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Protecting Cannabis – Are Plant Patents Cool Now?

With the rise of the legalized cannabis[1] industry, there is also a rise in legal questions about how to protect the cannabis-related inventions being developed by the industry. Many practitioners do not appreciate that there are three different statutory mechanisms in the United States to protect plant-related inventions: plant patents under 35 U.S.C. § 161 et sec., the Plant Variety Protection Act (PVPA) under 7 U.S.C. § 2321, and utility patents under 35 U.S.C. § 101.

Each of these statutes has different requirements and protections, so they are not mutually exclusive of each other.[2] In fact, the same Cannabis variety could be protected by more than one of these statutes at the same time. However, due to the differing requirements of each statutory mechanism, Cannabis plants are currently only protectable via plant and utility patents.

Plant Patents

Plant patents protect distinct and new varieties of plants that have been invented or discovered and asexually reproduced.[3] For plant patents, asexually reproduced includes almost any means of propagation except seeds.[4] However, plants that are capable of sexual reproduction are not excluded if they have also been asexually reproduced. Since Cannabis can be reproduced both sexually and asexually, they are eligible for protection under the plant patent statutes. One advantage of protection as a plant patent is that, because such protection arises under 35 U.S.C § 161 and not under 35 U.S.C. § 101, the issues regarding protection of products of nature under Section 101 do not arise for plant patents. As long as the plant breeder has aided the course of nature, then the plant is eligible for protection under § 161.

Another advantage of plant patent protection is that a deposit of seed or plant material is not required in order to meet the application requirements.[5] As will be discussed further, this currently provides an advantage over both PVPA and potentially utility patent protection because meeting the deposit requirement poses a unique challenge for Cannabis plants due to their status as a Schedule I federally controlled substance.

However, a disadvantage of plant patents is the limited scope of protection – the single plant shown and described in the specification. In fact, a plant patent is limited to a single claim that describes this plant, such as: “A new and distinct variety of hybrid Cannabis plant, substantially as illustrated and described herein.”

An additional limitation on the scope of protection provided by plant patents relates to infringement of the patent. While the plant patent statute affords the patentee the right to exclude others from asexually reproducing, selling, or using the protected plant, courts have found an infringer’s asexual reproduction of the plant is a necessary element in plant patent infringement.[6] For example, if a party uses a protected variety of Cannabis in their breeding program without permission, then the patent owner must show the potential infringer asexually reproduced the plant as part of that infringing use in the breeding program.

Although Cannabis plants are currently protectable via plant patents, there are a surprisingly low number of published applications and granted plant patents claiming Cannabis strains. As of the writing of this article, only one plant patent has been issued for a Cannabis variety. U.S. PP27,475 issued on December 20, 2016 for “Cannabis plant named ‘Ecuadorian Sativa.’”

Plant Variety Protection Act

The PVPA provides a similar scope of protection as that offered by plant patents, but for sexually reproduced plant varieties.[7] However, applications under the PVPA are reviewed and granted by the U.S. Department of Agriculture’s Plant Variety Protection Office, not the U.S. Patent and Trademark Office.

One advantage of PVPA protection is the potential for a longer term of protection than provided under the patent laws – twenty years from the date of issuance of the PVPA certificate in contrast to term of twenty years from the date of filing awarded to both plant and utility patents.[8]

In the context of Cannabis, an important distinction between an application under the PVPA and an application under the Plant Patent Act is the seed deposit requirement. The PVPA requires every application to contain “[a] declaration that a viable sample of basic seed (including any propagating material) necessary for propagation of the variety will be deposited and replenished periodically in a public repository….”[9]

To acquire PVPA protection, seed samples must be deposited at the National Laboratory for Genetic Resource Preservation located in Fort Collins, Colorado and available for public access following the 20-year PVPA protection term. The sample must consist of 3,000 untreated seeds that germinate at 85% or greater. Germination rate is tested periodically during examination and protection, and additional deposits may be requested if sample size is inadequate or is low in germination.[10]

