Medical Device IP Checklist: Eligibility Screening, Filing Timing, Safe Harbour Use, Design and Trade Dress, and Labelling Review

By Casey Scott McKay · 2025-09-24

This checklist runs a medical device intellectual property programme against the regulatory calendar, because that is what actually governs the timing. It opens with the pre-submission filing gate and the three-track calendar, then screens eligibility with separate treatment for hardware and for diagnostics, where the correlation and the isolated sequence are both unavailable. It works the six claim layers - device, system, consumable, interface, manufacturing method, and design - and the continuation practice that converts a competitor's published clearance into claims. It covers the sale-versus-placement decision that determines aftermarket control, repair and reprocessing, software change control where the software is itself the device, promotional review across two parallel regimes, and virtual marking maintenance.

IP and Technology > Patent Counseling Transactions | Checklist | Published 24 September 2025 - Updated 10 August 2026 | Casey Scott McKay - marksy.us

Summary. This checklist runs a medical device intellectual property programme against the regulatory calendar, because that is what actually governs the timing. It opens with the pre-submission filing gate and the three-track calendar, then screens eligibility with separate treatment for hardware and for diagnostics, where the correlation and the isolated sequence are both unavailable. It works the six claim layers — device, system, consumable, interface, manufacturing method, and design — and the continuation practice that converts a competitor's published clearance into claims. It covers the sale-versus-placement decision that determines aftermarket control, repair and reprocessing, software change control where the software is itself the device, promotional review across two parallel regimes, and virtual marking maintenance.

Keywords: medical device checklist · pre-submission filing gate · eligibility screening · diagnostic claim drafting · claim layers · consumable and interface claims · manufacturing method claims · continuation practice · predicate monitoring · design patent timing · sale versus placement · exhaustion analysis · reprocessing and repair · software change control · promotional review · substantiation file · dual name clearance · term modelling · extension eligibility · virtual marking

How to use this checklist

| Phase | What it covers | |---|---| | 1 | The three-track calendar | | 2 | The pre-submission gate | | 3 | Eligibility: hardware | | 4 | Eligibility: diagnostics | | 5 | Claim layers | | 6 | Definiteness and obviousness | | 7 | Continuation practice | | 8 | Predicate monitoring | | 9 | Design filings | | 10 | Trade dress | | 11 | Name clearance | | 12 | Sale versus placement | | 13 | Consumable control | | 14 | Repair and reprocessing | | 15 | Servicing access | | 16 | Software change control | | 17 | Data rights | | 18 | Promotional review | | 19 | Term and marking | | 20 | Trade secrets and suppliers |

Boxes marked [Gate] must clear before a submission is filed, before a public disclosure, or before a software release ships.

The matter. The patent issued four years before the product could lawfully be sold, the clearance summary published a roadmap, and the competitor built the same device under a safe harbour the portfolio never reached.

Phase 1. The three-track calendar

[ ] [Gate] Maintain one document carrying development, filing, and regulatory tracks, with a named owner.
- Why. Regulatory holds its dates, prosecution holds its docket, and engineering holds the design freeze — and in most companies nobody holds all three.
[ ] Development track: concept, bench testing, design freeze, verification and validation, clinical work.
[ ] Filing track: provisional, conversion, foreign priority deadline, national phase, design filings, continuations.
[ ] Regulatory track: pre-submission meeting, submission, agency questions, clearance or approval, and the same sequence per foreign market.
[ ] Confirm design freeze precedes design patent filings, and that filings precede any public disclosure.
[ ] Confirm utility filings precede the submission.
[ ] Confirm a continuation is pending when clearance publishes.
[ ] Confirm foreign filings account for the absence of a grace period in most systems.
[ ] Hold a standing quarterly review with regulatory, prosecution, and engineering present.

