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Living Organisms as Patentable Subject Matter

Posted Sunday, November 4, 2012 by Mike Cicero

Generally, whether an invention qualifies as patentable subject matter under 35 U.S.C. § 101 is a low level inquiry that is given nominal, if any, attention during the patent prosecution process. Surely, the novelty and non-obviousness requirements of patentability under §§102-03, and to a lesser extent the various requirements under §112, are the subject of the majority of patent prosecution efforts. However, the territory of patentable subject matter under §101, although extensive, certainly has its boundaries and every so often these boundaries are challenged.

In Diamond v. Chakrabarty, the Supreme Court was faced with the narrow issue of whether a living human-made micro-organism is patent eligible subject matter under §101. 447 U.S. 303, 305 (1980). The case arose from a patent application filed by microbiologist Ananda Chakrabarty which claimed a genetically engineered “bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway” (emphasis added). Because the bacterium possessed the capability of “breaking down multiple components of crude oil” the invention would have obvious potential for the treatment of oil spills.

The claims of the application that were directed solely to the bacterium itself were initially rejected for two separate reasons. First, the examiner took the position that micro-organisms are “products of nature.” Second, the examiner took the position that living things are not patentable subject matter under §101. It is well settled that a naturally occurring product of nature cannot be patented even if its existence was previously unknown and it was discovered by the applicant; however, the discoverer may obtain a patent which claims it in a purified, isolated, or altered form. Whether a living organism may qualify as patentable subject matter had not previously been addressed by the Supreme Court.

The Court decided that the case should hinge on simple statutory interpretation of §101 which provides that “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” Accordingly, the Court narrowed its inquiry to whether the genetically engineered micro-organism constituted a “manufacture” or “composition of matter.”

After defining the precise inquiry, the Court set the tone of its opinion by noting that previous members of the Court had “cautioned that courts ‘should not read into the patent laws limitations and conditions which the legislature has not expressed.’” Id. *at 308 (quoting United States v. Dubilier Condenser Corp.,* 289 U.S. 178 (1933)). Next, definitions for the terms were set forth. The term “manufacture” was given its dictionary definition of “the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery.” The term composition of matter was given a common usage definition as including “all compositions of two or more substances and … all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids.”

Judged against the issue as framed and definitions provided, the Court held that the genetically engineered micro-organism plainly qualified as patentable subject matter.

Regarding the examiner’s first ground of rejection, the Court seemed to be persuaded by the lack of any naturally occurring bacterium which possessed the property of being able to degrade crude oil products. This is gleaned from the opinion wherein Chief Justice Burger stated that “the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.” That no naturally occurring bacterium possessed the same properties served as evidence that the claimed bacterium was non-naturally occurring. In light of recent discoveries, however, evidence that there are naturally occurring microbes that possess such properties, if it was then known, could possibly have weighed against the applicant. See Oil-eating microbe found in the Gulf of Mexico.

Regarding the examiner’s second ground of rejection, the Court found that Congress “recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.” Thus, because the genetically engineered micro-organism was a product of human creation rather than a mere naturally occurring product of nature, the subject matter was ruled to be patent eligible.

This ruling left open a wide incentive for potentially dangerous and/or morally reprehensible areas of research. For example, under the ruling in Chakrabarty would a human clone be patent eligible subject matter? Moreover, the Court simply left to Congress the task of imposing any meaningful limitations on what subject matter will be patent eligible. Congress in fact acted upon the Court’s invitation when writing the recently passed America Invents Act to alleviate the concerns of at least some regarding the patentability of human clones or organisms. Congress added to the already existing limitations on patentable subject matter, including laws of nature, physical phenomena, and abstract ideas. In the America Invents Act, Congress accepted this invitation and excluded claims “directed to or encompassing a human organism.”

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