Australia’s pre‑grant opposition proceedings are playing a more significant role in the strategies of patentees and challengers. 

However, facing a patent opposition in Australia is a new experience for many patent owners. So, what should a patent owner do when faced with an opposition in Australia?

Time is on your side, but don’t sit around

As a patent applicant, time is on your side at the start of the patent opposition procedure. Work on the overall defence plan should commence promptly. Early decisions can be crucial to success, and early mistakes could end up being fatal. Accordingly, long-term planning ought to be done sooner rather than later.  In the past, patent opposition proceedings in Australia often became protracted due to generous provisions relating to extensions of time for lodging evidence. This is no longer the case.

Evidentiary time periods are still extendable, but the regulations relating to extensions of time for evidentiary periods are now reasonably onerous and strictly applied by IP Australia. Unless a party can show that they acted promptly and diligently and made all reasonable efforts to file the evidence in time, an extension will not be granted. In situations where, for example, a party wishes to provide experimental evidence to support their case, such studies may need to be set up early on in the proceedings.

What does an Australian patent opposition involve?

Patent oppositions are conducted before the Australian Patent Office (IP Australia). Any person can oppose the grant of a patent on a patent application by filing a notice of opposition (a simple one-page form) within three months of publication of acceptance of the patent application. Straw man oppositions, where the opposition is filed in the name of a third party (usually a patent attorney firm), are also possible.

After filing the notice of opposition, the opponent has three months to file a statement setting out the grounds and particulars of the opposition, together with a copy of any documents referred to in the statement. The grounds for opposition include:

  • non-entitlement;
  • the invention is not a patentable invention (including not patentable subject matter, lack of novelty or inventive step, in-utility, prior secret use); and/or
  • the specification does not comply with the written description requirements section 40(2) or 40(3) of the Patents Act 1990 (Cth).

Both parties are given the opportunity to file evidence. The evidence in patent oppositions is filed in the form of declarations. In a typical opposition the evidence will include declarations by one or more experts. 

Once all the evidence has been filed, the opposition is then set down for a hearing. Submissions may be made at the hearing in person, by video-conference or in writing. The hearing officer usually takes about three to six months to issue a written decision. The decision in an opposition can also be appealed as of right to the Federal Court of Australia.

Develop a strategy early

Initially patent owners should conduct a cost-benefit analysis, e.g. evaluating the value of the patent versus the cost of fighting the opposition, in view of the likelihood of success. In doing so, it is important to bear in mind that the fact an opposition has been filed strongly indicates that it is at least commercially important to the opponent to try and ‘clear the path’.

If defence is warranted, it is critical to identify potential experts that might assist with providing evidence at an early stage. Obviously, any expert must have the relevant expertise, but they also need to be available to assist, both logistically and in terms of potential conflicts. In highly specialised technical areas the number of potential experts can be small, and it can be a race to secure the best options.

Whilst the case against the patent application cannot be fully understood until the evidentiary rounds are complete, we recommend conducting an analysis of the opposition at an early stage once the Opponent’s Statement of Grounds and Particulars is received, and then updating that analysis on receipt of the evidence. This early review includes understanding the commercial position, considering the patent specification and prior art, and reviewing prosecution history in Australia and other major countries. The analysis can assist with identifying suitable experts, understanding which topics are important to address in the evidence, and highlighting possible amendments that may strengthen the patent application.

Patent applications under opposition can be amended as of right at any time, even after a written decision has issued. The procedure takes time, however, as the amendments need to be advertised for two months and can delay the proceedings. If amendments might be required or desirable, it is important to consider the best timing for making those amendments.

Consider your options for new representation

Opposition practice is a specialised area of Australian patent law, particularly with regard to areas such as preparation of expert evidence, hearing preparation, dealing with procedural aspects and extending into commercial aspects such as settlement negotiations and licensing.

Not all Australian patent attorneys handle patent oppositions regularly and even some that do simply default to a ‘wait and see’ approach when acting for patent applicants. Sometimes that is the right approach, but not always. If your Australian patent attorneys are not proactively engaging with you on these issues, then it is worth considering whether they are the right team for your matter.

