifted to the role of copyright law in the life sciences. Session IV include three short presentations from: Michael W. Carroll (Professor of Law and Faculty Director, Program on Information Justice and Intellectual Property (PIJIP), American University Washington College of Law (WCL)), Mark Seeley (Consultant, SciPubLaw LLC and Adjunct Faculty, Suffolk University Law School), and Bhamati Viswanathan (Affiliate Professor, Emerson College).

Ms. Viswanathan began with a brief overview of copyright law and the balancing act it performs. Most people think of copyrights in terms of music and literature, but it can also protect software, databases, and other compilations of information. Like the patent system, one goal of copyright law is to promote innovations and investment in copyrightable works. And like patents, there exists an issue of balancing the incentive of ownership rights with access to those works. In the scientific community, copyright law seeks to balance the tendency for sharing and collaboration with the rights of the creators of original works.

Mr. Seely discussed two areas of scientific interest that are protected by copyright: scientific journals and searchable data repositories. He says that scientific knowledge is most valuable “when it is organized, standardized, updated, and indexed.” Publishers of scientific data are a crucial component of the current effort against COVID-19 because they provide useable data about known drugs, potential reactions, and other adverse events. By combining “published content, patents, with tactical mining capabilities and analytics,” these works support the pipeline of new treatments.

Prof. Carroll talked about the manner of distributing research outputs within the copyright system. The internet age has brought opportunities for vast dissemination of information. The challenge presented by open access movements has been in finding ways to utilize the internet’s potential while still protecting the IP rights of authors. Open access promotes innovation because it increases exposure of publications to readers beyond those within the narrow discipline from which the publications come, sparking new ideas in an interdisciplinary environment. It also provides information to under-resourced readers in low-income areas or developing nations. Prof. Carroll presented the standardized copyright licenses he helped develop with the Creative Commons organization, which allow authors to choose the particular terms and conditions under which their works are reused or distributed.

Panel Discussion II: Copyright discussion: Enhancing access to life science: How copyright can create incentives or barriers to building data or information pools, and related licensing

Session IV led immediately to a panel discussion by the presenters. Moderator Susan Allen (Attorney-Advisor, OPIA, USPTO) led a discussion of the role of copyright in disseminating information and supporting licensing models.

COVID-19 has resulted in many publishers voluntarily releasing relevant copyrighted information. Asked how this would affect publishing systems long term, Mr. Seeley was doubtful of any major impact. But he noted that downloads of information were much higher due to this change. If society decides, after the fact, that the emergency release was highly beneficial, it could impact future decisions about information sharing.

Prof. Carroll took the increase as an affirmation that open access systems are helping to fill an unmet need. He added that the pandemic has accelerated another trend towards the growth of pre-print servers—publication vehicles for preliminary results and yet unreviewed materials—but noted the growing pains associated with a public that is not accustomed to this type of early information sharing: “clinically actionable unreviewed results that then make it into the media can actually be harmful.”

Asked what role the government can play in supporting copyrights and information sharing, each panelist weighed in. Mr. Seeley said it’s important that governments do more than mandate certain types of publication and sharing—it should be coupled with funding to help make it happen. Prof. Carroll pointed to the recommendations he and others presented as part of the National Academies of Science, Engineering, and Medicine. He echoed Mr. Seely’s call for better funding of information infrastructure such as repositories, as well as better standardization. Ms. Viswanathan voiced support for initiatives like the Open Science Policy Platform (OSPP) and said she would like to see more empirical research on the impact that it has on business models of various stakeholders.

Closing Remarks

In closing, Mr. Yeh thanked the participants and encouraged all to tune in for day two of the conference, which would “explore different ways to expedite the development and use of therapeutics, diagnostics, and vaccines through competition, collaboration, and licensing.”

Categories
C-IP2 News

CPIP Expresses Condolences on Passing of Disney’s Richard Bates

night view of Washington, D.C.

CPIP expresses condolences to the family, friends, and colleagues of Richard Bates, long-time head of Disney’s Government Relations team in Washington, D.C., who died suddenly on December 31, 2020. Richard was a consummate professional and knowledgeable advocate for the interests of the creative community. His impact in the policy arena was far-reaching, and he was much respected and warmly regarded by those who had the good fortune to know and work with him over the years. CPIP is grateful for the opportunities we have enjoyed to interact with Richard and his team.

Categories
Copyright

Ninth Circuit Confirms: Fair Use Is an Affirmative Defense to Copyright Infringement

the word "copyright" written on a typewriterThe Ninth Circuit’s recent decision clarifying transformative fair use in Dr. Seuss v. ComicMix gives much to admire (see my deep dive into the opinion here). The court held that a mash-up of plaintiff Seuss’ Oh, the Places You’ll Go! (Go!) with a Star Trek theme—entitled Oh, the Places You’ll Boldly Go (Boldly)—by defendant ComicMix was not fair use since it merely repackaged the original work without new purpose, meaning, message, expression, or character—in other words, it utterly failed to be transformative. That holding should be welcome news for those who are concerned that the rule of the derivative right is being swallowed by the exception of transformativeness.

The Ninth Circuit also addressed another issue of central importance in the fair use doctrine, namely, whether fair use is an affirmative defense such that the burden is on the defendant to demonstrate the absence of likely market harm. That the burden issue even came up is itself remarkable, given the Supreme Court pronouncements and Ninth Circuit precedents on the matter. Nevertheless, this case presented a good vehicle for the Ninth Circuit to confirm that the burden of proving fair use remains with its proponent on each of the factors, including market harm. In this post, I’ll discuss the positions of the parties and the holdings of the courts on this important procedural aspect of fair use.