Phase 2. The pre-submission gate

[ ] [Gate] File before every regulatory submission, without exception.
- Why. The dossier describes the device in detail and the summary published on clearance is public. Anything the company intends to patent must be on file first.
- Trap. Treating the submission as confidential. Much of it is; the clearance summary is not, and it describes technological characteristics and intended use.
[ ] Establish the handoff: regulatory affairs notifies patent counsel before any submission is filed.
[ ] Confirm every feature in the submission is covered by a pending or granted application, or has been deliberately released.
[ ] Record the decision where a feature is deliberately not filed on.
[ ] Confirm foreign priority is claimed before the domestic submission where foreign markets matter.
[ ] Audit the handoff annually against actual submission dates.

Phase 3. Eligibility: hardware

[ ] Confirm the claim recites structure — apparatus, components, and arrangement — rather than a computation.
[ ] Where the inventive contribution is a computation, anchor it: the sensor arrangement producing the signal, the specific processing hardware, or the actuation the result drives.
- Trap. A signal processing method with no meaningful structural limitation invites the Alice v. CLS Bank International framework in an art where structural claiming was available.
[ ] Confirm any method claim recites physical steps performed on or by the apparatus.
[ ] Avoid claiming a clinical judgment or a decision rule as such.
[ ] Record eligibility rejections and the amendments made, because they define what the claims cover and a competitor will read them.

Phase 4. Eligibility: diagnostics

[ ] [Gate] Confirm no claim is directed to observing a correlation between a marker and a condition.
- Why. Mayo Collaborative Services v. Prometheus Laboratories holds that a natural correlation plus conventional detection steps is ineligible.
[ ] Confirm no claim is to an isolated naturally occurring sequence, per Association for Molecular Pathology v. Myriad Genetics.
[ ] Move the invention into the reagent — an engineered probe, primer set, antibody, or construct not occurring in nature.
[ ] Move it into the apparatus — the instrument, cartridge, optical path, or fluidics.
[ ] Move it into the detection method, where the technique itself is unconventional rather than routine.
[ ] Move it into sample preparation, where a genuinely new step exists.
[ ] Move it into a treatment method, claiming what the clinician does differently.
[ ] Apply the test. Does the claim recite what the practitioner does differently, or what they learn? The first survives.
[ ] Assess enablement for any biological genus claim against Amgen v. Sanofi, and support a genus with a described common structure and enough embodiments.

Phase 5. Claim layers

[ ] Device. Structural claims to the apparatus and its arrangement.
[ ] System. The device with consumables, controller, and data path.
[ ] Consumable. Cartridges, tips, electrodes, sensors, cassettes.
[ ] [Gate] Interface. The engagement between durable and disposable — connector geometry, authentication handshake, fluidic or electrical coupling.
- Why. This is the layer a compatible third-party consumable must practise, and it is the one most often omitted.
[ ] Manufacturing method. Reaches production even where the finished device is designed around, and is invisible in a teardown.
[ ] Design. Under 35 U.S.C. § 171, on housing, handpiece, display, cart, and cartridge form.
[ ] Method of use where relevant, drafted knowing it will be enforced against the supplier through inducement rather than against clinicians.
[ ] Confirm the claim set concentrates where the revenue is, which for most device businesses is the consumable and the interface.
[ ] Plan for restriction requirements separating device, method, and manufacturing claims, and budget divisionals.

Phase 6. Definiteness and obviousness

[ ] Confirm any clinical parameter recited functionally has a defined measurement method, instrument, and conditions.
- Why. Nautilus v. Biosig Instruments exposes functional recitation without a way to determine the boundary.
[ ] Confirm ranges and thresholds are tied to a stated measurement protocol.
[ ] Assess obviousness under 35 U.S.C. § 103 against the dense prior art typical of this art.
[ ] Harvest secondary considerations from the regulatory record — clinical outcomes, adoption data, documented long-felt need.
- Why. The record is generated anyway, and it is the best obviousness evidence most device companies hold.
[ ] Confirm the specification is broad enough to support later continuation claims, because a narrow specification forecloses the option regardless of how long the family stays live.

