Reproduced with permission from Daily Report for Executives, No. 122, pp. A-41 - A-42 (June 23, 2000). Coprright 2000 by The Bureau of National Affairs, Inc. (800-372-1033)

The Bureau of National Affairs

Some Senators Cry Foul Over Inclusion
Of Patent Extension Rider in Spending Bills
Language allowing Columbia University to apply for an extension on its co-transformation patent has been inserted into the military construction supplemental appropriations bill, an industry source told BNA June 22.

While there has been generalized opposition to including patent extensions as part of the appropriations process, because the Columbia University language already is in the bill, its likelihood for passage is increased, industry sources told BNA.

Congressional Procedural Moves

Due to various last-minute procedural moves in the Senate, the Columbia University patent extension language--which Sen. Judd Gregg (R-N.H.) inserted into the supplemental appropriations bill for agriculture--wound up being bundled with other supplemental appropriations bills--and was sent to the military construction conference committee, which is dealing with all supplemental appropriations.

Gregg's language would make Columbia University eligible for a patent extension on its co-transformation patent, which covers a process through which foreign DNA is inserted into mammalian cells to encourage protein production. An extension likely would garner an extra $150 million for Columbia, a university official told BNA.

Because conference committee members must vote either for or against the conference report, and cannot object to certain parts of the bill, sources told BNA they expect the Columbia patent extension language to make it through. If the supplemental appropriations are not approved by July 1, certain agencies will run out of money, increasing the urgency of passing a spending bill, a source told BNA. However, while the Columbia language is in the Senate bill, there is a question about whether House members would agree to support it.

Another source close to the generic industry told BNA, "the House side doesn't want anything to do with this [Columbia patent extension]."

Schering-Plough and Claritin

However, Columbia University's patent extension prospects may have been inadvertently brightened by Schering-Plough's reported attempts to interest members of Congress in introducing legislation that would--among other things--allow Schering-Plough to obtain a patent extension on its blockbuster allergy drug Claritin, sources told BNA.

A draft bill, the "United States Inventor Equitable Relief Act of 2000," which sources claim was drafted by Schering-Plough, would allow Schering-Plough, other human drug manufacturers, and makers of veterinary biologics, medical devices, food and color additives, to apply to the United States Federal Court of Claims for restoration of patent time allegedly lost to Food and Drug Administration regulatory delays.

Initially, sources said, Schering-Plough explored "piggybacking" their patent restoration language with the Columbia University language in the appropriations process, a charge that Schering-Plough has denied (8 HCPR 960, 6/12/00).

However, some sources told BNA the current political climate, with its emphasis on passing a Medicaid drug benefit and attention to rising drug prices, does not favor Schering-Plough's efforts to seek additional patent time.

"This is not a time to be going out and giving a goodie to Schering-Plough," one generic industry source said.

Some Senators Object to Riders

In the wake of the Columbia University language and talk of a patent extension for Schering-Plough, several senators, including Sens. Richard Durbin (D-Ill.) and Patrick Leahy (D-Vt.), both of whom are on the Senate Appropriations Committee, and Sens. John R. Edwards (D-N.C.), James M. Jeffords (R-Vt.), Tim Johnson (D-S.D.), Edward M. Kennedy (D-Mass.), Olympia J. Snowe (R-Maine), and Paul Wellstone (D-Minn.), sent a letter June 20 to committee chair, Sen. Ted Stevens (R-Alaska), and Sen. Conrad Burns (R-Mont.), chair of the military construction appropriations subcommittee, opposing the insertion of patent extension riders into the military construction appropriations bill

"We are concerned that efforts may be made to slip a variety of patent extension proposals into this bill and we urge you to object to all such proposals," the senators wrote.

"These proposed items should not be slipped into any Appropriations bills. They have not had appropriate congressional review and Congress has not had an opportunity to review their merits individually," the senators said.

"These riders should see the light of day before being added in conference to a bill that had no such provisions as passed by the House and Senate," the senators said.

"Senators are not enthused [about the Schering-Plough patent extension language] and don't want it in," one source told BNA.

"The only way the Schering-Plough bill is going to get through is through a backroom deal," Brad Cameron, spokesman for the Campaign for Fair Pharmaceutical Competition, a nonprofit coalition that includes senior and consumer groups, and generic manufacturers, told BNA June 22. "What we're looking at now is ... they're [Schering-Plough] just going to try to get it in the next [spending bill]," Cameron said.

While it is not clear when a vote would occur on the military construction supplemental appropriations conference report, a House Appropriations Committee spokesperson told BNA June 22 "we'd like to get it done before the recess."

Copyright 2000 by The Bureau of National Affairs, Inc., Washington D.C.