Our Principal Microbiology Expert Witness

Dr. Michael J. Miller has practical experience as a microbiology expert witness in patent litigation and product liability cases (see below for judge's opinions). He has successfully served as a microbiology expert witness on numerous cases, representing branded and generic drug companies, corporations and individuals, plaintiffs and defendants. Dr. Miller has supported his clients during fact finding/expert discovery and claim construction in addition to providing consultation, patent review, expert opinion, deposition and trial testimony. Dr. Miller has also provided technical guidance to counsel in preparation of taking depositions.

Pharmaceutical Microbiology Expert Witness and Legal Consulting

Dr. Miller has significant education, training, skill sets and experience who has previously provided legal support as a consultant and expert witness in at least the following areas:

  • Pharmaceutical microbiology
  • Sterility assurance
  • Contamination control
  • Sterilization
  • Preservative and antimicrobial effectiveness
  • Good Manufacturing Practices (GMPs)
  • FDA regulatory compliance
  • Compounding pharmacy microbiology
  • United States Pharmacopoeia (USP) testing
  • Laboratory operations
  • Ophthalmic formulations and contact lens care

Click here to download a PDF file of Dr. Miller's CV

Dr. Miller's Recent Expert Witness Experience

Dr. Miller has testified as an expert witness (deposition, Markman hearing and/or at trial) in the following cases:

  • 2022. Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG, Novartis Technology LLC, Novartis Pharmaceuticals Corp. Case IPR2021-00816.
  • 2020. Christina King and Klay King, individually and as Co-Personal Representatives of the Estate of Stephen King, deceased, v. Pharmatech, LLC; Raidel Figueroa; The Havard Drug Group, LLC dba Rugby Laboratories; Bayshore Pharmaceuticals, LLC. Case No. CACE 17-017934
  • 2019. Frances Ruiz as Personal Representative of the Estate of Luis Ruiz, deceased, v. Teva Pharmaceuticals USA, Inc.; Teva Parenteral Medicines, Inc.; Teva Pharmaceutical Industries, Ltd.; AmerisourceBergen Drug Corporation; Blue Medical Supply, Inc.; Jay Harlan Epstein, M.D.; Anesthesia Associates of Pinellas County, P.A. Hillsborough County, Florida Case No. 11-005957
  • 2016. Senju Pharmaceutical Co., Ltd., Bausch & Lomb Incorporated, and Bausch & Lomb Pharma Holdings Corp. v. Lupin, Ltd., and Lupin Pharmaceuticals, Inc. Civil Action File Nos. 1:14-cv-00667-JBS-KMW, 1:14-cv-04149-JBS-KMW, 1:14-cv-05144-JBS-KMW, 1:15-cv-00335-JBS-KMW; Innopharma Licensing, Inc., Innopharma Licensing, LLC, Innopharma, Inc., Innopharma, LLC, Mylan Pharmaceuticals, Inc., and Mylan Inc. Civil Action File Nos. 1:14-cv-06893-JBS-KMW, 1:15-cv-03240-JBS-KMW
  • 2013-2014. Astrazeneca LP and Astrazeneca AB v. Apotex, Inc. and Apotex Corp. Civil Action File No. 1:09-CV-1518 (RMB) (AMD) (Appeal)
  • 2014. Apotex Corp. v. Alcon Research, Ltd. Case IPR2013-00428, 00429 and 00430
  • 2014. United Therapeutics Corp. v. Sandoz Inc. et al. Civil Action File No. 12-1617 (PGS) (LHG) and 13-316 (PGS) (LHG)
  • 2013. Alcon Canada Inc. and Alcon Research, Ltd. and Apotex Inc. and The Minister of Health. Court File No. T-1667-12
  • 2013. Peter Robertson and Kindra Robertson v. McNeil-PPC, Inc. and Johnson & Johnson, and DOES 1. Case No. 2:11-CV-09050-JAK-SS
  • 2009-2012. Astrazeneca LP and Astrazeneca AB v. Apotex, Inc. and Apotex Corp. Civil Action File No. 1:09-CV-1518 (RMB) (AMD)
  • 2011. Alcon Research, Ltd. v. Barr Laboratories, Inc., Par Pharmaceutical, Inc. Civil Action No. 09-318-LDD (Consolidated)
  • 2009-2010. Aletia Moon and James Zachary Carrier v. Advanced Medical Optics, Inc. Civil Action File No. 4:08-CV-021-HLM

Dr. Miller has consulted on a number of other cases not listed herein, and additional expert witness cases may be pending.

Please contact Dr. Miller to discuss his legal fees and availability as a microbiology expert witness.

What The Judges Say

  • "Dr. Miller convincingly testified that these parameters were known to a POSA who would engage in routine optimization to determine the specific parameters . . ."
  • "Dr. Miller persuasively testified that to arrive at a pharmaceutically acceptable, sterile budesonide suspension, a POSA would combine the teachings of . . ."
  • "Thus, the evidence supports Dr. Miller's opinion that a POSA would have a reasonable expectation of successfully using this method . . ."
  • "Thus, as Dr. Miller persuasively testified, the inventors' data does not support the conclusion that . . ."
  • "Dr. Miller credibly testified that a POSA would understand that a pharmaceutical powder can include impurities . . ."

Opinion of Renee Marie Bumb, United States District Judge, District of New Jersey.
Filed February 15, 2015.
Consolidated Civil Action No. 08-1512.
AstraZeneca v. Breath, Apotex, Sandoz and Watson Laboratories.

  • "[T]he Court finds that the testimony of Dr. Miller . . . is persuasive in light of the objective CDC survey corroborating . . ."
  • "Dr. Miller's area of expertise is in pharmaceutical microbiology, specifically sterility assurance, contamination control, antimicrobial effectiveness, and the microbiological strategies associated with pharmaceutical manufacturing and drug development."
  • "Accordingly, this Court concludes that at the time of the . . . patent invention, a person of ordinary skill reading . . . would have had no motivation and no reason to make or use the invention of the . . . patent. (Tr. . . . (Miller), May 9, 2014.) . To find otherwise would impermissibly rely on hindsight."
  • "In light of expert testimony from . . . Dr. Miller, the Court further accepts the CDC survey as evidence . . ."

Opinion of Peter G. Sheridan, United States District Judge, District of New Jersey.
Filed August 29, 2014.
Civil Action Nos. 12-CV-01617 and 13-CV-316.
United Therapeutics Corp. v. Sandoz, Inc.

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