Newron Pharmaceuticals S.p.A v Arrotex Pharmaceuticals Pty Ltd (Application for Preliminary Discovery) [2025] FCA 1321
| Date of decision: | 18 February 2025 |
| Body: | Australian Patent Office |
| Adjudicator: | M. Umehara |
Background
Seqirus, Inc. opposed Translate Bio, Inc.’s patent application (AU2020202755) concerning the in vivo delivery of mRNA for augmenting proteins and enzymes in genetic diseases. The invention’s contribution lay in specific liposome-forming lipid combinations (and ratios) which encapsulate the mRNA to facilitate delivery into a cell. Whilst the specification exemplified liposomes with specific combinations and ratios of various lipids, the claims defined the combinations more broadly than what was exemplified.
Seqirus opposed the application on several grounds, including novelty, inventive step, utility, clarity, sufficiency and support. The fate of the opposition ultimately turned on the questions of sufficiency (clear enough and complete enough disclosure) and support.
Key Issues and Consideration
Novelty and Inventive Step
The novelty and inventive step debates were straightforward.
Seqirus raised a series of prior art documents on the question of novelty. The Delegate, however, was not persuaded that any of this prior art provided a clear and unmistakable direction for the claimed liposome composition having the required combination of lipid components, encapsulating within its interior mRNA having the required structure, and a size of less than about 150 nm.
The Delegate then considered inventive step based on the common general knowledge alone and taken together with a series of prior art documents. When considered in light of the common general knowledge alone, the Delegate stated that, at best, the evidence suggested that a person skilled in the art would have contemplated formulating mRNA with liposomes. However, it remained unanswered whether the liposome would have encapsulated or merely formed complexes with the mRNA, and what liposome formulation would have been used or what structural modifications may have been carried out on the mRNA. Ultimately, the Delegate found that, while each feature of the claims was individually known in the art, the combination of those features was not obvious. The Delegate also did not accept that a person skilled in the art faced with the problem of formulating mRNA for delivery, transfection and protein expression, and armed with any one of the prior art documents would arrive at the claimed invention as a matter of routine.
Utility
On the question of utility, both sides agreed that the specification showed that the scope of the claims included something that was capable of delivering mRNA to a cell and expressing the encoded protein in vivo. Seqirus argued that a therapeutic effect was also required (but not demonstrated). However, the Delegate, agreeing with Translate Bio, held that the ‘promise’ of the invention was delivery, transfection, and expression only, and that no therapeutic effect was required. Consequently, this ground of opposition failed.
Sufficiency (clear enough and complete enough)
This was the decisive issue (together with that of support).
Australia’s law on sufficiency requires the specification to disclose the claimed invention in a manner that is clear enough and complete enough to enable a skilled person to perform the invention across the full width of the claims without undue burden or further invention.
In the present case, the claims covered broad ranges of lipid ratios (e.g., 20–70% cationic lipid, 5%–90% non-cationic lipid (cholesterol and either DSPC or DOPE) and 1 %–15% PEG-modified lipids, but the specification only exemplified narrow ranges (e.g., 25–30% cationic lipid, ~40% cholesterol, 4% PEG-lipid). The question at hand, was whether Translate Bio’s contribution to the art extends to the general principle of encapsulating mRNA within the full breadth of the claimed liposomes and whether this has been sufficiently enabled. Experts on both sides agreed that small deviations in lipid content could collapse formulation stability of the essential liposome. In accepting the evidence presented, the Delegate concluded that each component in the liposome had structural and functional features, and that, if these components were not properly balanced, the successful formation of the liposome which was essential for delivery of the mRNA to the cell could be disrupted. Thus, the Delegate concluded that the specification did not provide a general principle for broader application beyond what was illustrated in the examples. As such the claims were said to be overly broad and not enabled across the full scope of the claims.
Support
For similar reasons, the broad monopoly claimed was not commensurate with the technical contribution. Translate Bio’s demonstrated contribution lay in identifying certain four-component lipid mixtures suitable for encapsulating and delivering mRNA, not a general principle covering all the broadly claimed ranges.
Outcome
The opposition succeeded on grounds of insufficiency and lack of support. All claims were found invalid in their current form. Translate Bio was given two months to propose amendments to overcome these deficiencies, but no amendments were proposed before the deadline. The application was formally refused on 12 May 2025, and costs were awarded to Seqirus.
Implications
Patent applicants should be careful to:
- describe the invention thoroughly in the specification and include multiple different embodiments and variations traversing the full scope of the claims;
- exercise caution when drafting claims which go beyond what is exemplified;
- avoid overly broad generalisations which are not supported by a clear and detailed description; and
- provide a clear and logical progression from the worked examples to the broader embodiments, including a detailed outline of any claimed principle of general application.
About Pearce IP
Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.
In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.
Helen Macpherson
Executive, Lawyer (Head of Litigation –Australia)
Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.
Donna Meredith
Associate, Patent & Trade Mark Attorney
Donna is a Patent and Trade Mark Attorney with more than 8 years’ post-qualification experience, and a background in biotechnology and biology.
Donna supports Australian and international clients in a range of life sciences fields including nanoparticles, pharmaceuticals, biopharmaceuticals, biotechnology, DNA sequencing, cell and gene therapy, CRISPR technologies, protein chemistry, formulation chemistry, chemical compounds, biofuels, plant varieties, ag-tech, food-tech and medical devices.