Enhancing antibody patent protection using epitope mapping information
Wednesday, October 10, 2018
1:00 - 2:00 PM Eastern
12:00-1:00 PM Central
11:00 AM -12:00 PM Mountain
10:00 - 11:00 AM Pacific
As the $100B therapeutic monoclonal antibody (mAb) market continues to grow, developers of therapeutic mAbs increasingly face the need to strengthen patent protection of their products and enforce their patents in courts. In view of changes in the patent law landscape, patent applications are strategically using information on the precise binding sites of their mAbs, i.e., the epitopes, to support patent novelty, nonobviousness, subject matter, and a tightened written description requirement for broad genus antibody claims. Epitope data can also allow freedom-to-operate for second-generation mAbs by differentiation from patented first-generation mAbs. Numerous high profile court cases, including Amgen v. Sanofi over rival mAbs that block PCSK9 activity, have been centered on epitope mapping claims, highlighting the importance of epitopes in determining broad mAb patent rights. Based on these cases, epitope mapping claims must describe a sufficiently large number of mAbs that share an epitope, and each epitope must be described at amino acid resolution. In this webinar, we review current best practices for the use of epitope information to overcome the increasing challenges of patenting mAbs, and how the quality, conformation, and resolution of epitope residue data can influence the breadth and strength of mAb patents.
This webinar is aimed at IP lawyers with biotech/pharma interests
Ben Doranz, Integral Molecular
Ben Doranz is President and CEO of Integral Molecular. Dr. Doranz co-founded the company in 2001 and has led all aspects of the company’s growth since its inception, bringing five different technologies from research to market and growing the company into a profitable commercial entity. He is an inventor on six of the company’s patents, the principal investigator on over 20 NIH grants, and an author on over 75 publications, including articles published in Cell, Science, and Nature. He invented the Shotgun Mutagenesis technology used for antibody epitope mapping.
Dr. Doranz is an established life science entrepreneur previously responsible for directing the biotechnology program at the Port of Technology business incubator in Philadelphia and helping create startups at the Center for Technology Transfer at the University of Pennsylvania. Dr. Doranz earned a Ph.D. in Cellular and Molecular Biology from the University of Pennsylvania where he was involved in the discovery of the coreceptor for HIV (CCR5), an MBA at the Wharton School of Business, and a B.A. at Cornell University.
Dr. Ulrich Storz's main areas of practice are managing and enforcing patents and patent applications, as well as drafting FTO analyses and opinions. He also provides advice on strategic patent issues, notably in life sciences in the field of therapeutic antibodies. Dr. Storz is regularly involved in major antibody opposition cases before the European Patent Office. He has significant expertise in gene-editing technologies, including CRISPR, TALEN und ZFN, and works in the field of CAR T-cells, stem-cell technologies, plant biosciences, and enzymes.
Dr. Storz received his PhD from the University of Münster in 2002 with a thesis in neurobiology. He then completed his training to become a German patent attorney and joined the list of professional representatives before the European Patent Office in 2006. In recent years, he has provided representation in a large number of sizable due diligence projects in the field of pharmaceuticals and life sciences with a volume of EUR 500,000 to EUR 100m.
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