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    Wisconsin Biotech: A New Frontier for Lawyers

    Impressive dividends await lawyers who have the initiative, flexibility, and imagination to approach the world of biotechnology. There are many entry points, and you don’t have to be a scientist to participate.

    Halina Zakowicz

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    Bill Adolfsen and Chuck Sara

    Bill Adolfsen (left) and Chuck Sara visit the U.W. Biotechnology Center, Madison. While having a science background is helpful, and both patent attorneys recommend it, a science background is not a requisite to practicing in the biotech arena. Hear from these and other lawyers practicing in the biotech arena at the Biotech and the Law 2016 Global Conference & Expo, May 5-7, in Madison. Photo: Andy Manis

    When Exact Sciences Corporation released Cologuard®, a noninvasive colorectal cancer screening test, the company filed 17 patents, including patents regarding the product’s use. This effort was achieved by the company’s lawyers, the majority of whom are knowledgeable about not only patent law but also how that law applies to biotechnology.

    According to the company’s general counsel, Scott Coward, having a biotech-savvy legal team was of utmost importance to the success of the company’s screening test. “Legal support has been critical for Exact throughout the process of Cologuard’s development and commercialization,” notes Coward. “Our patent lawyers have helped us secure a number of patents that protect inventions related to Cologuard. We have also entered into multiple agreements with third parties that range in levels of complexity. Finally, we are governed by complex federal and state laws that impact how we market Cologuard and how we bill and collect payment for it.”

    “Cologuard is approved by the FDA, and we were supported by expert outside counsel throughout that approval process. We look to health care and other regulatory counsel to help us maintain legally compliant practices.”

    Exact Sciences is just one example of a Wisconsin-based biotech company that relies on its legal team to make sure Cologuard is protected from intellectual property (IP) litigation and helps improve patient health. Within the entire state of Wisconsin, however, there are more than 1,600 establishments and approximately 36,000 employees in the bioscience industry.1 These establishments and employees rely on legal experts to resolve commercial disputes, navigate through jurisdictional issues, and keep abreast of developments in federal and state policies regarding biotechnology.

    Wisconsin's Bioscience Industry Economic Impact infographic

    Source: “Energizing Wisconsin’s Economy: 2015 Wisconsin Bioscience Economic Development Report,” BioForward Inc. Much of the information in this report is based on 2013 data.

    Click image to view larger version.

    Retaining a lawyer who is capable in biotech can mean the difference between profitability and potential revenue loss. Mark Jackson, the founder of IMMUN-IP, relates how a Wisconsin biotech company filed a patent on its technology but did not cite all usable (patentable) examples. A continuation application, which would have addressed possible future uses of the technology, was also not filed. As a result, some applications of the technology became open source; anyone could copy those applications and profit from them.

    “In the biotech space, it’s critical to have patent lawyers with the necessary expertise to protect a company’s technology,” Jackson says. “Those lawyers need to have both a technical and legal understanding of your niche so they can create a strategy that protects the company’s intellectual property.”

    Wisconsin’s Biotech Landscape is Flourishing

    Wisconsin’s academic research and development (R&D) expenditures for 2013 totaled almost $1.3 billion, with $856 million of that amount spent on life sciences. Federal spending R&D obligations totaled $654 million for the same period.2 These investments bring significant dividends; 754 bioscience patents were published in 2013 alone.

    “The biotech business world that’s burgeoning in Wisconsin is the end result of a lot of work by a lot of different individuals over the last two decades,” says Jean Baker, partner at Quarles & Brady, Milwaukee. “To have a vibrant biotech business environment, you need people who are qualified to work and lead in this industry as well as legal resources and venture funding. A lot of biotech innovation is derived from our different educational resources and research institutions in the area, including the University of Wisconsin, Medical College of Wisconsin, Marquette University, and the Blood Center of Wisconsin. All of these entities spin out technologies that are capable of starting small businesses.”

    Also spearheading this effort is the Wisconsin Alumni Research Foundation (WARF), a private, nonprofit organization that, for the past 90 years, has helped commercialize discoveries made at the laboratory bench. The commercialization process begins when a researcher submits a discovery to WARF, after which it is evaluated. If deemed patentable, WARF contacts area businesses that are good candidates for the new technology. Lawyers are involved throughout the process, helping with patent applications and commercial licensing agreements.

