Biosimilars Deals 2021

Perfect Day, Inc. v Commissioner of Patents [2025] FCA 270

Introduction

Earlier this year, the Federal Court of Australia handed down judgment in proceedings between Perfect Day, Inc. and the Commissioner of Patents, in an appeal from an opposition decision concerning a patent application for dairy substitute food compositions.  Justice Rofe dismissed Perfect Day’s appeal and refused to allow the application to proceed to grant, finding that the claims failed to meet the heightened support and sufficiency requirements introduced under the ‘Raising the Bar’ amendments.

Background

Perfect Day was the applicant for patent AU2015305271 (the Application),  entitled ‘Compositions comprising a casein and methods of producing the same’.  The Application was directed to dairy substitutes that aim to replicate the characteristics of mammalian milk, based on the discovery that only a subset of components in the milk can be used to generate a composition that has similar characteristics, such as flavour, appearance, nutritional value, aroma, and mouthfeel.  The Application described various milk proteins, though most relevant to the Application were the casein proteins, α-lactalbumin (ALA) and β-lactoglobulin (BLG) proteins and their recombinant equivalents, rALA and rBLG, respectively.

The Application claimed an earliest priority date of 21 August 2014, and was assessed under the Patents Act 1990 following the ‘Raising the Bar’ amendments which introduced heightened requirements for support and sufficiency.  Fonterra Co-operative Group Ltd successfully opposed the Application before a delegate of the Commissioner of Patents in Fonterra Co-operative Group Ltd v Perfect Day, Inc. [2022] APO 59, delivered on 23 August 2022.  The Delegate found that the specification was directed to dairy substitute foods comprising casein proteins, not compositions with only rALA and rBLG as claimed, and so concluded that all claims lacked support and that the specification failed to disclose the invention clearly and completely enough for performance by a person skilled in the art.

Perfect Day appealed to the Federal Court in September 2022, and also filed two interlocutory applications to amend the Application, seeking to narrow claim 1 to a food composition suitable as a dairy substitute comprising rALA and rBLG and not casein.  Fonterra later withdrew as the respondent, with the Commissioner of Patents becoming a party to the proceeding pursuant to r 34.23(2) of the Federal Court Rules.

Key Issues

The appeal centred on two key requirements under the Patents Act 1990:

1. Section 40(3): Whether the claims were supported by the specification; and
2. Section 40(2)(a): Whether the specification disclosed the invention clearly enough and completely enough for performance by a person skilled in the art.

The Commissioner challenged claim 1 on both grounds.  Claim 1 read as follows:

A food composition, other than a cottage cheese or a hard cheese, that is suitable as a dairy substitute, said food composition comprising:

(i)    a recombinant β-lactoglobulin protein and a recombinant α-lactalbumin protein, wherein one or both of the recombinant β-lactoglobulin protein and the recombinant α-lactalbumin protein comprises a sequence that is at least 90% identical to the bovine protein amino acid sequence and has been produced by a fungal cell;

(ii)    one or more sweetening agents;

(iii)    ash; and

(iv)    optionally, one or more lipids,

wherein:

the food composition has one or more characteristics of a dairy food product selected from the group consisting of: taste, aroma, appearance, handling, mouthfeel, density, structure, texture, elasticity, springiness, coagulation, binding, leavening, aeration, foaming, creaminess, and emulsification; and the food composition does not comprise any other milk proteins than those in (i).

(Emphasis added – underlining/strikethrough denotes the proposed amendments)

On support, Justice Rofe had to determine whether the Application’s technical contribution to the art justified the broad scope of claim 1, which encompassed compositions with any combination of the 17 listed characteristics in claim 1 (such as taste, aroma, appearance…etc) (the Listed Characteristics), and whether the specification described the claimed invention being compositions containing only rALA and rBLG proteins without casein.

On sufficiency, Justice Rofe had to consider whether the specification provided adequate guidance for the skilled person to make the claimed compositions across their full scope in view of various alleged gaps in the Application’s teaching regarding fundamental aspects of formulating dairy products.

Consideration

Construction

An important threshold issue was the construction of claim 1, particularly the phrase “one or more” in relation to the Listed Characteristics.  Perfect Day contended that claim 1 covered compositions with only one characteristic, but not all or even a minimum number of Listed Characteristics, and substantiated this view by reference to infringement, arguing that the claim would be infringed if a product had one of the Listed Characteristics, even if it had more than one.  However, Justice Rofe accepted the Commissioner’s broader construction, finding that Claim 1 encompassed compositions with one, multiple, or all of the Listed Characteristics.

