US Supreme Court's Decision on the Patent Ineligibility of Human Genes BRCA1/BRCA2 as Products of Nature

摘要

The patent laws are in the U.S. Constitution dating back from 1790 to 1793 to promote, as articulated by one of the framers, Thomas Jefferson, and protect 'any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement thereof'. Although the U.S. Congress in 1952 replaced the word 'art' with the word 'process', the Congress, as well as the courts, have strived to retain the basic philosophy of the Constitutional mandate that 'ingenuity should receive a liberal encouragement'. In accordance with such constitutional mandate, and to follow the spirit of the mandate, the U.S. Supreme Court in 1980 boldly declared in the case Diamond v. Chakrabarty (447 U.S. 303, 1980) that anything under the sun that is made by man is patent eligible under the patent laws as long as it meets the statutory requirement of novelty (35 USC section 102), non-obviousness (section 103), detailed description for enablement (section 112) and utility (section 101/112). It is noteworthy that the framers of the Constitution not only put such language in the Constitution but to emphasize the spirit of such mandate, when the first US patent was granted to Samuel Hopkins on July 31' 1790 for 14 years, President George Washington and the Attorney General Edm. Randolph signed this issued patent followed by Secretary of State Thomas Jefferson who also signed and delivered the patent to Mr. Hopkins on the 4~(th) of August, 1790. This was thus an exciting beginning of both the promotion of the inventive spirit, legal protection of such inventions for a period of time, and the economic development in the United States. This commentary deals with a patent eligibility issue decided by the US Supreme Court on June 13,2013 in the case Association for Molecular Pathology, et al v. Myriad Genetics, Inc., et al (No. 12-398), where the Supreme Court held that a naturally-occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.