Kevin Buckley: Intellectual Property, Transactional and Regulatory Attorney

As a member of the Office of General Counsel at the University of Central Florida, I am the lead attorney for intellectual property, transactional and regulatory matters that are part of the University's research and technology commercialization efforts. My goal is to help UCF's innovators speed technology innovations to market while enhancing the potential for increased licensing revenue, investor funding, regulatory approval, and sales revenue.

The focus of my career has been helping entrepreneurial businesses commercialize their innovations. Combining my experience as a scientist, business owner and lawyer, I am especially interested in developing and implementing commercialization strategies for biopharmaceutical, small molecule pharmaceutical, medical device, in vitro diagnostics, and convergence technology innovations (technologies at the intersection of biotech, software, hardware and informatics). Prior to joining UCF, my clients included the entire spectrum of innovators from individual inventors to Fortune 500® corporations.

While in private practice, I was selected by my peers for many years to be included in The Best Lawyers in America® in the field of Biotechnology Law.

Legal Experience

I have experience with technology transfer, intellectual property licensing, forming institutional collaborations, competitive intelligence and freedom-to-operate analysis, legal opinion drafting, patent preparation and prosecution, business formation and corporate governance, intellectual property valuation, pharmaceutical life-cycle management, and due diligence in private investments. More specifically, my experience includes:

1. International intellectual property licensing, sponsored research transactions and technology transfer including acquiring and securitizing intellectual property rights (IPR) in intangible assets such as patents, trademarks, copyrights, trade secrets, know how and government licenses. Many of those transactions have involved complex International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR) considerations
2. Regulatory compliance involving U.S. Government agencies including HHS, FDA, USDA, and the EPA, Health Insurance Portability and Accountability Act (HIPAA), Investigational New Drug applications (IND), New Drug Applications (NDA), Hatch-Waxman, Abbreviated New Drug Applications (ANDA), Abbreviated New Animal Drug Applications (ANADA), 505(b)(2), 510(k), pre-market approval (PMA), Orange Book listings, safe harbor, market exclusivity, data exclusivity, Phase I through III clinical trials, and drug master files (DMF)
3. Complex litigation including patent, copyright, and trademark infringement litigation and Lanham Act violations
4. International patent issues including preparation, prosecution, and intellectual property due diligence in business transactions. Examples of patents I've prepared and prosecuted include:
   1. U.S. Pat. No. 8,076,457 assigned to The Scripps Research Institute titled "Crystal of a Cytochrome-Ligand complex and Methods of Use"
   2. U.S. Pat. No. 7,964,573 assigned to The Regents of the University of California titled "Regulating Expression of Transient Receptor Potential Channel Genes"
   3. U.S. Pat. No. 7,953,557 assigned to The Scripps Research Institute titled "Crystal of a Cytochrome-Ligand complex and Methods of Use"
   4. U.S. Pat. No. 7,906,104 assigned to The Regents of the University of California titled "Methods for Detecting Pancreatic Beta-Islet Cells and Diseases Thereof"
   5. U.S. Pat. No. 7,807,645 assigned to The Regents of the University of California titled "Method of Treating Degenerative Disorders of the Nervous System by Administration of Fibrinogen Fragment"
   6. U.S. Pat. No. 7,749,720 assigned to The Regents of the University of California titled "Methods of Identifying Compounds for Producing Insulin Sensitization"
5. Strategic consultations including patent validity, invalidity, infringement, non-infringement, clearance and freedom-to-operate (FTO) opinion drafting

I also represented The Scripps Research Institute and the Regents of the University of California in identifying commercial aspects of their innovations, protecting those innovations, and resolving complex legal and business disputes that accompanied their sponsored research, technology transfer and commercialization efforts.

I am a registered patent attorney with the U.S. Patent and Trademark Office and am admitted to practice law in Pennsylvania and Missouri. I have experience with matters pending before the USPTO, BPAI, and procedures related to the Patent Cooperation Treaty (PCT), European Patent Office and Japan Patent Office.