District Court Holds that Burden Is on Plaintiff to Show Likely Market Harm

One of the issues before the district court was whether Seuss had to show likely market harm under the fourth fair use factor. In its memorandum supporting its summary judgment motion, ComicMix acknowledged that it had the burden of proving fair use: “The proponent of fair use has the burden to show that it applies, because it is an affirmative defense.” However, it argued that, since Boldly is transformative, there is no presumption of market harm, and the “burdens on the fourth factor shift to the plaintiff” to “demonstrate a likelihood of potential harm.” Thus, while acknowledging that it ultimately held the burden of persuasion on market harm, ComicMix argued that Seuss had to produce evidence in order to win on this factor.

The Supreme Court discussed the presumptions and burdens of proof for market harm in Sony and Campbell. In Sony, the Court stated that “every commercial use of copyrighted material is presumptively . . . unfair,” such that, “[i]f the intended use is for commercial gain,” the “likelihood may be presumed” for market harm. And when the use is “for a noncommercial purpose, the likelihood must be demonstrated” with “a showing by a preponderance of the evidence that some meaningful likelihood of future harm exists.” ComicMix latched onto this statement that likely market harm must be demonstrated, despite its use being commercial, to argue that Seuss was required to make a showing on market harm. But that position is inconsistent with what the Court held later in Campbell.

The Supreme Court in Campbell walked things back significantly, explaining that the presumption from Sony only applies in the context of “verbatim copying of the original in its entirety for commercial purposes,” not in “a case involving something beyond mere duplication for commercial purposes.” When “the second use is transformative,” the Court continued, “market substitution is at least less certain, and market harm may not be so readily inferred.” The Court in Campbell thus distinguished verbatim, commercial copies (market harm presumed) and transformative, yet commercial, uses (no such presumption). Importantly, even though there was no presumption of market harm for the transformative use at issue, the Court placed the burden on the defendant to demonstrate an absence of market harm in order to succeed on that factor because “fair use is an affirmative defense.”

This understanding of who has the burden of proof on market harm must be understood in the context of the procedural posture. Fair use is only relevant once the plaintiff has made a prima facie showing of copyright infringement. If both Seuss and ComicMix were to fail in producing evidence on market harm, the factor might be neutral. But that neutrality would only hurt ComicMix—and not Seuss—since ComicMix is trying to overcome Seuss’ prima facie showing of infringement. The Supreme Court in Campbell drove this point home, holding that, in the absence of evidence, “it is impossible to deal with the fourth factor except by recognizing that a silent record on an important factor bearing on fair use disentitled the proponent of the defense . . . to summary judgment.” That “evidentiary hole,” the Court concluded, would need to “be plugged on remand” for the defendant to prevail.

In its opposition memorandum, Seuss started with the premise that ComicMix had the burden of proof on market harm: “As with all affirmative defenses,” ComicMix “bear[s] the burden of proof.” Suess argued that ComicMix could not carry its burden because it did “not offer a shred of admissible evidence about the relevant markets for Go!, derivatives of the [Seuss] Works, and Boldly.” Thus, both parties agreed that fair use is an affirmative defense, with ComicMix bearing the ultimate burden of persuasion on whether its use was fair. The only difference was whether, and to what extent, either party could or should have to demonstrate evidence of likely market harm or its absence.

Despite arguing in its memorandum that the burden of proof was on ComicMix, counsel for Seuss told a different story at the hearing on the motion. The court asked, “What burden, if any, does [Seuss] carry in establishing a likelihood of market harm in this case?” Seuss’ counsel responded that, assuming the use is transformative, there would be no presumption and that Seuss would then have to show market harm. The district court ultimately concluded that Boldly is “highly transformative,” and with Seuss’ concession during oral argument in hand, the court held that Seuss had the burden of introducing “[e]vidence of substantial harm to it . . . by a preponderance of the evidence.” After finding that Seuss “failed to introduce evidence tending to demonstrate that the challenged work will substantially harm the market for its Copyrighted Works,” the court held that the fourth fair use factor was neutral since “the harm to Plaintiff’s market remains speculative.”

Ninth Circuit Holds that Burden Is on Defendant to Show Absence of Market Harm

On appeal to the Ninth Circuit, the parties changed their tune somewhat. In its opening brief, Seuss argued that the district court erred by placing the burden on it to show likely market harm: “fair use is an affirmative defense, and its proponent must show absence of market harm even if the challenged use is transformative.” Moreover, Seuss claimed that since Boldly is nontransformative and commercial, there should be a presumption of market harm. But even if there is no such presumption, Seuss argued that ComicMix had the burden of “offering convincing proof that the plaintiff’s markets will not be harmed by the challenged work.” And, in a footnote, Seuss argued that any concession by its counsel during oral argument before the district court “would not control this Court’s resolution of a purely legal issue: who bears the burden of proof on the fourth factor.”

In its answering brief, ComicMix argued that Seuss’ “failure to present evidence of any negative market effect weighs in favor of fair use.” It contended that there is no presumption of market harm, even though Boldly is commercial, because that presumption does not apply when a work is transformative. As to which party held the burden of proof, ComicMix argued that fair use is not in fact an affirmative defense—a remarkable claim given the holding of Campbell and ComicMix’s contrary position in the district court. To support its argument, ComicMix cited the Ninth Circuit’s decision in Lenz as well as a pair of law review articles to conclude that, “while the proponent of a true affirmative defense generally bears the burden of proof as to all elements, for a standard defense like fair use, it suffices to show that the plaintiff failed to overcome it.”

The citation to Lenz is a puzzling one. The issue there was whether a copyright owner must consider fair use before sending a takedown notice under the Digital Millennium Copyright Act (DMCA). The copyright owner argued that fair use is not “authorized by the law” under the DMCA since it is an affirmative defense excusing conduct that would otherwise infringe. The Ninth Circuit disagreed, finding that this view conflates “an affirmative defense that is labeled as such due to the procedural posture of the case, and an affirmative defense that excuses impermissible conduct.” The court ultimately decided that fair use is “authorized by the law” as a statutory matter, even if it’s an affirmative defense as a procedural one. However, the court said nothing to the contrary about who bears the burden of proof on likely market harm in a context outside of the DMCA—like in overcoming a prima facie case of infringement in litigation over whether a use is fair.