Support

The Commissioner argued that the specification was directed to casein-containing compositions that may further include other milk proteins, and methods of making the same, whereas claim 1 was directed to compositions with rALA and rBLG as the only milk proteins and which did not include casein, making them fundamentally different inventions.

Perfect Day responded that the invention, as narrowly claimed, was disclosed in the specification, relying on the following:

(a)  The addition of a consistory clause – “…other than a cottage cheese or hard cheese, that is suitable as a dairy substitute, said food composition…”; and

(b)  Selected references in the specification as being a disclosure of the ALA and BLG proteins being in a food composition independently of casein, such as: “also provided are kits that include: (a) a mixture of one or more milk proteins, one or more fats, and one or more flavour compounds; and (b) a mixture of ash and at least one sweetening agent”. Further, the Application stated that in some embodiments of the kits, “the one or more milk proteins are selected from the group of: β-casein, κ-casein, [ALA], [BLG] … and serum albumin”

Justice Rofe found that the invention claimed was fundamentally different from the invention disclosed in the specification when read as a whole.  The specification described food compositions that included casein and may further include other milk proteins, whereas the claimed invention comprised rALA and rBLG as the only milk proteins and did not include casein (or any other milk proteins).  Critical to her Honour’s analysis was that, save for the consistory clause, and as accepted by Perfect Day’s expert witness, Professor Tong, there was no mention of a food composition suitable as a dairy substitute comprising BLG and ALA and no other milk proteins, nor any description of making such a composition.  Moreover, the specification positively stated that, if sufficient casein was not present, micelles would not form, leading to poor mouth feel in synthetic milk products as micelles were particularly important for the optimum behaviour of milk.

Her Honour also rejected Perfect Day’s reliance on selected phrases from the specification, finding that even the strongest reference – which described BLG and ALA as the primary component of “at least a part of the milk protein component or composition” – did not convey an “inferential disclosure of a composition comprising ALA and BLG and no other milk proteins”.  In the context of an extensive specification describing casein-containing compositions, her Honour stated that an absence of casein “would require express wording to that effect”.

The Commissioner also contended that that the technical contribution of the invention described in the specification did not support food compositions having more than one, or all of the Listed Characteristics.

In response, Perfect Day argued that the essence of the invention was not referrable to the combination of the Listed Characteristics, but was with respect to the development of a dairy substitute that used recombinant proteins without casein.  In view of this, Perfect Day contended that enabling one characteristic at a time was sufficient given the claim’s “one or more” language, and the resulting composition did not have to be a ‘good’ dairy substitute as long as the ‘important characteristic’ was replicated.

Justice Rofe agreed with the Commissioner’s position, finding that claim 1 encompassed “compositions which might have one of the Listed Characteristics, as well as compositions which have two or even all of the Listed Characteristics”.  Her Honour noted that Professor Tong’s evidence that recreating all the characteristics would be “tremendous” demonstrated that the scope of claim 1 exceeded the technical contribution provided by the specification as whole.  Although Professor Tong could make compositions with one characteristic “reminiscent” of dairy products, Justice Rofe found he was applying his own expertise rather than following the Application’s teachings, which failed to explain fundamental aspects such as whether post-translational modification caused rALA or rBLG to form micelles (critical for milk behaviour) or how to achieve coagulation with rennet in the absence of casein (necessary for cheese).  His evidence also revealed that different characteristics applied to different dairy products, further demonstrating that the broad scope of claim 1 could not be justified by the Application’s limited disclosure.  For these reasons, Justice Rofe concluded that the Application lacked support.

Sufficiency

The Commissioner’s arguments on sufficiency mirrored those made in respect of support, namely, that the invention claimed was different from that disclosed in the specification, and that the specification provided no meaningful assistance for producing the claimed products with combinations of Listed Characteristics, offering at best a ‘starting point’ that left the skilled person to rely on their common general knowledge alone.

Consistently with its position on support, Perfect Day argued that claim 1 only required that the claimed composition be “suitable as a dairy substitute” by possessing one Listed Characteristic, arguing that the sufficiency requirement should therefore not require more than enabling one characteristic at a time.  Perfect Day again relied on the consistory clause as sufficient disclosure and Professor Tong’s evidence that compositions with individual characteristics could be produced without undue burden.

In addition to the matters which her Honour had considered in the context of support, Justice Rofe noted that Professor Tong acknowledged that the Application did not disclose a formulation he could follow from start to finish and that his ‘starting point’ simply involved replacing casein with rALA and rBLG without being able to predict the resulting properties of the product.  Cross-examination of Professor Tong also revealed that many experiments, anywhere from “more than 10” and possibly within the realm of 100, might be required to produce a particular dairy substitute composition with the desired characteristic(s).

