Mr. Rhee has extensive experience analyzing individual patents and complex patent portfolios for institutional investors and other parties. He frequently conducts patent due diligence and risk assessment investigations in the context of mergers and acquisitions, and also provides strategic legal advice with respect to business matters.
He has rendered opinions on patentability, validity, infringement, licensing, and right-to-use issues. In addition, he has experience in the litigation of patent infringement disputes. He has advised both patent holders and patent infringers during pre-litigation and litigation phases.
He has assisted companies in fulfilling their business objectives within a complicated United States Food & Drug Administration (FDA) regulatory framework. From different types of drug and medical device applications to Hatch-Waxman Act issues, “Orange Book” listings, and enforcement actions, Mr. Rhee has advised clients on FDA issues affecting product development, clinical trials, product approvals, and commercial distribution. He has also testified before FDA on regulatory issues regarding follow-on biologics (e.g., biosimilars).
He has assisted companies in complying with numerous provisions governing electronic data security, privacy, and breach issues with a focus on regulations under the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act. His experience includes assisting clients with data sharing and data use of electronic health records (EHR) and protected health information (PHI). He routinely advises covered entities and business associates on a wide range of regulatory issues.
Mr. Rhee brings a strong background in biochemistry, health care, medical devices, pharmaceuticals, and pharmacology. He has experience with antibody-antigen interactions, biologics manufacturing, polypeptide chemistry (vaccines and therapeutics), cancer immunotherapies, and recombinant DNA technology.
He has also assisted clients in the automotive technology and racing industries with driver-sponsor-team contracts, and legal concerns often involving trade secrets, confidentiality, patents, and other intellectual property issues. He has significant practical experience in these industries having been involved in automobile racing for five years.
Mr. Rhee was a licensed pharmacist for eight years before becoming an attorney. During this time, he gained considerable experience in clinical settings, traditional community pharmacies, and in the management of a pharmacy corporation.
