For the first time, the Federal Court of Australia has considered the more stringent claim support requirements introduced to the Patents Act 1990 (Cth) (Patents Act) by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (RTB Act). As a result of the relevant dates of patents in suit, Burley J compared and contrasted the pre-RTB Act 'fair basis' requirement with the more stringent post-RTB Act support and sufficiency requirements. The differences led to one patent being valid under s 40(3) of the pre-RTB Patents Act as the claims were fairly based, whereas another patent was invalid under s 40(3) post-RTB Act for lack of support.

The proceeding was brought by Merck Sharp & Dohme Corporation (MSD) challenging the validity of three patents owned by Wyeth LLC (Wyeth) in relation to a pneumococcal vaccine. Two patents were composition patents (parent and child divisional) and the other related to a container.

The technology

Streptococcus pneumoniae is a bacteria that is commonly referred to as 'pneumococcus'. The pneumococcus bacteria has a polysaccharide coating (polysaccharide capsule), which contains an antigen that the human immune system responds to by producing antibodies. Variables in the polysaccharide capsule change the antigen, which creates different 'serotypes' of pneumococci, requiring a different antibody response. The composition patents concern protection against more than one serotype (polysaccharide capsule) of pneumococci and are therefore considered to be 'multivalent' immunogenic compositions.

The composition patents describe 13 distinct serotypes, whereby each capsular polysaccharide is conjugated (covalently bonded) separately to a carrier protein known as CRM197. Conjugation to a carrier protein creates a stronger antibody response to improve the immunogenicity of the vaccine.

Claim support

Section 40(3) of the post-RTB Patents Act requires patent claims to be: ''clear and succinct and supported by matter disclosed in the specification''

This requirement replaces the previous s 40(3), that all claims are to be 'fairly based on the matter disclosed in the specification'. Justice Burley commented that ''[t]he case advanced by both parties was confined in closing submissions to only a handful of paragraphs and little in the way of oral address, despite the fact that the claim support obligation is new to the law of Australia''. Therefore, it appears that Burley J has conducted his own research into the new support obligation and, helpfully for patent litigators and attorneys moving forward, provided a comprehensive analysis of the new legal requirement.

Justice Burley highlighted that the intention of the RTB Act was to raise patent standards as well as bring Australian law into conformity with its major trading partners. Justice Burley further noted that there can be 'little doubt' that parliament considered it appropriate for the Court to regard the laws in both the European Union and the United Kingdom in the application of the requirement for the new claim support obligation. As a result, Burley J conducted a considerable amount of research regarding UK and European law as it relates to the support obligation and has provided a useful overview in his decision.

Sufficiency and support

Prior to the amendments made to the Patents Act by the RTB Act, s 40(2)(a) of the Patents Act required that a complete specification must ''describe the invention fully'. In addition to introducing the 'support' requirement, the RTB Act also introduced a new 'sufficiency' requirement. Section 40(2)(a) of the Patents Act now requires that 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'

For reasons that are not at all clear, MSD did not run a sufficiency ground with respect to the divisional composition patent. Given the close relationship between the support and disclosure obligations, this not only appears to have been a missed opportunity by MSD, but is unfortunate for patent litigators and attorneys. It would have been useful for the decision to also provide a compare and contrast of the pre-RTB Act and post-RTB Act disclosure obligations. Regardless, given the overlap between sufficiency and support in UK law, both were considered in some detail by Burley J.

Section 14(5)(c) of the UK Act requires that 'the claim or claims shall…(c) be supported by the description.' This claim support requirement is for the grant of a patent in the UK. However, unlike in Australia, there is no corresponding provision in the UK for the revocation of a patent. In contrast, with respect to sufficiency (or the disclosure obligation), the UK Act includes provisions that relate to both grant and revocation of a UK patent. Section 14(3) of the UK Act provides for the disclosure obligation, while s 72(1)(c) provides a corresponding ground of invalidity.

As a result, UK case law has developed two types of 'insufficiency'; namely 'classical insufficiency' and 'Biogen insufficiency'. 'Classical insufficiency' corresponds with the enablement (disclosure) obligation in Australia post the RTB Act. 'Biogen insufficiency' corresponds with the support obligation in Australia post the RTB Act.

The law of support in Australia

Justice Burley made it clear that in Australia, the obligation for disclosure (s 40(2)(a)) and the claim support obligation (s 40(3)) are to be considered separately, as each ground provides a basis for a patent to be revoked. As a result of differences between the Acts, this requires a careful consideration of UK and EU laws.

