Inclusive Patent Claims: Have They Lost Support post-Raising the Bar?

What you need to know

• Late last year, the Australian Federal Court invalidated a patent claim to a product "comprising" (or including) certain features, because the breadth of the claim was not supported by matter disclosed in the patent specification. 
• The decision was the first detailed judicial consideration of the post-"Raising the Bar" claim support requirement in Australia.  
• Justice Burley held that the claim in question exceeded the patentee's technical contribution to the art disclosed by the specification.  

What you need to do

• Patentees should carefully consider the support requirement when using inclusive language in patent claims.  On the other hand, the support requirement may assist those wishing to challenge patent claims containing inclusive language.
• The parties have appealed Justice Burley's decision to the Full Federal Court, so stay tuned for further developments on this issue.  

Patent claims are often drafted using inclusive language, using words like "comprises" and "comprising".  Such language is intended to stake the patentee's claim broadly and capture all products and processes that include the claimed invention, even if the alleged infringer adds further elements to the product or process.  However, the decision of Justice Burley in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477 illustrates the perils of using inclusive language in a patent claim.  

The decision is part of a long-running dispute between Pfizer and Merck, Sharp & Dohme (MSD) concerning vaccines against Streptococcus pneumoniae, a bacterial pathogen that causes a number of life-threatening illnesses including meningitis and pneumonia.  Pfizer sued MSD for infringement of three patents in the name of Wyeth LLC (part of the Pfizer group), and MSD cross-claimed that the patents were invalid.  This article focuses primarily on one of the three patents, described in the decision as the "844 patent".  

Pfizer's 844 patent

Claim 1 of Pfizer's 844 patent claimed a multivalent immunogenic composition "comprising" polysaccharide-protein conjugates, wherein each of the conjugates "comprises" a capsular polysaccharide of one of 13 specific serotypes (or variants) of Streptococcus pneumoniae conjugated to a carrier protein.  Capsular polysaccharides are antigens that, when conjugated to the carrier protein, provoke an immune response.  

The specification of Pfizer's 844 patent identified the 13 chosen serotypes by reference to 7 serotypes from Pfizer's previous generation vaccine (called Prevnar 7), plus an additional 6 serotypes selected by Pfizer to improve the immune response.  The specification described how to make conjugates with each of the 13 chosen serotypes, but no others.

In the standard way, the specification stated that the words "comprising" and "comprised" should be "understood to imply the inclusion of a stated integer … but not the exclusion of any other integer".  Justice Burley therefore held that "comprising" in claim 1 means "including", and that any multivalent immunogenic composition including each of the 13 chosen serotypes infringes claim 1.  MSD's product, a 15-valent vaccine containing conjugates with each of the 13 chosen serotypes plus 2 more, therefore infringed claim 1. 

The support requirement 

MSD argued that claim 1 of Pfizer's 844 patent did not meet the requirement under section 40(3) of the Patents Act 1990 (Cth) that the claims be "supported by matter disclosed in the specification".  Justice Burley's decision is the first detailed judicial consideration of this requirement, which was introduced by the 2012 "Raising the Bar" reforms.  The support requirement replaced the previous section 40(3) requirement that the claims be fairly based on matter described in the specification.  

Justice Burley considered that Parliament's intention when introducing the support requirement was to align Australian patent law with overseas jurisdictions including the UK and Europe.  Justice Burley provided an overview of the case law on support in the UK.  His Honour elegantly summarised how support and sufficiency (clear and complete enough disclosure under section 40(2)(a)) are part of a single concept of "enabling disclosure" under UK patent law.  Both concern the "essential patent bargain" that the scope of the patentee's monopoly must correspond with the patentee's technical contribution to the art disclosed in the specification. 

Application to this case

Applying the UK authorities, Justice Burley held that Pfizer's technical contribution described in the 844 patent specification was the identification of the 6 serotypes additional to the 7 previously included in Pfizer's Prevnar 7 vaccine, the choice of protein carrier, and the provision of a means by which the claimed 13-valent composition may be made.  

It was clear from the specification and expert evidence that the information in the 844 patent could not be extrapolated to include additional serotypes, and that adding serotypes to the 13-valent composition was "a complex and difficult process".

Justice Burley therefore held that the inclusively-worded claim 1 did not correspond with Pfizer's technical contribution to the art.  Claim 1 included within its scope products that the specification did not enable.  Claim 1 and its dependent claims did not meet the support requirement.  

Another patent relied upon by Pfizer in the case, the 013 patent, was from the same patent family and in near-identical terms to the 844 patent, but fell under the pre-"Raising the Bar" Patents Act.  Justice Burley held that the 013 patent met the fair basis requirement under the old law.  The different outcome in respect of the two patents demonstrates how the introduction of the support requirement has "raised the bar" for patent claims.   

Leaving the door open for inclusive patent claims

Justice Burley's decision means that patentees should consider the support requirement carefully when using words such as "including" or "comprising" in a patent claim.  Justice Burley made it clear that his decision does not mean that every patent claim using inclusive language is liable to revocation for lack of support.  Each case will depend on the particular language used by the claim and the disclosure of the specification.

Justice Burley also acknowledged the UK authorities that if a patent specification contains a principle of general application, then that may support claims that are drafted in correspondingly general terms.  Justice Burley referred to the principles set out by UK Supreme Court in Regeneron Pharmaceuticals Inc (Respondent) v Kymab Ltd (Applicant) [2020] UKSC 27, including that patentees may rely upon a principle of general application if it appears reasonably likely to enable the whole range of products within the scope of the claim to be made. 

However, Justice Burley rejected Pfizer's argument that the specification of the 844 patent disclosed a principle of general application.  His Honour considered that Pfizer's contribution to the art was no more than the identification, enablement and conjugation of the 13 chosen serotypes to the carrier protein.

Disposition and appeal

Although the relevant claims of Pfizer's 844 patent were found to be invalid, Pfizer succeeded in relation to one of the other patents asserted against MSD.  In November 2020, Justice Burley made final orders restraining MSD from exploiting its 15-valent vaccine while also revoking the relevant claims of the 844 patent.  In December 2020 Pfizer filed an appeal to the Full Federal Court and in January 2021 MSD filed a cross-appeal.  Justice Burley's decision is therefore unlikely to be the final word on this issue.  

Authors: Stuart D'Aloisio, Partner; and Melanie Kitchin, Senior Associate.