Jennell Bilek, PharmD, PhD, JD
PharmD, University of Minnesota
PhD, Social & Administrative Pharmacy, University of Minnesota
BS, Journalism, Iowa State
Juris Doctorate (JD), Mitchell Hamline School of Law
Jennell co-directs the pharmacy law course for the College of Pharmacy. She is an equity partner with the downtown Minneapolis based law firm, Carlson Caspers, where she advises clients on a wide range of legal and regulatory matters.
Jennell’s litigation experience includes pre-filing investigations, motion practice, Markman hearings, all aspects of fact and expert discovery, trials, appeals to the Court of Appeals for the Federal Circuit, and Inter Partes reviews before the USPTO Patent Trial and Appeal Board.
Jennell’s regulatory counseling practice focuses on issues facing drug, biological, and nutraceutical clients and wholesale distributors. For instance, procurement, navigating the drug supply chain, labeling claims, obtaining approvals, product lifecycle management, and patent/exclusivity assessments. She also advises clients on complying with federal and state drug and pharmacy laws and regulations. Jennell’s transactional experience includes contract drafting and negotiation, and patent opinions.
Her industry experience includes work as a community pharmacist, deputy director of the Minnesota Board of Pharmacy, consultant to large employers when implementing pharmacy benefit manager driven cost controls, and assisting a pharmaceutical market expert with disputes that concerned antikickback and misbranding statutes, False Claims Act, and misappropriation of trade secrets.
- Intellectual property (patent, trade secret, and trademark)
- Regulation of prescription, OTC, and compounded drug products
- Health care fraud and compliance
Bilek JC, The Relationship Between Overall Utilization and Settlements Involving Off-Label Promotion of Prescription Drugs, Ph.D. Dissertation (2013).
Bilek JC, Antitrust and the Pharmacist-Patient Relationship, 45 JAPHA 290 (2005).
Bilek JC, Sepulveda D, Schondelmeyer SW. Comparative Analyses of Drug Treatment Costs between Therapeutically Similar Alternatives. American Pharmacist Association (APhA) Annual Meeting Supplemental Symposium Proceedings (2005).
Bilek JC, Carlson AM, Morris LS. Prescribing Trends for Combination Products in the Treatment of Type II Diabetes. International Society for Pharmacoeconomics and Outcomes Research Annual Meeting Supplemental Symposium Proceedings (2005).
Schwartzman DS, Bilek JC, Harvey M, Hoyt RH, Kohler J, Ujhelyi MR. Does Ambulatory 600 mg Oral Propafenone Benefit Patients Managed with Implantable Atrial Defibrillation Therapy? 26(4p2) PACING AND CLINICAL ELECTROCARDIOLOGY 929 (2003).