Robert T. Hrubiec, Ph.D., J.D.
Bob is a seasoned intellectual property attorney and business executive with over 30 years in-house experience as a scientist and in-house IP counsel in both large and small pharmaceutical and biotechnology companies.
Bob served as Vice President and Chief IP Counsel of Cephalon, Inc., a mid-sized biopharmaceutical company and as an Intellectual Property Attorney for GlaxoSmithKline, a multi-billion dollar pharmaceutical company.
Bob earned his doctoral degree in Synthetic Organic Chemistry from the University of Connecticut. He also served a post-doctoral fellowship (Pharmacology/Biochemistry) at Yale University School of Medicine and earned his law degree from North Carolina Central University School of Law (evening division). Bob has been a member of the North Carolina Bar since 1998, the Pennsylvania Bar since 2010 and a member of the United States Patent and Trademark Office Bar as a Patent Agent since 1992 and as a Patent Attorney since 2000. Prior to his admission to the Patent Bar, Bob had various roles as a scientist in academics and the pharmaceutical industry.
Bob’s passion for science, technology and the law along with his entrepreneurial spirit create smart, strategic solutions to the management of IP.
Selected Accomplishments*
- Evaluated and advised on IP estates of several target companies/products which led to the acquisition of several companies and in-licensing of several development/commercial products (small molecules, formulations, monoclonal antibodies and stem cells) and billions in revenue
- Identified issues with target products/companies patent estates which significantly reduced the overall deal value and resulted in hundreds of millions in savings
- Managed outside counsel resulting in significant cost savings
- Identified and implemented strategies that significantly reduced patent costs and resulted in savings of hundreds of thousands for a single patent family
- Received Deals of Distinction award from the Licensing Executives Society which recognized a creative IP-based licensing and business arrangement in the stem cell business sector
- Identified and implemented IP and regulatory strategies that significantly increased IP protection for key products and extended product protection by several years
- Identified and obtained additional patents to prevent design around products and significantly increased patent protection for major products (identified several new patents around a single key product)
- Assisted in managing patent litigation for a major product which resulted in several years of exclusivity and billions in revenue
- Identified and obtained creative patent protection for a key product which extended exclusivity for fifteen years
- Devised a combined patent/FDA creative strategy for a key product which extended protection for several years
- Leveraged the patent estate of a product which resulted in a significant negotiated reduction in payments to a collaborator
Todd W. Spradau, Ph.D., J.D.
Todd is a highly accomplished life sciences counsel with over twenty years of experience working for both branded and generic pharmaceutical companies.
He has a proven track record of obtaining strong, long lasting patent protection, maximizing Hatch-Waxman and other regulatory exclusivities, improving patent estates, and providing clear advise on freedom to operate, patentability, validity and infringement.
Todd also has extensive experience negotiating life sciences agreements of all kinds, including in- and out-licensing, consulting, clinical trials, API/drug product manufacturing, and other services.
Todd earned his doctoral degree in Organic Chemistry from the University of Illinois at Urbana-Champaign and his law degree from New York University School of Law. Todd has been a member of the New York bar since 2001, the Pennsylvania bar since 2014, and the United States Patent and Trademark Office bar since 2002.
Selected Accomplishments*
- As the sole in-house attorney for a small biotech, Todd extended the scope and duration of patent protection for the company’s oncology clinical candidate and negotiated all of the company’s business agreements.
- Identified new patentable subject matter in narrow formulation patents and successfully obtained broader, stronger patents that eliminated the possibility of generic design-around
- Filed new patent applications to protect new methods of drug administration, combinations with other drugs, indications, and next generation compounds
- Negotiated commercial agreements to further clinical development, discovery research, and other business needs
- As the lead IP attorney for business development at a mid-sized pharmaceutical company, Todd conducted IP due diligence on third party drugs for possible in-license/acquisition.
- Analyzed patent landscapes of target products and provided clear guidance on patent protection, freedom to operate, and regulatory exclusivity, resulting in completed deals worth more than $4 billion
- Evaluated patent estates of hundreds of drugs at various stages of development
- Negotiated IP provisions of all term sheets and license agreements
- As the lead IP attorney for specific marketed and in-development products at a mid-sized pharmaceutical company, Todd prepared and prosecuted patent applications, analyzed freedom to operate and patentability, and negotiated relevant agreements.
- Obtained Orange Book listed formulation patents for an extended-release pain medicine that survived validity challenge and provided several years of additional market exclusivity
- Identified and implemented a strategy to expand the scope of a compound patent for a de-prioritized chemical series to instead cover a third party oncology clinical candidate, and out-licensed the resulting patent to the third party for $350 million
- Created a new prosecution approach for an in-licensed injectable product, focusing on administration protocol instead of formulation specifics, and obtained new Orange Book patents that survived validity challenge and provided more than two additional years of market exclusivity
- As the lead IP attorney for a small generic pharmaceutical company, Todd analyzed innovator patents, advised on invalidity and design-around strategies, and worked closely with scientists on product development.
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