How we can help

Griffith Hack’s experts have extensive experience in handling Australian patent oppositions. Our combined patent attorney and legal team provides integrated scientific and legal expertise, together with strategic, commercially-relevant insight, and has a proven track record in delivering results.

To discuss patent oppositions further with a member of our team, click on their profiles on this page.

Cytec Industries Inc. v Nalco Company [2021] FCA 970

In a recent opposition appeal decision of the Federal Court of Australia, Nalco Company’s Australian patent application no. 2012220990 was found invalid for lack of support and lack of clear enough and complete enough disclosure (sufficiency).1

The decision highlights the Court’s approach in considering the meaning of claim terms that might on first glance be considered conventional, and emphasises the need to consider whether the claims are commensurate with the technical contribution provided by the specification. Toby ThompsonKathryn Morris, and Tim Fyfe discuss.

The technology

The technology of the application related to the “Bayer process”, an industrial process used to extract alumina from bauxite. Precipitation of aluminosilicate scale can occur during the process, forming obstructions and affecting efficiency. The patent application was directed to methods for reducing scale during the Bayer process, involving use of additive compositions containing certain small molecules.

Support and sufficiency

A key issue in the proceedings was the requirement in claim 1 for:

“a composition comprising at least one small molecule selected from the group consisting of compounds (I)…(LX) within a product mixture formed from the reaction of…”

The judge first decided that the language of claim 1 encompassed a composition made up of a single type of small molecule, alongside encompassing mixtures of small molecules. Such a finding is uncontroversial, and most practitioners would agree that it is common when drafting to use “at least one” to cover situations where either a single component or multiple components are to be protected.

Having arrived at that construction, the judge went on to hold that the claims lacked support as a result. The specification described the small molecules as being produced by the reaction of three components, which resulted in the production of complex mixtures of small molecules. However, there was no disclosure regarding how to produce a single small molecule, or how to separate components of the product mixture. Whilst embodiments of claim 1 involving mixtures of small molecules were supported, embodiments involving only a single type of small molecule were not.2

For similar reasons, the judge also found that the specification did not disclose the claimed invention in a clear and complete enough manner for it to be performed by a person skilled in the art (insufficient). Insofar as the claims included a product mixture made up of a single type of small molecule, undue experimentation was required to perform the invention.3

Vulnerability of claims containing conventional terms

The decision in Cytec v Nalco follows on the heels of MSD v Wyeth last year, where use of an apparently conventional drafting term also resulted in invalidity (see our article here). In that case, the term “comprising” resulted in claims directed to vaccine compositions being held to lack support, insofar as the claims encompassed vaccines having additional polypeptide-protein conjugates beyond the thirteen specified.4 The decision in MSD v Wyeth also cemented that evaluation of compliance with Australian support provisions involves assessment of the technical contribution to the art disclosed by the specification, and requires that the breadth of the monopoly claimed must be justified by that technical contribution.5

On the face of it, these decisions might cause concern that other patents containing similar commonly used claim terms might also be vulnerable. However, in both MSD v Wyeth and Cytec v Nalco, the decisions were heavily dependent on the facts. As discussed above, in Cytec v Nalco there was a lack of disclosure in the specification relating to production or isolation of single small molecule products. The expert evidence further indicated that a skilled person would not have known how to obtain a single small molecule. In MSD v Wyeth, the evidence supported that the selection of additional serotypes beyond the 13 specified in the claims would be a complex and difficult process. Given that, it should not be assumed that all Australian patents using terms such as “at least one” or “comprising” are likely to be considered to lack support or be insufficient.

However, these decisions highlight the approach of the Australian courts, not only in carefully considering the language of the claims, but in also evaluating whether all embodiments falling within the claims can be obtained based on the specification and the common general knowledge. We can also expect that challengers will continue to raise lack of support and insufficiency attacks in invalidity proceedings. As a result, particularly for cases where litigation may be anticipated, patentees should consider whether the claims of their patents reflect the technical contribution to the art.