    However, the legal landscape for biotech companies involves more than just intellectual property (IP) protection and litigation. Biotech companies, just like other companies, require experts in business formation, contracts, mergers and acquisitions, and capital investments.

    “The first time I went to the national BIO [Biotechnology Industry Association] conference, I met a dozen finance attorneys before meeting a single patent attorney,” says Yali Friedman, the chief editor of the Journal of Commercial Biotechnology and a former instructor of biotechnology management at the National Institutes of Health. “There is a strong need for attorneys to manage mergers, acquisitions, and bankruptcies. Contract lawyers play an important role in helping to structure the complex partnerships of biotechnology firms. And, of course, biotechnology companies still need HR.”

    “Technical people, loving the science, can get into the weeds very quickly,” jokes Bill Adolfsen, a lawyer at Andrus Intellectual Property Law LLP, Madison. “There’s a lot of value that people with nontechnical degrees can add to litigation and other more law-oriented areas. After all, these people are trained to be lawyers, and often it’s those skills that may be more important for dealing with a particular case.”

    Biotech companies, just like other companies, also experience nonscientific business processes, such as facing the risk of bankruptcy proceedings. “Biotechs often hold manufacturing and technology patents, and these patents’ real value often is in their licensing,” says David Krekeler, of Krekeler Strother S.C., Madison.

    Halina ZakowiczHalina Zakowicz has worked in numerous biotechnology companies including Thermo Fisher Scientific, Promega Corporation, and Clontech/TAKARA. Prior to this time, she completed two postdoctoral appointments at U.W.-Madison after performing research at the National Cancer Institute of the National Institutes of Health.

    “These license agreements become part of the bankruptcy estate, and could be liquidated for the benefit of creditors. Such agreements may constitute executory contracts, which may be either assumed or rejected by the trustee or the debtor, depending on the circumstances. Knowing how potentially profitable the license agreements are now, as well as in the future, may be a key to successful liquidation or reorganization.”

    Within the growing field of bioethics, one can explore end-of-life and elder care, patient privacy, insurance coverage, personalized medicine, and drug safety. Continually evolving federal and state regulations regarding such hot-button topics as cloning and stem cell research have resulted in a steady stream of work for the appellate lawyer.

    Workplace safety is another area of legal opportunity for the biotech-savvy lawyer. “While the use of radioactive labels has dropped, labs are still full of reagents and machines that are very dangerous if mishandled,” says Joseph (Joe) Leone, a lawyer at DeWitt Ross & Stevens. “Workplace regulations regarding worker exposure to toxic materials and hazardous conditions are an interlocking web of local, state, and federal mandates.”

    The fact that Wisconsin biotech companies are organized into many and distinct categories including agriculture, basic research, supply and distribution, drugs and pharmaceuticals, medical devices and equipment, and testing and medical laboratories, means there is a plethora of opportunities for the aspiring lawyer.

    Biotech Lawyer Profiles

    Bill Adolfsen

    Bill Adolfsen, who holds a Ph.D. in molecular biology, says it’s becoming more common for people who complete a Ph.D. program in life sciences to look for alternative careers, such as in patent law. Photo: Andy Manis

    How does a junior or even seasoned lawyer gain access to the exciting but daunting world of biotechnology? The following lawyers have taken unique paths to their current positions, and share their experiences below.

    Bill W. Adolfsen, Ph.D., Attorney, Andrus Intellectual Property Law LLP

    Adolfsen entered the biotech arena after completing his Ph.D. in molecular biology at M.I.T. “It’s becoming more common for people who complete a Ph.D. program in the life sciences to look for alternative careers,” Adolfsen says. “One of those careers is patent law, and it’s often how they get into the legal field.”

    “It’s actually rather common for people who are in the lab to do their graduate work and then pursue the law. What was appealing to me, at least in patent law, is that it allows you to focus on many different areas of science, not just one. You interact with faculty members at universities, or researchers at companies, that are working in many different areas of science. You actually learn a lot more science doing something like that than working in a lab on a single project.”

    Adolfsen decided to pursue patent law after gaining some work experience outside of academia. “I had done some patent-related work at WARF and a start-up company, and that’s where I had my exposure to patent law,” he says. “My technical background was a good fit, and that’s why I decided to pursue patent law.”

