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Patentability of Biotech Inventions in USA – Patentable Subject Matter
First Publication Date: 27th December 2010
To be patentable subject matter in USA, an invention should be a process, machine, manufacture or composition of matter or any improvement thereof. There are three judicially created exclusions to patentable subject matter in USA. They are Laws of nature, physical phenomena, and abstract ideas. Biotechnology (Biotech) inventions are considered to be eligible subjects as Compositions of matter or manufactures.
The exclusion most relevant for biotech inventions is ‘Laws of nature’ exclusion. US Courts have consistently held that as per the exclusion anything that naturally exists or is a ‘product of nature’ is not patentable. The question relating to patentability of micro-organisms first came before the US Supreme Court in Funk Bros. Seed Co. v. Kalo Inoculant Co. The case involved an invention relating to a mixed culture of Rhizobium bacteria capable of simultaneously inoculating the seeds of plants belonging to several cross-inoculation groups. The court in this case held that the mere aggregation of species fell short of invention within the meaning of the patent statute because the combination of species produced no new bacteria and no change in the six species of bacteria. As there was no change in the species, the court stated that qualities of the non-inhibitive strains were the work of nature and therefore not patentable subject matter.
Later, the US Supreme Court in Diamond v. Chakrabarty, a landmark biotech case, observed that everything under the sun made by man is patentable. The case related to patentability of a genetically modified pseudomonas bacterium capable of degrading oil spills and a process by which four different plasmids, capable of degrading four different oil components, could be transferred to and maintained stably in a single Pseudomonas bacterium. The patent application relating to the bacterium was rejected on the ground that the bacterium was a product of nature and that it is a living organism. On appeal, the US Supreme Court held that the invention is patentable because it is a new bacterium with markedly different characteristics from any found in nature. The Supreme court further stated that the test for determining whether an invention falls within the scope of ‘Product of nature’ is whether the invention in question involves a hand of man. If yes, the invention is not product of nature or naturally existing. If No, it is naturally existing and therefore not patentable.
As the pseudomonas bacterium in the case involved the hand of man in inserting four different plasmids into it, the court held that it was not naturally existing and therefore patentable. It also stated that living organisms were not excluded from the scope of patentable subject matter in USA.
After the Chakrabarty’s decision expounded the product of nature doctrine, patents have been granted to various multi-cellular organisms. Patents were granted to polyploid oysters, genetically modified mice, rabbits and so on. Furthermore, in USA, gene sequences, gene therapies and so on have also been held to be patentable subject matter. With respect to gene sequences, the extent of their patentability is today before the Court of Appeals for the Federal Circuit, which is the patent appeals court in USA.
Though the scope of patentable subject matter is very broad in USA, human beings are not considered to be patentable subject matter. A patent application filed by Dr. Stuart Newman of New York Medical College covering fusion of embryonic human and animal cells to create chimeras for medical research was rejected by USPTO and such rejection was later approved by the Court.
Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) Diamond v. Chakrabarty, 100 S.Ct. 2204 (1980).J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124 (2001). No Patent On Embryonic Human-Animal Chimera, 24 Biotechlr 290 (June, 2005).