The biotechnology world was buzzing Tuesday with the news that the National Institutes of Health, along with Genetic Therapy Inc. of Gaithersburg, Md., has been awarded a surprisingly broad patent on a key gene therapy technique.
The patent could be worth millions of dollars in royalties to Genetic Therapy, and the fledgling firm's stock jumped $1.50 Tuesday to close at $10 on the Nasdaq exchange. But industry experts had mixed opinions as to whether the patent will promote progress in the field by clarifying the intellectual property issue, or thwart progress by inviting litigation.
"Everybody is very concerned about the breadth of the claims in this patent and surprised that something that broad was issued," says Pam Sherwood, patent agent with Flehr, Hohbach & Test in San Francisco.
The National Institutes of Health won the patent from the U.S. Patent and Trademark Office, and under prior agreement immediately awarded exclusive rights to commercialize the technology to Genetic Therapy. Since 1988, the company and NIH have spent millions of dollars to develop it in a joint research program.
The technique involves removing human cells and using specially developed biotechnology drugs to insert into the cells new genes that correct disease-causing defects. The cells are then put back into the patient to combat disease. More than half of all the gene therapy trials now under way use this method.
The other major gene therapy technique involves inserting new genes directly into a patient's body in such a way that the genes find and insert themselves into the proper cells. This approach is considered more promising in the long term but more difficult in the short term.