AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
• Justice Yates did not err in considering the specifi ‑ cation of the patent, nor in observing that particular passages of the specification supported his rea ‑ sons. The Full Court was satisfied that the relevant passages did not determine or drive the primary judge’s construction of claim 1, which would have been contrary to a key principle of claim construc ‑ tion. • A construction requiring both salts to be present, and separate, was consistent with not only the plain English meaning of the claim but with the meaning accepted by the expert witnesses, who had agreed that the composition of claim 1 includ ‑ ed two APIs and their pharmaceutically acceptable salts. A complex, on the other hand, is a singular entity that cannot be divided into its constituent parts, including its anions and cations in the solid. As a result, a salt of the complex would not fall within the scope of claim 1, as it represents one salt (not two distinct and separate salts). • Claim 1 is a product claim, which on its proper construction relates to the state of components and in the pharmaceutical composition prepared. Claim 1 is not a claim to the use of valsartan and sacubitril in the preparation of a pharmaceutical composition, or a claim to “something that hap ‑ pens” to the composition after administration. By upholding the primary judge’s construction, the Full Court concluded that VALTRESTO was not within the scope of claim 1, and Pharmacor had not, there ‑ fore, threatened infringement of the patent. Similarly, ENTRESTO was held not to be within the scope of claim 1, meaning that the PTE was wrongly granted. The High Court of Australia subsequently refused Novartis’s application for special leave to appeal. Sanofi v Amgen: Evolocumab (Repatha) Litigation Another case in 2025 that turned on claim construc ‑ tion was Sanofi v Amgen Inc (No 3) [2025] FCA 387, where Justice Nicholas dismissed Sanofi’s appeal to overturn the Patent Office’s decision allowing Amgen’s patent applications relating to evolocumab (Repa ‑ tha). This appeal was decided under provisions of the Patents Act 1990 (Cth) as they existed prior to the enactment of the Intellectual Property Laws Amend ‑ ment (Raising the Bar) Act 2012, meaning that a lower
standard applied to some validity grounds than those in the current version of the Patents Act. The case involved five patent applications relating to antibodies that inhibit PCSK9. Sanofi argued that Amgen’s claims failed to define the invention, lacked fair basis, were not fully described and lacked inven ‑ tive step. Central to these arguments was Sanofi’s assertion that the claims failed to include any struc ‑ tural features to define the antibodies of the invention. Sanofi argued that the patents failed to define the invention because the claims did not specify the ami ‑ no acid sequences of the antibodies, such that oth ‑ ers could not know in advance whether a MAb they proposed to make would fall within the claims. Justice Nicholas disagreed, finding that it was not necessary to define an invention so that others know whether a product would infringe before making it, and that defining the physical characteristics of the antibodies was impractical. His Honour held that describing func ‑ tional outcomes (limitations by result) was sufficient, even if experimentation is then required to assess whether a product falls within the claims. As to fair basis, Sanofi claimed that, by describing antibody function by amino acid residues in the speci ‑ fication, but by epitopes in the consistory clauses, the specification lacked fair basis. Justice Nicholas disagreed, stating that scientific proof of the relation ‑ ship between residues and epitopes included in the specification was sufficient. His Honour also held that a claim may be fairly based even where it omits some elements described in the specification, unless those omissions cause the claim to cover a fundamentally different invention. Justice Nicholas also found that the specification need not exemplify all antibodies fall ‑ ing within the claims and no impermissible extrapola ‑ tion was required by the person skilled in the art. With regards to inventive step, Justice Nicholas reject ‑ ed Sanofi’s expert evidence that developing a PCSK9 inhibiting antibody would be straightforward, owing to the expert’s opinion being “heavily influenced by hind ‑ sight”. His Honour determined that the skilled person would not have been naturally led to antibodies target ‑ ing the PCSK9-LDLR interaction, due to uncertainty
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