Grace period applicable to “novelty-only” patent publications

An unsuccessful lack of novelty attack was also made by Cytec based on an earlier filed-later published “whole of contents” Nalco publication “WO 873”. In confirming that the Australian grace period provisions are applicable to such documents, the judge confirmed the position taken by the Australian Patent Office in recent years,6 providing additional clarity in this area.

The judge disagreed with the Opponent’s view that the 12-month grace period only applied to prior art documents which had already been published by the priority date of the claim, holding that a reading down of the words “publicly available” in section 24 of the Patents Act to exclude prior unpublished patent specifications from the grace period provisions, was unwarranted.

For more information regarding this case, or if you have questions regarding how to navigate Australia’s support and sufficiency requirements, please get in touch with a member of our team.


1Cytec Industries Inc. v Nalco Company [2021] FCA 970.

2Cytec Industries Inc. v Nalco Company [2021] FCA 970, [129]-[133].

3Cytec Industries Inc. v Nalco Company [2021] FCA 970, [149].

4Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477;

5Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477, [547].

6Biogen Idec MA Inc. [2014] APO 25; Rozenberg & Co Pty Ltd. v Velin-Pharma A/S [2017] APO 61

In a recent decision of the Australian Patent Office, Cytec Industries Inc. successfully defended its Australian Patent Application No. 2014370386 against all grounds of opposition.1 The decision highlights some key aspects of Australian patent oppositions, including the emphasis placed on expert evidence by the Patent Office when deciding on grounds such as inventive step, and the importance of formulating a clear position supported by the evidence in hearing submissions.

Griffith Hack were involved in the latter stages of CSIRO v Cytec, handling preparation of submissions and hearing strategy on behalf of Cytec.

Technology

The patent application concerned the production of polyacrylonitrile (PAN) polymer suitable for use in producing carbon fibre and having particular properties, including a requirement for high molecular weight and narrow polydispersity index. Claims were directed to a multi-step process for producing the polymer including the use of reversible addition/fragmentation chain transfer (RAFT) agents, and also to processes for producing carbon fibre from the polymer.

Straw Man Opponent

Any person can oppose grant of a patent application in Australia, and in CSIRO v Cytec the opposition was originally filed by a ‘straw man’ opponent. A so-called ‘straw man’ opposition usually involves an attorney or attorney firm opposing on behalf of somebody else – to conceal the identity of the true opponent. Opponent status was transferred to CSIRO late in the proceedings, after questions were raised about a possible association between some of the expert witnesses and the true opponent.

Expert Evidence

In Australian patent oppositions, providing strong expert evidence on matters such as common general knowledge or steps that a person skilled in the art (PSA) would have taken is often critical. The hearing officer will generally rely on such evidence rather than their own technical expertise. It is also preferable to involve independent experts where possible.

In CSIRO v Cytec the Delegate considered that, whilst one of the opponent’s expert witnesses had considerable expertise in RAFT polymerisation and a high level of inventive capacity, they were not truly representative of a polymer scientist of ordinary skill. Whilst the evidence was not excluded, consideration was given as to whether it went to the issue of what the common general knowledge was and what a PSA would do, rather than what the witness themselves knew.2

Two expert witnesses emerged as being employees of the true opponent, and a third was a director of a joint venture set up by the opponent. Concerns over the identity of the true opponent not being disclosed earlier in the process, and its impact on the value of the evidence, were also addressed by the Delegate.

He emphasised that the witnesses were provided with the Federal Court’s Expert Evidence Practice Note, and were aware of their role in providing relevant and unbiased evidence, and so their evidence was not disregarded.

However, it was also noted that at times declarants went beyond the role of providing evidence on technical issues. The Delegate further commented that, whilst witnesses will understandably disagree with each other, and may express those differences in strong terms, such statements can indicate a lack of objectivity or suggest that the witness is acting as an advocate. As a result, some of the evidence was approached with caution.3

Inventive Step

Alongside preparation of evidence, a key facet of opposition practice is the ability to set out a party’s case strongly in written and oral submissions, and to anticipate and respond to arguments made by the other side.

