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Bush plan aims to speed access to generic drugs

Proposal would limit the ability of brand-name drugmakers to fend off generic competition.

By Markian Hawryluk, amednews staff. Nov. 11, 2002.

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Washington -- Medicare beneficiaries might not get a prescription drug benefit this year, but the Bush administration is seeking to reduce the amount those beneficiaries must pay for drugs by boosting access to generic medications.

In October, the White House proposed a rule that would implement Federal Trade Commission recommendations for improving generic-drug availability.

An FTC report earlier this year detailed seven cases in which major brand-name drug manufacturers extended their periods of market exclusivity by filing additional patents on their medications.

Under the Hatch-Waxman Act of 1984, brand-name manufacturers must list their patents on each drug. Generic makers must certify equivalency for every patent that is listed or assert that a patent does not apply to their drug.

If the original manufacturer sues to challenge those assertions, it triggers a 30-month protection against generic competition. With carefully timed filings of additional patents, a brand-name drug manufacturer can extend a medication's patent life almost indefinitely, critics say.

The administration's measure would allow only one 30-day automatic stay for patent infringement litigation involving a generic drug application. It also would limit the types of patents that manufacturers could use to protect their brand-name drugs.

"Our message to brand-name manufacturers is clear," the president said. "You deserve the fair rewards of your research and development. You do not have the right to keep generic drugs off the market for frivolous reasons." [...]