Overview of Regenerative Medicine, Role of Law, & Bioethics
Keynote Speakers: Julie Watson and Dr. John D. Jackson
Julie Watson, Chief Legal Counsel for the Institute for Regenerative Medicine at the Wake Forest School of Medicine, opened the Wake Forest Journal of Business and Intellectual Property Law Symposium by introducing the first speaker of the day, Dr. John D. Jackson. Dr. Jackson, an associate professor at the Institute since 2010, began the day’s events by explaining the technical components of the Institute.
Wake Forest Institute for Regenerative Medicine (WFIRM) started about 15 years ago by Dr. Anthony Atala, Director of WFIRM and the W. Boyce Professor and Chair of Urology at Wake Forest University. What was once a team of 20 physicians and scientists has now expanded to an interdisciplinary team of over 300 full-time staff. The current focus of WFIRM is on regenerative medicine, which works to both treat and cure health conditions. There were many world first achievements out of WFIRM, such as the first demonstration that complex, layered tissue structures can be engineered using cells, or the first creation of a laboratory-grown organ that was successfully implanted in patients.
One area that is really moving forward is 3D Bioprinting. 3D Bioprinting attempts to build replacement tissues and organs for transplant use in humans. This method has the potential to overcome many of the problems with traditional organ printing. The researchers at WFIRM have developed an integrated organ printing system to develop organ structures that can be manipulated and will withstand transplant. Dr. Jackson stated that although the technology has a way to go before widespread use in human transplants, this is one of the goals of WFIRM’s research.
Keynote Speaker: Kirk Hartley
Kirk Hartley calls on almost 35 years of experience as a trial lawyer and consultant for very large public companies to inform his work in the intersection of medicine and IP, business, and mass tort litigation. His pro bono service includes a broad range of medical-legal issues facing persons with cancer, including work serving as an unpaid director for a national non-profit called Triage Cancer. He believes there are new ways that knowledge can be utilized as we start working to change legal structures and systems in order to overcome the problems that have stymied cancer therapies and diagnostics. He says that the law in its present form cannot keep up – legal structures, polarized environmental views, and anti-science outlooks create an undesirable framework for getting things done. Scientists have to care how legal systems work so that their hard work is not done in vain and lawyers have to care about medical advancements that could transform their practice. A multidisciplinary approach is vital to continued advancement in medicine and biotechnology.
Mr. Hartley says that the legal world has been somewhat responsive and cites the FDA’s announcement of new categories for breakthrough drugs that go around existing statutes and create a pigeonhole to get new drugs to market.
Reinventing legal rules can change the practice of medicine and lawyers must be put on notice of the potential for medicine to change the practice of law altogether. Mr. Hartley sees a world in which awarded damages in an asbestos case are a new lung instead of cash, and such a future could change the way insurance intersects with medicine and the law. There is a range of opportunities for regenerative medicine to provide solutions in tort law, from solutions to car accident injuries, drug defect litigation, exposure to harmful substances, tobacco litigation, workplace accommodations, and medical monitoring.
Mr. Hartley sees a potential for real success in multidisciplinary teams and believes lawyers, scientists, risk managers, and finance professionals all have to work together to look to the forward, not backward or sideways. If we all work together, we can see the future coming.
The Intersection of Bioethics & the Law
Panel Speakers: Professor Christine Coughlin, Nancy King, and Mark Furth
Ms. Nancy King, has thirty years of experience in the field of bioethics. After receiving her Juris Doctor from the University of North Carolina School of Law, King spent twenty years as a faculty member of the University of North Carolina School of Medicine. King currently serves as Co-Director of the Wake Forest University Graduate Program in Bioethics and Center for Bioethics, Health, and Society.
Professor Christine Coughlin teaches “Law and Medicine” at the Wake Forest University School of Law. Coughlin also serves as a core faculty member at the Wake Forest University Graduate School of Arts and Sciences where she teaches “Bioethics and the Law,” and “Law and Medicine.” Professor Coughlin has received multiple awards for both teaching and scholarship.
Dr. Mark Furth, Ph.D. specializes in Molecular Biology and facilitates the translation of basic discoveries from Wake Forest Baptist Health researchers into commercial products. He helps bridge the gap between researchers and industry by identifying commercial opportunities within the Medical Center’s strategic priorities, pulling from his experience in academic research at Wake Forest University, the Memorial Sloan-Kettering Cancer Center, and the National Cancer Institute, as well as nearly twenty years in the biopharmaceutical industry.
