Biosimilars Deals 2021

Shanghai Lytone Biochemicals, Ltd. v Fresh Inset S.A. [2026] APO 10 (19 March 2026)

Introduction

This decision concerns an opposition to the grant of Australian patent application no. 2019258844, filed by Fresh Inset S.A. (the Applicant) and opposed by Shanghai Lytone Biochemicals, Ltd. (the Opponent).  The application relates to compositions and articles comprising complexes of 1-methylcyclopropene (1-MCP) and alpha-cyclodextrin (α-CD), which are used to prolong the shelf life of plant products by inhibiting the effects of ethylene.  The matter was determined on the papers (absent any filed evidence) by Delegate M. Umehara, with the opposition ultimately failing on the sole ground raised.

Background

The invention addresses a well-recognised challenge in post-harvest plant science, namely, controlling ethylene exposure to delay the maturation, browning, and aging of fruit and vegetables.  The specification describes a composition combining a 1-MCP/α-CD complex with a polymer binder — specifically polyvinylpyrrolidone (PVP) or its copolymers — in a defined weight ratio, which releases 1-MCP gas upon exposure to moisture in a controlled manner.  The composition is capable of being formed into adhesive labels, sticks, or composite films for use in packaging.

Claim 1 (the only independent claim) reads:

A composition comprising:
a) a complex of 1-methylcyclopropene and α-cyclodextrin and
b) a polymer binder selected from the group consisting of polyvinylpyrrolidone, copolymers thereof, and combinations thereof,
wherein the ratio of polymer binder to complex on a weight to weight basis ranges from about 1:2 to about 4:1, and
wherein the composition is capable of releasing the 1-methylcyclopropene in the form of a gas when exposed to moisture, the composition having a release profile characterized in that when exposed at room temperature in a sealed vessel to conditions of 85% relative humidity, the composition releases substantially no 1-methylcyclopropene for a first time period of at least 1 hour after exposure; and releases 1-methylcyclopropene for a second time period of at least 5 hours that starts after the first time period.

The application was accepted in January 2025.  The Opponent filed a notice of opposition on 30 April 2025, with a statement of grounds and particulars (SGP) filed on 30 July 2025.  Notably, the Opponent filed no evidence in support of its opposition and later indicated it did not wish to be heard, though it declined to formally withdraw the opposition.  The Applicant also filed no evidence but lodged written submissions on 26 February 2026.  The Delegate observed that, where an opponent loses interest in prosecuting an opposition, the appropriate course is ordinarily to withdraw the opposition, which would then prompt consideration of re-examination before grant.

Key Issues

The sole ground of opposition raised was lack of inventive step.  The Opponent argued that claims 1 to 17 would have been obvious to a person skilled in the art in light of: (1) common general knowledge; (2) WO 2012/134539 A1 (D1), relating to cyclodextrin complexes with controlled moisture; (3) US 20170150716 A1 (D2), relating to a polymer laminate for inhibiting plant ethylene response; or any combination of these.

Consideration

The Delegate noted that the burden of proof (on the balance of probabilities) rests with the Opponent.  Applying principles from Hood v Bush Pharmacy Pty Ltd [2020] FCA 1686, the Delegate confirmed that obviousness requires more than identifying that something was “worthwhile to try” — there must be a reasonable expectation of success and a direct path from the prior art to the claimed invention.

On common general knowledge alone, the Delegate accepted that the general use of 1-MCP and its complexation with α-CD were known in the art, but found that the SGP provided no reasoning as to how this knowledge would lead a skilled person to the specific combination of PVP binder, the claimed ratio range, and the particular release profile claimed.  The inventive step ground therefore failed based on common general knowledge alone.

Regarding D2, the Delegate observed that the worked examples in D2 already disclosed a PVP-to-1-MCP/α-CD complex ratio of approximately 3:1 — falling squarely within the claimed range (of “from about 1:2 to about 4:1”).  However, when tested under conditions of 89.9% humidity at 25°C, D2’s composition released 69% of its 1-MCP within the first hour and completed release by five hours.  This directly contrasts with the claimed profile, which requires substantially no release in the first hour.  The Delegate noted that it is apparent that not all compositions having these components will achieve the claimed release rate.  The Delegate further noted that the worked examples in the specification provide guidance for a person skilled in the art to prepare compositions having the claimed 1-MCP release profile and comprising 1-MCP/α-CD complex and PVP or copolymers thereof with additional carrier excipients as well.  The Delegate concluded that since no expert evidence was provided by the Opponent at all, the Opponent had failed to sufficiently convince the Delegate how a skilled person would, through routine adjustment of the polymer-complex ratio or other additives, arrive at a composition achieving the claimed delayed-release profile — particularly given that D2’s composition, already within the claimed ratio range, failed to achieve it.  As a result, claims 1-17 did not lack an inventive step in light of D2, alone or in combination with the provided common general knowledge.

