Does the Alice/Mayo test apply to natural phenomenon?
The Fed. Cir. just issued a very interesting biotech patentable subject matter case under 35 U.S.C. § 101: REGENXBIO v. Sarepta Therapeutics. The reason why I find it interesting is because the court addressed whether the Alice/Mayo test applies to a natural phenomenon.
The case involves host cells that include a recombinant nucleic acid molecule that does not and cannot exist in nature. The court applied the “markedly different characteristics” framework (MDC) for analyzing whether the claimed composition was directed to a natural phenomenon, which it described as asking “whether the claimed host cells have ‘markedly different characteristics’ and have ‘the potential for significant utility’ from that which is naturally occurring.” The court noted that the Supreme Court has never applied the Alice/Mayo two-step framework to natural phenomenon claims.
In applying the MDC test, the court considered the claimed host cells to be similar to Chakrabarty’s man-made plasmid combining four naturally occurring bacteria because “the recombinant nucleic acid molecule must be spliced together via human intervention from at least two different species to meet the claim limitations.” The court distinguished the claims from Funk Brothers because “the claims here are not merely directed to repackaging products of nature.” The court also criticized the district court’s invalidity finding by failing to consider “whether the claimed composition as a whole was ‘not naturally occurring.'”
Interestingly, the court cited to Diehr (inappropriate to dissect claims into old and new elements) when rejecting an argument to disregard conventional limitations in the MDC test. The court concluded by noting that its analysis could end after performing the MDC test. Nevertheless, they stated, “[h]owever, if resort to the Alice/Mayo framework is necessary, then at step one we conclude the asserted claims are not directed to a product of nature for the reasons stated above.” This is belt and suspenders.