Justice Burley approved the approach taken by Aldous J in the UK decision of Schering Biotech Corp’s Application [1993] RPC 249:

'[I]t is necessary to ascertain what is the invention which is specified in the claims and then compare that with the invention which has been described in the specification... [the claim support obligation] requires the description to be the base which can fairly entitle the patentee to a monopoly of the width claimed'.

Justice Burley added an additional requirement for the support obligation to be met, commenting that:

'To it may be added the requirement that the technical contribution to the art must be ascertained. Where it is a product, it is that which must be supported in the sense that the technical contribution to the art disclosed by the specification must justify the breath of the monopoly claimed.'

Justice Burley notes that within the Explanatory Memorandum to the RTB Bill, in referencing overseas law, the 'support' obligation is made up of two concepts, namely; 'there must be a 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'.

The invention

Claim 1 of the divisional composition patent defines:

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.

The specification focusses on the 13 serotypes defined in claim 1. Justice Burley determined that the specification discloses 'the idea to add serotypes 1, 3, 5, 6A, 7F and 19A to the Prevnar 7 serotypes and to conjugate them to CRM197, coupled with the practical means by which this is achieved.' Prevnar 7, a pneumococcal conjugate vaccine that was available at the priority date, was known to be highly successful in reducing disease caused by pneumococci. Importantly, Burley J found that '[t]here is no disclosure of the conjugation of any additional serotypes to CRM197.'

The evidence of Professor Paton, an expert called by MSD, was that it is not possible to extrapolate the data in the patent to other serotypes, because the specification is focused on the serotypes covered by the patents. Professor Paton's evidence was uncontested. Importantly, with regard to the common general knowledge at the priority date of the patent, Burley J found that 'adding serotypes to the composition claimed would be a complex and difficult process.'

Application of the law

Justice Burley ultimately found that the claims of the divisional composition patent were invalid for lack of support under s 40(3) Patents Act. Justice Burley concluded that 'the inclusively worded claims do not correspond to the technical contribution to the art. The claims cover products that the specification does not enable, and the specification discloses no principle that would enable others to be made.'

This conclusion was reached by Burley J based on the following considerations:

• the word 'comprising' (as used in claim 1 of the divisional composition patent) is to be construed inclusively, such that any composition 'comprising' the 13 chosen serotypes would be included in the claim, even if the composition contains additional serotypes;
• although the specification discloses all 13 serotypes and how to conjugate them to the CRM197 protein, as well as the practical means by which this is achieved, there is no disclosure of the conjugation of any additional serotypes to CRM197;
• the addition of serotypes to the composition claimed, based on the common general knowledge, would be a complex and difficult process. Further, based on expert evidence, it was not considered possible to extrapolate the data from the specification to other serotypes; and
• the technical contribution lies in the disclosure of the specification of the 13 identified serotypes, and is not for general application beyond that (i.e. to further serotypes).

Interestingly, although the divisional composition patent did not meet the support obligation under the post-RTB Act, Burley J found that the parent composition patent was valid under the pre-RTB Act. Dismissing MSD's argument that the claims were not fairly based as there was no disclosure beyond the 13 serotypes, Burley J found the claims to be fairly based as the patent specification disclosed in a 'general sense' the invention as claimed.

Conclusion

This decision means that in circumstances where the patent claims are broad, any 'inventive' improvement to the product that meets the requirements of the claims may result in the claim being invalid. It is very common for patents in Australia to be drafted with broad inclusive language, such as the words 'comprising' or 'including'. However, this decision means that many of those patent claims may be considered to be invalid for lack of support under s 40(3) of the Patents Act, and possibly also for lack of sufficiency under s 40(2)(a), if the disclosure of the invention provided by the specification does not encompass the breadth of the claims. Patentees should consider reviewing granted Australian patents to which the post-RTB Act applies, and consider amending the claims before the Australian Patent Office.

When drafting and prosecuting applications in Australia, patent attorneys should consider including claims that include exhaustive language that are directed towards the matter specifically disclosed in the specification. Further, patent attorneys should strongly consider including claims to the method in addition to the product. Where additions have been made to a product (e.g. additional serotypes in the present case), it is possible that an infringer will need to implement the claimed method before adding additional features to a product. A relatively limited method claim may therefore not only be supported by the specification, but also infringed by a competitor despite any potential 'inventive' additions that are made to the product.