Heidi Kraus is Partner with the firm and has over twenty years of experience counseling life sciences companies and university research departments regarding U.S. patent law.
As former Chief IP Counsel and General Counsel of two pharmaceutical companies with both generic and proprietary drugs, she gained extensive experience regarding patent law issues related to Abbreviated New Drug Applications (ANDAs). She has counseled generic companies regarding freedom to operate, designing around patent claims, patent certification filing strategies, data exclusivity, product label carve-outs, exclusivity forfeiture issues, and patent term extensions.
Her experience is also valuable to proprietary drug product owners, as she is skilled at drafting and prosecuting patent applications with an eye towards future enforcement of those applications against competitors. She is also skilled at identifying weaknesses in existing 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 several hundred 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 numerous 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. After the acquisition, Ms. Kraus was Executive IP Counsel for Teva, where her focus was protection of proprietary products. 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.