Carol Pitzel Cruz

Partner

Seattle

206-405-2000

carol.pitzel.cruz@knobbe.com

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Overview

Experience

Recognition

Resources

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. Carol has represented pharmaceutical and medical device clients in patent litigation in district courts, the ITC and on appeal at the Federal Circuit. Carol has also represented beverage companies in trademark and trade dress infringement disputes in the district court.

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 and intellectual property 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.

Education

The George Washington University Law School (J.D.), Honors

University of Washington (UW) (B.S. Chemistry)

The George Washington University Law School

University of Washington (UW)

State Bar of California

State Bar of Washington

U.S. Court of Appeals for the Federal Circuit

U.S. District Court - Central District of California

U.S. District Court - Northern District of California

U.S. District Court - Eastern District of Washington

U.S. District Court - Western District of Washington

U.S. Patent and Trademark Office

Biosimilars

Chemical

Pharmaceuticals

Food & Beverage

Medical Devices & Procedures

Practice Areas

Appellate Litigation

Hatch-Waxman Litigation

Medical Device Litigation

Trade Secret & Employment Mobility Litigation

Trademark & Brand Protection Litigation

In Re Certain Light-Based Physiological Measurement Devices and Components Thereof, USITC Inv. No. 337-TA-1276 (ITC 2023)

Represented Masimo against Apple in International Trade Commission investigation relating to infringement of Masimo’s patented pulse oximetry technology. Obtained exclusion order and cease and desist order banning importation and sale of Apple Watches. Appeal pending.

Bristol-Myers Squibb Co. v. Lupin Inc., Case No. 3:20-cv-07810 (2021)

Represented Lupin in Hatch-Waxman litigation in the District of New Jersey concerning patents related to dasatinib (the active ingredient in BMS’s Sprycel® product). Achieved a favorable disposition for the client prior to claim construction briefing.

Vital Pharmaceuticals, Inc. (VPX) v. Monster Energy Company and Reign Beverage Company, Case No. 0:19-cv-60809 (2021)

Represented Monster and Reign in a trademark and trade dress infringement suit brought by VPX alleging infringement of trademark and trade dress rights in its Bang energy drink. After a bench trial, the court entered final judgment in favor of Monster and Reign, holding that VPX’s alleged Bang trade dress was not distinctive and that Monster and Reign’s REIGN drink cans did not infringe any valid rights of VPX.

iCeutica Pty Ltd. and Iroko Pharmaceuticals, LLC v. Lupin Limited and Lupin Pharmaceuticals, Inc., Case No. 1:17-cv-00394 (2018).

Represented the Lupin defendants in a patent infringement action in the District of Maryland on patents relating to meloxicam (the active ingredient in Iroko’s Vivlodex® product.) On February 1, 2018, the U.S. District Court for the District of Maryland granted Lupin’s Motion for Summary Judgement. In its Motion, Lupin argued that prosecution history estoppel applied, legally barring Plaintiffs from asserting that Lupin’s products infringed under the doctrine of equivalents. During prosecution of the patents-in-suit, plaintiffs had repeatedly narrowed the particle size limitations to overcome the prior art and had argued that the claimed particle size was a distinguishing feature over the prior art. In opposition to Lupin’s Motion, plaintiffs argued that prosecution history estoppel did not apply as any amendments made during prosecution were merely tangential to the alleged equivalent. Judge Garbis ruled in favor of Lupin finding that both argument-based and amendment-based prosecution history estoppel applied. As plaintiffs could not prove literal infringement of the particle size limitation and were barred from asserting infringement under the doctrine of equivalents, the case was dismissed.

iCeutica Pty Ltd. and Iroko Pharmaceuticals, LLC v. Lupin Ltd. and Lupin Pharmaceuticals, Inc., Case No. 14-cv-01515 (2017).

Represented the Lupin defendants in a patent infringement action in the District of Delaware on patents relating to diclofenac acid (the active ingredient in Iroko’s Zorvolex® product). Achieved favorable case-dispositive settlement for client.

Merck Sharp & Dohme Corp. v. Xellia Pharmaceuticals, ApS et al., Appeal No. 2015-1905 (2016).

Represented the Xellia defendants on appeal in a patent infringement action relating to caspofungin diacetate (the active ingredient in Merck’s Cancidas® products). Achieved favorable case-dispositive settlement for client.

