This article is part of a series that covers the proposed reforms to EU pharmaceutical...
In the recent decision in the Australian front of the Prevnar 13 patent litigation, Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477 (MSD v Wyeth), the Federal Court found that MSD infringed or threatened to infringe only one of the three patents asserted against it. While ultimately successful, two of Wyeth’s patents asserted were held invalid. The Court found that while it was content to construe one of these patents broadly, this broad construction led to one of the three asserted patents being found to be infringed but invalid for lack of “support”.
This is the first application by Australian Courts of the requirement that a patent’s claims must be supported by the disclosures in the specification, since its introduction by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)
The patents
The case concerned three patents relating to Wyeth’s Prevnar 13 vaccine for Streptococcus pneumoniae. Two of the patents both entitled “Multivalent pneumococcal polysaccharide-protein conjugate composition” were directed to vaccine compositions comprising 13 specified polysaccharide-protein conjugates (Composition Patents). The third patent was directed to a siliconized container for stabilising polysaccharide-protein conjugates (Container Patent).
Merck Sharp & Dohme (MSD) sought revocation of all three of the Wyeth patents on a number of grounds, including lack of support, novelty, inventive step and utility. Wyeth cross-claimed asserting that a vaccine MSD proposed to supply in Australia would infringe various claims of the Composition and Container Patents.
Ultimately it was found that the Container Patent and one of the Composition Patents (the 844 Patent) were invalid. The remaining Composition Patent (013 Patent) was found to be valid and infringed by MSD’s vaccine.
Construing “comprising” widely
A key issue in relation to whether MSD’s vaccine infringed the Composition Patents was the construction of the word “comprising”. Claim 1 of each of the Composition Patents claimed “A multivalent immunogenic composition, comprising…” polysaccharide-protein conjugates formed from capsular proteins from 13 specified Streptococcus pneumoniae serotypes attached to a specified carrier protein (CRM197). MSD’s vaccine contained the polysaccharide-protein conjugates from the 13 specified serotypes, plus an additional two which were not the subject of the claims. As a result, it was accepted that if “comprising” was read to mean “including” the MSD vaccine would necessarily infringe, whereas if it was read to mean “consists of” it would not.
The specification for each patent included the statement:
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.
In the context of this statement and the language of the claims, Justice Burley found that “comprising” in claim 1 was intended to be read in an inclusive sense, such that any composition which included the conjugates from the 13 serotypes would infringe, even if it also included additional conjugates not contemplated by the patents.
This broad construction brought the claim of lack of support into play (for the 844 Patent).
The relevant provision is Section 40(3) of the Patents Act 1990 (Cth) (Patents Act) – “The claim or claims must be clear and succinct and supported by matter disclosed in the specification.”
The earlier 013 Patent was considered under the old Section 40(3) and was upheld as fairly based and therefore valid.
Broad claim drafting leads to a lack of support
In relation to the 844 Patent, the Court found the inventive contribution disclosed in the specification was the selection of the 13 specific serotypes in combination with a specified carrier protein. On the basis of the disclosure in the specification, a skilled addressee could perform the preparation, purification and conjugation to the carrier protein of the chosen serotypes to produce a vaccine. There was no disclosure relating to the use of any further serotypes, nor was there a disclosure of a “principle of general application” as expert evidence was given that it was not possible to extrapolate the information in the patent to additional serotypes. As a result of the Court’s finding that “comprising” in claim 1 of the 844 Patent must be read inclusively, the scope of the claims extended to a potentially unlimited range of vaccines, provided they all included the specified serotypes. Accordingly the scope of claim 1 extended well beyond the technical contribution of the patent (which was limited to the specified 13 serotypes) and was invalid for lack of support.
Comparing this to the challenge made to the asserted claim of the 013 Patent – lack of fair basis- the court held that there was a real and reasonably clear disclosure of a multivalent composition comprising the 13 chosen serotypes conjugated to CRM197 together with a physiologically acceptable vehicle within that claim, and as such the claim was fairly based. The fact that infringement occurred if other material in addition to the 13 serotypes would infringe was not relevant to this consideration of fair basis.
In considering the “support” requirement, despite noting the differences between the UK and Australian legislative context, Justice Burley accepted the approach to the concept of “support” taken by courts in the UK was generally applicable to the support requirement in section 40(3) of the Patents Act. With this in mind, His Honour endorsed the approach taken by the Australian Patent Office in CSR Building Products Limited v United States Gypsum Company [2015] APO 72, (following Schering Biotech Corp’s Application [1993] RPC 249) stating:
a) to determine if the claims are supported by the description in the specification it is necessary to ascertain the invention specified in the claims and compare that with the invention described in the specification;
b) to do this is necessary to ascertain the technical contribution of the invention to the art;
c) the court then must decide whether the invention in the claims is supported by the specification;
d) the mere mention of a feature in the specification is not necessarily sufficient. The technical contribution to the art must justify the breadth of the monopoly claimed.
