Author: Mike Palmedo

I-MAK Challenges Validity of Remaining Hepatitis C Drug Patent in China

[Initiative for Medicines, Access & Knowledge press release, Link (CC-BY)] In a move that could strike down barriers to treatment for the exploding hepatitis C epidemic that kills 700,000 people every year, attorneys and scientists from the Initiative for Medicines, Access & Knowledge (I-MAK) filed a legal challenge against Gilead’s (NASDAQ:GILD) remaining patent for the hepatitis C medicine sofosbuvir in China. Branded as Sovaldi®, this patent covers the sofosbuvir base compound and is founded on previously published techniques, and does not meet the legal criteria for a patent. This new filing follows another legal challenge filed by I-MAK in 2015, which helped result in a rejection in June 2015 by China’s State Intellectual Property Office (SIPO) on the other critical patent application on sofosbuvir. SIPO found that this patent, covering the prodrug that activates the otherwise inactive base compound in the body, did not deserve a patent under the law. The hepatitis C virus, which the World Health Organization has called a “viral time bomb,” affects about 80 million people globally. When left untreated, the virus can lead to liver disease or liver cancer. The World Health Organization has added hepatitis C treatments, including sofosbuvir, to its list of essential medicines and called for lower prices to help ensure every person who needs the medicine can get it. While the rejection on the prodrug patent application in 2015 in...

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Trump Administration Draft Notice of Intent to Renegotiate NAFTA

Here is the Trump administration’s draft notice of intent to renegotiate NAFTA, which was put out by Inside U.S. Trade.  The administration says many elements of the agreement as it currently stands are “clearly outdated,” and that FTA provisions on intellectual property rights have been “improved in newer trade agreements.” A few excerpts of interest to readers of this blog follow.  These are what are listed in the letter as “specific negotiating objectives.” Intellectual Property Rights: Seek to establish standards to be applied in NAFTA countries that build on the foundations established in the WTO Agreement on Trade Related Aspects of Intellectual Property Rights and other international intellectual property agreements, such as the World Intellectual Property Organization (WIPO) Copyright Treaty, the WIPO Performances and Phonographs Treaty, and the Patent Cooperation Treaty; Seek to secure fair, equitable and nondiscriminatory market access opportunities for U.S. persons that rely on intellectual property protection. Where appropriate, seek commitments from the NAFTA countries to strengthen their laws and procedures on enforcement of intellectual property rights, such as by ensuring that their author4ities have authority to seize and destroy pirated and counterfeit goods, equipment used to make such goods, and documentary evidence. Seek commitments from the NAFTA countries to: (1) strengthen their measures that provide for compensation of right holders for infringements of intellectual property rights, and (2) provide for criminal penalties under their respective...

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Eli Lilly Reported to Have Lost NAFTA Investor-State Dispute Against Canada

NAFTA dispute panel arbitrators are reported to have issued a decision in the dispute brought by Eli Lilly against the government of Canada, though the decision has not been made public yet. Lilly had alleged that Canada’s patentability requirements had an overly high standard of what was considered ‘useful’, causing it to lose patent cases, and that this had violated NAFTA’s requirement that each country grant patents on inventions  that “are new, result from an inventive step and are capable of industrial application.”  On Friday, the Investment Arbitration Reporter published a story saying that “a unanimous award was rendered on March 16, 2017, with arbitrators dismissing the claims on their merits,” and ordering Eli Lilly to pay $5 million of Canada’s legal fees. For more details about the original case, and for Eli Lilly’s Notice of Arbitration, please see my earlier post on this...

