Heidi L. Kraus
• J.D., High Honors, George Washington University Law School
• B.S., Biology, Pennsylvania State University
• Admitted in NY, DC, Maryland and before the USPTO
Heidi Kraus has more than fifteen years of experience counseling pharmaceutical companies regarding U.S. patent law. Most of her experience is in advising generic pharmaceutical companies regarding patent law issues related to Abbreviated New Drug Applications (ANDAs). She has counseled companies regarding patent certification filing strategies, and regarding data exclusivity, product label carve outs, exclusivity forfeiture issues, and patent term extensions.
Ms. Kraus has rendered hundreds of invalidity, noninfringement, freedom-to-operate, and patentability opinions relating to pharmaceutical patents, including patents that claim API, polymorphs, crystal forms, salts, chemical synthesis, and/or pharmaceutical formulations. Her experience includes serving as the Chief Intellectual Property Counsel for Barr Laboratories, a generic pharmaceutical company, and for Barr’s affiliate, Duramed Pharmaceuticals, a proprietary pharmaceutical company. In this position, she managed the global intellectual property department until Barr was acquired by Teva Pharmaceuticals. In addition, Ms. Kraus served as the General Counsel for a small specialty pharmaceutical company that develops generic and proprietary drug products. Before joining Barr, Ms. Kraus was a director at an intellectual property law firm located in Washington DC.
As in house counsel, Ms. Kraus supervised several ANDA patent infringement cases brought under the Hatch-Waxman Act, and provided litigation and strategic advice concerning claim construction, invalidity and infringement issues, and expert reports. In addition, she assisted with proprietary product selection, development and launch by providing advice regarding lifecycle management strategies and freedom to operate, and by drafting patent applications and procuring intellectual property for these products. In addition, she performed pre-acquisition due diligence analyses on products and companies.
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