This is an informal case summary prepared for the purposes of facilitating exchange during the 2025 WIPO IP Judges Forum.
Session 2: Pharmaceutical Patents
Federal Court of Australia [2020]: Merck Sharp & Dohme Corporation v Wyeth LLC (No 3), [2020] FCA 1477; 155 IPR 1
Date of judgment: October 14, 2020
Issuing authority: Federal Court of Australia
Level of the issuing authority: First Instance
Type of procedure: Judicial (Administrative)
Subject matter: Patents (inventions)
Plaintiff: Merck Sharp & Dohme Corporation and Merck Sharp & Dohme (Australia) Pty Ltd Defendant: Wyeth LLC
Keywords: Validity, Lack of support, Technical contribution to the art, UK and EU Law, Lack of support established for one composition patent
Basic facts: This case concerned the infringement and validity of three patents. Of present relevance is one patent entitled “Multivalent pneumococcal polysaccharide-protein conjugate composition”.
Claim 1 provided:
(1) A multivalent immunogenic composition, comprising (2) polysaccharide-protein conjugates together with a physiologically acceptable vehicle, (3) 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, (4) wherein the carrier protein is CRM197 (5) for use as a vaccine to protect or treat a human susceptible to pneumococcal infection.
It will be seen that feature (3) of the claim identifies 13 different serotypes (integer (3)). This was the important integer for the case. The defendant’s vaccine contained 15 different serotypes, including the 13 serotypes identified in feature (3).
The case concerned the infringement of this (and other) claims and also a substantial challenge to the validity of the claims on the basis of lack of inventive step, lack of novelty, lack of patentable subject matter.
Held: The claim in suit was invalid for lack of support. That was because the specification contained no disclosure of any immunogenic composition that included anything other than the 13 serotypes identified in the claim. The earlier finding that the claim was not obvious was because of the finding that it was beyond the skill of the ordinary uninventive person in the art to have arrived at the 13 serotype composition. However, the claim was for any composition containing those 13 serotypes and any other serotypes that were added to it. The specification contained no teaching as to how the person skilled in the art would add serotypes beyond the 13 identified.
Accordingly, the claims lacked support.
Relevant holdings in relation to pharmaceutical patents:
Claim Construction:
In order to establish infringement, the patentee argued that the claim was not confined to a composition that was limited only to the 13 serotypes listed. It argued that a composition that included more than 13 serotypes would infringe the claim because the specification defined the word “comprises” as meaning “includes”. The Court accepted that argument. The consequence was that the defendant’s 15-valent vaccine fell within the scope of the claims. Subject to the question of validity, the claim was infringed.
Lack of Inventive Step:
The defendant argued that it was not inventive for the patentee to develop a 13-valent immunogenic composition because the more serotypes included in the vaccine, the broader the spectrum of protection that patients would receive. Those skilled in the art had previously developed 7-serotype vaccines of the type claimed.
The patentee contended that it was inventive to identify potential serotypes, select appropriate ones and develop a composition that could incorporate them. On the basis of the evidence advanced, that argument was accepted: the defendant failed to establish that the composition claimed was obvious.
Lack of Support:
This case involved the first application in Australia of a new requirement for internal validity of a claim based on “lack of support” in s 40(3) of the Patents Act 1990 (Aus). Previously, claims were assessed on whether or not the claims were “fairly based” which is a test requiring that there simply be a “real and reasonably clear disclosure” in the body of the specification of something that fell within the claims. The test did not require that the disclosure of the specification provide disclosure equivalent to the breadth of the claims.
In bringing the amended s 40(3) into effect, the Australian Parliament noted that it wished to raise the requirements for the validity of patents and bring them into line with the requirements of Australia’s trading partners, particularly Europe and the United Kingdom; Second Reading Speech and the Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Aus).
The new statutory requirement under s 40(3) is:
The claim or claims must be clear and succinct and supported by matter disclosed in the specification.
This requirement is similar to Article 84 of the Convention on the Grant of European Patents (“clear and concise and supported by the description”) and s 14(5)(c) of the Patents Act 1977 (UK) (“The claim or claims shall…be supported by the description”).
In practice, the Australian Courts have drawn on the UK law as a starting point for the development of its requirement of support. In its simplest form, the question posed is whether or not the specification discloses the invention claimed clearly and completely enough for the person skilled in the art to perform it across the full scope of the claims. Another way that the Courts have considered its application is whether or not the claims are no broader than the technical contribution to the art conferred by the disclosure in the specification.
Relevant legislation: s 40(3) of the Patents Act 1990 (Australia), Article 84 of the Convention on the Grant of European Patents, s 14(5)(c) of the Patents Act 1977 (UK)