Intellectual Property of Plants and Plant Products: Is Fruit Juice Eligible for Patent Protection?

Abstract

In the past few years, the Supreme Court of the United States has issued a number of decisions on the eligibility of natural products and methods involving natural compositions for patent protection under 35 U.S.C. § 101. Following this lead, the United States Patent and Trademark Office (USPTO) issued a guidance memorandum (Guidelines) earlier this year to aid patent examiners and applicants in determining whether new patent application claims relating to natural products are eligible for patent protection. In the present article, we expand on a previously published article in this journal to focus on how the recent Supreme Court decisions and USPTO Guidelines may affect the patent eligibility of claims directed towards plants and plant products.¹

Protecting Plant Intellectual Property

In the US, there are three potential ways to protect an invention relating to plants and/or plant products. The first is a so-called “utility” patent, which is the standard US patent used to protect most types of inventions. Some people may not be aware that utility patents can also be used to cover certain compositions of plants and/or plant products and methods of making or using such compositions. In addition, if the invention is a new plant with desirable features that distinguish it from a known variety from which it derives, then the plant may be subject to protection with a “plant patent” or under the Plant Variety Protection Act (PVPA). In some situations, the possibility exists to protect a plant, for example, a new variety of hybrid tea rose, using all three mechanisms: a utility patent; a plant patent; and a certificate under the PVPA.

Utility Patents

In 1980, the US Supreme Court affirmed in Diamond v. Chakrabarty that living organisms can constitute patent eligible subject matter under 35 U.S.C. § 101.¹ In 2001, the Court provided additional clarification in J.E.M. Ag Supply v. Pioneer Hi-Bred that utility patents could also cover plants. The Court explicitly held that rights under US utility patents, plant patents, and PVP certificates were not mutually exclusive, and the USPTO “has assigned utility patents for plants for at least 16 years, and there has been no indication from either Congress or agencies with expertise that such coverage is inconsistent with the PVPA or the PPA.”²

Notably, a utility patent remained the sole option among the three mentioned here for ensuring protection of compositions and methods related to organisms such as bacteria, yeast, fungi, and algae, as well as new products derived from plants. However, given the US Supreme Court's more recent decisions, for example, in Myriad and Mayo v. Prometheus, and the recent USPTO Guidelines, it may now be impossible to obtain (or maintain) a US utility patent for a naturally occurring plant or certain natural products derived from plants.^4,5 However, it should still be possible to obtain a utility patent on a genetically modified plant or products derived from such a plant.

Plant Patents

Initially, all plants were considered to be products of nature and thus not eligible for patent protection. This standard changed when Congress passed the Plant Patent Act (PPA) in 1930 to promote the horticulture industry. Plants became eligible for patent protection under 35 U.S.C. § 161, which states that a plant patent is available for “[w]hoever 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, subject to the conditions and requirements of this title.”

As the above statute indicates, plant patents cannot provide protection for all plants. Only asexually reproduced plants are eligible. For example, tuber propagated plants, such as the potato or the Jerusalem artichoke, are not eligible, because the tuber portion of the plant used for asexual reproduction is also the portion that is available as a food product. In addition, plants “found in an uncultivated state” are also excluded, as they are still considered to be products of nature.

In 1940 the Court of Customs and Patent Appeals in In re Arzberger limited the definition of “plant” to commonly recognized plants, and held that bacteria cannot be protected with a plant patent, even though some authorities at the time considered bacteria to be closely related to plants.³ In Arzberger, the court determined that, as far as the Plant Patent Act is concerned, the standard dictionary definition of plant as a “young tree, shrub, or herb, planted or ready to plant; a slip, cutting, or sapling”⁴ applied, and that “Congress, in the use of the word ‘plant,’ was speaking ‘in the common language of the people,’ and did not use the word in its strict, scientific sense.”^7,5 By analogy, this ruling also removed yeast, fungi, and single-celled algae from plant patent eligibility.

Nevertheless, for example, a new and distinct variety of transgenic tobacco plant created by engineering and asexual reproduction (e.g., by grafting methods), may be eligible for plant patent protection. Such a plant patent application requires a description of the variety and its distinctiveness compared to known varieties, and typically contains a drawing or photograph of the plant. Unlike a utility patent described above, the plant patent is limited to a single claim describing the new plant variety itself. Plant patents are unaffected by the recent Supreme Court cases and the USPTO Guidelines, since they are governed by different US statutory sections (35 U.S.C. § 161–163).⁶