    Jean Baker

    Jean Baker, who holds a Ph.D. in biochemistry, was one of the first attorneys at Quarles and Brady to specialize in biotechnology. Her motivation was to be part of the world of nonabstract technology, which could develop into products that benefited people, and which they actually use. Photo: Andy Manis

    For junior lawyers hoping to pursue biotech law, Adolfsen recommends biotech patent litigation as one avenue, and especially for those lawyers who don’t have a science degree. “There’s really nothing holding you back if you’re interested in doing biotech patent litigation, or even getting into FDA law. In my prior position, I worked with a lot of nontechnical people; I do think there’s a lot of opportunity in biotech law even for people who don’t have technical backgrounds.”

    Jean C. Baker, Partner, Quarles & Brady LLP

    Baker had already earned both a B.S. and Ph.D. degree in biochemistry when she entered law school. “What interested me was the idea of seeing technology actually applied and being realized in products and services. It was exciting for me to be a part of that nonabstract world of biotechnology.”

    “It’s great fun to be part of an idea that’s born in a lab, and then to see that idea develop into a patentable claim, become part of a business, and then become something that people invest in.”

    Baker has been working in law for more than 25 years and has seen many developments in the field of biotechnology. In addition to her work as a partner at Quarles & Brady, she has taught patent prosecution at Marquette University Law School for almost a decade.

    “When I went to law school in the late 80’s, biotechnology was just starting to be a big deal,” she says. “I was one of the first attorneys at Quarles and Brady who specialized in biotechnology. My motivation was to be part of the world of nonabstract technology, of technology that developed into products that benefited people, and which people actually used.”

    Lisa Mueller

    Lisa Mueller says her B.S. degrees in chemistry and biology was a huge help in understanding biotechnology, allowing her to work with cutting-edge technology and to help bring that technology to the market.

    Baker notes how some of the technological patents she filed have resulted in products that are now for sale in the market. “That’s kind of wonderful,” she notes.

    Lisa Mueller, Partner, Michael Best & Friedrich LLP

    Some biotech lawyers hold degrees in the life sciences, which help them understand the nuances of a gene patent or protein manufacturing process. Mueller, a partner at Michael Best & Friedrich, Chicago, and a member of its management committee, received B.S. degrees in chemistry and biology before pursuing her law degree.

    “My educational background was a huge help,” says Mueller. “Whether you’re working as a patent or corporate attorney, or doing transactional work and trying to facilitate deals, having an understanding of biotechnology is crucial.”

    Initially, Mueller was planning to go to medical school; she changed her mind after spending a few summers volunteering at a hospital. After earning her J.D., she ended up pursuing patent law as a career.

    “Being able to work with cutting-edge technology, and to bring that technology to market, is exciting, and it’s something that I really love to do,” says Mueller, who is chair of the firm’s life sciences and chemical group.

    Mueller particularly likes working on patents that involve small molecules and biologics. “It’s been very rewarding to watch individuals take their discoveries and visualize them in the real world, and to see those discoveries make an impact on human health.”

    Charles S. Sara, Partner, DeWitt Ross & Stevens S.C.

    Charles Sara

    Chuck Sara, a patent attorney in Madison, says law school provided him an opportunity to use his dairy science background. He recommends that lawyers striving to enter patent law should have a specified technical background generally in the field of science.

    Madison patent attorney Charles (Chuck) Sara arrived at Virginia Tech with intentions of becoming a veterinarian. Over the course of his time there, Sara ventured into dairy science and eventually to George Mason University, where he completed his J.D.

    “Law school provided me with a great opportunity to use my dairy science background,” notes Sara. “In my first year, I was approached by a patent law firm that needed a summer clerk. I found I liked the work. More importantly, I realized that I was one of only two in my class of about 100 who had the necessary background to become a patent attorney. I figured that would help me get a job after graduation and it did.”

    For a lawyer striving to enter patent law, that “individual should have a specified technical background generally in the field of science (chemistry, biotechnology, and so on), electronics, or mechanical engineering. These requirements can be found in the U.S. Patent and Trademark Office [USPTO] guidelines.”

    “At a minimum, this typically means a bachelor of science degree. Beyond that, there are excellent courses designed to enhance your background.”

