The Device and the Approval: Medical Device and Diagnostic IP Across Two Regulatory Clocks
By Casey Scott McKay ·
A medical device lives under two clocks that rarely align - the patent clock, which starts at filing and runs whether or not the product can be sold, and the regulatory clock, which decides when it can. This article works the interaction. It covers eligibility for devices and for diagnostics, where Mayo and Myriad narrowed what can be claimed far more sharply than for hardware, and the claim drafting that survives it. It then works the regulatory interface - what a 510(k) submission discloses and when, how the safe harbour at section 271(e)(1) protects development activity, and why the predicate system creates competitors rather than blocking them. It closes with design patents and trade dress, software as a device, labelling, and the aftermarket fights over servicing and reprocessing.
IP and Technology > Patent Counseling Transactions | Article | Published 30 November 2024 - Updated 12 August 2026 | Casey Scott McKay - marksy.us
Summary. A medical device lives under two clocks that rarely align — the patent clock, which starts at filing and runs whether or not the product can be sold, and the regulatory clock, which decides when it can. This article works the interaction. It covers eligibility for devices and for diagnostics, where Mayo and Myriad narrowed what can be claimed far more sharply than for hardware, and the claim drafting that survives it. It then works the regulatory interface — what a 510(k) submission discloses and when, how the safe harbour at section 271(e)(1) protects development activity, and why the predicate system creates competitors rather than blocking them. It closes with design patents and trade dress, software as a device, labelling, and the aftermarket fights over servicing and reprocessing.
Keywords: medical device patents · diagnostic eligibility · Mayo v Prometheus · Myriad · Alice framework · 510(k) clearance · premarket approval · predicate devices · safe harbour · section 271(e)(1) · Merck v Integra · design patents on devices · device trade dress · software as a medical device · labelling and off-label · aftermarket servicing · single use reprocessing · repair and reconstruction · standard essential connectivity · regulatory exclusivity
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