Promoting Innovation in the Life Sciences and Supporting Pro-Competitive Collaborations:
The Role of Intellectual Property
Director of the U.S. Patent and Trademark Office Andrei Iancu
September 23, 2020
As prepared for delivery
Thank you, Nyeemah, for the very kind introduction, and for being one of today’s masters of ceremonies. Good afternoon, everyone, and welcome to the first day of our program focused on ways to accelerate American innovation in the life sciences. Our goal is to enhance collaboration among innovative companies and researchers to solve one of the most vexing health problems we have faced as a country in the past century.
A big thank you to everyone in the Antitrust Division at the Department of Justice for co-hosting this program with the U.S. Patent and Trademark Office. The collaboration between our two agencies is truly innovative, and it, too, is directed at helping to find ways to end the pandemic as soon as possible.
Over the course of American history, innovations in the life sciences have alleviated suffering, cured diseases, and improved quality of life. Since the dawn of the industrial revolution, those breakthroughs have almost doubled U.S. life expectancy from only 40 years in 1870 to 79 years in 2020.
One example is that before the early 1920s, people diagnosed with diabetes were “treated” by a “starvation diet” and were generally dead within two years. But in 1921, scientists Fredrick Banting and others discovered insulin, a protein hormone secreted by the pancreas that allows the body to use glucose for energy. Shortly after the discovery, in 1922, insulin extracted from dogs was first used for the treatment of diabetes with promising results. Almost 100 years later, scientists are still making advances in insulin therapies, allowing those with diabetes to live full and productive lives.
Throughout our nation’s history, American ingenuity and the IP rights granted to inventors have resulted in the creation of entirely new industries that have transformed the global economy. An example is that of Dr. Marvin Caruthers, co-founder of Amgen, now one of the largest bio-pharmaceutical companies in the world. Dr. Caruthers told me that without the protections offered by patents, the United States “would not have had a serious biotechnology industry.” He added that patents are the reason investors “lay down millions of dollars to start a company.”
Today, the pandemic has galvanized the global research community into a full-scale assault on the virus. It has also propelled the USPTO to create initiatives to accelerate the development and deployment of diagnostics, therapeutics, and vaccines aimed at ending transmission of the virus.
We are expediting the examination of patent and trademark applications filed by small businesses related to COVID-19. We launched the Patents 4 Partnerships — or P-4-P platform — to connect innovators with potential licensees who can accelerate the development and application of promising technologies. We have extended deadlines, waived fees, and eliminated barriers to patenting COVID technologies.
And just last week, we announced an initiative to encourage the early disclosure of COVID-related patent applications on the USPTO website in exchange for the deferral of provisional application fees. This action could lead to the sharing of ideas and a collective burst of creative thinking about solutions to the pandemic. Our patent examiners and administrative judges have been running at full throttle to keep the U.S. patent system at the forefront of protecting and nourishing the nation’s most important asset: its intellectual property.
We have also undertaken a major initiative to renew our economy in the long term by significantly increasing the number of people engaged in the U.S. innovation economy. Last week, we hosted the inaugural meeting of the National Council for Expanding American Innovation. Its directive is to help us broaden the population of American inventors to include women, minorities, and millions of potential young entrepreneurs who live far from any of the current technology hubs.
We need all hands on deck – not only to fight and defeat COVID, but to invent America’s future. The patent system remains crucial in this effort.
Due to the rigors of the regulatory process, it takes years to bring new therapies and pharmaceuticals to market. And, depending upon the therapy, the cost to bring a new drug to market varies from hundreds of millions of dollars to more than $2 billion. The patent system provides the incentives and protections needed to enable such significant risks and large-scale investments in R&D.
Our patent system also fosters innovation by promoting the disclosure of inventions, such that others can learn from them, avoid them where needed, and improve upon them when possible. Without the patent system, seminal discoveries might be kept from the public as trade secrets, stifling breakthroughs and additional innovation. Plus, patents turn intellectual creativity into financial and legal instruments that facilitate trade, licensing, and transfer of technologies from lab-to-market and in-between entities.
The bottom line is this: patents and other forms of intellectual property are critical drivers of innovation and human development. You need only look at one weekly issue of the Official Gazette of the U.S. Patent and Trademark Office to know that this is the case, and to see the amazing inventions that come through our office.
We must do everything we can to ensure a strong, reliable, and balanced IP system that promotes innovation. The USPTO and the DOJ Antitrust Division are working relentlessly towards this shared vision. During the course of this conference, we invite you to provide us with ideas and actions the Administration can take to even better support innovation and the development of COVID-19 inventions.
I look forward to moderating a panel of experts this afternoon on whether changes to patent law could generate additional innovation in the life sciences. There will also be a session exploring the importance of copyrights for the dissemination and use of leading-edge research.
We are especially pleased that DOJ will lead the second part of the program, which is tomorrow, to discuss how we can promote partnerships to accelerate the application of new products and processes that can end this pandemic and ward off any future threats.
Additional speakers and panelists will address licensing strategies, the regulatory and antitrust issues and risks associated with collaborations, and incentives needed to spur a new wave of innovation in the life sciences.
And, tomorrow, I look forward to having a one-on-one discussion with Makan Delrahim, the Assistant Attorney General for the Antitrust Division at the U.S. Department of Justice, when we will delve further into these issues. As a special treat, Federal Circuit Judge Kathleen O’Malley has agreed to moderate our discussion.
Thank you, again, for everything each and every one of you do to generate the innovation — and nurture the innovators — responsible for solving the greatest health threats facing mankind.
Now, I turn it back to Nyeemah.