Transcripts For CSPAN3 Hearing 20240704 : vimarsana.com

CSPAN3 Hearing July 4, 2024

Live coverage on cspan. All of our witnesses on the first and second panel are participating today. I apologize for being a few minutes late. We were in the middle of a two vote series so all of us at some point will get up and go vote and come back in my hope is we will be able to use this hearing regardless. I would like to particularly thank my Ranking Member and friend, senator tillis, and his staff for working so well together and putting this hearing together on a consensus basis. Today we are examining the patent eligibility act, our second drive through this ticket, and i am looking forward to a return. To a reconsideration of the court issues. More than 70 years ago, Congress Passed the patent act, and that law defined patent law subject matter very clearly. Congress intended to allow anything under the sun as made by man to be patentable. Other provisions in the act require that it should be novel, not obvious. Written descriptions served as defined filters, and that all changed roughly a decade ago when the Supreme Court announced a new two step test for determining patent eligibility. Judges have to determine whether an invention is directed to a patent ineligible concept like the law of nature or abstract idea, and if so, the examiner or judge has to consider whether the patent claim contains an inventive concept. The results to my fewer inventions are patent eligible in the United States, particularly in rapidly advancing fields, medical diagnostics, software, artificial intelligence. Those same inventions are still eligible for patent protection abroad, which means if innovators and investors dont have confidence in our ability to protect inventions in the United States, they may or will take their skills and investments elsewhere. This new test does not just with the u. S. At a competitive disadvantage, it is also quite difficult for judges to apply with any degree of certainty. Here is how judges on the federal circuit described the state of u. S. Eligibility law. Incoherent, fraught, unclear, inconsistent, and confusing. Things are so bad that the chief judge has made an unprecedented plea for guidance from the Supreme Court. Multiple solicitors general of the u. S. Have asked the court to clarify this law, and the Patent Trademark Office has said the illegal uncertainty has caused unique challenges. In 2019, senator tillis and i had a marathon three days of hearing and heard from 45 witnesses on the issue of patentability. Almost every witness agreed that eligibility law was a mess and needed further clarity and guidance. The Supreme Court has consistently refused to step in, denying every one of the roughly 100 petitions raising this question over the past decade. With the Supreme Court unwilling come unlikely to act, legislation is the best and may be the only path forward, which is why i was happy to once again join senator tillis in introducing something that will return patentability to important inventions. It will be clear what is not patent eligible, ideas, discoveries of what already exists in nature, like unmodified human genes, and social or cultural content, things that everyone agrees is beyond the scope. To be able to a compass this in three ways, first, abolish those set forth in the Supreme Court two step test. Second, clarify eligibility determinations are made by considering every claim element of the patent as a whole and without regards to novelty nondisclosure requirements, and a list of excluded subject matter while maintaining the existing statutory categories. I look forward to continuing this work with senator tillis and with the wide range of stakeholder groups presented by witnesses here today as we move forward. We have assembled two panels with diverse views and perspectives views and perspectives pro and con. I will introduce the first panel of witnesses in a moment, but first i will turn it over to senator tillis of north carolina. Ranking member tillis thank you, mr. Chairman, and thanks everyone for being here. These are two of the most significant issues we must address within the patent community. Today we focus on patent eligibility reform. While i do believe i dont always believe the best fix is allegedly to fix, but i think we reached a point where legislation is needed. As a result of a series of u. S. Supreme Court Decisions which created categories of judicial exceptions, patent eligibility law has become confused, constricted, unclear, and unclear over the years. Inconsistent case decisions, and certainty innovation, and investment communities, at unpredictable business outcomes. This lack of clarity threatens to hinder innovation and to unseat the United States as the World Innovation leader especially in medicine, artificial intelligence, computing, and 5g wireless and beyond. This impacts individual inventors and businesses both large and small. Furthermore, this lack of clarity has the potential to cripple our Economic Growth and will leave our country vulnerable to foreign bad actors, primarily the Chinese Communist party who wish to undermine ip rights. In 2021, i worked with david and a judge to file an amicus brief in the american axle case. I was disappointed to see the Supreme Court declined this opportunity to offer clarity on patent eligibility. There was another reason why this is another reason why Congress Must act and why i introduced the patent eligibility restoration act of 2023 along with senator coons. This will secure inventions across several key areas of technology. The existing categories of eligible subject matter worked well over two centuries, and it addresses concerns regarding inappropriate eligibility constraints by enumerating a specific but extensive list of excluded subject matter. This reform will directly and meaningfully impact all stages of patent lifecycle from prosecution to litigation. I look forward to continuing to