When companies in the life sciences industry are facing an intellectual property dispute, they trust Martina Tyreus Hufnal to protect their interests and their IP.
As co-leader of Fish’s Life Sciences Industry Team, Martina puts her extensive experience in Hatch-Waxman litigation, biosimilar cases, and medical device disputes to use in some of the firm’s most complex pharmaceutical and health care industry cases. She has also prevailed in chemical, electrical, and software cases.
Martina has been lead counsel in cases related to small molecule formulations, biosimilar protein formulations, polymer chemistry, gasoline blending technologies, and load balancing software. With experience ranging from competitor-competitor jury trials to Hatch-Waxman bench trials, Martina knows how to strategically position her clients for success, whether through victory in District Court, a win at the Federal Circuit, or a favorable settlement. This long-term strategic perspective, coupled with her deep understanding of her clients’ priorities and business objectives, helps her to lead clients to favorable resolutions in even the most complex disputes.
From her noninfringement trial victory for Microsoft against well-known patent assertion entity Parallel Networks to the successful patent infringement defense of Gilead against Merck regarding Gilead’s Hepatitis C treatment drugs Sovaldi® and Harvoni®, Martina has handled some of the most contentious, high-stakes matters for industry-leading clients. Her Hatch-Waxman litigations include Latuda®, Zorvolex® (co-lead), Vivlodex® (co-lead), Combigan®, and Lumigan®. She has also headed litigations against Humira® (adalimumab) — the world’s top-selling drug by revenue.
While she focuses her practice in U.S. District Courts and has appeared in them across the country, Martina has also practiced before the U.S. Court of Appeals for the Federal Circuit and the U.S. Patent and Trademark Office. Martina has represented clients in multiple post-grant proceedings, including inter partes reviews and post grant reviews. Martina excels in litigation strategy and offers clients a well-rounded perspective on litigation’s impact on business.
Regarded as an outstanding litigator, Martina is recognized year after year. Her many accolades include “Lawyer of the Year,” The Best Lawyers in America (2022); “Best Lawyers Litigation – Intellectual Property” (2018-2023); “The World’s Leading Patent Professionals,” IAM Patent 1000 (2017-2023); Notable Practitioner in Intellectual Property, Chambers USA: Delaware (2018-2023); and “IP Star,” Managing Intellectual Property (2018-2023). According to clients, she is an “outstanding lead counsel” who is “known for her prowess in post-grant proceedings and great in Hatch-Waxman actions.”
Martina is a sought-after panelist at conferences discussing litigation preparation and management. She often presents on cutting-edge legal developments, from case decisions to litigation strategy.
Before joining the firm, Martina clerked for the Honorable Judge Sue L. Robinson in the U.S. District Court for the District of Delaware for a year and practiced IP litigation in Delaware for four years.
Alvotech USA Inc. et al v. Abbvie Inc et al(E.D. Va., N.D. Ind.) – Martina represented Alvotech in its multi-jurisdiction biosimilar dispute with AbbVie over arthritis drug adalimumab, sold as Humira®, the world’s top-selling drug by revenue, with more than $75 billion in sales in the past four years. In April 2021, AbbVie sued Alvotech in the Northern District of Illinois, asserting infringement of four of its patents. In May 2021, Alvotech filed a patent case in theEastern District of Virginia to invalidate AbbVie’s patents and assert claims of patent misuse by AbbVie for its assertion of more than 60 patents in the “minefield of IP” (as described by AbbVie’s CEO) that AbbVie uses to deter competition in the market. In March 2022, these matters were resolved through a settlement under which AbbVie granted Alvotech a license to its Humira® patents and the nonexclusive right to market a Humira® biosimilar.
Sunoco Partners Marketing & Terminals LP, et al. v. Magellan Midstream Partners LP (Fed. Cir.) – In a battle over a chemical invention, Martina served as co-lead counsel representing Magellan Midstream Partners in a case centered on the meaning of “gasoline” for an invention that injected butane into gasoline to make it more volatile. Martina persuaded the United States Patent and Trademark Office to kill the patent claims over a prior butane mixing system. Patentee Sunoco argued on appeal that its patent was limited to systems that blended outside the refinery, whereas the prior systems were in-refinery systems. But Fish persuaded the Federal Circuit that the patent spoke of “gasoline” both inside and outside the refinery, and thus was not effectively different from the prior systems, leading to a summary affirmance.
Parallel Networks Licensing LLC v. Microsoft Corp. (D. Del. May 11, 2017) – Martina was co-lead trial counsel for Microsoft in a trial victory against Parallel Networks, a well-known patent assertion entity. In addition to handling an inventor at trial, she spearheaded the damages strategy, winning pre-trial motions that set up the jury trial for success, securing significant Daubert wins precluding Parallel Networks’ evidence presentation, and cross examining the damages expert. The jury came back in under two hours with a finding for Microsoft of non-infringement.
