Article 18.46: Patent There will no longer be a Intellectual Property Term Adjustment for requirement to adjust, (18) Unreasonable Granting upon request, a patent’s Authority Delays term of protection to compensate the patent owner if there are unreasonable delays in a patent office’s issuance of patents. This provision would not have required Australia to make any legislative changes. There will no longer be a Intellectual Property Article 18:48: Patent requirement to adjust a Term Adjustment for (18) pharmaceutical patent’s Unreasonable term of protection to Curtailment compensate the patent owner for unreasonable curtailment of the effective term of a patent as a result of the marketing approval process for a pharmaceutical product. This provision would not have required Australia to make any legislative changes. Article 18.50: Protection There will no longer be a Intellectual Property of Undisclosed Test or requirement for five years (18) Other Data of protection for test or other data submitted to a regulatory authority for the purposes of obtaining regulatory approval to market a pharmaceutical product. This provision would not have required Australia to make any legislative changes. Article 18.51: Biologics There will no longer be a Intellectual Property requirement for five years (18) of protection for test or other data submitted to a regulatory authority for the purposes of obtaining regulatory approval to market a biologic
Intellectual Property (18) Article 18.46: Patent Term Adjustment for Unreasonable Granting Authority Delays There will no longer be a requirement to adjust, upon request, a patent’s term of protection to compensate the patent owner if there are unreasonable delays in a patent office’s issuance of patents. This provision would not have required Australia to make any legislative changes. Intellectual Property (18) Article 18:48: Patent Term Adjustment for Unreasonable Curtailment There will no longer be a requirement to adjust a pharmaceutical patent’s term of protection to compensate the patent owner for unreasonable curtailment of the effective term of a patent as a result of the marketing approval process for a pharmaceutical product. This provision would not have required Australia to make any legislative changes. Intellectual Property (18) Article 18.50: Protection of Undisclosed Test or Other Data There will no longer be a requirement for five years of protection for test or other data submitted to a regulatory authority for the purposes of obtaining regulatory approval to market a pharmaceutical product. This provision would not have required Australia to make any legislative changes. Intellectual Property (18) Article 18.51: Biologics There will no longer be a requirement for five years of protection for test or other data submitted to a regulatory authority for the purposes of obtaining regulatory approval to market a biologic
tpp-11_analysis_of_regulatory_impact_on_australia.docx