Kevin Buckley News & Announcements
University of Central Florida - Office of General Counsel
November 1, 2011 - I joined the University of Central Florida Office of General Counsel where I am the lead attorney for intellectual property, transactional and regulatory matters that are part of the University's research and technology commercialization efforts. Although I am no longer in private practice, I continue to find myself surrounded by talented attorneys and serve some of the best scientists and innovators in academics and industry. As the university grows with Lake Nona Medical City (which includes the UCF Health Sciences Campus, Sanford-Burnham Medical Research Institute, VA Medical Center, Nemours Children's Hospital, University of Florida Academic & Research Center, MD Anderson Orlando Cancer Research Institute), the Florida Space Institute, and numerous other institutions in the Orlando area, the opportunities to impact technology commercialization are sure to keep growing.
UCF Office of Research & Commercialization
The Best Lawyers in America® - Biotechnology Law
September 2, 2011 - The third time is a charm...
I am honored once again to have been selected by my peers to be listed in The Best Lawyers in America® 2012 edition in the field of Biotechnology Law.
Pennsylvania Bio Knowledge Fair and Summer Social
June 8, 2011 - What a pleasure is was to speak at the Pennsylvania
Bio Knowledge Fair and Summer Social that took place on Penn State
University's Great
Valley campus. This first inaugural event was attended by 300 entrepreneurs
and PaBio service providers in 100 degree weather.
IP Strategy Informed by the Commercialization Process
Philadelphia's Best Lawyers
January 28, 2011 - What an HONOR to be among this group of attorneys. The guide is excerpted from the 2011 edition of The Best Lawyers in America®, the preeminent referral guide to the legal profession in the United States. Published for nearly three decades, Best Lawyers® lists attorneys in 82 practice areas, representing all 50 states and the District of Columbia. The 2011 edition is based on more than 3.1 million evaluations of lawyers by other lawyers. The attorneys in the guide were nominated by and voted in by their peers. Lawyers cannot buy their way into this guide, but must earn a spot through exemplary legal work that attracts the notice of their colleagues. According to Americal Lawyer Media, to remain on the list, the attorneys must be at the top of their game, year after year.
Philadelphia's Best Lawyers Acrobat
Penn Biotech Group
October 1, 2010 - It has been an incredible experience becoming a mentor with the Penn Biotech Group. PBG is 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. PBG addresses the challenges and obstacles facing the biotechnology industry today by providing its members the real-world experience to advance client interests in industry.
The Best Lawyers in America® - Biotechnology Law
August 1, 2010 - I am honored to have been selected again by my peers to be listed in The Best Lawyers in America® 2011 edition in the field of Biotechnology Law. Considered to be the oldest and most respected peer-review publication in the legal profession, Best Lawyers® conducted confidential surveys of leading attorneys who cast more than 3.1 million votes on the legal abilities of other lawyers in the same and related specialties. The 2011 reference guide lists more than 39,766 attorneys in the United States in 80 different specialties and covers all 50 states and the District of Columbia. Best Lawyers® has come to be regarded - by both the legal profession and the public - as the definitive guide to legal excellence in the U.S.
St. Louis Magazine - "Best Lawyers 2010" in Biotechnology Law
February, 2010 - It's fun to see my name in St. Louis Magazine ! Selections are based on the Best Lawyers® criteria (see news below), but only attorneys in private practice are included. Unfortunately, a highly regarded St. Louis attorney was not included because he works in-house for MasterCard International. Dennis Kennedy was selected this year as a Best Lawyer® for Information Technology Law which, in my view, is long overdue. Dennis has certainly been one of the best lawyers in St. Louis for many years and I hope other publications will include his name on such lists.
St. Louis Magazine - Best Lawyers 2010 Biotechnology Law
Washington University School of Law - Biotechnology Law
January 11-15, 2010 - It was an extraordinary pleasure teaching Biotechnology Law at Washington University in St. Louis School of Law with Tom Redick, a principal at Global Environmental Ethics Counsel. What made the teaching experience most rewarding was leading the interaction between juris doctor, LLM, and Ph.D. candidates, many of whom have technical backgrounds in biochemistry, engineering and medicine. I was especially impressed with the LLM candidates who reside outside the United States. I am grateful to Chuck McManis and Mike Koby who provided the opportunity to present our materials -- a summary of the materials I presented can be found at BioCommercialization.com. It goes without saying that five days was not enough time to review every aspect of biotechnology law, but we discussed many important topics at a high level including controversial patent, biosimilar ("follow-on biologic") and regulatory issues. I always understood that Washington University attracted the most qualified law school candidates, which I can now attest to with certainty.
Olin Business School at Washington University
October 13, 2009 - I was a guest lecturer in Peter Finley's class "Entrepreneurial Investing" at Olin Business School at Washington University. I provided the class a detailed anatomy of a patent as well as the process for obtaining international patent protection. The students had some good questions regarding optimization at various stages of the entire commercialization process. We used Genentech's Avastin® patent, Biological License and reimbursement regimen as examples of what might be required in due diligence at different points in the value chain. Peter Finley also steered the conversation in interesting directions, and his experience as a former Director at Thompson Street Capital Partners shone through. Teaching this class was a total blast and I hope to do more with the Business School again.
