Foley Hoag
Firm overview:
Founded in 1943, Foley Hoag has established a nationally and internationally recognised intellectual property practice.
Foley offers clients the full gamut of IP services, focusing on the life sciences, technology, energy, climate, and cannabis sectors. The practice is active in patent prosecution, patent litigation, trade secret litigation and Patent Trial and Appeal Board (PTAB) proceedings.
Its Boston, New York, and Washington, DC offices are where the firm’s patent services are concentrated. In terms of patent prosecution, the Boston and New York offices serve clients like AbbVie, Harvard, MIT, and Ginkgo Bioworks. The team also advises on global IP strategy in collaboration with the Food and Drug Administration (FDA) practice, and Emerging Companies and Venture Capital Practice.
In patent litigation, the Foley Hoag team has been involved in major victories in high-profile, bet-the-company cases and complex Abbreviated New Drug Application (ANDA) litigations under the Hatch-Waxman Act.
Its relatively small patent practice punches above its weight, being frequently on the other side of the ‘v’ against many of the leading firms in patent litigation and winning many significant litigations.
The firm has successfully tried major life sciences disputes in federal and state court, the International Trade Commission (ITC), and the Patent Trial and Appeal Board (PTAB), and defended victories on appeal.
Foley specialises in representing clients in complex IP disputes that arise out of research collaborations and joint development agreements involving research institutions, small companies, and large biopharma companies. A sweet spot are disputes combining patent rights, contract rights, and trade secret rights.
In particular, Foley’s litigation teams are staffed from a pool of more than 50 attorneys or technical specialists with PhDs in life sciences-related fields.
One client says they chose Foley for representation in contentious litigation with a dominant competitor, “because they came highly recommended” and have "just been phenomenal”.
“They clearly had a very deep knowledge in the biotech space. One of the things that I've been very impressed with is, they have so many PhDs and doctors, and their knowledge of the science involved in the patent dispute has been critical for us because we are in a very highly technical field.”
Team overview:
Barbara Fiacco, David Halstead, and Joshua Jarvis are co-chairs of the Intellectual Property department. Jeremy Younkin and Barbara Fiacco are co-chairs of the Patent, Trade Secrets and Related Rights Litigation Practice; and Susan Abelleira and Lucas Watkins are chair and deputy chair, respectively, of the Patent Prosecution, Strategy & Management Practice.
Fiacco, recognised as one of WIPR’s Influential Women in IP for 2024, was also ranked in WIPR’s USA Trade Secrets Rankings 2024 as a Recommended individual. A prominent first chair patent and trade secrets litigator, she is widely recognised in rankings nationally.
Fiacco has been selected for multiple leadership positions by her peers in the IP legal community, serving as AIPLA’s president from 2019-2020, and is currently the counselor for the prestigious Alan D. Lourie Boston IP American Inn of Court. Among Fiacco’s clients is Enanta Pharmaceuticals, for which she is lead counsel in its patent infringement suit against Pfizer for the sale of its COVID anti-viral Paxlovid.
A satisfied client praised their Foley team in their litigation support, particularly Don Ware, Sarah Burg and Brendan Jones. “They've led the whole strategy. We've been able to provide our information from the company side, but it's really been their expertise that has [driven success in our litigation].”
Ware’s knowledge and expertise is “just tremendous”. “He has always sourced unique ideas and some of those have been very successful. He's also just a very good person and very good to work with.”
Burg focuses her practice on representing life sciences companies and research institutions in patent litigation, and has litigated cases concerning technologies around recombinant DNA, monoclonal antibodies, small molecules compounds, medical devices, and more.
Jones manages the worldwide prosecution of patent portfolios for a diverse range of clients, as well as representing both patent challengers and owners in post-grant proceedings.
Key matters:
Prosecution:
- Ginkgo Bioworks
Brendan Jones, Thi Dio, and Janine Ladislaw are key counsel for Ginkgo, managing the prosecution of Ginkgo’s patent portfolios related to the engineering of mammalian cells. This includes the ongoing prosecution of dozens of complex, worldwide portfolios directed to Ginkgo’s chimeric antigen receptor (CAR) platform, its adenovirus gene delivery platform (including patent families acquired from Stride Bio), and its circular nucleic acid platform (including patent families acquired from Circularis).
- Atara Biotherapeutics
David Halstead and his team at Foley have advised Atara for nearly a decade. Atara focuses on discovering, developing and commercialising novel treatments for patients with cancer, autoimmune and viral diseases that leverage biological features of T cells to target and attack cells that contribute to illness.
Halstead, along with associate Allison Gilder and others, assist the client in its collaborative innovations, and in developing and implementing IP strategies designed to protect its adoptive immunotherapy pipeline from manufacturing to therapeutic application.
