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Abstract

The advent of patent protection for genetically engineered inventions occurred in 1980 with the landmark Supreme Court decision in Diamond v. Chakrabarty. Following the lead of the Supreme Court, the Patent and Trademark Office ("PTO"), in 1987, issued a new regulatory ruling that expanded the PTO's statutory interpretation of 35 U.S.C. § 101 patentable subject matter to include devices based upon nonnatural occurring manufacture or composition of matter resulting from some level of human intervention in the modification of nonhuman organisms. One year following the PTO proclamation, the first patent for a transgenic animal issue to Professors Leder and Stewart for mammals such as those embodied by a strain of mice carrying an activatable transgene that induces the development of human tumors. Nearly a decade after the issuance of Leder's transgenic mice patent, the scientific and patent communities are presented with cloning, an advance in biotechnology that forces heightened examination of patent protection for biotech devices. The cloned organisms resulting in Dolly the lamb and Gene the bull-calf made headlines in 1997 and continue to evoke debate among scientists, ethicists, and legal scholars. Clones are explored as articles of composition under the patent statutes, and cloned organisms represent a logical scientific advancement in transgenically modified organisms. Therefore, clones should receive such recognition by the PTO and federal courts.