Wednesday, February 20, 2019
Keynote Address - Post-Issuance Options for Challenging U.S. Patents
This session will review the various post-issuance options available at the U.S. Patent and Trademark Office for challenging the validity of a patent, such as inter partes and post grant reviews as well as ex parte reexamination. Specifically, this session will discuss the requirements for each of these post-issuance options, the similarities and differences between each, the requisite filing requirements, the timelines for submission and response, how each of these post-issuance options has affected biotechnology and pharmaceutical related patents and the important role that searchers play in helping attorneys prepare the documents needed in support of a post-issuance options or in defense thereof.
For over twenty-five years, Lisa has provided strategic counsel on complex patent issues to clients in the pharmaceutical, biopharmaceutical, biotechnology and chemistry sectors. She brings an in-depth knowledge and extensive experience to her work advising clients on the global patent protection, freedom to operate and validity of blockbuster drugs they aim to produce and distribute.
Since 2001, Lisa has worked closely with in-house legal departments of global pharmaceutical firms regarding their patent development and enforcement strategies. In this partnership, she provides training to new in-house counsel and meets with scientists and other business development to anticipate and resolve a wide array of problems including navigation of U.S. Food and Drug Administration approval.
A thought leader on pharmaceutical and biopharmaceutical patent law, Lisa speaks frequently to legal and industry groups, and publishes widely. She was the author of an award-winning blog, BRIC Wall, which provides unique insights on patent law developments in the life sciences industry in Brazil, Russia, India and China. Lisa is currently the author of the blog, BRICS & Beyond (https://bricsandbeyond.blog/) which provides unique insights on patent law developments in the life sciences industry not only in Brazil, Russia, India and China but in other countries outside of the United States.
Using CPC in Biotechnology Areas
Cooperative Patent Classification (CPC) is the current classification system used by USPTO, and it is jointly maintained by USPTO and EPO (European Patent Office). In this presentation, a brief overview of the CPC areas that cover biotechnology and chemical subject matters and how to classify using CPC will be provided. Examples of searching using CPC including C-set searching will be discussed.
Sue Liu is currently a Supervisory Patent Examiner in the biotechnology area at the United States Patent and Trademark Office (USPTO). Her Art Unit examines applications in pharmaceutical formulations, biocides, cosmetics, and related areas. She joined USPTO as a patent examiner in the Combinatorial Chemistry Art Unit. Before joining the USPTO, Sue was a postdoctoral fellow at FDA. Sue studied transcriptional regulation in vaccinia virus for her Ph.D. thesis and graduated from the Department of Biochemistry, Purdue University. She obtained her BS degrees in Chemistry and Psychology from Arizona State University (ASU) and graduated from ASU’s Honors College.
The Evolving Patent Landscape of Therapeutic Manipulation of the Human Microbiome
The earliest stage companies focused on human microbiome therapies have progressed into late stage clinical trials. I will review early approaches used to identify human microbiome focused companies and recommended updates for searching the space. I will build off of my 2016 presentation at the 2016 PIUG Biotech meeting with updates on language, classes, companies to watch. Additionally, I will present a some representative examples of different patented technologies in the space that have progressed into the clinic.
Larry Mulcahy is a Solution Consultant at Clarivate Analytics where his primary responsibility is to train and consult with users on Derwent based databases and solutions, specializing in research and analytics of patent and non-patent literature. With his background in education, Larry has conducted patent search and patent landscaping courses as part of two master’s programs. Larry has experience in several life sciences fields as a graduate student, postdoctoral fellow, and applications scientist. Larry received his Ph.D. from Brown University in Molecular & Cellular Biology and Biochemistry. He lives with his family in the suburbs of Boston, MA.
Patent Family Differences across Databases and How It Impacts Search and Report
As a professional patent searcher the use of multiple patent information databases is essential. There are many advantages to using more than one resource when researching life science-related, technical inventions. However, each resource may group and present the data in slightly different ways, including the way in which patents are grouped into families. It is important to understand these differences and to make the necessary adjustments to your search strategies in order to run a complete search.
This talk will review the differences between major patent information resources and give examples of features to consider for inclusion into your search report.
Alison Taylor is a patent searcher in the Legal Department at Abbott Labs., Abbott Park, Illinois, USA. She has a Bachelor’s in Biochemistry from the University of Surrey, U.K. and a PhD in Biochemistry / Molecular Biology from King’s College London, U.K. She was a researcher in the Molecular Biology Labs. at Abbott for five years at the start of her career but has been a searcher since 1995, after leaving the lab. and working in the library at the Nutrasweet Company, part of Monsanto. She later moved on to the pharmaceutical research library of Monsanto, which became Pharmacia, and following closure of this site in 2004, joined Threshold Information, a small private information search company. In 2009 she joined Abbott Labs. as a patent searcher with a focus on biological / life sciences and currently supports the Legal division on searches related to diagnostics, biologic pharmaceuticals and competitive intelligence.
WIPO Standard ST.26 in a Nutshell
Current WIPO Standard ST.25 for the presentation of sequence listings in patent applications became effective in 1998 and has not been substantively revised since then. The Committee on WIPO Standards (CWS) established a Sequence Listing Task Force in 2010 to revise the standard and create new WIPO Standard ST.26. This presentation will provide a brief overview, including the benefits of the new standard, the major differences between ST.25 and ST.26, transition provisions, and the various components of the standard.
