Plant and Agricultural IP Checklist: Route Selection, Deposit and Description, Seed Agreements, Exhaustion, and Enforcement Evidence

By Casey Scott McKay · 2024-07-04

This checklist runs a plant and agricultural intellectual property programme against the deadlines that actually bind, starting with the disposition diary because every novelty bar runs from it and nobody reconstructs it accurately afterwards. It works route selection across the three regimes, then the mechanics of each filing - the plant patent description, the variety certificate and its denomination, the utility claim layers, and the biological deposit whose accessibility carries the enablement basis. It covers germplasm provenance and inbred security, trait and grower agreements with the formation discipline that decides whether the contractual layer holds, and sampling with chain of custody. It closes with defences, proportionate enforcement, marking, and the three-calendar matrix.

IP and Technology > Patent Counseling Transactions | Checklist | Published 4 July 2024 - Updated 3 December 2024 | Casey Scott McKay - marksy.us

Summary. This checklist runs a plant and agricultural intellectual property programme against the deadlines that actually bind, starting with the disposition diary because every novelty bar runs from it and nobody reconstructs it accurately afterwards. It works route selection across the three regimes, then the mechanics of each filing — the plant patent description, the variety certificate and its denomination, the utility claim layers, and the biological deposit whose accessibility carries the enablement basis. It covers germplasm provenance and inbred security, trait and grower agreements with the formation discipline that decides whether the contractual layer holds, and sampling with chain of custody. It closes with defences, proportionate enforcement, marking, and the three-calendar matrix.

Keywords: plant IP checklist · route selection · disposition diary · novelty bars · plant patent application · PVP application · denomination selection · utility claim layers · biological deposit accessibility · germplasm provenance · inbred security · winter nursery contracts · trait licence terms · stacking provisions · technology use agreement formation · audit and sampling · chain of custody · seed conditioner liability · marking and bag tags · regulatory matrix

How to use this checklist

| Phase | What it covers | |---|---| | 1 | The disposition diary | | 2 | Route selection | | 3 | Plant patent filing | | 4 | Variety certificate filing | | 5 | Denomination and brand | | 6 | Utility claim layers | | 7 | The biological deposit | | 8 | Germplasm provenance | | 9 | Inbred and nursery security | | 10 | Material transfers | | 11 | Trait licences | | 12 | Increase and bailment | | 13 | The grower agreement | | 14 | Formation discipline | | 15 | Marking and bag tags | | 16 | Detection | | 17 | Sampling and custody | | 18 | Claims and defences | | 19 | Proportionality | | 20 | The three calendars |

Boxes marked [Gate] must clear before material leaves the programme, before a filing deadline passes, or before an enforcement action begins.

The matter. The variety was excellent, the patent application was well drafted, and the foreign rights were gone before it was filed — because forty plants went to a trial grower eighteen months earlier under no agreement at all.

Phase 1. The disposition diary

[ ] [Gate] Record the earliest disposition date for every variety, at the time it happens.
- Why. Every novelty bar runs from it — 35 U.S.C. § 102 for patents and 7 U.S.C. § 2402 for certificates — and reconstructing it later from shipping records is unreliable.
[ ] Treat each of these as a disposition: sale of seed or plants; distribution to trial growers without an agreement; supply to a retailer for evaluation; a published catalogue description; entry in a public trial where material is disclosed; distribution at a trade show.
[ ] Confirm these are not dispositions: confidential trials under agreement, internal testing, breeding within the programme, regulatory submissions.
[ ] Record the domestic bar date and the foreign bar dates separately, because they differ.
- Trap. Assuming the foreign window matches the domestic one. It is frequently shorter, and a variety sold domestically may be time-barred abroad sooner than the calendar suggests.
[ ] Diary the filing deadline from the disposition date, not from the release decision.
[ ] Review the diary at every release meeting with the breeding team.