Furth identified an intersection of law and science by discussing research conducted on the human genome. The intersection, he considers, is whether a biopharmaceutical company has the right to own a specific gene. For example, genes have been used to identify the probability of obtaining diseases such cancer and diabetes. The legal question that arises is if a company discovers a particular gene, should it then be able to acquire rights in that gene’s discovery? The rationale is, by having exclusive rights to this gene, pharmaceutical companies can create drugs specifically designed to target that gene.
This marks a change in the way drugs are produced and distributed. The previous model was the Blockbuster Drug Model, in which companies attempted to create a drug that is popular enough to gross more than $1 Billion in annual sales. As a result, blockbuster drugs yield great success and notoriety to the company, but these drugs only have about a 50-60% success rate. Companies are now moving to a Stratified Drug Model in which companies identify drugs that target specific genes with success rates closer to 70-90%.
A stratified model raises many ethical questions. With so much information about patients, how will the information be used? How will the confidentiality of patients be protected? Since there is more information about the patient, will there be a heightened burden to treat the identified disease? Now that drugs can be specifically targeted to alter genetics, will current pharmaceuticals return back to a time similar to the eugenics movement?
King began by discussing some of the major policy issues involved with emerging biomedical advances. Body-on-a-chip, enabling technologies, and combination products were among the major technological advances that pose significant ethical questions. The major intersection between these new biotechnologies and the law focuses on the change of the perceived need for care. As new technologies become more commonplace, patients may begin to expect receipt of them.
As society progresses, the panelists agree that it will be important to continue these efforts to develop and implement new medicines and medical technologies that are capable of improving the lives of many. However, while these changes are occurring, it is imperative that the interests of the public remain a major consideration. King concluded in stating that science is essentially a service of society, while the goal of research is learning. Companies will be eager to develop and implement these technologies as quickly as possible, but accuracy and effectiveness will ultimately take time.
Consideration for Intellectual Property Protection of Medical Devices
Speakers: Justin Nifong, John Alemanni, and John Zimmer
Sponsor: Smith Moore Leatherwood LLP
The moderator of the panel was Dr. John Zimmer. Dr. Zimmer is a partner at Smith Moore Leatherwood LLP and leads their Intellectual Property team. He focuses his practice on patent prosecution and counseling in chemistry, material science, and related fields. He also has experience in medical imaging and medical devices. Dr. Zimmer is an inventor himself and holds seven patents related to colloidal semiconductor nanocrystals. Additionally, he has co-authored 13 papers appearing in peer-reviewed scientific journals.
The panel consisted of Justin Nifong and John Alemanni. Justin Nifong is a founder of NK Patent Law and an experienced Patent Attorney. He is recognized as a preeminent North Carolina Patent Attorney by peers and publications. Mr. Nifong’s practice focuses on patent prosecution before the United States Patent and Trademark Office and in foreign countries. Mr. Nifong also renders patentability and clearance opinions and counsels clients in regards to preparing for intellectual property litigation. Practicing as a patent attorney, Mr. Nifong has represented many companies, universities, and startups across the country. Additionally, Mr. Nifong is a frequent speaker on intellectual property issues for entrepreneurial and business organizations.
John Alemanni focuses his practice on trials before the Patent Trial and Appeal Board and related appeals to the U.S. Court of Appeals for the Federal Circuit. His practice also includes client counseling, patent litigation, and strategic patent prosecution. He is the co-chair of the Kilpatrick Townsend’s Patent Office Litigation team and has served as lead and back-up counsel on dozens of trials before the PTAB. Notably, Mr. Alemanni focuses on hardware and software technologies, including mobile devices, bioinformatics and laboratory information management, as well as mechanical and electromechanical devices.
At the beginning of the panel, the panelists began by briefly discussing the market for medical device patents. In sum, the market for medical device patents is massive. In the United States alone, there is a massive demand and market for these medical device patents. However, the need goes beyond the United States as a patentee is not limited to filing his patents in the United States. In fact, patents are often filed in multiple jurisdictions/countries, which often have different rules and requirements. The attorney must then be careful to abide by the rules relative to each different jurisdiction. In addition, some jurisdictions have public policies against using certain medical devices in resolving human concerns. For example, a medical device may be patentable in the United States, but not Japan or China. As a result of varying jurisdictional rules and rigid public policies, attorneys must establish unique strategies when drafting patent applications in the medical devices area.
