In an article published by nonprofit educational medtech incubator Fogarty Innovation, Knobbe Martens partner Kregg Koch shared practical strategies for medtech companies and entrepreneurs looking to protect and maximize the value of their intellectual property.
The feature piece grew out of a Fogarty “Lunch & Learn” presentation led by Koch, ‘Building an IP Moat, Not Just a Patent Portfolio,’ in which Koch discussed how medtech startups can build durable patent protection, use AI strategically while managing its risks, identify infringement threats before they become deal killers, and understand what investors expect to see when diligence starts. “As the innovators and CEOs of a company, you must have a finger on the pulse of the IP,” Koch said. “It’s what prevents other people from copying the product that you spent millions of dollars and years of research and development on.”
First among Koch’s recommendations was to file early, and thoroughly. He urged innovators to file a provisional patent application as a “stake in the ground,” but cautioned that a provisional is only as good as the disclosure it contains. “If the provisional application can’t support the limitations in the ultimate claims you want to protect your core technology,” he warned, “that provisional application may not only be worthless, but can give the inventor overconfidence that can lead to big problems down the road.” Koch also stressed the importance of crafting comprehensive disclosures rich in alternative embodiments and diverse claims designed to withstand examination at the Patent Office, as well as potential inter partes reviews or other competitor challenges down the road.
Koch also emphasized that founders and inventors should stay closely involved in the patent drafting process rather than delegating it entirely to outside counsel. He noted that he had seen many cases where “a really remarkable point in the technology wasn’t communicated as well as it could have been to the [lawyers] and therefore didn’t end up in the patent application.” He recommended that innovators align their claim strategy with the competitive advantages they highlight in their own marketing materials, focusing on the features they would pitch to doctors and hospitals, as a checklist for what should be protected.
Noting that patent protection is a long-term investment, Koch encouraged innovators to align their patent strategy with their overall business strategy. He outlined a staged approach to IP portfolio development: at the early stage, companies should focus on protecting core technology with a comprehensive initial application and initiating international filings. At the mid-stage, companies should pursue granted U.S. patents with diverse claim coverage and begin covering future product iterations and have some granted patents covering at least the core technology in key markets outside of the U.S. And, at the commercial stage, companies should have at least a strategic portfolio of granted patents covering multiple product generations in the U.S. and across key international markets.
Koch also discussed the role of artificial intelligence in inventorship and the patent application process, suggesting strategies innovators can use to mitigate risk associated with AI tools. He compared AI to “a very sharp knife – an effective tool if used carefully, but with dire consequences if not.” Koch addressed AI’s impact on inventorship, explaining that because U.S. patent law requires human inventors, relying on AI to generate new ideas or technical solutions can create substantial risk that the resulting inventions will not qualify for patent protection. Koch advised companies to keep detailed records proving human conception of each inventive element before generating any AI-assisted content.
For more insights on how to build a strong IP strategy, read “Building Stronger, More Strategic Patent Protection” on the Fogarty website here.
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