As in most countries, the global financial crisis has affected Australian business confidence over the last few years. Between 2007 and 2010, patent applications filed in Australia decreased by about 9%. Over the 2010 to 2011 period, we have seen a turnaround, with an increase of about 1.5% in the total patent applications filed. A breakdown shows that 58% of Australian patent filings in the 2010/2011 period were PCT National Phase applications; 20% non-National Phase standard applications; 5% innovation patent applications and 17% provisional patent applications. Interestingly provisional patent application filings continue to decrease as the number of innovation patent application filings continues to rise.
The IP landscape in Australia in 2011 was very active, with new laws introduced to the Australian Parliament and a number of significant IP issues being discussed in the mainstream media.
Raising the Bar Bill 2011
The substantive changes for considering patent validity (for example tougher inventive step or obviousness test, and stricter utility or usefulness and enablement requirements) will only apply to patent applications where a request for examination has not been filed by the date of commencement.
The commencement date will likely fall in early 2013.
Utility is defined for the first time in the draft legislation, as a "specific, substantial and credible use for the invention" and the provisions require that use to be disclosed in the specification.
The words come from USPTO Guidelines for assessing utility in relation to biotech related inventions, and particularly nucleic acid sequences. The intent of the AU Patent Office is that the words will have the same meaning as applied by the US Courts and USPTO. We understand that there have been a couple of US decisions which have attempted to clarify the meanings of the three terms.
An enablement requirement is now recited in that both provisional and complete specifications must be "clear enough and complete enough" for a skilled person to perform the invention.
The amended provisions adopt language that is similar to section 14 (3) of the UK patents legislation, which has been interpreted as imposing the requirement of enablement across the full scope of the claim. The wording is also similar to article 83 of the European Patent Convention, which has also been interpreted as requiring full claim scope enablement. The intention is that section 40 (2) (a) be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation, the European Patent Convention and the Patent Cooperation Treaty.
The explanatory memorandum states that a specification that provides a single example of the invention may satisfy the requirements. But only where the skilled person could reasonably expect that the teaching in relation to the single example might be extended to produce the invention across the full scope of the claim, without undue burden, or the need for further invention.
However, it is expected to be more likely that, where the claims are broad, the specification will need to give a number of examples or describe alternative embodiments or variations extending over the full scope of the claims. This ensures that the monopoly extends only to that which could reasonably be said to be disclosed and no further.
Most importantly, after an application is filed it may not be possible to amend it to include additional disclosure which may be necessary to meet the new sufficiency requirements.
|Patent applications filed in Australia 2001/02-2010/11|
These are narrow claims which strictly claim an invention by reference to specific examples or figures in the specification. Although narrow, they have to date served a useful purpose. Under the proposed legislation, they will not be allowed in applications not examined by commencement of the legislation.
The present Australian Patents Act already provides an existing infringement exemption for acts occurring within Australia relating to solely obtaining regulatory approval (either within or outside Australia) of pharmaceuticals, when those acts would otherwise have constituted patent infringement.
The provisions propose a broader infringement exemption for acts required to obtain regulatory approval, within or outside Australia, in that exemption will apply to all technologies for which regulatory approval must be obtained prior to release, such as veterinary and agricultural products, medical and electrical devices. As with the existing pharmaceutical exemption provisions, the exempted use must be solely for obtaining regulatory approval.
Under the current exemption, for the purposes of obtaining regulatory approval of a generic pharmaceutical product, a generic company can, for example, use any patented starting material, process or equipment or patented indication. This exemption would apply to acts carried out after commencement of the section. There is some thought that a qualification should be placed on both the existing and proposed exemptions to the effect that they only apply where use of a patented invention could not be reasonably avoided in carrying out the activity required for regulatory approval. However, it should also be considered that innovators can equally utilise these provisions, particularly when conducting comparative trials.
Significant Australian Intellectual Property Law Changes Proposed
The draft legislation removes the local restriction on the person skilled in the art (PSA) which limited the common general knowledge (CGK) to that in Australia. Currently, for obviousness the prior art information must be information the PSA could, before the priority date, be reasonably expected to have ascertained, understood and regarded as relevant, and combined. It is now proposed that the CGK is that which existed at the priority date whether in or out of Australia. For the assessment of obviousness that CGK can be combined with a single piece of prior art or with a combination of prior art if the PSA would be reasonably expected to combine the prior art.
An expanded grace period is introduced to accommodate secret use by the applicant and to apply to disclosures outside the scope of the claim that would otherwise render a claim obvious.
Standard of proof
A higher standard of proof will be imposed by the Australian Patent Office when deciding to accept a patent application. The present situation requires the examiner to be satisfied that the invention as claimed is novel and inventive and apply a benefit of the doubt test to other examinable grounds. The draft Bill introduces the requirement that the examiner be reasonably satisfied that the invention as claimed meets all patentability criteria. Whilst this higher standard should translate into a greater presumption of validity if and when a patent is challenged, time will tell whether that occurs in practice.
This option, available since the early 1970s, is proposed to be removed. The provision has not been extensively used and the differences in examination standards and laws have diminished its value.
