Plant Patents

Plant patents cover asexually reproduced new and distinct plant varieties: STATUTE — 35 U.S.C. § 163: 'Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor'; ASEXUAL REPRODUCTION REQUIREMENT: the variety must be capable of reproduction by asexual means (budding; grafting; cutting; apomictic seeds; layering); this excludes most cereal crops; corn; soybeans; and other field crops that are reproduced from seed (sexually reproduced); DISTINCT AND NEW REQUIREMENTS: DISTINCT: the variety must differ from known varieties in at least one distinguishing characteristic; characteristics may be visual (flower color; leaf shape; growth habit; fruit size); or non-visual (disease resistance; improved yield — but utility patent may be better for non-visual traits); NEW: the variety must not have been sold or released to the public more than 1 year before the US filing date; analogous to the § 102(b) grace period; WHAT CAN BE CLAIMED: a single plant variety as shown by description and characteristics; plant patents cannot claim the underlying genetic material (gene patents require utility patents); EXCLUSIONS: tuber propagated plants (potatoes; Jerusalem artichokes) — explicitly excluded; plants found in an uncultivated state (wild plants that weren't cultivated); PROTECTION TERM: 20 years from filing date; same as utility patents under current law; SCOPE OF PROTECTION: the plant patent owner has the right to exclude others from asexually reproducing the plant; using; offering for sale; or selling the plant so reproduced; importing the plant; SINGLE CLAIM: like design patents, plant patents have a single claim describing the plant variety; DRAWINGS: photographs or botanical line drawings are essential for plant patent applications; IMPORTANCE IN HORTICULTURE: plant patents are extensively used for fruit trees; roses; ornamentals; and ornamental shrubs; less commonly used in agriculture (where PVPA or utility patents are preferred).

The PVPA provides a certificate-based system for sexually reproduced varieties: WHAT THE PVPA PROTECTS: the Plant Variety Protection Act of 1970 (7 U.S.C. §§ 2321-2582) provides intellectual property protection for sexually reproduced plant varieties (varieties reproduced from seed); this fills the gap left by plant patents (which require asexual reproduction); PVPA CERTIFICATE REQUIREMENTS: NOVEL: variety not sold by or with the consent of the owner more than 1 year before US filing; 4 years abroad for seeds; 6 years for vines/trees; DISTINCT: distinguishable from all known prior plant varieties; UNIFORM: any variations are describable; predictable; commercially acceptable; STABLE: unchanged reproduction characteristics through repeated cycles; ADMINISTRATION: PVPA is administered by the USDA (not the USPTO); certificates are issued by USDA's Agricultural Marketing Service (AMS); TERM: 20 years from issuance (25 years for trees and vines); SCOPE OF PROTECTION: PVPA certificates protect against unauthorized sale; offering for sale; reproduction; export; import; and conditioning (preparing for sale) of the protected variety and varieties that are 'essentially derived' from it; KEY DIFFERENCES FROM PLANT PATENTS: (1) REPRODUCTION: plant patent = asexual only; PVPA = sexual (seed reproduction); (2) ADMINISTRATOR: plant patent = USPTO; PVPA = USDA; (3) EXEMPTIONS: PVPA includes two significant exemptions plant patents do not have: RESEARCH EXEMPTION: breeders may use PVPA-protected varieties for plant breeding research without infringing; this promotes innovation by allowing development of new varieties; FARMER'S EXEMPTION: farmers may save and replant seed from PVPA-protected varieties for their own farm use; this is a controversial exemption that limits PVPA's value for commercial seed companies; these exemptions do NOT apply to utility patents (see J.E.M. Ag Supply v. Pioneer Hi-Bred); (4) EXAMINATION: PVPA = administrative examination (less rigorous than USPTO); plant patent = USPTO examination.

J.E.M. Ag Supply established that plants are patentable as utility patents: J.E.M. AG SUPPLY v. PIONEER HI-BRED INTERNATIONAL (S.Ct. 2001): THE QUESTION: can sexually reproduced plants (specifically hybrid corn seed) be protected by utility patents under 35 U.S.C. § 101, in addition to the more specific Plant Patent Act (§ 163) and PVPA? THE HOLDING: YES — utility patents cover plants; the more specific plant-specific statutes (Plant Patent Act; PVPA) do not displace utility patent protection for plants; BACKGROUND: Diamond v. Chakrabarty (S.Ct. 1980) held that 'anything under the sun made by man' is patentable subject matter under § 101; J.E.M. applied Chakrabarty's broad interpretation to specifically include newly developed plant varieties; SIGNIFICANCE FOR THE SEED INDUSTRY: utility patents on plant varieties are NOT subject to the PVPA farmer seed-saving exemption; utility patents are NOT subject to the PVPA research exemption; a farmer who saves and replants utility patent-protected seed INFRINGES the patent (no exemption); this transformed the commercial seed industry — Monsanto and DuPont Pioneer could now use utility patents to prevent saved seed planting; MONSANTO TECHNOLOGY AGREEMENTS: after J.E.M., Monsanto (now Bayer) required farmers to sign Technology/Stewardship Agreements as a condition of purchasing patented seeds; the agreements prohibit saving seed; Bowman v. Monsanto Co. (S.Ct. 2013): a farmer cannot exhaust a seed patent by planting purchased seeds because growing new seeds is making copies, not using the original; the patent is not exhausted by the sale of the first-generation seed when it comes to producing second-generation seed; WHAT CAN BE PATENTED UNDER UTILITY PATENTS: plant varieties (whole plant claims); seeds; plant traits (specific genes; genetic constructs); transformation methods; plant-derived chemicals; proteins expressed in plants; utility patents on plants can have hundreds of claims covering all aspects of the variety.

