Senate Finance Committee Chair Ron Wyden (D-OR), Ranking Member Mike Crapo (R-ID) and Senators Bob Menendez (D-N.J.), Charles Grassley (R-IA), Catherine Cortez Masto (D-NV) and Ben Sasse (R-NE) sent a letter today to U.S. Trade Representative (USTR) Katherine Tai asking that she “dramatically improve” transparency in the negotiations surrounding waiver of intellectual property rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The letter noted that details of the draft text of a waiver agreement were announced in March, before Congress had been briefed or shown the text. Most recently, a new draft was shared with all World Trade Organization (WTO) Member States that has caused controversy on all sides of the issue.
The Information Technology & Innovation Foundation (ITIF) this week released a report titled “A Worker-Centric Trade Agenda Needs to Focus on Competitiveness, Including Robust IP Protections.” The ITIF is a nonprofit, nonpartisan research and educational institute that focuses on technological innovation and public policy. The report explained that U.S. trade policy has long been contentious. Traditionally, trade policy prioritized U.S. consumer interests. However, in response to a decline in U.S. manufacturing jobs and output due to unbalanced trade, President Biden raised a “worker-centric trade agenda,” turning away from this traditional approach. In his shift to a “worker-centric trade agenda,” the report recommended that President Biden should reject the counsel of anti-corporate, anti-trade progressives who deny that U.S. companies’ interests align with U.S. workers’ interests. A new competitiveness-focused approach to trade policy can support both.
Nine months in, and we are still awaiting the Biden administration’s decision as to whether the law of patent eligibility should be clarified. This area of patent law has in recent years become increasingly unpredictable, and the consequences of that unpredictability have largely fallen on startups, whose primary assets are often inventions. On May 3, 2021, the Supreme Court invited the Solicitor General to recommend whether certiorari should be granted in American Axle v. Neapco Holdings, LLC—a case in which a method for manufacturing vehicle driveshafts was deemed ineligible under 35 USC § 101 as being directed to a law of nature.
From the “one hand doesn’t know what the other hand is doing” category, believe it or not, the Food and Drug Administration (FDA) is effectively refusing to release documents it possesses relating to the approval of the Pfizer-BioNTech COVID-19 vaccine. More precisely, Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and scientists, submitted a Freedom of Information Act (FOIA) request for documents relating to the approval of the Pfizer COVID-19 vaccine. After the FDA denied a request by the PHMPT to expedite release of the documents, a lawsuit was filed. In response to that lawsuit, the FDA proposed to release 500 pages per month, which would allow the agency time to redact material as necessary. Given that there are 329,000 pages responsive to the PHMPT request, at the proposed FDA rate of 500 pages per month it would take 55 years for the FDA to fully release the Pfizer COVID-19 vaccine documents.
Former U.S. Patent and Trademark Office (USPTO) Directors Andrei Iancu and David Kappos, and former Secretary of Commerce Gary Locke, today released a White Paper calling the Biden Administration’s decision to support a waiver of intellectual property protections for COVID-19-related technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) “strategic folly.” The report was produced by the Center for Strategic and International Studies (CSIS). In the paper, titled “The Shot Heard around the World”, the three officials, two of whom served under the Obama Administration, explained that the United States must indeed ramp up its efforts to improve vaccine diplomacy and to distribute more vaccines globally, but that “[w]aiving IP protections would not lead to the manufacture of a single additional dose of a vaccine.” Instead, they proposed a number of alternative solutions to solve the “real problems.”
On July 20, President Joe Biden nominated Jonathan Kanter as Assistant Attorney General, a position that would place him at the head of the Antitrust Division at the Department of Justice. Kanter is an antitrust lawyer with over 20 years of experience. He is currently a partner at The Kanter Law Group LLP, which is a boutique antitrust law firm that advocates in favor of federal and state antitrust law enforcement. Prior to founding the The Kanter Law Group, he was Co-Chair of the antitrust practice at Paul, Weiss, Rifkind, Wharton, and Garrison LLP. Kanter also served as an attorney for the U.S. Federal Trade Commission’s Bureau of Competition.
What would you say about a technology commercialization system that kept on performing even through the worst pandemic in over a century? How about if it improved its performance over the previous year and was a critical factor in developing desperately needed therapies to protect people around the world? Would it seem reasonable that this was something that all of us should highly value and want to protect? You might think so, but some in Washington apparently don’t agree.
President Joe Biden’s recent executive order was billed as “promoting competition in the American economy,” but is a prime example of why one should always read the fine print. Rather than boosting the technology and innovations that spur American competitiveness in the global marketplace, the Biden administration is pushing a directive that reinforces the dominance of technology giants like Apple and Google. Part of the executive order addresses the complex but essential way we protect those who develop standard technology – such as the shared technologies that make mobile communication possible across multiple networks. Standards enable critical technologies such as 5G, the Internet of Things, video transmission, artificial intelligence, and autonomous vehicles. Nations that develop these technologies and the standards they are based on will have a significant advantage in gaining the lead in the next industrial revolution.
