Holding: A biological composition is patent‑eligible when the claimed construct, viewed as a whole, does not occur in nature and exhibits characteristics or utility that differ meaningfully from its natural components.
REGENXBIO owns US Patent No. 10,526,617, which is directed to a method of detecting or identifying adeno-associated virus (AAV) sequences and isolating the AAV sequences. AAVs have biological properties that make them useful for gene therapy, and the ‘617 Patent focuses on engineered cells that contain DNA from a specific AAV strain (rh.10) to support gene‑delivery work.
Claim 1 of the ‘617 Patent recites a cultured host cell containing a recombinant nucleic acid molecule encoding an AAV vp1 capsid protein and that further comprises a heterologous non-AAV sequence. This results in a genetically engineered cell that contains a man‑made DNA molecule combining the new AAV rh.10 capsid sequence with DNA from a different species, so those cells can be used to produce gene‑delivery vectors. Such engineered host cells do not exist in nature.
REGENXBIO accused Sarepta of infringement of the ‘617 Patent based on Sarepta’s production of the rh.74 AAV variant cultured in host cells to make a gene therapy product referred to as SRP-9001, which can be used to treat Duchenne muscular dystrophy. Sarepta alleged that the claims of the ‘617 Patent were not patentable under Section 101 as claiming a natural product. The district court agreed with Sarepta, finding the claims of the ‘617 Patent to be patent ineligible, as none of the individual naturally occurring components in the claims had been changed. According to the district court, combining natural products and putting them into a host cell does not make the invention patentable under Section 101. However, the Federal Circuit reversed the district court’s decision.
In its analysis, the Federal Circuit looked to the standard set in Chakrabarty[1] in asking whether the claimed host cells have “markedly different characteristics” and the “potential for significant utility” compared to that of the naturally occurring components. In the ‘617 Patent, the claimed host cell includes a recombinant nucleic acid molecule which contains segments from one source that are manipulated or inserted into the nucleic acid of another source. Additionally, the claimed host cell includes a heterologous non-AAV sequence that comes from a different species. Thus, the claimed molecule must be created through human intervention.
Additionally, the claimed recombinant nucleic acid molecule is not a mere repackaging of products that can be found in nature. The claimed host cell is created through genetic engineering that fuses two nucleic acid sequences from different species into one molecule and introduces that molecule into a host cell, resulting in a cell containing genetic material that does not occur naturally. This is similar to the bacterium found patentable in Chakrabarty, in which the inventors transferred four different naturally occurring plasmids into a bacterium that was capable of degrading four different oil components.
The Federal Circuit also found that the claimed host cell in the ‘617 Patent has the potential for significant utility. Although isolated AAV rh.10 sequences and non-AAV sequences do not allow for gene delivery on their own, the claimed composition is beneficial for gene delivery. Although this functional benefit is not explicitly claimed, the court may still consider this potential for significant utility in its patentability analysis. This is supported by Chakrabarty, which considered the hydrocarbon-degrading properties of the claimed plasmids, even though these properties were not directly stated in the claims.
Sarepta argued that the Federal Circuit should focus only on isolating the AAV rh.10 sequence because the other portions of the claim are conventional and would not be patentable enhancements on their own. However, the Federal Circuit held that the limitations cannot be read out of the claims merely because they are found in the prior art or known to those skilled in the art.
[1] Diamond v. Chakrabarty, 447 U.S. 303 (1980).
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