Health Care

Health Care - Life Sciences Technology & Commercialization

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

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Client Alerts

Joint Agency Cyber Alert Warns of Imminent and Credible Ransomware Threat Against U.S. Health Care and Public Health Sectors

A joint cybersecurity advisory alert issued October 28, 2020, warns of an imminent cybercrime threat to the U.S. health care sector.

by Sarah Cronan Spurlock, Ian T. Ramsey, and Dustyn B. Jones November 02, 2020
Events

Tech Transfer: Methods That Work, IIPCC Fall IP Experts Panel Series

Date: 10/6/20
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.

Mandy Wilson Decker September 22, 2020
Press Releases

Managing IP Selects Mandy Wilson Decker to 2020 “Top 250 Women in IP” List

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.

by Stites & Harbison, PLLC August 07, 2020
Events

Kentucky Health Law Institute

Date: 9/2/20 - 9/3/20
Time: 8:00 a.m. - 5:00 p.m.

WEBINAR (via Zoom)

Sarah Spurlock, Janet Craig and Dustyn Jones will be presenters at this WEBINAR presented by UK Law Continuing Legal Education on September 2-3, 2020.

Sarah Cronan Spurlock, Janet A. Craig, and Dustyn B. Jones June 30, 2020
Client Alerts

Healthcare Fraud and Abuse Laws are Relaxed During COVID-19

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).

by K. Kelly White Bryant and Ozair M. Shariff April 13, 2020