Phase 2. Route selection

[ ] Determine the propagation method: asexual points to 35 U.S.C. § 161; sexual or tuber points to 7 U.S.C. § 2402; a utility patent is available either way after J.E.M. Ag Supply v. Pioneer Hi-Bred International.
[ ] [Gate] Identify the commercial threat — a breeding competitor or a replicating customer.
- Why. 7 U.S.C. § 2544 exempts breeding use from a certificate entirely, so a breeding competitor is reached only by a utility patent.
- Trap. Assuming a certificate stops a competitor breeding from the variety. It does not, and this is the most consequential misunderstanding in the field.
[ ] Assess whether the variety would survive obviousness under 35 U.S.C. § 103, noting the certificate has no such requirement.
[ ] Determine whether the value sits in the variety or in a trait moving across varieties.
[ ] Determine whether the parent lines are the real asset, which for hybrids they usually are.
[ ] Identify the markets, noting that foreign protection runs largely through breeder's rights with an essentially derived variety provision.
[ ] Write a one-page route memorandum stating what is filed, what is kept secret, and why.

Phase 3. Plant patent filing

[ ] Confirm asexual reproduction has been performed and the characteristics held true through it.
[ ] Confirm the plant was not found in an uncultivated state, which 35 U.S.C. § 161 excludes.
[ ] Identify the closest comparison variety and describe the plant against it.
- Trap. A description that stands alone without positioning against the nearest known variety invites a rejection and produces a weaker patent.
[ ] Prepare a botanical description covering the distinguishing characteristics.
[ ] Tie every colour designation to a recognised colour chart.
[ ] Prepare colour photographs or drawings that actually show the claimed characteristics.
[ ] State the origin — parentage or the circumstances of discovery — and the location of the asexual reproduction.
[ ] Draft the single claim in formal terms as 35 U.S.C. § 162 permits.
[ ] Confirm the origin statement does not admit a public disposition outside the grace period.
[ ] Note the rights are limited to asexual reproduction of that plant under 35 U.S.C. § 163, so independent breeding is not reached.

Phase 4. Variety certificate filing

[ ] Confirm the four criteria: new, distinct, uniform, stable.
[ ] Confirm novelty against the disposition diary, including the longer foreign disposition period.
[ ] Prepare an objective description with comparison data against the most similar varieties.
[ ] Prepare the breeding history.
[ ] [Gate] Prepare the seed deposit, which becomes the reference sample for any later infringement comparison.
[ ] Confirm the deposited material is representative, viable, and correctly identified.
[ ] Confirm replacement obligations are understood and diarised.
[ ] Note there is no obviousness requirement, which is why a certificate is available where a patent is not.
[ ] Note the term under 7 U.S.C. § 2483 — twenty years, twenty-five for trees and vines.
[ ] Note the exemptions the certificate carries and record them in the route memorandum, so nobody later assumes protection it does not give.

Phase 5. Denomination and brand

[ ] [Gate] Choose the denomination and the commercial brand at the same meeting, and keep them separate.
- Why. The denomination becomes generic by operation of the certificate and 15 U.S.C. § 1052 will refuse it as generic for the goods.
- Trap. Letting marketing choose the denomination, then discovering the goodwill sits in a term the company loses.
[ ] Confirm the denomination is not misleading as to characteristics, value, or origin.
[ ] Confirm it does not conflict with a denomination for the same or a closely related species.
[ ] Confirm the same denomination will be used in every country, which is a coordination requirement most companies discover late.
[ ] File the commercial brand on an intent-to-use basis ahead of launch.
[ ] Cover the classes the plan contemplates — seeds and agricultural products, and the processed goods the crop becomes.
[ ] For a trait licensed across varieties, treat the trait mark as the consumer-facing asset and control its use in the licence.
[ ] Consider a certification mark under 15 U.S.C. § 1054 where a grower association wants a regional designation, with written standards and consistent enforcement.
[ ] Confirm no mark or claim implies a characteristic the regulatory seed label cannot support.

