IPA patent 7.12.1.8-first-regulatory-approval-date — IP Australia Patent Manual of Practice and Procedure – 7.12.1.8 First Regulatory Approval Date

Also in this Chapter: 7.12.1.1 Pharmaceutical Substance per se 7.12.1.2 Meaning of Pharmaceutical Substance 7.12.1.3 Meaning of ＂when produced by a process that involves the use of recombinant DNA technology＂ 7.12.1.4 Meaning of ＂mixture or compound of substances＂ 7.12.1.5 Meaning of ＂in substance disclosed＂ 7.12.1.6 Meaning of ＂in substance fall within the scope of the claim＂ 7.12.1.7 Included in the Goods ​​​​​​​ Key Legislation: ​​​​​​​Patents Act: ​​​​​​​ s70 Applications for extension of patent s71 Form and timing of an application s77 Calculation of term of extension Related Chapters: 7.12.2.2 Time for Applying In this topic: Case Law Pfizer Corp v Commissioner of Patents [2006] FCAFC 190 AbbVie Biotechnology Ltd [2015] APO 45 Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39 ​​​​​​​ Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40 Under section 70(3) , the period beginning on the date of the patent and ending on the first regulatory approval date for the pharmaceutical substance must be at least 5 years. The first regulatory approval date, in relation to a pharmaceutical substance, is defined in s70(5) as: where there is no pre-TGA marketing approval in relation to the substance, the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, the substance; or where there is pre-TGA marketing approval in relation to the substance, the date of the first approval. Goods may be included in the ARTG as registered goods, provisionally registered goods, listed goods, biologicals or medical devices. Importantly, not everything that is included in the ARTG will satisfy the other requirements of section 70 (for example, medical devices, or biologicals which are used to replace parts of the anatomy in a person, are unlikely to be considered pharmaceutical substances per se ). ‘First inclusion in the ARTG’ means the first time the goods are included in the ARTG, regardless of what part of the register the goods are included in. Note: ‘Registered goods’ are assessed by the TGA for quality, safety and efficacy. ‘Listed goods’ are assessed for quality and safety, but not efficacy. ‘Biologicals’ comprise, contain or are derived from human cells or tissues. According to s71(2) an application for an extension of term must be made within 6 months of the latest of the date of grant of the patent or the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, any of the pharmaceutical substances referred to in s70(3) (see 7.12.2.2 Time for Applying ). Where there is more than one pharmaceutical substance that satisfies s70(2) and s70(3), this means the earliest of set of ARTG inclusion dates relating to the relevant pharmaceutical substances, irrespective of who sought the inclusion in the ARTG (Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39). Pfizer Corp v Commissioner of Patents [2006] FCAFC 190 The case concerned 4 patents, each relating to a pharmaceutical substance. The term of each patent was extended on the basis that the first regulatory approval date was the date on which the relevant pharmaceutical substance was entered into the part of the ARTG relating to registered goods. However, it was subsequently found that the pharmaceutical substances had previously been entered into the part of the ARTG relating to listed goods. Consequently, the Commissioner altered the expiry date of the patents to reflect the date of first listing, thereby reducing the lengths of the extensions of term. The Court considered the issue of whether the first regulatory approval date was the date on which the substance was entered into the part of the ARTG relating to registered goods, or the date on which the substance was entered into the part relating to listed goods. It was held that the goods in question were first included in the ARTG when they were included in that part relating to listed goods. Furthermore, there was no error on the part of the Commissioner in treating the first inclusion of the relevant goods in the part of the ARTG relating to listed goods, as the first regulatory approval date of those goods. AbbVie Biotechnology Ltd [2015] APO 45 The earliest regulatory approval date was the date of the goods were first registered, not the date of subsequent inclusions for various different indications. This decision was affirmed by the AAT in AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682 at [82]-[89]. Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39 The Full Court held that whether the s70 conditions are satisfied is “a matter of objective determination” ([118]-[126)]. In particular, in circumstances where there are multiple entries in the ARTG with respect to pharmaceutical substances disclosed and claimed in a patent, s71(2)(b) refers to the first regulatory approval date of any of those substances, meaning the date of commencement of the first inclusion in the ARTG from the set of entries, irrespective of any relationship between the sponsor on the ARTG and the patentee ([123]). Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40 Where more than one pharmaceutical substance per se is in substance disclosed and claimed in the relevant patent and there are multiple regulatory approvals for goods that contain or consist of those substances, the earliest first inclusion in the ARTG of goods relating to any of those substances is relevant for the purpose of the s77 calculation of the length of any extension ([79]). In particular, the Full Court found that in circumstances where goods containing a relevant pharmaceutical substance were included in the ARTG less than five years from the date of the patent, the patent term could not be extended based on the later listing of goods containing another relevant pharmaceutical substance. The reference to the ‘first inclusion in the ARTG’ in s70(5) encompasses any part of the ARTG, not only the Registered Goods portion of the ARTG ([113]) (the Full Court chose not to depart from the decision in Pfizer Corp above ([114])).