Inovating Drug Patents - RM Raskin's Opening Remarks

Thank you, Chairman Issa. Thanks to all the witnesses for joining us today. Since I became the Ranking Member, I've met with some superb IP lawyers bringing their perspectives on a wide variety of issues to me, from suits against AI companies for training large language models, from AuthorsWorks to the U.S. Patent and Trademark Office Director filing for a trademark on behalf of the Board of Peace. The various issues percolating before this excellent subcommittee are important and essential to the practice of law. But as I've told every single one of the people who's come to see me, I never took patent law in law school, much less taught it when I was there. And so the field is new to me and my mind is open. And so I welcome very much the perspectives being advanced at this hearing. We're often called to weigh in on important issues that we need to learn about quickly, and it's easiest when we've got a personal connection to the problem. As an author myself, it's easy for me to understand why having your words stolen is unfair. As a former con law professor, I know that a member of the executive branch contorting his position to personally benefit the sitting president is a dangerous abuse of power. And while facially one might expect patents for medical innovation to be somehow an opaque or esoteric or inaccessible topic, in fact all of us have benefited from the medical patent system. As small children we got a polio vaccine, a smallpox vaccine, a measles vaccine, among others. We cut our fingers, we got a tetanus shot. When we were sick, we enjoyed access to antibiotic treatments. And when we were hit by the global COVID-19 epidemic, we all got access to the innovative mRNA vaccines. So we are fortunate and grateful to be living in a time of medical discovery where things that killed people in our grandparents' generation are now survivable to us. Before insulin was discovered in the 1920s, diabetes type 1 was devastating. HIV-AIDS was a death sentence when I was in college. But modern antiretroviral therapy now can help people who are able to get early treatment reduce the virus to almost undetectable levels. Bacterial pneumonia, lymphoma, breast cancer, cystic fibrosis, which has affected people in my family, all of these have been downgraded from certain killers to manageable diseases. But I also understand that as a person with good health insurance, I have a type of access to vaccines and medical innovations that not many people around the world, and not everybody in the United States can match. Cures and treatments mean little to people who cannot access and afford them. Efforts to reform our healthcare system to cover more people have been steadily eroded since Congress passed the Affordable Care Act in 2010. In part because of this, too many Americans are forced to forego a treatment simply because they can't afford it. It's imperative that we continue to innovate and produce new cures. It's also vital that we find a way to ensure people can access new medicines, therapeutics, and diagnostics. I know some people believe the answer is to change the way drug patents work in the United States so that generic drug manufacturers can access protected inventions earlier. Others argue that if we allow generic and biosimilar drug manufacturers to more readily take advantage of others' work, we're not just taking inventors' property but dramatically changing the incentive structure for future research and development. How to strike the right balance between promoting universal access and incentivizing new research and discovery isn't a new question. When the framers wrote the Constitution, they were already familiar with the basic idea of promoting the public interest by protecting individual patent rights. In England, the Parliament passed the Statute of Monopolies in 1624, which allowed the monarch to issue letters of patent to single persons. In the Constitution, the framers bequeathed to Congress the power to promote the progress of science and useful arts by securing for limited times to authors and investors the exclusive right to their respective writings and discoveries. In Federalist 43, Madison wrote, quote, the utility of this power will scarcely be questioned. The copyright of authors has been solemnly adjudged in Great Britain to be a right of common law. The right to useful invention seems with equal reason to belong to the inventors. The public good fully coincides in both cases with the claims of individuals. This utilitarian approach is reflected in our patent system today. Throughout our history, legislators have asked how we can ensure inventors are able to protect their creations in exchange for meaningful public access to the use of those ideas. Today, drugs remain exclusive or covered by a patent for an average of 12 years, as opposed to the statutory 20. I understand that's because of the complicated nature of market entry, extensive research and development, and other relevant factors. I'm looking forward to hearing from our witnesses today how this system is working, how it's not working, and how we can our system continues to promote the public good through the individual and through our laws. I close with the words of Thomas Jefferson, who, in addition to being our third president, was our first patent examiner. In 1813, he wrote, quote, considering the exclusive right to invention is given not of natural right but for the benefit of society, I know well the difficulty of drawing a line between the things which are worth to the public, the embarrassment of an exclusive patent, and those which are not. I thank the witnesses for helping us to draw that same line in the 21st century, and let us all hope for the wisdom and discernment of the third president of the United States, Thomas Jefferson. Thank you, Mr. Chairman, and I yield back to you.