The PVPA’s requirement of allowing public access to the seed sample following the expiration of the 20-year protection term is currently a firm roadblock when attempting PVPA protection for Cannabis plants. While legalized in some states for both recreational and medicinal use, cannabis remains a federally illegal Schedule I controlled substance. Under federal law, Schedule I controlled substances cannot be made publicly available. Because of this paradox between current cannabis laws and the PVPA seed deposit requirements, inventors in the cannabis industry are currently unable to gain protection via the PVPA.[11]

Utility Patents

Both sexually and asexually reproduced plants may also be protected under 35 U.S.C. § 101. The biggest advantage of protection of Cannabis varieties under traditional patent protection is the potential increase in the scope of protection afforded for the invention because the applicant is not limited to a single claim encompassing the entire plant. Instead, the applicant can seek protection for plant parts, tissues, cells or clones of the invented variety, as well as extracts or products made from the invented variety. The applicant can also seek protection for methods of making or using the invented variety.

Because the scope of protection is broader, the requirements for patentability are higher as well. Currently, the biggest hurdles for protecting Cannabis varieties under this approach are (1) passing the Mayo/Myriad test for patentable subject matter under 35 U.S.C § 101 (i.e., not a product of nature)[12] and (2) meeting the written description requirement under 35 U.S.C. § 112. When an invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, a deposit of the biological material (such as seed) can be made prior to or during the pendency of the application to help satisfy the written description requirements under 35 U.S.C. § 112.[13]

While this deposit option raises a controlled substance issue similar to that of PVPA protection, at least one applicant has figured out a way to circumvent this issue by making their seed deposit at an approved repository located outside of the United States.[14] The applicant deposited seed samples with the National Collections of Industrial, Food and Marine Bacteria (“NCIMB”) facility in the United Kingdom. The seed deposit was accepted by the International Depositary Authority, and then later converted to a deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedures. This method provides a significant advantage to the applicant because it requires that all parties to the Treaty, regardless of depository authority location, recognize the seed deposit as part of the patent procedure.

To date, there are several issued utility patents and pending utility patent applications that are directed to Cannabis plants, clones, plant parts, cells, or tissues that comprise certain amounts of cannabinoids and/or specific terpene profiles. For example, claim 1 of U.S. Patent No. 9,095,554, entitled “Breeding, production, processing and use of specialty cannabis,” recites:

A hybrid cannabis plant, or an asexual clone of said hybrid cannabis plant, or a plant part, tissue, or cell thereof, which produces a female inflorescence, said inflorescence comprising:

a) a BT/Bgenotype;

b) a terpene profile in which myrcene is not the dominant terpene;

c) a terpene oil content greater than about 1.0% by weight; and

d) a CBD content greater than 3%;

wherein the terpene profile is defined as terpinolene, alpha phelladrene, beta ocimene, careen, limonene, gamma terpinene, alpha pinene, alpha terpinene, beta pinene, fenchol, camphene, alpha terpineol, alpha humulene, beta caryophyllene, linalool, cary oxide, and myrcene, and wherein the terpene oil content is determined by the additive content of the terpenes in the terpene profile; and wherein the terpene contents and CBD content are measured by gas chromatography-flame ionization detection (GC-FID) and calculated based on dry weight of the inflorescence; wherein a representative sample of seed producing said plants has been deposited under NCIMB Nos. 42246, 42247, 42248, 42249, 42250, and 42254.

As another example, Claim 1 of pending U.S. Patent Application Publication No. 2016/0000843, entitled “High cannabidiol cannabis strains,” recites:

A cannabis cultivar that produces an assayable combined cannabidiolic acid and cannabidiol concentration of at least about 20% by weight.

There is also at least one pending utility application directed to transgenic Cannabis plants. Claim 1 of U.S. Patent Application Publication No. 20120311744, entitled “Marked cannabis for indicating medical marijuana,” recites:

A Cannabis plant stably transformed to express an extrinsic bio-marker.