Life Sciences Background

Before becoming a lawyer, I was a biochemist in both academics and industry. I grew up just down the street from the University of California, San Diego where I eventually became a Research Scholar and received a B.S. in Biochemistry/Chemistry with a minor degree in Economics. While conducting research in the laboratory of Dr. Dennis Carson, founder of the UC San Diego Moores Cancer Center, I investigated the role of novel purine nucleoside analogs in autoimmune diseases and cytokine mediated cell responses including apoptosis, rheumatoid arthritis, AIDS and cancers. I then pursued my interests in the biotech industry where I investigated ribonucleic acid (RNA)-based therapeutics for treating viral infections.

Life sciences innovations I have worked with include small molecule pharmaceuticals and biopharmaceuticals (e.g., central and peripheral pain therapeutics, formulations and delivery; enzyme mimetics; therapeutic polypeptides and polynucleotides including vaccines, monoclonal antibodies, antibody fragments, siRNA, shRNA, miRNA, ribozymes, antisense DNA, and various enzymes); medical devices (e.g., magnetically driven catheter systems, magnetic nanoparticle delivery and hydrodynamic systems, fully implantable stimulators, in vitro diagnostics); structural proteomics; three-dimensional molecular modeling and drug design; stem cells and therapeutic cloning methods; transgenic plants and animals; and cell culture equipment and methods. 

Personal Background

After meeting my wife Celine Buckley at a start-up biotech company, I followed her to Pittsburgh, Pennsylvania where she attended the University of Pittsburgh School of Medicine and I attended the University of Pittsburgh School of Law. During my last year of law school, I was the Editor-in-Chief of The Pittsburgh Journal of Technology Law & Policy and founded a non-profit foundation to support the publication. I followed Celine again to St. Louis, Missouri where she completed her radiology residency at the Mallinckrodt Institute of Radiology, part of the Washington University School of Medicine. Celine completed her fellowship in abdominal and cardiothoracic imaging at the University of Pennsylvania. We then moved to Winter Park, Florida where Celine is a member of Radiology Specialists of Florida, a radiology practice affiliated with Florida Hospital, and I became Associate General Counsel at the University of Central Florida where I directly assist the University of Central Florida Office of Research & Commercialization.

I thoroughly enjoyed being an adjunct professor at the Washington University School of Law where I taught a Biotechnology Law course. My lifelong commitment to education, both of my own and of others, began with the many exceptional experiences I had at The Bishop's School, a college preparatory school in La Jolla, California. Seven members of my family taught classes at various levels during their careers (my Mom still teaches elementary school), so it seems natural that I should enjoy engaging with students at all levels.

I am also committed to developing the entrepreneurship community and have volunteered for a number of business and economic development organizations. I am currently a member of BioOrlando and BioFlorida where I hope to help develop the Central Florida entrepreneurial community. I was recently a mentor to the Penn Biotech Group, a cross-disciplinary student run organization at the University of Pennsylvania representing graduate students from the School of Engineering and Applied Sciences, The Wharton School, the Law School and the School of Medicine. I especially enjoyed being a mentor to Innovation Acceleration Partnership Fellows who are funded by a National Science Foundation grant through the Skandalaris Center for Entrepreneurial Studies at Washington University in St. Louis. I also regularly spoke about the implementation of commercialization strategies with emerging businesses and finance students at the Olin Business School.

I have been involved in stem cell politics since 2000. This has included work with the International Society for Stem Cell Research and assisting both state legislators and U.S. Senate Judiciary Committee counsel in evaluating pending legislation and initiatives.

Some of my other outside interests include standup paddling, windsurfing, fly-fishing and gardening.

Growing up in La Jolla, I spent as much time as possible in the ocean where I enjoyed surfing, kayaking, swimming at La Jolla Cove, womping, skin diving, sailing, wind surfing, and a few other sports that my friends and I may have invented. Because my father is a mountaineer, I also grew up rock climbing in Joshua Tree, hiking in the Sierra Nevada and Baja California, and ice axing in Yosemite. Although I don't get back often enough, my favorite activities include taking long walks that include the Cove and Torrey Pines, and enjoying long conversations with Celine, our family and old friends at the Pannikin and Brockton Villa.

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