The U.S. Patent and Trademark Office (PTO) has notified bothOhio University in Athens and GenPharm International ofMountain View, Calif., that it will issue patents on theirtransgenic mice on Dec. 29.

The Ohio University patent, No. 5,175,385, is on a virus-resistant transgenic mouse carrying the gene for human beta-interferon (beta-IFN). The GenPharm patent, No. 5,175,384, ison a transgenic immunodeficient mouse (TIM) to be used as arecipient of human immune tissue. GenPharm will also get ause patent, No 5,174,986, for its PIM transgenic mouse(engineered to contain the PIM-1 oncogene) for carcinogenicitytesting.

These are only the second and third animals to receive patentssince Phillip Leder's "Harvard oncomouse," engineered to growmalignant tumors for studying cancer, was patented four yearsago.

"The issuance of transgenic animal patents is a significant eventfor the biotechnology industry," said Lisa Raines, vice presidentfor government affairs at the Industrial BiotechnologyAssociation (IBA) in Washington, D.C.

"Since Harvard University received the first transgenic animalpatent in 1988, there has been continued debate aboutwhether or not additional animal patents would be granted,"she said. "This PTO decision marks a positive step forward forprotecting important U.S. research."

Carl Pinkert, director of the Transgenic Animal/EmbryonicStem Cell Resource at the University of Alabama, Birmingham,and editor of the year-old scientific journal TransgenicResearch concurs.

"Different companies will need patent protection to move aheadwith the steep investment they will need to devote to thedevelopment of these important models." Pinkert said. "Thereneeds to be this sort of guarantee to protect the return on theinvestment."

Pinkert predicted that perhaps a "cluster of animal patents"will now issue in the U.S. and that even the Europeans, whodidn't approve the Harvard mouse until 1991, may be "readyto move ahead."

Ohio University's patent is one of several it has received ontransgenic technology developed by molecular and cellularbiologist Thomas Wagner and his colleagues at the OhioUniversity Edison Animal Biotechnology Center. It was Edison'sXiao Chen, then a graduate student in Wagner's lab, whocreated this newly patented virus-resistant mouse, as part ofhis doctoral research about seven years ago.

"The mouse itself expresses human beta-IFN at a low level,"Wagner said. "We don't see any side effects in these animals,even after about 10 generations. ... If you introduce anendogenous IFN you produce an animal that is not normal orhealthy." Moreover, Wagner said that these engineered miceare "significantly resistant to viral challenge."

In research results published in the Journal of Virology severalyears ago, these mice were protected against a challenge withotherwise lethal pseudorabies. And "they have been exposed tonormal mouse viruses in the colony. We've never seen infectionin these animals," Wagner told BioWorld.

"I hope that this interferon transgenic mouse model willcontribute to our understanding of how interferons function inour bodies in fighting against viral infections, as well ascancer," said Chen.

And the transgenics might just prove to be a better breed oflaboratory animal. "It's not trivial to maintain animals that arefree of disease," Wagner said, and the mice also might exhibitreduced levels of morbidity and mortality.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.

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