Additionally, applicants have pursued utility patent applications on Cannabis plants via entering U.S. national phase from a pending International Application.[15] Although now abandoned, claim 1 of U.S. Patent Application Publication No. 2011/0098348, which was a U.S. National Phase Application of PCT/GB2009/000947, entitled “Cannabis sativa plants rich in cannabichromene and its acid, extracts thereof and methods of obtaining extracts therefrom,” recited:

A Cannabis sativa plant producing as its major cannabinoid cannabichromenic acid or cannabichromene (CBC(A)), characterised in that it comprises at least one genetic factor encoding prolonged juvenile chemotype (PJC) and it has a Bo/Bogenotype.

Conclusion

While plant patents are typically viewed as a less desirable protection option in the traditional agricultural industry, they provide a unique option for the developing cannabis industry. They allow a viable means of protection of varieties arising out of traditional breeding programs. They also avoid the difficulties associated with depositing biological materials for a Schedule I controlled substance that arise under the PVPA, while being significantly more cost effective than utility patents. Accordingly, for the cannabis industry, plant patents may become the preferred option to secure protection of Cannabis plant under the current federal climate.



[1] The authors italicized and capitalized “Cannabis” when referring to the biological genus name of the plant itself, but did not italicize the word when referring generically to the term.

[2] See J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124, 143-46 (2001) (holding that plants were eligible for utility patents under § 101 even though a separate statute, the PVPA, also provided for plant protection).

[3] See 35 U.S.C. § 161.

[4] Acceptable modes of asexual reproduction for purposes of plant patents can include, for example, rooting cuttings, apomictic seeds, division, layering, and grafting and budding. The purpose of asexual reproduction is to ensure uniformity of the plant. See General Information About 35 U.S.C. 161 Plant Patents, USPTO.GOV, https://www.uspto.gov/patents-getting-started/patent-basics/types-patent-applications/general-information-about-35-usc-161#heading-2 (last visited Oct. 10, 2017).

[5] See Manual of Patent Examining Procedure (MPEP) § 1605 (“The rules on Deposit of Biological Materials, 37 CFR 1.801-1.809, do not apply to plant patent applications in view of the reduced disclosure requirements of 35 U.S.C. 162, even where a deposit of a plant has been made in conjunction with a utility application (35 U.S.C. 101).”).

[6] See, e.g., Imazio Nursery Inc. v. Dania Greenhouses, 69 F.3d 1560 (Fed. Cir. 1995).

[7] See 7 U.S.C. § 2402(a).

[8] See 7 U.S.C. § 2483(b).

[9] 7 U.S.C. § 2422(4)

[10] See PVPO Frequently Asked Questions, AMS.USDA.GOV, https://www.ams.usda.gov/services/plant-variety-protection/pvpo-frequently-asked-questions (last visited Oct. 11, 2017).

[11] This information was obtained by speaking directly with a representative at the USDA’s Plant Variety Protection Office.

[12] See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012); see also Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (noting that “a new plant found in the wild is not patentable subject matter” under § 101).

[13] See MPEP § 2403.02 (“[T]he deposit of plant material together with the written specification must enable those skilled in the art to make and use the claimed invention.”)

[14] See, e.g., File History for U.S. Application No. 14/742,493, Exhibits A-D to the Office Action Response Filed on Dec. 23, 2015. However, the same applicant deposited cellular samples representative of the claimed Cannabis plants at a U.S. depository as indicated by the claims of a patent in the same family. See claims 1 and 19 of U.S. Patent No. 9,642,317 (reciting specific Bigelow National Center for Marine Algae and Microbiota (“NCMA”) accession numbers, which is a WIPO-designated International Depositary Authority located in Maine).

[15] Patenting plant-based inventions in international jurisdictions is challenging because plants are not considered patent-eligible subject matter in every country. For example, while plants are patentable in Australia, they are not patentable in Canada and China. In Europe, the Administrative Council of the European Patent Office recently amended the rules of the European Patent Convention to exclude plants obtained from essentially biological processes from patentability. This rule took effect on July 1, 2017. See Rule 28(2) EPC (“European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.”).

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