Phase 6. Utility claim layers

[ ] Claim the construct or isolated sequence where eligible.
[ ] Claim the plant, the seed, the plant part, and the progeny.
[ ] Claim methods of producing the plant.
[ ] Claim methods of using it.
[ ] Claim the hybrid produced from identified parents.
- Why. Each layer catches conduct the others miss, and a portfolio with only variety-level claims does not reach a trait moving into another variety.
[ ] [Gate] Screen eligibility against Association for Molecular Pathology v. Myriad Genetics — a naturally occurring sequence is not eligible merely because isolated.
[ ] Assess enablement and written description under 35 U.S.C. § 112, noting that Amgen v. Sanofi exposes functional genus claims supported by a handful of events.
[ ] Assess obviousness under 35 U.S.C. § 103, which is the real hurdle and which the certificate route avoids.
[ ] Confirm the claim set reaches the actual commercial threat identified in phase 2.

Phase 7. The biological deposit

[ ] Deposit with a recognised international depositary authority.
[ ] Make the deposit before or at filing, and add the accession number to the specification.
[ ] Obtain confirmation of viability.
[ ] [Gate] Obtain and file an accessibility statement confirming the material will be available to the public on issue, without restriction beyond what the regulations permit.
- Why. 37 C.F.R. § 1.801 makes accessibility the operative condition, and a deposit that fails it is an enablement failure the applicant generally cannot cure after issue.
[ ] Confirm the replacement obligation if the material becomes non-viable or unavailable.
[ ] Confirm the term extends at least thirty years from deposit or five years beyond the last request.
[ ] Diary the maintenance and any renewal or fee obligations.
[ ] Record the deposit details in the variety record alongside the filings.
[ ] Confirm foreign filings requiring their own deposits are covered, since not every jurisdiction accepts the same depositary.

Phase 8. Germplasm provenance

[ ] Record every accession entering the programme with its source and the agreement it came under.
[ ] [Gate] Identify material collected in other countries and confirm access permissions were obtained.
- Trap. Material collected without access-and-benefit-sharing permissions may be commercially unusable regardless of the breeding result, and the defect surfaces in diligence.
[ ] Record material from gene banks and their onward transfer restrictions.
[ ] Record material from universities and public institutes, and confirm any Bayh-Dole obligations that travel with it.
[ ] Record material from commercial sources and what the transfer agreement permitted.
[ ] Size the unknown-provenance category and treat it as a finding rather than a documentation gap.
[ ] Confirm no protected variety entered as a breeding parent where the applicable regime does not permit it.
[ ] Retain the provenance record for the life of any line descended from the accession.

Phase 9. Inbred and nursery security

[ ] Identify what is actually secret: inbred parental lines, unreleased elite material, marker-trait associations, pedigree records, nursery locations, and pre-publication trial data.
[ ] Identify what is not: the commercial hybrid, published descriptions, and anything deposited.
[ ] Restrict nursery access with logging.
[ ] Hold field plot maps separately from the plant material.
[ ] Restrict greenhouse and growth chamber access.
[ ] [Gate] Reconcile seed store inventory against plantings, and treat an unreconciled inventory as a finding.
[ ] Restrict marker and pedigree databases by role, with export logging.
- Trap. A breeder who can download the entire pedigree file is a breeder who can leave with it.
[ ] Execute confidentiality agreements with breeders, technicians, nursery contractors, and analytical laboratories before access.
[ ] Obtain exit acknowledgements recording what the departing person could reach.
[ ] Assess the programme against the reasonable measures standard in 18 U.S.C. § 1836.
[ ] Accept that reverse engineering is lawful and that a released hybrid tells a sophisticated competitor a great deal about its parents.