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PIJIP to Host Globalizing Fair Use: Exploring the Diffusion of General, Open and Flexible Exceptions in Copyright Law

On March 29, PIJIP will team up with the American University International Law Review  and a number of other organizations to host a one-day conference: Globalizing Fair Use: Exploring the Diffusion of General, Open and Flexible Exceptions in Copyright Law. 9:00 – 3:30: An academic symposium co-hosted by PIJIP and the American University International Law Review will exploring new directions in domestic and international copyright law promoting adoption of general copyright exceptions that are open and flexible. Click here for the symposium agenda. 4:00 – 6:30: A policy roundtable will be co-hosted by PIJIP, the Computers and Communications Industry Association, Google, the Re-Create Coalition and the R Street Institute. This public event and webcast (live and on demand) will gather leading international experts to discuss global debates around extending fair use rights abroad. A panel discussion will lend insights from local copyright debates followed by a discussion of academic members of the Global Expert Network on Copyright User Rights. Click here for the roundtable agenda....

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My Testimony to the Special 301 Committee, Re: Foreign Affiliates of U.S. Firms in Countries That have Adopted Fair Use

Delivered March 8, 2017 at the Open Hearing that USTR conducted as part of the 2017 Special 301 Review Thank you for the opportunity to testify at this hearing. My name is Mike Palmedo, and I work for American University Washington College of Law’s Program on Information Justice and Intellectual Property (PIJIP). We are an academic research program that promotes the public interest in IP policy. Much of my recent research at PIJIP has involved the comparison of copyright limitations in different countries, and the examination of outcomes associated with different copyright limitation structures. My testimony has four key points: U.S. firms that rely on copyright exceptions benefit when foreign nations adopt open, flexible and general exceptions such as fair use Copyright industries still earn money from countries that adopt fair use The Special 301 Committee should include analysis of copyright limitations when evaluating whether a country provides adequate and effective protection of IP The 2017 Special 301 Report should highlight countries that are moving to adopt more flexible copyright practices in its “Best Practices” section U.S. firms benefit from open, flexible and general copyright limitations in other countries Intellectual property law in the United States balances the interests of those who own IP and those use it. In the field of copyright, this involves protections against infringement, and when appropriate, limitations allowing unauthorized reproduction and use. Robust copyright...

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Limiting the Snippet Levy to Commercial Use Is Tangling Up an Already Muddy Issue

[Natalia Mileszyk, Communia Association, Link (CC-0)] The Rapporteur Marc Joulaud of the Committee on Culture and Education (CULT) recognises the problem with proposed article 11 regarding protection of press publications concerning digital uses – it can threaten hyperlinking and various ways users use content online. In Communia’s opinion the Commission’s proposal to introduce a right for press publishers is poorly aligned to the objective of modernising the EU copyright framework and adapting it to the challenges of a fast-evolving digital environment. In the light of the above we believe that the only solution is to remove the whole idea from the directive. This is not the approach shared by CULT – instead 3 problematic changes were proposed: the limitation of the ancillary copyright is only for commercial purposes, the confusing and vague attempt to carve out snippets, and the term of protection is to be 3 years, which is still too long for news. Muddy area’s still unclear Instead of solving the problem, the Rapporteur Marc Joulaud made everything even more tangled by adding to the proposed scheme the requirement that press publication must be used ‘for commercial purposes’. As we raised before in freedom of panorama discussion, implementing a distinction between commercial and non-commercial use, namely two very vague terms, is never a good idea. It will muddy any legal certainty for citizens engaged in sharing press publications....

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US Trade Associations Write Congressional Leadership on IP in India, Suggest WTO Dispute Settlement As a Negotiating Tool

Twenty trade associations have written the House and Senate leadership urging Congressional engagement on the trade relationship between the U.S. and India. Their letter identifies intellectual property protection as an “ongoing challenge.” It highlights diplomatic structures where the countries have discussed IP and other issues, then notes that “WTO dispute settlement has played and should continue to play a key role in ensuring that India follows through on its international commitments.” The signatures on the letter include RIAA, MPAA, PhRMA, BIO, and the U.S. Chamber of Commerce. A recent International Trade Commission investigation into Indian barriers to trade surveyed businesses operating in the country, and found that intellectual property concerns were actually more muted than the rhetoric in DC would suggest. As I wrote in an earlier blog, the report found that “Overall, three quarters of the firms (73.9%) that answered the survey indicated they were not substantially adversely  affected by Indian policies. Among the firms that reported problems, “Measures in two policy areas — tariffs and customs procedures, and taxes and financial regulations — have the heaviest effect on U.S. companies  … IP-related impediments rated lower than tariffs and taxes as barriers to doing business in India, even by U.S. companies that considered IP protection very important to their operations.” Data from the survey that support this: Share of U.S. companies engaged in India that are substantially affected by...

