PATENTING ORGANISMS AND BASIC RESEARCH

Patents give inventors the right to prevent others from making, using, or selling their inventions for a limited time. The U.S. Constitution justifies the patent system as a way to promote technological progress (U.S. Constitution, Article I, Section 8, Clause 8). The U.S. patent system promotes technological progress through the financial incentives it creates for innovation and through its disclosure requirement. In exchange for exclusive rights patent applicants must disclose their inventions in terms that enable others who are skilled in the field to make and use them (U.S. Patent Act, Section 112). When a patent is issued, that broad disclosure becomes available to the public, and when the patent term expires, the public is free to make, use, and sell the patented invention.

Background and History

As commercial interest in biological products and processes has grown, inventors have turned to the patent laws, seeking rights to inventions that involve living materials. Under traditional patent doctrine, patents on living materials raise a number of concerns. For example, products and phenomena of nature are not patentable under U.S. law even when they are newly discovered (Funk Brothers Seed Co. v. Kalo Inoculant Co.).

Even before the explosion of modern commercial biotechnology, however, judicial decisions reduced the significance of that obstacle to patent protection by permitting patents on materials derived from natural sources through human intervention, such as purifications of naturally occurring products, as long as the patent claims did not cover the products in their natural state. Under that interpretation of the law, courts upheld the validity of patents on purified prostaglandins (Bergstrom), purified acetylsalicylic acid (Kuehmsted v. Farbenfabriken), and a purified adrenaline composition (Parke-Davis & Co. v. H. K. Mulford & Co.). Nonetheless, before 1980 it was not entirely clear that living materials were patentable. (Funk Brothers Seed Co. v. Kalo Inoculant Co.).

The 1980 decision of the U.S. Supreme Court in Diamond v. Chakrabarty stated unequivocally for the first time that living materials are patentable. In that case the Court held that a living single-celled bacterium that was transformed with DNA plasmids (small circles of bacterial DNA) through human intervention to give it the capacity to break down multiple components of crude oil could be patented as a "manufacture" or "composition of matter." In arriving at that decision the Court stated that the patent statute allows patents to be issued on "anything under the sun that is made by man" (Diamond v. Chakrabarty, p. 309).

With that broad directive from the Supreme Court the Patent and Trademark Office (PTO) quickly expanded the categories of living organisms it considered eligible for patent protection. In 1985 the PTO held that corn plants were eligible for standard utility patents, as opposed to the more limited plant variety protection (Hibberd ), and two years later it held that polyploid oysters fell within the range of patentable subject matter (Allen). Shortly afterward the commissioner of patents issued a notice stating that the PTO "now considers nonnaturally occurring nonhuman multicellular living organisms, including animals, to be patentable subject matter" (U.S. Patent and Trademark Office 1077:24). Any claim covering a human being would not be considered patentable, however, because "the grant of a limited, but exclusive property right in a human being is prohibited by the Constitution."

The first patent on a genetically altered animal (U.S. Patent No. 4,736,866) was issued in April 1988 to Harvard University for the development of a mouse harboring a human oncogene that makes it susceptible to cancer (HARVARD/Onco-Mouse Application). The decision to extend patent protection to animals generated considerable public controversy and was the focus of numerous hearings in the U.S. Congress (Dresser).

In 1998 the PTO's policy of refusing to grant patents on human beings was tested by a patent application on "chimeric embryos" (embryos containing human and nonhuman cells) filed by Jeremy Rifkin. In rejecting the application the PTO argued that Congress did not intend product patents on human organisms to fall within the scope of patentable subject matter (Ho). The widespread adoption of cloning techniques has tested the PTO's policy once again. By 2001 the PTO had granted patents on cloning processes that produce mammalian embryos, both human and nonhuman (U.S. Patent Nos. 6,211,429 and 6,235,970).

Although national patent laws vary somewhat, as a general rule the range of biotechnology inventions that can be patented outside the United States is somewhat more restricted than it is under U.S. law. Two provisions of the European Patent Convention have presented obstacles to the issuance of standard utility patents covering plants and animals in Europe (Dickson). Article 53(b) of the European Patent Convention states that European patents will not be issued for plant or animal varieties and essentially biological processes for the production of plants or animals with the exception of microbiological processes and the products of those processes. Article 53(a) of the European Patent Convention bars the issuance of a patent on an invention if its publication or exploitation would be contrary to public order or morality. The European Patent Office (EPO) concluded, however, that neither of those provisions barred the issuance of a European patent to Harvard University for its transgenic mouse (HARVARD/Onco-Mouse Application).

The recently issued European Biotechnology Directive generally follows the European Patent Convention and the case law of the EPO but suggests that slight human interference is sufficient to make a process for the production of plants and animals patentable (European Community Directive 98/44, 1998). In addition, Article 6 of the directive specifically prohibits, among other things, patents on processes for cloning human beings and processes for modifying the germline identity of human beings.

Objections to Patenting Organisms

Some of the objections to patenting living organisms, including humans, that have emerged in the wake of these legal developments are better understood as objections to the underlying technology rather than to its protection under patent law (Dresser; Merges). Objections of this character include concerns about the hazards of genetic engineering to public health and to the environment and concerns that transgenic animal research involves cruelty to animals. With respect to humans many people believe that creating humans through cloning processes violates principles of freedom, equality, and human dignity (President's Council on Bioethics).

