Life science and pharmaceutical patent prosecution in Australia

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 but require payment of an official fee if they are considered before examination.

Requesting examination

A request for examination must be filed within 5 years from the international filing date of the application. However, at any time before this date, the Patent Office may direct the filing of a request for examination on 2 months’ notice (currently the Patent Office is issuing directions around 4 years from the earliest priority date). Examination may be requested at any time (e.g., at the time of filing of the application) and expedited examination is available. 

Examination reports and acceptance deadlines

An examination report will usually be issued approximately 12 months from requesting examination (2?4 months for expedited examination), setting a 12-month deadline for overcoming all objections and placing the application in order for acceptance. This deadline is inclusive of any time taken by the Australian Patent Office to consider a response and also inclusive of the time taken to respond to further examination reports.

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. Serial filings of divisional applications are permitted in Australia.

Excess claim fees

Excess claim fees of AU$110 are payable for each claim in excess of 20 at the time of acceptance (there is no need to reduce the number of claims at filing or when requesting examination, as the claim number can be reduced any time prior to acceptance). Multiply dependent claims are allowable in Australia and count as a single claim for the purposes of calculating claim fees.

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.

Grace periods

Australia currently has a 12-month grace period in relation to any disclosures made before the filing date of an Australian complete patent application or a PCT application designating Australia (a provisional application will not suffice). The grace period covers disclosures of an invention made by or with the consent of the applicant or patentee, or disclosures made without the consent of the patentee by another person who derived the information from the applicant or patentee.

Medical use claims

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 use in the treatment of disease Y”, 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.

Claims to 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.

Antibody claims

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 required to produce the desired activity.

Nucleic acid claims

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-optimized 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.

Diagnosis claims

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 five years beyond the normal 20-year term. The PTE request must be lodged within six months of the grant of the patent or within six 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 five 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.

Contact Details

If you have any questions regarding the above, please do not hesitate to contact [email protected].