Susan Krumplitsch

Susan Krumplitsch

Partner
About

Susan Krumplitsch represents life science companies in intellectual property disputes, with an emphasis on patent and trade secret litigation. Her clients include innovative biotechnology, pharmaceutical and medical device companies and she regularly appears in federal courts across the country and in post-grant review proceedings at the US Patent and Trademark Office.

Her practice involves a wide variety of technologies, including next-generation DNA sequencing, therapeutic monoclonal antibodies, transgenic animals, pharmaceutical formulations, small molecule drug compounds, mammalian cell lines, biofuels, fungicides and medical imaging. Susan also advises clients on complex patent strategies and is a frequent publisher and speaker on intellectual property issues surrounding the life science industry's increasing adoption of artificial intelligence technology.

Susan is a member of the Board of Directors of BIOCOM, the association representing the California life science industry.

Susan serves as a member of DLA Piper’s Northern California Pro Bono Committee. She also has significant pro bono experience representing asylum applicants and drafting immigration-related amicus briefs for various US Circuit Courts of Appeal and the Supreme Court of the United States.

 
Bar admissionsCalifornia
CourtsSupreme Court of the United StatesUnited States Court of Appeals for the Second CircuitUnited States Court of Appeals for the Fourth CircuitUnited States Court of Appeals for the Seventh CircuitUnited States Court of Appeals for the Ninth CircuitUnited States Court of Appeals for the Federal CircuitUnited States District Court for the Northern District of CaliforniaUnited States District Court for the Central District of California

EXPERIENCE

  • An innovative next generation sequencing company in patent litigation involving digital sequencing technology and liquid biopsy
  • A global biopharmaceutical company in patent litigation involving transgenic rodent drug discovery platforms    
  • A branded pharmaceutical company against an ANDA filer in the District of Delaware regarding an ophthalmic drug product used for the treatment of glaucoma
  • A branded pharmaceutical company against five ANDA filers in the Districts of New Jersey and Delaware regarding a fixed-combination drug product used for pain relief. Also represented the company in multiple inter partes review challenges before the PTAB
  • A biopharmaceutical company in BPCIA litigation over a biosimilar monoclonal antibody used to treat HER2-positive breast cancer
  • A branded pharmaceutical company in Hatch-Waxman litigation in the District of Delaware involving a dermatological product indicated for the topical treatment of plaque psoriasis
  • A pharmaceutical company in a trade secret misappropriation case against multiple overseas defendants regarding the company’s proprietary aryl hydrocarbon receptor agonist
  • A university in the Eastern District of Pennsylvania and Federal Circuit in an enforcement action filed against a pharmaceutical company regarding the company’s commercialization of monoclonal antibody used to treat EGFR-expressing metastatic colorectal cancer and advanced squamous cell carcinoma of the head and neck. Also represented the university in an inter partes review challenge at the PTAB
  • A biotechnology company in defending patents covering next-generation, high throughput DNA sequencing in multiple inter partes review challenges at the PTAB
  • A biopharmaceutical company in an arbitration, affirming companies’ exclusive rights to a small molecule used to treat chronic hepatitis C
  • A branded pharmaceutical company in Hatch-Waxman litigation against multiple generic challengers regarding a treatment for hyponatremia 
  • A biopharmaceutical company in a pre-BPCIA challenge by a generic company seeking to market an infringing peptide used to stimulate the growth of white blood cells
  • A biopharmaceutical company against a branded challenger in pre-BPCIA litigation filed in the District of Massachusetts regarding a peptide used to treat anemia
 
Education
  • J.D., Northeastern University School of Law
  • M.S., Immunology and Infectious Disease, Harvard University School of Public Health
  • B.A., University of California at Los Angeles

Awards

  • The Legal 500 United States
    2021 - Recommended, Patent Litigation: Full Coverage
  • Super Lawyers Rising Star: Intellectual Property (2013-2015)

Bylines

  • "Generative Artificial Intelligence, Drug Discovery, and U.S. Patent Law," Intellectual Property & Technology Law Journal, 36(7), July-August 2024
  • "FTC continues to scrutinize Orange Book patent listings," 03 May 2024
  • "Generative AI, drug discovery, and US patent law," 15 April 2024
  • "Challenging the USPTO’s Patent Term Adjustment calculation: An uphill battle," 08 March 2024
  • "Orange Book alert: Improper patent listings could be investigated as potential violations of the FTC Act," 04 October 2023
  • "CMS selects ten drugs for Inflation Reduction Act Medicare Drug Price Program: Key observations and what to expect," 12 September 2023
  • "New frontiers in genome editing and an update on the CRISPR patent wars," 16 August 2023
  • "Reshaping the boundaries of patent law: The top cases before the Supreme Court this term," 27 February 2023
  • "The CRISPR patent wars," 16 November 2022
  • "AI Inventorship Decision Leaves Open Questions," Law360, 17 September 2021

Seminars

  • Invited panelist, “Artificial Intelligence from Molecule to Market: How AI Accelerates Innovation and Regulatory Approvals for Biologics and Biosimilars,” ACI Biosimilars & Innovator Biologics, June 2024
  • Invited speaker, "Patenting AI," 18th Annual Advanced Patent Law Institute at the USPTO, UT Law, 31 March 2023
  • Moderator, "Patenting Biotech and Pharma Innovations Associated with AI," Life Science Patent Network, 3 November 2022
  • Panelist, "In-Depth Look at 180-day Exclusivity," ACI Hatch-Waxman and BPCIA, October 2022
  • Panelist, "The Doctrine of Equivalents: Analyzing the effects of recent federal circuit decisions on ANDA litigation strategies," ACI Paragraph IV Disputes, 6 October 2020

Media Mentions

Prior Experience

  • Before attending law school, Susan was a research associate at Brigham and Women’s Hospital in Boston, Massachusetts.

Memberships And Affiliations

  • American Bar Association
  • Women in Bio
  • California Bar Association
  • CHiPs

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