From: Bureau of National Affairs Medical Research Law & Policy Report, 3/3/04

http://www.bna.com/products/health/mrlr.htm

Intellectual Property

Patent on Lung Infection Model in Beagles
Challenged on Both Ethical, Legal Grounds

By: M. Alexander Otto

Hoping they have found a test case that will help end the practice of patenting animals, an animal welfare group and patent watchdog organization have asked the U.S. Patent and Trademark Office to overturn a patent recently issued to the University of Texas.

The patent in question (6,444,872) was issued Sept. 3, 2002, to the UT Board of Regents under the title, "Large animal model of invasive pulmonary aspergillosis in an immunocompromised host."

It describes exposing healthy beagles to drugs and radiation in order to destroy the dogs' immune systems. Thereafter, the animals are infected with the aspergillosis fungus. The goal is to simulate the often-fatal, AIDS-related lung infection in order to test drugs to fight it.

Researcher Borje S. Andersson, who invented the procedure, already has used the beagle model three times to test a drug he hopes one day will be approved by the Food and Drug Administration. Animal testing is necessary to justify further study of experimental drugs in humans, he said, and beagles make good subjects because they are inexpensive and docile.

On Feb. 25, however, the American Anti-Vivisection Society and the PatentWatch Project asked PTO to throw out the patent on the grounds that the method used to induce the infection would be obvious to any biomedical researcher and that neither beagles nor any other animal fit into any of the statutory categories of patentable subject matter.

Test Case.

Andersson maintained that his school simply patented the process of inducing aspergillosis in a large animal, and that the University of Texas probably would enforce the patent if it were used in any animal, not just beagles.

But AAVS Senior Policy Analyst Crystal Miller-Spiegel said the patent refers so often to beagles that it could be construed as a general patent on beagles for scientific use. She also noted that the 23-claim patent seeks to protect "a beagle dog" and "obtaining a beagle dog."

She said the real goal of the challenge is to end the practice of patenting animals, which the groups' press materials said is "neither legally valid nor morally acceptable."

"This is the first legal challenge to the overall concept of patenting animals as inventions," as opposed to past challenges, which simply disputed who owned the patent, Miller-Spiegel told BNA (see, for example, 2 MRLR 722, 10/15/03).

"Since 1987, the USPTO has accepted almost 500 applications for patents, ranging from genetically engineered mice to rabbits who have been merely conventionally sexually bred," AAVS explained in a press statement. "The legal linchpin upon which the USPTO allows such patents is their categorization of all animals, from mice to monkeys, as mere 'manufactures' or inventors' 'compositions of matter.' To date, their strained interpretation of patent law has neither been directly challenged nor confirmed in a court of law."

The groups claimed that two out of three Americans, once made aware of the issue, oppose animal patents. European patent authorities have questioned whether the beagle model "is contrary to public order or morality," Miller-Spiegel said.

Success Possible.

The activists' efforts might work, PTO spokeswoman Brigid Quinn said.

When a third party asks PTO to re-examine a patent, the patent is cancelled 12 percent of the time, and one or more of the patent's claims are thrown out in 58 percent of the cases, she said. Only 30 percent of challenged patents remain intact, Quinn noted.

It could take up to 18 months before the office reaches a decision, she added.

Meanwhile, Andersson told BNA he thinks the challenge is absurd "because beagles were invented by the Lord." He added that the experimental anti-fungal agent he is testing so far has worked in the dogs.


The re-examination request for patent 6,444,872 is available on the Web at http://www.stopanimalpatents.com/images/request.pdf.


Copyright 2004, The Bureau of National Affairs, Inc., Washington, D.C.