BASF Corp. v. Johnson Matthey Inc. (D. Del., Nov. 30, 2016; Johnson Matthey Inc., et al. v. BASF Corp. IPR 2015-1267) – Martina was co-lead counsel for Johnson Matthey in this patent infringement battle over a patent that controls and reduces emission of nitrogen oxide in heavy diesel trucks. At the Markman hearing, she argued that BASF’s claims were indefinite. The court agreed, entering a judgment pre-trial that the asserted claims of the patent-in-suit were invalid. On remand, the case settled prior to trial.
iCeutica Pty. Ltd., et al. v. Lupin Ltd., et al. (D. Del.) – Fish represented Iroko and iCeutica in this Hatch-Waxman litigation involving the drug Zorvolex®. Martina, who served as co-lead counsel in this case, argued the Markman hearing and obtained favorable claim constructions. The case settled a week before trial.
Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. No. 2018-1691 (Fed. Cir.) – In October 2019, the Federal Circuit ruled for Fish client Gilead Sciences when it denied, in a precedential decision, Idenix’s bid to reinstate a $2.5 billion verdict. The court accepted Fish’s argument that Gilead’s landmark hepatitis C drugs were not liable for infringement of Idenix’s patent, finding that the patent was invalid for lack of enablement. The decision came 18 months after “one of the biggest litigation comebacks of all time” when Fish argued and won a JMOL motion that reversed the $2.5 billion jury verdict, the largest patent damages award in history, against Gilead. In January 2021, the U.S. Supreme Court denied certiorari, bringing this remarkable case to a close.
Gilead Sciences Inc. v. Merck & Co. Inc., et al. (N.D Cal. Mar. 20, 2016; June 6, 2016) – Fish represented Gilead in this competitor litigation over Gilead’s blockbuster drugs Sovaldi® and Harvoni®, which are used to treat chronic Hepatitis C. Merck asserted that Gilead’s products infringed two of its patents. After the jury trial, the court held a bench trial and found that Merck had engaged in misconduct, including “lying to Pharmasset, misusing Pharmasset’s confidential information, breaching confidentiality and firewall agreements, and lying under oath at deposition and trial.” These findings led the court to void Merck’s $200 million jury verdict due to “unclean hands.”
Invista North America S.A.R.L. et al. v. M&G USA Corp. et al. (Fed. Cir. Aug. 13, 2014; D. Del. July 24, 2013) – Fish client Invista alleged that M&G’s PoliProtect product infringed two Invista patents that relate to polyester barrier resins — plastic materials that limit the permeation of gas and protect food or beverage contents from contamination or spoilage. Martina co-led and won both the District Court and appellate victory for Invista.
Martina was a member of the trial team on a series of Hatch-Waxman cases regarding pharmaceutical company Allergan’s eye care drugs. In August 2015, the Federal Circuit affirmed a win that blocked Allergan's four competitors from selling a generic version of its Lumigan® 0.01% glaucoma treatment, which has $200 million in annual sales, until 2027.
In August 2011, the Eastern District of Texas found Allergan’s claims in four patents valid and infringed by copies of Combigan® and issued an injunction against the generics companies from selling their own version of the drug until Allergan’s last patent expired in 2022. In May 2013, the Federal Circuit agreed in a precedential opinion that one key patent was valid and infringed.
Won a 2013 trial that blocked four generic versions of Allergan’s Latisse® from entering the market until 2024.
Achieved a win in the Eastern District of Texas when the court found that opposing party "Actavis PLC…jumped the gun by asserting Allergan's patents for its dry-eye medication Restasis® were invalid or unenforceable before its application for a generic version of the drug was accepted by the Food and Drug Administration," which is a violation of federal law.
Recognitions & awards
Best Lawyers in America
Chambers USA: Delaware
IAM Patent 1000
Delaware Litigator of the Year
Managing Intellectual Property (MIP)
AV Preeminent Lawyer
Delaware Lawyer of the Year for Patent Law
Life Sciences Star
LMG Life Sciences
Women Worth Watching
Profiles in Diversity Journal
40 Under 40
Delaware Business Times
American Bar Association
Intellectual Property Owners Association
American Institute of Chemical Engineers
Delaware State Bar Association
American Intellectual Property Association
Federal Bar Association (Executive Board Co-Chair Federal Civil Panel Section 2011-2013)
Federal Bar Association (Executive Board Co-Chair Intellectual Property Section 2013-2014)