Daschle Rips Rx Patent Extensions, But Spares His Drug-Patent-Lobbying Wife By David Freddoso

Senate Majority Leader Tom Daschle (D.-S.D.) is co-sponsoring legislation to prevent pharmaceutical companies from extending patents on proprietary drugs—even though his wife, lobbyist Linda Hall Daschle, recently lobbied on behalf of Schering-Plough Corp. for special legislation to extend its patent on the prescription allergy drug Claritin.

Although Daschle made a scathing generalized attack last Tuesday on the efforts made by pharmaceutical companies to extend their patents, he later exempted his wife’s lobbying activities from this criticism when questioned by Human Events.

As Democrats began a push to stop drug companies from extending the patents on their proprietary drugs, Daschle accused the companies of engaging in morally suspect practices in order to extend those patents. "I think this is also an issue of corporate integrity," he told reporters July 16. "I think that often-times pharmaceutical companies are doing things to extend monopolies that I believe are unfair and, if not illegal, questionable."

But when asked by Human Events, Daschle denied that his wife—lobbyist Linda Hall Daschle—had promoted such "unfair" or "questionable" practices by lobbying Congress two years ago for a Claritin’s patent extension. "The answer is no," he said in a written statement, adding; "As I have indicated in past responses to your questions, my wife does not lobby me or the Senate on any matter."

Daschle is co-sponsoring the Greater Access to Affordable Pharmaceuticals Act of 2001 —drafted by Senators Chuck Schumer (D.-N.Y.) and John McCain (R.-Ariz.)—which would allow more legal challenges to be filed against pharmaceutical companies seeking to extend their patents, and eliminate a customary 30-month stay that courts often put on the manufacture of identical generic drugs when such patents expire.

Senate records show that Mrs. Daschle lobbied Congress in 1999 and 2000 on behalf of Schering-Plough in order to extend the patent of the prescription allergy drug Claritin. After the lobbying effort failed, Schering-Plough tried to effectively extend its unique market position relative to the allergy medicine by patenting a slightly altered version of the drug—a tactic that Daschle’s bill seeks to prevent.

Mrs. Daschle has often explained her lobbying career—in which she has represented mostly airlines, airports and aircraft manufacturers since before she married Sen. Daschle—in the light of her life-long interest in aviation. Asked by Human Events why she chose to lobby for a pharmaceutical company, her spokeswoman simply replied, "Mrs. Daschle is a respected leader in the aviation industry and continues to devote her career to the aviation sector."

Mrs. Daschle and six other members of her firm lobbied for a bill—the Patent Fairness Act of 1999—that was so clearly designed to help Schering-Plough that the Congressional Record Service lists it as the "Claritin Patent Renewal bill." The bill, co-sponsored by a bipartisan crew of 77 congressmen, would have given extra patent life to drugs whose approval by the Food and Drug Administration (FDA) had been held up for more than five years. Claritin, originally patented in 1981 and presented for FDA approval in 1986, could not be marketed until 1993 because FDA bureaucrats objected to the proposed dosage of the allergy pill.

Mrs. Daschle’s spokeswoman told Human Events that the patent extension was well deserved for that reason. "The extension was sought because the FDA had originally delayed Claritin’s release by almost a decade," she said.

Claritin’s original patent term of 17 years had already been extended by two years under provisions of the 1984 Hatch-Waxman Act, and by nearly two more under the General Agreement on Tariffs and Trade (GATT). Still, the drug has had only nine years of patent protection since its FDA approval.

Schering-Plough’s lobbying effort failed when the House bill died in a Judiciary subcommittee in July 1999. As a result, the patent for Claritin will expire this December, at which point the brand-name drug will be forced to compete with cheaper generic alternatives.

After failing to keep its patent alive, Schering-Plough employed another tactic for extending the profitability of its proprietary drug—a tactic that Sen. Daschle opposes and which the Schumer-McCain bill would effectively forbid.

The company has patented and begun to market a new, slightly different version of the allergy drug, called Clarinex, causing some to complain that the new drug is merely a marketing ploy. Whereas Claritin—which will soon be marketed over the counter—causes the body to produce certain chemicals that inhibit allergens, prescription Clarinex directly supplies the body with the same chemicals.

The European Agency for the Evaluation of Medicinal Products—the European Union’s equivalent of the FDA—studied trial results for the two drugs and concluded that Clarinex is "probably not superior" to Claritin, the Washington Post reported in March. The British National Health Service came to a similar conclusion.

The bill that Daschle is co-sponsoring would allow generic drug manufacturers to mount legal challenges against new patents on spin-off drugs like Clarinex.

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-- Anonymous, July 20, 2002