The main ground of opposition pressed at the hearing in CSIRO v Cytec was lack of inventive step. The Delegate agreed with Cytec’s position that the problem solved by the invention was the provision of PAN polymer suitable for use in producing carbon fibre, and having a low polydispersity and high molecular weight, preferring that to the opponent’s alternative problem of producing PAN polymer with low polydispersity.4

Further, Cytec’s position was preferred on a number of key issues, supported by their expert evidence, including that:

  • it was not common general knowledge that RAFT could be used to prepare PAN copolymers; and
  • there was a technical prejudice in the art that RAFT presented challenges in achieving the appropriate properties for PAN copolymers, namely achieving both high molecular weight and low polydispersity.5

Attention was also drawn to a contemporaneous paper published by CSIRO authors. The parties presented differing views as to what the paper taught, but ultimately the Delegate held that the document indicated that the manufacture of PAN polymers having high molecular weight and low polydispersity suitable for production of high quality carbon fibre presented challenges.6

Against that background, the claims were held to be inventive, both in the light of the common general knowledge alone, and the common general knowledge together with the cited prior art documents.

Final Thoughts

Since the Raising The Bar Amendments to the Patents Act 1990 came into force a number of years ago, Australia has become a more challenging jurisdiction for patent applicants requiring greater consideration of strategy than in the past. An opponent now only needs to prove their case on the balance of probabilities rather than demonstrating that the application is clearly invalid, and there are increased support and sufficiency requirements intended to align with UK and European provisions.

Whether an owner or a challenger, careful preparation of evidence and submissions is a key aspect of opposition practice. Factors important for success in Australian oppositions also include an understanding of the scientific and legal issues, developing an effective opposition strategy, and evolving that strategy as necessary as the opposition progresses.

When faced with an opposition, patentees should consider whether they have the best team to successfully defend the patent application. Transfer of the representative on an opposed application is allowable, and may be preferable for some high value cases and situations where opposition experience is essential.

How we can help

Griffith Hack has a patent attorney and legal team with a strong track record, not only in defending patent applications where we have been responsible for prosecution, but also in getting across the scientific and legal issues quickly, and delivering results when we are brought in specifically to handle the opposition.

To discuss patent oppositions further with a member of our team, click on their profile below.


Commonwealth Scientific and Industrial Research Organisation v. Cytec Industries Inc. [2021] APO 27.
2 Ibid, [36]. 
3 Ibid, [37]-[39].
4 Ibid, [63].
5 Ibid, [85}, [91].
6 Ibid, [100].

With Australia’s innovation patent system set to end later this month, pre-grant opposition proceedings will likely play a significant role in the strategies of challengers going forward – and owners will want to be prepared. Gavin AdkinsDr Toby Thompson and Amanda Stark discuss. 

Australia’s innovation patent system is ending soon. As a result, Australia’s pre‑grant opposition proceedings will likely play a more significant role in the strategies of patentees and challengers in the future.

Innovation patents are subject to a different ‘post-grant’ opposition procedure to standard patents that is stayed by the commencement of court proceedings. As a result, divisional innovation patents are sometimes used as a litigation tool in order to, among other things, short circuit the enforcement delay associated with the pre‑grant opposition procedure for standard patents. As the innovation patent system is phased out, this tactic will fall away.

Australia’s pre-grant patent opposition procedure is long-standing but has undergone some important changes in recent years that will become critical in the future.  These changes include higher requirements for several grounds of opposition, resulting in a less pro-patentee opposition regime than was previously the case.   

Lower burden of proof

Previously, in order to succeed in opposing grant of an Australian patent it was necessary for an opponent to establish that the patent, if granted, would be clearly invalid.

Now an opponent need only satisfy the Hearing Officer on the balance of probabilities that a ground of opposition to the grant of the standard patent is made out.

