CaryMiller Ph.D.

Partner

(T) + 1.858.314.1122

With more than 15 years of experience, Dr. Cary Miller's practice focuses on assisting life sciences clients with their patent issues. She works with clients in patent prosecution, prelitigation analysis, PTAB proceedings, and patent litigation.

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 litigation, biosimilars litigation (Biologics Price Competition and Innovation Act [BPCIA]), and in litigation relating to 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. She has conducted intellectual property due diligence studies and has filed numerous patent term extension applications for drugs, biologics, and medical devices.

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.

Experience

  • Quanterix expands IP strategy for next generation healthcare solutionsJones Day is providing intellectual property advice and guidance on patent strategy for advances in Quanterix Corporation's biomarker detection technologies.
  • Celgene asserts its POMALYST® patents against multiple generic companies under Hatch-Waxman ActJones Day is representing Celgene Corporation as a plaintiff to enforce its patents against multiple pharmaceutical companies including Teva Pharmaceuticals USA, Inc.; Apotex, Inc.; Hetero Labs Limited; Aurobindo Pharma Ltd.; Mylan Pharmaceuticals Inc.; Breckenridge Pharmaceutical, Inc.; and Natco Pharma Limited in several Hatch-Waxman litigation matters involving their proposed generic versions of POMALYST®, which is prescribed for treating multiple myeloma.
  • Royalty Pharma acquires EMGALITY® royalty from Arteaus Therapeutics for $260 millionJones Day advised Royalty Pharma, the industry leader in acquiring pharmaceutical royalties, in its $260 million acquisition of the royalty interest held by Arteaus Therapeutics, LLC on future global net sales of Eli Lilly and Company’s EMGALITY® (galcanezumab), an anti-CGRP antibody for the prevention of migraine.
  • Celgene successfully blocks PTAB institution of IPR involving REVLIMID®Jones Day represented Celgene Corporation in successfully blocking institution of inter partes review ("IPR") of a patent covering the use of Celgene's REVLIMID® brand drug to treat multiple myeloma.
  • Celgene successfully blocks institution of inter partes review on three patents listed in the Orange Book for its blockbuster REVLIMID® productJones Day represented Celgene Corporation in successfully blocking institution of inter partes review ("IPR") of three patents covering the use of Celgene's REVLIMID® brand drug to treat myelodysplastic syndrome (“MDS”).
  • Celgene to be acquired by Bristol-Myers Squibb for approx. $74 billionJones Day advised Celgene Corporation (NASDAQ: CELG) in connection with the intellectual property and technology transactions aspects of its cash-and-stock merger with Bristol-Myers Squibb (NYSE: BMY) which has an equity value of approximately $74 billion.
  • Celgene asserts its REVLIMID® patents against Apotex Inc. under Hatch-Waxman ActJones Day is representing Celgene Corporation as a plaintiff to enforce its patents against Apotex Inc. in a Hatch-Waxman litigation matter involving Apotex’s proposed generic versions of REVLIMID®, which is prescribed for treating multiple myeloma and other cancers.
  • Celgene asserts its REVLIMID® patents against Sun Pharma under Hatch-Waxman ActJones Day is representing Celgene Corporation as a plaintiff to enforce its patents against Sun Pharma Global FZE, Sun Pharma Global Inc., Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries Limited in a Hatch-Waxman litigation matter involving Sun’s proposed generic versions of REVLIMID®, which is prescribed for treating multiple myeloma and other cancers.
  • Celgene enforces its REVLIMID® patents against Lotus Pharmaceutical under Hatch-Waxman ActJones Day is representing Celgene Corporation as a plaintiff to enforce its patents against Lotus Pharmaceutical Co., Ltd. in Hatch-Waxman litigations involving proposed generic versions of REVLIMID®, which is prescribed for treating multiple myeloma and other cancers.
  • Celgene asserts its REVLIMID® patents against Cipla under Hatch-Waxman ActJones Day is representing Celgene Corporation as a plaintiff to enforce its patents against Cipla Limited in Hatch-Waxman litigation matters involving Cipla’s proposed generic versions of REVLIMID®, which is prescribed for treating multiple myeloma and other cancers.
  • Celgene successfully blocks Apotex's bid for inter partes review of REVLIMID® patentJones Day represented Celgene Corporation in successfully blocking institution of an inter partes review (IPR) petition filed by Apotex against U.S. Patent No. 8,741,929, which is listed in the Orange Book for Celgene's REVLIMID® brand drug.
  • Celgene asserts its REVLIMID® patents against Dr. Reddy’s Laboratories under Hatch-Waxman ActJones Day is representing Celgene Corporation as a plaintiff to enforce its patents against Dr. Reddy's Laboratories in several Hatch-Waxman litigation matters involving DRL's proposed generic versions of REVLIMID®, which is prescribed for treating multiple myeloma and other cancers.
  • Celgene prevails in Apotex and Cipla IPR challenges of Abraxane® patentsJones Day served as lead counsel and successfully defended Celgene Corporation in connection with six inter partes review (IPR) petitions filed by Apotex or Cipla against U.S. Patent Nos. 8,138,229, 7,820,788, and 7,923,536, which are related to formulations for Celgene's chemotherapeutic drug marketed as Abraxane®.
  • Celgene enforces its Revlimid® patents against Zydus Pharmaceuticals under Hatch-Waxman ActJones Day is representing Celgene Corporation in a patent litigation against Zydus Pharmaceuticals and Cadila Healthcare over Revlimid®, Celgene's blockbuster drug for treating multiple myeloma and other cancers.
  • Additional Publications

    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

    September 2013

    Disclosure Rules Bring New Risks, Chemical Watch

    July 9, 2012

    Pathway for Follow-on Biologics Survives the Supreme Court, BNA Pharmaceutical Law & Industry Report.

    March 2006

    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.

    2002

    The embryology of the uterus, In The Endometrium. Eds. Glasser, S., et al.  Taylor & Francis (2002) UK, p. 3-18.

    1998

    Fetal exposure to DES results in de-regulation of Wnt7a during uterine morphogenesis. Nature Genetics, 20: 228-230.

    1998

    Wnt-7a maintains appropriate uterine patterning during the development of the mouse female reproductive tract.  Development, 125: 3201-3211.

    1998

    Differential expression patterns of Wnt genes in the murine female reproductive tract during development and the estrous cycle. Mechanisms of Development, 76: 91-99.

    1998

    CDO, a robo-related cell surface protein that mediates myogenic differentiation.  Journal of Cell Biology, 143: 403-413.

    1995

    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.

    Speaking Engagements

    • 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

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