work with stakeholders to develop a proposal that strikes the right balance and most importantly can pass the senate and become law. I encourage everyone to reach out and engage with my office regarding this bill, especially those who oppose it. And again, i will make my traditional disclaimer. Just come at us with good arguments. Dont try and undermine it behindthescenes. It never ends well. We have said many times before it is better to be at the table than on the table. Lets get this right because often times when you come with a point of view with the data to back it, we will try to accommodate it. Mr. Chair, thank you again for holding the hearing. I look forward to continuing to work closely with you and your staff to move them through the senate together. Now i look forward to hearing your testimony. Thank you, mr. Chair. Chair coons thank you, senator tillis. Thank you, senator, for joining us. Today, we welcome two panels of witnesses to testify. Our first witness this andrei iancu is andrei iancu. Welcome. We second have richard blaylock, an ip strategist for an genetic testing company. Thank you, richard. We have courtenay c. Brinckerhoff, a partner who has been advising life sizes clients for more than 25 years in obtaining and defending licensing and enforcing patents. Finally, we were here from philip johnson. A coalition of patent owners from a wide range of industry sectors. Mr. Johnson has been a leading voice in patent law for more than 40 years. Briefly about the mechanics after i swear in this panel of witnesses, you will each have five minutes to make an opening statement. We will proceed to questions and each senator will have five minutes. We will likely have a second round of questions, then we will recess and bring in the second panel. But first to be sworn in. Could all the witnesses please stand . Please raise your right hand. Do you swear and affirm the testimony you will give before this testimony will be the truth, the whole truth, and nothing but the truth, so help you god . Thank you. Mr. Iancu, you may proceed. Mr. Iancu thank you, mr. Chairman, Ranking Member tillis, members of the subcommittee. Good afternoon, and think it really to discuss and thank you for the opportunity to discuss. I want to thank the subcommittee for undertaking the task of modernizing the statute which in essence first appeared in the patent act of 1793, and when madison and jefferson were drafting patent laws. A lot has changed in the world of Technology Since 1793, and courts will be forgiven for struggling to apply an 18thcentury statute with 21st century technology. Our Founding Fathers were brilliant. But even they did not anticipate dna processing or the internet. The current state of section 101 law is the result of many quick decisions over the many decades trying to determine whether these modern technologies fit into categories defined in 1793 or whether they are subject to certain exceptions courts have imposed since then. These quick decisions also have resulted in certain de facto rules such as diagnostic techniques for example generally not eligible for patent in the United States. This congress has never considered, debated, or passed in the law. If the United States does not recognize patents for certain categories of inventions, they would otherwise be part of categories outlined by congress, than it is up to congress to make that rule. In other words, congress defined the categories of invention that are eligible for patents. If there are to be exceptions to those categories, they must likewise come from congress. One of the biggest errors is the Court Decisions have recently poured into section 101 analysis other parts of patent law such as questions of novelty, which are dealt with in section 102, questions addressed in section 103, questions of specificity and disclosure, which would be addressed in section 112 analysis. All of this has even sown confusion among the expert ranks of the hardworking patent examiners and the u. S. Pto. To address this issue, the Patent Office for beleaguered guidelines in 2019 that synthesize and provided a significantly improved framework for analyzing eligibility under 101. This is dramatically improving the analysis at the u. S. Pto. For example, a study has shown that uncertainty of section 101 decisions for the relevant technologies decreased by 44 in just that first year following publication of the guidelines. It is working really well. Courts however are independent and not bound by administered of guidelines, so they persist. They persist in their approach, which has caused profound uncertainty in the lower courts and among inventors, investors, and patent law practitioners alike. As a result, congressional action is needed to determine affirmatively which categories of invention should be deemed statutorily patentable or unpatentable. Here is the most important point. Congress needs to create clear rules. Whatever those rules may end up being after the legislative debate, at least the public deserves to know what the rules of the road are. Fortunately, it provides a legislative vehicle for the United States to correct the state of the law. It outlines the correct threestep framework for analysis. First, it maintains the broad categories of what qualifies as an invention in the u. S. In other words, what is in the patent system. It then expressly outlines certain categories that are not considered to be eligible for patents. In other words, what is out of the patent system. And further indicates . Not to create any other exceptions that are not in the statute. Third, it clarifies the excluded matter does not automatically destroy eligibility. Specifically an invention that combines excluded matter with eligible matter into a useful, practical application, and that combination may still be eligible. In the end, once the categories of included and excluded matter after debate and adjustment is appropriate are settled on and passed into