The cites to the law review articles are equally perplexing as they both explicitly acknowledge that the burden of proof rests with the party claiming fair use. The first, Proving Fair Use: Burden of Proof as Burden of Speech by Ned Snow, acknowledges that, “[a]s an affirmative defense, fair use places the burden of proof on its proponent.” The thrust of the article is that, while “the defendant bears the burden of proof” for fair use, it would be better to shift that burden to the copyright owner because of free speech concerns. The second article, Fair Use: An Affirmative Defense? by Lydia Loren, likewise concedes that Campbell “[c]learly . . . placed the burden of producing evidence to support fair use on the defendant.” The article then argues that, as a normative matter, we should put that burden on the copyright owner. Neither of these articles provides any support for the point ComicMix sought to establish, i.e., that the burden of proof is on Seuss.

In assessing the fourth fair use factor, the unanimous Ninth Circuit panel sided with Seuss: “Having found that Boldly was transformative—a conclusion with which we disagree—the district court . . . erred in shifting the burden to Seuss with respect to market harm. That shifting, which is contrary to Campbell and our precedent, led to a skewed analysis of the fourth factor.” The court declined to hold that ComicMix’s nontransformative, commercial use raised a presumption of market harm, though it did recognize that market harm could be inferred from the circumstances. The court made quick work of ComicMix’s argument that fair use is not an affirmative defense and that the burden is on Seuss to show likely market harm: “Not much about the fair use doctrine lends itself to absolute statements, but the Supreme Court and our circuit have unequivocally placed the burden of proof on the proponent of the affirmative defense of fair use.” ComicMix’s argument went nowhere because “Campbell squarely forecloses” it.

To ComicMix’s argument that Lenz compels placing the burden of proving market harm on Seuss, the Ninth Circuit pointed out that Lenz “involved fair use in a different corner of the copyright law,” namely, the safe harbors under the DMCA. The question there was of statutory interpretation under the DMCA, and the analysis was explicitly limited to “that context.” Lenz changed nothing about the procedural burdens in other contexts: “In no way did we deviate from our characterization of fair use as an affirmative defense under § 107. To the contrary, in addition to clarifying that, unlike copyright misuse and laches, fair use is not an excuse to copyright infringement, we reiterated that ‘the burden of proving fair use is always on the putative infringer.’”

Turning to the merits, the Ninth Circuit held that it was ComicMix, “as the proponent of the affirmative defense of fair use,” that “must bring forward favorable evidence about relevant markets.” Given that ComicMix chose to argue instead that it didn’t have the burden of proof, there was only “scant evidence” to consider. ComicMix’s principal evidence was an expert report, but the court found that the “entire report is premised on Boldly being transformative, which it is not, and on the expert’s misunderstanding about fair use and U.S. copyright law.” But even accepting the report’s “methodology and conclusions,” the court found that it still “fails to account for key fourth-factor considerations,” including the fact that Boldly was “intentionally targeted and aimed to capitalize on the same graduation market as Go!” and that “Boldly would curtail Go!’s potential market for derivative works.” Having found that ComicMix failed to carry its burden, the court held that ComicMix’s fair use defense failed as a matter of law.

Conclusion

In Dr. Seuss v. ComicMix, the Ninth Circuit addressed important aspects of the fair use doctrine—and some novel arguments that flew in the face of settled precedent. Not only did the court rein in various overly broad notions of transformative use urged by ComicMix and its amici that would have further eroded a copyright owner’s exclusive right to make derivative works, but it also confirmed the fundamental holding of Campbell that fair use is an affirmative defense, with the burden of proof to show an absence of market harm falling squarely on the party claiming fair use. ComicMix attempted to sidestep its duty by claiming that there was none; it wanted the benefit of fair use without its burden. Thankfully, the Ninth Circuit emphatically rejected this approach as one that would “‘create incentives to pirate intellectual property’ and disincentivize the creation of illustrated books,” contrary to copyright’s constitutional goals.

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Copyright

Ninth Circuit Clarifies Transformative Fair Use in Dr. Seuss v. ComicMix

a gavel lying on a desk in front of booksThis past Friday, the Ninth Circuit handed down its opinion in Dr. Seuss v. ComicMix, a closely watched transformative fair use case. The decision marks an important milestone in the development of the fair use doctrine, especially as applied to mash-ups—where two or more preexisting works are blended together to create a new work. However, the court’s careful explanation of what constitutes transformativeness is not limited to mash-ups, and it will surely be influential for years to come. In this post, I’ll look at the various views expressed by the parties, amici, and courts as to what it means for a use to be transformative, and I’ll explain how the Ninth Circuit’s new guidance on transformativeness reins in some of the overly broad positions that have been urged. This decision should be welcome news for those who worry that a copyright owner’s right to make derivative works has been excessively narrowed by ever-expanding notions of transformative use.

In Dr. Seuss v. ComicMix, the plaintiff, Dr. Seuss Enterprises L.P. (Seuss), was the assignee of the copyrights to the works by Theodor S. Geisel, the late author who wrote under the pseudonym “Dr. Seuss.” Seuss sued the defendants, ComicMix LLC and three individuals (collectively, ComicMix), for copyright infringement over, inter alia, ComicMix’s mash-up of Seuss’ iconic Oh, the Places You’ll Go! (Go!) with a Star Trek theme, entitled Oh, the Places You’ll Boldly Go! (Boldly). The Boldly mash-up featured slavish copies of the images and overall look and feel of Go!, but with the Seussian characters replaced with the crew of the Enterprise from Star Trek and the text and imagery reinterpreted for Trekkies.

ComicMix admitted that it copied Go! to create Boldly, and the issue on appeal was whether its use was fair. The district court held that it was fair use, finding in particular that ComicMix’s mash-up was “highly transformative.” After the decision was appealed to the Ninth Circuit, there were amicus briefs filed for both sides. Some argued that Boldly was transformative, and others argued that it was not. In the opinion for the unanimous Ninth Circuit panel by Judge McKeown, the court held that Boldly wasn’t transformative at all. This decision gives us what is perhaps the clearest explanation of what it means to be a transformative use to date by an appellate court. And the fact that it comes from the Ninth Circuit—the “Hollywood Circuit” as Judge Kozinski once called it—makes it all the more interesting and important.

