In 2012, we decided to ask one of our panelists or an additional scholar to write texts for each of our Action Speaks’ topics. This one accompanies the 1980 Diamond v. Chakrabarty show on October 3, 2012. We hope that you enjoy it.
By Sophie Kim, JD Candidate, Harvard Law School & I. Glenn Cohen, Assistant Professor, Harvard Law School and Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.
Throughout the 1970s, as scientists began filing more patent applications for biotechnologies, the U.S. Patent and Trademark Office (PTO) as well as the courts struggled to decide whether whether living organisms were patentable under the existing patent law passed by Congress.1 This was also a time when many members of the public, fearful of genetic engineering, opposed patenting in biotechnology.2
The watershed case on the matter, Diamond v. Chakrabarty, was decided by the U.S. Supreme Court in 1980. The Supreme Court ruled that living, human-made microorganisms were patentable under a law stating that a patent could be awarded for any inventions that were a “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”3
The case concerned the patentability of a genetically engineered bacterium that could break down crude oil that was developed by Ananda Mohan Chakrabarty, an engineer for General Electric, to treat oil spills. In a 5-4 ruling, the Court decided in favor of Chakrabarty and patentability of the bacterium, stating that while natural laws, physical phenomena, discovery of minerals or plants, and abstract ideas such as mathematical formulas were not patentable, the bacterium in question was a living, human-made microorganism patentable under Title 35 U.S.C. Section 101. A genetically engineered bacterium capable of breaking down crude oil was not a product of nature, the court held, and thus constituted a new and useful “ manufacture” or “composition of matter” within the meaning of the statute. The Court further held that it did not make sense to assume that an unforeseen new technology was not patentable since patents were intended to protect unforeseen advances. It was the Court’s position that judges should not place limits on patent law where such limits were not evident in the plain language of the statute. In reaching its decision, the Court noted that the legislative history accompanying the 1952 Patent Act “inform[s] us that Congress intended statutory subject matter to ‘include anything under the sun that is made by man.’”4 This conveyed an expansive understanding of the scope of patentable subject matter.
The decision in Chakrabarty settled the biotechnology industry’s uncertainty about the patentability of its products.5 The case emboldened the industry to seek patent protection on a broadening range of technological advances by providing biotechnology companies with the incentive to invest in developing new medical treatments, drug therapies, diagnostic tools, and disease resistant crops. Since the decision, the PTO significantly expanded the types of inventions it was willing to patent, including plants, animals, computer technologies, and business methods.6 As of 2011, there were 1,870 biotechnology companies in the United States and U.S. revenues for the biotechnology industry had increased from $8 billion in 1992 to $58.8 billion in 2011.7 Moreover, the industry spent $17.2 billion in research and development and employed 98,560 people in 2011.8 The number of patent applications and issued patents has also dramatically increased since Chakrabarty. For example, the number of biotechnology patents granted by the PTO rose from 2,160 in 1989 to 7,763 in 2002. Today, Chakrabarty is still viewed as the landmark decision that was pivotal to a shift in U.S. patent policy and was crucial to opening the door to countless breakthroughs in medical therapies, increased crop yields and renewable fuels.9
But despite settling one fundamental question, Chakrabarty left others open. Most pressing today is the question of patentability of genes. In particular, there has been ongoing legal controversies relating to Myriad Genetics’ right to patent the “isolated” genes BRCA1 and BRCA2, which account for most inherited forms of breast and ovarian cancer.
1 Rebecca S. Eisenberg, Story of Diamond v. Chakrabarty, The: Technological Change and the Subject Matter Boundaries of the Patent System in Intellectual Property Stories, J.C. Ginsburg and R.C. Dreyfuss, eds. New York: Foundation Press, 2006; pp. 327-357.
3 447 U.S 303.
4 Id. ( citing S. Rep. No. 82-1979, at 5 (1952); H.R. Rep. No. 82-1923, at 6 (1952)).
5 Ernst & Young, LLLP, Global Biotechnology Report 2006
6 Eisenberg, supra note 1.
7 Ernst & Young, LLP, Annual Biotechnology Report 1993-2012
8 Ernst & Young, LLP, Global Biotechnology Report 2012
9 David Kappos, Under Sec’y of Commerce and Dir. of the U.S. Patent Tech. Office, Celebrating 30 Years of Biotechnology Innovation: From Diamond v. Chakrabarty to Today, Opening remarks at the 2011 BIO International Convention (Jun 29. 2011)