One might question whether these kinds of objections are the concern of the patent laws or whether they might be met better through other types of regulation or outright prohibition of the research. However, withholding commercial rewards may be an effective way to slow the pace of such research without prohibiting it altogether (Kass). Some have argued that the patenting of life forms promotes an unwholesome or irreverent materialistic conception of life (Hoffmaster). A strong version of this argument holds that characterizing a life form as a patentable manufacture or composition of matter reduces a patented organism to a material object (Kass). A more attenuated version of that argument would stress the potential for commercial interests to debase people's attitudes toward life when life forms are treated as commodities to be bought and sold in the market (Murray). However, because patents do not provide an affirmative right to use an invention (they provide only a right to bar others from using it), the extent to which patents contribute to commodification is not clear. Allowing the creation of particular life forms, as well as patents on those life forms, patents would be consistent, for example, with a regime in which sales of life forms were banned (Rai).

Ownership of Other Living Materials

Moral objections have been voiced to the ownership of living materials such as the human genome sequence and single-nucleotide polymorphisms (SNPs), which are single-base variations in the genetic code. In both of those cases, however, preemptive actions to put genetic information into the public domain largely have prevented such ownership. In the case of the human genome sequence the public Human Genome Project instituted a policy of putting large-scale genomic sequence information immediately into the public domain (National Human Genome Research Institute). As a consequence the private company Celera, which had undertaken its own sequencing project, could not patent raw genome data. Moreover, although Celera maintains its genome database as a trade secret, the value of that database is diminished by the fact that genome data are publicly available. In the case of SNP data a consortium of pharmaceutical companies that were worried about the effects of patents on those upstream research inputs came together to fund an effort to put SNPs into the public domain (SNP Consortium Website). The public domain also has been enhanced to some extent by the recent decision of the PTO to require that those who seek to patent DNA sequences show the functional significance of those sequences (Patent and Trademark Office).

A major arena in which the ownership of living materials continues to raise moral concerns pertains to the ownership of human genes. Companies that own those genes often require universities and other institutions that perform genetic tests to pay large licensing fees. In some cases the size of the fee has led institutions to stop performing such tests (Merz).

rebecca s. eisenberg (1995)

revised by arti k. rai

SEE ALSO: Agriculture and Biotechnology; Animal Research; Commercialism in Scientific Research; Environmental Ethics; Law and Bioethics; Pharmaceutical Industry; Private Ownership of Inventions; Technology

BIBLIOGRAPHY

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Bergstrom, In re. 1970. 427 F.2d 1394, 57 (C.C.P.A.) 1240, 166 U.S.P.Q. (BNA) 256.

Diamond v. Chakrabarty. 447 U.S. 303, 65 L. Ed. 2d 144, 100 S. Ct. 2204 (1980).

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Dresser, Rebecca. 1988. "Ethical and Legal Issues in Patenting New Animal Life." Jurimetrics Journal 28(4): 399–435.

European Community Directive 98/44/EC. 1998. Official Journal of the European Communities, July 30, pp. 213/13–213/21.

Funk Brothers Seed Co. v. Kalo Inoculant Co. 333 U.S. 127, 192 L. Ed. 588, 68 S. Ct. 440 (1948).

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Ho, Cynthia. 2000. "Splicing Morality and Patent Law: Issues Arising from Mixing Mice and Men." Washington University Journal of Law & Policy 2: 247–286.

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Kuehmsted v. Farbenfabriken. 179 F. 701 (7th Cir.), cert. denied, 220 U.S. 622, 55 L. Ed. 613, 31 S. Ct. 724 (1910).

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Merges, Robert P. 1988. "Intellectual Property in Higher Life Forms: The Patent System and Controversial Technologies." Maryland Law Review 47: 1051–1075.

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Murray, Thomas H. 1987. "On the Human Body as Property: The Meaning of Embodiment, Markets, and the Meaning of Strangers." University of Michigan Journal of Law Reform 20(4): 1055–1088.

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Patent and Trademark Office. 2001. "Utility Examination Guidelines." Federal Register 66: 1092.

President's Council on Bioethics. 2002. Human Cloning and Human Dignity: An Ethical Inquiry. Washington, D.C.: Author.

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U.S. Congress, House Committee on the Judiciary. 1988. Patents and the Constitution: Transgenic Animals: Hearings before the Subcommittee on Courts, Civil Liberties and the Administration of Justice. 100th Cong., 1st Sess.

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U.S. Patent and Trademark Office. 1987. "Commissioner's Notice, Animal Patentability." Official Gazette of the Patent and Trademark Office 1077: 24.

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INTERNET RESOURCES

National Human Genome Research Institute. 1996. Policy Regarding Intellectual Property of Human Genome Sequence. Available from <http://www.nhgri.nih.gov/Grant_info/Funding/Statements/RFA/intellectual_property.html>.

SNP Consortium. 2003. Available from <http://www.snp.cshl.org>.