Phase 10. Material transfers

[ ] [Gate] Permit no material to leave the programme without a transfer or trial agreement.
- Why. This is the single control that prevents the disposition failure in phase 1 and the germplasm leak in phase 9.
[ ] State the purpose and prohibit any other use.
[ ] Prohibit propagation beyond what the purpose requires.
[ ] Prohibit onward transfer.
[ ] Require return or destruction on completion, with certification.
[ ] Confirm the arrangement is confidential, so the transfer is not a public disposition.
[ ] Apply the same discipline to universities and gene banks, which are the routine leak.
[ ] Winter nurseries. Address custody, prohibition on retaining or propagating samples, destruction of surplus and volunteers, audit rights, and local personnel confidentiality.
- Trap. Counter-season nurseries hold breeding material outside direct supervision under contracts that are frequently thin.
[ ] Maintain a transfer register: material, recipient, date, purpose, restrictions, and the return or destruction confirmation.
[ ] Review the register before any transaction, because a transfer years earlier surfaces in diligence.

Phase 11. Trait licences

[ ] Define the field and crops by species and market segment.
[ ] Define the territory by reference to where the trait has regulatory approval, not by commercial preference.
[ ] Specify the royalty basis — per unit, per acre, per bag, or a share of the technology fee — and the measurement mechanism.
[ ] [Gate] Address stacking: whether the licensee may combine the trait with others, from whom, and how the royalty stack is allocated.
- Why. Products routinely carry traits from several owners, and without a stacking provision reducing each rate proportionately subject to a floor the economics break.
[ ] Flow down quality and stewardship obligations — refuge requirements, resistance management, application practices — to the licensee's own customers.
[ ] Permit sublicensing to distributors and growers, which the structure requires.
[ ] Allocate regulatory responsibility: who obtains approvals in which markets, who maintains them, and what happens if one lapses.
[ ] Address pipeline varieties on termination — whether varieties in development may be completed and sold, and for how long.
[ ] [Gate] Obtain an indemnity for third-party claims that the trait infringes.
- Why. A defective trait contaminates every variety carrying it, and the licensee's exposure vastly exceeds the licence fee.
[ ] Confirm the indemnitor can support the indemnity, and negotiate a supercap above the general liability cap.

Phase 12. Increase and bailment

[ ] State expressly that the grower holds the company's material as bailee.
[ ] Require delivery of the entire production.
[ ] Prohibit retention of any portion.
[ ] Require destruction or return of surplus and screenings, with certification.
[ ] Prohibit planting volunteers in following seasons, and specify the isolation and rotation requirements.
[ ] Include inspection rights during the growing season.
[ ] Address conditioning, storage, and the identity preservation requirements.
[ ] Confirm the interaction with any public certification system's class structure and agency rules.
[ ] Confirm insurance and loss allocation for the bailed material.
[ ] Diary the destruction certifications, because an uncollected certification is an uncontrolled inventory.

Phase 13. The grower agreement

[ ] State the grant: a single commercial crop, from the seed purchased, on identified acreage.
[ ] Prohibit saving seed for replanting.
[ ] Prohibit transferring seed to any other party for planting.
[ ] Prohibit supplying the harvest into seed channels.
[ ] Prohibit planting outside permitted territories, since a trait deregulated in one country may not be in another.
[ ] Prohibit use for breeding or research.
[ ] Require delivery of the entire harvest to commercial channels.
[ ] Require compliance with stewardship obligations.
[ ] Require retention of purchase records and field maps for a defined period.
[ ] [Gate] Include entry, inspection, and sampling rights on notice.
- Why. Infringement is proved by sampling and genetic comparison, and a contractual right of access converts an expensive investigation into a routine visit.
[ ] Specify consequences: termination of the right to purchase, liquidated damages as a genuine pre-estimate, and costs.
[ ] Specify dispute resolution and forum, because these disputes are geographically dispersed.
[ ] Note that Bowman v. Monsanto settles deliberate replanting of patented seed, and the contract carries everything the patent does not.