Patenting Human Genes
September 14, 2009 - I led a discussion on September 30, 2009 from 7:00 to 8:15 PM as part of the Constitutional Law Lecture Series held at St. Louis Community College Florissant Valley. I spoke about "Science and Commerce: Who Owns the Building Blocks of Life?" and analyzed the intellectual property and constitutional implications of a law suit the American Civil Liberties Union filed against the U.S. Patent & Trademark Office and Myriad Genetics. The law suit challenges the patentability of the BRCA1 and BRCA2 genes which are diagnostic for breast and ovarian cancers. More information is available about the ACLU's legal position, Myriad Genetics' hereditary breast and ovarian cancer detection system, and the complaint filed by the ACLU.
Constitutional Law Lecture SeriesAcrobat
The Best Lawyers in America® - Biotechnology Law
July 30, 2009 - I am honored to have been selected by my peers to be listed in The Best Lawyers in America® 2010 edition in the field of Biotechnology Law. Considered to be the oldest and most respected peer-review publication in the legal profession, Best Lawyers® conducted confidential surveys that enabled more than 24,126 leading attorneys cast more than 2.8 million votes on the legal abilities of other lawyers in the same and related specialties. The 2010 reference guide lists more than 29,000 attorneys in the United States in 78 different specialties and covers all 50 states and the District of Columbia. For 27 years, Best Lawyers® has come to be regarded - by both the legal profession and the public - as the definitive guide to legal excellence in the U.S.
Washington University’s Skandalaris Center for Entrepreneurial Studies
Technology Commercialization Panel Discussion
July 10, 2009 - I participated on the Technology Commercialization panel with Bill Simon (COO of the Center for Emerging Technologies), Dr. Yie-Hwa Chang (Principal of Mediomics LLC), and Dr. Kunal Rehani (a Washington University Innovation Acceleration Partnership Fellow and recent founder of Eyelten Therapeutics, Inc.). It was plenty of fun speaking with the Skandalaris Center summer interns over lunch and speaking with Ken Harrington, director of the Skandalaris Center for Entrepreneurial Studies.
Washington University in St. Louis - Skandalaris Center for Entrepreneurial Studies
Intellectual Property Management Fund
February 16, 2009 - I am honored to have been appointed to the State of Missouri Intellectual Property Management Fund (IPMF) Committee. IPMF is funded by the Missouri Technology Corporation as part of the Lewis and Clark Discovery Initiative and is supported by the Grow Me State Initiative. IPMF assists Missouri researchers and entrepreneurs in protecting and commercializing their research and innovations. The IPMF Committee manages the fund providing low-interest loans for protecting intellectual property.
St. Louis Business Journal
August 15, 2008 - I was recently interviewed for an article related to the Food & Drug Administration (FDA) drug application backlog. The impact of the backlog is apparent as time-to-market is increasing for all pharmaceutical and biopharmaceutical companies, as well as the cost of clinical trials increasing as the FDA becomes more stringent in analyzing safety data. The market has responded in interesting ways. For example, venture capitalists are typically funding companies later and later in the drug development process to both diminish the downside risk of early-stage investments as well as shorten the amount of time their investments are tied up in the drug development process. Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) are also becoming booming as pharmaceutical companies seek to outsource clinical development work to more cost-effective resources. Patent and pharmaceutical life cycle management strategies are also changing in response the backlog as patent term extension (PTE) becomes increasingly important, especially in the United States where the PTE is shorter than most other countries.
FDA Attempts to Streamline its Drug Pipeline with Hires
6th Corn Utilization & Technology Conference
June 2-4, 2008 - I helped the National Corn Growers Association organize the "ABCs of Commercialization" panel where I discussed strategies for developing strong intellectual property as a platform for increasing license revenue, venture capital funding, regulatory approval, sales revenue and reaching the market more efficiently. Many thanks to Dr. Richard Glass, Vice President of Research & Business Development, and Nathan Fields, Director of Research & Business Development, who provided expert support and the foresight to provide information on commercializing agriculture biotechnologies in the context of building an international carbohydrate-based economy. Our moderator was Nathan Danielson, President of Biocognito, who provided a humorous introduction to each of the panelists presenting their perspectives on agriculture biotechnology patent, licensing, funding, regulatory and market strategies. Eric Lund, Commercialization Manager of the Pacific Northwest National Laboratory, provided a primer on licensing technologies from a large basic science research institution. Michael Peck, General Partner at Open Prairie Ventures, followed up by providing a detailed summary of a venture capitalist's perspective on investing in AgBio technologies. Tom Redick of Global Environmental Ethics Counsel detailed many of the pitfalls and promises of regulating agriculture biotechnologies in a global and "flat" environment. Finally, Derek Rapp, CEO of Divergence, Inc. synthesized his strategies for intellectual property protection, licensing, funding and obtaining regulatory approval for his nematode genomics technologies in order to efficiently reach market. Derek's success as the leader of a start-up enterprise that will shortly enter the market with a novel product inspired all of us with his deep understanding of the commercialization process.
