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Copyright 2000 St. Louis Post-Dispatch, Inc.  
St. Louis Post-Dispatch

June 30, 2000, Friday, FIVE STAR LIFT EDITION

SECTION: NEWS, Pg. A1

LENGTH: 1029 words

HEADLINE: PATENT EXTENSION PROMISES A WINDFALL FOR MAKER OF ALLERGY DRUG;
CRITICS SAY IT WOULD KEEP COSTS HIGH FOR CONSUMERS

BYLINE: Deirdre Shesgreen; Post-Dispatch Washington Bureau

DATELINE: WASHINGTON

BODY:


As Congress bickers over a prescription drug benefit to make medicine more affordable to seniors, lawmakers are also floating a proposal that could provide a billion-dollar windfall to one pharmaceutical giant.

At issue is a patent extension for Schering-Plough Corp.'s anti-allergy drug Claritin. The company's patent on the medicine expires in 2002, at which point generic drug companies could move in and offer a cheaper version.

Staffers for Sen. Orrin Hatch, R-Utah, chairman of the Senate Judiciary Committee, drafted legislation to extend Schering-Plough's patent and the patents on several other drugs; the staffers began to circulate it this month. Critics say the bill would allow Schering-Plough to protect the $ 2 billion in annual sales it reaps from Claritin and that the move could cost consumers more than $ 7 billion over five years.

A spokesman for Schering-Plough said the company is not seeking a patent extension, but is pushing other legislation that could allow it to recoup lost time Schering-Plough endured waiting for regulatory approval of the drug.

Hatch's bill surfaced after another lawmaker, Sen. Judd Gregg, R-N.H., started pushing a patent extension that would allow Columbia University to continue to collect royalties on a drug manufacturing process that its researchers developed. Gregg was trying to add the Columbia extension to a military construction bill, and critics feared that Schering-Plough lobbyists would try to hitch a ride on the same legislation.

"Another catch-call spending bill is in the works," Sen. Patrick Leahy, D-Vt., the ranking Democrat on the Judiciary Committee, said at a news conference Tuesday. "These willy-nilly patent extension efforts will keep a handful of drugs at a very high cost. This is why nobody wants this to see the light of day."

Sen. Dick Durbin, D-Ill., said that because of the current debate over prescription drug costs for the elderly, "America is tuned in to drug prices today more than ever, and (lawmakers) can't get away from the fact that this would raise prices."

Some of the ire has been aimed at Sen. John Ashcroft, R-Mo., who is also a member of the Judiciary Committee. Schering-Plough contributed $ 50,000 to the Ashcroft Victory Committee, a joint fund-raising account set up by Ashcroft and the National Republican Senatorial Committee. The company made the contribution in September.

Frank Clemente, director of Public Citizen's Congress Watch, a group founded by consumer activist Ralph Nader, said the contribution is the only such soft money donation the company made directly to a candidate, as opposed to the party committees.

"It just stands out," he said. "I can't imagine they would give such a contribution for any other reason that he was tied to this effort. . . . This money is never given for nothing.

"We need people like him to stand up and say this is inappropriate," Clemente added, "to show he's not doing the bidding of Schering-Plough."

Ashcroft is a co-sponsor of another bill backed by Schering-Plough. That legislation, introduced last year, would allow certain companies, including Schering-Plough, to seek added protected market time for their drugs if they can prove to the Patent and Trademark Office that they suffered undue regulatory delays. The legislation is pending before the Judiciary Committee.

Ashcroft campaign spokesman David James dismissed the group's accusations. "Public Citizen has zero credibility and is known as a Democrat-based attack group," James said. The legislation Ashcroft has signed on to "is a meritorious bill that allows administration officials to decide on applications to extend the patents on lifesaving research," James said.

James also said that Ashcroft "does not receive a dime of this contribution," which goes to the Republican Senatorial Committee. He noted that Schering-Plough has made similar contributions to the Democratic Senatorial Campaign Committee, which is supporting Gov. Mel Carnahan's campaign against Ashcroft.

James said Ashcroft was not involved in the Claritin patent extension and had no position on it. In the past, Ashcroft has supported patent extensions on lifesaving medical research, James added.

Schering-Plough spokesman William O'Donnell said the Hatch legislation "is not our bill" and defended the company's earlier legislative push for a review process for aggrieved companies.

"Our company believes Congress should establish a fair and independent process for considering requests by certain pharmaceuticals that have lost years of useful patent life due to lengthy delays in the regulatory review process," O'Donnell said. "We are not seeking a patent extension. We are looking for a fair and equitable process to make our case heard."

O'Donnell said the company donated money to Ashcroft because he is a good senator. "Senator Ashcroft is widely recognized as an advocate for the advancement of technology and protection of intellectual property," O'Donnell said. "Schering-Plough has supported Senator Ashcroft because we believe these principals are key to maintaining the country's leadership position in the discovery and development of therapies that can save lives and enhance the quality of life."

Hatch also denied any plans to slip the bill into any spending bill without public scrutiny. "This is a tempest in a teaspoon," he said.

Hatch said his staff drafted the patent extension without his knowledge and it "goes far beyond" the earlier legislation considered by his committee. "Neither I nor my staff have ever attempted or said we would attempt, anonymously or non-anonymously - to attach this draft proposal to" any appropriations legislation, the statement said.

Democrats and consumer groups are skeptical, saying that previous stealth efforts have cropped up every year for the past four years. Although the two patents were not included in the military construction bill, Democrats say there will be other targets as Congress finishes its work on the 13 annual spending bills.

"They're circling the wagons," one Democratic aide said of the Schering-Plough lobbyists, "so it's not a dead issue."

LOAD-DATE: June 30, 2000




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