The issue of transformativeness is primarily analyzed under the first fair use factor, i.e., the purpose and character of the use, but it also weighs heavily on the other three factors. If the use is transformative, courts often ignore the creativeness of the original work, give the copyist more leeway when assessing the amount and substantiality of the use, and overlook the copyist’s effect on the potential market for the original work. As some have observed, in a transformative use case, the fair use analysis tends to collapse into a single factor: Is the use transformative? Indeed, Jiarui Liu published a study last year showing that “transformative use appears to be nearly sufficient for a finding of fair use.” Once the dispositive decisions included in the study found transformative use, they eventually held that there was fair use 94% of the time.

District Court Finds Boldly Is “Highly Transformative”

In the district court, the parties filed cross-motions for summary judgment, with ComicMix claiming fair use. The court had assessed fair use earlier in the litigation when denying ComicMix’s motion to dismiss. There, the court rejected ComicMix’s contention that Boldly was a parody, reasoning that it did not comment on or criticize the original work. Parodies juxtapose the original work for comedic effect, and the necessity of referencing the original justifies the copying. However, the court found that there was no such juxtaposition here, instead noting that Boldly merely used the “illustration style and story format as a means of conveying particular adventures and tropes from the Star Trek canon.” Nevertheless, the court found that Boldly was “no doubt transformative” since it “combine[d] into a completely unique work the two disparate worlds of Dr. Seuss and Star Trek.” Even though many elements were copied, the court reasoned that Go! had been “repurposed” because ComicMix added “original writing and illustrations” that transformed its Seussian pages into “Star-Trek-centric ones.”

The district court ultimately denied the motion to dismiss as it had to take Seuss’ allegations of market harm in the complaint as true and there was no evidence to the contrary in the record. Lacking evidence of market harm, the court found a “near-perfect balancing of the factors” and held that ComicMix’s “fair use defense currently fails as a matter of law.” However, once the court turned to the summary judgment motions, it had a developed record from which to work. On market harm, the court placed the burden on Seuss—despite fair use being an affirmative defense—and found that it failed to demonstrate likely harm to Go! or its licensed derivatives. On the issue of transformativeness, the court adopted and then expanded on its reasoning when addressing the motion to dismiss.

Suess had asked the district court to reassess its fair use analysis given the intervening Federal Circuit decision in Oracle v. Google. In that case, it was not fair use when Google copied computer code verbatim and then added its own code. The court here distinguished Oracle, reasoning that ComicMix did not copy the text or illustrations of Go! verbatim. While ComicMix “certainly borrowed from Go!—at times liberally—the elements borrowed were always adapted or transformed,” and that made Boldly “highly transformative.” Furthermore, the court found that Go! and Boldly served different purposes, with the former aimed at graduates and the latter tailored towards Trekkies. And to Seuss’ argument that Boldly was a derivative work, the court responded that derivative works can be transformative and constitute fair use.

Strangely, when addressing the motion to dismiss and the summary judgment motions, the district court failed to cite the holding of Dr. Seuss v. Penguin Books—even though that binding precedent involved the same plaintiff making similar arguments about a similar mash-up (there, Dr. Seuss and the O.J. Simpson murder trial). In Penguin Books, the Ninth Circuit held that the accused mash-up, The Cat NOT in the Hat! A Parody by Dr. Juice, was neither parody nor fair use. Rather than ridiculing the Seussian style itself, the court held that it merely copied that style “to get attention” or perhaps “to avoid the drudgery in working up something fresh”—as the Supreme Court put it in Campbell v. Acuff-Rose. Indeed, because the mash-up failed to conjure up the substance of the original work by focusing readers instead to the O.J. Simpson murder trial, the court held that there was “no effort to create a transformative work with ‘new expression, meaning, or message’” as required by Campbell.

Amicus Briefs Offer Differing Views on Transformativeness

Once the case was appealed to the Ninth Circuit, amicus briefs were filed on both sides addressing the transformativeness issue. Some argued that Boldly epitomized transformative fair use, and others argued that it was the antithesis. It is difficult to exaggerate the doctrinal gulf between the views of these amici.

The Motion Picture Association (MPA) amicus brief, by Jacqueline Charlesworth, argued that ComicMix’s use was not transformative since it failed to comment on or add new meaning to Go! and instead merely used it as a vehicle to achieve the same purpose—entertaining and inspiring readers. Moreover, ComicMix admitted that it could have used a different book on which to base its mash-up, thus defeating any claim of necessity. The MPA brief explained that Boldly was indeed a derivative work (the district court had expressively reserved the point) as defined by the Copyright Act since it transformed or adapted a preexisting work. The district court had dismissed Suess’ argument that Boldly was a derivative work by pointing out that it transformed and adapted Go!, but the MPA brief called this “troubling logic” since it conflated derivativeness with transformativeness and presumably would make every derivative work a transformative fair use.

Peter Menell filed an amicus brief, joined by Shyam Balganesh and David Nimmer, taking issue with the district court’s “categorical determination” that mash-ups generally are “highly transformative” as it would “undermine[] the Copyright Act’s right to prepare derivative works.” The Menell brief argued that Boldly “might well strike a lay observer as clever, engaging, and even transformative in a common parlance sense of the term,” but this misunderstands the transformativeness inquiry, which turns on whether it “serves a different privileged purpose” such that it survives the “justificatory gauntlet.” The question was whether Boldly “merely supersede[d] the objects of the original” or instead used the copied material “in a different manner or for a different purpose.” Here, the Menell brief concluded, Boldly drew on Go!’s popularity to follow its same general entertaining purpose while adding little “new insight and understanding.”

