Daypro

WASHINGTON -- The generics drug industry and its al lies are working overtime to defeat new efforts by branded drug manufacturers to extend the patent life of some blockbuster medications. The effort reached the boiling point this month over Senate deliberations on a new patent-extension proposal in Congress.

Bills have been introduced in both the House and Senate that would grant additional patent protection to seven manufacturers of eight branded medications, including Schering-Plough's Claritin. The proposals spawned new levels of cooperation among the big three generics industry trade groups: the Generic Pharmaceutical Industry Association, the National Association of Pharmaceutical Manufacturers and the National Pharmaceutical Alliance. All three have joined in a coordinated effort to head off the legislation and breathe new life into the terms of the original 1984 compromise legislation that laid the ground rules for drug patents and generics approvals.

Moves by branded-drug makers to head off generics competition are nothing new. Nor are ongoing efforts by generic drug makers to gain support and credibility among lawmakers, federal oversight agencies, healthcare advocates and American consumers.

The newest threat to the generics industry comes in the form of two bills now making their way through committee in Congress: the Senate version, "Drug Patent Term Restoration Review Procedure Act of 1999," or S. 1172; and the near-identical "Patent Fairness Act of 1999," or H.R. 1598, which was introduced in the House in late April.

The aim of both bills is to grant extensions of up to three years on eight big-selling drugs whose patents are set to expire by 2002. Of those eight products, Schering-Plough's Claritin is by far the top seller, with 1998 sales of roughly $1.8 billion. The list also includes SmithKline Beecham Pharmaceuticals' Relafen, with 1998 sales of $450 million, and G.D. Searle's Daypro, generating $300 million in 1998 revenues. Rounding out the wish list are Dardiogen-82, Dermatop, Nimtop, Eulexin and Penetrex.

Combined, the eight pioneer drugs generate some $2.7 billion in annual sales.

In testimony before the Senate Judiciary Committee Aug. 4, Schering-Plough chairman Richard Kogan told senators the extensions were necessary to offset long delays in the approval process for many new drugs by the Food and Drug Administration The FDA's review of Claritin, for example, took more than six years, Kogan said, biting deeply into the drug's window of market exclusivity and discouraging research and development of new drugs.

Testifying on behalf of GPIA and NPA, however, Dr. Carole Goldfine Ben-Maimon, M.D., senior vice president of research and development at Teva Pharmaceuticals, called S. 1172 merely a patent extension for a multibillion-dollar allergy drug." She charged that the bill, co-sponsored by Sen. Robert Torricelli, D-N.J., John Ashcroft, R-Mo., and others, was ''clearly focused on the extension of several long-running monopolies at the expense of the patients who suffer from the diseases these products treat."

In addition, Ben-Maimon noted that Claritin's marketing exclusivity already had been extended twice. The first time, she told senators, was for two years of additional patent life under the original terms of the Hatch-Waxman compromise. "It also is important to note," she testified, "that in addition to the two-year extension, Claritin enjoys a 22.5-month extension under the General Agreement on Trade and Tariffs. As a result of past extensions, in June 2002, Claritin will have enjoyed patent life of approximately 21 years--four years beyond the original patent term."

Ben-Maimon added: "We in the generics industry oppose any new process for obtaining patent extensions. The extension of patents for pharmaceutical products must be considered in light of the impact on patients who will now be required to pay more for prescription drugs, and who may now have to wait longer for new and improved drugs as the lack of incentive for their development may delay their market entry.

"The Hatch-Waxman Act was to encourage future investment in research and development, not to reward past investment," she asserted. "This is why the act provides new chemical entities with the opportunity to seek up to five years of additional patent life when drugs such as Claritin were limited to the two-year patent extension."

In an earlier statement, GPIA president Dr. Alice Till, Ph.D., argued that the House version of the bill "paves the way for extending the monopolies of several highly profitable drugs, and would deny millions of American consumers timely access to more affordable generic equivalents.

"The bill is merely a recycled version of the proposal which was rejected, justifiably, at the end of the 105th Congress," Till noted.

Three associations unite

To battle patent-extension proposals and foster use of generics, GPIA, NAPM and NPA have formed a lobbying and advocacy group called the Coalition for Affordable Pharmaceuticals, or CAP. The coalition aired its views in July before a House subcommittee considering H.R. 1598, when CAP representative Andrew Berdon sought to convince legislators that the proposal would generate higher drug costs and stifle generics competition.

"H.R. 1598 ... not only costs the consumer--particularly the elderly-- billions of dollars, it also has a tremendous fiscal impact on government programs offering a drug benefit, such as Medicaid and programs offered by the Veterans Administration and the Department of Defense," said Berdon, who is vice president and general counsel of Purepac Pharmaceutical. "We believe it is ironic that as this Congress debates ways to reduce the high cost of prescription medications to the elderly and Medicare Reform, we are here today to discuss ... patent extensions of up to three years to eight brand-name products and numerous others that have not been identified, but are expected to come off patent this year and next year."

In addition, generic drug manufacturers themselves have joined with several consumer groups representing the highest population of prescription users, including the Gray Panthers and the Seniors Coalition, in a coordinated effort to head off challenges to generics competition. Together, generic drug makers and the seniors groups have formed The Campaign for Fair Pharmaceutical Competition to lobby Congress and to foster research into the cost-saving benefits of me-too drugs.

In a statement opposing S. 1172, Gray Panthers spokeswoman Patti Rizzo noted: "Senators who push this special interest bill cannot possibly be aware of the havoc it will wreak. Millions of Americans are going without critical medicine because they cannot afford it. Seniors are the hardest hit because they pay the most out-of-pocket for prescription drugs.

"Some pay up to 25 percent of their annual income; it's outrageous. S. 1172 must be defeated," Rizzo said.

Research sponsored by NAPM and conducted by the Prime Institute of the University of Minnesota's College of Pharmacy concluded that the extra patent life sought by 5. 1172 and H.R. 1598 would cost consumers more than $11 billion from 2002 to 2012 because of a delay in generics competition. The study, issued on the eve of the Senate hearing early this month, predicted that a three-year delay in generics competition for Claritin would cost U.S. consumers $5.3 billion from 2002 to 2007 and asserted that "only 3.6 percent of this windfall for Schering-Plough would be used for the discovery of new drugs.

In addition, noted study author Prime Institute director Stephen Schondelmeyer, Pharm.D., Ph.D., "Much of this added cost for prescription drugs will be paid by individual consumers, such as senior citizens, low-income families with no health insurance and others who do not have prescription drug coverage. Insurers, managed care plans, self-insured employers and corporate sponsors of health benefits plans also will bear some of the cost of this legislation."

COPYRIGHT 1999 Lebhar-Friedman, Inc.
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