Regulatory Review Exception

Section 68B of the NZ Patents Act reads: “It is not an infringement of a patent for a person to make, use, exercise, or vend the invention concerned solely for uses reasonably related to the development and submission of information required under New Zealand law or the law of any other country that regulates the manufacture, instruction, use, or sale of any product .” The thinking behind this addition to the Act is to make it easier for both entry into the New Zealand market of generic products, particularly generic pharmaceuticals, veterinary and agricultural products, and to assist New Zealand manufacturers of generic products to gain access to both New Zealand and export markets.

The amendment is similar to the Canadian situation and will allow manufacturers of generic products to circumvent patent infringement liability if they make, sell, conduct field trials or experiments in respect of a patented product, regardless of the extent of those activities as long as they can prove that the use was to obtain regulatory approval for the product. The wording of the section allows any manufacturer of a generic product to produce in NZ any patented product that requires regulatory approval anywhere in the world.

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