    Finding Qualified Lawyers Is the Newest Biotech Challenge

    Finding lawyers qualified in both science and advocacy is not easy. “Experienced biotech attorneys can add value, save time, and prevent waste,” says Ayla Annac, the CEO and president of InvivoSciences. “They can even be an integral partner in the commercialization process itself. However, finding a good match can take time and be a challenge.”

    R. Alta Charo

    R. Alta Charo, the Warren P. Knowles Professor of Law & Bioethics at the University of Wisconsin, says it’s extremely helpful to understand the science when presenting a challenge to the substance of a federal rule, or a technical assumption in a business dispute.

    The challenge becomes even greater when a new lawyer decides to engage in appellate practice. “At the appellate level, you’re often using science to challenge the reasonableness of the lower court’s finding,” states R. Alta Charo, the Warren P. Knowles Professor of Law & Bioethics at the University of Wisconsin. “When defending or attacking a patent, a substantial scientific background is tremendously useful.”

    Charo adds, “When presenting a challenge to the substance of a federal rule, or a technical assumption in a business dispute, understanding the science is extremely helpful. Consider, for example, a dispute between a company growing organic crops in a field adjacent to one where another company is growing an engineered crop. Understanding the possibilities and limits of genetic drift is very important.”

    “There are a ton of current legal issues in the biotech space,” says DeWitt’s Leone. “One of these issues is containment. If a lab is dealing with genetically modified organisms, there are many rules regulating if and when those organisms can be sold or otherwise released from the lab. A lawyer advising a lab needs to know what containment protocols are deemed acceptable and what regulatory approvals are necessary before moving the organism out of the lab.”

    What It Takes to Succeed

    Biotechnology is often visualized as being the sole province of scientists working in labs. In reality, the biotech arena is populated by not only scientists but also entrepreneurs, inventors, marketers, writers, government officials, and lawyers.

    James Casey

    James Casey, co-chair of the Biotech and the Law 2016 Global Conference & Expo, says the event provides connecting opportunities and subject matter knowledge to lawyers and nonlawyers who work in the biotech ecosystem. He says biotech is a fascinating field and a key component of the global economy; and offers more opportunities than just IP and patent work.

    “Success in biotech involves the willingness to be flexible, to use your skills in different ways, and to have imagination,” says Casey, who is also director of the Office of Sponsored Programs at American University in Washington, D.C. and president of the State Bar of Wisconsin Nonresident Lawyers Division.

    “There’s a lot of opportunity in biotech, not just for the scientists that conduct bench research, but for lawyers and nonscientists too.”

    In fact, lawyers, and even lawyers not trained in a scientific discipline, can be vital to the success of a court case. “In the patent litigation area, there is a benefit to having a team of lawyers with a mix of technical and nontechnical backgrounds,” notes Adolfsen. “While lawyers with technical backgrounds may be better equipped to delve into the intricacies of a technology, lawyers not having a technical background are often critical in devising ways that a complicated technology can be explained to a lay jury or nontechnically trained judge.”

    Lawyers who choose to work in the biotech arena often have a profound effect on laws touching on topics such as IP and patents, health care, bioethics, and regulatory affairs. Furthermore, there are plenty of entry points along the way so that a new or even seasoned lawyer need not go back to school for an advanced degree in genetics or biotechnology.

    “It’s a mistake to think that the only attorneys who can be involved in the biotech boom are those with Ph.D.s in biotechnology,” says Baker. “There’s much of this business that is well served by attorneys with skills in licensing, litigation, immigration law, and corporate law.”

    For those lawyers who have the initiative, flexibility, and the imagination to approach the world of biotechnology, impressive dividends await.


    How to Get Started in Biotechnology

    Textbooks and References

    For a lawyer just out of law school and with no background in biotech, Mueller recommends taking advantage of resources including The BioTech Primer (written and published by BioTech Primer Inc.), A Beginner’s Guide to Biotechnology (authored by Biopharmaceutical Technology Center Institute, published by Quantum Scientific Publishing), Building Biotechnology: Biotechnology Business, Regulations, Patents, Law, Policy and Science (authored by Yali Friedman, Ph.D, published by Logos Press), and Biotechnology Law Report (published by Mary Ann Liebert Inc.).