Susan Wolski has been a PCT Special Programs Examiner in International Patent Legal Administration (formerly Office of PCT Legal Administration) at the USPTO since 1998. She teaches classes to patent examiners on international and national stage applications filed under the Patent Cooperation Treaty, gives seminars on the Treaty and the filing of biological sequences to various groups outside the USPTO, and participates in a number of special projects, including modification of the standard for the filing of biological sequences in patent applications. Sue began her tenure at the USPTO in 1990 as a patent examiner in biotechnology (immunoassays), completed her law degree at George Washington University during that time, and is now member of the Virginia Bar. She has earned two Department of Commerce Gold Medal Awards and four Bronze Medal Awards for her work, as well as an Exceptional Career Award. Prior to joining the USPTO, she earned a Bachelor of Science degree in Microbiology and a Master’s Degree in Immunology from the University of Maryland (College Park). She has also worked in biological research at the University of Maryland, the American Type Culture Collection, and the Uniformed Services University, and in the sales of scientific instrumentation for Beckman Instruments.
Panel Discussion: Sequence Searching Past, Present, and Future
Yugong Cheng Research Consultant, Elanco
Yugong Cheng is currently a patent research consultant at the Elanco Animal Health (a spin-off from Eli Lilly and Company) in Greenfield, IN, focusing on patent searches and analysis for biotech and biomedicine. Prior to joining Lilly in 2007, he was a computational biologist at Molecular Kinetics and a research associate at Indiana University Purdue University at Indianapolis. He has a PhD in Biochemistry and a MS in Computer Science from University Vermont, Burlington, VT, and a BS in Chemistry from Beijing University, Beijing, China.
Cynthia Gallagher, PhD Manager, Patent Searching & Information, Pfizer Legal Division
Cynthia Gallagher has been part of Patent Searching & Information (formerly known as GLIST) in the Intellectual Property department at Pfizer since 2005. When she started at Pfizer, she provided search support for chemistry related patent search requests and now provides search support for biotechnology related patent search requests. She started her career as an information Scientist as a chemistry searcher at Merck in 2004.
She has a PhD in Chemistry from the University of Vermont, an MA in Biology from Lehman College, CUNY and a BA in Chemistry from the College of Holy Cross
Lisa L. Mueller Casimir Jones, S.C.
Victoria Smith, PhD Patent Analyst I, Novartis Institutes for BioMedical Research
Victoria Smith received her Ph.D. in Biological Sciences from the University of Notre Dame in 2016. While at the university, she worked in the areas of immunology, cancer biology, and infectious diseases. During her time in the lab, Victoria began to transition her career interests to intellectual property and, in 2015, enrolled in a Master of Science in Patent Law program at the University of Notre Dame. Through participation in this program and a subsequent internship at the University of Notre Dame Office of Technology Transfer, she was taught the foundations of patent law, application drafting, and patent searching and analysis. Victoria joined Novartis in October 2017 as a patent analyst for the Research & Development IP team at NIBR.
Monica Wu Patent Information Specialist, Merck
Man “Monica” Wu is currently a patent information specialist at Merck company in Rahway, NJ and provide patent information services to all bio-related IP area. She started her career as a patent searcher at DuPont in 2010 and supported Biotechnology and Agriculture business units.
She has a Master in Biophysics from University of Virginia and a BS in Medicinal Chemistry from Beijing Medical University.
Bringing Patent Information to the Engineering Community
The American Society of Mechanical Engineers (ASME) recently launched an initiative to support engineers in the bioengineering and medical devices industries. As part of this initiative, known as the Alliance of Advanced Biomedical Engineering (https://aabme.asme.org), we identified the top challenges expressed by our stakeholders, which include:
We are looking to connect the ASME/AABME community with PIUG, as we believe such a connection can enable exchange of information and instruction that can ultimately solve these challenges.
ASME, a not-for-profit professional society and standards developing organization, was founded in 1880 to advance a mission of improving the quality human life. The mission continues to this day, serving 130,000 members worldwide.
Christine Reilley is business development director of Healthcare for the American Society of Mechanical Engineers (ASME), based in New York City. As director, she leads the ASME Alliance of Advanced Biomedical Engineering (AABME), which focuses on creating and growing the Society’s portfolio of programs, products, and services in this area.
Christine had previously served as program manager in the ASME Emerging Technologies unit, developing content and conferences in areas focusing on bioengineering, nanotechnology, thermofluids, and materials. Previously, she spent more than 10 years in ASME Codes and Standards Publishing as an editor, overseeing the production of codes.
She earned an MS in Biomedical Engineering with a concentration in Tissue Engineering and Biomaterials from New Jersey Institute of Technology (NJIT). She received a BA in Journalism and Mass Media with a minor in Biological Sciences from Rutgers University, Douglass College.
The Growth of the Medical Devices and Its Impact on the USPTO
The medical device industry has grown quickly over the years, the devices becoming more sophisticated and encompassing technologies from different areas. In this presentation a brief discussion of how this growth has impacted examiners at the USPTO and how they search.
Jackie Cheng is currently a Supervisory Patent Examiner in the biomedical area at the United States Patent and Trademark Office (USPTO). Her Art Unit examines applications in a variety of medical diagnostics including cardiovascular monitoring, respiratory monitoring, and analyte sensing. She started her career at the USPTO as a Patent Examiner examining applications in the field of medical imaging. She obtained her dual degree BS in Electrical and Computer Engineering and in Biomedical Engineering from Carnegie Mellon University.