Plant Variety

Three distinct federal legal frameworks protect plant varieties in the US: UTILITY PATENT (35 U.S.C. §§ 1-376): the strongest protection; covers any plant variety (sexually or asexually reproduced; tubers included); protects: making, using, selling, offering to sell, importing; can cover: the plant itself; the plant's seeds; methods of using the plant; the plant's genetic traits; NO farm-saved seed exception under utility patent law — growers must purchase new seed each season; Diamond v. Chakrabarty (S.Ct. 1980): living organisms can be patented; JEM Ag Supply v. Pioneer Hi-Bred (S.Ct. 2001): utility patents can protect plants notwithstanding the plant-specific statutes; term: 20 years from filing; PLANT PATENT (35 U.S.C. §§ 161-164): limited to ASEXUALLY REPRODUCED plant varieties (not grown from seed); covers: grafted, budded, cut, layered, divided plants; does NOT cover: sexually reproduced (seed-grown) plants; tuber-propagated plants (potatoes, Jerusalem artichokes); protects: the VARIETY (not the plant's parts or seeds separately); narrow scope: one claim per variety; term: 20 years from filing; PLANT VARIETY PROTECTION (PVP) (7 U.S.C. §§ 2321-2582): administered by USDA (not USPTO); covers: sexually reproduced varieties (grown from seed); also: tuber-propagated varieties (potatoes); EXCEPTIONS: research exemption (researchers can use PVP-protected variety for research and breeding without license); saved-seed exemption: farmers can save seed for replanting own land under certain conditions; certificate term: 20 years (trees/vines: 25 years).

Each regime has distinct eligibility requirements: UTILITY PATENT FOR PLANTS: eligible subject matter: any plant variety meeting standard patent requirements; requirements: novelty (§ 102); non-obviousness (§ 103); written description (§ 112); enablement (depositing seeds with ATCC or another depository may be required for full enablement of some varieties); deposit requirement: for varieties that cannot be fully described in writing, a biological deposit is required; claims may cover: specific gene sequences; transformed plants; breeding methods; phenotypic traits (e.g., 'a plant having drought tolerance > X'); PLANT PATENT: eligibility: asexually reproduced — by grafting, budding, cutting, layering, division (NOT seed); the variety must be: NOVEL: distinct from known varieties at filing date; DISTINCT: clearly distinguishable from other known varieties; UNIFORM: stable and uniform in its essential characteristics after reproduction; NOT FOUND IN UNCULTIVATED STATE: cannot be a variety discovered in the wild and merely reproduced; application: one claim per variety; claim describes the overall variety, not its parts; PLANT VARIETY PROTECTION CERTIFICATE: eligibility: sexually reproduced or tuber-propagated varieties; the variety must be: NEW: not sold or disposed of to others for more than 1 year in the US or 4 years (6 years for trees/vines) abroad; DISTINCT: clearly distinguishable from all prior known varieties; UNIFORM: sufficiently uniform in relevant characteristics; STABLE: remains unchanged after repeated reproduction; UPOV COMPLIANCE: US PVP implements UPOV 1978 (not the stricter UPOV 1991); UPOV 1991 provides no saved-seed exception and stricter 'essentially derived variety' (EDV) rules.

The saved-seed exception is a central policy distinction between utility patents and PVP certificates: UNDER UTILITY PATENT: NO saved-seed exception; seed saved from a patented variety = making the patented invention; each season's replanting requires new licensed seed; Monsanto Canada v. Schmeiser (Canada S.Ct. 2004): farmer who saved patented canola seed infringed, regardless of whether saving was intentional; US courts apply the same principle; UNDER PVP CERTIFICATE: saved-seed exception (7 U.S.C. § 2543): a farmer who purchases PVP-protected seed may save seed for replanting on own holding; limits: saved seed may only be used on the farmer's own land; cannot sell or transfer saved seed to others for reproductive purposes; the exemption is designed to protect traditional farming practices; PRACTICAL LIMITS: modern hybrid seed does not reproduce true-to-type in the second generation — farmers have limited practical incentive to save hybrid seed regardless of legal status; saved-seed exception mainly valuable for open-pollinated (non-hybrid) varieties; RESEARCH EXEMPTION (PVP): any person may use a PVP-protected variety for research purposes without license; can breed using PVP-protected variety as parent to create new varieties; the new variety developed using PVP material may be freely sold without license (unless it is an 'essentially derived variety'); this research exemption does NOT exist in utility patent law; ESSENTIALLY DERIVED VARIETIES (EDV): UPOV 1991 concept (not in US PVP under UPOV 1978): a variety that is predominantly derived from another variety but only differs in a few traits; EDV status means the EDV variety still requires a license from the original variety's rights holder; US PVP does not currently fully implement EDV provisions — a key difference from European PVP.

