Dr. Cary Miller assists life sciences clients with their patent issues, primarily relating to drug candidates and Food and Drug Administration (FDA) approved products. She has more than 17 years of experience working with clients in patent prosecution, prelitigation analysis, Patent Trial and Appeal Board (PTAB) proceedings, and patent litigation and has filed dozens of patent term extension applications for drugs, biologics, and medical devices.
Cary currently represents Celgene in several Hatch-Waxman patent litigations involving the pharmaceuticals Abraxane®, Pomalyst®, and Revlimid®. Prior to joining Jones Day, Cary participated in numerous biotechnology and pharmaceutical patent lawsuits, including representing companies in Hatch-Waxman cases, biosimilars litigation (Biologics Price Competition and Innovation Act [BPCIA]), and in litigation relating to next generation DNA sequencing. She has successfully litigated patent cases throughout the United States, including in California, New Jersey, New York, Delaware, Texas, and Nevada and before the Federal Circuit and Supreme Court.
Cary has drafted and prosecuted patents relating to breakthrough therapies in a number of areas, including antibodies and antibody-drug conjugates, cancer therapeutics and diagnostics, small molecules, human embryonic stem cells, and drug delivery devices.
Additional products for which Cary has litigation or prosecution experience with litigation include: Nuplazid®, Otezla®, Vidaza®, Padcev®, and Palynziq®.
Cary holds a Ph.D. in cellular, developmental, and molecular biology. She writes extensively on PTAB proceedings and on biologics and biosimilars. Her scientific articles appeared in Nature Genetics, Development, Mechanisms of Development, Journal of Cell Biology, and the American Journal of Human Genetics. She also coauthored a book chapter in The Endometrium.
PTAB Upholds GILENYA™ Method of Treatment Patent, Prompting New ANDA Litigation, PTAB Litigation Blog
Publications Prior to Jones Day
January 23, 2014
Form PCT/IB/382: Legal Implications in Countries with Compulsory Licensing Rules, LANDSLIDE, Vol. 6, No. 3
Disclosure Rules Bring New Risks, Chemical Watch
July 9, 2012
Pathway for Follow-on Biologics Survives the Supreme Court, BNA Pharmaceutical Law & Industry Report.
Practical Tips When Invoking the CREATE Act. Intellectual Asset Management: IP to IP.
December 10, 2004
The CREATE Act of 2004. Intellectual Asset Management: IP to IPO.
April 23, 2003
Experimental Uses and Research Tool Licensing Alternatives. ICLE Third Annual Symposium on Biotechnology, Atlanta, GA.
The embryology of the uterus, In The Endometrium. Eds. Glasser, S., et al. Taylor & Francis (2002) UK, p. 3-18.
Fetal exposure to DES results in de-regulation of Wnt7a during uterine morphogenesis. Nature Genetics, 20: 228-230.
Wnt-7a maintains appropriate uterine patterning during the development of the mouse female reproductive tract. Development, 125: 3201-3211.
Differential expression patterns of Wnt genes in the murine female reproductive tract during development and the estrous cycle. Mechanisms of Development, 76: 91-99.
CDO, a robo-related cell surface protein that mediates myogenic differentiation. Journal of Cell Biology, 143: 403-413.
Identification and expression of rare mutations in acid β-glucosidase causing types 1 and 2 Gaucher in non-Jewish patients. Am. J. Human Genetics, 57: A246.
- July 16, 2019
Strategies for Biotech/Medtech Startups: Successfully Navigating the USPTO and FDA (presented by the USPTO and FDA in collaboration with Biocom)
- March 2019
Hatch-Waxman, Biosimilars and IPRs USD School of Law's 9th Annual Patent Law Conference
- October 25, 2016
Update on Biosimilar Litigation: Beginning to Unwrap the "Riddle Wrapped in a Mystery Inside an Enigma", Jones Day IP Round Table
- April 2016
Biosimilar Hot Topics: IPRs, Patent Exchange Process and Recent Litigation, Seminar
- April 2016
Status of Safe Harbor Under 35 U.S.C. 271(e)(1), Seminar
Speaking Engagements Prior to Jones Day
May 28, 2015
Inter Partes Review Strategy and Trends in the Life Sciences Industry: Implications for Patent Prosecutors and Litigators, Webinar
January 14, 2014
Building and Evaluating a Robust IP Portfolio, Morrison & Foerster, Seminar
June 25, 2012
Exploring the Link between the FDA Approval Process and the Patenting of Drugs and Biologics, Hatch-Waxman Boot Camp
- Columbia University (J.D. 2002; Harlan Fiske Stone Scholar; Managing Editor, Columbia Science and Technology Law Review); Mount Sinai School of Medicine (Ph.D. in Biomedical Sciences 1999); Queen's University, Canada (B.Sc.H. in Life Sciences 1993, Class I)
- California, Georgia, U.S. Supreme Court, and registered to practice before the U.S. Patent & Trademark Office
Best Lawyers in America (2013-2020) for biotechnology and life sciences law, including being named "San Diego Biotechnology Law Lawyer of the Year" for 2013, an honor given to a single lawyer in the metropolitan area
The Legal 500 US: recommended lawyer for patent prosecution (2017)