In brief

The Federal Court decision in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477 (MSD v Wyeth) is the first detailed consideration by the Federal Court of the claim support requirement under section 40(3) of the Patents Act 1990 (Cth) (the Patents Act) following the reforms made by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (the RTB) to Australian patent law. Justice Burley’s contrasting findings on lack of fair basis and lack of support make clear that broad claims seeking a monopoly exceeding the technical contribution disclosed in the specification will be invalid, despite the specification including textual reference to features of the invention claimed.

Background

The proceedings concerned three of Wyeth LLC’s (Wyeth) patents to the Prevnar 13 vaccine, which protects against Streptococcus pneumoniae, a leading cause of serious infections, including pneumonia, in children and the elderly.

The first two patents (the 013 Patent and the 844 Patent) claim compositions comprising 13 distinct polysaccharide-protein conjugates (together, the Composition Patents). The 013 Patent is the grandparent to the 844 Patent and the specification of both patents are near identical. The third patent includes claims to a siliconized container for stabilising polysaccharide-protein conjugates (the Container Patent).

Merck Sharp & Dohme Corp. and Merck Sharp & Dohme (Australia) Pty Ltd (together, MSD) sought revocation of the Composition Patents and Container Patent to ‘clear the way’ to launch its own 15-valent pneumococcal conjugate vaccine. Wyeth cross-claimed for infringement.

Notably, the applicable version of the Patents Act for the 013 Patent and the Container Patent is that before the RTB reforms and, for the 844 Patent, is that after the RTB reforms. Thus, the old law of fair basis applied to the former and the new law of support to the latter.

Infringement

MSD’s 15-valent vaccine uses the 13 polysaccharide-protein conjugates specified in claim 1 of the Composition Patents and two further polysaccharide-protein conjugates not specified in any of the claims of the Composition Patents.

MSD submitted that the correct reading of ‘comprising’ was to read the term to mean ‘consists of’. Wyeth, however, argued that the correct reading of ‘comprising’ was to read it to mean ‘including’. MSD accepted that if ‘comprising’ was construed to mean ‘including’, then its 15-valent vaccine would infringe each of the asserted claims of the Composition Patents.

Justice Burley found in favour of Wyeth’s construction and therefore, that MSD infringed the patents. Justice Burley considered there to be no ambiguity in the words ‘comprising’ and ‘comprises’, which were clearly defined in the specification in an inclusive sense unless context required otherwise, and in this case the context did not.

Invalidity

In regard to the Composition Patents, Justice Burley found that MSD had failed to prove invalidity on all grounds except one, with the 844 Patent lacking support. The 031 Patent, on the other hand, was found to be fairly based. We discuss this contrast in more detail below.

Justice Burley found the Container Patent to be invalid for lack of inventive step.

Fair basis

MSD submitted that the disclosure in the specification of the 013 Patent is restricted to a composition containing only the 13 serotypes disclosed and no more, and therefore there is no real and reasonably clear disclosure of an immunogenic composition with more than 13 serotypes.

Justice Burley considered MSD's submission to distract from the real enquiry, which he considered to be whether the claimed invention is disclosed in the specification, not whether the infringing article is disclosed in the specification, or whether a particular embodiment is disclosed. Burley J held that the specification did contain a real and reasonably clear disclosure of a multivalent composition as claimed in the 013 Patent (a fact which MSD did not dispute), and as such the claims were fairly based.

Support

MSD argued that the claims of the 844 Patent were not supported by matter disclosed in the specification because there was no description or disclosure of a pneumococcal conjugate vaccine other than one having the 13 identified serotypes.

Wyeth, in contrast, submitted that the specification provides clear support for the invention claimed and that it need not provide support for a composition comprising more than 13 serotypes, ‘because any composition comprising the 13 chosen serotypes conjugated to CRM₁₉₇ would nonetheless embody the technical contribution made by the invention with respect to those named serotypes’.

