IP SPOTLIGHT 20 APRIL 2020

THE PSPS The PSPS must generally be the subject of a claim for the substance itself, rather than a substance produced by a method or process 8 or the subject of a Swiss style claim. 9 The Act provides that a pharmaceutical substance includes a mixture or compound of substances, and must be for a therapeutic use whose application involves a chemical/physico-chemical interaction with a human physiological system; or action on an infectious agent, toxin or other poison in a human body; but does not include a substance that is solely for use in in vitro diagnosis or testing. 10 individual active agents. There is some discussion in the case law about what constitutes a PSPS. For example, PTEs relying on claims to extended release formulations 11 , transdermal patches, 12 unit doses and nanoparticulates 13 have been allowed. This is in contrast to the position in other jurisdictions, such as Europe where only “basic patents” covering active pharmaceutical ingredients ( APIs ), combinations thereof, processes for obtaining APIs or application of APIs can be the subject of an extension. Therefore, the PSPS can be a mixture of substances and is not limited to

THE T IMI NG OF AN APPL I CAT ION FOR A PTE The 6-month window to make an application for a PTE is a strict requirement. The identification of the correct ARTG registration to base the PTE on is therefore important in determining the deadline for filing the PTE application in most cases. Often, whether a prior ARTG registration (earlier than the ARTG registration on which the patentee seeks to rely) covers a PSPS disclosed and claimed in patent is a contested issue. There is also some ambiguity on how this time limit will apply where there are multiple PSPSs disclosed in a patent. As each PSPS may be the subject of multiple ARTG registrations (e.g. for different dosages, indications, or formulations), the date of the “first inclusion” may refer to: – – the date on which the first ARTG registration for a product containing the particular PSPS on which the PTE application is based was made (i.e. a “first inclusion” for each PSPS disclosed and claimed in the patent) ( Interpretation A ), or – – the date on which the first ARTG registration for a product containing any of the PSPSs in the patent was made (i.e. only one date per patent based on the very first PSPS that was registered) ( Interpretation B ).

WHAT ARE THE PATENTEE’S R IGHTS DUR I NG THE EXTENDED PER IOD? A PTE extends the term of the whole patent. However, during the extended term, infringement can only occur where a person exploits the PSPS for a therapeutic use and not other forms of the invention such as methods (including methods of treatment and Swiss style claims) or processes. CONCLUS IONS The Australian PTE system allows patentees to seek a PTE based on patents which claim APIs, combinations thereof as well as other pharmaceutical substances such as formulations. Therefore, the PTE system can be a valuable way of extending patent rights for many patentees. – – monitor the ARTG for any registrations for products containing PSPSs disclosed in their patents, whether made by the patentee’s licensees, related parties or any other third party; – – seek to file an application for a PTE within 6 months of any such “first inclusion”, regardless of whether the patentee has themselves secured ARTG registration for that PSPS or is seeking to exploit that particular PSPS/product; and Patentees seeking a PTE should, as best practice:

No Australian court has considered which of the interpretations A or B is preferred. However, the Australian Patent Office has decided a number of cases in favour of Interpretation B. 14 It does not matter whether the patentee or another third party was the sponsor of the “first inclusion”. OPPOS I T IONS The application for a PTE can be opposed by any third party on the basis that the application does not satisfy one or more of the factors identified above. The Registrar’s decision at the Patent Office level can be appealed to the Federal Court of Australia. HOW I S THE LENGTH OF THE EXTENS ION CALCULATED? The length of the extension is calculated by determining the period beginning on the date of the patent and ending on the “earliest first regulatory approval date”, reduced by 5 years. However, the maximum term of the extension is 5 years. The “earliest first regulatory approval date” is the first approval date for any of the pharmaceutical substances disclosed and claimed in the patent. Even if there are many such substances disclosed in the patent, “earliest first regulatory approval date” refers to the first regulatory approval date for the first PSPS that was registered.

– – not delay the filing of a PTE application by intending to rely on a later ARTG registration for products containing other PSPSs disclosed and claimed in the patent. If you require any assistance or additional advice in relation to PTEs in Australia, please get in touch with the author of this article.

BINDHU HOLAVANAHALLI Associate

8 Except where the PSPS is produced by a process that involves the use of recombinant DNA technology 9 Boehringer Ingelheim International GmbH v Commissioner of Patents (No 2) (2001) 112 FCR 595; Prejay Holdings Ltd v Commissioner of Patents (2003) 57 IPR 424. 10 Schedule 1 Patents Act 1990 (Cth). 11 Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd (2013) 216 FCR 344. 12 LTS Lohmann Therapie Systeme AG and Schwarz Pharma Ltd and Commissioner of Patents [2010] AATA 809.. 13 iCeutica Pty Ltd [2018] APO 76, 77, 78. 14 Re: G D Searle LLC (2008) 80 IPR 210; Re Celgene Corp (2011) 93 IPR 309; Re Iceutica Pty Ltd (2018) 146 IPR 342 15 Section 78 Patents Act 1990 (Cth).

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