Questions on filling for extentions under Waxman-Hatch Rules

From: Loggins Shiela AD US (shiela.loggins@cibasc.com)
Date: Fri Sep 08 2000 - 14:28:11 EDT


I have several questions on filing for extension under the Waxman-Hatch
ruling:

1. Given that an extension is allowed for a particle drug, can other related
patents which cover that drug also be extended?

2. Is there a time limit for filing extensions? It looks like from the rule
in the CFR the limitation is "60 days period beginning on the date the
product first received permission for commercial marketing...". But I
believe I have seen exceptions to this rule.

3. Is there a good resource for discussion of the Waxman Hatch (in somewhat
layman terms)?

Any help would be greatly appreciated.
Thank you,

Shiela Loggins

Ciba Specialty Chemical Corp.
Tarrytown, NY 10591

shiela.loggins@cibasc.com



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