Susan Krumplitsch is a seasoned intellectual property litigator representing life sciences companies in high-stakes patent and trade secret disputes. She advises clients across the biotechnology, pharmaceutical, and medical device sectors, regularly appearing in federal courts nationwide and before the U.S. Patent and Trademark Office in post-grant review proceedings.
Susan’s practice spans a broad range 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. She works with both established branded pharmaceutical and medical device companies and emerging innovators in biotechnology and veterinary science.
Beyond litigation, Susan counsels clients on sophisticated patent strategies and is a frequent speaker and author on intellectual property issues, particularly those arising from the life sciences industry’s increasing adoption of artificial intelligence.
Committed to pro bono work, Susan has represented asylum applicants and partnered with immigration advocacy organizations to draft and file amicus briefs before various U.S. Circuit Courts of Appeal and the Supreme Court of the United States.
She serves on the board of directors for Biocom, a leading California-based life science industry organization, and actively mentors through Women in Bio and ChIPs, continuing her advocacy for diversity and leadership in the science and law.
Representative Experience
Any result the lawyer or law firm may have achieved on behalf of clients in other matters does not necessarily indicate similar results can be obtained for other clients.
- Led patent litigation for an innovative next-generation sequencing company involving digital sequencing technology and liquid biopsy.
- Represented a global biopharmaceutical company in patent litigation involving transgenic rodent drug discovery platforms.
- Represented a branded pharmaceutical company in ANDA litigation in the District of Delaware concerning an ophthalmic drug product for glaucoma.
- Represented 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.
- Represented a biopharmaceutical company in BPCIA litigation over a biosimilar monoclonal antibody used to treat HER2-positive breast cancer.
- Represented 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.
- Represented a pharmaceutical company in a trade secret misappropriation case against multiple overseas defendants regarding the company’s proprietary aryl hydrocarbon receptor agonist.
- Represented 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 a 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.
- Defended a biotechnology company’s patents covering high-throughput DNA sequencing in multiple inter partes review challenges.
- Represented a biopharmaceutical company in an arbitration, affirming companies’ exclusive rights to a small molecule used to treat chronic hepatitis C.
- Litigated Hatch-Waxman claims for a branded pharmaceutical company against multiple generic challengers involving a treatment for hyponatremia.
- Counseled a biopharmaceutical company in a pre-BPCIA challenge involving a peptide used to stimulate white blood cell growth.
- Represented a biopharmaceutical company against a branded challenger in pre-BPCIA litigation filed in the District of Massachusetts regarding a peptide used to treat anemia.
Professional and Civic Engagement
- Biocom California, Board of Directors
- ChIPs
- Women in Bio
- MedtechWOMEN
- American Bar Association
- California Bar Association
Thought Leadership
- Author, "Generative Artificial Intelligence, Drug Discovery, and U.S. Patent Law," Intellectual Property & Technology Law Journal, 36(7), July-August 2024
- Author, "FTC continues to scrutinize Orange Book patent listings," May 2024
- Author, “Generative AI, drug discovery, and US patent law," April 2024
- Author, "Challenging the USPTO’s Patent Term Adjustment calculation: An uphill battle," March 2024
- Author, "Orange Book alert: Improper patent listings could be investigated as potential violations of the FTC Act," October 2023
- Author, "CMS selects ten drugs for Inflation Reduction Act Medicare Drug Price Program: Key observations and what to expect," September 2023
- Author, "New frontiers in genome editing and an update on the CRISPR patent wars," August 2023
- Author, "Reshaping the boundaries of patent law: The top cases before the Supreme Court this term," February 2023
- Author, "The CRISPR patent wars," November 2022
- Author, "AI Inventorship Decision Leaves Open Questions," Law360, September 2021
- 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, March 2023
- Moderator, "Patenting Biotech and Pharma Innovations Associated with AI," Life Science Patent Network, 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, October 2020
- Quoted, "AI-Assisted Inventions Could Spur New Patent Litigation Wave," Bloomberg Law, August 2022
- Quoted, "Future Of Patents For Inventions By AI In Congress' Hands," Law360, August 2022
Honors & Awards
- Recommended in The Legal 500 USA in Patent Litigation: Full Coverage, 2021
- Recognized in Super Lawyers Rising Stars list for Intellectual Property, 2013-2015