On D1, the Delegate found that there would be no motivation for a skilled person to substitute the curable monomer required in D1 with PVP and/or copolymers thereof as disclosed in D2.  The adhesive referenced in D1 served an entirely different function to the polymer binder in claim 1.  The Opponent’s suggestion that the claimed release profile could be achieved merely by controlling atmospheric moisture levels was dismissed as not equivalent to a composition having a given release profile when exposed to conditions of 85% relative humidity at room temperature in a sealed vessel.  The Delegate noted that the Opponent did not provide any evidence to show how this may be conceived by a person skilled in the art or how it may be achieved without invention. As a result, claims 1-17 did not lack inventive step in light of D1, alone or in combination with the provided common general knowledge and/or D2.

Outcome

The opposition failed.  The Opponent did not establish that the subject matter of claims 1 – 17 lacked inventive step in light of common general knowledge, D1, D2, or any combination thereof.  Costs were awarded against the Opponent.

Implications

This decision offers several practical insights.  First, it underscores the critical importance of filing evidence in patent oppositions — an opponent who fails to support its grounds with expert evidence faces a near-insurmountable burden, particularly on the inherently fact-intensive question of inventive step.  Second, the decision illustrates that where prior art discloses compositions with overlapping parameters yet fails to achieve the claimed functional result, a functional limitation in a claim can carry genuine patentable weight.  The release profile requirement in claim 1 proved decisive.  Third, the Delegate’s comments about the appropriate conduct of opponents who lose interest in proceedings serve as a practical reminder that withdrawal, rather than passive non-participation, is the proper course — and may avoid adverse cost consequences.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

Provectus Algae Pty Ltd v v2food Pty Ltd [2026] APO 1 (23 January 2026) and v2food Pty Ltd v Provectus Algae Pty Ltd [2026] FCA 436

Introduction

These decisions concern Australian Patent Application No. 2021247417 (“Food Colouring Agents”), in the name of v2food Pty Ltd.  The application relates to the use of phycoerythrin – a protein obtainable from algae including Porphyridium and Rhodomonas species – as a colouring agent in meat mimetic (plant-based meat) products, capable of mimicking the colour change that occurs when animal meat is cooked.  The matter proceeded first before a delegate of the Commissioner of Patents at the Australian Patent Office (APO), and then on appeal to the Federal Court of Australia before Justice Perram.

Background

v2food’s patent application describes the application of phycoerythrin to impart a pink or red colour to meat mimetic products that visually changes upon cooking to an internal temperature of approximately 50–95°C, thereby closely replicating the appearance of cooking real meat.  Existing plant-based colouring agents such as beetroot extract are noted to lack this heat-responsive colour-change property.

The application was accepted in August 2023 and Provectus Algae Pty Ltd filed a notice of opposition in November 2023, raising multiple grounds of opposition including lack of novelty, inventive step, clarity, best method, sufficiency and support.  The opposition was heard by Delegate Felix White in Melbourne in May 2025 (Provectus Algae Pty Ltd v v2food Pty Ltd [2026] APO 1).

Key Issues

At the APO, the Delegate narrowed the live issues to novelty, inventive step, clarity, best method, sufficiency, and support.  Priority was also contested, as its validity affected which prior art documents could be relied upon.

The Delegate found that the priority date of 31 March 2020 was validly claimed, which limited the available prior art.  On novelty, the Delegate found that none of the cited documents contained a clear and unmistakeable direction to use phycoerythrin derived specifically from Porphyridium or Rhodomonas in meat mimetics, and so the opposition on the novelty ground failed.  All other grounds of opposition also failed, except inventive step.