Genetically engineered (GE/GMO) plants are primarily protected by utility patents: PATENT PROTECTION FOR GE PLANTS: utility patents protect both the transgene (inserted genetic sequence) and the plant containing it; protection extends to: the specific DNA sequence; the promoter elements; the transformation event (the specific insertion site); the plant variety containing the event; seed produced from the plant; downstream growers' crops containing the patented trait; SEED LICENSING: GE seed companies (Bayer/Monsanto, Corteva, Syngenta) license GE seed under technology agreements; farmers agree not to save seed; farmers agree to purchase new seed each season; violation = patent infringement; TRAIT STACKING: multiple GE traits from different companies may be in the same seed variety; each trait is separately licensed; technology use agreements (TUAs) govern the combined license; cross-licensing between companies enables stacking; PATENT TERM AND TRAIT ACCESS: as Monsanto's original Roundup Ready (glyphosate tolerance) patents expired, competitors introduced generic Roundup Ready seeds; farmers can access expired traits without technology agreement; stacked traits with later expiration dates remain licensed; BROWN BAG SEED: selling or giving patented seed without license = infringement; investigations and enforcement are active; BOLAR EXEMPTION: 35 U.S.C. § 271(e)(1): activities solely for developing information for regulatory submissions are not infringement; broader than pharma context — may allow some research activities with GE plants for regulatory purposes; GENE PATENTS AND § 101: Ass'n for Molecular Pathology v. Myriad Genetics (S.Ct. 2013): naturally occurring DNA sequences (isolated from nature) are not patentable; synthetic cDNA is patentable; GE plant genes that are synthetically designed or modified are generally patentable.

International plant variety protection differs significantly from US law: INTERNATIONAL UNION FOR PROTECTION OF NEW VARIETIES (UPOV): the primary international framework for PVP; two main acts: UPOV 1978 (US implements this version) and UPOV 1991 (EU and many countries implement this); UPOV 1978 vs. 1991: 1978: stronger saved-seed exception; no EDV provisions; 1991: no saved-seed exception (except members may include narrow exception); EDV provisions (essentially derived variety); broader breeder's right scope; EUROPEAN COMMUNITY PLANT VARIETY RIGHTS (CPVR): EU-wide protection; administered by CPVO (Community Plant Variety Office); implements UPOV 1991; covers all plant genera and species; research and breeding exemptions; saved-seed exception for farmers (small farmers exempt from royalties); EUROPEAN PATENTS: European patents can also protect plants and plant breeding methods; BRÜSTLE case (CJEU) and similar cases restrict patenting of plant varieties under EPC Rule 27 (exclusion of essentially biological processes); JAPAN: PVP under Seeds and Seedlings Act; implements UPOV 1991; CHINA: Plant Variety Protection Regulations; implements UPOV 1978 elements; growing importance for agricultural biotech; DEVELOPING COUNTRIES: TRIPS Article 27(3)(b): members may exclude plants and animals from patentability but must provide protection for plant varieties either by patents, by an effective sui generis system, or by a combination; creates flexibility — many developing countries use UPOV-based systems rather than utility patents; INTERNATIONAL SEED TREATIES: ITPGRFA (Treaty on Plant Genetic Resources for Food and Agriculture): establishes a Multilateral System for access and benefit sharing of major food crops; members exchange plant genetic material under standard terms.