Tuesday, February 28, 2017
Global Filing Strategies for the Biotech/Pharmaceutical Patents
Global filing strategies for protecting biotechnological and pharmaceutical discoveries requires the careful consideration of a multitude of factors, including cost, overall IP budget, local laws, market size, enforceability of the patents, to name but a few. In addition, such filings need to be closely coordinated with ongoing development, clinical, manufacturing and regulatory activities. In this presentation, I will review these factors in close detail, with particular focus on protecting therapeutic products and, wherever possible, provide recommendations for companies of different stages/sizes.
Gene is Senior Intellectual Property Counsel at Ironwood Pharmaceuticals. He has experience working at biotech and pharmaceutical companies ranging from early-stage startups to global pharmaceutical companies, protecting and evaluating IP on a broad range of technologies and molecules, ranging from biological and small molecule therapeutics, gene and oligonucleotide therapies, and microbiomes. Prior to joining Ironwood, Gene worked at Pfizer, Indigo Agriculture, Synageva BioPharma, Alnylam Pharmaceuticals and Biogen. Gene received his Ph.D. in Biology from the University of Pennsylvania, and his J.D. from the Suffolk University Law School.
Quantifying EPO-Style Sequence Listings
The format of amino acid sequence listings varies between the European Patent Office (EPO) and the United States Patent & Trademark Office (USPTO). There are distinct differences in the presentation of alternative or variable amino acids in sequences (e.g., when the residue at a given position could be alanine or glycine). The EPO requires selection of one of the amino acids in the group to be represented in the sequence, while other offices, such as the USPTO, require the use of Xaa to represent these alternative amino acids. This presentation aims to discuss the prevalence of these EPO-style sequence listings in sequence databases. In order to investigate and quantify these types of sequences, the annotation/feature tables must be heavily replied upon, since the sequence alone is not useful in the identification. The majority of the statistics presented here are based on the freely available sequence data set at EBI-EMBL produced by the EPO. This data set was queried using Python scripts, which provide more flexibility in the type of queries and fields that can be searched when compared to most commercial databases.
Tom is currently in Pfizer's Patent Searching & Information group and has been a small molecule patent searcher at both Pfizer and Wyeth for a combined 12 years. Prior experience includes an additional 4 years searching as a Senior R&D Information Scientist at Dow Chemical after many years as a bench chemist at ANGUS Chemical, a small specialty chemicals company. He has a PhD in Organic Chemistry from Texas A&M University and a BS in Chemistry from the University of Connecticut.
The Constraint Potential of Biotechnology Patents and Determining When a Biosimilar Could Enter the Market
Patent thickets around a biologic molecule can make it hard for a patent analyst to determine which patents are truly protective and prevent the entry of a biosimilar onto the market, and those which could be circumvented. As many as 20 key patent families could relate to the biologic molecule, but in reality, a maximum of 5 are likely to be genuine blockers. This challenge is even larger when considering variability of protection in different geographies. In this session we will explore how the proprietary constraint analysis of the QuintilesIMS Ark Patent Intelligence database can be used to compare the expiry dates of these patents, and alongside data/marketing exclusivity, be used to identify a date at which probable biosimilar entry can be achieved. We will also use examples to explore strategies which have been employed to protect biologics by Innovators such as Amgen, who have managed to prolong the protection of Neulasta® (pegfilgrastim) using patents that protect manufacturing processes rather than the product itself.
Siobhán Palmer has a BSc in Chemistry from the University of Surrey. Siobhan joined QuintilesIMS, previously IMS Health, 8 years ago as a patent analyst for IMS Health’s Patent Focus database. Siobhan’s current role is as Product Manager for the Ark Patent Intelligence database.
Biosimilars: Trends and Developments in the United States and Europe
Biosimilars are an emerging competitive force within the biopharmaceuticals industry. Blockbuster biologics have lost patent and market exclusivity in major markets including the US and Europe. Major firms such as Sandoz, Amgen and Hospira (Pfizer) have launched biosimilars in Europe and the US and they have more products in the late stages of development and approval. Thomson Reuters will review the current pipeline of biosimilars and how they directly or indirectly threaten branded products. We will look at the challenges of bringing these products to market and how innovators and biosimilars developers are applying strategies to influence the landscape in their favor.
David Dunn is US Practice Lead and Scientific Advisor in the Portfolio and Licensing Services group at Thomson Reuters. He has over 20 years of experience in the pharmaceutical industry and advises clients on management and optimization of their research and commercial portfolios.
