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5 January 2023FeaturesGeneticsBrian Hausman

Will de-extinct animals be patent eligible in the US?

Using DNA from extinct animals in conjunction with advanced technology to bring these animals back to life has been popularised by science fiction films such as “Jurassic Park”. However, developments in “de-extinction” processes have made the possibility of resurrecting these extinct animals a reality.

The processes to bring back extinct animals present challenges to the existing legal framework in the US. With reference to patent law, there are debates concerning whether one can obtain a patent on such an animal, and if so, what are the issues to be considered.

These procedures are also expensive, so patent protection may provide an avenue for private funding. Armed with a patent, an owner of a resurrected, previously extinct animal would be able to control the exclusivity of that animal with respect to the public. For example, the owner could license certain zoos or other institutions to use the animal and restrict others from using the animal.

While it is highly likely that the methods developed by scientists working on de-extinction will be patent eligible, there are thornier issues to be addressed when considering whether the resultant animals themselves satisfy patent eligibility requirements in the US—as articulated in the “Alice/Mayo framework”. In particular, one issue is whether such animals would sidestep the judicially created exception to patent eligibility for natural phenomena.

De-extinction processes

Somatic cell nuclear transfer

Somatic cell nuclear transfer (SCNT) is one available strategy to produce a clone from an extinct animal. SCNT involves removing the nucleus from an egg cell of one organism and replacing it with the nucleus from a somatic cell belonging to a second organism that is then stimulated to begin development.

As the animals in question are extinct, somatic cells may be the only cellular material available to scientists, and even then, their viability for an SCNT approach will depend on how the extinct animal has been preserved.

The availability of sufficient DNA from the extinct animal provides the main challenge to a successful SCNT procedure. Even if there is a discovery of a specimen for an extinct animal, its DNA may be unusable as DNA generally starts to decay after death. For older extinct animals, it is unlikely that complete samples of DNA will be available, and genetic engineering processes may be necessary to attempt to bring back the extinct animal.

Genetic engineering

Genetic engineering is the process of modifying an organism’s existing genome. It may include inserting or removing DNA to change the genetic makeup of that organism’s cells. For a given extinct animal, there may be an incomplete genome available for resurrecting that species.

Scientists often compare the incomplete genome to one belonging to a relative species of that animal to reconstruct the extinct animal’s genome through gene sequencing. Once reconstructed, the extinct animal’s genome may be introduced into cells of the existing relative species.

The resultant product would be a hybrid organism having characteristics and traits from the extinct animal. The hybrid animal may carry embryonic cells containing DNA of the reconstructed extinct animal that, when bred with another hybrid animal, could potentially produce the once-extinct animal.

Artificial selection

Artificial selection is a process by which organisms are selectively bred to develop particular traits. With respect to bringing back an extinct species, there is a form of artificial selection called “breeding back” where animals are bred in such a way as to achieve an animal breed resembling its ancestor.

However, this would only work if the ancestral trait desired is still available in the population and is unlikely to be successful in reclaiming all the traits necessary to revive an extinct species.

Patent law

Up until the late 20th century, living subject matter was generally not considered eligible for patenting. The seminal case addressing this issue in the United States is Diamond v Chakrabarty.

At issue in this case was the fact that Chakrabarty had engineered a bacterium capable of breaking down multiple components of crude oil, and he had filed for a patent on the bacterium itself in addition to methods of producing said bacterium.

The Supreme Court held that Chakrabarty’s “micro-organism plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter.”

The court held that Chakrabarty produced a new bacterium with “markedly different characteristics from any found in nature” and is accordingly sufficient patentable subject matter under 35 USC § 101, the statute governing patent eligibility in the US.

In support of its holding, the court explained that “Congress thus recognised that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.”

The Supreme Court’s holding in Chakrabarty was more recently addressed in the SCNT context by the Court of Appeals for the Federal Circuit. In In re Roslin, the team that produced a cloned sheep named “Dolly” had filed for a patent claiming the cloned mammal itself, but after their application was rejected by the US Patent and Trademark Office (USPTO), they filed an appeal.

The Federal Circuit affirmed the USPTO’s rejection, noting that while the claimed clone “may be called a composition of matter or a manufacture” as required by § 101, it was ineligible for patent protection because it constituted a natural phenomenon that did not possess “markedly different characteristics than any found in nature.”