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Intellectual Property Law and the Promotion of Welfare

Authors: Christopher Buccafusco and Jonathan S. Masur Abstract: The U.S. Constitution grants Congress the power “to Promote the Progress of Science and the Useful Arts” by granting copyrights and patents to authors and inventors. Most courts and scholars understand this language to entail a utilitarian or consequentialist approach to intellectual property (IP) law. Unlike IP systems in other parts of the world, U.S. IP law generally eschews so-called “moral” or deontological considerations such as justice and fairness. Yet while there is considerable consensus regarding U.S. IP law’s philosophical orientation, there has been little discussion of its deeper normative goals. Most courts and scholars agree with the idea that IP law should provide incentives to creators, but there has been almost no analysis of why creativity and innovation are good. What, exactly, are the interests that IP law should promote? Various answers to these questions exist. One possibility would be to interpret the constitutional language literally and narrowly. On this view, IP law should encourage developments in knowledge and technology irrespective of broader interests. Another option would be to interpret the constitutional language broadly to encompass a general social welfare calculus. In this chapter we discuss a variety of ways of understanding the normative goals of a consequentialist IP regime. We argue that the best approach derives from recent work in the field of hedonic psychology. The principal consequentialist goal...

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Candidates for Director-General of the World Health Organization Outline Their Plans for Tackling Unaffordable Medicines and the Lack of Innovation in Priority Areas

[Joint press release from six civil society groups, Link] The six candidates for Director-General of the World Health Organization (WHO) – of whom one will be elected this May – have published responses to an open letter asking them to make clear their plans for the future of the WHO’s work in promoting a new system of equitable drug R&D. The original open letter was signed by 18 civil society organizations, and titled “Will you support a patient-centred R&D agreement?“. The WHO Executive Board convenes today to begin 9 days of meetings during which the candidates will be interviewed, and up to 3 of the 6 shortlisted for a final vote in May 2017. The candidates recognised that urgent problems exist in the current system of drug R&D. Dr Douste-Blazy (France) wrote that “past failures to invest in research and development are killing millions today”. Dr Nishtar (Pakistan) recognised “the failure of market mechanisms to incentivise innovation” and asserted that the “WHO already has a strong mandate for action”. Dr Bustreo (Italy) noted that “high prices of health technologies and lagging innovation […] impede people’s access to quality health care”. In her response, Dr Flavia Bustreo made the bold commitment to convening discussions with WHO member states on a “global agreement on research and development R&D for medicines, vaccines, and diagnostics” based on the decade of work undertaken at...

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USTR Requests Comments for the 2017 Special 301 Report

The U.S. Trade Representative has requested comments for the 2017 Special 301 Report, in which it lists countries that it alleges “deny adequate and effective protection of intellectual property rights (IPR) or deny fair and equitable market access to U.S. persons who rely on intellectual property protection.” The content is based on written comments (mostly those submitted IP owners and business associations), testimony at a hearing, and on consultations with other governmental departments. Any interested party may submit comments, and any interested party may testify at the open hearing.  The deadline for submissions and requests to testify is February 9; the hearing is February 28; and the Special 301 Report will be released “On or about April 30.”  See the Federal Register notice for further details and submission instructions. Click here for the full Federal Register...

