Answer ... IP Australia is the governing body that controls registration of all IP rights (patents, trademarks, designs and plant breeders’ rights) in Australia. IP Australia falls within the Department of Industry, Innovation and Science, but acts largely autonomously.

Within IP Australia, Australian patent registration and related matters are controlled by the Australian Patent Office.

Answer ... The official fees from filing to registration are typically in the order of US$900, which comprises the filing fee (US$300), the examination fee (US$400) and the acceptance fee (US$200). Additional official fees (US$80) are payable for each claim in excess of 20 at the time of acceptance.

Annuities are payable each year, starting from the fourth anniversary of the filing date

Answer ... An application may be rejected on any one of the following grounds:

• The claims are not novel;
• The claims lack inventive step;
• The claims are not clear;
• The claims are not supported across their whole scope by the description;
• The invention as claimed is not disclosed in the description;
• The claims do not define patentable subject matter;
• The invention as claimed has no specific, substantial and credible use;
• The nominated person is not entitled to grant of the patent; or
• The application is for more than one invention.

Answer ... An applicant may request that the Australian Patent Office expedite the examination of an application. Examination may be expedited if the commissioner of patents is reasonably satisfied that it is in the public interest to do so, or that there are special circumstances that make this desirable. Special circumstances include, for example, that the applicant has become aware that infringement is taking place or is likely to take place, or that there is a significant commercial imperative for the applicant in doing so. If necessary, material in support of the request to expedite examination can be provided to the Australian Patent Office. The Australian Patent Office is generally agreeable to such requests. If a request to expedite examination is allowed, a report can usually be expected within about eight weeks.

Further, Australia is part of the Global Patent Prosecution Highway (GPPH) programme. Any requests for examination to proceed under the GPPH are automatically dealt with in an expedited manner.

Answer ... Most claim formats are allowable in Australia, provided that they meet the requirements of clarity and support.

Specifically, in relation to medical method claims, the Australian Patent Office accepts both direct method of treatment claims and ‘Swiss-style’ claims. These are considered non-identical in scope as they are directed towards different infringers. EPC2000 format treatment style claims, while allowable, are not considered under Australian law to be materially different from the corresponding composition claims per se.

‘Reach through’ claims, directed towards compounds that are characterised only in terms of their action with a specific receptor, for instance, are generally not allowable, as they are deemed to be speculative and encompass compounds not disclosed in the specification.

‘Omnibus claims’, directed towards the embodiments of the invention as disclosed, are not generally allowable, on the basis that they do not clearly define the monopoly sought, unless the claimed invention is such that it cannot be otherwise reasonably claimed.

Claims directed towards a product prepared by a specific process are allowable; however, claims directed to products ‘obtainable’ by a specified process are generally not allowable, unless the claimed invention is such that it cannot be otherwise reasonably claimed.

Answer ... Patent term can be extended only under very specific circumstances. Where the subject of the patent is a pharmaceutical substance per se or a pharmaceutical substance produced by recombinant DNA technology, and the substance requires regulatory approval prior to being introduced on the market, an extension of patent term may be possible if there has been a delay on obtaining regulatory approval. The length of any patent term extension depends upon the length of the regulatory delay and is determined by calculating the amount of time elapsed between the filing date of the patent and the date of first regulatory approval. The patent term extension is effectively the regulatory delay minus five years. If the regulatory delay is less than five years, no extension of term is possible. The extension of term is capped at five years, which means that if the regulatory delay has been 10 years or more, the maximum possible five-year extension (to 25 years) may be available.

Answer ... The Patents Act specifically excludes as subject matter “human beings, and the biological processes for their generation”. This means that the following are not considered to be patentable subject matter:

• fertilised human ova, zygotes, blastocysts, embryos and foetuses, and processes for growing or culturing them;
• totipotent human cells, including those that are the products of nuclear transfer procedures;
• methods of in vitro fertilisation or methods for introducing transgenes and donor genetic or donor cytoplasmic material into fertilised ova, zygotes, embryos or similar; and
• certain cloning processes.

In addition, the High Court has held in D’Arcy v Myriad Genetics Inc (2014) 224 FCR 479 that isolated nucleic acid sequences are not patentable, on the basis that the information stored in the nucleic acid sequences is the same as that contained in the DNA of the organism from which the nucleic acid is isolated. Such information is considered to be not ‘made’ by human action and consequently the isolated nucleic acid sequences do not meet the manner of manufacture requirements.

Schemes and plans are not patentable subject matter, so business methods per se are not patentable. Merely implementing a scheme or a plan on a computer is likewise unlikely to be considered patentable subject matter. However, software-related inventions are patentable, provided that the invention has industrial applicability and involves a technical contribution – merely using a computer as a tool to carry out calculations or to arrange or present information is not patentable. The law in relation to the patentability of software aspect is currently evolving.

Answer ... Under Australian law, the issuance of a first examination report sets in place a 12-month deadline for placing the case in order for acceptance (and ultimately grant). Within that timeframe, any number of responses and subsequent reports may be exchanged. Third and subsequent reports are reviewed by a supervising examiner. There is no ‘final’ office action under Australian law; but if the responses fail to make progress, a hearing may be set down. This is usually at the request of the applicant; however, it is possible for the Australian Patent Office to set down a hearing to resolve matters even if the applicant has not requested it.

A hearing is not strictly an appeal. The matter is heard by a hearing officer unconnected with the case. The original examiner may attend the hearing, but has no official part to play and the matter is ex parte, with the applicant making the case to the hearing officer. The hearing officer may agree to allow the case, refuse the case or make a partial decision on the issues in dispute and return the case to the originating examiner for completion.

Hearings of such a nature must be requested within the timeframe for acceptance. The hearing may be conducted in person or on the written record. The acceptance deadline may be extended until a period ending three months from the date on which the hearing officer’s decision is made.

The applicant may appeal any decision of the Australian Patent Office to the Federal Court. This includes refusal by the examiner to accept the application, with or without a hearing.

In the case of an appeal relating to certain specified procedural matters, an appeal to the Administrative Appeal Tribunal is also available.