Shana K. Cyr, Ph.D., secures, defends, and enforces patents in the chemical, pharmaceutical, and biotechnical arts. She also counsels clients on coordinated intellectual property and regulatory strategies for pharmaceutical, biological, combination, diagnostic, and medical device products. She employs her strong technical knowledge to specialize in working with inventors and experts.
Shana’s patent litigation practice focuses on Hatch-Waxman litigations related to abbreviated new drug applications (ANDA) and 505(b)(2) applications. She also has experience with traditional patent litigation before the U.S. district courts, proceedings before the U.S. International Trade Commission (ITC), and appeals to the U.S. Court of Appeals for the Federal Circuit.
Shana has managed fact and expert discovery, worked with experts to prepare reports on patent infringement and validity issues, prepared inventors and experts for depositions, taken and defended fact and expert witness depositions, prepared inventors and experts for trial, and drafted motions and briefs at the trial and appellate levels.
Shana’s experience before the U.S. Patent and Trademark Office (USPTO) includes patent prosecution, inter partes reviews (IPR), inter partes reexaminations, and interferences. She has drafted patent applications and responses to office actions, drafted IPR petitions and patent owner responses, worked with inventors and experts to prepare declarations on patent validity issues, prepared witnesses for depositions, and drafted motions, briefs, and other papers.
Shana counsels clients on coordinated intellectual property and regulatory strategies for pharmaceuticals, biologics, combination products, diagnostics, and medical devices. She provides advice and guidance on patent infringement, validity, and enforceability issues, as well as issues relating to the U.S. Food and Drug Administration’s (FDA) Orange Book for drugs, the FDA’s Purple Book for biologics, and regulatory exclusivities. Shana has also provided due diligence and freedom-to-operate analyses and opinions.
Shana’s pro bono work includes representing disabled veterans before the U.S. Court of Appeals for Veterans Claims and representing disadvantaged children as guardian ad litem before the U.S. Superior Court of the District of Columbia.
Shana regularly publishes and presents on intellectual property and regulatory topics related to pharmaceuticals, biologics, combination products, diagnostics, and medical devices. She is also actively involved in the American Chemical Society (ACS) and the American Intellectual Property Law Association (AIPLA), including serving as vice chair for the AIPLA Food and Drug Law Committee for 2018-2020.
- Rutgers University School of Law – Camden J.D., with high honors, 2009
- University of Virginia Ph.D., Chemistry, 2006
- University of Richmond B.S., Chemistry, 2000
- U.S. Court of Appeals, Federal Circuit, Hon. Kimberly A. Moore
- American Association of Pharmaceutical Scientists (Regulatory Sciences Section)
- American Bar Association (Intellectual Property Law Section)
- American Chemical Society (Biological Chemistry Division; Chemistry and the Law Division; Medicinal Chemistry Division; Organic Chemistry Division)
- American Intellectual Property Law Association (Biotechnology Committee; Chemical Practice Committee; Food and Drug Law Committee, vice chair, 2018-present, programs coordinator, 2017-2018, media coordinator, 2016-2018, webinar coordinator, 2016-2017)
- Federal Circuit Bar Association
- Medical Device Manufacturer’s Association
- Virginia Biotechnology Association
Rate : $$$