PIUG 2014 Biotechnology Conference
Staying on the Cutting Edge of Biotechnology Patent Searching
Monday, February 24, through Wednesday, February 26, 2014
Hindsight analysis of litigation-based investigations on best-practice searching for non-litigation matters
David A. Casimir
Searching is often conducted in the context of patentability and freedom-to-operate investigations during early phases of technology and product development with the goal of best predicting what might happen to an intellectual property asset or technology through its lifespan. Budget constraints almost always necessarily limit the scope of such investigations. In contrast, when such economics become trivial, as in the case of patent litigation (regarding patentability) and substantial commercial success (regarding freedom-to-operate) - whether via blockbuster product, company acquisition, IPO, or other major transaction - budgets are often effectively unlimited when directed to the investigations of patentability and freedom-to-operate and may include the use of private detectives, expert interviews, and international travel. Using several case studies, this presentation will highlight the most valuable items identified when budgets were no issue to help identify and suggest best practices for maximizing the chances of finding such items (to the extent possible) when budgets are more limited. The benefit of conducting at least limited detective work into the historical context of a technology will be emphasized.
Dr. Casimir is a founding shareholder of Casimir Jones, SC located in Madison, Wisconsin and is also an adjunct Professor at the University of Wisconsin Law School. He was educated at the University of Michigan – Ann Arbor where he obtained a B.S. in Cellular and Molecular Biology. He then gained a PhD in Biochemistry from the University of Wisconsin- Madison and a law degree from Stanford Law School.
Dr. Casimir counsels clients in all areas of intellectual property including patents, trademarks, copyrights, and trade secrets. He has participated in the prosecution of over a thousand patent applications spanning topics such as molecular diagnostics, imaging systems, disease therapies, drugs, vaccines, drug delivery systems, research tools, enzymes, genes, artificial organs, transgenic animals, stem cells, nucleic acid synthesis, organic synthesis, multimedia information processing, material sciences, sensory substitution and enhancement, medical devices, nutraceuticals, ballistics systems, software, and Internet applications.
Dr. Casimir has worked with numerous small and large companies, universities, and institutes on all aspects of the intellectual property life cycle. Dr. Casimir is also frequently engaged to provide freedom-to-operate opinions, including non-infringement and invalidity opinions.
Therapeutic antibodies comprise an increasing proportion of drugs and drug candidates. Thirty three therapeutic antibodies have received FDA approval in the US, and that number continues to rise. It is essential to conduct a comprehensive intellectual property clearance search prior to commercialization of an antibody product.
Potentially relevant IP may include patents drawn to antibodies that bind the target antigen, possess particular functional characteristics, have a particular epitope specificity, possess the same binding properties as a reference antibody, or contain defined CDR and/or variable region sequences.
What is the best way to identify these patents when conducting a freedom-to-operate assessment? We will walk through a step-by-step strategy for identifying patent documents relevant to a commercial antibody product. Specific considerations include identifying appropriate keywords for searching the patent literature in the antibody space, designing sequence-based searches for the antibody CDR and variable regions, searching the target antigen, and determining other technological areas where IP clearance may be needed. Exemplary patent claims that are easy to miss will be highlighted.
Briana Erickson is a member of the life sciences intellectual property group at Nelson Mullins Riley & Scarborough LLP in the Firm's Boston office. Her practice focuses on patent portfolio management and intellectual property due diligence in the areas of biotechnology, pharmaceuticals, oncology, immunology, nutraceuticals, and molecular diagnostics. She has a PhD in Molecular Biology from Brown University, a BS in Biology from Boston College, and a JD from Suffolk University Law School.
As biopatent searchers, we all want to maintain our competitive edge while being open to new techniques and technologies as they become available. How can we best do this in an efficient and effective way? This talk will provide both a managerial and a searcher perspective on the tools, techniques, and strategies that you need as a professional biopatent searcher. We’ll look at how you might go about breaking down a complex request into manageable parts, finding the relevant information, and presenting this information in such a way as to enable customers to make quick decisions. We’ll discuss how you might leverage existing assets while identifying and developing new skills to help you progress within your career. From advances in scientific technologies to utilizing current resources, we’ll discuss not only what you need to know to be successful, but also the most professional way to stay on the cutting edge.
Barbara Miller is currently the US Regional Head of the Search and Analytics Team at the Novartis Institutes for Biomedical Research (NIBR) in Cambridge, MA. Prior to joining Novartis in August of 2009, she was an Information Scientist at Pfizer in Groton, CT, where she supported a variety of research and development teams by providing literature, patent, regulatory, and competitive information. Barbara began her searching career at the Pfizer facility in Ann Arbor, MI, in 2001 as a biopatent searcher after completing a postdoctoral fellowship at the University of Michigan. 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.
