The current sufficiency and support requirements for patents in Australia came into effect on 15 April 2013 as a result of the Raising the Bar amendments (RTB Amendments) to the Patents Act 1990 (Cth) (Act).[i] These provisions apply to all patents and pending applications for which examination was requested on or after 15 April 2013. Now, over 10 years later, patents subject to the RTB amendments are increasingly appearing before the courts, providing insights into the interpretation of the support and sufficiency requirements.
We previously reported on the Federal Court decision in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477 (MSD), in which the inclusive construction of the term “comprising” in the claims resulted in a finding of lack of support. A more recent decision by the Federal Court in Boehringer Ingelheim Animal Health USA Inc v Zoetis Services LLC [2023] FCA 1119 (Boehringer) provides further guidance on the operation of the term “comprising” under Australian law and the risks to validity if the use of this term casts the patentee’s monopoly broader than its contribution to the art.
Sufficiency and support requirements
Sufficiency
Under Australian law, a complete specification must “disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art”.[ii] This means that 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.[iii]
The sufficiency requirement replaces the pre-RTB requirement to “describe the invention fully”, which has been interpreted by the courts as a requirement merely to “enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty”.[iv]
Support
The claims must also be “supported by matter disclosed in the specification”.[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 support requirement replaces the pre-RTB requirement that the claims be “fairly based on the matter described in the specification”, which has been interpreted by the courts as a requirement for a “real and reasonably clear disclosure” of the claimed invention.[vii]
The “comprising” conundrum
The MSD decision
The decision of Burley J in MSD concerned, inter alia, a patent directed to a 13-valent pneumococcal conjugate vaccine. Claim 1 was directed to:
A multivalent immunogenic composition, comprising polysaccharide-protein conjugates together with a physiologically acceptable vehicle, wherein each of the conjugates comprises a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to a carrier protein, and the capsular polysaccharides are prepared from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, wherein the carrier protein is CRM197 for use as a vaccine to protect or treat a human susceptible to pneumococcal infection. [Emphasis added]
The patentee (Wyeth) asserted that MSD’s 15-valent pneumococcal conjugate vaccine infringed claim 1 above. MSD asserted that the claims lack support on the basis “there is no description or disclosure in the specification of any pneumococcal polysaccharide-protein vaccine other than one having pneumococcal polysaccharides from the 13 chosen serotypes identified in the specification and claims”.
The questions of both infringement and support turned on the construction of the terms “comprising” and “comprises”. These terms were defined in an inclusive sense in the specification, except where the context dictates otherwise. In the context of the specification as a whole, Burley J favoured Wyeth’s inclusive construction of the term “comprising”, such that any composition that includes the 13 chosen serotypes (including MSD’s 15-valent vaccine) would infringe the claims if valid.
However, uncontested evidence was adduced by MSD that it is not possible to extrapolate the data in the patents to other serotypes. Thus, Burley J favoured MSD’s position that the claims lack support, because “adding serotypes to the composition claimed would be a complex and difficult process” and “[t]he disclosure of the specification is not for a principle of general application beyond the product”. Accordingly, the claims were invalid and MSD’s 15-valent product did not infringe.
The Boehringer decision
The decision of Rofe J in Boehringer concerned an appeal from an opposition by Boehringer to the grant of three patent applications owned by Zoetis – AU 2013243535; and (AU ‘535), AU 2013243537 (AU ‘537) and AU 2013243540 (AU ‘540). Claim 1 of AU ‘535 provides:
An immunogenic composition comprising the supernatant of a Mycoplasma hyopneumoniae (M. hyo) culture, wherein the supernatant of the M. hyo culture has been separated from insoluble cellular material by centrifugation, filtration, or precipitation and is substantially free of both (i) IgG and (ii) immunocomplexes comprised of antigen bound to immunoglobulin.
Claim 1 of AU ‘537 is drafted in similar terms and relates to a multivalent immunogenic composition comprising the M. Hyo platform and a porcine circovirus type 2 (PCV-2) antigen. Claim 1 of AU ‘540 is also drafted in similar terms and relates to a trivalent immunogenic composition comprising the M. Hyo platform, a PCV-2 antigen, and a porcine reproductive and respiratory syndrome (PRRS) virus antigen.
