Patentability of Genetically Modified, Selectively Bred, or De-Extinct Animals

By Lulu Lipman, L’26

In 1987, the United States Patent and Trademark Office (USPTO) issued a historic notice stating that “[n]on-naturally occurring, nonhuman, multicellular living organisms, including animals,” were patentable. Since then, the USPTO has issued patents to hundreds of animal models. As the practice of patenting animals has exploded, it has sparked ethical concerns and questions, especially concerning where we draw the line on patenting living things.

For an animal to be eligible to be patented, it must be genetically modified and thus not naturally occurring or found in nature. This criterion can include animals “produced through selective breeding.” In 2012, the USPTO rejected an application to patent the Pixie-Bob (a cross between a bobcat and a domestic cat) under §101 because the two species could naturally breed without human involvement, thus rendering them a product of nature and not patent-eligible. However, the USPTO distinguished the Pixie-Bob case from other instances where animals are selectively bred to have specific traits, like in U.S. Patent 5,603,302, where scientists bred guinea pigs to be bronchial hypersensitive to be used for research. In differentiating between when selective breeding is patent-eligible, the Office of the Solicitor clarified that “[the] claims recite a specific desired trait and [the] patent discloses a specific method of breeding used to obtain that trait, distinguishing [the] claimed guinea pigs from those in nature.”

The guinea pigs described in Patent 5,603,302 are representative of the most commonly patented species in the United States: transgenic animals altered by scientists to exhibit traits that make them advantageous for research. For example, the first “higher form” animal patented was the OncoMouse in 1988. Scientists at Harvard University genetically engineered mice to be predisposed to cancer, thus allowing them to “study the disease in an intact living organism” and, in turn, “transform cancer research.” Advocates of patenting animals have cited its benefits as expediting scientific discovery, increasing favorable health outcomes, and contributing to medical breakthroughs.

The practice of animal patenting has also been the subject of staunch criticism. One of the most outspoken critics is the American Anti-Vivisection Society (AAVS). The organization believes that patenting animals is cruel and incentivizes harming animals “in the interest of profit, but under the guise of scientific research, testing, and experimentation.” In 2004, AAVS challenged U.S. Patent 6,444,872, claiming it was unethical. The patent, which was granted to scientists at UT Austin, involved inducing invasive pulmonary aspergillosis in beagles to test the efficacy of a new drug intended to treat leukemia in humans. The patent covered both the novel methodology of infecting the dogs and the immunocompromised dogs themselves. In May 2004, following public backlash, the USPTO agreed to re-examine the patent, and the Board of Regents of UT Austin chose to “disclaim …the entire remaining term of all the claims.” AAVS called this a “tremendous victory.” Another win for AAVS came in 2008, when, after three years of lobbying, it successfully convinced the USPTO to revoke U.S. Patent 6,924,413. The patent covered rabbits whose eyes were wounded to imitate the effects of humans who have dry eyes.

Based on the proliferation of animal patents since the OncoMouse debuted thirty-five years ago, it seems like the practice is not slowing down. However, mounting ethical concerns must be weighed against the emerging scientific advancements facilitated by animal patents. So, where does the future lie for animal patents? Some, like Harvard geneticist George Church and the Colossal Laboratories & Biosciences team, envision “patenting’ de-extinct animal species” as the next frontier of animal patents. The Colossal Laboratories team hopes to resurrect a wooly mammoth within the next five years; however, the process of “de-extinction” will introduce new complexities regarding which revived species can be patented. Thus, the question remains: “Can someone really patent a mammoth? And if they can, should they?”