"Welcome to the PIUG 2011 Biotechnology Meeting"
Monica Weiss-Nolen, Program Chair
Monica Weiss-Nolen is currently an Information Scientist in the scientific and patent Information Research and Analysis group at sanofi pasteur, supporting the North America Intellectual Property group and R&D scientists. Previously, she served as a Senior Analyst for the Business Intelligence group at Ortho Biotech, a Johnson & Johnson company, and prior to that was an information scientist at DuPont Pharmaceuticals for 10 years, conducting patent and scientific searches for R&D. She started her information science career at BIOSIS creating current awareness searches. She holds a BS in Biochemistry from Millersville University of PA and an MSIS from Drexel University. She has been a member of the PIUG for over 10 years.
Potent Antibody Drugs by Design
Antibodies have come of age as therapeutics since the late-1990s with 24 antibody therapeutics marketed in the USA and >240 additional antibodies in clinical development. The focus of this presentation is the creation of even better next generation antibody drugs - a major area of interest in the field. The rationale to develop better even antibody therapeutics comes from a convergence of clinical, scientific, and commercial considerations in conjunction with technological advances that provide the tools to do so.
Dr. Carter has 25 years of experience in biotechnology: Genentech (1986-2000 and 2010-present), Immunex/Amgen (2000-2003), Seattle Genetics (2003-2008) and VLST (2008-2009). Dr. Carter's accomplishments in drug development include initiating the antibody humanization program at Genentech and co-inventing Herceptin®, a humanized antibody approved by the FDA for the treatment of HER2-overexpressing breast and gastric cancers. He is an inventor or co-inventor on 25 issued US patents. Dr. Carter has authored or co-authored 95 scientific publications that together have been cited >7,000 times. Dr. Carter received a B.A. in Natural Sciences from Cambridge University in 1982. He obtained a Ph.D. in 1986 under Sir Gregory Winter, Ph.D., F.R.S. at the MRC Laboratory of Molecular Biology in Cambridge. From 1986-1989 Dr. Carter was a Postdoctoral Fellow with Dr. James A. Wells at Genentech.
Biosimilars: New Decisions and New Opportunities
The enactment of the legislative basis for biosimilar approval in March 2010 has brought some clarity to this area for those involved in the biotechnology industry. However, details about the specific procedures, the specific standards to be applied, and the ultimate impact of biosimilars on current and future products remain uncertain. During the maturation of the biosimilar approval process biotechnology industry leaders will face new decisions - decisions, if to be made intelligently, that will require accurate information about their products, their competitor's products, and the involved intellectual property coverage and approval histories. This presentation will examine new decisions related to biosimilars that will be faced by management in the coming years and the type of information that will be required to make informed choices at these junctures. If armed with correct information, biotechnology companies will be able to seize the new opportunities presented by the biosimilar approval process and use it to expand the choices available to patients relying on biologic treatments.
Michelle L. Lewis is a Senior Patent Attorney at ZymoGenetics, Inc., a biotechnology company located in Seattle, Washington which recently became a wholly owned subsidiary of Bristol-Myers Squibb. She has a Masters degree in Genetics from Columbia University and a biology degree from Duke. She began her patent career as an Examiner at the United States Patent Office in the Complex Biotechnology Arts. After leaving the office and working as a patent agent for several years, she attended Rutgers-Newark Law School, graduating with honors. Following a stint in law firms as an associate, she joined ZymoGenetics where she has worked for eight years. At ZymoGenetics she drafts, prosecutes, and manages worldwide patent and agreement portfolios for a number of company projects. Beyond prosecution and transactional responsibilities, she routinely briefs management on recent developments in the biotech arena, such as biosimilars and the current challenges to the patentability of genes and diagnostics.
Sequence Business Process and Frequently Asked Questions on Sequence Compliance Issues
The presentation provides a brief overview of USPTO current sequence business process. The presentation then covers common sequence compliance issues and frequently asked questions related thereto.
Mr. Nguyen is a graduate of the Virginia Polytechnic Institute and State University and Johns Hopkins University. He works at the U.S. Patent & Trademark Office, where he served as the supervisory patent examiner of Art Unit 1633 and TC 1600 Quality Assurance Specialist from 2004-2009. He currently manages the Patent Examination Art Unit 1634 directed to personalized medicine and pharmacogenetics, and serves as a specialist and coordinator for the Sequence Business Process.