Phase 7. Continuation practice

[ ] [Gate] Keep a continuation pending through the approval gap.
- Why. Competitors' devices clear and publish during that gap, and a live family lets claims be drafted to them using the original priority date.
[ ] Do not abandon a family at issue while the product line is developing.
[ ] Confirm the specification supports the claims a competitor's clearance might invite.
[ ] Budget divisionals where restriction separates device, method, and manufacturing claims.
[ ] Confirm foreign equivalents, since continuation practice is not universal and some systems impose stricter divisional timetables.
[ ] Track term adjustment under 35 U.S.C. § 154 separately from regulatory delay.
[ ] Review pending families annually against the product roadmap and the predicate landscape.

Phase 8. Predicate monitoring

[ ] Monitor clearances in the product's classification as a standing task, not a periodic search.
[ ] Record each clearance summary's stated intended use and technological characteristics.
[ ] Compare against the company's pending claims and its continuation options.
[ ] Identify where a competitor's cleared device reads on a pending claim, and draft accordingly.
[ ] Identify where a competitor has cited the company's own device as a predicate.
[ ] Maintain a competitor register: entity, cleared products, indications, predicates cited, and assertion history.
[ ] Feed the register into both continuation strategy and freedom-to-operate analysis.
- Trap. Treating clearance summaries as a regulatory artefact rather than a competitive intelligence feed. They are the best public description of what a competitor actually built.

Phase 9. Design filings

[ ] Identify candidates: housing, handpiece, display bezel, cart, cartridge form, distinctive silhouette.
[ ] [Gate] File before any public disclosure — trade shows, investor presentations, clinical site placements, published clearance summaries.
- Why. Most foreign systems have no grace period, and design rights abroad are lost outright.
[ ] Claim in solid lines and disclaim in broken lines to control scope.
[ ] File multiple embodiments covering different feature combinations.
[ ] Consider an embodiment claiming only the distinctive element with the remainder disclaimed.
[ ] Include sufficient views to define the design completely.
[ ] Note no secondary meaning is required, which is the advantage over trade dress.
[ ] Note the term under 35 U.S.C. § 173 matches a device generation with no maintenance fees.
[ ] Confirm a design change after filing has not left the claimed design unmatched to the shipped product.

Phase 10. Trade dress

[ ] Identify elements used consistently across the product line — colour schemes, cartridge shapes, benchtop family appearance.
[ ] Assess functionality under TrafFix Devices v. Marketing Displays, noting most device form is driven by ergonomics, sterilisation, or manufacturing.
- Trap. Colour coding that signals a connector type is functional; a distinctive housing silhouette across a family may not be.
[ ] Confirm secondary meaning is being built, since Wal-Mart Stores v. Samara Brothers requires it for product configuration.
[ ] Write look-for advertising into campaigns directing attention to the appearance as a source indicator.
[ ] Maintain the file: dated examples across generations, advertising spend, sales figures, unsolicited press, and instances of copying.
[ ] Hold the elements constant across product generations, or nothing accumulates.
[ ] Consider a 15 U.S.C. § 1125 claim where a competitor's device or packaging mimics closely enough to cause confusion in a clinical setting, which is both a trademark and a safety argument.

Phase 11. Name clearance

[ ] [Gate] Run register clearance and the clinical confusion assessment in the same pass.
- Why. A proprietary device name is assessed for confusion risk with other device names, drug names, and bedside abbreviations. A name that clears the register can fail it, and a rebrand after submission costs the marketing spend plus the submission time.
[ ] Search the register in device, software, and services classes.
[ ] Assess descriptiveness and any suggestion of a performance characteristic the clearance does not support.
[ ] Assess look-alike and sound-alike risk against marketed device and drug names.
[ ] Confirm the name does not imply an indication outside the cleared use.
[ ] Confirm suitability in foreign markets where the product will be sold, including local confusion assessments.
[ ] File on an intent-to-use basis ahead of launch.
[ ] Confirm the mark is separate from any descriptive product designation used in the labelling.
[ ] Record the outcome of both tracks before the submission is filed.

