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.—The American Bar Association (ABA) Health Law Section has ranked Stites & Harbison, PLLC in 7th place in its Seventh Annual Regional Law Firm Recognition List for the South region for 2019. This year marks Stites & Harbison’s sixth consecutive time being named to the Top 10 list.
LOUISVILLE, Ky.—Managing Intellectual Property magazine recently selected Stites & Harbison, PLLC attorney Mandy Wilson Decker to the 2019 edition of Managing Intellectual Property’s “Top 250 Women in IP.”
LOUISVILLE, Ky.—Fund for the Arts has elected Stites & Harbison, PLLC attorney Terry Wright to its Board of Directors. He will serve a three-year term.
Marshall University, Huntington, W.Va.
Attorney Terry Wright will present three free intellectual property seminars focusing on 3-D designs and manufactured goods, pharmaceuticals and medical devices presented by the Marshall University Technology Transfer Office in Hunington, W.Va.
Did you decide that 2019 will be the year you tackle those cybersecurity threats to your organization that keep you up at night? It’s February, and a good time to take stock of whether your organization is following through on its cybersecurity goals. Some estimate that 80% of resolutions fail by the second week of February.