Carol is the Managing Partner of Knobbe Martens’ Seattle office and co-chair of the firm’s Hatch-Waxman Litigation practice. Carol is an accomplished intellectual property litigator and registered patent attorney who represents clients in all aspects of intellectual property litigation, including patent, trademark and trade dress cases.
While she handles cases in a wide array of technologies, Carol offers a particularly deep experience in pharmaceutical matters. Carol has represented generics in dozens of ANDA litigations under the Hatch-Waxman Act involving some of the best-selling drugs in the world.
Carol is passionate about each client’s distinct needs. Carol is known for being diplomatic, smart, hard-working and respectful when positioning her client favorably before decision makers and judges. She is valued for her consistent ability to devise the most efficient path forward without losing sight of realizing the best strategic result.
Carol understands the risks and opportunities facing her clients when it comes to safeguarding their investment. Whether she is called upon to enforce a patent or trademark or defend against a claim of infringement, Carol is committed to protecting her client’s valuable IP and business interests.
Carol is recognized as a leading intellectual property litigator by numerous industry publications. She is listed among The Best Lawyers in America in patent litigation, in the "World's Leading Patent Professionals” of the “Patent 1000” guide by Intellectual Asset Management (IAM) magazine, and in Super Lawyers magazine as a “Rising Star” and among the "Top Women Attorneys in Washington."
Prior to the law, Carol worked in the biotechnology industry in Seattle, focusing on quality control, high-throughput drug screening and lab automation.
- Named a “Leading Litigator – IP Litigation, esp. Hatch-Waxman” in the 2022 edition of Lawdragon’s “500 Leading Litigators in America” guide
- Recognized by The Legal 500 "United States" for Patent Litigation (2022)
- Ranked amongst Top 100 Most Active ANDA Attorneys Representing Defendants by Patexia Insight's 2021 ANDA Litigation Intelligence Report
- Selected by her peers for inclusion in the 2017 - 2023 editions of The Best Lawyers in America® for her work in Patent Litigation.
- Named one of the "World's Leading Patent Professionals" for litigation in the 2018 - 2022 Patent 1000 guide by Intellectual Asset Management (IAM) magazine. Carol was described as "an excellent advocate and representative of the litigation practice" and a "thorough and diligent litigator" to call on "when complex patent infringement problems requires decisive answers"
- Recognized as a Patent Star in the 2020 - 2022 Managing IP's "IP STARS" Guide for her outstanding intellectual property legal work.
- Named Top Patent Challenger Attorney 2020 by Docket Navigator
- In a survey of her peers published in Super Lawyers magazine, Carol was named as one of Washington’s “Rising Stars” in intellectual property litigation (2011 - 2014). She was also named as a "Top Women Attorneys in Washington - Rising Star" in 2014.
Carol Pitzel Crus, Nathanael Luman, Kerry Taylor, "Three Statistics Every ANDA Filer Needs to Know About Orange Book Patent Trials At the USPTO," Knobbe Martens Firm Alert (March 2018)
Carol Pitzel Cruz and Sheila Swaroop, "Patent licensing considerations for biologics under the BPCIA," Journal of Commercial Biotechnology (May 2013)
Speeches & Seminars
Panelist, "Bridging the Generational Gap: Working Across the Divide to Move Everyone Forward," ACI Women Leaders in Life Sciences Law, Boston, MA (July 2018)
Moderator, “Getting Ahead: Tips for Reaching the Top in Public Sector, Law Firms, and Corporations.” ACI’s Conference on Women Leaders in Life Sciences Law, Boston, MA (July 2017)
Panelist, "Mapping Out the BPCIA Process: A Cheat Sheet on Navigating the Biosimilars Pathway," ACI Biosimilars Conference, New York, NY (June 2016)
Panelist, "The Next Battle Ground: Strategies for Obtaining or Challenging Preliminary Injunctions," ACI Biosimilars Conference, New York, NY (June 2015)
Panelist, “Momenta v. Amphastar and Bioequivalence: Understanding the Implications for the Future of Biosimilars" ACI Biosimilars Conference, New York, NY (June 2014)
Carol Pitzel Cruz, Sheila Swaroop and Eli Loots, "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework," Knobbe Martens Webinar Series (July 2013)
Carol Pitzel Cruz, “The Red Flags Every Patent Attorney Needs to Know to Successfully Navigate the Regulatory Landscape for Biosimilars,” C5 Forum on Biotech Patenting, Munich, Germany (March 2013)
Sheila Swaroop and Carol Pitzel Cruz, "Preparing for Litigation Under the Biosimilars Act," IP Impact - Seattle 2012: Innovative Intellectual Property Litigation Strategies, Seattle, WA (February 2012)
Carol Pitzel Cruz and William Zimmerman, "In-Depth Review of Recent Decisions and Trends in Hatch-Waxman Litigation; The Orange Book vs. The Black Box, Comparison of Pre-litigation Activities Under the Hatch-Waxman and Biosimilars Acts," 4th Annual Product and Pipeline Enhancement for Generics Conference: Navigating Regulatory Pathways and Patent Strategies to Ensure Market Sustainability (July 2011)