Phase 12. Sale versus placement

[ ] [Gate] Decide before the first instrument ships, because it cannot be reversed for the installed base.
[ ] If sold, confirm Impression Products v. Lexmark International exhausts the instrument patents as to that unit regardless of post-sale restrictions, including for sales abroad.
[ ] Confirm Quanta Computer v. LG Electronics extends exhaustion where the item substantially embodies the invention.
[ ] Recognise that a single-use label does not make reuse infringement of the instrument patent.
[ ] If aftermarket revenue matters, confirm the consumable, the combination, or the interface is separately claimed.
[ ] If placing, confirm there is no authorised sale: title retained, permitted use defined, consumables sourced as specified, service by authorised parties, software licensed, and return on termination.
[ ] Confirm the arrangement is genuinely a service rather than a disguised sale, with a real service level.
[ ] Record the commercial rationale for the structure chosen.

Phase 13. Consumable control

[ ] Confirm the consumable itself is claimed.
[ ] Confirm the interface is claimed.
[ ] Confirm the combination of instrument and compliant consumable is claimed, reaching the user directly and the supplier by inducement.
[ ] Where authentication is used, confirm whether it protects copyrighted firmware, which engages 17 U.S.C. § 1201 independently of patent rights.
[ ] [Gate] Document the safety, calibration, or performance justification for every aftermarket restriction.
- Why. A restriction supported only by revenue is indefensible on competition grounds and reputationally, and this is the record that answers both.
[ ] Assess competition exposure where the company has market power, under the aftermarket reasoning in Eastman Kodak v. Image Technical Services as narrowed by Verizon Communications v. Trinko.
[ ] Apply the policy consistently across similarly situated customers.

Phase 14. Repair and reprocessing

[ ] Apply the repair and reconstruction line: replacing a worn component is repair; rebuilding the article from its remains is reconstruction.
[ ] Assess each accused activity on its facts, since the line is fact-specific.
[ ] For single-use device reprocessing, note the reprocessor is a manufacturer for regulatory purposes and must clear its reprocessed device.
- Why. The regulatory argument is frequently more effective than the patent one, and it is independent of it.
[ ] Confirm whether the reprocessed device is being marketed as equivalent to the original, which raises false designation exposure.
[ ] Assess whether a hospital reprocessing programme operates at commercial scale before considering it a target.
[ ] Confirm the labelling supports any single-use designation with a stated basis.
[ ] Record the clinical basis for single-use designation, because it is the answer to the reputational attack as well as the legal one.

Phase 15. Servicing access

[ ] Define the policy on access to service manuals, diagnostic software, calibration tools, and parts.
[ ] Confirm the policy is applied consistently across similarly situated requesters.
[ ] Record the safety and regulatory basis for any restriction.
[ ] Assess exposure where the company has market power in the service aftermarket.
[ ] Confirm no communications describe the purpose as disadvantaging independent servicers rather than protecting performance.
[ ] Assess whether refusing access to diagnostic software engages 17 U.S.C. § 1201 questions for those who circumvent it.
[ ] Confirm foreign markets where access obligations are imposed on manufacturers by law.
[ ] Review the policy annually, because market position changes and a restriction lawful at low share is a different question at high share.

Phase 16. Software change control

[ ] [Gate] Confirm whether the software is itself a regulated device under 21 U.S.C. § 321. See software as a medical device guidance.
[ ] [Gate] Build a change assessment gate into the release pipeline, owned by quality, with a named assessor.
- Trap. A software team shipping on its own cadence in a regulated product is the recurring compliance failure in this sector.
[ ] Assess each release for whether the modification could significantly affect safety or effectiveness, or changes the intended use.
[ ] Record the assessment and its basis for every release.
[ ] Negotiate a predetermined change control plan with an envelope as wide as the evidence supports, particularly for adaptive algorithms.
[ ] Run composition analysis over shipped firmware and distributed tooling.
[ ] Identify copyleft components in shipping code and remediate, noting remediation requires a change assessment as well as engineering effort.
[ ] Maintain the software bill of materials, which cybersecurity expectations require anyway — produce once, use twice.
[ ] Confirm cybersecurity documentation is current for connected devices.