Challenges in Searching Biosimilar Sequences
Biosimilar monoclonal antibodies present many challenges for information retrieval. What does similar really mean and what are the consequences when searching patents? Examples of recent biosimilars on the market will be reviewed to highlight the oncoming obstacles for researchers and patent searchers.
Julien Doudement is a Product Manager at GQ Life Sciences. He advises customers on patent search best practices, while advancing new product features and content delivery. With 10 years at the company, he combines extensive biological research experience with a deep understanding of the GQ platform. Previously at Servier Laboratories, he immersed himself in the daily application of information technology to biological problems in drug discovery. He holds Master Degrees in Biology and Bioinformatics.
Shining a Light into the Black Box of Patent Examination – the Nordic Approach
Gain an insight into practical patent examination and the thought processes of an examiner and use this insight when evaluating the relevance of prior art in your own searches. In this presentation you will be introduced to the daily life of an examiner from the Nordic Patent Institute (NPI). I will illustrate how the examiners at NPI work and, in particular, how we think when considering novelty and obviousness. A key part of the process involves a dialogue between applicant and examiner prior to search. The dialogue serves to accurately determine the essence of the invention and identify fallback positions not necessarily apparent from the initial claims. Tailoring the search accordingly, the examiner can thus provide the applicant with the information necessary for adapting the application for further progress around the world.
Louise Boisen has worked as a patent examiner at the Nordic Patent Institute (NPI) and the Danish Patent and Trademark Office (DKPTO) since January 2014. Apart from searching and examining national and PCT patent applications, she also delivers IP services to businesses throughout the world. In addition, Louise is responsible for implementing best practice procedures and developing new services for the commercial search service units of both NPI and DKPTO. Louise has a background in recombinant antibody technology with a PhD from the University of Aarhus, Denmark, and did her postdoctoral training at Warwick Medical School, Coventry, UK
Going beyond the Traditional Patent Search: The Use of Patent Metric Indicators To Assess Technological Advantage
The traditional patent search for determining FTO or patentability involves the use of multiple resources to take advantage of value-added indexing or searcher developed free-text strategy. Once a set of references has been identified, the results are typically summarized to bring to the attention of the practitioner relevant aspects of the identified references as they pertain the query. The searcher is often asked to rank results by relevance, date, number of family members or those with dominating claims. This is a subjective exercise representing a snapshot in time but does not display trends or allows for a comprehensive view with a reliable and objective method. New methods to review patent search results are now available as a way to assess the competitive advantage of assignee’s portfolio. Early efforts to establish rankings were based on quantitative or qualitative assessments that lacked global coverage or relied on statistical correlations to patent maintenance rates. The use of empirical indicators such as Market Coverage™, Technology Relevance™, Competitive Impact™ and the Patent Asset Index™ can establish a reliable and objective numerical value of an individual patent family or an organization’s entire portfolio. In this presentation these empirical indicators developed by PatentSight will be used to analyse the clustered regularly interspaced short palindromic repeats (CRISPR) area, a method to edit or delete existing genes, as a method to assess the technological position of an organization, its innovativeness as well as sustainable competitive advantage.
Biography, Prof. Dr. Holger Ernst
Holger Ernst is full professor of business administration, esp. technology and innovation management at the WHU - Otto Beisheim School of Management, Vallendar, Germany. Prof. Ernst is further visiting professor at the Kellogg School of Management, Northwestern University, USA and honorary professor and principal fellow at the Melbourne Business School, The University of Melbourne, Australia. Prof. Ernst’s research interests lie in the fields of strategy, innovation, commercialization of technologies, new product development and intellectual property. Prof. Ernst has published in leading international journals and has received multiple research and teaching awards. Prof. Ernst is co-founder of PatentSight, located in Bonn, Germany, that specializes in the development and selling of software products and consulting services in the field of business intelligence based on patent data. Prof. Ernst has developed and runs the InnovationSuccess Panel (IsP®), a comprehensive audit tool that benchmarks a firm’s innovation management against innovation and market leaders across multiple industries. Prof. Ernst advises and speaks to corporations worldwide and serves on the board of multiple start-up firms.
