2105 Patent Eligible Subject Matter — Living Subject Matter
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I. INTRODUCTION
Prior to 1980, it was widely believed that living subject matter was not eligible for patenting, either because such subject matter did not fall within a statutory category, or because it was a judicial exception to patent eligibility.
- However, the decision of the Supreme Court in Diamond v. Chakrabarty, made it clear that the question of whether an invention embraces living matter is irrelevant to the issue of patent eligibility.
- Note, however, that Congress has excluded claims directed to or encompassing a human organism from eligibility.
II. LIVING SUBJECT MATTER MAY BE PATENT ELIGIBLE
A. Living Subject Matter May Be Directed To A Statutory Category
In Chakrabarty, the Supreme Court held that a claim to a genetically engineered bacterium was directed to at least one of the four statutory categories, because the bacterium was a “manufacture” and/or a “composition of matter.”
- In its opinion, the Court stated that “Congress plainly contemplated that the patent laws would be given wide scope” because it chose to draft 35 U.S.C. 101 using “such expansive terms as ‘manufacture’ and ‘composition of matter,’ modified by the comprehensive ‘any.’”
- The Court also determined that the distinction between living and inanimate things was not relevant for subject matter eligibility.
- Thus, the Court held that living subject matter with markedly different characteristics from any found in nature, such as the claimed bacterium produced by genetic engineering, is not excluded from patent protection by 35 U.S.C. 101.
Following the reasoning in Chakrabarty, the Board of Patent Appeals and Interferences determined that animals are patentable subject matter under 35 U.S.C. 101.
In Ex parte Allen, the Board decided that a non-naturally occurring polyploid Pacific coast oyster could have been the proper subject of a patent under 35 U.S.C. 101 if all the criteria for patentability were satisfied.
- Shortly after the Allen decision, the Commissioner of Patents and Trademarks issued a notice stating that the Patent and Trademark Office "now considers nonnaturally occurring, non-human multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.
With respect to plant subject matter, the Supreme Court held that patentable subject matter under 35 U.S.C. 101 includes newly developed plant breeds, even though plant protection is also available under the Plant Patent Act and the Plant Variety Protection Act.
B. Living Subject Matter May Be Eligible for Patent Protection
The Supreme Court in Chakrabarty held a claim to a genetically engineered bacterium eligible, because the claimed bacterium was not a “product of nature” exception.
- As the Court explained, the modified bacterium was patentable because the patent claim was not to a “hitherto unknown natural phenomenon,” but instead had “markedly different characteristics from any found in nature,” due to the additional plasmids and resultant capacity for degrading oil.
Subsequent judicial decisions have made clear that the Supreme Court’s decision in Chakrabarty is “central” to the eligibility inquiry with respect to nature-based products.
- For example, the Federal Circuit has indicated that “discoveries that possess ‘markedly different characteristics from any found in nature,’ … are eligible for patent protection.”
In re Roslin Institute, the claimed invention was a live-born clone of a pre-existing, non-embryonic, donor mammal selected from cattle, sheep, pigs, and goats.
- An embodiment of the claimed invention was the famous Dolly the Sheep, which the court stated was “the first mammal ever cloned from an adult somatic cell.”
- Despite acknowledging that the method used to create the claimed clones “constituted a breakthrough in scientific discovery”, the court relied on Chakrabarty in holding the claims ineligible because “Dolly herself is an exact genetic replica of another sheep and does not possess ‘markedly different characteristics from any [farm animals] found in nature.’
III. HUMAN ORGANISMS ARE NONSTATUTORY SUBJECT MATTER
Congress has excluded claims directed to or encompassing a human organism from patentability. The Leahy-Smith America Invents Act (AIA) states:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
