Sanofi v Amgen Inc. (No 3)

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FEDERAL COURT OF AUSTRALIA

Sanofi v Amgen Inc. (No 3) [2025] FCA 387

File number: NSD 876 of 2022
Judgment of: NICHOLAS J
Date of judgment: 23 April 2025
Catchwords:

PATENTS – appeal from decision of Delegate of Commissioner of Patents holding oppositions to patent applications unsuccessful – applications for patents including claims to isolated monoclonal antibodies that bind to epitopes on PCSK9 that include one or more specified amino acid residues and which block binding of PCSK9 to LDLR and claims to isolated monoclonal antibodies that bind to at least one specified amino acid on PCSK9 and which block binding of PCSK9 to LDLR – where opposition based on (inter alia) alleged failure to meet requirements of s 40 of the Patents Act 1990 (Cth) in the form it took before amendment by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) – whether claims would be clearly invalid if Applications proceeded to grant – whether claims fairly based on the matter described in the specifications – whether claims fail to define the invention – whether claims fail to describe the invention fully –whether claims to a single invention comprising a class of antibodies or a multiplicity of different inventions not fully described – whether claims for a manner of manufacture – whether claims entitled to priority date of 23 August 2007 based on provisional application filed on that date – whether claims involve an inventive step – whether notional skilled team would have been directly led to try to generate antibodies in the expectation that they may well block binding between PCSK9 and LDLR – consideration of state of the art at the priority date

PATENTS – whether claims to isolated monoclonal antibodies that compete with specified reference antibodies for binding to PCSK9 lack clarity by failing to specify a numerical value or otherwise failing to provide a workable standard with respect to such competition

Held: Appeal dismissed   
Legislation:

Evidence Act 1995 (Cth) s 57

Patents Act 1990 (Cth) ss 18(1)(a), 40, 60

Patents Act 1952 (Cth) s 40

Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)

Patents Act 1949 (UK) s 4(3)(c)

Patents Act 1977 (UK) s 14 

Cases cited:

Aktiebolaget Hässle v Alphapharm Pty Ltd (2002) 212 CLR 411

Albany Molecular Research Inc v Alphapharm Pty Ltd (2011) 90 IPR 457

AMP Inc v Utilux Pty Ltd (1971) 45 ALJR 123

Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1

Ariosa Diagnostics, Inc v Sequenom, Inc (2021) 391 ALR 473

Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents (2022) 274 CLR 115

AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324

Atlantis Corporation Pty Ltd v Schindler (1997) 39 IPR 29

Austal Ships Pty Ltd v Stena Rederi Aktiebolag (2005) 66 IPR 420

British Thomson-Houston Company Ld. v Corona Lamp Works Ld. (1922) 39 RPC 49

Burroughs Corp (Perkins’) Application [1974] RPC 147

CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260

Commissioner of Patents v…

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Details
Case
[2025] FCA 387
Decision Date

CaseChat Overview and Summary

Sanofi brought an appeal against the decision of the Delegate of the Commissioner of Patents, who held that oppositions to five patent applications by Amgen Inc. were unsuccessful. The patent applications claimed isolated monoclonal antibodies that bind to epitopes on PCSK9 that include one or more specified amino acid residues and block the binding of PCSK9 to LDLR. The oppositions were based on several grounds, including the alleged failure to meet the requirements of section 40 of the Patents Act 1990 (Cth). The court was required to decide whether the claims would be clearly invalid if the applications proceeded to grant, whether the claims fairly based on the matter described in the specifications, whether the claims failed to define the invention or failed to describe the invention fully, whether the claims to a single invention comprising a class of antibodies or a multiplicity of different inventions were not fully described, whether the claims were for a manner of manufacture, whether the claims were entitled to priority date based on a provisional application, whether the claims involved an inventive step, and whether the skilled team would have been directly led to try to generate antibodies in the expectation that they may well block binding between PCSK9 and LDLR.

The court dismissed the appeal and affirmed the decision of the Delegate. The court found that the Competition Claims were clear, as they required that the MAb competes with a reference antibody so as to prevent or inhibit the latter binding to PCSK9. The court found that competition is determined by an assay, and it does not matter what causes the competition. The court found that the claims required that the MAb competes with a reference antibody so as to prevent or inhibit the latter binding to PCSK9, and some MAbs will compete strongly, while others will compete less strongly. The court found that either way, on the proper construction of the Competition Claims, if there is any competition between the relevant MAb and the reference antibody, this requirement of the claim will be met.

The court held that the appeal be dismissed, and the decision of the Delegate be affirmed. The court held that the patent applications proceed to grant and that the time within which any application for leave to appeal must be made is extended to 21 May 2025. The court held that the appellant pay the respondent’s costs of the appeal. The court held that exhibits GAP-A7 and GAP-A8 be returned to the respondent’s solicitors.

Orders

Orders of the court

1. The appeal be dismissed.

2. The decision of the Delegate of the Commissioner of Patents made on 26 September 2022 be affirmed.

3. Each of Australian Patent Applications AU 2013203677, AU 2013203748, AU 2013203685, AU 2013203689 and AU 2013203751 proceed to grant.

4. The time within which any application for leave to appeal must be made is extended to 21 May 2025.

5. Order 3 is stayed subject to any further order:

(a) until 21 May 2025; or

(b) if any application for leave to appeal is filed by that date, until the determination of that application or the determination of any appeal if leave to appeal is granted.

