Month: June 2021

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C-IP2 News Communications Progress Reports

CPIP Second Quarter Progress Report (March-May 2021)

Sean O'ConnorGreetings from CPIP Executive Director Sean O’Connor

We are cautiously optimistic as locations around the globe move towards greater control of the COVID pandemic. With luck, diligence, and generosity by public and private sectors around the world, we can all strive for vaccines to be more widely accessible and a future in which we can see other in person again.

Our Second Quarter Progress Report for 2021 covers CPIP’s and our affiliates’ events, news, scholarship, and more from March through May of this year. Our team has just wrapped up the fourth iteration of the WIPO-U.S. Summer School on Intellectual Property at CPIP, and we’re looking forward to in-person and hybrid programming in the coming months––look for details in our future progress reports and communications. We also have an exciting new name announcement coming later this week, and we’re looking forward to seeing what the rest of the year brings. In the meantime, I’m pleased to present this report on CPIP’s output from the past few months.

CPIP Hosted & Co-Hosted Events

On Wednesday, March 3, Arlington Economic Development’s BizLaunch network co-hosted a public online event entitled “Mason Law Clinic @BizLaunch: Which Entity is Right for Your Startup?” with George Mason University Antonin Scalia Law School’s Innovation Law Clinic, which is led by CPIP Executive Director Sean O’Connor. The virtual clinic addressed entrepreneurship and which business entities might best fit a business’s needs and attract investment. The panelists were Kenneth Silverberg, Senior Counsel at Nixon Peabody, and third-year Scalia Law students Mitch Gibson and Rebecka Haynes. A video of the event is available on CPIP’s YouTube page.

Now in its seventh iteration, CPIP’s 2021-2022 Thomas Edison Innovation Law and Policy Fellowship had its first virtual meeting on Thursday, March 18, and Friday, March 19. The Edison Fellowship is a year-long non-resident fellowship program that brings together a group of scholars to develop research papers on intellectual property law and policy. The Edison Fellowship is one of the centerpieces of CPIP’s mission to promote a better academic discussion about intellectual property rights with substantial scholarship produced from rigorous research that examines the moral and economic value of innovation. This year’s topics include: the PTAB, patent disclosures and artificial intelligence, levels of licensing of SEPs, SEPs vs NEPs in litigation, drug repurposing and generics, regulatory exclusivities, copyright law, privacy law, and the right of publicity.

From April 15-16, CPIP hosted a virtual roundtable discussion on Copyright and the Constitution. This private, invitation-only roundtable explored current and historical topics in Copyright and the Constitution. Proposals to address challenges faced by authors and owners of copyrighted works are frequently met by claims from opponents that the proposals do not pass constitutional muster. Such allegations are typically baseless; however, they delay and increase the costs of pursuing legislative and other measures intended to protect and promote the creativity of authors. This roundtable investigated what has transpired in the courts and public discourse as well as how these precedents might inform current and future efforts to protect the interests of the creative community and ultimately the public.

On May 4 and as part of Arlington Forward’s 20:20 Series, CPIP co-hosted a virtual panel, Protecting What You Build: Intellectual Property as the Entrepreneur’s Core Asset, with CPIP Directors Professor Sean O’Connor, Professor Sandra Aistars, and Joshua Kresh as the featured speakers. Great entrepreneurs execute on an innovative vision to improve the lives of others. Whether for profit or not for profit, the core of these ventures consists of particular solutions to tough problems. Such solutions in turn are combinations of information and practical methods, code or devices that are legally defined as intellectual property. Patents, copyrights, trade secrets and trademarks play different roles in defining the scope, title and rights to innovative solutions. This session guided attendees through these types of intellectual property and explained how experienced entrepreneurs rely on them to implement their visions. A video of the event is available on CPIP’s YouTube page.

News & Speaking Engagements

On Tuesday, March 30, the U.S. News & World Report Rankings came out, and CPIP is pleased to report that Scalia Law placed 41 overall and that the IP program went from 30 to 26. Also, the part-time law program at Scalia Law ranked No. 4 among public and private institutions.

Congratulations to all the Scalia Law students who graduated on May 15! This was a challenging year with unprecedented obstacles and we appreciate the students’ patience in adjusting to the online class format and doing their best. Well done and best of luck!

Further, CPIP would like to congratulate The Honorable Kimberly A. Moore, who became Chief Judge of the United States Court of Appeals for the Federal Circuit on May 22, 2021. She succeeded the Honorable Sharon Prost, who served as Chief Judge since May 31, 2014. Before joining the bench, Judge Moore was a faculty member of our George Mason University School of Law.

The Innovation Law Clinic, an affiliate of CPIP, was mentioned in the article “New pilot space debuts in Arlington” in Mason’s newsletter, The George, on May 27. The Clinic and other related innovation programs will temporarily be housed in a “showroom” location at Vernon Smith Hall until moving into the Mason Exchange building under construction here on the Arlington campus with a scheduled opening date of May 2025.