Sesame Workshop filed an amicus brief by Dean Marks distinguishing transformativeness for derivative works from transformative use under the first fair use factor and arguing that the district court conflated the two. The Sesame brief explained that Boldly was only transformative in the fair use sense if it, per Campbell, added “something new, with a further purpose or different character” as “commentary” and provided “social benefit, by shedding light on an earlier work.” While Boldly did add new material, it did not add “any new meaning or message” or “provide any new insight or commentary on Go!.” It instead delivered “the exact same inspirational message” to appeal to Seuss’ “existing market.” The danger of the district court’s logic, the Sesame brief concluded, is that it “could stand for the proposition that all mash-ups constitute fair use, a holding that would greatly diminish the derivative work right.”

An amicus brief by Erik Stallman on behalf of a group of IP professors, including Mark Lemley, Jessica Litman, Lydia Loren, Pam Samuelson, and Rebecca Tushnet, took a broad view of transformative fair use, arguing that the district court properly did not require Boldly to criticize, comment on, or parody Go! itself. It also claimed that fair use is not an affirmative defense such that the district court properly put the burden on Seuss to show market harm. The crux of the IP professor brief was that, even though on a high level of abstraction both works had the same entertainment purpose, there were nonetheless “differences in expressive meaning or message” that made Boldly transformative. As there were such differences at a lower level of abstraction—e.g., Go! had a “hyper-individualistic character” while Boldly focused on “institutional structures that promote discovery through” combined “efforts”—the IP professor brief concluded that it was transformative in the fair use sense.

Finally, an amicus brief by Mason Kortz on behalf of the Electronic Frontier Foundation (EFF), Organization for Transformative Works, Public Knowledge, and others concluded that “Boldly is a significantly transformative work” that “recasts, recontextualizes, and adds new expression or meaning to Go! in order to create a new, significant work of creative expression.” The EFF brief argued that uses can be transformative even if “they fail to comment on or parody the original” so long as they have different “expressive content and message.” Here, Boldly was transformative because it “adapt[ed] the stylistic, visual, and rhyming elements from Go! to create new expression” and added “new meanings that speak with particularity to the themes of Star Trek beloved by its community of fans.”

Ninth Circuit Holds that Boldly Is Not Transformative

Turning back to the parties, Seuss argued on appeal that ComicMix’s “use was exploitative and intended to grab the attention of potential buyers, not transformative,” since it added no “new purpose or meaning.” ComicMix answered that its use was “highly transformative,” with a “radically distinct purpose and effect,” that crafted “new meanings from the interplay between Star Trek’s and Seuss’s creative worlds.” Judge McKeown, writing for the unanimous Ninth Circuit panel, sided completely with Seuss: While the “fair use analysis can be elusive,” if not metaphysical, “[n]ot so with this case.” The court held that “Boldly is not transformative” and that all of the fair use “factors decisively weigh against ComicMix.”

Quoting Campbell, the court started with the premise that a transformative work “adds something new, with a further purpose or different character, altering the first with new expression, meaning, or message,” and a work that “merely supersedes the objects of the original creation” is not transformative. It also noted Campbell’s explanation that commentary with “no critical bearing on the substance or style of the original” and which is used “to get attention or to avoid the drudgery in working up something fresh” has less—if any—claim to fair use. The court then cited to its previous holding in Dr. Seuss v. Penguin Books (mentioned above as having been ignored by the district court below despite the glaring similarities) that the mash-up at issue there merely copied the Seussian style without critiquing it. The court there held that the defendant was only trying “to get attention,” and the court here found that the same result holds true. ComicMix’s “post-hoc characterization” that it was “criticizing the theme of banal narcissism of Go!” or “mocking the purported self-importance of its characters falls flat.”

The court then turned to ComicMix’s argument that, even if Boldly was not a parody or a critique, it was nonetheless transformative since it substituted Seussian characters and elements with Star Trek themes. The court rejected this framing as foreclosed by Penguin Books, noting that it “leverage[s] Dr. Seuss’s characters without having a new purpose or giving Dr. Seuss’s works new meaning.” And without “new expression, meaning or message” that alters Go!, ComicMix merely added “Star Trek material on top of what it meticulously copied” and failed to engage in transformative use. Helpfully, the court laid out three “benchmarks of transformative use,” which it gleaned from Campbell and Ninth Circuit precedent, to explain why Boldly was not transformative: “Boldly possesses none of these qualities; it merely repackaged Go!.”

First, the “telltale signs of transformative use” include a “‘further purpose or different character’ in the defendant’s work, i.e., ‘the creation of new information, new aesthetic, new insights and understanding.’” The court found that Boldly had neither a further purpose nor a different character since it paralleled the purpose of Go! and propounded its same message. Without a “new purpose or character” that would make it transformative, the court found that Boldly “merely recontextualized the original expression by ‘plucking the most visually arresting excerpt[s].”

The second of the “telltale signs” looks for “‘new expression, meaning, or message’ in the original work, i.e., the addition of ‘value to the original.’” The court found that ComicMix likewise failed to do this: “While Boldly may have altered Star Trek by sending Captain Kirk and his crew to a strange new world, that world, the world of Go!, remains intact.” The court’s focus was on whether Boldly changed Go! itself or merely repackaged it into a new format. Here, “Boldly does not change Go!,” and ComicMix’s admission that it could have used another work as the basis of its mash-up indicated that “Go! was selected ‘to get attention or to avoid the drudgery in working up something fresh,’ and not for a transformative purpose.”

The last of the “telltale signs” considers “the use of quoted matter as ‘raw material,’ instead of repackaging it and ‘merely supersed[ing] the objects of the original creation.’” The court, embedding several side-by-side images into the opinion to demonstrate the point, found that Boldly merely repackaged Go!. For the illustrations, the “Star Trek characters step into the shoes of Seussian characters in a Seussian world that is otherwise unchanged.” And for the text, rather than “using the Go! story as a starting point for a different artistic or aesthetic expression,” ComicMix instead matched its structure in a way that “did not result in the Go! story taking on a new expression, meaning, or message.” Since Boldly “left the inherent character of the [book] unchanged, it was not a transformative use of Go!.”

