Plant Variety

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).

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:

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:

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.

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.

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 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.