Phase 17. Data rights

[ ] Map what the device collects: clinical data, telemetry, images, usage, and identifiers.
[ ] Confirm the consent basis under which each category was collected.
[ ] [Gate] Confirm the right to use data for product improvement, for model training, and for commercial purposes, in the placement agreement, the clinical trial agreement, and the customer contract.
- Trap. A study run under a template silent on downstream use forecloses the training question before it is asked.
[ ] Confirm de-identification standards where data is used beyond the treatment context.
[ ] Confirm retention limits, access rights, and deletion obligations are operationally supported.
[ ] Confirm cross-border transfer mechanisms for multinational deployments.
[ ] Confirm third-party processors are under adequate terms. See Licensing Data as a Commercial Asset.
[ ] Confirm what happens to data on termination of a placement or a customer relationship.

Phase 18. Promotional review

[ ] [Gate] Run one process across labelling and instructions, packaging, website and sales materials, and clinician-facing content.
- Why. POM Wonderful v. Coca-Cola means regulatory compliance is no answer to a competitor's false advertising claim under 15 U.S.C. § 1125, and competitors in this field bring them quickly.
[ ] Confirm no material promotes a use outside the cleared or approved indication, which is misbranding under 21 U.S.C. § 352.
[ ] Build a substantiation file before publication, with the basis for every performance, comparative, and outcome claim.
[ ] Scrutinise establishment claims, since a claim that studies prove a result invites scrutiny of the studies.
[ ] Confirm clinical data in a submission supports the claim, and that marketing has not extrapolated beyond it.
[ ] Confirm reprint and clinician communication distribution meets the applicable conditions.
[ ] [Gate] Train the sales force on the boundary between cleared indication and clinical practice.
- Why. Misbranding exposure is created verbally in the field, by people who were never told where the line is.
[ ] Re-review on every new claim, design change, new indication, and annually against current materials.

Phase 19. Term and marking

[ ] Model the effective commercial life: nominal expiry under 35 U.S.C. § 154 less the time consumed before clearance or approval.
[ ] [Gate] Assess extension eligibility under 35 U.S.C. § 156 at approval, because the conditions are narrow and the calculation unforgiving but the recovery is material.
[ ] Track term adjustment for office delay separately.
[ ] Assess extension availability in each foreign market on its own terms, since device eligibility differs from pharmaceutical eligibility.
[ ] Confirm marking under 35 U.S.C. § 287, noting devices are small and labels regulated, so virtual marking is the practical route.
[ ] Maintain the virtual marking page against the current portfolio, and verify it annually.
- Trap. A stale marking page quietly cuts off pre-suit damages on exactly the patents being asserted.
[ ] Confirm marking on packaging and instructions where physical marking is feasible.
[ ] Record the date of each verification.

Phase 20. Trade secrets and suppliers

[ ] Identify the process secrets: tolerances, cure schedules, surface treatments, sterilisation validation, and yield-critical settings.
[ ] Identify tooling and fixturing, yield and failure data, qualified supplier specifications, and algorithm tuning parameters.
[ ] Assess reasonable measures against 18 U.S.C. § 1836: site access controls, compartmentalisation, agreements executed before disclosure, marking, and exit acknowledgements.
[ ] [Gate] Confirm the contract manufacturer agreement contains confidentiality surviving termination indefinitely, a prohibition on producing similar devices defined by specific characteristics, ownership of process improvements, subcontracting restrictions with flow-down, audit rights, and destruction of specifications with tooling disposition.
[ ] Coordinate what enters the regulatory submission with what the company intends to keep secret, since regulatory records are discoverable.
[ ] Accept that reverse engineering is lawful and that the durable secrets are in the process rather than the product.
[ ] Audit supplier compliance annually.