Various dependent claims further included the feature of “additional antigens” to microorganisms that cause diseases in pigs, other than those specified in the relevant claim 1. The questions of both support and enablement for these dependent claims turned on the construction of the term “comprising” in claim 1 of each application, which is defined inclusively in the specification of each application (and in the same terms as in the patent at issue in MSD).
Zoetis argued that “comprising” was inclusive in the sense that immunogenic compositions containing an additional antigen would infringe the claims, but that such additional antigens need not be specifically disclosed in order for the claims to be supported. However, Rofe J construed claim 1 of AU ‘535 as claiming an immunogenic composition that is not limited to the inclusion of just one M. hyo antigen, but is limited insofar as any additional antigens in the composition must be M. hyo antigens.
An analogous construction was also applied to claim 1 of AU ‘537 and AU ‘540, such that the claims could include any number of M. hyo antigens in addition to the PCV-2 antigen (AU ‘537) or PCV-2 and PRRS virus antigens (AU ‘540), but no other antigens. Rofe J also recognised that the claimed compositions could comprise inessential elements, such as excipients and adjuvants, which “the skilled person would understand to be required for an immunological composition, but not to be an essential part of the invention”.
In relation to claims that expressly include additional antigens, Rofe J “[did] not consider that it is a straightforward exercise to combine the additional antigens with the M. hyo platform, to produce an immunogenic composition including a vaccine. A research project would be required”. Such claims were considered to be broader than Zoetis’ contribution to the art.
Key takeaways
The decisions in MSD and Boehringer reflect the existing case law that the term “comprising” cannot be given unbridled operation.[viii] In MSD, the claims were construed as including compositions comprising Streptococcus pneumonia serotypes beyond the 13 listed, but “not serotypes at large unrelated to Streptococcus pneumoniae”.[ix] Similarly, the claims at issue in Boehringer were construed as being limited in scope to compositions comprising antigens to the microorganisms listed in each respective claim 1, but not any additional antigens to other microorganisms.
However, in MSD, the claims were not supported because the teaching of the specification was not generalisable to compositions comprising other Streptococcus pneumonia serotypes. In contrast, in Boehringer, the invention would be reasonably expected to work with additional M. hyo antigens.
These decisions also indicate that where a dependent claim adds a new essential feature (e.g., an additional active agent to a pharmaceutical composition), that feature must be sufficiently enabled and supported by the teaching of the specification, optionally together with the common general knowledge in the art. A mere laundry list of possible additional active agents is unlikely to suffice where those additional agents have the potential to change the way the invention works or require undue burden to successfully incorporate into the inventive product (or process).
Further developments in sufficiency and support
The RTB amendments were intended to align the law on sufficiency and support in Australia with other jurisdictions, and “be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation and the European Patent Convention”.[x] On this basis, another recent decision of the Full Federal Court in Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2023] FCAFC 178 endorsed the controversial UK Supreme Court decision in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27, thereby importing the concept of a “relevant range” into the assessment of sufficiency and support in Australia.
The patentee (Jusand) has sought special leave to appeal the decision to the High Court, which, if allowed to stand, could have significant ramifications for the validity of a vast number of patents and applications in Australia. The authors of this article are involved in an application by the Institute of Patent and Trade Mark Attorneys of Australia to intervene and be heard as amicus curiae on the proper construction of the sufficiency and support requirements under Australian law. The special leave hearing is scheduled for later this month, and we will provide our detailed analysis of the implications of this decision after the hearing.
In the meantime, please contact Claire Gregg (cgregg@dcc.com) or Michael Caine (mcaine@dcc.com) if you have any questions about sufficiency and support in Australia.
[i] Intellectual Property Laws Amendment (Raising the Bar) Act 2012
[ii] Patents Act 1990 (Cth), s40(2)(a)
[iii] Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (EM), Item 8
[iv] Kimberly-Clark Australia Pty Limited v Arico Trading International Pty Limited [2001] HCA 8; 207 CLR 1 at 25
[v] Patents Act 1990 (Cth), s40(3)
[vi] EM, Item 9
[vii] Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274 at [69]
[viii] Actavis Pty Ltd v Orion Corporation [2016] FCAFC 121
[ix] See Boehringer at [216]
[x] EM, Item 8