by Dustin Mauck
Fulbright & Jaworski LLP
ANIMAL PATENTS – RIGHT OR WRONG?
It may seem strange and it is definitely controversial, but the United States is one of a select few countries that will grant a patent on an animal, such as a mouse or a dog. Should the United States grant patents on animals? Opponents argue that granting animal patents is immoral and unethical, while proponents argue that animal patents stimulate innovation and enhance research related to humanitarian problems. Hence, a debate rages on.
What Is an Animal Patent?
Patents may be obtained for non-naturally occurring animals. This is not to say that you can patent your mixed breed dog or cat, or that you can patent an improved dairy cow or a pig created through years of selective breeding. A plant or animal that can be found in the wild is not patentable.[1] Patentable animals are limited to those that have been engineered by humans, and thus do not exist in the wild. These animals are commonly referred to as “transgenic” animals because their genome has been manipulated with genes or DNA from other animals or humans.[2] Scientists manipulate these animals to exhibit characteristics that are desired for research or experimentation.
One of the most famous transgenic animals is the Harvard “oncomouse.” Researchers at Harvard genetically engineered a mouse that was highly susceptible to cancer for use in cancer research.[3] In 1988, the United States Patent Office granted a patent on the oncomouse, which sparked a heated debate over the patenting of transgenic mammals. Pro-patenting groups argue that patent protection is necessary to stimulate funding of the research needed to develop medical breakthroughs, while anti-patenting groups argue that the patenting of animals leads to their suffering and exploitation. Since the oncomouse patent was granted, over 660 patents have been issued for transgenic animals such as pigs, rabbits, dogs, cattle, and mice.[4] Patents have been obtained for transgenic animals that help to fight diseases such as Parkinson’s and the HIV virus.[5]
Who Grants Animal Patents?
Many countries do not allow the patenting of animals. When the Canadian patent for the Harvard oncomouse reached the Supreme Court of Canada in 2002, the court ruled that higher life forms, such as mammals, are not patentable.[6] Other countries such as Belarus, Brazil, China, Denmark, India, Ireland, Netherlands, Norway, the Philippines, Russia, and Thailand agree with Canada and prohibit animal patents.[7] However, in addition to the United States, the European Patent Office, United Kingdom, Australia, and Japan grant animal patents.[8]
The United States patent system has two noteworthy restrictions related to the availability of animal patents: (1) a utility restriction that the invention be useful or beneficial to society, and (2) a moral restriction prohibiting patents on human/animal chimeras.[9] Generally, patents on transgenic animals satisfy the utility restriction because they are used for beneficial research, although inventions directly related to humans are excluded from patent protection. The European Patent system has additional exclusions for inventions that are contrary to public policy and morality. Under this regime, non-technological concerns, such as the well-being of animals, ethical consequences, and environmental risks, are considered during the patent process.[10] Furthermore, in deciding whether to grant an animal patent, the European Patent system weighs the benefits to humanity derived from the invention against the suffering of the corresponding animals.[11] Several groups feel that these additional non-technological concerns should be adopted in the United States.
The Great Debate Over Animal Patents
There are numerous groups that oppose animal patents, including the American Anti-Vivisection Society (AAVS), the Alternatives Research & Development Foundation (ARDF), and PatentWatch. These groups argue that “animal patents provide an incentive to harm animals for economic gain.”[12] The manipulation of these animals leads to their suffering and exploitation, they argue, especially for animals that are engineered to have a defect or malady that enhances its research value. As an example of this exploitation, opponents point to: (1) a patent for creating rabbits with a mutation of the eyes that are used for research on human eyes, and (2) a patent for producing beagles with weakened immune systems that are used for research on infections of the lungs. Opponents urge that the mutations of these animals and the corresponding research evidence their suffering and exploitation. Overall, the opponents of animal patents feel that the engineering of animals is immoral and unethical, and that granting patent rights for transgenic animals promotes this practice.
The proponents of animal patents, including research institutions and biotechnology companies, argue that animal patents “facilitate the development of more efficient food sources and better human disease models, increase productivity, and yield other significant benefits.”[13] Patents enable investors and companies to risk resources and capital on research and development for the hope of obtaining a patent and the corresponding monopoly. This provides the necessary incentive to innovate. For example, the Harvard oncomouse was created to further cancer research in humans, and other genetically engineered animals are used to produce beneficial drugs or medications.[14] Supporters of animal patents admit that there are moral issues involved, but they believe that the greater good is served by promoting research to solve social and medical problems.[15]
However, the patent system may not be the proper vehicle to address the concerns animal patent opponents have about animal suffering. A patent for a transgenic animal provides a relatively brief monopoly for the patent owner (approximately 20 years), but this may not be the main incentive for experimenting with transgenic animals. Research institutions and corporations use transgenic animals to research treatments and medications that will benefit society, and transgenic animals that exhibit desired characteristics improve the efficiency and quality of this research. The engineering of transgenic animals will likely continue with or without patent protection. Moreover, at this time, Congressional action would be required to alter the law concerning the patenting of transgenic animals. As a result, new laws regarding the control and protection of transgenic animals may provide a better way to address the prevention of animal suffering.
[1] See Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (“[T]he laws of nature, physical phenomena, and abstract ideas have been held not patentable.” (citing Parker v. Flook, 437 U.S. 584 (1978)).
[2] “Bioethics and Patent Law: The Case of the Oncomouse,” WIPO Magazine (2006), http://www.wipo.int/wipo_magazine/en/2006/03/article_0006.html (last visited April 13, 2011).
[3] See U.S. Patent No. 4,736,866 (filed June 22, 1984) (widely known as the first patent for a “Transgenic Non-Human Mammal”).
[4] See “USPTO Accepts Challenge on Legality of Animal Patents,” American Anti-Vivisection Society (2007), http://www.stopanimalpatents.org/images/pressrelease_rabbit_challenge_accepted.pdf (last visited April 13, 2011).
[5] See, e.g., U.S. Patent 7,550,649 (filed Oct. 28, 2004) (claiming a transgenic mouse that is a model for Parkinson’s disease); U.S. Patent 5,574,206 (filed Aug. 24, 1994) (claiming a transgenic mouse carrying a transgene that expresses non-infectious HIV RNA).
[6] “Bioethics and Patent Law: The Case of the Oncomouse,” WIPO Magazine (2006), http://www.wipo.int/wipo_magazine/en/2006/03/article_0006.html (last visited April 13, 2011).
[7] Stop Animal Patents FAQ, http://www.stopanimalpatents.org/faq.html (last visited April 13, 2011).
[8] Id.
[9] Jerzy Koopman, “The Patentability of Transgenic Animals in the United States of America and the European Union: A Proposal for Harmonization,” 13 Fordham Intell. Prop. Media & Ent. L.J. 103, 179-181 (2002).
[10] See id. at 181.
[11] See id.
[12] See “USPTO Accepts Challenge on Legality of Animal Patents,” American Anti-Vivisection Society (2007), http://www.stopanimalpatents.org/images/pressrelease_rabbit_challenge_accepted.pdf (last visited April 13, 2011).
[13] David Manspeizer, “The Cheshire Cat, the March Hare, the Harvard Mouse: Animal Patents Open up a New, Genetically-Engineered Wonderland,” 43 Rutgers L. Rev. 417, 455 (1991).
[14] See id. at 426-28.
[15] See id. at 455.