In considering this issue, Burley J referred to various secondary materials, including the Second Reading Speech and the Explanatory Memorandum to the RTB Bill. Justice Burley found that these materials make plain that the intention of the changes to the Patents Act was to bring Australian patent law into alignment with that of the United Kingdom and Europe and, therefore considered it appropriate to have regard to the law in those jurisdictions.

In particular, Burley J considered the law in the United Kingdom as it developed in respect of insufficiency and found that ‘Biogen insufficiency’ (as opposed to ‘classical insufficiency’) provides guidance on the approach the Federal Court should take with section 40(3). Biogen insufficiency is an objection to a claim that is broader than the technical contribution of the patent to the art, even when it can be performed.

Justice Burley then referred to CSR Building Products Ltd v United States Gypsum Company [2015] APO 72, citing the following summary adopted by the Patent Office from Aldous J in Schering Biotech Corp’s Application [1993] RPC 249 at 252-253, which states:

…to decide whether the claims are supported by the description it 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. Thereafter the court’s task is to decide whether the invention in the claims is supported by the description. I do not believe that the mere mention in the specification of features appearing in the claim will necessarily be a sufficient support. The word “support” means more than that and requires the description to be the base which can fairly entitle the patentee to a monopoly of the width claimed.

Justice Burley considered Aldous J’s approach, with some qualification, to encapsulate broadly the claim support requirement under section 40(3). This can be summarised as follows:

• ascertain the invention specified in the claims
• ascertain the invention described in the specification
• ascertain the technical contribution to the art
• compare the invention specified in the claims with the invention described in the specification
• where the claim is to a product, determine whether the technical contribution to the art disclosed by the specification justifies the breadth of the monopoly claimed^[1]
• the mere mention in the specification of features appearing in the claim will not necessarily be sufficient to support the breadth of the monopoly claimed.

Applying these steps, Burley J considered the technical contribution to the art, as described in the specification to be the identification of the six additional chosen serotypes to Prevnar 7, the choice of CRM₁₉₇ as the carrier protein and the provision to the skilled reader of a means to make the claimed 13-valent composition. Wyeth had established in its specification a new product which has a beneficial effect – the 13-valent immunogenic composition using the 13 chosen serotypes. However, the claims are to a monopoly that includes compositions that are not the product of the technical contribution to the art. His Honour concluded that the claims cover products that the specification does not enable and that the specification discloses no principle of general application beyond the 13-valent immunogenic composition using the 13 chosen serotypes. Justice Burley therefore held that the MSD has established that the claims of the 844 Patent are invalid for lack of support.

Justice Burley’s contrasting findings in respect of the lack of fair basis challenge to the 013 Patent and the lack of support challenge to the 844 Patent, makes clear that the bar has been raised for Australian patents and that broad claims to a monopoly exceeding the technical contribution disclosed in the specification will be invalid, despite the specification including textual reference to features of the invention claimed.

MSD appealed aspects of Burley J’s decision to the Full Court. The appeal was heard in late May 2021 and judgment is reserved.

What you need to know

• MSD v Wyeth is the first decision from the Federal Court providing detailed guidance on the claim support requirement of section 40(3) of the Patents Act and its application.

• This decision also highlights the difference in application of the claim support requirement in post-RTB section 40(3) and the fair basis requirement in the pre-RTB section 40(3).

• To meet the claim support requirement of section 40(3), the technical contribution to the art as disclosed in the specification must justify the breadth of the monopoly claimed. Patentees should be mindful of this when drafting claims to ensure that the language of the claims do not extend the monopoly claimed beyond the technical contribution disclosed in the specification.

• The claim support requirement in Australia is now aligned with the support requirements in the United Kingdom and Europe.

^{[1] This is based on Burley J’s consideration of the United Kingdom Supreme Court’s decision in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC, which held that the technical contribution to the art for a product claim is the product rather than the process by which the product is made or the inventive step.}