Untitled Document

Press Office

April 1999

Bipartisan Effort on Health-Care Reform

Bryant-McDermott Bill Would Restore Patent Fairness

FOR IMMEDIATE RELEASE: APRIL 26,1999

Bipartisan Effort on Health-Care Reform

Why, in the world's wealthiest nation, are there 44 million people without health insurance?

How should the United States provide health coverage for this group, mostly working poor, aged 18-34, whose employers do not provide health plans?

U.S. Reps. Jim McDermott, D-WA., and James Rogan, R-CA., along with the Heritage Foundation, will discuss their bipartisan plan for a health care tax credit at noon Tuesday, April 27, at the Heritage Foundation's Lehrman Auditorium, 214 Massachusetts Ave. N.E.

McDermott and Rogan will discuss how the tax code discourages those who are not covered by their employer from getting health insurance on their own. They are co-sponsoring legislation with would give a tax credit worth 30% of the cost of health insurance premiums to those not covered by their employer.

A copy of McDermott's speech is available upon request.

FOR IMMEDIATE RELEASE: APRIL 28, 1999

Bryant-McDermott Bill Would Restore Patent Fairness - Independent Panel Would Review Patent Starus of Pipeline Drugs

Washington, D.C. - Reps. Ed Bryant (R-Tenn) and Jim McDermott, (D-Wash) today introduced legislation to ensure fair patent treatment for a group of pharmaceutical products that were deprived of patent protection because of unexpectedly long regulatory reviews. The legislation, [insert bill name], would establish an independent process within the U.S. Patent and Trademark Office to consider whether patents should be restored for so-called "pipeline drugs" that experienced delays in the FDA approval process.

"Patent integrity is the cornerstone of research and development by giving innovators the chance to benefit from their work," Rep. Bryant said. "We believe this bill protects that important principle by correcting for regulatory delays that partly undermined the benefits of the Hatch-Waxman Act."

Hatch-Waxman was enacted in 1984 to enable generic drugs to get to market faster and also to restore some of the patent life that branded drugs were losing to lengthy regulatory reviews. At the time of passage, Congress expected relatively swift approval of drugs already in the Food and Drug Administration's approval pipeline and granted them just two years of patent restoration, compared to five years for other pharmaceuticals. But many of these "pipeline drugs" experienced unanticipated delays in FDA approval and were deprived of the full measure of patent protection intended by Congress.

The Bryant-McDermott bill asks the commissioner of the patent office to set up an open, independent process to see whether patent extension is warranted for the pipeline drugs.

Patent Fairness Promotes R&D That Can Save Lives

By enabling innovators the chance to earn a fair return on their research investments, patents and other intellectual property protections provide an incentive for innovation and pioneering products.

"We all know pharmaceutical research is one of the best patient protection policies Americans can buy," Rep. McDermott said. "As a medical doctor and psychiatrist, I have seen first-hand the benefits of breakthrough drugs - and the fruits of fair patents."

The Bryant-McDermott process would enable companies to seek patent restoration of up to three years for pipeline drugs that spent an inordinate time of five or more years in the FDA's New Drug Approval process. All interested parties would have the opportunity to make their case to the review panel, which would be bound by a set of objective criteria. The panel's decision would be subject to judicial review.

"Our bill would take the politics out of the equation and allow each claim to rise or fall on its merits," McDermott said. "There would be no preferences, no arbitrary decisions, no guarantees. Every petitioner would be treated the same."

"These medicines were kept off the market and away from the American public, in many cases for 10 years or more, because of administrative delays that had nothing to do with their safety to consumers," McDermott said. "We are asking the Patent and Trademark Office to oversee a procedure which will investigate whether the patents for any of these medicines should be extended."

U.S. patent law generally provides the patent owner with 20 years of exclusive right to the product. But for pharmaceuticals and some other products which require government review, that right can be significantly shortened. Patents are assigned when a drug is first brought to the FDA, and before it is tested for market safety. So a lengthy clinical review can significantly shorten the normal 20-year patent life.

This proposal could potentially apply only to seven drugs: Eulexin, Claritin, Nimotop, Relafen, Dermatop, Penetrex and Cardiogen-82. In one case, that of Eulexin, which is prescribed for prostate cancer, the total regulatory review time was more than 17 years.