Despite obstacles created by various jurisdictional rules, the key to patentability of a medical device is to thoroughly describe, in the patent application, how the medical device is implemented. Simply describing the device itself is not typically enough for patentability. Oftentimes, these medical devices can seem rudimentary without the proper explanation from someone familiar with the technology. Therefore, it is crucial for the attorney to take the time to describe each component in such a complex field. Furthermore, the information that the examiner is going to consider will depend on what type of patent is filed. When filing a patent application for a device claim the examiner almost solely focuses on how the device works and not the steps described in the patent application. However, when filing a patent application for a method claim, the examiner will also consider the steps within the process. Thus, to increase chances of patentability for a medical device, the applicant should first know exactly what they are doing and what they are asking for and second, be able to describe in detail the implementation of the device and make clear how this device is better than other similar devices currently on the market.
The IP Implication of Commercialization in Regenerative Medicine
Panel Speakers: Julie Watson, Mike Mireles, and Peter Young
The final panel of the day discussed “The IP Implications of Commercialization in Regenerative Medicine.” Mike Mireles, Professor of Law and Director of the Intellectual Property Concentration at the University of the Pacific, McGeorge School of Law in Sacramento, California, spoke first on “The Bayh-Dole Act and the California Regenerative Medicine IP Policy.”
As Mireles pointed out, the Economist once gushed that “[p]ossibly the most inspired piece of legislation to be enacted in America over the past half-century was the Bayh-Dole act [of 1980].” So the question then becomes, were they right? Mireles implied that maybe, to an extent.
The Act, he said, is the of the chief reasons the U.S. dwarfs the world in terms of biotech research spending. (The U.S. spends about $26 billion of annually whereas the next closest country, France spends roughly $3 billion.) Prior to the Bayh-Dole Act, there was no uniform system for universities to capitalize on their research and therefore no clear incentives.
The Act intended to solve this problem by awarding title to the universities who developed intellectual property even though they used public funding. This involves a trade-off: arguably the public must pay twice, first, because when funded the research and, second, when the often-expensive technology is licensed in the marketplace. Mireles, however, pointed out that, especially in the wake of the Great Recession, the research may not have occurred in the first place without the Act’s incentives.
One criticism is that the regulatory scheme not strong enough to ensure public interests are sufficiently served. In contrast, the more recent California Institute of Regenerative Medicine (CIRM), which has similar goals, has stronger regulatory requirements, but there are questions about whether they are too burdensome. As of 2017, $2.4 billion in grants had been awarded, accounting for 8 patents and over $286 million in tax revenue for California, so “people are taking the money.” Then the question is whether the CIRM and/or the Bayh-Dole Act be improved? This will be an ongoing discussion moving forward.
Where Mieles emphasized the public aspect of biotech, the final speaker Peter Young reported on industry trends from the private sector perspective. Young, as he pointed out, is not a lawyer, scientist or doctor but a seasoned industry veteran with three-and-a-half decades of pharma and biotech experience. Young oversees translational medicine initiatives at Pappas Capital and is the Program Manager for the Wake Forest Technology Program. He pointed to the Innovation Quarter itself as a monument to public-private initiatives.
Young was pleased to report that across a variety of metrics, the United States biotech industry is healthy and thriving. Disruptive technologies like regenerative medicine can take a generation to mature. Therefore, they need multidisciplinary support to flourish and would not exist without public funding. One of the industry’s biggest challenges, Young said, was educating the regulators at the FDA who do not understand the technology as well as researchers.
On a higher level, one of the continuing challenges, however, is how we balance economic incentives with overall societal interests. The panel closed the day with a series of considered comments about the ongoing tradeoffs and tensions among how we allocate funding, in what areas, and who will benefit and when.
The Journal sincerely appreciates each speaker, panelist, and volunteer. Additionally, the Journal wishes to thank the Innovation Quarter for facilitating and hosting this collaboration.
It is the Journal’s hope that the symposium discussions helped to provide a platform from which further collaboration between the legal and medical communities can flourish to solve the life-saving issues that our society faces.
Alumni & Board of Advisors Outreach
We hope you have enjoyed the third quarterly update of the 2017-2018 school year.
This year we have been striving to grow and strengthen our alumni network. As such, if you have not already, please consider taking 5 minutes to complete this survey so that JBIPL can have your information moving forward.
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JBIPL Call for Authors
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