Sandra Aistars (CPIP Director of Copyright Research and Policy; Founding Director, Arts & Entertainment Advocacy Clinic; Clinical Professor of Law, George Mason University Antonin Scalia Law School)

    • Spoke at Scalia Law’s virtual Admissions Event on March 18
    • Along with filmmaker Lynn Hughes, was a featured speaker for an online clinic, “Copyright Law and the CASE Act,” on March 23. The event was organized under Prof. Aistars’ guidance by the Arts & Entertainment Advocacy Clinic at Antonin Scalia Law School and co-hosted with Washington Area Lawyers for the Arts (WALA). The clinic also conducted a live Q&A session for artists.
    • Spoke that same evening (March 23) on a virtual panel, “Representing Women: A Conversation on Representation for Artists and of Women in the Arts,” as part of the George Washington Law Association for Women’s March webinar series Nine: Portraits of Women in the Law
    • On April 6, moderated a virtual panel entitled “Artist Roundtable: Representing and Working with Artists in the Digital Age,” which was hosted by Scalia Law’s Arts & Entertainment Advocacy Clinic. The panel consisted of three creators on the forefront of art and creativity in the digital age: musician, singer, and songwriter David Lowery; film director, producer, and editorial photographer Stacey Marbrey; and author, communications professional, and copyright advocate David Newhoff. They spoke about their careers and what artists look for when partnering with legal counsel or other advocates, as well as issues that matter to artists and businesses in the arts today.
    • Spoke on the virtual panel “Platform Liability in the US and EU” during the 28th Annual Fordham IP Conference on April 9
    • Organized and signed an April 15 letter to the Biden Administration urging opposition to the proposed WTO waiver to the TRIPS Agreement’s IP protections
    • Moderated a virtual Federalist Society panel, “Courthouse Steps Decision Webinar: Google v. Oracle,” on April 16 (the podcast version is also available via the link)
    • Participated as a panelist during an IP law section discussion on Google v. Oracle hosted virtually by the American Bar Association on April 29
    • Participated in Scalia Law’s Law & Economics Center’s program Introduction to the Economics of Information, Privacy, and Data Security from May 19-23
    • Co-wrote, organized, and filed a May amicus brief, signed by IP scholars, stating that the Federal Circuit should reverse the Eastern District of Texas’ judgment in SAS Institute Inc. v. World Programming Ltd.: “The Court’s holding that Plaintiff’s works are uncopyrightable in their entirety was reached through a flawed examination, in the context of a novel proceeding, that is inconsistent with both the Copyright Act and applicable case law. If sustained, this approach would significantly undermine Congressional intent of promoting and rewarding copyright registration, and set the bar of establishing copyrightability so high that it would prejudice copyright owners not merely in the software sector, but across the full spectrum of creative works.” Students of the Arts & Entertainment Advocacy Clinic helped to research and prepare the brief; Robert W. Clarida (Partner, Reitler Kailas & Rosenblatt, LLC) served as counsel of record, and Steven M. Tepp (President & CEO, Sentinel Worldwide) provided valuable advice.

Jonathan Barnett (CPIP Senior Fellow for Innovation Policy & Senior Scholar; Torrey H. Webb Professor of Law, USC Gould School of Law)

Eric Claeys (CPIP Senior Scholar; Professor of Law, George Mason University Antonin Scalia Law School)

Devlin Hartline (Former Director of Communications, CPIP; Former Assistant Professor of Law, George Mason University Antonin Scalia Law)

    • Served as Presiding Officer on March 23, the first day of the virtual 16th Annual Advanced Patent Law Institute, and introduced Acting USPTO Director Drew Hirshfeld, among others. This event was co-sponsored by the University of Texas School of Law and the Antonin Scalia Law School and hosted by the USPTO.
    • Attended the University of Akron School of Law’s virtual 23rd Annual Symposium on Intellectual Property Law and Policy on March 25-26 and moderated the final panel, “The Latest Tools and Challenges for Copyright Enforcement,” on March 26
    • Signed an April 15 letter to the Biden Administration urging opposition to the proposed WTO waiver to the TRIPS Agreement’s IP protections
    • Along with other IP scholars, signed a May amicus brief stating that the Federal Circuit should reverse the Eastern District of Texas’ judgment in SAS Institute Inc. v. World Programming Ltd.
    • As of late May 2021, Devlin Hartline has left CPIP and George Mason University Antonin Scalia Law School. Devlin joined CPIP in May 2015 and, as a core member of the team, has contributed substantially to CPIP’s mission, events, programs, and scholarship––as well as team morale––over these past six years. As his teammates, we will miss working with him, and we want to thank him for all his contributions and dedicated work at CPIP. We also wish him the best as he joins the Hudson Institute this July. For now, you can find Devlin on Twitter @devlinhartline.