In view of the cloning process, the Federal Circuit found that the resultant animal was an “exact genetic replica of the adult mammal from which the somatic cell nucleus was taken.” The scientific team argued that its claimed clones should be considered patent eligible because they are distinguishable from the donor mammals through phenotypic differences and differences in mitochondrial DNA.

The scientific team did admit, however, that the phenotypic differences were the result of environmental factors, and the court responded by pointing out that neither those phenotypic differences nor the mitochondrial DNA differences were recited in the claims.

While the Federal Circuit agreed that these particular claimed clones amounted to unpatentable subject matter, the court noted that “having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case.” Accordingly, whether claims describing clones having markedly different characteristics from their donor animals are patent eligible remains an open question.

The Alice/Mayo framework for 35 USC § 101

The Alice/Mayo framework describes the process by which the USPTO and US courts determine whether claims are patent eligible. The framework is used after first determining whether a claim falls within one of the statutory categories of inventions (ie, “machine,” “process,” “manufacture,” or “composition of matter”).

The Alice/Mayo framework identifies whether claims are directed to a judicial exception and then evaluates whether additional elements in that claim provide a sufficiently inventive concept to render the claim patent eligible. These objectives are split up into Step 2A and Step 2B of the USPTO’s eligibility analysis, respectively.

Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception.

The markedly different characteristics analysis under Prong One of Step 2A

When a law of nature or natural phenomenon is claimed as a physical product, courts have often referred to the exception as a “product of nature”. As explained in Ass’n for Molecular Pathology v Myriad Genetics, products of nature are considered to be an exception because they tie up the use of naturally occurring things.

When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis to evaluate the nature-based product limitation and determine the answer to Step 2A Prong One.

To show a marked difference, a characteristic must be changed as compared to its naturally occurring counterpart. If there is a change in at least one characteristic, and the change was produced by the applicant’s efforts, then the change will be considered a markedly different characteristic such that the claimed product does not fall within the product of nature exception.

If there is no change in any characteristic, the claimed product is considered a product of nature and falls within the exception to what is generally considered to be patent-eligible subject matter. If the claim falls within the exception, the analysis proceeds to Prong Two of Step 2A.

Prong Two of Step 2A

Even if a claim does fall into the judicial exception, a claim that integrates the subject matter of the judicial exception into a practical application will impose meaningful limits on the judicial exception such that the claim is considered patent eligible.

The intent of this prong is to safeguard against drafting efforts designed to creatively add limitations, while still monopolising the judicial exception. Examiners evaluate such integration of additional limitations with respect to their ability to convert the claim into a “practical application” of the judicial exception by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application.

Step 2B

If the claim does not integrate a judicial exception into a practical application, the analysis proceeds to Step 2B, which is commonly referred to as a search for "inventive concept".

An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. If there is an inventive concept, the claim satisfies 35 USC § 101. Otherwise, the claim will be rejected as being directed to unpatentable subject matter.

Analysis and conclusion

Whether de-extinct animals are able to satisfy 35 USC § 101 may depend in large part on their method of production. As outlined above, the relevant test in these determinations is the markedly different characteristics analysis as a claim to an “animal” would likely be initially considered to constitute a law of nature, natural phenomena, or product of nature.

If, however, the de-extinct animal can pass the markedly different characteristics analysis, it is likely that it will be considered to be patent-eligible subject matter.

With reference to extinct animals that are revived via genetic engineering, the resultant animal would necessarily carry differences at the genetic level that distinguish it from both its original genome and its closest living naturally occurring counterpart.

The fact that the resultant animal would not be an exact replica of either the extinct animal or its closest living counterpart can be relied upon to underscore the marked differences between the two. Thus, it is highly likely that such an engineered animal would be considered, like the bacteria in Chakrabarty, to be patent eligible in the US under 35 USC § 101.

In view of the holding in In re Roslin, an extinct animal produced entirely through SCNT, without any other genetic modifications, may not satisfy 35 USC § 101.

If, however, a patent examiner determines that there is a distinct characteristic of that de-extinct animal to its naturally occurring counterparts and the claim language recites such distinctions, eg, differences in mitochondrial DNA or some other difference in characteristics attributable to human intervention, the resultant animal may satisfy Step 2A Prong One of the Alice/Mayo framework and subsequently 35 USC § 101.

Brian Hausman is a patent agent at Baker Botts. He can be contacted at:  brian.hausman@bakerbotts.com

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