Critically, Justice Rofe found that the Application provided no guidance for making dairy substitute compositions with two or more of the Listed Characteristics, concluding that such work would require “an exercise of inventive skill or ingenuity or undue effort” rather than routine work by a skilled person.  Accordingly, her Honour found that claim 1 lacked sufficiency.

Outcome and Implications

Justice Rofe dismissed Perfect Day’s appeal, finding that claim 1 of the amended Application lacked both support and sufficiency and should not proceed to grant.

The decision provides important guidance on the heightened support and sufficiency requirements under the “Raising the Bar” amendments to the Patents Act.  Justice Rofe’s decision also illustrates the risks of claiming broad ranges of characteristics in complex technical fields, and reinforces that consistory clauses and vague references cannot cure fundamental disconnects between specifications and claims.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

The NOCO Company v Brown and Watson International Pty Ltd [2025] FCA 887

Introduction

Justice Moshinsky of the Federal Court has delivered judgment in patent proceedings between The NOCO Company (NOCO) and Brown & Watson International Pty Ltd (B&W) relating to portable vehicle battery jump starters.  In a complete victory for B&W, Justice Moshinsky found all asserted claims across three patents to be invalid.  The decision offers valuable insights into the sufficiency requirements for claiming priority from earlier applications, and clarifies that best method disclosure obligations are assessed at the filing date of the earliest complete application from which the patent term runs.

Background

The case concerned three Australian patents held by US company NOCO, relating to portable vehicle battery jump starter apparatus with safety protection:

• 2020201223 (the 223 Patent)
• 2021258059 (the 059 Patent)
• 2022201338 (the 338 Patent)

All three patents are from the same family, each claiming priority from PCT/US2014/045434 (the PCT Application) filed on 3 July 2014.

The patents address safety problems with traditional jump starter devices, where jumper cables could accidentally contact each other or be connected with reverse polarity, causing sparking and potential injury.  The patented solution involves a control system that detects both battery presence and correct polarity before allowing a power switch to connect the internal battery to the external vehicle battery.

NOCO brought proceedings against B&W, alleging infringement of the patents by B&W’s ‘Projecta’ brand jump starters.  B&W cross-claimed, seeking to invalidate all asserted claims on grounds of lack of novelty, lack of inventive step, failure to disclose the best method, lack of support, insufficiency and lack of utility.  Justice Moshinsky addressed all grounds of invalidity except lack of support, insufficiency and lack of utility in his judgment, these grounds being unnecessary for his Honour to decide given his findings on the other invalidity grounds.

Although many claims were in issue, considerable attention was given to Claim 1 of the 223 Patent, which is in the following terms:

1. 1.1 A jump starter apparatus for boosting or charging a depleted or discharged battery having a positive battery terminal and a negative battery terminal, the apparatus comprising:
2. 1.2 a power supply;
3. 1.3 a positive battery connector for connecting the jump starter apparatus to the positive battery terminal of the depleted or discharged battery;
4. 1.4 a negative battery connector for connecting the jump starter apparatus to the negative battery terminal of the depleted or discharged battery;
5. 1.5 a power switch connected in circuit with the power supply and the positive and negative battery connectors, the power switch configured to turn power on or off from the power supply to the positive and negative battery connectors;
6. 1.6 a control system or circuit connected to and controlling the power switch, the control system or circuit configured to detect presence of the depleted or discharged battery when connected between the positive and negative battery connectors and to detect polarity of the depleted or discharged battery when connected between the positive and negative battery connectors;
7. 1.7 wherein the control system or circuit switches on the power switch to connect the power supply to the depleted or discharged battery only when the depleted or discharged battery is present and properly connected between the positive and negative battery connectors and the depleted or discharged battery is properly connected with a correct polarity between the positive and negative battery terminals.

Key Issues

The key issues which Justice Moshinksy addressed in his judgment were as follows:

Construction

Multiple disputes arose regarding claim interpretation, including whether the asserted claims required automatic power switch activation upon satisfaction of preconditions (the Automatic Start Issue), whether devices with manual override functionality fell within the claim scope (the Manual Mode Issue), and whether references to ‘USB’ encompassed USB-C technology.

Priority Date Entitlement

B&W challenged whether the patents were entitled to claim priority from the PCT Application, arguing that the claimed inventions were not adequately disclosed in the PCT Application.

Novelty and Inventive Step

B&W contended all claims were obvious based on common general knowledge alone, or in combination with prior art documents, including a 2013 HP Manual and 2014 QTC Brochure.

