Heidi L. Kraus
• J.D., High Honors, The George Washington University Law School
• B.S., Biology, Pennsylvania State University
• Admitted in NY, DC, Maryland and before the USPTO
Heidi Kraus has over fifteen years of experience counseling life sciences companies and university research departments regarding U.S. patent law.
She has extensive experience advising generic pharmaceutical companies regarding patent law issues related to Abbreviated New Drug Applications (ANDAs). She has counseled companies regarding freedom to operate, patent certification filing strategies, data exclusivity, product label carve outs, exclusivity forfeiture issues, and patent term extensions.
Her generic pharmaceutical experience is also valuable to proprietary drug product owners, as she is skilled at identifying weaknesses in patent portfolios and advising patent owners regarding strategies to strengthen patent protection and delay generic competition. In addition, this experience is valuable to potential investors wishing to perform due diligence or valuation for a patent portfolio.
Ms. Kraus has rendered hundreds of invalidity, noninfringement, freedom-to-operate, and patentability opinions for pharmaceutical patents, including patents that claim API, polymorphs, crystal forms, salts, chemical synthesis, methods of use, pharmacokinetics, and/or pharmaceutical formulations. She has also written and prosecuted many patent applications for pharmaceutical and biologic products. In addition, she has performed several patent portfolio due diligence analyses, and has counseled companies seeking advice regarding strengthening their own patent portfolios.
Ms. Kraus’s 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, D.C.
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. She also performed pre-acquisition due diligence analyses on products and companies.
Due to Ms. Kraus’s experience as in house counsel, she understands the business and regulatory context of patent issues, budget constraints, FDA regulatory issues that might block patent design-around options, and can provide practical legal advice in plain English.