Clinical Research and Clinical Trials
We understand the unique and complex challenges and protocols of clinical research and clinical trials. Stites & Harbison health care lawyers represent academic medical centers, teaching hospitals, universities and other institutions, as well as principle investigators. We counsel clients in the numerous standard agreements associated with clinical research (master service agreements, confidential disclosure agreements, material transfer agreements, federal and private contracts, grants, clinical and research service agreements, etc.), scientific integrity, scientific misconduct, privacy, human subject protection, and FDA reporting. Our clients also include biotechnology, life sciences, pharmaceutical and medical device companies.
We serve our clients in areas including:
Intellectual Property Protection Counseling
- Patentability, freedom to operate, patent infringement, and patent validity analyses.
- Preparation and prosecution of domestic and international patent applications.
- Due diligence analysis including review and assessment of existing intellectual property portfolios.
- Trademark availability analyses.
- Preparation and prosecution of domestic and international trademark applications.
- Domain name disputes resolution; domain name assignments and sales agreements.
- Privacy policies and terms-of-use for commercial web sites.
- Traditional and web site advertising review.
Enforcement of Intellectual Property Rights and Litigation:
- Appeals to U.S. Patent and Trademark Office, Board of Patent Appeals and Interferences
- Defense and prosecution of patent infringement lawsuits and declaratory judgment actions in federal court
- Defense and prosecution of trademark and copyright infringement lawsuits in federal court and before administrative bodies, including the USPTO Trademark Trial and Appeal Board and U.S. Copyright Office
Intellectual Property Licensing and Technology Transfer
- Non-disclosure agreements and internal confidentiality policies
- Review of co-branding, Internet, and traditional advertising agreements
Risk Management for Pharmaceutical, Biomedical, and Biotechnology product launch
LOUISVILLE, Ky.—Stites & Harbison, PLLC attorney Mandy Wilson Decker was elected as 2023-24 Chair-Elect of the newly-formed Kentucky Bar Association (KBA) Intellectual Property (IP) Law Section.
LOUISVILLE, Ky.—Kentucky Intellectual Property Alliance (KYIPA) elects Stites & Harbison, PLLC attorney Mandy Wilson Decker as inaugural Chair of its Board of Advisors. She has served on the group’s Executive Advisory Committee since 2021.
LOUISVILLE, Ky.—Managing Intellectual Property (Managing IP) magazine recently selected Stites & Harbison, PLLC attorney Mandy Wilson Decker to the 2023 edition of Managing IP’s “Top 250 Women in IP.” This is the ninth time Decker has been honored on this list, and she is the only attorney honored from Kentucky.
LOUISVILLE, Ky.—The American Bar Association (ABA) Health Law Section has ranked Stites & Harbison, PLLC in its Tenth Annual Regional Top 10 Law Firm Recognition List of Top 10. The firm ranked 8th in the inaugural National Top 10 list and 4th in the South Top 10 list. Stites & Harbison has been honored nine consecutive times to the South list.