Mr. Nguyen's current assignments in the agency include:
- Supervisory Patent Examiner, Art Unit 1634
- Workgroup 1630 Hiring Program Coordinator
- Co-Lead of SharePoint Business Process
- Co-Lead of Automation & Sequence Business Process
- Member of the Enhancing Technical Knowledge Between Examiners Working Group - Patents Process Reengineering Team
Search and Examination for Biotech Applications in the JPO
Japanese Patent Office
It will be explained how patent applications in biotechnology field are searched and examined in the Japan Patent Office. Especially, the methods for searching about DNA and protein sequence and the examination standards in biotech will be discussed.
After I received B.A. and M.A. degrees in Biotechnology from University of Tokyo in Japan, I started my career at the Japan Patent Office (JPO) as a patent examiner in 2000. I have worked at the JPO almost 11 years, and examined a lot of patent applications related to biotechnology and medical science fields. During the period, I had a chance to work at the Examination Standard Office, and now I am in charge of deputy director of the Examination Policy Planning Office.
Beyond gene patenting turmoil: a reality check for patent protection of biosequences in Europe
Since mid 1990's, genomic-based discovery was instrumental in expanding, and testing, the limits of institutional policies and industry practices on gene patenting. Relevant data on the actual impact of the extensive integration of genetic information within patent documents can be extracted by integrating IPC-, keyword-, and sequence-based search strategies that are developed and performed in accordance to the content and the search features of sequence-based and full-text patent databases.
A case study on major trends on the content and the outcome of examination at EPO for biosequence-containing PCT applications that have been filed in the late 1990s-early 2000s is presented in parallel to major recent decisions of EPO Board of Appeals in this field. This analysis is intended to provide quantitative and qualitative elements, as well as some methodological tips, that may be helpful for evaluating patent situation and strategies associated to an R&D project, a technology, or a company, in presently changing economic and legal environments.
Luca Falciola is Director for Intellectual Property at Genfit (Loos, France). He previously held positions at RiboVax Biotechnologies (Petit-Lancy, Geneva, Switzerland) as Director for Intellectual Property & Collaborative Research, and at Serono as Patent Information Specialist and Patent Attorney.
Luca holds a PhD in applied genetics and has done post-doc research in molecular biology. He is Member of AIDB (Italian Association of Patent Searchers), wherein he acts as editor of "AIDB Newsletter" and as AIDB representative in the working group of CEPIUG (Confederacy of European Patent Information User Groups) on professional certification. He provided courses and presentations on methods for searching patent & scientific information.
Advice to Beginner and Intermediate Searchers for a Biotechnology Patent Search
Science IP® (Chemical Abstracts Service)
As biotechnology patent information consultants, we bring together the three spheres of our experience, as scientists, information professionals, and patent specialists. We leverage that combined knowledge to answer questions such as: When to do a sequence search, key word search, or both? What type of sequence search? How to conduct information analysis? How much value-add is too much? My talk will present and explain answers to these questions, as encountered during the pre-interview, interview, pre-search, search, report, and "information analysis" stages.
Ken is a Senior Searcher at Science IP®, the professional search service of Chemical Abstracts Service (CAS), a division of the American Chemical Society. Prior to joining CAS in 2007, Ken worked for 12 years in the pharmaceutical industry at Pfizer, where he conducted molecular biology research in drug discovery for six years and then provided patent and scientific information research for in-house patent attorneys for six years. Prior to his pharmaceutical industry experience, Ken worked in academic molecular biology research laboratories at Harvard Medical School, Beth Israel Hospital Boston, and the University of Connecticut Health Center's Department of Biochemistry. Ken focuses on comprehensive biological and biosequence patent retrieval and analysis in support of patentability, freedom to operate, validity, infringement, and due diligence activities within the legal and corporate environment. Ken has a MS in biology.
Comparison of USGENE vs. GQ-PAT and Geneseq
The Patent Documentation Group's Biotechnology Information Working Group has conducted a series of studies to compare and evaluate patent sequence databases. Several sequences were searched on three different occasions (March 2008, March 2010 and December 2010) to find similar sequences from three well known sources: USGENE, GQ-PAT and GENESEQ. The results presented show interesting differences in content, coverage and database update.
Fanny Coignard has a biotechnology engineer degree (~MSc) from the E.S.B.S. (Strasbourg University) and has recently obtained the Certificat d'Animateur en Propriete Industrielle (I.N.P.I.). Fanny has been working as a Patent Information Scientist in the GLobal Legal Information Science Team (GLIST) at Pfizer for 6 years. Fanny specializes in biotechnology related patent questions, including sequence analysis. Before joining Pfizer, Fanny worked as a research scientist for 6 years at Bristish Biotech (Oxford, U.K.) , Epigene (Paris, France) and Exonhit Therapeutics (Paris, France) where she gained experience in molecular biology, cell biology, bioinformatics, and proteomics.
