A Comparative Review of New Developments
New Directions in Patent Law series
Edited by Emanuela Arezzo and Gustavo Ghidini
Chapter 10: Gene Patents Under Fire: Weighing the Costs and Benefits
Christopher M. Holman INTRODUCTION In 1980, the US Supreme Court helped jumpstart a fledgling biotechnology industry with its landmark decision in the case of Diamond v. Chakrabarty.1 At issue was the ‘patent eligibility’ of a non-naturally occurring, genetically engineered micro-organism.2 Dr. Chakrabarty’s invention was a bacterium he had modified in the laboratory by the introduction of genetic material encoding enzymes capable of metabolizing crude oil, thereby (in principle) conferring upon the bacterium the ability to break down an oil spill.3 The United States Patent and Trademark Office (PTO) had rejected a claim directed towards the bacterium, asserting that a living organism is not patent eligible, notwithstanding the fact that the organism is ‘man-made’ and satisfies all the other statutory requirements of patentability, such as novelty, nonobviousness and practical utility. In a close 5–4 decision, the Court decided in favor of a patent eligibility not only for Dr. Chakrabarty’s genetically engineered bacterium, but by implication generally for genetically engineered organisms and other products of biotechnology created using naturally occurring biological Diamond v. Chakrabarty, 447 U.S. 303 (1980). 35 USC 101 is the source of the so-called ‘patent eligibility’ doctrine, which requires a patent claim to encompass only subject matter that is ‘patent eligible’. It is a threshold requirement of patentability; a patent claim is invalid if it covers subject matter that is patent ineligible. See Chakrabarty, supra note 1; Bilski v. Kappos, 130 S.Ct. 3218(2010). The terms ‘patentable subject matter’ and ‘patent eligibility’ are used interchangeably to describe this...
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