The High Court has refused to grant Special Leave to the patentee (Jusand) to appeal the decision of the Full Federal Court in Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2023] FCAFC 178 (Jusand). The Federal Court’s application in Jusand of the concept of a “relevant range” from the UK Supreme Court decision in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27 (Regeneron) could have serious ramifications for a large number of Australian patents and patent applications having claims that rely on a principle of general application to enable and support the breadth of the claims.
The only reasons given by the High Court for refusing Special Leave were that the appeal did not have sufficient prosects of success and that this particular case is not a suitable vehicle for the point of principle at issue.
Sufficiency and Support Requirements
Under Australian law, a specification must disclose the claimed invention in a manner that is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art (Sufficiency Requirement).[i] This means sufficient information must be provided to enable the whole width of the claimed invention to be performed by the skilled person without undue burden, or the need for further invention.[ii] The Explanatory Memorandum (EM) to the the Raising the Bar amendments to the Patents Act (RTB Amendments) indicates an intention on behalf of the legislature that the Sufficiency Requirement, “be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation and the European Patent Convention”.
An (external) Sufficiency Requirement also applies to priority claiming. Thus, an earlier (priority) application must provide a clear enough and complete enough disclosure of an invention claimed in a later (priority-claiming) application for the priority claim to be valid (Priority Date Requirement).[iii] The Federal Court has confirmed that the Priority Requirement is to be assessed in the same manner as the Enablement Requirement.[iv]
The claims must also be supported by matter disclosed in the specification (Support Requirement).[v] This means there must be basis in the description for each claim and the scope of the claims must not be broader than is justified by the extent of the description, drawings and contribution to the art.[vi] The EM indicates that the Support Requirement was “intended to align the Australian requirement with overseas jurisdictions’ requirements (such as the UK)”.
The Jusand decision
The innovation patent claim at issue in Jusand, and which was found to be invalid for want of sufficiency and support at first instance, is in the following terms:
- A safety system for protecting against a hazard of drill rod failure in a drilled rock bore above horizontal, and especially a hazard posed by a broken drill rod section within the bore, comprising:
an anchor member configured to be fixed in a proximal end region of the bore adjacent to a rock-face; andan impact reduction member for reducing an impact of the broken drill rod section striking the anchor member in the proximal end region of the bore, wherein the impact reduction member is configured to be located in the proximal end region of the drilled bore and to extend within the bore above the anchor member to be impacted or struck directly by the broken drill rod section falling within the bore.
The components of the safety system, i.e., the anchor member and impact reduction member, are defined in functional terms, reflective of the notion that the invention will work with an anchor member and an impact reduction member constructed of any suitable material that is capable of performing the recited function (essentially, a “principle of general application”). However, the specification teaches only how to make the invention using steel.
The Full Court considered that while the innovative concept underpinning the invention is the “ingenious conversion of downward weight force into lateral braking forces”, the claim was nonetheless found to lack sufficiency and support because it was “plausible” the invention could be carried out using materials other than steel. The selection of plausible materials from which Jusand’s invention could be made was considered a “relevant range in the Regeneron sense”, with respect to which Lord Briggs (with whom Lord Reed, Lord Hodge and Lord Sales agreed) stated in Regeneron at [56]:
The requirement to show enablement across the whole scope of the claim applies only across a relevant range. Put broadly, the range will be relevant if it is denominated by reference to a variable which significantly affects the value or utility of the product in achieving the purpose for which it is to be made. [Emphasis added]
The Full Court also referred to the decision of Birss J in Illumina Cambridge Ltd v Latvia MGI Tech SIA [2021] EWHC 57 (Pat); RPC 12 (Illumina) to assist in determining whether a range is “relevant” in the Regeneron sense. In that regard, Birss J stated at [279]:
An example of another range, not relevant in the Regeneron sense, will be a descriptive feature in a claim (whether structural or functional) which can cover a variety of things, but for which that variety does not significantly affect the value or utility of the claimed product or process in achieving its relevant purpose. The relevant purpose is judged in all the circumstances, starting from the terms of the claim itself but also, where appropriate, by reference to the essence or core of the invention. [Emphasis added]
In Illumina, Birss J further considered that the “essence or core of the invention” is “closely related to the technical contribution and/or the inventive concept”. In that regard, the Full Court considered that Jusand’s contribution to the art resides in how to make the invention using steel and, as such, the choice of material was a “relevant range” in the sense contemplated by Regeneron.
Relevantly, Rattlejack produced a competing product made from plastic, which Jusand alleged to infringe, inter alia, claim 1 above. However, despite finding the Rattlejack product does not infringe claim 1, the Full Court nonetheless considered that, putting aside materials the skilled person would not seriously consider (such as glass or paper), there were still materials other than steel (including plastic) that could be used to carry out the invention, and which affected the utility of the invention. In that regard, the Full Court stated at [479]:
… the Patents provide no guidance to the person skilled in the art seeking to perform the invention by making a safety system out of a material other than steel. In order to make a safety system out of plastic (or another material other than steel) the skilled person would need to undertake a process of prolonged research, enquiry and experiment. It would not be the work of a non-inventive skilled person, requiring an exercise of inventive skill or ingenuity or undue effort.