This presentation is given on behalf of the Patent Documentation Group's Biotechnology Information Working Group, which Fanny has been a member of since 2006.
Comprehensive Search Strategy for Genomics-Based Intellectual Property Protection
Steve Chappell Mitchell
A comprehensive genetic search strategy in Biotechnology includes sequence-based discovery and analysis at protein level, DNA level, and conceptual keyword/classification coding combinations. This talk in genomics-based intellectual property protection will cover considerations within this comprehensive method:
- Caution when using percent identity in algorithms
- Developing a process for dealing with confounding DNA genomic interspersed repeat comprised sequences
- When using percent identity, defining uses of the differential mathematical models from KERR (GenePAST) and BLAST algorithms
Sequence-based discovery is vital, and necessary to combine with conceptual, keyword, coding-based search approaches within a most comprehensive method.
Steve Chappell Mitchell is the Director of Biotechnology and Genomic Services at Technology & Patent Research (TPR) International. Before joining TPR, Steve was Senior Information Scientist at Abbott Laboratories where his work with attorneys was recognized with the 'President's Award'. Steve's successful experience as a cancer discovery scientist at Harvard University and Cedars Sinai/UCLA, and his participation on the Human Genome Project at CalTech, have provided him with firsthand knowledge of gene cloning and sequencing. Also, Steve's numerous patented inventorships confirm him as being on the cutting edge of technology and the patent process. In intellectual property protection at TPR, Steve's clients include most major pharmaceutical companies, and a large group of biotechnology companies and law firms worldwide
Improving FTO Patent Analysis- Focusing Results Using Scientific Analysis
Barbara H. Miller
Novartis Institutes for BioMedical Research, Inc.
For pharmaceutical patent attorneys who are making decisions in areas such as Freedom to Operate (FTO), it can be time-consuming to find all relevant legal information related to a particular target or therapy. Search savvy and proactive patent analysts can assist in the decision making process by providing attorneys with reports that contain more decision-enabling information than merely the results of blast and keyword searches. Providing information in areas such as legal status, current patent claims, relevant prior art, IP portfolio, and competitive intelligence when necessary will provide the attorney with a better context in which to frame an issue. By doing basic scientific analysis on documents resulting from Blast and keyword searches to determine relevance to the FTO issue, patent analysts can provide attorneys with the necessary information to facilitate FTO decision making.
Barbara Miller is currently a Patent and Scientific Analyst at the Novartis Institutes for Biomedical Research (NIBR) in Cambridge, MA. Prior to joining Novartis in August 2009, she was an Information Scientist at Pfizer in both Groton, CT and Ann Arbor, MI. She has a PhD in Biological Sciences from Emory University in Atlanta, GA, a MS in Regulatory Affairs and Quality Assurance from Temple University, and a BS in Chemistry from Rhodes College in Memphis, TN.
Biologics - Searching Patent Classes at the USPTO, WIPO, EPO, and JPO
James L. Grant
Corporate search protocols have been developed to comprehensively capture biotech and biosequence data within world patent and journal collections for all aspects of due diligence. The large growth of biotech patent specifications led the patent offices to develop classifications of their own. The primary purpose of classification systems is to facilitate the searching and retrieving of patent documents by patent offices and users. Classification systems are hierarchical in nature with main headings covering a general area of technology and sub-headings covering a given type of invention. The systems allow searchers to identify the classification areas in which the technology is assigned to Art Units within the respective Offices. After identifying potential classification areas from the index, the class schedules must be consulted to determine the best and most exact classification groups in which to search. USPTO, WIPO, EPO, and JPO classification systems exist and must be searched separately so that technical aspects of an invention, to which a patent document relates, can be classified completely. The classification systems may provide an excellent 'front end' to searching for macromolecules that contain peptides, sugars, chemical linkers, etc.; methods & platform technologies; and anitbodies. Further, the class systems may reveal dominating claims to genus or classes not revealed by word or by sequence. The United States Patent Classification To International Patent Classification Concordance will be discussed in light of the EPO and JPO classification schema.
James L Grant has a PhD in Chemistry and is registered to practice as a Patent Agent before the USPTO. He works as a Consultant in chemical and biotechnology research sectors most recently in patent portfolio review and patent research for SciMed Partners Inc. James has also participated in IP Forums for WIPO. He recently presented lectures in Tunis highlighting USPTO content along with others presenting patent content from WIPO and the EPO. James has worked in patent research at Pfizer, Inc. and Bristol-Myers Squibb.