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Australian Government Productivity Commission Recommends the Introduction of Fair Use in Copyright Law

The Australian Government Productivity Commission has released its final report on ‘Intellectual Property Arrangements,’ which recommends a number of reforms to IP law, including changes to the law on patents, copyrights and enforcement. Regarding copyright and related rights, the Australian Government Productivity Commission warns that the scope of works eligible protection is too broad and the term of protection is too long, forcing copyright users face higher costs. It recommends clarifying the law on geoblocking and allowing parallel trade in books in order to expand access to works. The report recommends “Introducing a system of user rights, including the (well-established) principles–based fair use exception.”  Below is an excerpt that briefly presents the Commission’s case for introducing fair use in Australia: A fairer system of user rights Australia’s current limited exceptions, fair dealing being the most well-known, do little to restore the copyright balance. Australia’s exceptions are too narrow and prescriptive, do not reflect the way people today consume and use content, and do not readily accommodate new legitimate uses of copyright material. Legislative change is required to expand the categories of use deemed to be fair. Even when this occurs, changes have simply ‘caught up’ with existing community practice — Australia did not legalise the wide-spread practice of home VCR recording until as late as 2006, by which time most VCRs were household relics. Universities Australia summarised the extent...

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Antigua & Barbuda: “Suspension of Copyright” on U.S. Intellectual Property If WTO Dispute Remains Unsettled by Year’s End

Last week, the government of Antigua and Barbuda announced to the WTO Dispute Settlement Body (DSB) that it will move forward with the “suspension of copyright on the sale of U.S. intellectual property” by the end of the year if the U.S. does not comply with the DSB’s findings in the long-running dispute regarding online gambling. Twelve years ago, the DSB found that the United States violates the WTO’s General Agreement on Trade in Services by discriminating against foreign providers of online gambling services. It found that various federal and state level laws forbade Antiguan firms from offering online gambling services comparable to services offered by domestic firms. The DSB ordered the United States to pay $21 million in annual compensation to Antigua and Barbuda until its laws were brought into compliance with GATS. Furthermore, it permitted cross-sector retaliation by Antigua and Barbuda in the event that the United States did not comply with the DSB’s findings.  Since the DSB found the United States in violation of GATS, no compensation has been paid, and the law has not changed.  Antigua claims that total damages now exceed $250 million, a significant sum considering its total GDP is around $1 billion. Click here for Antigua and Barbuda’s full statement to the WTO Dispute Settlement Body....

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APEC Ministers Endorse Best Practices in Trade Secret Protection and Enforcement Against Misappropriation

Much of the news covering last week’s Asia-Pacific Economic Cooperation  (APEC) conference discussed the TPP, RCEP and FTAAP, but there was also work to establish new intellectual property norms. The main outcomes reported by the Chair include an agreement among the trade Ministers “to foster cooperation in intellectual property (IP) rights protection and enforcement, and raise SMEs awareness of IP commercialization. They encouraged the completion of the APEC Best Practices in Trade Secrets Protection and Enforcement on the basis of consensus at the earliest possible time.” According to a USTR press release, the Best Practices include “Broad standing to claims for the protection of trade secrets and enforcement against trade secret theft; Civil and criminal liability, as well as remedies and penalties, for trade secret theft; Robust procedural measures in enforcement proceedings; and Adoption of written measures that enhance protection against further disclosure when governments require the submission of trade secrets.” The full document, Best Practices in Trade Secret Protection and Enforcement Against Misappropriation, is here. U.S. Trade Representative Michael Froman said that his office will work with APEC countries “to raise standards for trade secret protection and enforcement, including the adoption of these best practices.” In the 2016 Special 301 Report, USTR singled out China, India and Taiwan as lacking adequate trade secret...

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Calzada and Gils Use Evidence from Spain’s 2014 “Google Tax” to Examine the Economic Role of News Aggregators