Tara Rix & Tasha Witham
Sequence Listing rules dictated by WIPO Standard ST.25 directly impact the content of sequence databases. As such, they directly influence search strategy and the manner in which search professionals formulate their approach. Searchers may have experience searching in the sequence databases, but how cognizant are searchers of the rules regarding the inclusion or exclusion of sequences in Sequence Listings? This presentation will cover this subject matter and discuss the impact of WIPO Standard ST.25 on searching, as well as venture into the proposed new WIPO Standard ST.26 and the hypothetical impact it may have on sequence searching.
Tara Rix has been a searcher with Harbor Consulting IP Services, Inc. for almost 7 years. Her background is in Chemistry. Tasha Witham has been a searcher with Harbor Consulting IP Services, Inc. for just over 6 years. Her background is in Biology.
Ellen Doran Sherin; Denis Bayada
Approximately 50% of patent records originating in DDBJ have misassigned Sequence Identifier Numbers in comparison to both the corresponding sequence listings and filed patent documents. The error originated in the treatment of JPO/WIPO documents by DDBJ, which changed the sequence order from the sequence listing, and made a consecutively-numbered nucleotide sequence block followed by an amino acid sequence block. This error first appears in DDBJ and is subsequently propagated to EMBL and Genbank, and any other databases that take their data feed directly from any of these databases. This error affects database records with JP and WO patent or publication numbers. These misassignments can be corrected by direct access to the JPO/WIPO sequence listings and, importantly, by a recent update of DDBJ's published format.
Ellen Doran Sherin is a graduate of University of Massachusetts at Amherst and New Mexico State University, Las Cruces. She has worked at DuPont for over 30 years; in the biotech field for the majority of this time. She worked in the area of automated oligonucleotide synthesis during its infancy and was on the team that was first to sequence the AIDS virus in the mid 1980's. She's also worked in automated DNA sequencing and scientific IT, including management of commercial sequence databases. She's worked in the patent area for the last seven years with a specialty in sequence search and analysis, and is both a searcher and licensed US patent agent. She's also developed and implemented internal sequence search documentation and training programs.
The talk will focus on the Lens, a public global patent search site, and its associated PatSeq Toolkits. This includes mapping global patent-derived sequences onto genomes (human and others) with detailed analytical tools to search, explore claims, and so on. The Lens is a free and open service and aims to remain free, as opposed to ‘freemium’.
The Gates Foundation has just further committed serious funds from Global Health to build out Lens. A new Lens platform with a new User Experience and greatly enhanced collections management, annotation, sharing, etc is being launched on December 7th, 2013 and the talk will highlight the new features and functionality.
Richard is a molecular biologist, agricultural scientist, innovation systems strategist, and the leading exponent of 'Innovation
Cartography'. He is the Founder & CEO of Cambia, Professor at the Queensland University of Technology and Group Leader at National ICT Australia. Richard conducted the world's first field release of a biotech crop and created, distributed and supported the most widely cited and licensed enabling plant biotechnology. In 1989, Richard founded Cambia as an autonomous global non-profit social enterprise.
He created the BiOS Initiative, the first patent-based open licensing commons, and Patent Lens, the leading public global patent search site. This work has led to the 'The Lens'- a new digital public good to disrupt and democratize the innovation system.
Profiled in diverse media including The Economist, Newsweek, Nature and the New York Times, he has been named to the Scientific American List of the World's 50 most influential technologists.
As of 2011, there had been almost 8.7 million patent applications submitted before SIPO, with more than 8.6 million patent documents published. With the skyrocketing trend of patent applications and granted patents especially in recent years, China has become one of the largest patent markets over the world.
In order to facilitate the public use and dissemination of China patent information, SIPO, the sole authoritative agency governing patent application and examination and other patent related polices, has made extensive efforts and provided several publicly accessible patent databases online.
This topic covers some of those main databases by shedding lights on the various features of the platforms including PSS, CNIPR and CTCMPD
Focus will be on the CTCMPD, a human indexed and value-added patent search platform for searching China Medicine Patents. CTCMPD offers various search entrances and useful terminology dictionaries in Chinese traditional medicines and western medicines as well. This platform is almost the only existing free source to search for China Medicine Patents. Practical applications and cases will be discussed.
It’s hoped that with information from this topic, practitioners in the bio- and medicine field can search for China Medicine Patents more efficiently and more cost-effectively.
Mr. Binqiang Liu is now an IP Law Master Student at UNH Law, New Hampshire. Before coming to US, Mr. Liu was a patent examiner at SIPO (State Intellectual Property Office of China) for more than 7 years after his graduation in 2006. He has both Bachelor and Master Degrees in Engineering and an advanced-study Master degree in Civil and Commercial Law. His research interests extend from patent examination to patent policy and patent commercialization. He is experienced in patent analysis, patent market and NPE phenomenon. Mr. Liu speaks at IP forums and conferences held by various institutions, including Tsinghua University School of Law, Peking University School of Law and China Patent Agent Committee. He is member of AIPPI (Association Internationale pour la Protection de la Propriete Industrielle) and PIAC (Patent Information Annual Conference) China. Mr. Liu is a regular writer, and has published more than 20 papers on patent related topics published at journals within SIPO and outside.