Development of a “support” requirement in Australia
Prior to the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (Raising the Bar Act) section 40(3) only required that claims be “fairly based on the matter described in the specification”. In practice this fair basis requirement represents a low barrier to patentability and findings of invalidity due to a lack of fair basis have historically been rare.
The Raising the Bar Act introduced a package of reforms designed to align Australia’s patent system more closely with other major jurisdictions. The Explanatory Memorandum to the Raising the Bar Bill noted that other key jurisdictions such as Europe and the UK include a support requirement, which requires:
a) There must be a basis in the description for each claim; and
b) 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 Raising the Bar Act amendments entered force on 15 April 2013; however, until now there has been little judicial consideration of the new support requirement and how its application will differ from that of fair basis. A decision of the Patent Office in CSR Building Products Limited v United States Gypsum Company [2015] APO 72 (CSR Building Products) provided some indication of how the support requirement could be applied. The only relevant Federal Court decision to date, Encompass Corp Pty Ltd v InfoTrack Pty Ltd [2018] FCA 421 gave no guidance on the applicable law of support in Australia, neither endorsing, nor rejecting the approach taken by the Patent Office.
Applicability of “European Support” in Australia
Acknowledging the lack of Australian judicial consideration of the support requirement, Justice Burley started by considering the policy context for the introduction of the Raising the Bar Act. His Honour noted Parliament’s goal of aligning the Australian patent system more closely with Europe and the UK, concluding from the reading speech and Explanatory Memorandum “there can be little doubt that Parliament considers that it is appropriate for the Court to have regard to the law in the European Union and the United Kingdom in considering the scope of the requirement for “support””.
His Honour then undertook a survey of support requirements in the Patents Act 1977 (UK) (UK Act) and the Convention on the Grant of European Patents, opened for signature 5 October 1973, 1065 UNTS 199 (EPC), noting in particular that the support requirement in section 14(5)(c) the UK Act is very similar to that in section 40(3) of the Patents Act.
In UK jurisprudence support (sometimes referred to as Biogen insufficiency) is considered as part of the requirement in section 14(3) for an enabling disclosure (referred to as classical insufficiency). This arises as a result of a “logical gap” in the drafting of the UK Act which means there is no direct route to revoke a patent that does not comply with the support requirements in sections 14(5)(c) and 5(2)(a).
Justice Burley noted that no such gap exists in relation to section 40(3) of the Patents Act. As a result, although the law of support in Australia is broadly aligned with that in Europe and the UK, not all of the language adopted by the UK courts is applicable. In particular it is necessary to separate discussion of classical insufficiency (which relates to disclosure) from Biogen insufficiency (which relates to support), as only the latter is relevant to the support requirement in section 40(3).
Courts in the UK have consistently commented that the requirement that a patent’s claims be supported by disclosures in the specification forms part of the essential bargain between society and the patentee. The reward of the patent monopoly should be commensurate to the contribution made to the art. Accordingly for a claim to be supported, it must correspond to the technical contribution of the patent to the art.
To determine if a claim is adequately supported it is necessary to first identify the technical contribution to the art disclosed by the specification. This is not necessarily the same as the inventive step. It is the ability of a person skilled in the art to make the claimed product.
The UK Supreme Court in Regeneron Pharmaceuticals Inc (Respondent) v Kymab Ltd (Applicant) [2020] UKSC 27 (Regeneron) made it clear that a claim will lack support if the disclosure in the specification is not sufficient to allow a skilled addressee to make substantially all the embodiments which fall within the scope of the claims. However, it is not necessary to demonstrate that every embodiment has in fact been tried and tested. The technical contribution in some cases may be a “principle of general application”, which may support correspondingly broad claims.
Although Justice Burley did not explicitly adopt all the principles expressed in Regeneron, it is from the decision in this case that many of the underlying concepts and the general approach taken is highly persuasive in the Australian context.
Key takeaways
- The Federal Court has provided the first guidance on how the “support” requirement in section 40(3) should be applied and how it differs from the previous “fair basis” requirement.
- The support requirement in Australia broadly matches those articulate by courts in the UK and Europe.
- For a claim to be adequately supported, it must not extend beyond the technical contribution disclosed in the specification. This does not require that everything falling within the scope of the claim must be enabled, but the scope of the claim must be justified by the disclosure.
- Given the significantly more restrictive nature of the post Raising the Bar Act support requirement, patentee’s must now pay careful attention to balancing the breadth of the language of the claims with the disclosures in the specification to avoid invalidity.