    Sometimes, understanding biotechnology is simply a matter of knowing its esoteric terminology. “A lot of biotechnology is just vocabulary. If you can understand the vocabulary, you’ve gone a long way toward your comprehension of this field,” Mueller says.

    “Science articles and publications, such as Scientific American, that are designed for a lay audience, can explain a technological innovation without requiring that the audience have a Ph.D. in biochemistry,” says Baker.

    Lawyers may also consider subscribing to legal blogs that explore issues in biotechnology. One example includes BRIC Wall, which is owned and operated by Mueller. The State Bar of Wisconsin recently identified 49 active Wisconsin legal blogs operated by firms; the posts published in these blogs often focus on biotech matters.3

    Educational Opportunities

    There are also science training courses, which are often sponsored by biotech companies and affiliated institutions. In Wisconsin, the BioPharmaceutical Technology Center Institute (BTCI) offers beginner, intermediate, and advanced courses on forensic DNA analysis, genetic engineering, and molecular technologies like PCR (polymerase chain reaction – a technology used to make multiple copies of a particular DNA sequence).

    Online, students can sign up to BiotechU, an online series of instructional videos taught by Friedman. BiotechU not only covers the science of biotechnology, but also patents, regulations and policies, and even company formation and funding.

    For those lawyers who endeavor to explore biotech in greater detail, there is the Master of Science in Biotechnology Program at U.W.-Madison. This program offers three lab courses as well as a capstone thesis project that each student must complete in order to graduate.

    “The University of Wisconsin’s Master of Science in Biotechnology Program educates those with a law background on the current science that drives biotechnology with hands-on laboratory experience, as well as the regulatory environment in which Wisconsin operates,” notes Natalie Betz, the program’s associate director. “We also focus on the business of biotechnology and how it differs from common consumer products, with examples and case studies drawn from the biotechnology community.”

    “To get a decent job out of law school, the candidate should consider a higher degree such as a Master’s or Ph.D.,” says Sara. “Good grades and experience also help. When we review the resumés of potential candidates, these factors are important in our decision process.”

    Conferences

    The inaugural Biotech and the Law 2016 Global Conference & Expo, to be held in Madison, Wis., will gather domestic and international lawyers who are working within government, industry, and academia to fuel useful discussions resulting in productive collaborations.

    “The conference provides a professional development opportunity for lawyers interested in biotech,” says James Casey, who is co-chair of the Biotech and the Law Conference, sponsored by State Bar of Wisconsin PINNACLE®. “This event provides connecting opportunities for lawyers, as well as nonlawyers, who work in the biotech ecosystem. Those nonlawyers include scientists, entrepreneurs at private start-ups, and policymakers. There is also the opportunity to pick up subject matter knowledge and gain an understanding of the broader scope of biotech – in other words, there’s more to biotech than just IP and patent work.”

    “Biotechnology is a fascinating field and a key component of the global economy. Come to Madison to experience it firsthand,” says Casey.

    The upcoming Biotech and the Law Conference will not only feature speakers but also offer excursions to area start-ups, attendee and speaker group discussions, and science labs.

    Bioforward, which is the Wisconsin chapter of the national Biotechnology Industry Association, presents an annual Bioscience Summit in Madison. The Bioscience Summit features biotech speakers and entrepreneurs and also individuals who work in the legal and regulatory sectors. Bioforward also works to help shape public policy on biotech issues and to educate its members on those issues.

    Internships

    As an alternative to getting yet another degree, Adolfsen recommends that lawyers interested in the biotech field complete internships at firms that deal with biotech issues. “The key, for a new lawyer, is finding a group or a job in a law firm that is already dealing with biotech; that’s one way to gain exposure.”

    “Depending on the legal area, a new lawyer with no technical background could work at a firm specializing in biotech, such as litigation or FDA issues. Newly minted lawyers, and even lawyers without a technical background, have plenty of areas to pursue in biotech.”

    Endnotes

    1 Wisconsin Biosciences Economic Development Report, conducted by consulting firm Ernst and Young, 2015.

    2 NSF Science and Engineering State Profiles.

    349 Wisconsin Law Blogs: Attorneys Writing Their Way to New Business,” by Joe Forward (InsideTrack, March 4, 2015).