6. The appellant pay the respondent’s costs of the appeal.

7. Exhibits GAP-A7 and GAP-A8 be returned to the respondent’s solicitors.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Background

Background to the litigation

Several expert conclaves were conducted, and four separate joint expert reports (“JERs”) were produced. Dr R Parker and Professor Horton produced a JER regarding knowledge as to the mechanism of action of PCSK9 reducing LDLR levels and approaches to the inhibition of PCSK9. Professors Petsko, Hudson, Lopez, M Parker and Mahler (“the Antibody and Crystallography Experts”) jointly produced a JER documenting the results of a conclave dealing with both antibody and crystallography related issues. Professors Mahler, Lopez and Hudson (“the Antibody Experts”) also produced a JER dealing with further antibody issues, and Professors M Parker, Petsko and Hudson (“the Crystallography Experts”) produced a JER dealing with crystallography issues. SCIENTIFIC BACKGROUND The parties have filed an “Agreed Primer”, which contains some scientific background relevant to the invention and the CS. The following background information has been extracted from the Agreed Primer, the CS, or evidence otherwise agreed by the relevant experts. Antibody structure An antibody (also known as an immunoglobulin) is a type of protein. Proteins are complex molecules made up of amino acids (often referred to as “amino acid residues” or “residues”). The sequence of amino acids is referred to as the “primary structure” of the protein. There are 20 naturally occurring amino acids, and in sequences they are represented by either a one-letter or a three-letter abbreviation. For example, aspartic acid is represented by the three-letter abbreviation “asp”, and the one-letter abbreviation “D”. A specific amino acid residue on a protein can be referred to using the abbreviated name and its position number in the protein. For example, D238 means the aspartic acid residue at position number 238 of the protein. Stretches of protein will typically arrange into distinct local conformations, referred to as “secondary structures”. The secondary structure of a protein is determined by the primary structure. The secondary structure of the protein will assemble into a 3D structure, the overall shape of which is referred to as the “tertiary structure” of the protein. Antibodies can be represented two dimensionally as having a Y shaped structure, comprised of heavy and light chains of amino acids, as shown below: In reality, antibodies have extremely complex three-dimensional (“3D”) shapes. The biological function of a protein is dependent on its 3D shape, because the shape of a protein affects how it interacts with other molecules. As depicted above, there are five different classes of antibodies in mammals (IgA, IgD, IgE, IgG and IgM). Each of the classes is made up of various sub-classes (or isotypes). For example, the IgG class has four subclasses (IgG1, IgG2, IgG3 and IgG4 antibodies). The light and heavy chains are made up of different regions, also referred to as “domains”. Each light chain consists of one variable domain, and one constant domain. Each heavy chain consists of one variable domain and three constant domains. The constant domains are referred to as such because the amino acid sequence in these domains is highly similar in all antibodies of the same class. The light and heavy chains are held together by disulfide (-S-S-) bonds, as shown below: The “constant end” of an antibody (in the antibody depicted above, the two heavy chain CH2-CH3 regions) is called the Fc region.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

Full text does not contain this section.

Ratio Decidendi

Legal Principle Established

CS [0231] refers (non-exhaustively) to the types of competition which might occur (e.g., the test ABP competes with the reference ABP to bind to the same epitope or an adjacent epitope “sufficiently proximal” so that steric hindrance occurs). Later, in CS [0565], reference is made to competition observed due to “conformational changes”, meaning that the ABPs need not compete for the same or adjacent epitopes, but the binding of the test ABP causes a conformational change (i.e., change in shape) to the antigen which impedes binding of the reference ABP. This is discussed in more detail below. CS [0229] also contemplates the concept of competition by means other than competition for the same or adjacent epitopes: The term "neutralizing antigen binding protein" or "neutralizing antibody" refers to an antigen binding protein or antibody, respectively, that binds to a ligand and prevents or reduces the biological effect of that ligand. This can be done, for example, by directly blocking a binding site on the ligand or by binding to the ligand and altering the ligand's ability to bind through indirect means (such as structural or energetic alterations in the ligand)…(Emphasis added) In my view, “competes” as used in the CS and the Competition Claims can refer to any scenario in which the test ABP prevents or inhibits the reference ABP from binding to the common antigen. While Sanofi’s closing written submissions suggested that Amgen attempted to confine “competes” to ABPs competing for the same epitope, Amgen’s submissions are agnostic to the mechanism of competition. It explained: Sanofi addresses the various causes of competition that are posited in the [CS]… For the purposes of construction, these matters are irrelevant. Competition is determined by an assay, and it does not matter what causes the competition. I agree with that interpretation of the CS and the Competition Claims. CS [0231] identifies various types of assays that may be used to determine whether the test ABP competes with a reference ABP, but it does not require that they compete to any particular degree. The range of percentages provided in the paragraph is not exhaustive, and is prefaced with the word “usually”. The claims require that the MAb competes with a reference antibody so as to prevent or inhibit the latter binding to PCSK9. Some MAbs will compete strongly, while others will compete less strongly. Either way, on what I regard as the proper construction of the Competition Claims, if there is any competition between the relevant MAb and the reference antibody, this requirement of the claim will be met. My construction of the Competition Claims broadly accords with Professor Hudson’s and Professor Lopez’s evidence of their understanding of the term. Although Professor Hudson did, at one point, suggest that for antibodies to be competing within the meaning of the specification there had to be “significant competition”, his response indicates that he was focussed on CS [0231] and was qualified by his clarification, “[a]nd I think you’re asking me is 45 per cent significant. Yes. If that was the question.” His responses to other questions during cross-examination support the view that he understood competition to be a binary concept, in particular his statement that “competition is competition” and “[i]t’s a sliding scale from 100 per cent down to zero”. His evidence, and Professor Lopez’s evidence, indicates that competition which was less than “complete” would still be understood to fall within the Competition Claims. Contrary to Sanofi’s submission, I do not accept that the Competition Claims lack clarity because they fail to impose a numerical threshold for the purpose of determining whether there is competition.