Patentability of Living Organisms: Can a living organism be patented?
Can a living organism be patented? The quick answer is “sometimes.”
by: Jake Mace | July 31, 2017
The Supreme Court made it clear that abstract ideas, natural phenomena, and laws of nature are not patentable subject matter.[1] So it really comes down to whether a living organism should be considered a natural phenomenon. Consider these scenarios:
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You found an organism.
If you only found an organism, then you CANNOT patent it. It doesn’t matter if you scoured the deepest Amazon jungle to find the rarest of insects – if it’s naturally occurring, then it’s not patentable. The Supreme Court dealt with this in Funk Brothers Seed Co. v. Kalo Inoculant Co. where the product was essentially a bacterial culture in powder or liquid form.[2] The Court held that although Kalo had discovered the bacteria and its unique ability to form a nitrogen-fixing association with legumes, the product was not patent eligible because the bacteria were a “phenomenon of nature.”[3] The Court stated that the qualities of the bacteria “are part of the storehouse of knowledge of all men” and “manifestations of laws of nature,” discovery of which is not patentable.[4] The rationale of the Court seemed to suggest that no living organisms could be patented due to the “laws of nature” exclusion, but they could not predict the advancements in science and technology would bring about transgenic organisms.
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You created an organism AND it cannot be found in nature.
If you created an organism and is unlike anything found in nature, then you CAN patent it. In Diamond v. Chakrabarty, the Supreme Court held that Chakrabarty’s genetically-modified oil-metabolizing bacterium was patentable.[5] Initially, both the patent examiner and the PTAB rejected the claims for the bacterium because they believed that Congress made it clear through its actions in passing the Plant Patent Act (PDP) and Plant Varieties Protection Act (PVPA) that living organisms were only patentable when explicitly allowed by statute.[6] They believed that living organisms were not covered by section 101 and that neither the PPA nor PVPA extended protection to microorganisms.[7] The Supreme Court, however, disagreed and held that in order for an invention to avoid the physical phenomena exclusion from patentable subject matter, the invention must have “markedly different characteristics from any found in nature.”[8] Thus, Chakrabarty’s bacterium was indeed patentable subject matter because it performed functions that the naturally-occurring counterparts did not, namely metabolize oil.
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You created an organism AND it can be found in nature.
If you created an organism and it is just like one found in nature, then you CANNOT patent it, UNLESS… it happens to be a plant. This scenario is really only applicable to cloning. Although the Supreme Court has not tackled this issue yet, the Federal Circuit has denied patent eligibility to cloned sheep. In In re Roslin, the Roslin Institute attempted to patent not only a cloning process, but the also the cloned organism itself.[9] Applying the “markedly different characteristics” test from Chakrabarty, the Federal Circuit held that clone was an “exact genetic replica of another sheep” and denied its patent eligibility.[10]
Although animals are off the table, clones of plants can be patented. In fact, the only statues that specifically address the patentability of living organisms are the PPA and the PVPA, which extend patent protection to asexually reproduced plants and sexually-reproduced plant varieties. These statutes have some stringent limitations about which plants can be patented. Essentially, if a plant exists in nature and has reproduced, then it cannot be patented since it is naturally occurring. However, if a plant exists in nature, but is infertile (as is often the case with crossbreeds) then it could be patented if someone is able to cultivate it through asexual methods (e.g., grafting).[11] Thus, if you are able to clone the infertile plant and continue producing more of them, then the PPA and PVPA allow you to patent it.
Footnotes:
[1] Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. _, 132 S. Ct. 1289, 1293-94, 101 USPQ2d 1961, 1965-66 (2012).
[2] Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 129 (1948).
[3] Id. at 130.
[4] Id.
[5] Diamond v. Chakrabarty, 447 U.S. 303, 318 (1980).
[6] Id. at 311.
[7] Id.
[8] Id. at 319-22.
[9] In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335 (Fed. Cir. 2014).
[10] Id. at 1337-39.
[11] Plant Patent Act of 1930, 35 U.S.C. §§ 161-164, and Plant Variety Protection Act of 1970 (PVPA), 7 U.S.C. §§ 2321-2582.