Christopher Holman (CPIP Senior Fellow for Life Sciences & Senior Scholar; Professor of Law, University of Missouri-Kansas City School of Law)

    • Participated as a Distinguished Senior Commentator in the first meeting of the 2021-2022 Thomas Edison Innovation Law and Policy Fellowship, held virtually March 18-19
    • With CPIP Executive Director Prof. Sean O’Connor, submitted written comments on April 5 to NIST on proposed changes to Bayh-Dole Regulations
    • Signed an April 15 letter to the Biden Administration urging opposition to the proposed WTO waiver to the TRIPS Agreement’s IP protections

Joshua Kresh (CPIP Deputy Director)

    • Attended the 28th Annual Fordham IP Conference on April 8-9
    • Signed an April 15 letter to the Biden Administration urging opposition to the proposed WTO waiver to the TRIPS Agreement’s IP protections
    • Served as a coordinator for AIPLA’s 2021 Virtual Spring Meeting, which was held from May 10-14 (the event program can be viewed here)

Erika Lietzan (CPIP Senior Scholar; William H Pittman Professor of Law & Timothy J. Heinsz Professor of Law, University of Missouri School of Law)

Hina Mehta (CPIP Scholar; Director, Office of Technology Transfer, George Mason University)

    • Gave a webinar on Research Trends at George Mason University for University of Bahrain’s event UoB Research Nights held in mid-May

Sean M. O’Connor (CPIP Executive Director; Founding Director, Innovation Law Clinic; Professor of Law, George Mason University Antonin Scalia Law School)

    • Featured CLE speaker at Washington State Patent Lawyers Association’s event, “Bypassing Patents in the Pandemic? The Biden Administration Should Beware Revisionist Accounts of March-In Rights and Sec. 1498” on March 17
    • Spoke at Scalia Law’s virtual Admissions Event on March 18
    • Quoted in a March 29 article by FiercePharma, “Biden faces calls to break COVID-19 vaccine patents. Would that boost global supply?”
    • With CPIP Senior Scholar Prof. Chris Holman, submitted written comments on April 5 to NIST on proposed changes to Bayh-Dole Regulations
    • Featured CLE speaker at Patent and Trademark Office Society (PTOS) event “Bypassing Patents in the Pandemic? The Biden Administration Should Beware Revisionist Accounts of March-In Rights and Sec. 1498” held virtually on April 6
    • Spoke on the virtual panel “Copyright & Music” during the 28th Annual Fordham IP Conference on April 9
    • Spoke on the virtual panel “Intermediary Liability at the Application Layer and Beyond” at the Silicon Flatirons conference, Platform Policy for Networks, Infrastructure, and Applications, on April 14
    • Signed an April 14 “Open Letter by Academics in Favor of Direct EV Sales and Service” supporting direct-to-consumer sales by EV manufacturers such as Tesla (the accompanying letter by public interest organizations can be found here)
    • Signed an April 15 letter to the Biden Administration urging opposition to the proposed WTO waiver to the TRIPS Agreement’s IP protections
    • Spoke on the virtual panel “Google v. Oracle: An Initial Appraisal” hosted by Berkeley Center for Law and Technology on April 20
    • Participated in the U.S. Embassy Tokyo’s World IP Day virtual program on IP & SMEs: Taking your ideas to market, speaking on the panel entitled “Patents to Patients: The Role of Intellectual Property in Innovative Healthcare” on the evening of April 26 JST (Japanese-language video of event available here)

Kristen Jakobsen Osenga (CPIP Senior Scholar; Austin E. Owen Research Scholar and Professor of Law, University of Richmond School of Law)

    • Moderated a Federalist Society panel, “Courthouse Steps Oral Argument Webinar: United States v. Arthrex Inc.,” on March 1
    • Starting in March 2021, Prof. Osenga has taken over the chair of the Federalist Society Intellectual Property Group Executive Committee from Professor Mark Schultz.
    • Featured in a short video by the Federalist Society on “What is a Trademark? [Legal Terms]” on April 13
    • Signed an April 15 letter to the Biden Administration urging opposition to the proposed WTO waiver to the TRIPS Agreement’s IP protections
    • Spoke on the virtual panel on “The Common Purposes of Intellectual Property and Antitrust” with Ashley Baker and Seth Cooper and organized by the Committee for Justice on April 19 (Video of panel available here)
    • Mentioned in an April 28 Patently-O post, “The Public Private Nature of Patents,” by Dennis Crouch, as representing the appellant company Kannuu in Kannuu Pty Ltd. v. Samsung Electronics Co., Ltd.
    • Featured in the Gray Matters podcast on May 4 in the episode “Regulating Vaccines After COVID-19: A Conversation with Sam Kalabi and Kristen Osenga”
    • Featured in a video by University of Richmond School of Law, “The Synopsis: Patents on COVID Vaccines,” on May 12

Eric Priest (CPIP Senior Scholar; Associate Professor, University of Oregon School of Law)

    • Along with other IP scholars, signed a May amicus brief stating that the Federal Circuit should reverse the Eastern District of Texas’ judgment in SAS Institute Inc. v. World Programming Ltd.

