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Title: Prohibits Pharmaceutical Companies from Delaying the Release of Generic Drugs
Vote Smart's Synopsis:
Vote to adopt an amendment to S 3187 that authorizes generic drug manufacturers to file patents for and begin marketing generic drugs prior to the end of the 180-day exclusivity period.
- Authorizes a “first applicant” to file a patent for a generic drug immediately if the applicant signs an agreement with the manufacturer of a listed drug, whereas existing law required an 180-day exclusivity period.
- Defines “first applicant” as an individual who has lawfully filed a patent application for a drug biologically equivalent to a listed drug for which the patent is invalid or will not be infringed if the new drug is manufactured.
- Specifies that the first applicant's patent will remain valid if action for patent infringement is not taken within 45 days or, if action is taken, a court dismisses the action for patent infringement.
- Exempts drug makers who have signed an agreement with a generic drug manufacturer that prohibits the generic manufacturer from marketing the generic drug prior to the end of the 180-day exclusivity period from the provisions of this bill.
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NOTE: THIS LEGISLATION NEEDED A TWO-THIRDS MAJORITY VOTE TO PASS