Shana K. Cyr Ph.D.
Shana Cyr's practice covers all aspects of patent law relating to pharmaceuticals, biologics, diagnostics, and other products regulated by the Food and Drug Administration (FDA). She has experience with traditional patent litigation, Hatch-Waxman litigation related to Abbreviated New Drug Applications (ANDAs) and 505(b)(2) Applications, proceedings before the International Trade Commission (ITC), client counseling, inter partes reviews and other proceedings before the U.S. Patent and Trademark Office (USPTO), and appeals.
Prior to joining the firm, Dr. Cyr earned a doctorate from the University of Virginia for her work on the modification of genes and proteins. From 2015 to 2016, Dr. Cyr served as law clerk to the Honorable Kimberly A. Moore at the U.S. Court of Appeals for the Federal Circuit.
Dr. Cyr is an adjunct professor for scholarly legal writing at George Washington School of Law. Her pro bono work includes representing clients before the Social Security Administration, serving as guardian ad litem for children in the Superior Court of the District of Columbia, and representing military veterans before the U.S. Court of Appeals for Veterans Claims.
- Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. (S.D. Ind.). Representing Eli Lilly and Company in Hatch-Waxman patent litigation relating to osteoporosis drug Forteo®.
- Coalition for Affordable Drugs V LLC v. Biogen MA Inc. (PTAB). Assisting in representing Biogen in inter partes review proceeding relating to multiple sclerosis drug Tecfidera®.
- Washington University v. Wisconsin Alumni Research Foundation (D. Del.). Represented WARF in breach of contract litigation relating to patents for chronic kidney disease drug Zemplar®.
- Represented Abbott Laboratories, AbbVie Inc., and Wisconsin Alumni Research Foundation in multiple Hatch-Waxman patent infringement litigations relating to chronic kidney disease drug Zemplar®.
- Mylan Pharmaceuticals, Inc. v. Senju Pharmaceutical Co. (PTAB). Assisted in representing Senju Pharmaceutical and others in inter partes review proceedings relating to ophthalmic drug Bepreve®.
- Bausch & Lomb Inc. v. Sandoz Inc. (D.N.J.). Assisted in representing Bausch and Lomb and others in Hatch-Waxman patent litigation relating to ophthalmic drug Bepreve®.
- Precision BioSciences v. Institut Pasteur (USPTO). Assisted in representing Institut Pasteur in multiple inter partes reexamination proceedings relating to enzymes for gene modification.
- Grünenthal GmbH v. Actavis Elizabeth LLC (D.N.J.). Assisted in representing Grünenthal in Hatch-Waxman litigations related to analgesic drugs Nucynta® and Nucynta® ER.
- Certain Gemcitabine & Products Containing Same, 337-TA-766 (ITC). Assisted in representing Eli Lilly and Company in ITC proceeding relating to cancer drug Gemzar®.
- Performed due diligence and freedom-to-operate analyses relating to pharmaceutical products, medical devices, cosmetic products, and food products.
- American Association of Pharmaceutical Scientists (Regulatory Sciences section)
- American Bar Association (Intellectual Property Law section)
- American Intellectual Property Law Association (Biotechnology, Chemical Practice, Education, Food and Drug, Patent Law, Patent Litigation, and Women in IP Law committees)
- American Chemical Society (Medicinal Chemistry and Chemistry and the Law divisions)
- Federal Circuit Bar Association
- Served as an assistant editor for Last Month at the Federal Circuit, Finnegan's monthly newsletter summarizing precedential decisions from the U.S. Court of Appeals for the Federal Circuit.
- Coauthor. "Dead Zone: Are Your Biological Products Ready for FDA's Regulatory Transition?," American Pharmaceutical Review, April 2017.
- Coauthor. "Combination Products: Regulatory and Patent Issues You Should Consider Now," Pharmaceutical Technology, Feb. 23, 2017.
- Coauthor. "FDA Issues Its First Postmarketing Safety Reporting Regulations for Combination Products," FDA Flash! Blog, Feb. 2, 2017.
- Coauthor. "FDA Amends Regulations for 505 (b)(2) Applications and ANDAs," FDA Flash! Blog, Nov. 29, 2016.
- Coauthor. "Preparing Pharma for Generics' IPR Attacks," BNA Pharmaceutical Law and Industry Report, Aug. 15, 2014.
- Coauthor. "Preclinical Patent Considerations," Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, ABA Section of Intellectual Property Law, 2014.
- Coauthor. The Chemical and Pharmaceutical Innovation Report 2013, Dec. 2013.
- Contributed to ABA Annual Review of Intellectual Property Law Developments, 2010.
- "Analogues of Firefly Luciferase and Dihydrofolate Reductase Exhibiting Novel Emission Properties," Ph.D. Dissertation, University of Virginia, Aug. 2006.