Jazz Pharmaceuticals, Inc., et al. v. Amneal Pharmaceuticals, LLC et al., Case Nos. 13-cv-00391 and 15-cv-08229 (2016).

Represented the Ranbaxy defendants in a patent infringement action in the District of New Jersey on patents relating to sodium oxybate (the active ingredient in Jazz’s XYREM® product) and patents relating to the REMS system for the product. Achieved favorable case-dispositive settlement for client.

Forest Laboratories Holdings Ltd., et al v. Apotex Corp., et al., Case Nos. 13-cv-01602 and 13-cv-01604 (2016).

Represented the Lupin defendants in a patent infringement action in the District of Delaware on patents relating to milnacipran hydrochloride (the active ingredient in Forest Laboratories’ Savella® product). Achieved favorable case-dispositive settlement for client following a full bench trial.

Teijin Ltd., et al. v. Lupin Ltd., et al., Case No. 14-cv-00184 (2016).

Represented the Lupin defendants in a patent infringement action in the District of Delaware on a patent relating to febuxostat (the active ingredient in Takeda’s Uloric® product). Achieved a favorable case-dispositive settlement for client.

Eisai Co., Ltd., et al. v. Lupin Ltd., et al., Case Nos. 13-civ-1279 and 13-civ-1281 (2015).

Represented the Lupin defendants in a patent infringement action in the District of Delaware on patents relating to rufinamide (the active ingredient in Eisai’s Banzel® product). Achieved favorable case-dispositive settlement for client.

UCB, Inc., et al. v. Ranbaxy Laboratories, Ltd., et al., Case No. 13-cv-01215 (2014).

Represented the Ranbaxy defendants in a patent infringement action in the District of Delaware on a patent relating to lacosamide (the active ingredient in UCB’s Vimpat® products). Achieved a favorable case-dispositive settlement for client.

Pfizer Inc. et al. v. Ranbaxy Labs. Ltd. et al., Case No. 1:07-cv-00138 (2007).

Represented defendants in patent infringement action on method patent relating to the use of atorvastatin calcium/amlodipine besylate (the active ingredients in Pfizer’s Caduet® product). Achieved favorable case-dispositive settlement for client.

AstraZeneca AB et al. v. Ranbaxy Labs. Ltd. et al., Case No. 3:05-cv-05553 (2005).

Represented defendants in patent infringement action in the District of New Jersey concerning six patents related to esomeprazole magnesium (the active ingredient in AstraZeneca’s Nexium® product). Achieved favorable settlement for client.

Ranbaxy Labs. Ltd. et al. v. Abbott Labs. et al., Case No. 1:04-cv-8078 (2004).

Represented declaratory judgment plaintiff in the Northern District of Illinois on three patents relating to extended-release formulations of clarithromycin (the active ingredient in Abbott’s Biaxin XL® product). At preliminary injunction stage, achieved ruling that two patents were likely invalid for inequitable conduct. Subsequently achieved favorable case-dispositive settlement for client.

Awards & Honors

Recognized in the "Best Lawyers 2025 Guide" for Intellectual Property Litigation in Best Lawyers in America (2024)
Recognized in the WIPR Leaders Guide of the world’s leading IP practitioners (2024)
Recognized for outstanding work in patent law in the 2024 edition of the Intellectual Asset Management (IAM) "Patent 1000 Guide" for Litigation (2024)
Recognized by The Legal 500 "United States" for Patent Litigation (2024)
Recognized as a Patent Star in Managing IP''s "2024 IP STARS" (2024)
Named a “Leading Litigator – IP Litigation, esp. Hatch-Waxman” in the 2023-2024 edition of Lawdragon’s “500 Leading Litigators in America” guide
Recognized by The Legal 500 "United States" for Patent Litigation (2022 - 2023)
Selected by her peers for inclusion in The Best Lawyers in America® for her work in Patent Litigation (2017 - 2024) and Intellectual Property Litigation (2024)
Named one of the "World's Leading Patent Professionals" for litigation in the 2018 - 2023 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 - 2023 Managing IP's "IP STARS" Guide for her outstanding intellectual property legal work.
Ranked amongst Top 100 Most Active ANDA Attorneys Representing Defendants by Patexia Insight's 2021 ANDA Litigation Intelligence Report
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.

Articles

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)