Mark Schultz (CPIP Senior Scholar; Goodyear Tire & Rubber Company Chair in Intellectual Property Law, University of Akron School of Law; Director, Center for Intellectual Property Law and Technology)

    • Participated as a Distinguished Senior Commentator in the first meeting of the 2021-2022 Thomas Edison Innovation Law and Policy Fellowship, held virtually March 18-19
    • Was the drafting team co-lead on the 2021 Sedona Conference’s Framework for Analysis on Trade Secret Issues Across International Borders: Extraterritorial Reach, which has been published for public comment as of March
    • Held the University of Akron School of Law’s 23rd Annual Symposium on Intellectual Property Law and Policy virtually on March 25-26
    • Signed an April 15 letter to the Biden Administration urging opposition to the proposed WTO waiver to the TRIPS Agreement’s IP protections
    • On April 28, spoke on the World Intellectual Property Organization (WIPO) webinar “Closing the Gender Gap in Intellectual Property – Mapping and Addressing Barriers”
    • On April 29, spoke on the virtual panel “How Intellectual Property Has Played a Pivotal Role in the Global COVID-19 Response,” which hosted by the Information Technology & Innovation Foundation (ITIF)
    • On May 27, spoke on a webinar on “The Role of Intellectual Property during the pandemic,” held by the Institute for Prospective and Innovation in Health (INNOS) in Colombia. Both the writeup and a link to the webinar recording can be found on this page.
    • Along with other IP scholars, signed a May amicus brief stating that the Federal Circuit should reverse the Eastern District of Texas’ judgment in SAS Institute Inc. v. World Programming Ltd.

Ted Sichelman (CPIP Senior Scholar; Professor of Law, University of San Diego School of Law; Director, Center for Intellectual Property Law & Markets; Founder & Director, Center for Computation, Mathematics, and the Law; Founder & Director, Technology Entrepreneurship and Intellectual Property Clinic)

    • Mentioned in an April 28 Patently-O post, The Public Private Nature of Patents, written by Dennis Crouch, as representing the appellant company Kannuu in Kannuu Pty Ltd. v. Samsung Electronics Co., Ltd.

Scholarship & Other Writings

Alden Abbott, Kevin Madigan, Adam Mossoff, Kristen Osenga, and Zvi Rosen, Holding States Accountable for Copyright Piracy, Regulatory Transparency Project of the Federalist Society (May 13, 2021)

Jonathan M. Barnett, Antitrust Lessons from AT&T’s M&A Fiasco, Truth on the Market (May 24, 2021)

Jonathan M. Barnett, Have tech platforms captured the Supreme Court?, The Hill (Apr. 17, 2021)

Jonathan Barnett, Investors and Regulators Can Both Fall for Platform Bubbles, Truth on the Market (Mar. 2, 2021)

Jonathan Barnett, Why Big Tech Likes Weak IP, Cato Institute (Spring 2021)

CPIP Staff, CPIP First Quarter Progress Report (December 2020-February 2021), CPIP Blog (Mar. 31, 2021)

CPIP Staff, UC Hastings’ Evergreen Drug Patent Search Database: A Look Behind the Statistics Reveals Problems with this Approach to Identifying and Quantifying So-Called “Evergreening,” CPIP Blog (Mar. 4, 2021)

Wade Cribbs, Accenture Report Outlines How 5G Technology Accelerates Economic Growth, CPIP Blog (Mar. 8, 2021)

Wade Cribbs, Scalia Law’s Innovation Law Clinic Partners with BizLaunch for Online Legal Clinic on Business Entities for Startups, CPIP Blog (Mar. 10, 2021)

Tabrez Ebrahim, Professor Tabrez Ebrahim on Clean and Sustainable Technological Innovation, CPIP Blog (Mar. 25, 2021)

Christopher M. Holman, Branded Drug Companies Are Successfully Asserting the Doctrine of Equivalents in Hatch-Waxman Litigation, 40 Biotechnology Law Report 72 (Mar. 2021)

Mark David Janis and Ted M. Sichelman, Patent Law: An Open-Source Casebook (Chapter 5: Anticipation) (Apr. 26, 2021)

