Overview

The American Anti-Vivisection Society, along with the PatentWatch Project of the International Center for Technology Assessment, filed a Request for Reexamination in 2004 to challenge patent #6,444,872 -- beagle dogs whose immune systems were weakened by chemicals and radiation and who thereafter were infected with a pulmonary fungal infection. The Request was based on the grounds that (1) animals should not be patented like inanimate objects, and (2) it has not fulfilled the nonobvious requirement of the U.S. Patent and Trademark Office (USPTO). This was the first time that a specific animal patent has been challenged by a civil society organization.

Patent # 6,444,872: Beagles

In 1999, experimenters at the University of Texas 'successfully' rendered 31 healthy beagles to be immunocompromised in order to 'mimic' humans with weakened immune systems due to various maladies such as HIV infection, chemotherapy, transplant surgeries, or from taking immunosuppressive medications to control cancer. These patients are susceptible to fungal (mold) infections in their lungs. Though similar experiments have been conducted in other animals (e.g. mice, rats, rabbits), the researchers claimed theirs was the first time this type of experiment has been performed on a "large animal."

The dogs received daily doses of steroids (to induce immunosuppression in their bodies) and were exposed to various levels of total body irradiation, which entailed putting individual dogs in a box and exposing them to x-rays. After several weeks, the beagles who survived, in a weakened state, were infected with a mold, Aspergillus fumigatus, which is the mold most commonly present (over 90%) in infections in patients with hematological cancer (e.g., leukemia, lymphoma, Hodgkin's, and multiple myeloma). The mold was deposited into the beagles through a tube inserted down their throats, which allowed for a localized infection in one lung lobe.

In 2002, the experimenters obtained a patent for this impaired beagle 'model' which they consider a "testing vehicle" for various treatments in the future, as well as a 'model' through which they can learn more about the pathophysiology of systematic fungal infections. The claims of the patent are not just for the sick beagles themselves, but also each and every step taken to make them sick, including the procurement of the beagles and the induction of immunosuppression. In order for the USPTO to grant the patent, the agency first made the judgment that sick beagles are somehow "manufactures" of "compositions of matter." Thereafter, it was established that the steps used to make them sick were "nonobvious." However, it is questionable as to whether the methods performed to obtain the beagles and infect them would not be nonobvious to those working in the biomedical research field. Moreover, there is no factual basis to consider a beagle as a mere "article of manufacture." In fact, during a preliminary examination of an application to establish this patent on beagles in Europe, the European Patent Office failed to find "inventive activity" in the patent and questioned "...whether the claimed treatment of beagle dogs is contrary to public order or morality...."

It has been determined that this patent has been exclusively licensed to Sandra Technology, Inc., a for-profit company in Texas. One can only conclude that this patent was sought in order to earn a profit from making animals very sick and killing them. The experimenters have stated that they see this 'model' as a way of ensuring that clinical drug trials in sick humans will result in greater success. They also suggest the future use of dogs, pigs, sheep, monkeys, and/or chimpanzees.

The American Anti-Vivisection Society, which is opposed to the use of animals in research, testing, and education, and the PatentWatch Project of the International Center for Technology Assessment adamantly assert that this patent, and others like it, do not fulfill the requirement of patent law, because neither beagles, nor any other animal fits into any of the patentable categories. In any event, the beagle patent fails to be nonobvious within the field of biomedical research.

Summary

• This patent involves claims on sick beagles and also claims on methods of obtaining healthy beagles and causing them to be immunosuppressed and infected with a specific mold species in order to characterize the infection, possibly treating the infection using several experimental methods, and understanding the pathophysiology of the infection.
• The European Patent Office failed to find "inventive activity" in this beagle patent and noted that, by treating dogs in this manner, public order or morality may be violated.
• It is questionable as to whether the methods performed to obtain the beagles and infect them would not be nonobvious to those working in the biomedical research field.
• This patent is owned by University of Texas, but also licensed to a for-profit company.
• The inventors state, "In alternate embodiments, [we] also contemplate the use of other large animals, such as dog, pig, sheep, monkey , or chimpanzee for the animal model" [emphasis added].
• The apparent purpose of this and other patents on animals is to profit from making animals sick and then killing them.