On inventive step, the critical question became whether a skilled worker in the field of meat mimetics, equipped with common general knowledge and either of two single prior art documents – D17 (concerning Rhodomonas salina phycoerythrin) or D18 (concerning, relevantly, Porphyridium cruentum phycoerythrin) – would have been led, as a matter of routine, to use those proteins to achieve a cooking-dependent colour change in meat mimetics.  The decision is notable because the Delegate treated D17 and D18 as single pieces of prior art information under post-Raising the Bar s 7(3)(a), even though they were outside the skilled worker’s technical field.  Each document disclosed that the relevant phycoerythrins lose absorption/emission in the 500-600 nm region at temperatures of approximately 60-80°C in aqueous/in vitro conditions.

Considerations

Person Skilled in the Art

A central issue in the APO decision was identifying the appropriate “person skilled in the art” — the hypothetical, non-inventive expert by whose knowledge novelty and inventive step are assessed.  The Delegate made an important distinction between the skilled person for construing the specification (relevant to sufficiency and support) and the skilled person for assessing novelty and inventive step.  Because the invention married two different technical fields — algal biochemistry and food technology — these could be different people.

From this, the Delegate drew a deliberate distinction between two different skilled person constructs:

• For construing the specification and assessing sufficiency and support, the skilled addressee would need expertise in both algal protein biochemistry and food technology, because understanding the full disclosure of the specification required knowledge of both fields.
• For assessing novelty and inventive step, the relevant skilled worker was confined to the field of food technology, specifically meat mimetics, because that is the field to which the invention is directed — the problem being solved (replicating the colour change of cooking meat) is a food technology problem, not an algal science problem.

This distinction limited the common general knowledge available for the inventive step analysis to what a meat mimetics specialist would know; it did not itself import algal biology or marine science as common general knowledge.  However, the Delegate also held that, under the post-Raising the Bar form of s 7(3)(a), a single prior art document may be considered with common general knowledge even if the document is outside the skilled worker’s technical field.  The distinction also shaped the weight given to the expert evidence, with the algal biotechnologists’ evidence carrying less weight on inventive step, and the applicant’s meat mimetics expert, Dr Ha, treated as the best placed witness for that purpose.

The Delegate accepted that the problem of providing a meat analogue with a realistic cooking-related colour change was part of common general knowledge in the field, referencing a 2019 review article (D39) on commercially available meat analogue products.

Inventive Step

The core of the lack of inventive step argument pressed by the Opponent at the oral hearing was that the choice of Porphyridium or Rhodomonas phycoerythrin to provide a colour change to meat mimetics was an obvious solution to the problem of providing a meat mimetic with a suitable indicator for colour change upon cooking, based on the known absorbance and denaturation properties of these proteins.  In essence, the Opponent asserted that the route taken by the inventors, as disclosed in the specification, was an obvious one.

The Delegate found that it was not objectively surprising that phycoerythrin would work as a colouring agent in meat mimetics.  The Delegate noted that the problem was to find a red pigment that loses colour at cooking temperatures. Prior art documents D17 and D18 showed that phycoerythrin from Rhodomonas and Porphyridium had that property, losing colour in the relevant temperature range. Although those experiments were performed in solution, the Delegate considered that sufficiently close to the wet or semi-solid environment of a meat mimetic matrix.

The Delegate was not persuaded by v2food’s arguments that the underlying mechanism was different from meat — thermal denaturation rather than oxidation — because the skilled person was a food technologist looking for colour-change performance, not a scientist focused on theoretical mechanisms.  There was also no persuasive evidence that the meat mimetic matrix would prevent phycoerythrin from denaturing and changing colour.

The Delegate gave less weight to the views of the algal biotechnology experts because the relevant skilled person for inventive step was a meat mimetics/food technology specialist, not an algal biotechnologist.

Accordingly, the Delegate held that the skilled worker would have had a reasonable expectation that phycoerythrin from Porphyridium or Rhodomonas “may well” work to provide cooking-related colour change in meat mimetics.  The need for further validation did not avoid obviousness, because Australian inventive step law does not require certainty of success — only an expectation that the proposed approach may well succeed.

The Delegate concluded that all 24 claims lacked an inventive step in light of common general knowledge combined with either D17 or D18 as single prior art documents.  A key aspect of the APO decision was the Delegate’s willingness to rely on single technical papers outside the skilled worker’s field as s 7(3)(a) information.