Mark David Janis, Ted M. Sichelman, John R. Allison, Thomas F. Cotter, Christopher Anthony Cotropia, Dmitry Karshtedt, Jeffrey A. Lefstin, Jason Rantanen, David Taylor and Shine (Sean) Tu, Patent Law: An Open-Source Casebook (Entire Book), UC Hastings Research Paper Forthcoming (May 6, 2021)

David J. Kappos and Jonathan Barnett, Covid-19 Vaccine Highlights the Need for Balanced Patent Policy, Bloomberg Law (Mar. 16, 2021)

Douglas C. Lippoldt and Mark F. Schultz, An Opportunity for Leadership on Trade Secrets Protection in the Australia-UK Free Trade Agreement, Institute for International Trade (Mar. 25, 2021)

Adam Mossoff and Devlin Hartline, Google v. Oracle: A Copyrightability Decision Masquerading as Fair Use, Washington Legal Foundation (May 7, 2021)

Christopher M. Newman, Isn’t Infringement Ever Apparent?: Toward a Balanced Reading of §512 of the Digital Millennium Copyright Act, George Mason Legal Studies Research Paper No. LS 21-03 (Mar. 5, 2021)

Kristen Osenga, If You’re Sailing Into the Headwinds, You Might Be Going In the Wrong Direction, RealClearMarkets (Apr. 20, 2021)

Kristen Osenga, Online Symposium: Prof. Osenga’s Top 2020 Federal Circuit Patent Decisions, FedCircuitBlog (Mar. 30, 2021)

Yogesh Pai, WTO IP waiver too simplistic: Global vaccine tech-transfer needs other strategies, CPIP Blog (Apr. 29, 2021) (Originally posted in the Express Pharma edition of the Indian Express, Apr. 28, 2021)

Jason Rantanen, Mark David Janis, and Ted M. Sichelman, Patent Law: An Open-Source Casebook (Chapter 7: Infringement) (Apr. 29, 2021)

Ryan Reynolds, Professors Balganesh and Menell on “The Curious Case of the Restatement of Copyright, CPIP Blog (Apr. 8, 2021)

Ryan Reynolds, Professor Justin Hughes on “Restating Copyright Law’s Originality Requirement, CPIP Blog (May 20, 2021)

Mark Schultz, The EU can put trust back into online commerce, The Brussels Times (Mar. 6, 2021)

Austin Shaffer, Artist Roundtable Presented by the Mason Sports & Entertainment Law Association and the Arts & Entertainment Advocacy Clinic, CPIP Blog (May 5, 2021)

Liz Velander, Ninth Circuit Narrows Copyright Owner’s Ability to Receive Multiple Statutory Damages Awards, CPIP Blog (Mar. 17, 2021)

Liz Velander, Recap of the Supreme Court’s Google v. Oracle Opinion,“ CPIP Blog (Apr. 23, 2021)

Categories
Healthcare International Law

A View from Both Sides: COVID-19, the TRIPS Waiver, IP Rights, and How to Increase the Supply of Vaccines

scientist looking through a microscopeIssue

The United States and other wealthy nations have access to plenty of COVID-19 vaccine doses and thus are beginning to get the pandemic under control, while less affluent countries do not have access to adequate doses and are still struggling with rising cases. In October 2020, India and South Africa proposed addressing this problem by waiving certain portions of the TRIPS Agreement, the most comprehensive agreement on intellectual property (IP) aspects of international trade among the WTO’s 164 member states. The waiver cites “an urgent call for global solidarity, and the unhindered global sharing of technology and know-how in order that rapid responses for the handling of COVID-19 can be put in place on a real time basis.” While this proposal broadly applies to any COVID-19-related technology, much of the conversation is currently focused on vaccines.

The proposal would temporarily suspend patent rights covering COVID-19 vaccines and possibly also be used to compel the transfer of trade secret “know-how” and “show-how.” Proponents say this would allow any manufacturer to begin production—boosting vaccine supply while slashing prices—to end the surge of cases in less developed nations. Critics argue that the reality is more complicated: the waiver will be ineffective, even harmful, and it would have a devastating impact on our readiness for future health crises.

In Support of the Waiver

For supporters of the waiver, the answer is clear: cases are rising in many nations because they still don’t have the vaccines they need. It’s only reasonable to make exceptions to our ordinary system of business incentives during times of global crisis.

The Biden Administration

That is essentially what U.S. Trade Representative Katherine Tai stated when the Biden Administration announced its support for the waiver: “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines.”

It affects all of us

WHO Director-General Dr. Tedros Adhanom Ghebreyesus says that the “me-first approach” among powerful nations “is self-defeating and will lead to a protracted recovery with trade and travel continuing to suffer.” Under this rationale, even purely self-interested parties should support the waiver, if only because modern commerce is so globally connected.

