Patentees of pharmaceutical substances are frequently unable to exploit their inventions until receiving regulatory approval for their products, often many years after the commencement of the patent term. Recent decisions from IP Australia and the Australian Federal Court indicate that the Australian patent term extension system is quite favourable to patentees at the moment. Multiple patents can be extended based on the registration of a single pharmaceutical product. So, how can this system enhance the term and value of your Australian patent rights?
The term of a standard patent in Australia is 20 years.[1] However, provisions in the Patents Act 1990 (Cth) (the Act) provide for the term of certain patents relating to pharmaceutical substances to be extended by up to five years.
Patentees of pharmaceutical substances are frequently unable to exploit their inventions until receiving regulatory approval for their products, often many years after the commencement of the patent term. Accordingly, the effective term during which the patentee is able to enjoy their monopoly may be much shorter than the full 20 year term. The rationale for patent term extensions (PTEs) is to partially compensate such patentees.
Recent decisions from IP Australia and the Australian Federal Court indicate that the PTE system in Australia is quite favourable to patentees at the moment compared with other jurisdictions. Multiple patents can be extended based on the registration of a single pharmaceutical product. Further, the PTE system is not limited to novel active agents, and while methods of treatment and processes are not eligible for PTE, patents which cover salt forms of the active, formulations and even novel patches, dosage forms, nanoparticulates and sustained release compositions can be extended provided they meet the criteria of the Act.
What factors must be satisfied to obtain a PTE?
The following factors must be satisfied in order to obtain a PTE:
- at least one pharmaceutical substance per se, or a pharmaceutical substances produced by a process that involves the use of recombinant DNA technology (PSPS), must in substance be disclosed in the specification and fall within the scope of the claims; [2]
- goods containing or consisting of the substance must be included in the Australian Register of Therapeutic Goods (ARTG)[3];
- the first regulatory approval for that pharmaceutical substance must have occurred more than 5 years after the date of the patent[4]; and
- the application must be made within 6 months of either the date the patent was granted or the date of the first inclusion in the ARTG of goods that contain or consist of any of the PSPS, whichever is later.[5]
Only one PTE can be granted per patent,[6] but multiple patents can be extended based on a single registration on the ARTG.
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[7] or the subject of a Swiss style claim.[8]
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.[9]
Therefore, the PSPS can be a mixture of substances and is not limited to 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[10], transdermal patches,[11] unit doses and nanoparticulates[12] 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.
The timing of an application 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)
- 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).
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.[13] It does not matter whether the patentee or another third party was the sponsor of the “first inclusion”.
Oppositions
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 is the length of the extension 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.
What are the patentee’s rights during the extended period?
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.[14]
Conclusions
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.
Patentees seeking a PTE should, as best practice:
- 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
- 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.
[1] Section 67 Patents Act 1990 (Cth).
[2] Section 70(2) Patents Act 1990 (Cth).
[3] Section 70(3) Patents Act 1990 (Cth).
[4] Section 70(3) Patents Act 1990 (Cth).
[5] Section 71(2) Patents Act 1990 (Cth).
[6] Section 70(4) Patents Act 1990 (Cth).
[7] Except where the PSPS is produced by a process that involves the use of recombinant DNA technology.
[8] 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.
[9] Schedule 1 Patents Act 1990 (Cth).
[10] Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd (2013) 216 FCR 344.
[11] LTS Lohmann Therapie Systeme AG and Schwarz Pharma Ltd and Commissioner of Patents [2010] AATA 809.
[12] iCeutica Pty Ltd [2018] APO 76, 77, 78.
[13] Re: G D Searle LLC (2008) 80 IPR 210; Re Celgene Corp (2011) 93 IPR 309; Re Iceutica Pty Ltd (2018) 146 IPR 342.
[14] Section 78 Patents Act 1990 (Cth).