National phase entry
The deadline for filing a national phase application in Australia from a PCT application is 31 months from the earliest priority date. A PCT application must enter Australian national phase in the form in which it exited international phase. Amendments to the specification may be filed at any time during prosecution.
Translations
A translation of a PCT specification filed in a language other than English must be filed at the time of national phase entry.
Requesting examination
A request for examination must be filed within 5 years from the effective filing date of the application. This deadline is usually brought forward by the Australian Patent Office issuing a Direction to Request Examination around 2½ years after national phase entry, setting a 2-month deadline to request examination. Examination may be requested at any time (e.g., at the time of filing of the application) and expedited examination is available (see below).
Examination
A first examination report will usually issue 12 to 18 months after requesting examination (see here for current timeframes). Issuance of the first examination report sets a 12-month deadline for overcoming all objections and placing the application in order for acceptance. This deadline is not merely for responding and is inclusive of any time taken by the Australian Patent Office to consider submissions and possible issue further examination reports. The application will lapse if it is not accepted by this deadline.
Expediting examination
Examination under the Global Patent Prosecution Highway (PPH) based on a clear IPRP or an allowed/granted patent application issued by a participating patent office (see here for a list). Australia also participates in a PPH program with the European Patent Office. All claims in the Australian application must sufficiently correspond to the allowable/patentable claims. Amendments for conformity with Australian practice are permitted (e.g., the inclusion of product-by process claims, Swiss-style claims, and multiple dependencies) but a claim which introduces a new/different category of claims to those claims indicated as allowable/patentable is generally not considered to sufficiently correspond. Requesting examination under the PPH will result in the first examination report issuing within 2 months.
An alternative to requesting examination under the PPH is to request expedited examination, which will also result in the first examination report issuing within 2 months. In order to request expedited examination, we simply have to state that it is required for commercial reasons (supporting evidence is not required). Requesting expedited examination may be preferable to requesting examination under the PPH, as it allows for more flexibility with the type of claims and the claim scope. This may be advantageous if amendments were required during foreign prosecution that may not be applicable to Australia (e.g., overcome an inventive step objection resulting from mosaicking of prior art).
Excess claim fees
Excess claim fees are calculated based on the number of claims when the first examination report issues (AU$125 per claim between 21 and 30, and AU$250 per claim over 30). The number of claims can be reduced before issuance of the first examination report to minimise excess claim fees and it is advisable to file amendments at the time of requesting examination, or shortly thereafter. If the number of claims increases after issuance of the first examination report, additional excess claim fees will be charged at acceptance. Multiply dependent claims are allowable in Australia and count as a single claim for the purposes of calculating claim fees.
Divisional applications
In the event that the application cannot be placed in order for acceptance before the 12-month deadline, a divisional application may be filed before the acceptance deadline in order to maintain a pending application. If the application is accepted, the deadline for filing a divisional application is 3 months after the advertised date of acceptance.
Divisional applications may also be filed to pursue subject matter not successfully prosecuted in a parent application. Serial filings of divisional applications are permitted in Australia.
Acceptance and grant
Once the application is in order for acceptance, a Notice of Acceptance will issue. The acceptance is published in the official journal, which commences a three month opposition period, during which any interested third party may oppose the granting of the patent.
Assuming no opposition to grant is made, an electronic Certificate of Grant will issue around one month after the expiry of the three month opposition period.
Renewals
Renewals are payable in Australia from the fourth anniversary of the international filing date, regardless of whether the patent has been granted yet or not. Renewal fees are then due each anniversary after that until the patent ceases.
Medical use
Method of treatment and Swiss-style claims are the judicially considered and accepted formats for medical use claims in Australia. As the claims are directed to different potential infringers, it is advisable to include both claim types.
With regard to purpose-limited composition clams, such as those drafted in the format “Composition X for treatment of disease Y” or “Composition X for use in the treatment of disease Y”, please note that the term “for” in the context of a composition claim is construed under Australian patent law as only indicating that the composition is suitable for the specified use (i.e., it is not limited to the specified use). Accordingly, a novelty objection may be raised if the composition is known. Should the limitation be required for patentability, such claims should be replaced with method of treatment and Swiss-style claims.
