Is It All In Our Nature?

 Le développement des produits biotechnologiques et chimiques est en progrès constant et les systèmes de protection par brevet doivent s’adapter à ces évolutions. Notre consoeur  américaine E. Kate Berezutskaya du cabinet Greer Burns & Crain, Ltd nous donne son analyse concernant les évolutions récentes dans la loi sur les brevets aux Etats-Unis et fournit des recommandations pour protéger par brevet les inventions biotechnologiques et chimiques appartenant à la catégorie des produits issus de la nature aux Etats-Unis.

 

In recent years, significant progress has been made in developing various biotechnological and chemical products. To name a few examples from an ever growing list, various technological innovations have allowed us to produce recombinant insulin in a laboratory, grow a recombinant bacterium which can digest an oil spill, prepare a food supplement comprising a highly beneficial combination of vitamins, and synthetize a set of DNA oligonucleotide primers which can be used in a test assessing the risk for developing breast cancer. The purpose of this article is to consider recent developments in US patent law and provide practical recommendations for patenting biotechnological and chemical inventions in category of nature-based products in the US.

Two broad types of claims are available in the US: product/composition of matter claims and method claims. The latter group, method claims, will not be considered in this article, but it should be noted that so long as a method for obtaining a nature-based product is novel and non-obvious and other patentability requirements are met, there is always a possibility of patenting the method claim even if the nature-based product by itself cannot be patented.

Generally, a product of nature is not patent-eligible subject matter. Based on this requirement, the US Supreme Court in Myriad held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.” Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 at 2111 (2013).

Following the Myriad Supreme Court decision, the US PTO has developed a guidance for analyzing nature-based products: “The 2014 Interim Guidance on Patent Subject Matter Eligibility Issued Dec. 16, 2014, 79 FR 74618.” This guidance and subsequently developed materials and examples provide a framework for distinguishing patent-eligible nature-based products from patent-ineligible nature-based products.

According to the US PTO, “nature-based products are those products [that] have been derived from natural sources.” They fall into two categories: a) patent-eligible nature-based products which have markedly different characteristics from any naturally occurring counterpart; and b) patent-ineligible nature-based products which are either naturally occurring or not naturally occurring, but do not have markedly different characteristics from any naturally occurring counterpart.

Thus, a claim to a patent-eligible nature-based product should recite such characteristics of the product which make the product markedly different from what is found in nature. In other words, it is impossible to claim recombinant insulin which is exactly the same protein as produced by a human body even if this recombinant insulin has been synthetized in a laboratory. However, it may be possible to obtain a claim to a recombinant insulin variant if the US PTO determines that the variant is markedly different from insulin found in nature.

The US PTO may consider various characteristics during its quest for addressing a question as to whether a particular nature-based product meets the markedly different standard. Such characteristics include biological and pharmacological functions, chemical properties, physical properties, phenotype, structure and form. The US PTO provides the following examples of patent-eligible claims directed to nature-based products which the US PTO has determined are markedly different from products found in nature.

 

 

US PTO Patent-Eligible Nature-Based Product Exemplary Claim

 

US PTO Rational for Finding the Claimed Product is Markedly Different

 

Gunpowder comprising: an intimate finely-ground mixture of 75% potassium nitrate, 15% charcoal and 10% sulfur.

 The claim is directed to a combination with a new property: the combination is explosive upon ignition, while none of the three substances are explosive in nature.

 

A beverage composition comprising pomelo juice and an effective amount of an added preservative.

 

This claim is directed to a composition with a new property - it spoils slower than the naturally occurring pomelo juice.

 

Purified 5-methyl amazonic acid.

 

This claim is directed to a product with a chemical difference in structure – only amazonic acid is found in nature.

 

A pharmaceutical composition comprising: a core comprising amazonic acid; and a layer of natural polymeric material enveloping the core.

 

This claim is directed to a composition in which two naturally occurring substances are physically combined together into a non-natural structure.

 

A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

 

The claimed bacterium has a different functional characteristic from naturally occurring Pseudomonas bacterium - the recombinant bacterium can degrade two different hydrocarbon types, while naturally occurring Pseudomonas bacterium can degrade only a single hydrocarbon type.

 

An inoculant for leguminous plants comprising a mixture of Rhizobium californiana and Rhizobium phaseoli.

 

In nature, R. phaseoli infects only garden beans, and R. californiana infects only lupine. When mixed together as claimed, the combination now infects a third species of plant: R. californiana infects both lupine and wild indigo, and R. phaseoli continues to only infect garden beans.

 

Isolated nucleic acid comprising a sequence that has at least 90% identity to SEQ ID NO: 1 and contains at least one substitution modification relative to SEQ ID NO: 1.

 

The claim is directed to a product different in structure from the product found in nature with SEQ ID NO: 1.

 

Isolated nucleic acid comprising SEQ ID NO. 1, further comprising a fluorescent label attached to the nucleic acid.

 

The claim is directed to a product different in structure from the product found in nature with SEQ ID NO: 1.

 

A vector comprising the nucleic acid comprising SEQ ID NO. 1 and a heterologous nucleic acid sequence.

 

The claim is directed to a product different in structure from the product found in nature with SEQ ID NO: 1.

A yogurt starter culture comprising: goat milk mixed with Streptococcus thermophilus and Lactobacillus alexandrinus

 

The claim is directed to a composition of two bacterial species which has a characteristic different from what either species has on its own, e.g., the two species act together to ferment milk into a lower fat yogurt, but neither of the two bacteria can produce a lower fat yogurt when individually mixed with the milk.

 

 

As can be seen from these examples, there are many options with respect to meeting the markedly different standard. It is advisable that during the drafting of a patent application for a nature-based product, all possible differences between the nature-based product, including structural, functional, biochemical and physical differences, are described in the specification for an easy reference during prosecution. It is also advisable that a claim drafted to a nature-based product recites at least one characteristic on which applicant plans to rely in order to meet the markedly different standard during prosecution. Finally, where the invention is directed a nature-based product which is indeed designed such that the product is an exact or very close replica of what is found in nature, it is advisable to draft claims directed to methods of making this product and perhaps devices for making this product, rather than to the product itself. Other claims such as directed to methods of using the product can be considered as well. In summary, while we cannot patent what mother-nature has created, we have plenty of options for obtaining patent protection for biotechnological and chemical inventions.

 

E. Kate Berezutskaya, Ph.D., J.D., Partner at Greer Burns & Crain, Ltd.

Email: kberezutskaya@gbclaw.net

Phone: + 1 312 987 2916