At today’s Heritage Foundation event in Washington, D.C., titled Restoring American Leadership in Patent Law and Innovation Policy, former U.S. Patent and Trademark Office Director (USPTO) Andrei Iancu began by lamenting the failure of decision makers to make the connection between intellectual property and innovation. Increasingly, policy makers think innovation just happens, Iancu explained, with too many believing monetization happens after the fact, rather than driving innovation. “Without IP, the free market does not participate, or does not participate to scale,” Iancu told the Heritage audience. Laurie Self, Senior Vice President and Counsel, Government Affairs, Qualcomm, agreed with Iancu and added that, without a strong patent system, there is no opportunity to maintain a strong innovation leadership position. Presumably alluding to developments such as the Biden Administration’s support for waiving IP rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) related to COVID-19 inventions and the recent Executive Order on Competition, Self said: “We are seeing a series of policies that if implemented would undermine our system… this cognitive dissonance is a threat.”
Capping months of anticipation, President Joe Biden on July 9 unveiled his Executive Order on Promoting Competition in the American Economy, which he argues will “lower prices for families, increase wages for workers, and promote innovation and even faster economic growth.” To achieve these lofty goals, the order prescribes regulatory interventions that interfere with property and contract rights in industry after industry. Undergirding the order is the premise that “competition has weakened in too many markets, denying Americans the benefits of an open economy and widening racial, income, and wealth inequality.” The White House offers only a handful of anecdotes to justify this sweeping conclusion, which remains highly disputed. In fact, few sectors of the U.S. economy are especially concentrated, and many markets that have become concentrated at the national level have become less concentrated at the local level, as national chains open up in more areas.
Late Friday, the Biden Administration unveiled what must be one of the longest Executive Orders in history, titled “Promoting Competition in the American Economy.” In 31 pages, it covers everything from agriculture, shipping and railroads to the internet. The aim is to promote a “fair, open and competitive marketplace” against the threats of “excessive market concentration.” Among the intended beneficiaries are entrepreneurs, who will receive “space to experiment, innovate, and pursue the new ideas that have for centuries powered the American economy and improved the quality of life.” Unfortunately, tucked away on page 28 is a directive to the Secretary of Commerce that could threaten to undermine the Bayh-Dole Act, which allows entrepreneurs to commercialize federally-funded inventions. The law has spurred the impressive formation of academic spin-out companies and resulted in approximately 70% of these discoveries being licensed to small companies. It’s also critically important to our economic growth and continued well-being.
Waiving intellectual property (IP) protections for COVID-19 vaccines will hinder rather than further three meritorious objectives of the current U.S. Presidential Administration: ending the pandemic as soon as possible, leveling the IP playing field with China, and pursuing a worker-centric trade policy. Ensuring equitable, widespread, and successful distribution of vaccines across the globe to meet the challenges of COVID-19, ending the erosion of U.S. IP at the hands of China, and putting Americans back to work are goals that most of us in the U.S. share. An examination of the facts, however, demonstrates that waiving IP rights in the name of COVID-19 relief undermines each of these three U.S. government goals.
Historically an esoteric area of law, in recent years, antitrust policy is drawing broader attention as a tool to curb the exercise of monopolistic market power, especially by big tech behemoths. Congressional reports on both Democratic and Republican sides of the aisle, multiple legislative initiatives to reform U.S. antitrust law, and a recent book by Senator Amy Klobuchar (D-MN), Chair of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights, are some indicators of this trend. Along these lines, broad outcry broke out against rumored Department of Justice (DOJ) Antitrust Division leadership appointments of candidates representing big tech interests, such as Karen Dunn (Apple, Amazon), Renata Hesse (Google, Amazon), Susan Davies (Facebook), and against Deputy Attorney General Lisa Monaco’s (Apple, Google) involvement in deliberations over the nomination of a DOJ Assistant Attorney General (AAG) for Antitrust.
Intellectual property (IP) made modern vaccines possible. It took billions of dollars in private and public investments in research and development to be able to create, in record time, multiple viable vaccines to fight the COVID-19 pandemic. The entire world should be celebrating the innovators that continue to push forward with new solutions to problems we will face in the future. This pandemic will end, but there will be another. We should be eternally grateful to have companies like Pfizer, Moderna and Johnson & Johnson that have the capability to create and manufacture vaccines at large scale…. It has been over four months since President Biden’s inauguration. As of yet there has not been a nomination for the Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office (USPTO). In addition to running the USPTO, the Director is responsible for advising the President on intellectual property issues. I believe that President Biden would have benefitted from an experienced voice knowledgeable about the dangers of supporting the erosion of property rights during the discussions on whether to support India and South Africa’s proposal to the World Trade Organization to waive IP protections under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
A group of 16 Republican senators sent a letter on Wednesday to U.S. Department of Commerce Secretary Gina Raimondo and U.S. Trade Representative (USTR) Katherine Tai denouncing the Biden Administration’s “disastrous decision” to support a proposal at the World Trade Organization (WTO) to waive intellectual property (IP) rights for COVID-19-related inventions and products. The letter explains that the waiver is not limited to vaccines and “will do nothing to end the pandemic,” but will instead “undermine the extraordinary global response that has achieved historically remarkable results in record time and our nation’s global leadership in the technologies, medicines, and treatments of the future.”