Microorganisms
A microorganism is patentable in Australia if technical intervention has resulted in an artificial state of affairs which does not occur in nature. Patent Office practice is that the isolation and cultivation of naturally occurring micro-organisms satisfy the requirements for technical intervention. A claim to a biologically pure culture of the naturally occurring micro-organism is also acceptable.
If the claims refer to a microorganism deposit required for enablement and that has made under the Budapest Treaty, it is necessary to file the deposit receipt and a translation thereof if it is not in English, as well as a Notice of Entitlement. If the microorganism is publicly available, amendment of the specification to include supplier details may be sufficient for enablement.
Peptides or proteins
The principle established for micro-organisms also applies to peptides and proteins. Generally, the inclusion of the terms “isolated” or “recombinant” in the claims is sufficient to distinguish the peptide or protein from their naturally-occurring counterpart and confer patent eligibility.
Antibodies
A claim to any antibody that specifically binds a new epitope is allowable in Australia where the specification discloses the new epitope and shows that antibodies can be raised against it. This is because raising antibodies to that epitope is a principle that can be generally applied to produce antibodies over the whole scope of the claim. Claims to antibodies defined by structure are also allowable in Australia providing it can be argued that performing the invention over the whole scope of the claim does not represent an undue burden. Generally, the Australian patent office is raising objections to claims that do not define all six CDRs or that contain variability within the CDRs. However, it may be possible to overcome such objections if there are sufficient examples in the specification to determine the minimum structural features and/or homology required to produce the desired activity.
Nucleic acids
Claims to isolated nucleic acids are patentable in Australia provided the nucleic acid sequence does not convey the same information as a sequence of nucleotides in the genome of an organism, plant or animal. The High Court in Myriad found that the act of isolation, purification or synthesis is not enough to confer patentability. This is the case even when the molecule is man-made (for example cDNA) if the genetic information in the man-made molecule is the same as that in the genome of an organism. However, claims to nucleic acid microarrays, interfering RNA and codon-optimised RNA are patentable as the substance of the claim is more than merely genetic information. Claims to nucleic acid constructs (e.g., vectors) may also be patentable if the combination of encoding nucleic acids and associated regulatory sequences do not exist naturally in one nucleic acid molecule in any organism.
Method of diagnosis
Claims to methods of diagnosis are patentable in Australia, including methods involving the use of genetic sequences or naturally-occurring correlations. This has been confirmed by a couple of recent court decisions, including the Federal Court upholding Sequenom’s patent directed to prenatal diagnostic methods.
Product by process claims
Australia has contributory infringement provisions which may provide adequate protection against infringement in a number of infringement scenarios. However, the existence of “product by process” claims is likely to avoid the need to rely on the contributory infringement provisions, thereby providing greater certainty as to the scope of protection available, and possibly simplifying infringement proceedings which may arise in future. Accordingly, it is advisable to include product by process claims.
Patent term extensions
If a product containing a pharmaceutical substance covered by a patent is registered with the Australian Therapeutic Goods Administration (TGA), the patent may be eligible for a patent term extension (PTE) of up to 5 years beyond the normal 20-year term. The PTE request must be lodged within 6 months of the grant of the patent or within 6 months of receipt of regulatory approval in Australia – whichever is the later.
In order for a patent to qualify for a PTE:
- The patent must relate to a pharmaceutical substance per se or a pharmaceutical substance when produced by recombinant DNA technology. The substance must be disclosed in the specification and must fall within the scope of the claims.
- The substance must be entered on the Australian Register of Therapeutic Goods (ARTG) before the 20-year term of the patent expires and the entry must be current at the time of application for extension.
- At least 5 years must have elapsed between the date of the patent (i.e., the effective filing date) and the date of inclusion on the ARTG.
The maximum length of extension available is 5 years. However if the date of inclusion of the pharmaceutical on the ARTG is between 5 and 10 years after the date of the patent, the extension will be less than 5 years.