Dropping IP barriers will facilitate greater collaboration

Many say the threat of IP litigation prevents the kind of collaboration needed to quickly ramp up production and development, and that a waiver can remove that threat. The president of Médecins Sans Frontières, Dr. Christos Christou, says that “[t]he waiver proposal offers all governments opportunities to take action for better collaboration in development, production and supply of COVID medical tools without being restricted by private industry’s interests and actions, and crucially would give governments all available tools to ensure global access.”

Patents were not meant to impede emergency action

A recent editorial in the journal Nature argues that patents are designed to protect ordinary commercial interests, not to hinder global cooperation against a common threat: “A pandemic is not a competition between companies, but a race between humanity and a virus. Instead of competing, countries and companies need to do all they can to cooperate to bring the pandemic to an end.”

It solves an immediate need without setting a troubling precedent

While opponents of the waiver argue that it will weaken future drug patent protection, Imron Aly and Ahmed M.T. Riaz of Schiff Hardin LLP call those concerns “unfounded” in their post at IPWatchdog. Not only is the current proposal limited specifically to COVID-19, but it was also not created carelessly. Instead, it “has taken substantial international efforts and official international law amendments.” Aly and Riaz say this exceptional action is appropriate if it can succeed where our IP system has yet to do so: “The TRIPS waiver simply allows countries the option to suspend patent enforcement to encourage COVID-19 vaccine production, which makes sense for those countries where current investment has not resulted in vaccine access.”

Even if the waiver doesn’t work, it might work

University of Houston Law Center Professor Sapna Kumar acknowledges a number of functional issues with the waiver approach but notes that it may still have a positive effect on the pandemic: “Overall, the greatest benefit of the Biden Administration’s support for the waiver is that it signals a departure from the prior approach of punishing countries facing health crises and that it might spur pharmaceutical companies to voluntarily increase out-licensing and donations of vaccines.” Her prediction was borne out by a recent pledge to donate 2.3 billion doses by Pfizer/BioNTech, Johnson & Johnson, and Moderna.

Opposed to the Waiver

Opponents of the waiver argue that it will not be effective because it fails to address the real problems. Further, it could actually be detrimental to quality control and supply chains in the present crisis, while quite possibly affecting how pharmaceutical companies choose to allocate investment dollars in the future.

It’s a long process that requires much more than a temporary waiver of licenses

Vaccines are not like other drugs. Writing for Foreign Affairs, Peter J. Hotez, Maria Elena Bottazzi, and Prashant Yadav say that we can’t compare the current situation to similar actions on HIV treatments, and that most nations are not prepared to make use of the patented technology: “Producing vaccines—particularly those as technologically complex as the messenger RNA (mRNA) inoculations against COVID-19—requires not only patents but an entire infrastructure that cannot be transferred overnight.” The authors state that “[t]he effective transfer of such complex technology requires a receiving ecosystem that can take years, sometimes decades, to build.”

We need another way

Professor Yogesh Pai of the National Law University Delhi says that simply waiving trade secret protection won’t automatically disclose everything a manufacturer needs to know. Accessing “hard tacit knowledge of manufacturing/quality control measures for production and clinical data required for regulatory clearances” could require forced technology transfer (FTT) by national governments. He recalls how detrimental such efforts were to India’s economy when it tried FTT with Coca-Cola in the 1970s, prompting the company to leave the country altogether.

Prof. Pai instead recommends efforts to encourage voluntary cooperation: “Where blunt legal instruments don’t work, using track-1 and track-2 diplomacy to place moral coercion on western governments to nudge firms to actively engage in technology licensing may still work wonders.”

“China First” policy?

Sixteen U.S. senators issued a sharply worded letter to the executive branch, questioning the true motives of “China and other countries which regularly steal American intellectual property—like India and South Africa,” and expressing shock that an American president would go along with it: “These nations are falsely claiming that granting such a waiver would speed the development of new vaccine capacity. Nothing could be further from the truth.” Instead, the senators are suggesting that the waiver is being used as a means to unfairly to acquire trade secrets that took massive resources and time to develop.

Reuters reports that “some U.S. officials fear the move would allow China to leapfrog years of research and erode the U.S. advantage in biopharmaceuticals” and quotes a senior U.S. official as saying that the country “‘would want to examine the effect of a waiver on China and Russia before it went into effect to ensure that it’s fit for purpose.’”

IP is not the Issue

A waiver on patent rights, even with the corresponding trade secrets, can only give permission to manufacture. But Eva Bishwal of Fidus Law Chambers writes that the real problems in India “are state inaction, dearth of raw materials and low production capacity.”

According to Patrick Kilbride of the U.S. Chamber of Commerce’s Global Innovation Policy Center, and as cited in Pharmaceutical Technology, “[p]roposals to waive intellectual property rights are misguided and a distraction from the real work of reinforcing supply chains and assisting countries to procure, distribute and administer vaccines to billions of the world’s citizens.”