Phase 14. Formation discipline

[ ] [Gate] Present the terms before or at purchase, not afterwards.
- Why. A term nobody was shown binds nobody, and the contractual layer carries most of the enforcement in this field.
[ ] Obtain a signature or a recorded electronic assent.
[ ] Retain the assent record against the purchase transaction.
[ ] Reference the terms on the bag and in the invoice.
[ ] Confirm any amendment was communicated and assented to rather than merely posted.
[ ] Renew annually, or take an annual acknowledgement under a multi-season term, so the record is current.
[ ] Train sales staff on formation, because they are the people presenting the agreement at a counter.
- Trap. Assuming a bag tag reference alone creates a binding agreement with a purchaser who never saw the terms.
[ ] Audit a sample of transactions annually to confirm the records exist.
[ ] Confirm the retained record identifies the purchaser, the variety, the quantity, and the date.

Phase 15. Marking and bag tags

[ ] Confirm bag tags carry current patent numbers, or use virtual marking with a maintained page.
- Why. 35 U.S.C. § 287 conditions damages on marking or actual notice, and stale numbers quietly cut off pre-suit damages.
[ ] Verify the marking page against the current portfolio at least annually.
[ ] Confirm the tag carries the denomination and the brand as distinct elements.
[ ] Confirm the regulatory seed label content — germination, purity, noxious weed, origin — is present and accurate.
[ ] Confirm the technology use agreement reference and how to obtain the terms.
[ ] [Gate] Review the tag as one document across legal, regulatory, and marketing.
- Why. It is the only artefact the grower actually sees, and it carries four separate compliance functions.
[ ] Update tags on every reformulation, variety substitution, or portfolio change.
[ ] Retain specimens of each season's tags, dated.

Phase 16. Detection

[ ] Build the purchase-to-acreage picture from the company's own records, because it establishes the discrepancy that justifies everything that follows.
[ ] Monitor reports from other growers, which is how most matters actually begin.
[ ] Monitor seed conditioner and cleaning facility activity.
[ ] Monitor retail channels for bagged seed of protected varieties.
[ ] Note that a conditioner cleaning saved seed for replanting may itself infringe under 7 U.S.C. § 2541, which reaches conditioning for propagation.
[ ] Note that a conditioner's records identify every grower it served, which is why it is frequently the efficient target.
[ ] Record every report with date, source, and the acreage or volume alleged.
[ ] Assess proportionality before escalating, per phase 19.

Phase 17. Sampling and custody

[ ] Sample from identified locations with coordinates and photographs.
[ ] Record the date, the sampler, and the conditions.
[ ] Take control samples of the company's own material from the same season.
[ ] Seal and label each sample uniquely.
[ ] [Gate] Maintain an unbroken chain of custody document from field to laboratory.
- Trap. A sampling record with a gap is a case with a gap, and defendants test it first.
[ ] Retain a portion untested for the defendant's own analysis.
[ ] Document the consent and its scope where entry is under the agreement's inspection clause.
[ ] Where consent is unavailable, sample from public land, commercial channels, or under process.
[ ] Instruct a laboratory able to testify to its methods, validation, and error rates.
[ ] Compare against the deposited reference sample or the internal reference.
[ ] Preserve field photographs with metadata, the purchase history, the agreement and its formation record, and the laboratory report.

Phase 18. Claims and defences

[ ] Plead utility patent infringement under 35 U.S.C. § 271 where utility claims exist.
[ ] Plead plant patent infringement under 35 U.S.C. § 163, noting it requires asexual derivation from the patented plant.
[ ] Plead certificate infringement under 7 U.S.C. § 2541.
[ ] [Gate] Plead the contract claim alongside the statutory ones, because it survives an invalidity finding and carries liquidated damages.
[ ] Anticipate farm-saving under 7 U.S.C. § 2543, construed narrowly after Asgrow Seed v. Winterboer and limited to the farmer's own holding.
[ ] Anticipate the research and breeding exemption under 7 U.S.C. § 2544, which is a complete answer to a certificate claim against a breeding competitor.
[ ] Anticipate exhaustion, addressed for deliberate replanting by Bowman v. Monsanto — planting is making, not using — with Impression Products v. Lexmark International not resolving self-replication.
[ ] Anticipate adventitious presence, where the trait arrived by pollen drift or volunteer carryover.
[ ] Anticipate invalidity, particularly obviousness and enablement.
[ ] Anticipate formation attacks on the agreement.
[ ] Assess injunctive relief under eBay v. MercExchange, where a practising seed company is usually well placed.

