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Copyright 2000 The New York Times Company  
The New York Times

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May 21, 2000, Sunday, Late Edition - Final
Correction Appended

SECTION: Section 1; Page 37; Column 1; Metropolitan Desk 

LENGTH: 778 words

HEADLINE: Columbia Gets Help From Alumnus on Patent Extension

BYLINE:   By ANDREW POLLACK 

BODY:
Columbia University has enlisted an alumnus in the United States Senate to sponsor legislation that would extend the life of an important biotechnology patent that brings the university about $100 million a year in revenue.

The alumnus, Judd Gregg, a New Hampshire Republican and member of the class of '69, attached an amendment permitting the extension to an agricultural spending bill that has already been approved by the Senate Appropriations Committee, which he heads. But the biotechnology and pharmaceutical industries have objected to the patent extension, and one senator has vowed to try to kill it on the Senate floor.

The patent covers a technique that allows animal cells to be used to manufacture proteins used as drugs. The patent has been used to produce many of the biotechnology industry's best-selling drugs, like Amgen's Epogen for anemia and Immunex Corporation's Enbrel for rheumatoid arthritis.

Columbia gets a royalty of 1 percent of the sales of such drugs and has collected $280 million since the patent was granted in 1983, with more coming in each year as the sales of the drugs have grown. But the patent, one of Columbia's largest sources of money for research, expires in August, prompting the university to scramble for a reprieve.

Michael M. Crow, executive vice provost of Columbia, said the university expected that under the proposed legislation, it would be entitled to an extension of 14 to 18 months, which would bring the university about $150 million in revenue. About 20 percent of the royalties go to the four scientists who invented the process and the rest go toward university research.

But the Biotechnology Industry Organization said the legislation would provide an "unjustified windfall" to Columbia and the wording of the provision could allow an extension of up to five years that would affect at least 18 existing drugs. In a letter sent Monday to Senator Orrin G. Hatch, the chairman of the Judiciary Committee and co-author of a law covering drug patents, the industry lobbying organization said law regarding drug patents should be subject to hearings.

Columbia and Senator Gregg said that in seeking the extension, they were trying to correct what they see as an inequity in the law covering drug patents. Under the 1984 Hatch-Waxman Act, companies can apply for an extension for a drug patent to compensate for delays in getting the product approved by the Food and Drug Administration.

But Columbia's patent covers a process used to make drugs -- not a drug itself -- and so it is not eligible for an extension under the act. The university contends that because the drugs made with its process, known as cotransformation, did experience regulatory delays, Columbia's royalties were reduced and it, too, should be entitled to a patent extension. The university said the money would be plowed into research and education, which would benefit the public.

"Patents like the Columbia University cotransformation patent should be eligible for patent extensions just like any other drug patent," Senator Gregg said in a statement, according to Bloomberg News. "This is an inequity my amendment addresses."

Senator Richard J. Durbin, a Democrat from Illinois, said he would move to strike the patent provision if it gets to the Senate floor.

Melissa Merz, a spokeswoman for Senator Durbin, said the patent royalties would mean higher prices for consumers. She added that the money to develop the patented technique came from federal research grants. "This is not their investment," she said. "This is the taxpayers' investment."

Dr. Crow of Columbia said that a 1 percent royalty does not contribute significantly to consumer prices and that the research benefits the public. He said the money is vital to Columbia because, unlike government and industry grants, it is not tied to specific projects. "We are able to do some things that none of our other resources allows us to do," he said.

Columbia, which spends about $400 million a year on research, began seeking the extension last fall after it learned that companies producing drugs using its patent were seeking extensions under the Hatch-Waxman Act, Dr. Crow said.

Despite their objections to Columbia's effort, pharmaceutical companies themselves often try to win patent extensions from Congress to stave off competition from cheaper generic drugs. It is usually attempted by a congressman who quietly attaches the extension to some other legislation.

The Schering-Plough Corporation, for example, has spent millions of dollars in lobbying and campaign contributions seeking an extension for Claritin, its allergy drug.  

http://www.nytimes.com

CORRECTION-DATE: May 23, 2000, Tuesday

CORRECTION:
Because of an editing error, an article in some copies on Sunday about Columbia University's efforts to extend a biotechnology patent misidentified the committee role of Senator Judd Gregg of New Hampshire, who has attached an amendment for that purpose to an agricultural spending bill. He is chairman of a Senate Appropriations subcommittee, not of the Appropriations Committee.



LOAD-DATE: May 21, 2000




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