As such, the Full Court found that the specification failed to meet the Sufficiency Requirement.
The Full Court did not provide a detailed consideration of support for the claims, but noted that sufficiency and support are often viewed as “two sides of the same coin”, although they can sometimes differ.[vii] The Full Court considered this a case where the analysis of sufficiency and support do not differ. Despite conceiving the “ingenious idea” underpinning the invention, the Full Court considered that how to construct the safety system was a second problem to be solved, and that solving that problem using a material other than steel extended beyond Jusand’s contribution to the art. Accordingly, the claims also failed to meet the Support Requirement.
Potential ramifications
The importation into Australian law of the concept of a “relevant range” in the Regeneron sense could have implications that extend to a large number of patents and patent applications that rely on a principle of general application.
Where such a claim includes a range that “significantly affects the value or utility of the product”, the identification of any embodiment within that range that “plausibly” requires undue burden or further invention to produce the product could invalidate the claim. Of particular concern are the implications for the following:
- Selection inventions, which allow the original innovator or a third party to obtain patent protection for individual embodiments or a subset of embodiments of a patented invention that are not explicitly disclosed and the selection of which is non-obvious.
- Patents of addition, which protect novel improvements or modifications of a patented invention. Similar to selection inventions, the improvements or modifications the subject of a patent of addition are not contemplated by the original patent.
There is a significant risk that certain selection inventions or patents of addition could invalidate the original patent for want of sufficiency based on an ex post facto analysis of undue burden or inventiveness. Indeed, an inferior embodiment of the invention that requires undue burden or invention in order to produce could also invalidate the patent.
Thus, there is a risk that applying the concept of a “relevant range” could disincentivise innovation by unduly limiting the scope of claims that are legitimately based on a principle of general application, or by placing undue burden on patent applicants to disclose each and every plausible embodiment of the invention (including inferior embodiments) to mitigate the risk of invalidity. Even then, it is not possible to anticipate embodiments that may be invented within the scope of the claims in future.
The Full Court decision also has potentially serious ramifications for priority rights. For example, the inclusion in a complete application of any new or improved embodiments within a “relevant range” disclosed in an application from which it claims priority – including to satisfy the “best method” requirement under Australian law – could end up invalidating the priority claim if those embodiments involve undue burden or further invention to produce or carry out.
Where to next?
While the current sufficiency and support requirements were introduced into Australian law with the RTB Amendments that came into effect nearly 11 years ago to the day, they have only recently begun to be considered by the courts. The decisions issued to date indicate a clear intention by the Federal Court to follow the law in the UK and Europe, including decisions such as Regeneron that were not contemplated at the time the RTB Amendments were introduced.
Decisions such as Regeneron and Illumina, will likely continue to be instructive moving forward. On the one hand, the UK Supreme Court in Regeneron stated:
Patentees may rely, if they can, upon a principle of general application if it would appear reasonably likely to enable the whole range of products within the scope of the claim to be made. But they take the risk, if challenged, that the supposed general principle will be proved at trial not in fact to enable a significant, relevant, part of the claimed range to be made, as at the priority date.
On the other hand, in Illumina, Birss J noted:
Once the concept of a relevant range is properly understood, I think it will be an unusual case in which the kind of ordinary descriptive or functional language one sees in most patent claims will be regarded a relevant range in the Regeneron sense.
The risk of invalidity in view of Jusand may depend in large part on whether the inventiveness resides in how the invention works or how it is made. For example, a selection invention that has an unexpected advantage over the original invention, but which could nonetheless have been made based on the original disclosure without undue burden or invention, it is unlikely to be considered a “relevant range” in the Regeneron sense. However, if the invention resides in making something within the scope of the claims that relates to the “essence or core of the invention” and which could not otherwise have been made or worked without undue burden or invention, the concept of a “relevant range” is likely to apply.
However, it remains to be seen how the Jusand decision will be applied by the courts and the Patent Office moving forward, although the Patent Office has already started raising objections that have an air of Jusand in recent months.
We will keep our readers informed of any new developments as they arise. In the meantime, if you have any questions in relation to Australia’s sufficiency and support requirements, please contact Claire Gregg (cgregg@dcc.com) or Will Hird (whird@dcc.com). Claire and Will are Council members of the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) and assisted with an application by IPTA to intervene and be heard by the High Court as amicus curae on the proper construction of the Sufficiency and Support Requirements in the event Special Leave was granted.
[i] Patents Act 1990 (Cth), s 40(2)(a)
[ii] Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011
[iii] Patents Act 1990 (Cth), s 43(2A)(b)
[iv] TCT Group Pty Ltd v Polaris IP Pty Ltd [2022] FCA 1493
[v] Patents Act 1990 (Cth), s 40(3)
[vi] Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011
[vii] Jusand at [155]; picking up on the comments of Burley J in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477at [543]