Isle corn may SAN FRANCISCO >> A company that has a federal permit to grow in Hawaii corn spliced with a herpes-fighting human gene received broad and exclusive commercial rights to "molecular pharming" technology when its academic partner was granted a patent.
help company make
drug for herpes
Corn grown in Hawaii would
be spliced with a human gene
to create a herpes drugBy Paul Elias
Associated PressSeveral biotechnology companies and research labs are racing to develop ways to grow drugs in crops such as corn, tobacco and rice by splicing human genes that produce disease-fighting proteins in the plants' DNA.
The U.S. Patent and Trademark Office granted the Scripps Research Institute a patent Tuesday that appears to give the La Jolla, Calif., research lab exclusive control of some of the most promising proteins -- called antibodies -- grown in all plants.
"It appears to be a very broad patent for all antibodies grown in all plants," said Lisa Haile, a San Diego patent attorney. "It's pretty amazing."
San Diego-based Epicyte Pharmaceutical Inc. holds exclusive commercial rights to the patent. The company's co-founders, Mitch Hein and Andrew Hiatt, are listed as the patent's inventors and developed most of the technology while working at Scripps.
"It benefits Scripps and benefits the company," said Scripps spokeswoman Robin Clark.
Details on Epicyte's plans for growing the biotech corn in Hawaii were not immediately available.
The company has a biotechnology permit from the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, said Janelle Saneishi, spokeswoman for the state Department of Agriculture.
The company and its corporate partner, Dow Chemical Co., hope to extract the herpes-fighting antibody from the corn and turn it into a topical gel. The company hopes to begin testing the gel on people sometime next year.
About 45 million Americans are afflicted with some type of herpes virus.
But the patent and the technology it covers have drawn the ire of a wide range of critics, who argue the plants may pose unforeseen environmental and health problems. Others oppose the patenting of biological processes.
"This is one more clear example of the dividing up of the human body into inventions and intellectual property, which is being controlled by a few life science companies," said Jeremy Rifkin, a prominent anti-biotechnology author.
Jonathan King, a Massachusetts Institute of Technology molecular biology professor, said he does not believe biological processes should be patented because they "are not the inventions of scientists." He also fears people may have immune rejection responses to antibodies grown in crops if inadvertently consumed. "I am very uncomfortable in moving an essential human protein into a plant so closely tied to the human food chain," he said.
Epicyte said it plans to tightly control how and where its corn is grown to ensure it will not "pollute" other varieties meant for human consumption. This could include planting the corn out of season and far from other crops as required by the U.S. Department of Agriculture. Its first crop of corn was grown in an Indianapolis greenhouse, and the company has a permit to grow outside in Hawaii.
There are currently 10 antibody drugs on the market, including several billion-dollar-a-year blockbusters such as Genentech Inc.'s cancer treatments Rituxan and Herceptin and Johnson & Johnson's rheumatoid arthritis drug Remicade. Antibody drugs had more than $2 billion in combined sales last year and are expected to grow to $8 billion by 2004.
Most of the antibody drugs on the market are grown in Chinese hamster ovary cells and made into drugs at large bioreactor plants that cost about $500 million each and take years to construct.
In fact, demand for the drugs now on the market far outstrips the industry's production capacity. And with a good portion of the 99 protein-based drugs now in late-stage human trials expected to hit the market soon, the shortage will get much worse before it gets any better, analysts say.
By 2005 the industry will need about four times the capacity it has now.