Phase 19. Proportionality

[ ] [Gate] Decide the enforcement posture before the first matter arises, not during one.
[ ] Reserve litigation for commercial-scale saving operations and seed conditioners rather than individual growers.
[ ] Publish stewardship expectations plainly, so a grower knows what is required before breaching it.
[ ] Publish an adventitious presence policy disclaiming enforcement where presence is genuinely accidental.
- Why. There is no clean statutory answer to pollen drift, and a published policy is worth more than the cases it forgoes.
[ ] Settle individual matters quietly.
[ ] Assess reputational exposure alongside recovery on every matter.
- Trap. The legal position may be entirely sound and the story will still be told the other way, because the defendant is a farmer and the plaintiff is not.
[ ] Agree the communications posture with the business before escalating.
[ ] Record every matter by target type and outcome, and review the mix annually.

Phase 20. The three calendars

[ ] Maintain the breeding calendar: crossing, generation advance, winter nurseries, yield trials, release decision.
[ ] Maintain the filing calendar: disposition dates, domestic and foreign novelty windows, priority deadline, national phase entries, deposit.
[ ] Maintain the regulatory calendar: event characterisation, safety assessment, domestic approval, import approvals per destination market.
[ ] [Gate] Build them as one document and review it quarterly with breeding, regulatory, and legal present.
[ ] Confirm the filing decision precedes any public disposition.
[ ] Confirm the regulatory submission follows the priority filing, never precedes it.
[ ] Confirm foreign filings are made before foreign commercialisation windows close, which may be sooner than the domestic one.
[ ] Confirm the denomination chosen domestically will work in every country where a breeder's right is sought.
[ ] Model the term remaining after regulatory approval, because a patent granted years before import approval loses a substantial share of its life to a queue.
[ ] Maintain the market matrix with three columns per market — filing status, regulatory status, access obligations — reviewed quarterly.

Phase 21. Abroad

[ ] Confirm the protection route in each market, noting most countries use a breeder's right rather than a patent and several exclude plants from patentability.
[ ] Assess essentially derived variety exposure, which closes the gap the domestic research exemption leaves open. See international convention for the protection of new varieties of plants.
[ ] Confirm the foreign novelty window at the first disposition, not at filing.
[ ] Confirm farm-saving exceptions in each market, which vary in scope and frequently carry a remuneration obligation.
[ ] Claim priority from the first filing and coordinate national or regional applications.
[ ] Confirm each market's deposit requirements, since not every jurisdiction accepts the same depositary.
[ ] Confirm import approvals in destination markets, because grain moves further than the filing programme contemplates.
[ ] Confirm access-and-benefit-sharing obligations for any material collected abroad.
[ ] Confirm export control of germplasm where it applies.
[ ] Instruct local counsel for the first filing in any new jurisdiction and reuse what is learned.

Phase 22. If you can only do four things

[ ] Record the disposition date at the time it happens. Every bar runs from it, and it cannot be reconstructed reliably.
[ ] Let no material leave without an agreement. One control, and it prevents both the novelty loss and the germplasm leak.
[ ] File utility claims where the threat is a breeding competitor. The certificate exempts exactly that conduct.
[ ] Get the deposit accessibility statement on file. A defective deposit is an enablement failure with no cure after issue.

