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Expert Analysis

510(k) In Patent Litigation: Applicants Should Be Cautious

Law360, New York (April 13, 2015, 10:57 AM EDT) -- Medical device manufacturers often view their patent strategies and risk assessment as wholly separate form their regulatory approval process. But there is at least one potential intersection of these two functions with serious implications: the use of representations regarding predicate devices in 510(k) devices in subsequent patent litigation. Consequently, in crowded technical areas or markets with histories of aggressive patent assertion, medical device companies would be well advised to understand the potential implications for representation made in the course of their 510(k) submissions....

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