“What are the chances this product will get seven or more years of market exclusivity (through patents or otherwise)?” As searchers, we frequently receive this kind of request for information on pharmaceutical exclusivities. Whilst it may appear to be a simple question, the answer can be multifaceted. This discussion will summarize the types of exclusivities that a potential pharmaceutical product may be able to obtain once it enters the market, either through the regulatory agencies (e.g., the FDA) or through patents or a combination of the two. In addition, a “cheat sheet” will be presented to capture various possible scenarios and the factors that determine the exclusivity periods. The “cheat sheet” was developed at Ironwood Pharmaceuticals through a collaborative effort involving the Intellectual Property, Regulatory Affairs and Pharmaceutical Development groups. The presentation will also provide an overview of some of the resources that were used and the type of information that can be obtained from each of them. Finally, this presentation will discuss how this information can provide insight into the potential market value of the product and how it will aid internal researchers and business development teams to make the most comprehensive and informed decision.
Bo Peng is a patent analyst who has 10+ years of experience in biopharmaceutical R&D, intellectual property, competitive intelligence and project management. She has conducted numerous prior art searches and analyses to support patentability, FTO, infringement and validity analysis for both internal programs and in-licensing opportunities. She is also a registered Patent Agent with United States Patent and Trademark office. Bo has been an active volunteer with PIUG since 2012. Prior to becoming a searcher, Bo worked as a medicinal and combinatorial chemist. Bo has a M.S. in Organic Chemistry from North Carolina State University and a B.S. in Chemistry from Peking University.
Each panelist will give a 10 minute talk on how they became a biotech patent searcher, and then all will participate in a question and answer session. We encourage members of the audience to share comments about how they learned to become a biotech searcher including any mentoring, training, and on the job experience that contributed to their skill set.
Gin Eggerichs, AbbVie
Gin Eggerichs has a B.S. in Molecular Genetics and a Ph.D. in Molecular, Cellular, and Developmental Biology from The Ohio State University. After graduation, Gin worked as an Applications Specialist for Chemical Abstracts Service (CAS) for almost 6 years. As an Applications Specialist, she trained searchers at several pharmaceutical and chemical companies on search techniques such as text, patent search, and sequence searching using STN. In addition to her responsibilities to commercial customers, she also worked with the USPTO Patent Academy and Chinese Patent Academy (SIPO) and trained the newly enrolled examiners on STN searching. Gin joined the Abbott Legal Search team in 2012 and in 2013 moved to AbbVie Legal Search team after the company split. Gin’s primary focus is to conduct patent/legal/literature searches in the biological area supporting AbbVie business.
Kenneth Hoppe, Science IP®
Ken is a Senior Searcher at Science IP®, The CAS Search Service; Chemical Abstracts Service is 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 numerous 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.
Seth Mendelson, Novartis Institutes for Biomedical Research (NIBR)
Seth Mendelson is a Patent and Scientific Analyst in the NIBR Patents group at Novartis Institutes for Biomedical Research. He has a BS in animal science and an MS in physiology, both from the University of Rhode Island. He has held several positions, beginning at the bench in a microarray lab at the Genetics Institute, spending two years in the bioinformatics group at Wyeth and finally moving into patent searching. Seth began working as a patent analyst in 2004 and has been at Novartis since 2008.
Ellen Doran Sherin, DuPont
Biography (above). (Press Alt-<left arrow> to return here.)
Alison Taylor, Abbott
Alison has a BSc in Biochemistry from the University of Surrey, U.K. and a PhD in Biochemistry / Molecular Biology from King’s College London, U.K. Since moving to the States following completion of her PhD, Alison has worked as a researcher at Abbott, Chicago, in the Molecular Biology Dept. In 1995, she moved into the biomedical searching arena at Monsanto for the Nutrasweet and G.D. Searle divisions of the company. She was taught how to search the scientific literature by library staff and vendors during the course of her new career. Alison later became Manager of the Chemical and Biological Searchers team at Monsanto, Skokie, IL (later Pharmacia Corp., later Pfizer, Inc.), and mainly worked with research scientists. After the Skokie site was closed down, she moved to a private search firm, Threshold Information, Inc., where her clients were from a more wide-ranging group of industries.
Alison moved back to Abbott in 2009 and currently works in the Legal Dept. where she provides FTO, prior art and other IP information services in the biotech and life sciences areas for the attorneys.