SUMMARY: Registered U.S. patent attorney in the chemical and pharmaceutical technologies. I am privileged to work in the intersection of law, technology, and business.Recent trial experience includes district court litigation in Laboratoire HRA Pharma v. Teva (Ella®). Recent PTAB experience includes IPRs in Pack Pharmaceuticals v. Alza Corporation (Glucotrol®), Teva v. Eli Lilly (Alimta®), Teva v. AstraZeneca (Onglyza®), and Teva v. Allergan (Restasis®).I am also a founding co-owner and managing director of a privately held pharmaceutical company. With an FDA approved facility located in Kansas City, the company focuses on identifying, developing, and commercializing niche products—505(b)(2) and P-IV ANDAs—on its own or in partnerships with other drug companies. The products span a wide-range of therapeutic indications and dosage forms. My role has required me to manage areas of business development, financing, product selection & forecasting, product development, clinical, legal, and regulatory.LEGAL AREAS: ▪ ANDA Hatch Waxman litigation and pre-suit investigation▪ Opinion drafting– Invalidity– Non-infringement▪ Reexaminations▪ Inter Partes Review (IPR)▪ Freedom-to-operate (FTO)▪ M&As▪ Due diligence▪ Life cycle management▪ FDA Regulatory▪ Licensing/transactional▪ IP Valuation– Patent ValuationTECHNICAL AREAS:▪ Pharmaceuticals – NCEs (e.g., small molecules)– Methods of medical treatment (all major therapeutic areas)– Dosage forms (e.g., injectable, solid orals, thin films, etc.)▪ Cosmetics & neutraceuticals▪ Agricultural▪ Industrial chemicals▪ Plastics & Polymers▪ Food & beverage▪ Clean tech– Fuel cells– Biofuels and biodiesel– Batteries– Oil & Gas– Solar▪ Process manufacturing▪ Medical devices▪ CannabisI moderate/own a discussion group "Freedom to Operate (FTO) and IP Due Diligence" on LinkedIn. I believe this is the only discussion group on LinkedIn dedicated to FTO and IP due diligence issues.
Listed skills include Patents, Patentability, Intellectual Property, Patent Prosecution, and 45 others.
