In a recent commentary for Breaking Defense, Sean O’Keefe, University Professor in the Maxwell School, noted the opening of President Ronald Reagan’s first inaugural address in 1981, where the Republican observed that the peaceful and orderly transfer of national authority…
A Welch Allyn Veteran Guides Innovation Law Center Students
Every semester, College of Law students in the Innovation Law Center (ILC) benefit from the extensive expertise and broad experience of practitioners who supervise student research projects for real-world clients.
One of the adjunct law professors overseeing the Innovation Law Practicum class is Chris Horacek, former vice president-deputy general counsel for Welch Allyn, a leading medical device manufacturer based in Central New York, and currently deputy general counsel for medical technologies company Quadrant Biosciences.
Horacek’s lessons for his student teams are grounded in 20-plus years of providing legal counsel on intellectual property (IP), compliance and business transactions. But he also understands intimately the strategic thinking, leadership qualities and communications approach a corporate counsel must bring to a company looking to manage and leverage an IP portfolio.
Summarizing the advantages of ILC’s applied learning course, Horacek says, “I wish I had had the benefit of a program like this when I was starting out!”
At the beginning of a semester, Horacek introduces his practicum team to an emerging technology client in need of a review of its IP, regulatory and market landscape. Clients often are referred to the Innovation Law Center by a regional business incubator. Medical industry clients typically find ILC via the Central New York BioTech Accelerator at Upstate Medical University, the University at Stony Brook, the University at Buffalo’s Center of Excellence in Bioinformatics & Life Sciences and MedTech, a biomedical industry group.
The student team’s job is to write a comprehensive report about the client’s IP, its market competition and the regulations that will impact its technology. The report then helps the client make wise business, legal and funding decisions.
“When I joined Welch Allyn, I had been practicing transactional law, and that’s what I was hired to do,” recalls Horacek. Nevertheless, given Welch Allyn’s industry and its wide portfolio of products—everything from blood pressure cuffs to vital signs monitors to sigmoidoscopes—Horacek, like his students, soon found himself reading up on IP law and medical industry regulations.
“After Welch Allyn encountered some regulatory issues, the company had to up its FDA compliance game, and someone needed to lead the legal aspects of the effort—that was me,” he says. “So I know what our students are going through learning all this. For a young corporate counsel, ILC’s Innovation Law Practicum projects are immensely useful, learning how laws apply to a company and how to use them to a company’s advantage.”
What Horacek means by using IP laws and regulation advantageously is that protecting copyrights, patents and trade secrets can help a company differentiate itself in the marketplace, fight off competition, and grow its business. It was this IP-based growth strategy that Horacek helped to craft over an 18-year career at Welch Allyn.
“Not every patent has to be a blockbuster,” Horacek continues. “Sometimes we’d look to patent a new feature on an existing product so that a competitor couldn’t copy it. Our patent strategy was to ask, ‘Who are our competitors? How can we differentiate?’ and ‘How can the legal team help drive sales?’ One of our jobs at Welch Allyn was to protect performance advantage.”
ILC medical industry clients in particular can benefit from an FDA regulation report, which helps them make an intelligent, informed business plan. “You need to make good assumptions when you write a business plan, including assumptions about IP, regulation and competition,” Horacek observes. Medical industry entrepreneurs must understand that medical devices, pharmaceuticals and supplements are expensive to bring to market, he says. “Compliance isn’t cheap. You need to budget for it, and not being aware of your regulatory issues and not budgeting correctly can lose a company credibility with an investor.”
At Welch Allyn, in addition to protecting critical improvements to existing products, Horacek says his legal team also created a foreign patent filing strategy to counteract IP theft and unfair competition from competitors abroad, and it worked closely with the company’s R&D engineers to help identify IP possibilities while inventions were still young. “We’d spend a lot of time working with the engineers, and we brought them into IP strategy meetings,” Horacek explains. “The beauty of doing it that way is, if their work couldn’t be turned into a patent, perhaps we could find a way to protect it as a trade secret.”
And here is another lesson for the apprentice counsels under Horacek’s supervision: “A company needs to understand what its IP is. You find that a lot of companies don’t know what their trade secrets are, for instance. At Welch Allyn, I think we did a pretty good job managing the company’s IP.”
Horacek says he is impressed how quickly and competently the practicum students navigate the dense forest of IP law and regulatory compliance. “ILC students must learn three areas very quickly,” he says. “They must learn IP law in a practical sense, in addition to the academic introduction they get in class; they must learn to communicate with clients, giving them complex information in plain language rather than as a memo or legal brief; and they need to learn clients’ sometimes-complex technologies.”
“The hard part is doing all three things simultaneously,” Horacek concludes, “but that’s why we are here, to guide them. It’s very nice to see the change from first to second semester, to see the students become more engaged and knowledgeable with the clients.”