WASHINGTON _ The Environmental Protection Agency hasapproved limited planting of genetically engineered potatoes, cornand cotton for the purpose of stockpiling seeds. The move marks thefirst time the agency has approved so-called "plant-pesticides" andsets the stage for full registration of the crops as commercialproducts.

Monsanto Co., of St. Louis, is now free to plant seed potatoes andcotton seed while Ciba Seeds, of Greensboro, N.C. (a unit of Swiss-based Ciba Geigy Corp.), and San Diego-based Mycogen PlantSciences (a subsidiary of Mycogen Corp.) can both plant corn seeds.The bioengineered seeds and/or products cannot be sold until thethree companies receive final EPA approval.

Under a new EPA definition, plant-pesticides are produced whengenetic material is transferred from a type of bacterium, Bacillusthuringiensis (Bt), to a crop plant. The inserted genetic code allowsthe plants to fend off pests because Bt naturally produces a toxin,called delta endotoxin, that kills insects when ingested. Bt toxins donot affect mammals.

"Plant-pesticides can offer an opportunity to reduce the use ofconventional pesticides and generally result in less risk to publichealth and the environment," stated an EPA document announcingthe ruling.

BT delta endotoxin allows potatoes to resist the Colorado PotatoBeetle, aids cotton plants in fighting off the cotton bollworm, tobaccobudworm and pink bollworm, and renders corn resistant to theEuropean Corn Borer and other Lepidopterous (moth) pests. Unlessrenewed by the EPA, the limited registrations for the three plant-pesticides will expire in 1996.

The seed production is limited in acreage and restricted to certainstates. For example, the genetically engineered potatoes can beplanted on 8,186 acres in Colorado, Idaho, Maine, Michigan,Minnesota, Montana, Nebraska, New York, North Dakota, Oregon,Washington and Wisconsin. The cotton and corn seeds can beplanted on 36,850 and 9,725 acres, respectively.

On March 1, an EPA advisory panel discussed safety andenvironmental issues surrounding Bt plant-pesticides, with a focus onthe bioengineered potato. That crop is expected to be the first oneapproved by EPA later this year.

Biotech Process Patent Protection Bill Reintroduced

Although the Biotechnology Process Patent Protection Act diedunceremoniously last year amid the chaos of the 103rd Congress'sfinal days, it has been resurrected in the 104th Congress. LastWednesday, the House Judiciary Committee's subcommittee onCourts and Intellectual Property held a hearing on a new bill, H.R.587, which was introduced in the House on Jan. 19.

The biotechnology industry has spent six years lobbying for a bill tochange patent laws in order to better protect biotechnologycompanies from foreign competitors. Although the seemingly endlessdebate over this issue has been an arcane one, some say it's critical tothe industry.

"Without process patents, the biotechnology industry simply does nothave the means whereby to prevent piracy of U.S. inventions byforeign competitors that want to sell to the U.S.," Peter Linsert,chairman and CEO of Columbia, Md.-based Martek BiosciencesCorp., told subcommittee members on Wednesday.

At issue is the manner in which the U.S. Patent and Trademark Office(PTO) grants patents for processes. The proposed legislation wouldsimplify and provide certainty in the determination of patentability ofprocesses using or making novel and "nonobvious" products. Itwould accomplish this by amending Title 35 of the U.S. Code withrespect to applications for process patents.

Under current law, inventors cannot prevent foreign competitors fromimporting products made by a process which uses a material patentedin the U.S., unless they have patent protection for that process. Butcompanies cannot always obtain patents for processes. For example,a company that develops a protein drug typically files a patent for theDNA sequence of the protein, the vector used to transfect the hostcell to produce the protein, the host cell itself and, last but not least,the end-product protein.

However, if the protein is one that has already been discovered andcharacterized by scientists, such as protein that occurs naturally in thehuman body, it may not be patentable as an end-product. In that case,the next best thing is to get a patent on the process used to producecommercial quantities of the protein.

But due to inconsistent court precedents on process patents, the PTOtends to grant companies patents for the individual components _DNA sequence, vector, host cell _ but not for the process.

The confusing situation leaves biotechnology companies vulnerableto foreign competitors who could take the individual componentsoffshore, combine them using the unpatented process, and thenimport the end-product back into the U.S. Because neither the end-product nor the process is protected, the inventing company has nolegal recourse to prevent this from happening.

"Last year this [process patent protection] bill got caught in apolitical crossfire on unrelated issues," Chuck Ludlam, vice presidentof government affairs at the Biotechnology Industry Organization,told BioWorld. "But it's not viewed as controversial legislation andwe believe it should pass this year." A mark-up of H.R. 587 isscheduled for later this month. n

-- Lisa Piercey Washington Editor

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

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