Low-quality vaccines could do more harm than good

Former USPTO Director Andrei Iancu voiced concern recently at a World IP Day event, asking, “if we waive IP rights, and exclude the original manufacturers, how are we going to control the quality of the vaccines that go into people’s arms? How are we going to control for the fake vaccines? Just last week we saw fake Pfizer vaccines.” And as Philip Thompson points out for IPWatchdog, when investigators are forced to “determine if adverse events or sub-par effectiveness originate from ‘real’ vaccines or fake doses, we should expect global production starts and stops to become much more frequent.”

It will discourage investment in the most critical areas

Pharmaceutical developers invest unfathomable amounts of money into bringing drugs to market. The path to success is long, expensive, and highly uncertain. But what is certain is that successful drugs can yield a profit that covers the loss from failures. Now critics are deeply worried that this waiver will skew future cost-benefit analyses against important classes of medicine. All other things being equal, a developer has a better chance at a positive return by investing in drugs that pose no risk of seizure during a global emergency. As Amanda Glassman of the Center for Global Development writes, the waiver sends the wrong message to innovators and investors: “don’t bother attacking the most important global problems; instead, throw your investment dollars at the next treatment for erectile disfunction, which will surely earn you a steady return with far less agita.” The scramble amongst pharmaceutical giants to develop a vaccine was an all-out race, with good reason, and that’s exactly how it should be. If those companies believe that forfeiture is waiting at the finish line next time around, we might see fewer contestants.

Even “no-profit” vaccine makers appear to oppose the waiver

Pfizer CEO Albert Bourla laid out everything the company has done to combat the vaccine in an equitable manner and argued that “waiver of IP rights could only derail this progress.” And while Pfizer and Moderna are selling their vaccines at a profit, Johnson & Johnson and AstraZeneca have pledged not to do so during the pandemic.

However, it appears that even those companies oppose the waiver. As reported in The Wall Street Journal, the trade group PhRMA, which represents Johnson & Johnson and AstraZeneca among many others, is “lobbying members of Congress to oppose the Biden administration’s support for the waiver.” Johnson & Johnson’s Chief IP counsel Robert DeBerardine says that patent rights are responsible for the breakneck pace of development and that the drug’s makers are the best-equipped people to continue the fight: “What we’re able to do, because we have control of the IP, is to pick the best companies to help us supply the world. If you were to give everything to everybody, you may see a flood of vaccines, but you would have no idea if they’re safe and effective.”

Conclusion

While we share the concerns of other organizations that effective, affordable, and accessible vaccines be made available to all persons regardless of location or wealth, we do not believe that upending longstanding U.S. patent policy for a solution that will do little if anything to increase the vaccine supply is advisable. Strong IP rights remain the best way to incentivize innovation and ultimately increase the supply of life-saving medicines. The Biden administration’s unprecedented support of the proposed WTO IP waiver, while well intended, is likely to create long-term harm and unlikely to have much of an impact on global vaccine supplies. Ultimately, encouraging companies to license IP and engage in voluntary knowledge transfer, along with the sharing of excess doses that are being produced, are methods far more likely to alleviate the vaccine supply issues than waiving IP rights and would be a better path forward out of the current crisis.

Categories
Copyright Legislation

Just What Is the Case with the CASE Act? A Brief Overview

The following post comes from Ryan Reynolds, a 3L at Scalia Law and Research Assistant at CPIP.

chrome copyright symbolBy Ryan Reynolds

The phrase “creators have rights, but no remedies” is likely familiar to those aware of the current landscape of copyright protection for individual creators and small businesses (“Creators”). While the Copyright Act of 1976 grants a bundle of rights to Creators for the protection of their works, for years Creators have faced an uphill battle enforcing those rights against infringers. There are many who are optimistic, however, that things might soon change with the passage of “The Copyright Alternative in Small-Claims Enforcement Act of 2020” (CASE Act).

Signed into law as part of H.R. 133, the Consolidated Appropriations Act, [for Fiscal Year] 2021 (“CAA”), the CASE Act creates a Copyright Claims Board (“CCB”) within the Copyright Office to handle small copyright claims (small only in the sense of their relatively modest economic value). As there is some time before the CCB comes into operation, the earliest being December 21, 2021, and the latest June 2022, now is a good time to provide an overview of just what the CASE Act does. Before venturing fully into the mechanics of the CASE Act, however, it is important to first highlight why its supporters felt it was needed.

Why Is It Needed?

Copyright cases are almost exclusively an area of federal jurisdiction, meaning that copyright infringement cases must be brought in a federal rather than state court; however, litigating a copyright infringement case in federal court is anything but easy. First, the average cost of litigating a copyright infringement claim has been estimated at $397,000—a cost that often greatly outweighs any potential recovery for Creators’ works. It is for this reason that many attorneys are simply unwilling to take Creators’ copyright infringement cases, leaving many Creators feeling disenfranchised.