The draft legislation proposes amendments intended to plug the hole in previous provisions that saw some communications, for example between Australian patent attorneys with overseas corporate attorneys, become discoverable. Under the proposal, communications between a registered patent attorney and a person "for the sole or dominant purpose of (the attorney) providing intellectual property advice to a client" will be privileged in the same way as corresponding lawyer communications. A registered patent attorney is an individual authorised to do patents work in any country or region. Patents work is specified as applying for or obtaining patents in Australia or elsewhere, preparation of patent specifications or other documents for the purposes of the patent laws of Australia or another country, and giving advice (other than advice of a scientific or technical nature) about the validity, or infringement, of patents. Intellectual property advice means advice in relation to patents, trade marks, designs, plant breeders' rights or any "related matters". It is hoped that the term related matters will include the overlap between copyright and designs and trade marks laws.
Samsung v Apple
The High Court of Australia denied Apple's request for special leave to appeal against the Full Federal Court's decision, effectively allowing Samsung to market its Galaxy Tab 1.01 in Australia pending a final hearing on Apple's patent infringement action.
Apple was initially granted an interlocutory injunction but that decision was overturned by the Full Federal Court after Samsung appealed. Apple applied to the High Court for special leave to appeal against the Full Federal Court's decisions. However, Apple's hopes of preventing Samsung from selling its Galaxy Tab 1.01 in Australia for the Christmas period were dashed when the High Court rejected Apple's special leave application. The High Court agreed with the Full Federal Court that Justice Bennett had not sufficiently considered the merits of Apple's claim that Samsung's product infringed Apple's patents. The matter will now be returned to Justice Bennett for a final hearing in due course unless the parties settle in light of the commercial reality that Samsung's product is now in the Australian market.
The gene patents debate
The patentability of genetic materials has been the subject of considerable community debate in Australia in recent years. The Minister for Innovation stated that "the response is designed to give confidence to the significant investments in biotechnology innovation and research and development. It will also ensure that patients will not be denied reasonable access to affordable treatments and essential diagnostic tests through inappropriate use of the Patents Act".
The Government response addresses many aspects of the debate and the ultimate question, namely whether genetic materials may properly be considered appropriate subject matter for patentability. Recommendation 7-1 of the ARLC 99 Report was that "[t]he Patents Act 1990 (Cth) should not be amended: (a) to exclude genetic materials and technologies from patentable subject matter; (b) to exclude methods of diagnostic, therapeutic or surgical treatment from patentable subject matter". In the Government response, Recommendation 7-1 (a) is accepted in principle and Recommendation 7-1 (b) is accepted in full.
During the course of the inquiries and public debates, the desirability of a technology-neutral approach to patentability arose. For example, the ARLC Report recommended (6-1) that "[p]atent applications relating to genetic materials and technologies should be assessed according to the same legislative criteria for patentability that apply to patent applications relating to any other type of technology". In accepting this recommendation the Government drew attention to Australia's obligations under TRIPS to maintain technology-neutral patentability criteria.
The Patent Amendment (Human Genes and Biological Materials) Bill 2010 seeks to exclude biological materials, including genetic materials, from patentability. That Bill remains pending. Other than noting that the Senate Gene Patents Inquiry recommended that the Bill be sent to the relevant Senate Committee for review and report, the Government's response to the inquiries does not directly express an opinion on that Bill. That Bill has now been the subject of a Senate Inquiry, the major finding of which was that the Bill should not be passed.
With the Government response to the inquiries now having stated agreement in principle with the ARLC 99 Report that the Patents Act should not be amended to explicitly exclude genetic materials from patentability, it is difficult to see how the Government could now support that Bill.
A single patent examination process
A future single examination process for patent applications made in both Australia and New Zealand was jointly announced by Prime Ministers Julia Gillard and John Key on February 16 2011. This development follows the creation of the Trans-Tasman Outcomes Implementation Group 2009 and extends the intellectual property Single Economic Market (SEM) outcomes. Other anticipated outcomes include single trade mark and plant variety rights regimes. Work sharing between the patent offices is likely to occur early 2012 with a single application process in early 2013.
While taking into account the separate national laws, the combined examination process will nevertheless result in separate Australia and New Zealand patents. Anticipated advantages of the combined process include providing a simplified and more convenient procedure for patent applicants to protect their intellectual property in both countries, and a reduction in duplicated workload at the respective patent offices.
Edward Genocchio is a chartered professional engineer and entered the patent attorney profession in 1997, now specialising in mechanical patents and designs.
He has a Bachelor of Engineering, a Master of Legal Studies, and a Master of Industrial Property from the University of Technology, Sydney.
Edward applies his extensive industry experience in heavy engineering to his practice, with specific expertise in power generation, mining and steel technology. He also has experience in industrial litigation and his patent practice covers a broad range of industries such as consumer and medical products; agriculture; sanitary ware; construction, and the military.
Edward is on the National Professional Engineers Register, he is a member of the Institute of Engineers Australia and the Australian Institute of Management. He is also a Fellow of the Institute of Patent and Trade Mark Attorneys of Australia, a member of the Intellectual Property Society of Australia and New Zealand, the Association of Asian Patent Attorneys and the American Intellectual Property Law Association.
Edward is a registered patent and trade mark attorney in Australia, and a registered patent attorney in New Zealand.