Tightening up
-
29/09/2002
-
Down To Earth
The Greater Access to Affordable Pharmaceuticals (GAAP) Act of 2002 is a pro-consumer law. It seeks to put an end to the underhand methods used by brand name drug manufacturers to extend patents:
The brand name holder would not be able to use the automatic 30-month stay by filing a case against the generic manufacturer, because it would first have to prove that its case has merit
Brand name manufacturers will have to list all of a drug's relevant patents and certify that the list is complete. This would expedite the legal process for challenging late-listed patents
There is a provision to prevent the patent holder from buying off the generic drug manufacturer to slow the entry of cheaper drugs into the market. According to this, if the first-to-file generic applicant fails to bring out its product within a reasonable time the licence would become available to the next applicant.
The brand name holder would not be able to use the automatic 30-month stay by filing a case against the generic manufacturer, because it would first have to prove that its case has merit
Brand name manufacturers will have to list all of a drug's relevant patents and certify that the list is complete. This would expedite the legal process for challenging late-listed patents
There is a provision to prevent the patent holder from buying off the generic drug manufacturer to slow the entry of cheaper drugs into the market. According to this, if the first-to-file generic applicant fails to bring out its product within a reasonable time the licence would become available to the next applicant.