Phase 21. Enforcement planning

[ ] Identify the realistic target before drafting method claims, since clinicians and hospitals cannot practically be sued.
[ ] Plan inducement against the supplier, with clinician conduct as the direct infringement.
[ ] Consider the reprocessor on the repair and reconstruction line, alongside the regulatory clearance argument.
[ ] Consider the third-party consumable supplier, which turns on whether the consumable and interface were claimed.
[ ] Consider 19 U.S.C. § 1337 at the trade agency, heavily used in this sector because an exclusion order runs on a statutory schedule and avoids the eBay v. MercExchange showing. See Section 337 at the ITC.
[ ] [Gate] Expect the public interest argument, which is available here and almost nowhere else, and prepare to show supply is available.
[ ] Expect the safe harbour at 35 U.S.C. § 271, read broadly in Merck KGaA v. Integra Lifesciences, to cover pre-launch development.
[ ] Assess damages under 35 U.S.C. § 284 with apportionment where the feature is one component of a system.
[ ] Confirm comparables from the industry's licensing history.

Phase 22. Cadence

[ ] Per submission. Filing gate cleared; features covered or deliberately released.
[ ] Per design freeze. Design filings before any disclosure; change notification if the design shifts afterwards.
[ ] Per release. Software change assessment documented; composition analysis run; bill of materials regenerated.
[ ] Per clearance published. Continuation reviewed against the summary; competitor register updated.
[ ] Monthly. Predicate landscape reviewed.
[ ] Quarterly. Three-track calendar review with regulatory, prosecution, and engineering present.
[ ] Annually. Marking page verified; substantiation file reconciled against current materials; supplier audits; trade dress file updated; servicing policy reviewed against market position; term and extension modelling refreshed.
[ ] On event. A new indication, a design change, a foreign market entry, an acquisition, a trade agency investigation in the category, or a competitor clearance reading on a pending claim.

Outcome. The four-year gap between issue and sale was not the problem; the missing handoff was. Regulatory now notifies patent counsel before every submission, and a coverage check confirms each feature is filed on or deliberately released. A continuation stays pending through every approval gap, and when a competitor's clearance published eleven months later the summary described a device that read on the pending specification — claims were drafted to it within the quarter. The cartridge and the interface were claimed for the next generation, and instruments moved to placement rather than sale, which put the aftermarket inside the contract as well as the patents. Design patents went in before the trade show, recovering foreign design rights that the previous generation had lost. The proprietary name cleared both tracks before submission for the first time. A change assessment gate went into the software release pipeline, owned by quality, and the predetermined change control plan was negotiated wide enough that routine retraining no longer triggers a submission. The portfolio did not get larger. It got pointed at the commercial act instead of the development one.

Phase 23. Diligence on a device company

[ ] Confirm the regulatory status of every product — cleared, approved, exempt, or pending — and the indication for each.
[ ] Confirm promotion has not exceeded the cleared indication, since misbranding exposure transfers.
[ ] [Gate] Assess whether diagnostic claims survive Mayo Collaborative Services v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetics, reading the file histories for eligibility rejections and the amendments made.
[ ] Model effective exclusivity rather than nominal expiry, and confirm whether extension was available and taken.
[ ] Confirm the consumable is claimed where the model depends on aftermarket revenue.
[ ] Confirm whether instruments are sold or placed, because exhaustion analysis differs entirely.
[ ] Run composition analysis over firmware, since copyleft in a regulated device requires a change assessment as well as remediation.
[ ] Confirm data rights for clinical and telemetry data, including training rights and the consent basis.
[ ] Confirm standards implemented and pool licences taken, with residual essential patent exposure identified.
[ ] Confirm the assertion history in the category, including trade agency investigations.
[ ] Confirm proprietary names were cleared on both tracks.
[ ] The recurring finding. A strong device portfolio, an unclaimed consumable, and a business model that depends on the consumable.