Clarity

The opponent argued that claim 1 contained internal inconsistencies because not all Porphyridium species produce red phycoerythrin and not all phycoerythrins change colour across the full 50–95°C range claimed.  The Delegate rejected this argument, finding that the claim was self-limiting — phycoerythrins that did not meet the stated performance criteria (colour change within the specified temperature range) simply fell outside the claim’s scope, and a skilled worker could readily determine whether any given phycoerythrin satisfied those criteria.

Best Method

The opponent argued that v2food had withheld a better method of formulating phycoerythrin into meat mimetics than that disclosed in the specification, pointing to an internal email describing early experiments with Porphyridium purpureum phycoerythrin.  The Delegate found that the language of the email — referring to having “had a play” and results “taking it in the right direction” — clearly indicated these were preliminary experiments rather than a superior undisclosed method, and the specification’s examples were broadly consistent with those experiments in any event.

Sufficiency

The opponent contended that the wide range of variables in the claims — different phycoerythrin types, different Porphyridium and Rhodomonas species, and different meat mimetic matrices — combined with expert evidence that validation would be needed for each product, indicated an undue burden on the skilled worker.  The Delegate applied the Jusand approach of only interrogating variables “relevant” to the technical contribution, finding that the core technical contribution was simply the ability to achieve a cooking-dependent colour change, and that variability in product formulation or phycoerythrin type did not undermine that contribution across the claim scope.

Support

The opponent’s submissions on support were brief, essentially arguing that because the claims lacked novelty there was no technical contribution and therefore the claims could not correspond to any technical contribution.  Having found that the application did have a genuine technical contribution — the use of suitable phycoerythrins from Porphyridium and/or Rhodomonas to confer a cooking-dependent colour change to meat mimetics — and that this was properly reflected in the claims, the Delegate found the support ground was not made out.

Conclusion

In the APO decision, the opposition succeeded because all claims were found to lack an inventive step.  The Delegate invited submissions on whether v2food should be given an opportunity to amend and made no award of costs.  V2food appealed the decision.

The Appeal

On appeal to the Federal Court (v2food Pty Ltd v Provectus Algae Pty Ltd [2026] FCA 436), the outcome changed significantly.  Provectus filed a submitting notice in March 2026, but had filed no evidence in the Federal Court proceedings.  The Commissioner similarly declined to take an active role in the appeal proceedings.  As a result, there was no evidentiary material before the Court capable of supporting any ground of opposition.

Perram J applied well-established principles confirming that an appeal under section 60(4) proceeds as a hearing de novo, with the opponent bearing the onus of establishing grounds of opposition.  Where, as was the case here, the opponent has filed no evidence and taken no active part, there is no basis on which the opposition can be upheld.  His Honour distinguished CSIRO v Urrbrae Foods [2025] FCA 1591, where Beach J had invited the patent applicant to file additional evidence because the delegate’s finding of invalidity had rested on a gap in the applicant’s own evidence rather than the opponent’s evidence.  In this matter, the invalidity finding at the APO arose from Provectus’s evidence on inventive step – evidence that was absent before the Court on appeal.  Perram J therefore did not need to, and did not, engage with v2food’s substantive criticisms of the Delegate’s inventive step reasoning.

Outcome

The Federal Court allowed the appeal, set aside the Delegate’s decision of 23 January 2026, dismissed Provectus’s opposition, and ordered that the patent application proceed to grant.  No order as to costs was made, consistent with the orders proposed by v2food.

Implications

The Federal Court decision reinforces an important principle in Australian patent opposition appeal practice, namely, where an opponent files a submitting notice and adduces no evidence on appeal, that will generally be fatal to the opposition if the delegate’s adverse finding depended on the opponent’s evidence: the opponent bears the onus and cannot discharge it without evidence.

For patentees and opponents in the food technology and alternative protein sectors, the outcome of these decisions is commercially significant but should be framed carefully.  v2food’s application proceeded to grant, but the Federal Court outcome was the result of a procedural decision rather than a substantive review of the Delegate’s inventive step analysis.  Perram J also confirmed that grant does not foreclose future validity challenges, leaving open the possibility of revocation proceedings.  The APO decision nevertheless remains useful because it illustrates how single scientific papers outside a skilled worker’s field may be used as s 7(3)(a) prior art in a post-Raising the Bar inventive step analysis.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.