Second, the complexity of the federal court system is often overwhelming for Creators. As stated in the Copyright Office’s 2013 Copyright Small Claims report, “Small copyright owners, who frequently lack experience with federal courts, often find federal litigation too difficult . . . and may be unable to navigate ‘the often complex procedural rules that govern federal litigation . . . .’” As highlighted in the report, even the Copyright Act’s registration requirement—the gateway requirement to launch a copyright infringement claim—can be problematic for Creators. It requires that a copyright owner successfully register, or receive a rejection of registration, from the Copyright Office before launching an infringement claim. Moreover, for a Creator to qualify for statutory damages and attorney’s fees, the Copyright Act requires the registration of the work within three months of its publication, or if unpublished, before the act of infringement. The failure to register within the required time is critical, as without the potential recovery of statutory damages (which can range up to $150,000 per work infringed), a Creator’s recovery would not likely overcome the legal fees incurred litigating the case.

As stated in the report, the result of this cost and complexity is that “federal court is effectively inaccessible to copyright owners seeking redress for claims of relatively low economic value, especially individual creators who are of limited resources.” Enter the CASE Act, which aims to create a less expensive and less procedurally complex alternative to the current system by creating the CCB within the Copyright Office. But how will the CCB operate?

How Will It Operate?

When the CCB becomes operational, a party will have the choice of commencing a copyright infringement proceeding in either federal court or the CCB. In contrast to federal court, and as will be discussed in more detail later, proceedings in the CCB are completely voluntary. Another way in which the CCB differs from federal court is in its authority over copyright infringement claims only where the total damages sought do not exceed $30,000. As to the CCB’s structure, it will be composed of three full-time Copyright Claims Officers. Each of the Officers must have seven years of legal experience; two of them must also have extensive copyright adjudication experience, while one must have extensive alternative dispute resolution experience. The Librarian of Congress will appoint these Officers to staggered six-year terms, and they will be supported by at least two full-time Copyright Claims Attorneys with at least three years of experience.

To make the CCB more accessible to Creators, the CCB’s proceedings aim to be more streamlined and user friendly than federal courts. A proceeding before the CCB begins when the claimant files a claim to the CCB that includes the proper filing fee and a statement of the material facts. In contrast to federal court, the CASE Act only requires a completed application for registration of the claimant’s work(s), rather than a certificate of registration or refusal of registration by the Copyright Office to commence the claim. After the claim is approved for compliance with the law and applicable regulations by a Copyright Claims Attorney, the claimant has 90 days to complete service. After receiving service, the respondent then has 60 days to opt out of the proceeding before it becomes “active”; however, in the “interests of justice,” the CCB can extend this window another 60 days.

The user-friendly goal of the CCB is best exhibited by the Act’s requirement that the proceedings take place solely “by means of written submissions, hearings, and conferences carried out through internet-based applications.” The only exception to this convenience is when there is “material” “physical or other nontestimonial evidence” that otherwise the CCB cannot review. Further, proceedings before the CCB will be more informal than in federal court. There is no requirement for representation by an attorney, there is limited discovery, and the formal rules of evidence do not apply. If the parties do not settle, at the close of the proceeding the CCB must make factual findings based on the preponderance of the evidence and issue a publicly available written determination.

With regard to remedies, the CCB has the authority to award either actual damages, and the respondent’s profits, or statutory damages. If the CCB awards statutory damages, it “may not make any finding that, or consider whether, the infringement was committed willfully,” and if timely registration has been made with the Copyright Office, the CCB can award up to $15,000 for each work infringed, though this is subject to a $30,000 maximum. In an important shift from existing law, however, even if the work was not timely registered, the CCB may still award up to $7,500 for each work infringed to a maximum total of $15,000 in a single proceeding.

Within 30 days of the issuance of the final determination of the CCB, a party can request reconsideration by the CCB. After giving the other parties an opportunity to respond, the CCB may either deny the request or amend the determination. If the CCB denies the request for reconsideration, a party then has 30 days to request the Register of Copyrights to review the CCB’s determination. After giving the other parties time to respond, the Register may deny or remand the proceeding to the CCB for reconsideration. Finally, within 90 days of the final determination, or the post-determination reconsideration, a party can appeal to a U.S. District Court. It is also in federal district court where a party can seek enforcement of the CCB’s determination if the other parties to the matter refuse to abide by its determination. For a visual representation of this process, the Copyright Alliance has put together an informative flowchart.

The CASE Act requires that three years after the CCB becomes operational the Register of Copyrights make assessment of its effectiveness. While whether the CASE Act will create the change hoped for by its supporters is yet to be seen, in my view, the attention given to address the challenges to Creators is critically important.