Outcome. The trial shipment that lost the foreign rights was the finding that changed the programme. A trial agreement template went into the shipping process, so that no material — to growers, universities, gene banks, or retailers — leaves without terms stating purpose, prohibiting propagation and onward transfer, and confirming confidentiality. A disposition diary was added to the variety record and populated at the point of shipment rather than at the release meeting. The route memorandum became a standing item, and the next three varieties were filed before any distribution, with utility claims where a breeding competitor was the threat and certificates where obviousness would have defeated a patent. The deposits were audited: two lacked accessibility statements and were corrected while the applications were still pending. Denominations and brands were separated at naming, and two marks were filed that would previously have been lost to genericness. The grower agreement was re-presented at the counter with a retained assent record, after a formation review found the prior version referenced only on a bag tag. Bag tags were reconciled against the current portfolio and two stale patent numbers removed. Nothing about the breeding programme changed. The rights that survive to the end of it did.

Phase 23. Diligence on an agricultural portfolio

[ ] Identify what is actually protected and by what, since a portfolio described as protected varieties may be certificates alone.
[ ] Confirm each deposit is with a recognised depositary, viable, replaceable, and publicly accessible on the required terms.
[ ] Obtain the germplasm provenance record, with the agreement each accession came under.
[ ] Confirm inbred security measures, because a hybrid programme whose parents have leaked is worth much less than its filing count suggests.
[ ] Review trait licences for stacking, sublicensing, territory, crops, and pipeline treatment on termination.
[ ] Confirm grower agreements are enforceable, with formation records and a history of enforcement.
[ ] Confirm regulatory approvals by market, and note they do not transfer as easily as patents.
[ ] Confirm the brand is separate from the denomination.
[ ] Review the enforcement record and whether the technology use agreement has ever been tested.
[ ] [Gate] Model the expiry cliff across all three regimes, because it is frequently closer than the seller's presentation implies.

Phase 24. Cadence

[ ] Per shipment. Transfer or trial agreement executed before material leaves.
[ ] Per disposition. Date recorded contemporaneously in the variety record.
[ ] Per release decision. Route memorandum written; filings elected; secrets recorded.
[ ] Per filing. Deposit made, accession added to the specification, accessibility statement obtained.
[ ] Per season. Bag tags verified against the current portfolio; seed inventory reconciled; destruction certifications collected.
[ ] Per licence. Stacking, stewardship flow-down, regulatory allocation, and indemnity confirmed.
[ ] Quarterly. The three-calendar review with breeding, regulatory, and legal present.
[ ] Annually. Germplasm security audit; provenance record refresh; nursery contract review; marking page verification; enforcement mix review; foreign filing matrix refresh.
[ ] On event. A new market, a trait approval or lapse, a breeder departure, a nursery change, an acquisition, or a report of unauthorised saving.

Phase 25. Metrics

[ ] Varieties with a route memorandum completed before first filing.
[ ] Disposition dates recorded contemporaneously, as a percentage.
[ ] Material transfers executed before shipment. Target one hundred per cent.
[ ] Filings made before any public disposition. Target one hundred per cent.
[ ] Deposits with an accessibility statement on file.
[ ] Accessions with documented provenance, and the size of the unknown category.
[ ] Winter nursery contracts containing destruction and audit obligations.
[ ] Grower agreements with a retained formation record, sampled annually.
[ ] Bag tags verified against current patent numbers.
[ ] Trait licences containing stacking and stewardship flow-down.
[ ] Markets current in the three-column matrix.
[ ] Enforcement matters by target type, and the proportion resolved without litigation.
[ ] The one that matters. Whether any variety lost protection in any market because a disposition preceded a filing. Entirely preventable, and recurrence means the disposition discipline is not working.

