Reported by Alexander Gelfand
law of technology
Return to Table of Contents
winter 2026
In the late 1970s, a firm partner approached James Haley, JD ’75, to work with a new client in the emerging field of recombinant DNA. Neither knew anything about the technology or its hoped for commercial implications. Young associate Haley took on the challenge.
That instinct—to embrace the unknown—would help shape modern biotech patent practice and, years later, lead Haley to co-found the international IP firm that bears his name, Haley Guiliano LLP.
Haley went on to draft, prosecute, and defend foundational patents in recombinant DNA and other areas of biotechnology, including the first genetically engineered vaccine for Hepatitis B, a patent later named by IP Worldwide among the “10 Patents That Changed the World.” The Biogen-invented vaccine—approved in 1986—is a milestone in biotech history.
“When I go back and look at my notes from those early Biogen Scientific Board meetings, I can’t read them,” he says. “And it’s not because of my handwriting. I didn't even know how to spell some of the words.”
Haley’s impact spans far beyond a single breakthrough. Over five decades, he has led the prosecution of hundreds of U.S. patents and thousands more abroad, and developed strategies and patent claim formats that have become industry templates.
Again and again, when science created new tools, Haley helped pioneer the claim formats that gave the biotech industry the legal vocabulary it needed to patent the results of that research. The “hybridization” claim, for example, which he developed with the Swiss inventor of recombinant alpha interferon, expanded a patent’s scope to related DNA sequences with similar functions. The claim, with a few tweaks, is still used today.
Just as important was the community of patent professionals Haley built. At Fish & Neave, he founded and led a Life Sciences Technical Advisor program that brought more than 70 PhDs from lab benches into IP law—scientists trained to translate biology, immunology and chemistry into claims that become important business assets of his clients. That program continues today at Haley Guiliano.
With a PhD in organic chemistry from Brandeis and a JD from Suffolk Law, Haley himself bridges both worlds. “You don’t necessarily need a scientific pedigree to work in patent law, although it certainly helps,” he says. “The people who succeed are those comfortable learning technology they know nothing about.”
Now, with a Lifetime Achievement Award from Managing IP on his shelf, Haley’s firm is looking to the next technology—AI, both in the context of drafting patent applications and making IP operations more streamlined. Haley believes AI will do more than improve back-office efficiency—it could raise the bar on patentability by transforming prior-art searches. Prior art refers to publicly available information that predates a patent filing, such as published research, existing products, and earlier patents, and is used to determine whether a new invention is truly novel.
In the past, prior-art searches meant digging through boxes of old patents called “shoes.” Then came digital databases. Now, AI can scan millions of documents in seconds, surfacing connections that would take humans weeks or months to find.
“AI is going to result in a more informed application of the standards of patentability,” Haley predicts, noting that faster, deeper searches will make it easier for examiners to assess applications and prior art and for third-parties to challenge issued patents.
As for AI’s use in preparing drafts of patent applications and responses to office actions, it is not perfect—but neither were his first attempts at biotech law. For Haley, the point isn’t getting it right the first time; it’s being willing to step into the unknown. While others debate whether AI is a threat, his team at the firm is learning how to make it a tool.
When Haley looks at AI, he sees a familiar assignment: Learn the language, test the technology, build a framework that rewards invention. And, be willing to look back at your early notes and admit you couldn’t spell half the words—until one day you could.
Now a member of the Law School’s Dean's Cabinet, he’s committed to opening doors for others. “Suffolk gave me an opportunity to find a career I love,” he says. “I want to give back in a way that will allow others to experience the same joys I’ve had practicing patent law.” For Haley, that means helping the next generation embrace the unknown.
Photography: Courtesy of James Haley, AI generated artwork
“The people who succeed are those comfortable learning technology they know nothing about.”
James Haley, JD ’75
Partner, Haley Guiliano
technology of law
“AI is going to result in a more informed application of the standards of patentability,” Haley predicts, noting that faster, deeper searches will make it easier for examiners to assess applications and prior art and for third-parties to challenge issued patents.
As for AI’s use in preparing drafts of patent applications and responses to office actions, it is not perfect—but neither were his first attempts at biotech law. For Haley, the point isn’t getting it right the first time; it’s being willing to step into the unknown. While others debate whether AI is a threat, his team at the firm is learning how to make it a tool.
When Haley looks at AI, he sees a familiar assignment: Learn the language, test the technology, build a framework that rewards invention. And, be willing to look back at your early notes and admit you couldn’t spell half the words—until one day you could.
Now a member of the Law School’s Dean's Cabinet, he’s committed to opening doors for others. “Suffolk gave me an opportunity to find a career I love,” he says. “I want to give back in a way that will allow others to experience the same joys I’ve had practicing patent law.” For Haley, that means helping the next generation embrace the unknown.