Plant Variety Protection Act

The Plant Variety Protection Act (PVPA) was enacted in 1970 and amended several times since then to extend protection to owners of new and distinct varieties of plants that were seed and tuber propagated.⁷ Unlike plant or utility patents that are governed by US Department of Commerce and USPTO rules, the US Department of Agriculture (USDA) issues a Plant Variety Protection (PVP) certificate. Owners of production crops often pursue such certificates. Similar to plant patents, PVP certificates require a description of the distinct characteristics of the new variety. An application must also include the breeding history, if known, and a seed sample deposit.⁸ The seed sample deposit must include an amount of viable seed to determine reduction to practice (typically about 2,500 seeds) and must be deposited with the USDA. Perhaps in consideration of the legal history of the Plant Patent Act, PVP certificates explicitly exclude bacteria and fungi from eligibility.⁹ PVP certificates are governed by 7 U.S.C. § 2402, and are thus also not affected by the recent Supreme Court decisions and new USPTO Guidelines concerning eligible subject matter under 35 U.S.C. § 101.

Comparison of the Different Types of Intellectual Property Protection for Plants

One possible reason to consider a plant patent, a PVP certificate, and a utility patent to protect a new plant variety is that the scope of protection may be different and complementary. Plant patents offer limited protection to a single, specific variety according to 35 U.S.C. § 163. In addition, the Court of Appeals for the Federal Circuit in Imazio Nursery confirmed that, as with US utility patents, the burden on proving infringement of a US plant patent is on the patent holder.¹⁰ Furthermore, it is insufficient simply to state that an allegedly infringing variety has the same essential characteristics of that covered by the plant patent:¹⁴

The statute requires asexual reproduction of the patented plant for there to be infringement. It is necessarily a defense to plant patent infringement that the alleged infringing plant is not an asexual reproduction of the patented plant. Part of this proof could be, thus, that the defendant independently developed the allegedly infringing plant.

Thus, plant patents, unlike utility patents, are quite narrow in their scope, as they do not cover the actions of anyone who independently develops a plant that might be very similar in appearance to the patented plant.

On the other hand, PVP certificates protect not only the variety in question, but also those “essentially derived from a protected variety.”¹¹ As defined in the PVPA, a variety described as “essentially derived” means the following:¹⁶

(i) is predominantly derived from another variety (referred to in this paragraph as the 'initial variety') or from a variety that is predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety;

(ii) is clearly distinguishable from the initial variety; and

(iii) except for differences that result from the act of derivation, conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety.

Thus, a PVP certificate may provide protection for a variety and closely related plants, beyond the single variety coverage provided by a plant patent. Further, the owner of a PVP certificate can prevent activities such as selling, stocking, conditioning, sexual multiplying, or tuber propagating a protected plant variety, notwithstanding several exceptions including a “farmer's exception,” which allows a farmer to “sell for reproductive purposes only such seed as he has saved for the purpose of replanting his own acreage.”¹² That is, farmers could save seeds to plant their own fields. Importantly, an issued PVP certificate also bars the unauthorized importing and exporting of a covered plant, the latter of which is not protected by either plant patents or utility patents.¹⁸

Utility patents covering plants may offer additional coverage, because, for example, they can significantly limit the saving of seeds that is permitted under the farmer's exception of the PVPA. Last year, in Bowman v. Monsanto Co., the Supreme Court held that a utility patent covering Monsanto's genetically modified Roundup® Ready soybeans, “does not permit a farmer to reproduce patented seeds through planting and harvesting without the patent holder's permission.”¹³ While the Court indicated that the Bowman decision was “limited — addressing the situation before us, rather than every one involving a self-replicating product,” companies as diverse as those using transgenic microorganisms for fermentation may be emboldened to set up licenses with tight restrictions on permitted end uses to follow the language of the Monsanto licenses involved in this case.²⁰

Potential Impact of Recent USPTO Guidelines on Plant Intellectual Property

As mentioned above, the recent USPTO Guidelines apply only to utility patents that are subject to evaluation under 35 U.S.C. § 101. In contrast to a plant patent or a PVP certificate, a utility patent may cover not only a plant itself, but also a composition derived from the plant, if it can be determined based on the Guidelines that the plant or composition is not a natural product such as “proteins and peptides; and other substances found in or derived from nature,” but is “markedly different” from what is found in nature.¹⁴ Although the subject matter at issue in the Myriad case was isolated nucleic acid sequences, the USPTO has concluded that the implications of the decision are broader, and that claims directed to foods, such as fruits, grains, or vegetables, and organisms, including plants, will now need to be evaluated under the “markedly different” standard. The major questions that remain are how “markedly different” from a natural product a new plant or product will need to be for patent eligibility, and how that difference will be determined.

As described in detail in the previous article, the USPTO will now use 12 factors weighing for or against patent eligibility to determine the answer to the third question USPTO Examiners must consider when evaluating patent claims that relate in any way to a natural product, natural law, or natural phenomenon:¹

Question 3: “Does the claim as a whole recite something significantly different than the judicial exception(s)?” If no, the claim is patent ineligible. If yes, the claim is patent eligible.