Phase 24. Scaling to the company

[ ] Single-product start-up. Utility filings before the submission on device and consumable; one continuation live; design patents before the first trade show; name cleared on both tracks; placement if the model depends on consumables; promotional review before the first sales deck.
[ ] Growth-stage device company. Add full claim layering including manufacturing methods, predicate monitoring feeding continuations, a foreign filing matrix aligned to the regulatory calendar, a substantiation file, and contract manufacturer terms with teeth.
[ ] Diagnostics company. Eligibility drafting dominates: reagent, apparatus, sample preparation. Assume correlation claims are unavailable and treat the instrument-consumable structure as the commercial protection.
[ ] Multinational manufacturer. Add the market matrix with regulatory, filing, and aftermarket columns; the European enforcement and revocation exposure decision; market-by-market extension assessment; and standard-essential exposure for connected devices.
[ ] Contract manufacturer or component supplier. The exposure inverts: confirm what the customer owns and what is retained, carve out general process know-how from any assignment, and confirm confidentiality does not prevent serving adjacent customers.
[ ] Reprocessor or independent service organisation. Almost pure defence: the repair line, the safe harbour, exhaustion, and the obligation to clear a reprocessed device in its own right.
[ ] [Gate] Confirm the programme matches the company's stage and model, because a diagnostics programme run at a hardware company leaves the eligibility exposure unaddressed and a hardware programme run at a diagnostics company files claims that will not survive.

Phase 25. If you can only do four things

[ ] File before the submission. One handoff, and it prevents the most expensive avoidable loss in the industry.
[ ] Claim the consumable and the interface. That is where the revenue is and where exhaustion otherwise leaves nothing.
[ ] Keep a continuation pending through the approval gap. Competitors publish during it, and a live family converts their clearance into your claims.
[ ] Put a change assessment gate in the software release pipeline. Owned by quality, with a named assessor, before every release.

Phase 26. Metrics

[ ] Filings made before the corresponding regulatory submission. Target one hundred per cent.
[ ] Products with a continuation pending through the approval gap.
[ ] Products with consumable and interface claims, where the model depends on aftermarket revenue.
[ ] Design patents filed before first public disclosure.
[ ] Diagnostic claims with the invention drafted into reagent, apparatus, or treatment step.
[ ] Effective commercial life after clearance, by product, trended.
[ ] Extension eligibility assessed at approval, as a percentage of products.
[ ] Software releases passing a documented change assessment. Target one hundred per cent.
[ ] Copyleft components in shipped firmware, and days to remediation.
[ ] Names cleared on both tracks before submission.
[ ] Promotional materials traceable to the substantiation file.
[ ] Marking page verified against the portfolio annually.
[ ] Contract manufacturer agreements containing the four required terms.
[ ] The one that matters. Whether any product's protection was lost or narrowed because a disclosure preceded a filing. Entirely preventable through one handoff, and recurrence means the handoff is not happening.

Phase 27. Working with other functions

[ ] Regulatory affairs. Three standing handoffs: notify legal before every submission; receive from legal the map of which claims depend on which features; review promotional materials together against one substantiation file.
[ ] Engineering. Notify legal on design changes after a design patent filing, so the claimed design still matches the shipped product.
[ ] Manufacturing. Own the compartmentalisation and the supplier terms that counsel specifies.
[ ] Quality. Own the software change assessment gate, because it will only hold inside the quality system.
[ ] Clinical. Confirm trial agreements address downstream data use before the study runs.
[ ] Sales. Trained on the indication boundary, repeatedly, because misbranding exposure is created verbally.
[ ] Foreign counsel. Instructed on the market matrix, with design filings sequenced before disclosures.
[ ] Corporate development. Given the product record, since the diligence questions are the same ones a buyer asks.

