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New Zealand: Government Consulting on Proposed Patent Term Extension Regulations

(July 15, 2016) On July 11, 2016, the New Zealand Minister of Commerce and Consumer Affairs, Paul Goldsmith, announced the release of a consultation document on proposed regulations for patent term extensions.  (Press Release, Paul Goldsmith, Consultation on Patent Term Extensions (July 11, 2016), BEEHIVE.GOVT.NZ.)

The regulations will implement specific intellectual property provisions in the Trans-Pacific Partnership Agreement Amendment Bill, which was introduced in May 2016 and is currently being considered by the Foreign Affairs, Defence and Trade Committee in Parliament.  (Trans-Pacific Partnership Agreement Amendment Bill, NEW ZEALAND PARLIAMENT (last visited July 13, 2016); Trans-Pacific Partnership Agreement Amendment Bill (as introduced) (TPPA Bill), cl 75, New Zealand Legislation website.)  These provisions will amend the Patents Act 2013 (New Zealand Legislation website) to provide for patent extensions for:

Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, is the government authority responsible for the regulation of therapeutic products in New Zealand.  (About Medsafe, Medsafe website (last updated Sept. 29, 2015).)

The proposed regulations for patent term extensions mainly relate to procedural matters, including:

  • the manner in which requests for extension of term must be made;
  • the information that must be provided (in addition to that required by the TPPA Bill) with requests for extension;
  • time limits for requesting an extension of term;
  • procedures by which third parties can oppose the grant of extensions of term for unreasonable curtailment, including the time limits by which oppositions must be made.  (Have Your Say: Consultation on Proposed Patent Term Extension Regulations, supra.)

The consultation document sets out options for approaching some of these matters in the new regulations.  (MBIE, Trans-Pacific Partnership Agreement Amendment Bill: Patent Term Extensions – Proposed Regulations (July 2016).)  The new regulations will be incorporated into the Patents Regulations 2014 (New Zealand Legislation website).

Trans-Pacific Partnership Agreement

The Trans-Pacific Partnership Agreement (TPPA) is a free trade agreement signed in February 2016 by 12 countries: New Zealand, Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, Peru, Singapore, the United States, and Vietnam.  The agreement must pass domestic ratification processes in order for it to come into force.  The TPPA Bill is the domestic legislative action required before the New Zealand government takes binding treaty action on the TPPA.  (Trans-Pacific Partnership, New Zealand Foreign Affairs & Trade website (last visited July 13, 2016).)

Patent Term Extensions and Adjustments under the TPPA

Chapter 18 of the TPPA relates to intellectual property.  Within that chapter, article 18.46, titled “Patent Term Adjustment for Unreasonable Granting Authority Delays,” requires that the parties to the agreement provide a means to adjust the term of the patent to compensate for unreasonable delays in the issuance of patents.  (TPPA ch. 18, art. 18.46-3, New Zealand Foreign Affairs & Trade website.)  “Unreasonable delays” include a delay in the issuance of a patent of more than five years from the date of the filing of the application, or three years after a request for examination of the application has been made, whichever is later.  (Id. art. 18.46-4.)

Article 18.48, titled “Patent Term Adjustment for Unreasonable Curtailment,” specifically relates to patents for pharmaceutical products.  It requires that each party “make available an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process.”  (Id. art. 18.48-2.)

A New Zealand Foreign Affairs & Trade fact sheet regarding the intellectual property provisions in the TPPA states, “[v]ery few unreasonable delays are expected to occur in New Zealand, and only in exceptional circumstances, given the efficiency of patent grant and regulatory approval by the Intellectual Property Office of New Zealand (IPONZ) and Medsafe respectively.”  (New Zealand Foreign Affairs & Trade, Trans-Pacific Partnership: Intellectual Property – Fact Sheet 3 (last visited July 14, 2016).)

Information on Patent Term Extensions in other Countries

The Law Library of Congress has published a report on the availability of patent term extensions in nine other countries: Law Library of Congress, Patent Term Extensions and Adjustments (Mar. 2016).