2008 Corn Utilization & Technology Conference
2nd Annual Global Healthcare Investing Conference
April 29 to May 1, 2008 - I spoke on the "Opportunities in Emerging Geographies" panel discussing the 2005 Patent Act of India, new Indian drug pricing policies, and evolving pharmaceuticals case law and current litigation in India. Related to these laws and policies, I discussed how investment opportunities in Indian pharmaceutical technologies and biotechnologies are changing as generic pharmaceutical manufacturers add innovative pharmaceutical products to their pipelines. Within that framework, I concluded with legal and business strategies that can be employed in conjunction with contract researcher organizations ("CROs") and investors to commercialize those new Indian technologies, especially in the U.S. The Global Healthcare Investing Conference is presented by BioEnterprise and International Business Forum Conferences.
Global Healthcare Investing Conference Agenda
St. Louis Business Journal
February 29, 2008 - I was quoted in an article focusing on the impact new patent case law, patent regulations and patent reform legislation may have on industry. I highlighted the heightened non-obviousness requirements for patent applications under the Supreme Court case KSR v. Teleflex and its progeny. On a lighter note, I tried to explain the heightened requirements to the reporter with an analogy that was published as: "a baker should not be able to obtain a patent for a chocholate chip cookie, a confection that any baker with imagination and access to cookie dough and pieces of chocholate could bake." While the analogy is oversimplified, I think it works. However, the next time I give an interview, I'll have to eat lunch beforehand...
St. Louis Daily Record
January 2, 2008 - In an article analyzing cost-effective ways for law firms to serve their clients better, I highlighted the important role nonlawyer scientists play in the practice of law. "It's acceptable, even practical, for a law firm to hire a new scientist with less work experience." "There's a real synergy between a new lawyer and someone fresh out of a Ph.D. program who knows all the new science. It's a pretty powerful combination." The article provides that there is a growing need for specialists in new technological developments in part because patent application filings are up 61% from 1996 to present. Law firms will continue to find themselves in need of technical expertise more than ever.
Law Firms Turn to Nonlawyer Scientists
Nature Biotechnology
November, 2007 - In an issue of Nature Biotechnology focusing on RNAi, I commented on patenting and funding in the evolving RNA interference (RNAi) field in Nature Biotechnology. In analyzing the effect of the new legal standard for patentability of biotechnology innovations, the article provides that "the probable IP clashes between Merck/Sirna and Alnylam will be made more confusing thanks to the tightening in April of the 'non-obviousness' requirement in patent applications." "The hurdle now [to get a patent issued] is to prove some kind of heightened, unexpected utility, some surprising use, which is going to be hard to do." Because part of my practice is setting up patent applications as vehicles for innovators to generated better venture capital investments, I focused on a problem many start-ups will likely face when generating the additional data that could be added to a patent application to meet the heightened non-obviousness requirement: "It's not part of a venture capitalist's model to spend money on preclinical work before you can even file a patent application."
Companies Jostle for Lead in RNAi, Despite Uncertainties Nature Biotechnology 25(11):1191-1192 (2007).
Kansas City Daily Record and St. Louis Countian
October 17, 2007 - There has been a lot of interest in the potential impact of changes at the U.S. Patent & Trademark Office will have in the near future. I commented on new rules promulgated by the U.S. Patent & Trademark Office (currently not in force and under injunction). Noting the current backlog for biotechnology innovations pending in the U.S. Patent & Trademark Office, I predicted that the new rules would not "speed up the process."
Patent Attorneys in U.S. Decry Changes to Rules
The National Law Journal
October 15, 2007 - I was quoted in the NLJ in an article focusing on the increasing law firm representation of companies, universities and political organizations related to stem cell technologies. Noting the public policy and legislative aspects of stem cell research, I stated that new regulatory groups formed by such legislation are "generating work for lawyers like us who can provide services in the stem cell area." This is important work for organizations such as the Missouri Coalition for Lifesaving Cures for whom I have spoken on behalf of.
Stem Cell Research Ramps Up Firm Work
Conversation with Lee Presser
Televised September 10 and 17, 2007 - I was featured
on a local television program Conversation with Lee Presser to discuss life sciences commercialization, patent law, and the evolving
manufacturing technologies within the biotechnology and pharmaceutical
industries.
For a DVD copy of the conversation, please contact Lee Presser directly:
St. Louis Business Journal "Who's Who in Technology"
July 20, 2007 - I was featured in a special section of the St. Louis Business Journal's "Who's Who in Technology." I focused on my law firm's commercialization services, including intellectual property, licensing, regulatory and venture funding capabilities.
St. Louis Business Journal - Who's Who in Technology
Inaugural Global Healthcare Investing Conference
June 20, 2007 - I was a panelist at the June 20-21 Global Healthcare Investing Conference presented by BioEnterprise and International Business Forum Conferences. The panel was titled "Bringing Overseas Start-Ups Into the U.S." Topics covered by the panel included solutions for obtaining funding for Indian and Chinese technologies in the U.S., regulating foreign technologies in the U.S. and Europe, and assembling a management team in the U.S. for start-up companies initiated overseas.
Global Healthcare Investing Conference Agenda Acrobat