Biography, Gregory E. Roland
Greg Roland is currently the Global Head of Search and Analytics within the patent department at the Novartis Institutes of BioMedical Research (NIBR) located in Cambridge, MA. Greg has 26 years of experience in the pharmaceutical industry and searching the patent literature and competitor pipeline databases. He started his career as a bench scientist at Parke-Davis in Ann Arbor, Michigan in the antiinfective group in 1990 before transitioning to the Research Library at Parke-Davis in 1999 taking on the role of supporting FTO requests for research tools. After Pfizer acquired Parke-Davis in 2000, Greg moved to a management role while continuing to be an individual contributor in the patent space and leading a team of biomedical, chemistry and CI professionals. In 2005 Greg transitioned to Pfizer’s Patent department as part of the Global Legal Information Science Team (GLIST) management team where he was a regional manager of team of information professionals at five sites. In August of 2009 he joined the Merck’s Knowledge Discovery Knowledge Management (KDKM) group in World Wide Licensing as a Director where he was responsible for the pre-clinical competitive intelligence.
Biography, Christopher S. Baldwin
Chris Baldwin is a Senior Consultant for PatentSight GmbH and is located in Wilmington, DE. Prior to working for PatentSight, Chris had several roles during his nearly 20 year tenure at the DuPont Company. Starting in 1996 as an associate chemist in the agricultural products division focusing on fungicide discovery, he developed an interest in intellectual property rights and strategy early on. In 1999, he transferred to Central Patent Information as a patent searcher, and under the guidance of Pat Dorler a founding member of PIUG, he learned how to effectively search complex chemical and polymer substances, formulations, and blends. Using this experience and knowledge of patent searching, in 2007 Chris went on to develop a new competency in Central Research & Development to improve their ability to successfully capture IP rights from its discovery programs. By using complex patent search techniques coupled with machine learning and analytics, Chris was able to offer these discovery teams access to broad technology landscapes and competitive insights. This greatly improved their understanding of the competitive threats and even uncovered potential opportunities from the insight gained on the current state of innovation within those domains. Chris now uses his experience to guide his PatentSight clients through the maze and complexity of the IP strategy and portfolio management world.
The Role of Text Mining in Patent Research at Boehringer Ingelheim
Scientists can spend a lot of their time separating patents relevant to a specific question from non-significant ones. We have developed a patent analysis workflow to prioritize the patents being reviewed in order to save the scientist’s time and cut costs by using text mining and other techniques. We will explain that process and the benefits derived from it. The optimal prioritization criteria can be defined freely for each project, making the workflow very flexible to use. We describe the general workflow using text mining and pipelining tools like Linguamatics I2E and KNIME, and take a look at challenges and possible future enhancements.
Thorsten is a Senior Information Scientist at the Scientific Information Center of Boehringer Ingelheim Pharma located in Biberach, Germany. He provides project support for early-to-late stage projects in RD&M with database research, information retrieval and text mining. He is a structural biologist by training and holds a PhD from the University of Mainz, Germany.
Quality In, Quality Out – Innovation at Minesoft To Help with the “In”!!
The quality of any search stems from the comprehensiveness of a search strategy. Although no database can do the search for you, it can provide features and functionality to help. Delivered from the perspective of an experienced biotech patent analyst, we will use case studies to discuss the challenges in ensuring comprehensiveness and the features and functionality of PatBase which can help, including: 1) PatBase Thesaurus to help identify synonyms, acronyms, names and numbers. 2) PatBase Semantic searching to broaden any patent search. 3) Non-patent literature searching in PatBase to identify relevant prior art. 4) The ability to link to relevant information including sequence information, clinical trial data and FDA OrangeBook information. This presentation will demonstrate how any user can benefit from the innovative features and functionality in PatBase to craft a meaningful patent analysis.
Rob is currently a Senior Manager (Innovation and Consulting) at Minesoft Ltd, UK. In 2000, and having completed a PhD in Biochemistry, Rob started his career at Pfizer as a Biotechnology Information Consultant providing biomedical, patent and competitive intelligence to both research scientists and patent attorneys. During 6 years at Pfizer, he helped form and lead a high performing team of information professionals within the Legal division. In 2006, he joined Novartis to create and manage the NIBR Search and Analytics team and during the last 3 years at Novartis, Rob completed an MBA at Warwick Business School which allowed him to take on additional operational and managerial responsibilities. With over 15 years of experience in the information industry, Rob has recently joined Minesoft to spearhead their future product development, to enhance their consultancy based approach and to bring an end user perspective to the company.