Stronger grounds for opposition

In respect of standard patent applications which are filed on or after 15 April 2013, or for which examination is requested after this date, there are four substantive changes that strengthen the grounds for challenging validity:

1. Broader prior art base for inventive step (obviousness)

Firstly, the background “common general knowledge” is no longer confined to that which existed in the art in Australia. In practice, this removes the need to use local Australian experts or otherwise prepare evidence in order to establish that the relevant art is ‘international’ in nature.

Secondly, in order for prior art to be eligible for assessing inventive step it is no longer necessary to establish that it must be “information that a skilled person […] could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded as relevant”. This removes another evidentiary obligation from an opponent and broadens the prior art base substantially.

2. US utility requirement

An express utility requirement was inserted to align with the US position such that “a specific, substantial and credible use for the invention (so far as claimed) is disclosed in the complete specification”. This is in addition to the pre-existing requirement for the invention itself to be useful.

3. UK/European enablement and support requirements

The disclosure requirement for complete applications has been amended to conform substantially to the corresponding UK provision, such that the complete specification must “disclose the invention in a manner which is clear enough and complete enough for an invention to be performed by a person skilled in the relevant art”.

Further, the ‘old test’ for fair basis has been replaced with a requirement based on UK/European law that that the claims are “supported by” the description. The ‘old test’ for fair basis was essentially limited to a textual comparison between the claims and the body of the specification or priority document that did not involve any inquiry into ‘technical contribution to the art’.

4. Tighter restrictions on amendments

While not a ground for invalidity, patent applicants are not allowed to add matter that goes beyond the disclosure contained in the specification at its filing date, except to correct a clerical error or obvious mistake.

Strict time-frames for evidence

In the past, patent opposition proceedings in Australia often became protracted due to generous provisions relating to extensions of time for lodging evidence. This is no longer the case.

Evidentiary time periods are still extendable, but the regulations relating to extensions of time for evidentiary periods are now reasonably onerous and strictly applied by IP Australia. Unless a party can show that they acted promptly and diligently and made all reasonable efforts to file the evidence in time, an extension will not be granted.

The procedure from filing the Notice of Opposition to the issuance of a written decision on validity can now be completed within about 18 months, although extensions of time (where allowed), amendments and procedural disputes can extend this time-frame.

Use all available options

It is currently still possible to file new applications for innovation patents in Australia, until 25 August 2021. Even after that date, it will still be possible to file applications for innovations which are divisionals of existing applications filed before that date.  As a result, if your invention is of significant commercial value and is likely to be commercialised in the short to medium term, an 8-year term innovation patent may still be a useful option.

How we can help

Facing a pre-grant opposition in Australian is often a new experience for many patent owners, and opponents also.  Opposition practice is a specialised area of Australian patent law, particularly with regard to areas such as preparation of expert evidence, hearing preparation, dealing with procedural aspects such as amendment requests and extensions, and extending into commercial aspects such as settlement negotiations and licensing.

Griffith Hack’s experts have extensive experience in handling Australian patent oppositions. Our combined patent attorney and legal team provides integrated scientific and legal expertise, together with strategic, commercially-relevant insight, and has a proven track record in delivering results.

To discuss patent oppositions further with a member of our team, click on their profiles below. 

AusBiotech has released a draft strategic roadmap for a new regenerative medicine Catalyst, and is now seeking sector feedback from those interested in the future of regenerative medicine in Australia.

On 29 July 2021, AusBiotech released for comment a draft roadmap for Australian regenerative medicine (RM), with the aim of developing strategic goals, objectives and priority actions for a national RM sector ‘catalyst” collaboration body, the Catalyst Body.

We welcome the impetus of the seven consortium members of the Regenerative Medicine Catalyst Project in seeking to advance the development and earlier access to ground-breaking regenerative medicine therapies for Australian patients.

The draft roadmap states:

“Our vision is that Australian patients have access to world-class regenerative medicine therapies sustained by a thriving Australian RM industry. 

Our mission is to create an end-to-end world-class value chain that can discover, develop, and distribute regenerative medicine, while creating jobs, commercialising research, and exporting Australian therapies to the world.