law, it will bring immediate certainty to section 101. I commend the subcommittee for holding this hearing to bring muchneeded reform to section 101 and to set our nation on a path of innovation and success for the 21st century and beyond. Thank you again for the opportunity to testify, and i look forward to your questions. Chair coons thank you for your testimony. Mr. Blaylock members of the subcommittee, thank you for the opportunity to address the topic of patent subject matter eligibility. I am appearing on behalf of the corporation for whom i have been council since its formation in 2010. The clinical diagnostic community it serves is concerned the patent eligibility restoration act as introduced would stifle innovation and harm patient care in the field of diagnostic genetic testing and precision medicine. The Company Delivers information for both children and adults and has served over 4 million patients and its success in providing critical information has been fostered by the current patent eligibility jurisprudence in the United States. We have often heard the suggestion the publication of the human genome is rendered moot the need for concern relating to patents on human genes. The argument rests on the already had patented human genes have passed because the sequences of human genes are no longer new. This represented a fundamental misunderstanding of the risks to science and patient care caused by permitting natural phenomena to be patented. Under current law, natural phenomena are not patent eligible subject matter, nor are applications of conventional technology to natural phenomena. No person has the standard human genome. All of us have variants in our genetic sequences. Some are clinically significant. A wellknown example, the brca genes that would present indicate a substantially elevated lifetime risk of breast cancer, pancreatic cancer, prostate cancer, or other types of cancer. Variants such as these are natural biomarkers and this information, including its association with disease risk, is in unpatentable natural phenomena. Also technologies to detect the absence or presence is unpatentable permitted by contrast, nothing in the current lot patenting of new type gnostic techniques such as new tools for sequencing genes. While certain biomarkers have been discovered, the human genome moves fast and far more important biomarkers are to be discovered. Our sophistication in understanding these enter clinical relevance is substantial to the practice of personalized medicine. The patents on natural phenomena has not impaired innovation in the Genetic Diagnostics industry. Quite the opposite is true. In the last decade, the genetic Testing Industry has thrived. The cost of genetic testing and genetic sequencing has fallen dramatically. There are no barriers to innovation with new, clinically relevant biomarkers. New biomarkers are being recognized on a routine basis. Pera would permit the position of natural phenomena the privatization of natural phenomena such as those embodied by genetic pera which shut the door. A new Patent Covering newly discovered biomarkers would appear and impede Patient Access to such basic information. Because so many are engaged in identification of new biomarkers, a Diverse Group of new tutees stand in the way of clinicians efforts to conduct analysis of a patients Genetic Information because stateoftheart testing would require permission from all of them. None of them would be required to grant such permission. That was the reigning set of conditions before the decisions. Pera would take us back, back to a time when the total charge for access to biomarkers in just the two brca genes was 4400. Today, a test with more information cost a fraction of that amount. The patent system should afford the opportunity to afford the cure but not the disease. These natural biomarkers and this information including association with disease risk im sorry. The patent system is not now and should im sorry. The patent system does now and should permit the protection of invention but not mere discoveries of innovation, and it does and should reward innovation in the form of new therapies and new tools for detecting biomarkers but not the biomarkers themselves. We urge the committee to recognize natural phenomena such as biomarkers as precompetitive Information Available to all. This can be accomplished by requiring natural phenomena, natural materials, and abstract ideas be treated as prior to all patent applications. This would be the most efficient way to effectively codify the essence of current supreme work jurisprudence on patent subject matter eligibility. We stand ready to offer any assistance the subcommittee may request to approach patent law reform while preserving the vitality of the genetic Testing Industry innovation and reportedly Patient Access, the promise of thank you. Chairman cans, Ranking Member tellis, thank you for the opportunity to speak on this issue. I have many years of experience helping clients with patents on their convention. My testimony is personal to be to me. I want to touch on three issues. Inconsistencies, the impact on mobile technologies, and ongoing absurd t. There are inventions that cannot be patented in the u. S. I can still be pat ted and other countries. These include products such as vaccines, and that are useful in commercial and industrial applications. Although some countries have limited exception, most sit still grabbed patents on methods of testing new diagnostic markers. Because you have the disclosure invention to obtain a patent, this means that inventors have to disclose their inventions to the whole world but cannot protect them to the same extent in the u. S. Pera would bring u. S. Eligibility back in line with patents that can be granted in other countries. The current inbound and the quid pro quo for patents is technologies related to microorganism. That incl

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