The court concluded that, “[a]lthough ComicMix’s work need not boldly go where no one has gone before, its repackaging, copying, and lack of critique of Seuss, coupled with its commercial use of Go!, does not result in a transformative use.” The first fair use factor thus “weigh[ed] definitively against fair use,” and the court went on to find that the other three factors favored Suess as well—without transformativeness to drive the analysis, ComicMix could not get the court to put its thumb on the scale in favor of fair use. Importantly, the court also rejected the holding below that the burden of proving likely market harm rested on Seuss: “the Supreme Court and our circuit have unequivocally placed the burden of proof on the proponent of the affirmative defense of fair use.” Additionally, the court chastised ComicMix for failing to address the “crucial right” of “the derivative works market,” noting that Boldly would likely “curtail Go!’s potential market for derivative works,” especially given that Seuss had “engaged extensively for decades” in this area.

Conclusion

All-in-all, the Ninth Circuit’s decision is a welcome development to the doctrine of fair use. Since Campbell was handed down over one-quarter of a century ago, the notion of transformativeness has taken on a central role—one that appears to be shrinking the exclusive right to prepare derivative works while expanding what it means to be transformative fair use. The accused work at issue here—Boldly—used the original work to create new expression, but lacking was any justification for the taking. ComicMix could have used any number of works for its mash-up, and the same nontransformative repackaging would have occurred because ComicMix’s purpose would not be tied to the particular work onto which it transposed the Star Trek universe. Thankfully, the Ninth Circuit was able to distinguish the transformative nature of a derivative work from the transformativeness that constitutes fair use. And given the prevalence of mash-ups in today’s culture, one suspects that this opinion will be cited and expanded upon for many years.

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Copyright

CPIP Applauds Congress on Passing CASE Act and Protecting Lawful Streaming Act

U.S. Capitol building

As advocates for individual artists and small businesses in the arts, CPIP is grateful this holiday season for the inclusion of the CASE Act and the Protecting Lawful Streaming Act as part of the end-of-year omnibus and COVID-19 relief package: the Consolidated Appropriations Act, 2021. These measures enjoyed overwhelming support and address longstanding challenges in IP enforcement. While there are many additional obstacles for artists and arts venues to overcome stemming from the pandemic, we are hopeful that these measures, which artists have worked many years to achieve, will be a building block to a more equitable future for independent arts businesses.

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C-IP2 News

Happy Holidays from CPIP!

The CPIP Team sends you and yours our best wishes for a happy, safe holiday season and a Happy New Year!

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Patent Law

Professor Daryl Lim Explores the Doctrine of Equivalents and Equitable Triggers

The following post comes from Yumi Oda, an LLM Candidate at Scalia Law and a Research Assistant at CPIP.

files labeled as "patents"By Yumi Oda

The term “claims” may not mean much to many, but it means the world to most patent practitioners. As Judge Giles Rich once observed, “[t]he name of the game is the claim.” Claims are the “metes and bounds” of a patent application, essentially defining what the inventor invented. In this sense, claims have a notice function to demarcate the scope of the claimed invention, which in turn allows subsequent inventors to “design around” the disclosed invention and come up with new inventions. This is exactly the type of incentive the U.S. Constitution envisioned “[t]o promote the Progress of . . . useful Arts.”

The interpretation of claims (i.e., claim construction) often becomes a central issue in patent litigation. Notably, patent protection is not limited to literal infringement, but may extend to “equivalents” of the patented invention. Rooted in equity, the doctrine of equivalents (DOE) asks whether the accused device contains elements “equivalent” to each claimed element of the patented invention. However, since the DOE affords courts flexibility in expanding claims and undermining the notice function of patent claims, practitioners and judges have long struggled with its inherent conflict.

This is the challenge tackled in a recent paper that was published in the Santa Clara High Technology Law Journal entitled Judging Equivalents by Professor Daryl Lim, a Professor of Law at John Marshall Law School. The paper, which comes from CPIP’s Thomas Edison Innovation Fellowship program, provides a contemporaneous, empirical survey of the law and literature on the DOE over the past 150 years in order to help contextualize its nature and evolution and to chart its future.

The Doctrine of Equivalents

Prof. Lim starts by looking at the origins and scope of the DOE. Claims were in fact not required in earlier patent legislation, so infringement at the time focused on the “essence” of the patented device through an inquiry into equivalence. This earlier tradition persisted even after the requirement for claims was established in 1836. However, with the introduction of “peripheral claims” (claims setting forth the exact boundary of the claimed invention) by 1870, the focus shifted to the literal language of the claims, with equivalents invoked only when required by equity.

Due to what Prof. Lim calls “ad hoc and amorphous boundaries,” as well as the fact-intensive inquiry involved, the DOE remains unruly and challenging to administer. Originally, the Supreme Court formally recognized the DOE in 1853, which may have been justified by the Lockean theory of justly rewarding inventors for their labor. However, in 1950, the Supreme Court shifted its focus and justified the DOE as an equitable safeguard for the defendant’s unjust enrichment. Nevertheless, the DOE was met with skepticism from its early days, and the creation of the Federal Circuit in 1982, although meant to resolve circuit splits, only added to the existing confusion. Moreover, when the Supreme Court set out a couple of limitations to the doctrine in 1997, questions regarding the applicability of these limitations further deepened the division.

Prof. Lim then moves on to describe the history and development of the doctrine in three words: incoherence, incompetence, and irrelevance.

To begin, “incoherence” refers to the courts’ “perennial struggle for clarity.” The Supreme Court has so far employed two alternative tests—“function-way-result” test and “insubstantial differences” test—without clarifying which test should be chosen. Additionally, the Federal Circuit has also failed to provide guidance regarding an appropriate formula, which in turn has forced lower courts to determine equivalents on an ad hoc basis. Prof. Lim partly attributes this “incoherence” to the inherently ambiguous nature of claim construction, which involves a question of law (what the claims mean to a hypothetical “person of ordinary skill in the art”) and a question of fact (whether the accused device falls within the scope of the claim, literally or under the DOE).

