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
A joint cybersecurity advisory alert issued October 28, 2020, warns of an imminent cybercrime threat to the U.S. health care sector.
Time: 12:00 p.m. - 1:00 p.m.
Join Mandy Wilson Decker in the third of this four-session webinar. Mandy will join a panel discussing tech transfer on October 6, 2020.
LOUISVILLE, Ky.—Managing Intellectual Property magazine recently selected Stites & Harbison, PLLC attorney Mandy Wilson Decker to the 2020 edition of Managing Intellectual Property’s “Top 250 Women in IP.” This is the sixth time Decker has been honored on this list, and she is the only attorney honored from Kentucky.
In response to the global COVID-19 pandemic, on March 30, 2020, the Secretary of the Department of Health and Human Services (HHS) issued nationwide blanket waivers of sanctions under the federal physician self-referral law (Stark Law) for “COVID-19 Purposes” (Blanket Waivers).