The USPTO has given hypothetical examples to aid Examiners and the public in determining which claims would be patent eligible.⁹ In one instance, the Guidelines state that a claim reciting “a beverage composition comprising: a) pomelo juice; and b) a preservative” includes mixtures that are not markedly different from what exists in nature. Because the “preservative” is not defined, the USPTO interpreted the claim broadly to include naturally occurring preservatives such as vitamin E. The fact that pomelo juice and vitamin E do not occur together in nature does not render the claim eligible for patent protection, because “a marked difference requires a product to be both (1) non-naturally occurring and (2) markedly different in structure.”⁹ Further, it is not sufficient that the claim encompasses one or more non-naturally occurring, patent-eligible examples, because every example within the scope of the claim must be patent eligible. Thus, the USPTO indicates that this claim is patent ineligible.

Another hypothetical example includes a claim directed to “a beverage composition comprising pasteurized pomelo juice.” The patent application describes “pasteurization” as a process that damages the chemical structure of vitamin C and flavonoids in the juice, thus providing a juice with a different taste and lower nutritional value than the naturally occurring juice. Therefore, the USPTO Guidelines consider the pasteurized pomelo juice to be “markedly different” than what exists in nature, and thus the claim was held to be patent eligible.

A third example shows how, in some cases, careful analysis of the evidence as a whole must be performed before determining whether a claim is patent eligible. For the claim: “a beverage composition comprising: a) pomelo juice; and b) preservative X,” several factors were relevant in evaluating patent eligibility. Weighing in favor of eligibility were the following factors:

• Preservative X was non-naturally occurring, and was structurally different from that which exists in nature. It was thus markedly different than what occurred naturally.

• Presence of preservative X meaningfully limited the claim scope to a particular application of the natural pomelo juice.

• Preservative X was more than nominally related to the natural product, because it formed part of the composition and prevented juice spoilage.

• The presence of the preservative more than just described pomelo juice, but was a specific instruction to use the natural product in an application.

Factors that weighed against a determination of patent eligibility included:

• Pomelo juice was a natural product.

• Preservative X in this hypothetical instance was well-understood, purely conventional, and routine in the beverage industry.

• Preservative X was not required to be used with pomelo juice. Pomelo juice could be used freshly squeezed or pasteurized, for example.

Because the balance of factors weighed in favor of patent eligibility, the USPTO concludes that the claim in this third example is patent eligible.

Obtaining the Right Protection

Given the recent US Supreme Court cases and USPTO Guidelines that are likely to impose significant limits on the use of utility patents to protect plants and plant products that are not significantly different from “natural products,” inventors today should carefully consider all of the options discussed here to obtain the best protection for their new plant-related inventions. Each option has its benefits and limitations, and neither plant patents nor PVP certificates cover all types of new plants, but they might be better options in the right case than utility patents. On the other hand, if the new plant is genetically altered by the inventor, or if a plant product is somehow significantly altered from its natural state, then a utility patent should be a viable option and, if granted, would provide broader protection than a plant patent or PVP certificate.

References

Shult

, Fasse

, The United States Patent & Trademark Office's current view on patent eligibility. Ind Biotechnol, 2014; 10(3):156–158.

Diamond v. Chakrabarty , 447 U.S. 303 (1980).

J. E. M. Ag Supply, Inc., dba Farm Advantage, Inc., et al. v. Pioneer Hi-Bred International, Inc. , 534 U.S. 124 (2001).

Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., 569 U.S. __ (2013).

Mayo Collaborative Services, dba Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., 566 U.S. __ (2012).

In re Arzberger, 112 F.2d 834 (1940).

Id. at 837.

Id. at 838.

United States Patent and Trademark Office. Evaluating Subject Matter Eligibility under 35 USC 101: March 2014 Update, March 19, 2014 presentation.

10.

United States Department of Agriculture. Plant Variety Protection Act and Regulations and Rules of Practice. February 2006.

11.

Id. at 10–11.

12.

Id. at 9.

13.

Imazio Nursery v. Dania Greenhouses , 69 F.3d 1560 (1995).

14.

Id. at 1570.

15.

Plant Variety Protection Act, at 19.

16.

Id. at 8.

17.

Asgrow Seed Co. v. Winterboer , 513 U.S. 179 (1994).

18.

Id. at 18.

19.

Bowman v. Monsanto Co., 133 S. Ct. 1761 (2013).

20.

Id. at 1769.

21.

United States Patent and Trademark Office. Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products, at 3. 2014. Available at www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf (Last accessed August 2014 ).