CaryMiller Ph.D.

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San Diego + 1.858.314.1122

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Dr. Cary Miller assists life sciences clients with patent issues, primarily for drug candidates and FDA (Food and Drug Administration) approved products. She has 20 years of experience handling prosecution, prelitigation analysis, PTAB (Patent Trial and Appeal Board) proceedings, and patent litigation. Cary has been recognized in Chambers as "able to translate sophisticated issues to a broad audience" and "a stellar business adviser for the pharma industry."

Cary currently represents Celgene in Hatch-Waxman litigation involving Pomalyst® and Revlimid®. Prior to joining Jones Day, Cary participated in numerous patent lawsuits, including representing companies in Hatch-Waxman and biosimilars litigation (Biologics Price Competition and Innovation Act [BPCIA]). 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 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. Cary has also filed dozens of patent term extension applications for drugs, biologics, and medical devices.

Additional products for which Cary has litigation or prosecution experience with litigation include: Abraxane®, 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.

Experience

  • Astellas and Agensys prosecute patent portfolios for novel monoclonal antibody and antibody-drug conjugate immunotherapeutics useful for certain cancer treatmentsJones Day represents Astellas Pharma Inc. and its subsidiary Agensys, Inc. in prosecuting their worldwide patent portfolios related to novel monoclonal antibody and antibody-drug conjugate (ADC) immunotherapeutics for use in the treatment of a variety of cancer indications, including PADCEV®, an ADC approved by the FDA in 2019 for the treatment of metastatic bladder cancer.
  • Patent owner challenges FDA regulatory review determinationJones Day represents a patent owner in challenging the U.S. Food and Drug Administration's (FDA) regulatory review period determination for its drug.
  • REGENXBIO sues Aldevron for infringement of patented host cells used to make DNA for gene therapy applicationsJones Day represents REGENXBIO Inc. in a patent infringement lawsuit brought against Aldevron LLC claiming that without authorization, Aldevron used and manufactured cultured host cells containing recombinant nucleic acid molecules with sequences encoding AAV8 capsid protein(s) and a heterologous non-AAV sequence.
  • Celgene acquired by Bristol-Myers Squibb for approximately $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.
  • 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 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.
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    February 2022 Commentary

    Tillis Urges FDA, USPTO to Investigate Potential False Narrative by Drug Critics

    January 2022 Commentary

    Inducement Suit Proceeds Against Insurance Company for Encouraging Use of Generic Drug

    October 2021 White Paper

    Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

    September 2021 Commentary

    Patent Linkage and Article 76 Proceedings in China: A Litigator's Perspective

    September 2021 Commentary

    Federal Circuit Vacates Judgment, Reinstates Jury's Verdict of Induced Infringement

    JUNE 2020 Alert

    FDA Launches Review of Orange Book Patent Listing Practices

    May 2019 Blog

    IPR Estoppel Applies Even After A Bench Trial On Validity, PTAB Litigation Blog

    April 2019 Blog

    Communications with, and Criticism by, FDA in Analyzing Obviousness, PTAB Litigation Blog

    April 2019 Alert

    Polymorph Patent Not Invalid as Obvious

    February 2019 Blog

    IPR Appeal Dismissed After Biosimilar Development Discontinued, PTAB Litigation Blog
    View All

    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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