An excellent summary of the strategic plan is provided in Figure 1 on page 8 of the draft roadmap, outlining priority actions to build stakeholder engagement and encourage investment within the sector, establish forward-looking regulatory pathways, and develop the requisite manufacturing capability needed to accelerate growth in regenerative medicine therapies.

The underlying theme of the draft roadmap is that the vision and mission will only be achieved through collaboration, with a call for greater coordination and cooperation concluding the draft roadmap.

The Australian RM sector is invited to comment on the draft roadmap by Friday, 13 August 2021 by providing feedback to Camille Shanahan, National Projects Manager – Regenerative Medicine.

We look forward the RM sector’s input on this important initiative.

In a recent decision of the Federal Court of Australia[1], Wyeth’s vaccine composition patent was found invalid for lack of support where the use of “comprising” language resulted in the claims encompassing vaccines having additional polypeptide-protein conjugates beyond the 13 specified in the claims.

Together with other recent decisions, the MSD v Wyeth judgment demonstrates the more exacting standard now required for the level of disclosure in patent specifications. It also cements the shift in Australia towards alignment with UK and European requirements.

Wyeth v MSD 

The judgment in MSD v Wyeth concerned three Wyeth patents[2], two directed to vaccine compositions containing polysaccharide-protein conjugates, and the third protecting a siliconized container for stabilising such compositions. The patents protected Wyeth’s Prevnar 13® vaccine which prevents pneumonia. MSD had sought to launch its own 15-valent pneumococcal conjugate vaccine.  Whilst one of the composition patents was held valid and infringed, the other two patents were found to be invalid.

At the heart of the case was the question of whether a claim to:

“A multigenic immunogenic composition, comprising polysaccharide-protein conjugates…wherein each of the conjugates comprises a capsular polysaccharide…prepared from serotypes 1,3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F…” 

in Australian patent no. 2013206844 was infringed by MSD’s 15-valent vaccine which contained not only the 13 capsular polysaccharides specified in the claims but also 2 others and, if so, whether the claim was consequently invalid for lack of support.

Given that an inclusive construction is typically given to the term “comprising”, it is not surprising that Burley J decided the former point in favour of the patentee and held that MSD’s vaccine infringed the claim.  MSD had argued that the claim language should be limited to a composition having only the 13 serotypes specified and excluding other serotypes, on the basis that their construction was consistent with the description of the invention in the specification. The judge rejected that position, referring to definitions in the specification which defined “comprising” inclusively, and highlighting inconsistencies resulting from MSD’s interpretation, since there was a dependent claim which specified additional components of the composition.

However, when it came to assessing whether the claims were supported, the breadth of the claims became problematic for the patentee.  The judge held that the technical contribution to the art lay in the identification of specific additional serotypes over those present in the prior art, by means of which a 13-valent composition could be made, but that the disclosure of the specification was not for a principle of general application going beyond that 13-valent product.  There was also evidence that the selection of additional serotypes would be a complex and difficult process. Although that assisted Wyeth’s inventive step position, it created difficulties for the patentee in arguing that claims covering MSD’s 15-valent vaccine were supported, and the claims were found to be invalid.

Notably, the grandparent patent 2006235013 was upheld when assessed under the previous (more lenient) support provisions of “fair basis” – despite having similar claims.

Towards a UK/European standard for specification disclosure requirements 

The MSD v Wyeth decision is one of several highlighting a shift with respect to the level of disclosure required in patent specifications, towards UK and European requirements. This aligns with the intent behind the Raising the Bar legislative changes in 2013[3].

In reaching his decision on the support issue, Burley J referred to UK jurisprudence concerning “Biogen insufficiency”[4]. Lack of support is not a ground of revocation in the UK, however the judge drew from the position of the UK House of Lords that the claim support obligation falls under the umbrella of the requirement that a patent specification must contain an enabling disclosure.  Burley J set out that, for a claim to be supported or justified across its breadth, it must correspond to the technical contribution to the art.  Reference was also made to principles summarised in the recent decision of the UK Supreme Court in Regeneron v Kymab[5]: that the technical contribution to the art is not necessarily the same as inventive step, rather for a claim to a product or group of products it is the products themselves; and that the disclosure in the specification should be sufficient to make substantially all embodiments, except for de minimis exceptions.