Yesterday, the American University economics department hosted a presentation by Joan Calzada of his working paper with Richard Gil, What Do News Aggregators Do? Evidence from Google News in Spain and Germany.  The paper studies the role of news aggregation, in which snippets from copyrighted news stories are reproduced on an aggregator’s website, which then provides a link to each full story on the copyright-holding newspapers’ own websites.  Calzada and Gils analyzed web traffic data for newspapers’ websites in Spain before and after Google News dropped out of the country following the imposition of a link fee. Calzada and Gils hypothesized there are two different effects a news-aggregator could have on online newspaper readership.  The market expansion effect is when the aggregator directs people to the full story on the newspaper’s website who otherwise would not have navigated to the page.  The substitution effect is when people who, in the absence of aggregation, would visit the newspapers’ websites to obtain news, instead obtain news by reading the headlines and snippets on the aggregator’s page. Under the substitution effect they no longer visit the newspapers’ sites. To test for the existence of a market expansion effect, the authors used data on overall daily visits to newspaper websites in Spain. They used the same data for French and German newspaper websites as a control. Their dataset was daily traffic between June 1,...

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Open Access Policy In Practice: A Perspective from the Wellcome Trust

Timothy Vollmer, Creative Commons, Link (CC-BY) It’s Open Access Week 2016. Open Access Week is an annual week-long event that highlights the importance of sharing scientific and scholarly research and data. Its goal is to educate people on the benefits of open publishing, advocate for changes to policy and practice, and build a community to collaborate on these issues. This year’s theme is open in action. Today we are exploring open access policy within philanthropy by interviewing Robert Kiley from the Wellcome Trust. From brokering the Bermuda Principles for immediate sharing of DNA sequence data in 1996 to being the first funder to mandate open access to our funded publication in 2005, Wellcome has been at the forefront of open research for over two decades. CC: Can you describe the Wellcome Trust and your role within the organisation? RK: Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations, and spark debate. I’m currently on secondment from the Wellcome Library and am the Development Lead for Open Research. In this role I’m responsible for developing a strategy for the Wellcome Trust which will set out what we could do to move the needle in making research outputs findable, accessible, interoperable, and re-usable – the FAIR principles....

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Indian Generic Firms Capturing Larger Share of U.S. Drug Imports

India is often called the “pharmacy of the developing world” because its pharmaceutical firms provide a large portion of the generic drugs consumed in the South. However, Northern countries are increasingly importing Indian drugs as well, as high prices have led to greater generic uptake. As an example, the United States has greatly expanded the amount of medicines it buys from India. UN Comtrade data shows that last year, 20% of U.S. pharmaceutical imports by quantity came from India, up from a negligible 0.002% in 1996. The unit of measurement is kilograms of “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale.” The share of imports from India as measured by dollar value is only 9%, indicating that these are relatively low cost imports. The data is not something one can break down, but it shows an unambiguous increasing trend.  It supports other stories of the growing presence of Indian generics in the U.S. market, such as the Wall Street Journal story reporting that a fifth of generic sales in the U.S. are from Indian firms. And the overall trend is likely to continue. The Organization of Pharmaceutical Producers in India notes that between 2011 and 2014, the U.S. FDA granted the same...

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U.S. Copyright Office Request for Comments for Section 1201 Study

The U.S. Copyright Office is requesting comments on Section 1201 of Title 17, which governs the circumvention of copyright protection systems.  The deadline for submitting comments is October 27.  There has been a previous round of comments associated with this study, and earlier comments are available here. The Copyright Office’s federal register notice includes three specific areas of inquiry (though interested parties may address “any other pertinent issues” related to Section 1201).   First, it seeks input on the possible of creating new permanent exemptions for assistive technologies for use by people with disabiities; device unlocking; computer programs; and obsolete technologies. One question related to this is whether the creation of new permanent exemptions for these reasons would “interact” with international obligations, including FTAs. Second, it asks whether legislation would be warranted to address concerns that “existing permanent exemptions for security testing, encryption research, and reverse engineering do not adequately accommodate good-faith research into malfunctions, security flaws, and vulnerabilities in computer programs.” Third, it asks two questions about anti-trafficing provisions: whether “section 1201 contains an implied right permitting a beneficiary of a statutory or administrative exemption to make a tool for his or her own use in engaging in the permitted circumvention;” and whether “in certain circumstances, third-party assistance may fall outside the scope of the anti-trafficking provisions and therefore may be permissible under current law.” The Electronic Frontier...

