Greater Access to Affordable Pharmaceuticals Act
HR 2491
Amends the Federal Food, Drug, and Cosmetic Act to: (1) limit a brand name drug manufacturer to one Food and Drug Administration (FDA) 30-month stay of competition in a patent infringement suit against a generic drug applicant; (2) permit a generic applicant being sued to file a counterclaim to correct or delete patent information; (3) limit damages that a brand name manufacturer may recover in an instance where such manufacturer failed to file certain patent information; (4) permit a generic drug applicant to seek declaratory judgment regarding patent infringement prior to marketing a drug; (5) forfeit the180-day market exclusivity period for a first generic drug applicant to a subsequent generic applicant if the first applicant engages in certain activities which impede such drug's timely marketing; and (6) permit alternative means to determine bioequivalence for drugs that are not absorbed into the bloodstream.
| Status: | | 25 Jun 2003
Referred to House Subcommittee on Courts, the Internet, and Intellectual Property. |
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