As pressure mounts on the United States government to support waiving intellectual property (IP) protections on the COVID-19 vaccines at the World Trade Organization, progressives are closely monitoring the Biden administration’s appointments to agencies that impact intellectual property matters such as the United States Patent and Trademark Office (USPTO).
With an ambitious nominee, the Biden administration can demonstrate its desire to remake an IP system that allows pharmaceutical companies to charge exorbitant prices for medicines and medical equipment, limiting peoples’ access to treatment while protecting monopoly profits. A break from the current system that has corporatized medical research is even more important as the world continues to reckon with the ongoing COVID-19 pandemic. Widespread vaccination of populations all over the world is key to putting the horrors of the pandemic behind us. Appointing a USPTO Director who acknowledges the need to prioritize public health over corporate interests can help bring us closer to that goal
WHAT DOES USPTO DO?
The U.S. Patent and Trademark Office is a fee-funded sub agency within the Department of Commerce. It is responsible for granting patents and trademarks in the United States.
In addition to processing patent and trademark applications, USPTO provides technical advice to the President, Commerce Secretary and U.S government agencies on intellectual property policy, protection and enforcement. Through its Office of Policy and International Affairs, USPTO develops domestic and international policy on IP protection and enforcement. The Office of Policy and International Affairs also helps the Office of the United States Trade Representative and Department of State define IP obligations in bilateral and multilateral treaties and trade agreements.
WHY IS THIS RELEVANT?
Patents, copyrights, trademarks and other forms of intellectual property are public policy with significant impact on the livelihoods of people all over the world. In the United States and beyond, the Patent and Trademark Office’s pursuit of innovation has come at a heavy societal and economic cost. Prescription drugs in the United States, for example, cost over $315 billion more in 2018 than they would in a free market, according to a study by CEPR economist Dean Baker. While drug prices are the most popular example, the current patent system is inflating prices in countless other sectors, including agriculture, software, and others.
Many of USPTO’s policies and practices contribute to this reality. Some, like lengthy patent periods and patent thickets, are sold as essential components of effective innovation policy, although the evidence for that claim is far from solid. Others are baked into the structure — like the fact that the office is funded exclusively by fees from patent awards, disincentivizing any policy that cuts the number of patents awarded — or plain manifestations of outsized corporate influence — like a public advisory board stacked with corporate representatives.
As the world buckles under the weight of the COVID-19 pandemic and the United States continues to face the fatal reality of prohibitive drug pricing, it’s long past time that the USPTO moves in a different direction. Biden’s choice to lead the office can and should use its considerable power to push for both immediate relief and structural reforms.
Intellectual Property And Vaccines
While the vaccination effort has proceeded quickly in the United States, it is just getting started throughout much of the world. Artificially limited supply and high costs are likely to limit the speed of the global vaccination program for the foreseeable future, with dire consequences from a humanitarian and public health perspective. At present, the World Trade Organization (WTO) is considering whether or not to grant a limited waiver of pharmaceutical companies’ intellectual property rights to facilitate the accelerated, low-cost production and distribution of generic vaccines. While the United States government’s decision to support the waiver (or to continue the Trump era policy of opposing) ultimately rests with the United States Trade Representative, vocal public support and vigorous behind-the-scenes advocacy from the next head of the Patent and Trademark Office would put a consequential thumb on the scale in favor of open access.
Additionally, IP policy will likely shape the ongoing, evolving response to the pandemic, from testing technologies, to boosters, and additional vaccines. In all of these cases, USPTO can either continue its policy of putting private profit above all else, or it can take steps to ensure life-saving technologies reach those who need them.
Intellectual property rules are a key component of most bilateral and multilateral trade agreements. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is a prominent example of that. Included in the 1994 agreement establishing the World Trade Organization, TRIPS was a culmination of decades of jockeying by corporate powers to enforce patent and copyright protections abroad. Scholars such as Dani Rodrik have noted that agreements such as TRIPS “pit advanced countries against developing countries, with the former demanding stronger and lengthier monopoly restrictions for their firms in the latter’s markets.”
By successfully defining IP as a trade issue, companies have been able to continuously obtain further protections in regional, bilateral and multilateral trade agreements. Take for example, the failed Trans-Pacific Partnership (TPP) where the pharmaceutical industry lobbied the Obama administration to include 12 years of monopoly pricing power for drug products despite opposition from all the other nations.
The USPTO’s Trade group is responsible for providing advice on patent and copyright issues to the Office of the United States Trade Representative. Rather than just support the wishes of corporate interests, USPTO can be more public-minded and consider public concerns of both the US and its trading partners.
The next head of the Patent and Trademark Office cannot stop at addressing the present crisis, but must target many of the structures and practices that have made intellectual property a tool for growing corporate power rather than advancing the public interest. First and foremost, that means changing understandings of what the office is meant to achieve. While, at the moment, advancing innovation is the agency’s exclusive aim, the office’s next leader could add goals such as advancing equity to its mission. Similarly, the office could expand the pool of people it considers its “users” from just patent applicants to those who patents will impact.
Making the patent system transparent and public would be one way for USPTO to embrace equity as part of its core mission. The next head of the office can push for the adoption of public hearings and roundtable sessions that engage with affected communities. After all, the impact of patent decisions are shared by the public, so why should they be shut out of the process. We need not look far for examples of such a model as some government agencies, including the Environmental Protection Agency and the Food and Drug Administration already recognize the importance of public input. Public engagement, however, should not be limited to hearings and sessions. The next USPTO director must look into changing the current patent challenge system to allow people to challenge patents even before they are filed. Such a move would precipitate greater patent scrutiny and remove patent challenges from the sole domain of larger companies.
Recent reforms to the pan-European patent system can serve as inspiration for a remodeled USPTO. The European Patent Office has more openly embraced civil society’s participation in its bureaucratic and court proceedings. It has also incorporated the public’s moral and socioeconomic concerns into its decision-making, going as far as inviting critics to participate in the development of its 2007 report – Scenarios for the Future – on the challenges that lie ahead. Sustained efforts to sensitize traditional stakeholders in the patent system (inventors, patent lawyers, technical examiners) to the views and concerns of the public regarding patents would be key to creating a much more equitable system.
These moves could begin to tackle another persistent challenge: USPTO approves many frivolous, flawed, and unnecessary patents. These patents can contribute to “patent thickets” (when companies file tens or even hundreds of patents on components of a drug or technology) that extend the period of effective exclusivity such that companies can keep prices high for decades. To really curb this problem, however, USPTO will also need to advocate for changes to its funding structure. As it stands, USPTO is funded exclusively from fees for patents it awards, disincentivizing any policy that slows the speed of patent awards.
Beyond taking steps to ensure fewer unnecessary or detrimental patents are awarded, the next head of USPTO can also make it easier for outside parties to challenge patent awards by reducing fees associated with filing patent challenges and reversing a Trump-era change that narrowed an alternative, less costly pathway for challenges.
While USPTO may be relatively obscure, the changes that would result from these sorts of reforms are anything but abstract. By abandoning the old, failed consensus around innovation and intellectual property policy, PTO can help deliver lower prices and greater access for medications, most obviously, but also agricultural products, food, technology and more. It is essential that Biden’s choice to lead USPTO be ready to break with past precedent and remake the patent system to serve the public interest.
Header image: “Pfizer-BioNTech COVID-19 vaccine (2020) E” by the U.S. Secretary of Defense is licensed under CC BY 2.0
This article was initially published on April 9, 2021. It was updated on April 23, 2021 with a new section, Trade Agreements and new language in the Additional Reforms section.