Phase 28. The one-page product record

Product — [name], [classification]. Regulatory: class [I / II / III]; route [exempt / notification / approval]; submission [date]; cleared or approved [date, number]; indication [text]; summary published [date]; predicates cited [list]; foreign approvals [markets, dates]. Filings: utility [numbers, filed before submission yes/no]; granted [numbers, expiry]; continuations pending [numbers]; design patents [numbers, before disclosure yes/no]; foreign [markets, status]. Claim layers: device / system / consumable / interface / manufacturing method / method of use / design [present or absent for each]. Eligibility: rejections [description]; amendments [summary]; diagnostic claims and where the invention sits [description]. Term: nominal expiry [date]; clearance [date]; effective life [years]; extension assessed [date, outcome]; adjustment [days]. Aftermarket: instruments [sold / placed]; consumable claimed [yes/no]; interface claimed [yes/no]; authentication [present, firmware copyrighted]; restriction justification [documented basis]; servicing policy [description]. Software: regulated [yes/no]; change gate [assessor named]; change control plan [scope]; composition analysis [date, copyleft N]; bill of materials [maintained]. Data: sources [list]; improvement rights [description]; training rights [permitted / not]; consent basis [description]. Marks: word mark [status]; clinical confusion assessment [date, outcome]; foreign [markets]. Trade dress: elements [list]; years consistent [N]; look-for advertising [campaigns]. Promotional: last review [date]; substantiation file [location]; sales training [date]. Trade secrets: process parameters [list]; contract manufacturer terms [four terms present yes/no]. Standards: [list]; pool licences [taken]; residual exposure [assessment]. Enforcement: assertions received [N]; trade agency matters in category [N]; marking page verified [date]. Outstanding actions: [list].

Key Authorities at a Glance

| Authority | Proposition | |---|---| | 35 U.S.C. § 101 | Eligibility | | 35 U.S.C. § 102 | Novelty; grace period | | 35 U.S.C. § 103 | Obviousness | | 35 U.S.C. § 112 | Enablement; definiteness | | 35 U.S.C. § 154 | Term; adjustment | | 35 U.S.C. § 156 | Patent term extension | | 35 U.S.C. § 171 | Design patents | | 35 U.S.C. § 173 | Design patent term | | 35 U.S.C. § 271 | Infringement; safe harbour | | 35 U.S.C. § 284 | Damages | | 35 U.S.C. § 287 | Marking and notice | | 21 U.S.C. § 321 | Definition of device | | 21 U.S.C. § 352 | Misbranded devices | | 21 U.S.C. § 360 | Premarket notification | | 21 U.S.C. § 360c | Classification | | 21 U.S.C. § 360e | Premarket approval | | 17 U.S.C. § 1201 | Anti-circumvention | | 18 U.S.C. § 1836 | Trade secret civil action | | 15 U.S.C. § 1125 | Trade dress; false advertising | | 19 U.S.C. § 1337 | Importation remedy | | Mayo Collaborative Services v. Prometheus Laboratories | Natural correlations ineligible | | Association for Molecular Pathology v. Myriad Genetics | Isolated DNA ineligible | | Alice v. CLS Bank International | Abstract idea framework | | Merck KGaA v. Integra Lifesciences | Safe harbour read broadly | | Amgen v. Sanofi | Enablement of genus claims | | Nautilus v. Biosig Instruments | Definiteness | | Impression Products v. Lexmark International | Exhaustion on authorised sale | | Quanta Computer v. LG Electronics | Exhaustion by substantial embodiment | | eBay v. MercExchange | Injunctive relief | | TrafFix Devices v. Marketing Displays | Functionality | | POM Wonderful v. Coca-Cola | Lanham Act alongside regulation | | Software as a medical device guidance | Regulatory treatment of software |

The five things people get wrong

One. They file after the submission. The dossier and the published clearance summary disclose what the application should already have covered. One handoff — regulatory notifies legal before filing — prevents the most expensive avoidable loss in this industry.

Two. They treat clearance as exclusivity. Substantial equivalence confers permission, creates a predicate for the next applicant, and publishes a summary that is a roadmap. The only exclusivity is in the portfolio.

Three. They claim the diagnostic correlation. Mayo Collaborative Services v. Prometheus Laboratories removed it and Association for Molecular Pathology v. Myriad Genetics removed the isolated sequence. The invention has to be drafted into the reagent, the apparatus, or the treatment step at the outset.

Four. They claim the instrument and not the consumable. Where the business model depends on aftermarket revenue and the consumable and interface are unclaimed, exhaustion under Impression Products v. Lexmark International leaves a label rather than a right.

Five. They ship software updates without a change assessment. Where the software is itself the device under 21 U.S.C. § 321, a modification affecting safety or effectiveness may require a new submission — and the assessment has to happen before release, by someone qualified.