This ambiguity has long raised concern in the courts about the jury’s competence in comparing the construed claims to the accused device, which leads to the next issue of “incompetence.” The jurors’ expected incompetence in the face of the complexity of their given task, combined with their substitution bias generally favoring inventors and the Patent Office and procedural limitations resulting in the unreviewable status of their general verdicts, led to the conventional wisdom that judges, who are often “repeat players” in patent litigation, are better suited for this task. However, Prof. Lim’s data notably shows that the jury’s incompetence may in fact have little factual basis.

Finally, Prof. Lim describes a substantial decline in cases where the DOE applies. This “irrelevance” of the DOE now leads us to the question of what role equitable triggers play in this decline.

Equitable Triggers

Equitable triggers can affect how widely or narrowly courts apply the DOE. Surprisingly enough, most (i.e., over 70%) of the cases examined did not even mention equity in any form, despite the doctrine’s equitable origin, suggesting the equitable nature of the cases did not determine their outcomes.

1. Copying. Copying is permitted as an intermediate step of designing around the patent as long as the defendant can show his or her new device “does more than just narrowly escape the claim.” Overall, copying has not been a prominent type of trigger, but it played a significant role in rivalry. In fact, among different types of equitable triggers, patentees were most favored with copying.2. Design-Arounds and Independent Invention. Design-arounds and independent invention (rivals producing their devices without knowledge or notice of the patented device) are justified by the basis of leapfrogging. Consistent with the copying cases, non-rival defendants were significantly more likely to prevail compared to rival defendants.

3. Pioneer Inventions. In contrast, pioneer inventions are justified because of a wide gap between the claimed invention and the prior art. Prof. Lim concludes that pioneer inventions were extremely rare, and no meaningful conclusion was drawn here, indicating that there is little incentive for patentees to even assert pioneer status.

In addition to these equitable triggers, Prof. Lim carefully draws a distinction between the DOE and means-plus-function (MPF), which is another common deviation from the literal meaning of the claims. MPF under 35 U.S.C. § 112(f) allows the scope of claims to be expanded from their literal meaning to capture similar structures described in the specification, performing the same function as the structure recited in the claim, and known at the time of patent filing. In contrast, the DOE expands beyond what has been described in the specification, and limits equivalence to newer technologies developed after the patent grant.

Limitations

Subsequently, Prof. Lim looks at four court-established bars to the DOE, each penalizing patentees “for sloppy or overly aggressive patent drafting and for strategic behaviors that shift the cost of information . . . from an inventor to the Patent Office and the public.” In practice, these limitations allow judges to absolve defendants from baseless patent infringement claims, as shown by summary judgment being the dominant procedural posture.

1. Prosecution History Estoppel. Prosecution history estoppel (PHE) prevents patentees who made a certain type of narrowing amendment from exploiting the DOE and asserting a contradictory, broadening scope of the claims later. Overall, defendants were on the winning side across the almost entire 10-year period in cases where PHE was employed, confirming the conventional wisdom that patentees generally do worse than defendants.2. “All-Elements” Rule. The “all-elements” rule requires the DOE to be applied to individual limitations of the claim, rather than to the invention as a whole. While patentees generally did worse than defendants in these cases, patentees did significantly better in 2009-2018 compared to earlier years.

3. Prior Art Bar. The prior art bar limits patentees to a scope that avoids prior art. Patentees won by a slight margin here—by far the best among the four limitations to the doctrine—because of the patentees’ expertise to navigate prior art arguments and survive summary judgment motions filed by defendants.

4. Public Dedication Rule. The public dedication rule assumes that, when a patentee discloses but fails to claim subject matter, the unclaimed subject matter is dedicated to the public. This is to prevent patentees from filing broad disclosure, while presenting only narrow claims (to avoid the claims being examined in view of more prior art), and then exploiting the DOE later only to capture the broad disclosure. While this rule continues to play a relatively small role, patentees did better more recently, as with PHE and the “all-elements” rule.

In conclusion, Prof. Lim’s paper offers a contemporaneous, doctrinal, and empirical survey of the doctrine of equivalents. And as the first empirical study on “equitable triggers,” it can fill a significant gap in the literature and help evidence-based decisionmaking in patent law and policy.

Categories
Patents Pharma

IP Scholars Question the Legality and Wisdom of Joint AG Proposal to Seize Remdesivir Patents

The following post comes from Colin Kreutzer, a 2E at Scalia Law and a Research Assistant at CPIP.

dictionary entry for the word "innovate"By Colin Kreutzer

While the vaccines are starting to roll out in the fight against COVID-19, the precise timelines for when they will be widely available continue to be uncertain. But we do have treatments currently available under Emergency Use Authorization authority that have been shown to blunt the impact of the coronavirus and reduce the length of hospital stays. The first one these was Gilead Sciences’ antiviral drug, remdesivir. In July, after an initial period in which Gilead donated its production supply, the company announced a price of $390 per vial, or $2,340 for an estimated 5-day course. While the price is lower than what many analysts were expecting, not everyone was happy about it.

In an August joint letter to HHS Secretary Alex Azar, thirty-four state Attorneys General urged him to do what they contend would resolve a problem of access to the drug: use the “march-in rights” provision of the Bayh-Dole Act to seize Gilead’s patent and license it to generic manufacturers. The response to this proposal from many IP experts can be roughly divided into three main points: (1) it is not legal; (2) it is not effective; and (3) it is dangerously unwise.

What Is Bayh-Dole?

The Bayh-Dole Act of 1980 was a watershed event in the growth of the American pharmaceutical industry. It allowed companies and universities to retain the IP rights to inventions that were developed using government-funded research. The goal was to improve the efficiency with which innovations were brought to market and to encourage investment and collaboration between government, university, and private researchers. Previously, many research developments never saw the light of day due to lack of commercialization, and likely many other inventions were never born in the first place. Bayh-Dole is widely regarded as a success story on both sides of the aisle.