Seed saving and research exemptions are among the most contested issues in agricultural patent law: FARMER SEED-SAVING HISTORY: historically, farmers saved seeds from one harvest to plant the following season; plant-IP law has progressively limited this practice; PVPA FARMER EXEMPTION: under the PVPA, farmers are permitted to save seed produced on their farm from PVPA-protected varieties for their own use in replanting on their own farm; farmers CANNOT sell saved seed as propagating material or condition it for sale; this exemption is limited to the farmer's own use; utility patents: NO farmer exemption; Bowman v. Monsanto (S.Ct. 2013) — patent exhaustion does not allow saving and replanting; MONSANTO CANADA v. SCHMEISER (S.Ct. Canada 2004): a Canadian farmer whose canola fields were contaminated with patented Roundup Ready canola (apparently from neighboring fields or wind) was found liable for patent infringement because he saved and replanted seed that happened to contain the patented gene; the fact that he did not purchase the patented seed was irrelevant once he knowingly selected and replanted it; RESEARCH EXEMPTION: US utility patent law has NO statutory research exemption for plant patents; the common law experimental use exemption is extremely narrow (mere curiosity; no commercial purpose; Madey v. Duke University, Fed. Cir. 2002); universities and public breeding programs that use patented varieties for research technically infringe unless they have a license; PVPA research exemption: PVPA explicitly allows breeders to use PVPA-protected varieties in breeding programs without a license; this is why PVPA is less commercially attractive than utility patents for seed companies (competitors can use your variety as a parent in breeding programs); INTERNATIONAL CONTEXT: UPOV Convention (Union for the Protection of New Varieties of Plants): an international treaty; two acts (1978 and 1991) with different standards; UPOV 1978: allows more farmer seed-saving and research rights; UPOV 1991: stronger protection closer to patent rights but still includes a breeders' exemption (research exemption; limited farmer privilege); developing countries have more flexibility to limit protection; most developed countries follow UPOV 1991; FOOD SOVEREIGNTY MOVEMENT: NGOs and some governments argue that strong plant IP rights harm farmers in developing countries by making seed unaffordable and preventing traditional seed-saving practices; this has led to international debates on balancing innovation incentives with farmers' rights.

The optimal plant IP strategy depends on the type of innovation and commercial goals: COMPARISON OF PROTECTION TYPES: PLANT PATENT (35 U.S.C. § 163): BEST FOR: asexually reproduced ornamentals; fruit trees; ornamental shrubs; ADVANTAGES: relatively simple prosecution; no examiner interview required (often allowed without rejection); no maintenance fees; strong 'as-reproduced' protection; DISADVANTAGES: limited to asexually reproduced varieties; narrow single-claim scope; no protection for genomic material; PLANT VARIETY PROTECTION CERTIFICATE (PVPA): BEST FOR: sexually reproduced field crops and vegetables where research exemption impact is limited; ADVANTAGES: USDA administration (less expensive than USPTO); 'essentially derived variety' protection (covers close derivatives); DISADVANTAGES: farmer seed-saving exemption; research exemption (competitors can use for breeding); weak enforcement history; UTILITY PATENT: BEST FOR: novel plant traits; genes; genetic constructs; sexually reproduced varieties where strict licensing required; ADVANTAGES: broad multi-claim protection; no farmer seed-saving exemption; no research exemption; can cover genes + traits + varieties simultaneously; DISADVANTAGES: more expensive to obtain ($15-50K); more complex prosecution; higher maintenance fees; maintenance required; BIOTECH PLANT STRATEGY (MONSANTO/BAYER MODEL): patent the key enabling traits (herbicide resistance genes; insect resistance traits; drought tolerance); license trait patents to seed companies along with transformation services; seed companies breed and sell varieties; farmers sign stewardship agreements; TRAIT PATENTS have broad claims covering: the specific gene/construct; plants containing it; seeds; methods of producing the plant; COMBINATION STRATEGY: for new crop varieties with novel traits: (1) utility patent on the trait/gene itself; (2) plant patent or PVPA on specific elite varieties that incorporate the trait; (3) contract law (stewardship agreements; bag-tag licenses) to control downstream use; INTERNATIONAL STRATEGY: PCT for major agricultural markets; UPOV-member country protection via national offices; key markets: US; EU; Brazil; Argentina; China; India; Australia.