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.
NOTE: THIS LEGISLATION NEEDED A TWO-THIRDS MAJORITY VOTE TO PASS