Prior to the judgment in MSD v Wyeth, there had been several Australian patent office decisions which addressed support and/or sufficiency requirements under the post-Raising the Bar regime. 

In the first decision to consider support and sufficiency post-Raising the Bar, CSR Building Products Ltd v United States Gypsum Company[6], a patent application having claims to fire resistant gypsum panels required to achieve certain properties was found to be invalid.  In that case, drawing from a UK decision Schering Biotech Corp’s Application[7], the Delegate in CSR referred to a general approach for assessing support based on ascertaining the invention specified in the claims and comparing that with the invention specified in the description, with “the description having to be a base which can fairly entitle the patentee to a monopoly of the width claimed”.  In MSD v Wyeth, Burley J agreed with the general approach adopted in CSR but emphasised in addition the need to ascertain the technical contribution to the art, as discussed above.

The CSR decision also considered sufficiency of disclosure and proposed the relevant question as being whether a person seeking to follow the instructions in the specification could adjust the process and materials so as to achieve with certitude the full combination of properties claimed.  However, more recent Australian patent office decisions that considered sufficiency have introduced a plausibility test, like the approach taken by UK courts.  For example, in the Evolva[8] and Gary B Cox v MacroGenics, Inc.[9]decisions, the Delegate set out a test for determining whether the specification provides an enabling disclosure of everything falling within the claims based on whether:

a) Is it plausible that the invention can be worked across the full scope of the claim; and

b) Can the invention be performed across the full scope of the claim without undue burden.

The move in Australian practice towards the UK and European position is also evident from the CSIRO v BASF decision earlier in 2020.[10] That case concerned the question of whether an amendment introduced added matter contravening s102(1) of the Patents Act 1990, rather than whether the claims were supported, but again emphasised the need for an Australian patent specification to contain a detailed disclosure of the invention. The amendment at issue involved the specification of one feature of an enzyme (conversion preference) in the claims without specifying another (substrate specificity), when the two features were only disclosed in combination in the original specification.  The amendment was found to be an impermissible intermediate generalisation based on the original disclosure, and reference was also made to the “clear and unambiguous disclosure” test referred to by the UK courts in Bonzel v Intervention[11].

“Comprising” claims in Australia 

In MSD v Wyeth,Wyeth raised concerns about the impact of a finding of lack of support in that case, on the validity of other Australian patents also having “comprising” product claims.  However, Burley J dismissed the proposition that finding the present claims invalid would automatically result in all product claims using the words “comprising” lacking support.  Rather, it was emphasised that validity of other claims would depend on the particular claim language used and the scope of the disclosure in the specification. 

As discussed above, in this case there was evidence supporting that the selection of additional serotypes beyond the 13 specified in the claims would be a complex and difficult process.  Accordingly, patents containing “comprising” claims may be more vulnerable in situations where there is a gap between the disclosure in the specification and the breadth of the claims, which cannot be not filled by the common general knowledge or the routine capabilities of the skilled addressee.

It seems likely that with respect of MSD v Wyeth, if exclusive “consisting of” terminology had been used to define the capsular polysaccharide-protein conjugate component of the composition, the claim may have survived. However, such a claim would have been of considerably less value to the patentee, encompassing Wyeth’s product but not the Merck 15-valent vaccine.

Final Comments

The judgment in MSD v Wyeth, together with other recent decisions of the Australian authorities, highlight that the shift towards UK and European practice in respect of disclosure requirements for Australian patent specifications is purposeful.  Impact on patent drafting practice in Australia is likely to be minimal, since most Australian-originating specifications are already drafted to meet requirements of major patent offices including the USPTO and the EPO. During invalidity proceedings to Australian patent applications, we may however expect to see increased references by parties to invalidity attacks raised in respect of corresponding UK and European patents.