Building from Atara’s adoptive T cell technology, the Foley team secures IP relating to, for example, Atara’s late-stage clinical adoptive T cell immunotherapies targeting virus-driven cancers, and multiple sclerosis, as well as CAR T cell therapeutics targeting cancer.
- Annexon
For almost a decade, David Halstead and his team have represented Annexon, a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the brain, body and eye.
The Foley team develops and implements IP strategies designed to protect Annexon’s advanced-stage clinical anti-C1q antibodies and early-stage clinical small molecule modulators of the classical complement pathway, and their use in treating certain medical conditions.
Litigation:
- Seminis Vegetable Seeds v Enza Holding et al, Case No. 8:23-cv-02882-MSS-AEP, US District Court for the Middle District of Florida, Tampa Division, 2024
Foley defended Enza Holding BV, Enza Zaden Beheer BV, and Enza Zaden USA (collectively, ‘Enza Zaden’) in a patent and plant variety protection infringement dispute brought by Seminis Vegetable Seeds.
Seminis alleged that Enza, a Dutch vegetable breeding company, infringed one of its patents directed to certain pepper plants, as well as Seminis’ Plant Variety Protection Certificate for a pepper variety. It claimed that Enza used its patented pepper to develop its own varieties without authorisation.
Seminis also argued that it has jurisdiction to assert an inducement of infringement claim over the Dutch parent entity solely based on ex-US activity, raising a novel question about the extraterritorial reach of US patent law on inducement.
The case settled in November 2024, after Foley filed a motion to dismiss Seminis’ complaint.
Leading the case for Enza Zaden at Foley were Barbara Fiacco and Jeremy Younkin, along with associates Urszula Nowak and Caroline Holliday.
Opposing counsel were Daniel DiNapoli and David Marsh of Arnold & Porter; and Coy Stull, Carlton Fields (opposing local counsel).
- ChromaDex v Elysium Health, Case No. No. 18-cv-1434, US District Court for the District of Delaware, Federal Circuit, Supreme Court, 2024
Foley successfully defended Elysium Health in its high-profile patent dispute over a substance found naturally in milk, brought by rival food supplement manufacturer ChromaDex, and Ivy League research university Dartmouth College.
The plaintiffs first sued Elysium in 2018, alleging that it infringed two patents directed to compositions containing nicotinamide riboside, a form of Vitamin B and a precursor of NAD+ (nicotinamide adenine dinucleotide).
The plaintiffs sought damages and a permanent injunction to bar Elysium from selling its protected dietary supplement ‘Basis’. Weeks before trial, the district court granted Foley’s motion for summary judgment, and held that all of the asserted claims were invalid under 35 USC §101.
Two months after appeal, the Federal Circuit issued a unanimous precedential decision upholding the district court’s decision, finding the asserted claims unpatentable. Foley defeated the plaintiffs’ petition for rehearing en banc. The plaintiffs thereafter filed a petition to the US Supreme Court for a writ of certiorari, which the court denied in October 2023.
The case concluded when US District Judge Colm Connolly issued a final judgment in October 2024. He granted Foley’s motion for $9.1 million in attorney fees and costs plus interest, making this an “exceptional” case, and challenging the strength of §101.
Lead counsel for Elysium were partners Jeremy Younkin and Donald Ware, and associates Nathanial McPherson and Brittany Saunders.
Attorneys from Covington & Burling represented ChromaDex.
- Exact Sciences Corporation v Geneoscopy, Ongoing
Foley Hoag is representing gastrointestinal health company Geneoscopy in a high-stakes patent litigation brought by Exact Sciences, alleging infringement of colorectal cancer screening methods by Geneoscopy’s trademarked ‘ColoSense’ screening test.
When launched, Geneoscopy’s product will compete against a $2 billion market leader seeking to block market entry and protect its trademarked product ‘Cologuard’.
Foley’s representation involves two pending federal district court cases with claims of patent infringement and false advertising, and counterclaims of trade secret misappropriation and unfair trade practices, as well as an inter partes review (IPR) petition in the US Patent and Trademark Office (USPTO) challenging the validity of Exact Science’s asserted patent.
The complexity of the dispute is heightened by its intersection with Food and Drug Administration (FDA) regulatory proceedings, including a parallel trade complaint brought before the FDA.
Donald Ware and Sarah Burg represent the client in district court proceedings, while Brendan Jones oversees PTAB proceedings. Other team members are associates Nathanial McPherson, Stuart Knight, Mital Patel, Brittany Saunders and David Shore.
Opposing counsel are from Quinn Emanuel.
Clients:
Geneoscopy, Becton, Dickinson and Company, Elysium Health, Ginkgo Bioworks, Enanta Pharmaceuticals, Annexon, Atara Biotherapeutics, Intellia Therapeutics, UCLA, Dana-Farber Cancer Institute, Enza Zaden, Dicerna Pharmaceuticals, and Absci.