What Are March-In Rights?

Since the aim of the law is to spur innovation and development, the march-in rights provision was included to counteract patent owners who “hold out” or fail to commercialize their inventions. Under very limited circumstances, it allows the government to “march in” and force the owners to license their patent on reasonable terms to a third party. Just how limited are those circumstances? So far, the 40-year-old provision has been used exactly zero times. It stands to reason that valuable products don’t need to be forced into the market, and many modern treatments–for cancer, diabetes and hepatitis­, among others–have been invented and commercialized under Bayh-Dole collaborations without any intervention.

It Is Not Legal

Notably absent from the list of Bayh-Dole creations is remdesivir. The law only applies to inventions that are “conceived or actually reduced to practice in the performance of work under a funding agreement,” i.e., things that were invented with government help. It does not apply to every case in which a drug maker has worked alongside a government agency at one stage or another. The AG letter cites $30 million in NIH-funded work on remdesivir. It claims that this funding exposes the drug to the march-in provision. The letter also makes a general appeal to our sense of fairness—the public paid for this, and so it rightly belongs to all of us.

As noted by Stephen Ezell of the Information Technology and Innovation Foundation (ITIF), the total government expenditure is actually closer to $70 million. That number includes additional work performed with USAMRIID, the U.S. Army Medical Research Institute of Infectious Diseases. Both projects took place in 2014. The Army study was investigating Gilead’s library of antiviral compounds for effective Ebola treatments. Remdesivir’s compound gave positive results, but other treatments proved better. The NIH project was a clinical trial to explore whether remdesivir could be used against coronaviruses as a general class. Again, it showed promise. But the relevant coronaviruses at the time (SARS and MERS) did not spread widely enough to make larger studies feasible. The NIH study might have enabled Gilead to home in so quickly on remdesivir as a COVID-19 treatment, and in that sense, it would have played a crucial role. But that is not the same thing as having a hand in the actual invention of the drug.

Critically, under both studies, the drug had already been invented by Gilead. Regarding the NIH work, a HHS spokeswoman told STAT that the department does not consider the march-in rights to apply. And as pointed out by Scalia Law Professor Adam Mossoff, Army lawyers have stated that their contributions did “not qualify USAMRIID as a joint inventor of the compound.” Even if they were joint inventors, the NIH has stated that “the extraordinary remedy of march-in is not an appropriate means of controlling prices.”

As CPIP Executive Director Sean O’Connor explains at The Hill, even if inventorship could be established, march-in rights would still not be legal in this case: “[m]arch-in rights under Bayh-Dole’s Section 203 only authorize the government to grant new licenses if the original funding recipient fails to take steps to bring the invention to the market (achieve ‘practical application’) or reasonably satisfy health or safety needs.”

And yet, while it pales in comparison to the over $1 billion that Gilead expects to spend this year on remdesivir, $70 million sounds like a lot of tax dollars. CPIP Senior Scholar Kristen Osenga argues that proponents of marching in “mislead the public, specifically regarding remdesivir and, more generally and dangerously, regarding government support of scientific research.” She urges people to understand that government collaborations are a great deal for the public, and among the most efficient ways that the government spends our money: “The Milken Institute estimates that the long-term boost to total economic output could be as high as $3.20 for every dollar the NIH invests in biopharmaceutical research. Even conservative estimates peg the value of the NIH at $1.70 of economic activity per dollar spent. If only all government spending were so productive.”

It Is Not Effective

The preceding section alone answers the question of whether Bayh-Dole is a legal means of seizing Gilead’s property rights. Clearly, though, it does not quiet the sentiment felt by many that something else needs to be done. In addition to the price tag, the AG letter speaks of a “dangerously low supply” of the drug. But the letter supports that claim with a dubious comparison of Gilead’s expected production output to every single confirmed case of COVID-19 in the country. It should be clear on its face that this is not a valid manner of determining how many patients would actually benefit from remdesivir. It would have been more appropriate to say that future demand is uncertain. Because of course, supply is only one half of the equation. Demand can vary greatly depending on whether we cooperate as a society to contain this virus.

Gilead has, in fact, licensed the drug to third parties in order to increase supply. Currently, its own production will remain domestic. But Joseph Allen at IPWatchdog notes that in addition to ramping up its own capacity, Gilead has deals with drug makers in Egypt, India, and Pakistan to provide supplies internationally. Mr. Allen is also is a former congressional staffer who worked on the Act with its namesake, Senator Birch Bayh (D-Ind.). He adds that, because march-in seizure is a hostile measure, it would involve a drawn-out legal battle. This would render the process far too slow to be effective in a pandemic.

It Is Dangerously Unwise

Far from being proof in support of the AGs’ position, Gilead’s work with NIH is a clear example of how damaging it would be to abuse the march-in rights provision. We desperately want these types of collaborations to continue. And if companies believe that doing so would expose them to the seizure of their IP, they will act accordingly.

Our intellectual property system provides the necessary incentives for companies to invest massive amounts of money and bring new lifesaving drugs to the world. We even allow patents for new uses of existing drugs. As CPIP Senior Fellow for Life Sciences Chris Holman points out, the next great cure might be hiding in your medicine cabinet. But without incentivizing the R&D expenditures that bring us these wonderful inventions, we may never realize it.

It is hard to worry about the future when the present appears so bleak, but it is critically important to understand why it is dangerous to weaken the incentives that have given us so many lifesaving developments. Even if exercising march-in rights were legal, and even if it could somehow increase production, it is necessary to consider the long-term implications. Taking away a company’s rights and forcing it to sell at close to the cost of production may help with the current situation, but it will likely decimate future research. Who would want to spend billions of dollars on R&D without the knowledge that they can obtain IP rights that will have a predictable value? We should ensure that companies remain strongly incentivized to research new treatments that benefit us all.