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Software Industry Claims Chinese Patent Law TRIPS Non-Compliant Due to Public Interest Grounds for Compulsory Licenses

Last week, the USTR-led inter-agency Trade Policy Staff Committee (TPSC) held a hearing on China’s compliance with WTO obligations, to inform its upcoming report to Congress on the matter. Comments submitted by Carl Schonander of the Software & Information Industry Association incorrectly claim Chinese patent law contains compulsory licensing provisions that do not comply with the TRIPS Agreement because compulsory licenses are intended for use in “national emergencies or other circumstances of extreme urgency.” Similar misreadings TRIPS Article 31 have come up (and been put down) in the IP and access to medicines debate, but this is the first time I’ve seen it regarding software. Here is the quote from page 15 of the comments “Some of the existing provisions in Chapter 6 of China’s Patent Law do not comply with all compulsory licensing restrictions in Article 31 of TRIPS. For instance, Article 49 of the law permits compulsory licensing when it is in the ‘public interest’ without defining those words. The substantive grounds referred to in TRIPS Article 31 which governs compulsory licensing are very narrow; they include ‘national emergencies or other circumstances of extreme urgency,’ but not the general ‘public interest’ recited in Article 49. In China, “public interest” might be defined very broadly.” Actually, TRIPS Article 31 does not contain a “very narrow” set of grounds under which compulsory licensing is permissible. Compulsory licenses can be...

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Cato Institute on the “Protectionist” Intellectual Property Provisions in the Trans Pacific Partnership

The Cato Institute has released a report that “presents a chapter-by-chapter analysis of the Trans Pacific Partnership (TPP) from a free trader’s perspective.” It notes that TPP is really more of a “managed” or “freer” trade agreement than an agreement that really promotes “free trade” in a classic sense. It finds that overall, the “terms of the TPP are net liberalizing,” but that some of the individual chapters – including the intellectual property chapter – are actually “protectionist.” Cato lists what it considers to be the pros and cons of the terms of the TPP’s intellectual property chapter, which it generally views as less strict than previous trade agreements, such as the U.S.-Korea FTA. However, it notes that the agreement generally requires trading partners to strengthen patent and copyright protections for rightholders, while “merely permitting” limitations. Cato also argues that the TPP may not require the U.S. to change its level of intellectual property protection, but it locks the U.S. into its current levels. It is also clear that the authors do not think intellectual property rights requirements ought to be a standard part of trade agreements, and they worry about the effects of over-strong protection: While a case can be made for some level of intellectual property protection, it is not clear why such protection should be included in trade agreements, as opposed to international intellectual property agreements....

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Public Knowledge Launches Report on Systemic Bias at the U.S. Copyright Office

Public Knowledge Press Release, Link (CC-BY-SA) Today we’re releasing our newest report, “Captured: Systemic Bias at the U.S. Copyright Office.” This report examines the role of industry capture and the revolving door between the major entertainment industries and the Copyright Office, and the implications that capture has had on the policies the Office embraces. In the report, we investigate how the Copyright Office: Regularly contorts basic questions of copyright law in ways that further the monopoly interests of major rightsholders; Advocates for expanded copyright with fewer limitations, exceptions, and consumer protections; Strives to insert itself into more and farther-flung policy debates, claiming “expertise” and issuing decisions on topics far beyond its mandate; Makes decisions based on predetermined outcomes, prioritizing its own views over input from non-self-interested stakeholders; and Is frequently overturned or ignored by courts, Congress, and other agencies. The following can be attributed to Meredith Rose, Policy Advocate at Public Knowledge: “The Copyright Office is one of the starkest examples of a captured agency operating within the government today. With limited accountability a pattern of favoritism toward industry and rightsholder groups, it is unsurprising that they have staked out tenuous positions and advocate for expansive copyright monopolies. It is clear from its positions–both implicit and stated–that the Copyright Office often acts more as an advocate for profit-maximizing entertainment industries, rather than as an impartial organ of government. “It...

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