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

Supreme Court Provides Additional Guidance on Assignor Estoppel in Patent Litigation

Assignor estoppel is an equity-based doctrine that can be invoked during the course of patent litigation to prevent an assignor, after assigning their interests to a patent to another, from later asserting that the patent is actually invalid.

by Gary N. Stewart (Nick) September 28, 2021
Press Releases

KYIPA Names Mandy Wilson Decker to Executive Advisory Committee

LOUISVILLE, Ky.—Kentucky Intellectual Property Alliance (KYIPA) names Stites & Harbison, PLLC attorney Mandy Wilson Decker to its Executive Advisory Committee.

by Stites & Harbison, PLLC August 11, 2021
Press Releases

Managing IP Honors Stites & Harbison Attorneys on “IP Stars” 2021 List

LOUISVILLE, Ky.—Managing Intellectual Property (Managing IP) magazine has named nine Stites & Harbison, PLLC attorneys to the 2021 “IP Stars” list. Managing IP recognizes the most highly regarded intellectual property attorneys in the U.S.

by Stites & Harbison, PLLC July 26, 2021
Press Releases

Well-Known King & Schickli Intellectual Property Attorneys Join Stites & Harbison

LEXINGTON, Ky. —Stites & Harbison, PLLC announces the addition of four attorneys to the firm’s Intellectual Property & Technology (IPT) Service Group.

by Stites & Harbison, PLLC July 15, 2021
Press Releases

Stites & Harbison Increases Rank on ABA Health Law Section’s Regional Top 10 List for 2020

LOUISVILLE, Ky.—The American Bar Association (ABA) Health Law Section has ranked Stites & Harbison, PLLC in 6th place in its Eighth Annual Regional Law Firm Recognition List for the South region for 2020.

by Stites & Harbison, PLLC April 14, 2021
Press Releases

Stites & Harbison Promotes Three Attorneys

LOUISVILLE, Ky.—Stites & Harbison, PLLC announced today that three attorneys have been promoted within the law firm effective January 2021.

by Stites & Harbison, PLLC January 04, 2021
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