Phase 26. Scaling to the client

[ ] Ornamental breeder or small nursery. Plant patents on the varieties worth it, filed before any distribution; one mark; a propagator licence with an audit right; a trial agreement template. Skip certificates and utility filings, and spend the budget on filing promptly rather than filing more.
[ ] Specialty crop or vegetable breeder. Add certificates, since the crops are seed-propagated and obviousness would defeat utility filings on many varieties. Add denomination discipline, a separate brand, and increase agreements with bailment terms.
[ ] Row crop and trait company. The full programme — layered utility claims, supplementary certificates, inbreds as secrets with real nursery and database security, trait licences with stacking and stewardship flow-down, grower agreements with formation discipline, and a regulatory matrix driving the commercial calendar.
[ ] Licensee seed company. The exposure inverts: confirm what the inbound trait licence permits, whether the indemnity is worth anything, and what happens to pipeline varieties on termination. Maintain the stewardship flow-down, because breach of it is the usual termination trigger.
[ ] Public institute or university programme. Bayh-Dole compliance dates and election deadlines run alongside everything above, with no cure for a missed election. Material transfer discipline matters most here, because academic sharing norms and germplasm security pull in opposite directions.
[ ] Grower association. A certification mark under 15 U.S.C. § 1054 with written standards, records, and consistent enforcement, plus provenance for any heritage material.
[ ] [Gate] Confirm the programme matches the client's crop economics. An ornamental programme run at a row crop company leaves the trait unprotected; a row crop programme run at a nursery spends the whole budget before the first patent issues.

Key Authorities at a Glance

| Authority | Proposition | |---|---| | 35 U.S.C. § 101 | Utility patent eligibility | | 35 U.S.C. § 102 | Novelty; grace period | | 35 U.S.C. § 103 | Obviousness | | 35 U.S.C. § 112 | Enablement; written description | | 35 U.S.C. § 154 | Term | | 35 U.S.C. § 161 | Plant patents | | 35 U.S.C. § 162 | Description and claim | | 35 U.S.C. § 163 | Rights conferred | | 35 U.S.C. § 271 | Infringement | | 35 U.S.C. § 287 | Marking and notice | | 7 U.S.C. § 2321 | Plant Variety Protection Act | | 7 U.S.C. § 2402 | Requirements for protection | | 7 U.S.C. § 2483 | Certificate contents and term | | 7 U.S.C. § 2541 | Infringement; conditioning | | 7 U.S.C. § 2543 | Farmer saved seed | | 7 U.S.C. § 2544 | Research exemption | | 18 U.S.C. § 1836 | Trade secret civil action | | 15 U.S.C. § 1052 | Registrability; generic terms | | 15 U.S.C. § 1054 | Certification marks | | 37 C.F.R. § 1.801 | Biological deposits | | J.E.M. Ag Supply v. Pioneer Hi-Bred International | Utility patents for plants | | Bowman v. Monsanto | Planting is making | | Asgrow Seed v. Winterboer | Farm-saving narrow | | Diamond v. Chakrabarty | Living matter patentable | | Association for Molecular Pathology v. Myriad Genetics | Isolated sequences ineligible | | Amgen v. Sanofi | Enablement of genus claims | | Impression Products v. Lexmark International | Exhaustion on authorised sale | | eBay v. MercExchange | Injunctive relief | | International convention for the protection of new varieties of plants | Breeder rights abroad |

The five things people get wrong

One. They assume a certificate stops a breeding competitor. 7 U.S.C. § 2544 exempts use of a protected variety for plant breeding outright, and the competitor may commercialise the result. Only a utility patent reaches that conduct, which is why every seriously commercial variety in a competitive crop carries utility claims.

Two. They let material leave without an agreement. Forty plants to a trial grower, a sample to a retailer, an entry in a public trial — each is a disposition that starts the novelty clock under 35 U.S.C. § 102 and 7 U.S.C. § 2402, and the foreign window closes first.

Three. They botch the deposit. A 37 C.F.R. § 1.801 deposit that is not publicly accessible on the required terms is an enablement failure, and it is generally not curable after issue.

Four. They market under the denomination. The denomination is generic by operation of the certificate and 15 U.S.C. § 1052 will refuse it. A company that built its goodwill there owns nothing when protection lapses.

Five. They present the grower agreement badly. These terms are delivered at a sales counter or on a bag tag, and a term nobody was shown binds nobody — which undoes the contractual layer that carries most of the enforcement.