Best Method

B&W argued NOCO failed to disclose the best method known for performing the invention, raising the question of whether knowledge should be assessed at the filing date of the PCT Application or the complete application for each patent.

Infringement

NOCO alleged B&W’s Projecta jump starter products infringed the patents, while B&W contended that the products fell outside the scope of the claim based on their construction of the asserted claims.

Consideration

Construction Issues

The Automatic Start Issue concerned whether certain claims (for example, integer 1.7 of Claim 1 of the 223 Patent) required the power switch to turn on automatically upon satisfaction of certain preconditions.  NOCO argued that the claims merely prevented the switch from turning on unless the preconditions were met, and emphasised that the claim language was “permissive” rather than requiring immediate automatic operation.  B&W contended that it was the ‘control system or circuit’ that must switch on the power switch when conditions are satisfied, not manual user action, and took the view that if “when” meant “at any point in time when,” the claims would encompass redundant products that switch on for insufficient time to jump start vehicles.

Justice Moshinsky agreed with NOCO for most claims, finding that the language “only when” meant the switch will not turn on unless preconditions are satisfied, but does not require automation upon satisfaction.  Importantly, his Honour distinguished claim 21, which uses the language “when, and only when”, finding that this wording implied both “(a) if the preconditions are not satisfied, the switch will not turn on; and (b) if the preconditions are satisfied, and upon that satisfaction, the switch will turn on”.

Regarding the Manual Mode Issue, NOCO argued that if a device had manual override features allowing users to force power switch activation when the preconditions were not met, this did not take the devices outside the scope of the claims provided they could operate in the automatic mode which met the claim requirements.  B&W argued that claims using “only when” language created clear requirements that control systems “must not switch on the power switch unless the stipulated antecedent conditions are satisfied”, and thus devices capable of manual override cannot satisfy this requirement.

The Court found that devices with manual override capability that allow power switch activation when no depleted battery is present, or when battery voltage is too low for detection, were “inconsistent with and therefor outside the scope” of the asserted claims which used the “only when” language.  The Court also rejected NOCO’s ‘additional feature’ argument, noting that the “only when” language is “essentially negative and unqualified”, and did not allow for, or describe any, alternative mode of operation.

Regarding the USB issue, B&W relied on expert evidence which asserted that the term “USB” in the patent referred to standard USB connection types available at the asserted priority date, including USB-A, Mini-USB and Micro-USB, and that “USB-C is a different type of connection to the set of standard USB-type plugs or sockets available” at the priority date.  NOCO relied on expert evidence which considered that the claims were “not specific regarding the type of USB” and used “forward-looking language that allows for future advancements”.  Justice Moshinsky found that “USB” referred to a “type or category” of quick fit connection rather than specific 2014-era implementations, and that USB-C was recognised in the field of power electronics as a form of USB technology.

Priority Date Entitlement

The Court considered whether the patents were entitled to claim priority from the PCT Application under s 43(2A) of the Patents Act 1990, which requires that the priority document disclose the invention in a manner that is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art.  B&W argued that the PCT Application failed to disclose the claimed inventions on three grounds:

1. (i) the PCT Application disclosed only ‘FET’ switches while the asserted claims were not so limited;
2. (ii) the PCT Application required two sensors while the asserted claims extended to a single sensor or other means; and
3. (iii) the PCT Application disclosed only automatic start devices (on NOCO’s construction) while the asserted claims were not so limited.

Justice Moshinsky found that Claim 1 encompassed different types of power switches and that the PCT Application did not disclose a power switch of that breadth.  His Honour stated that different switch types work in different ways with respective advantages and disadvantages, and that the “power switch is closely connected to the safety features that the invention is designed to achieve”.  Further, his Honour agreed that the number of sensors in the device impacted the way it worked such that the breadth of the feature as described in the asserted claims needed to be (but was not) disclosed in the PCT Application.

Justice Moshinsky rejected B&W’s argument relating to automatic start devices, finding that the PCT Application’s detailed description included temperature sensing that could prevent switching even when preconditions were met, meaning it disclosed “a device in which the power switch does not necessarily turn on upon satisfaction of the preconditions”.

Consequently, most of the asserted claims were not entitled to the 2014 priority date, and given NOCO’s concession that claims not entitled to the asserted priority date would be invalid for lack of novelty, these claims failed on that basis.

Novelty and Inventive Step

Although many of the asserted claims were held invalid due to not being entitled to the 2014 priority date, for completeness, Justice Moshinsky considered the remaining grounds of novelty and inventive step for all asserted claims.  To this end, B&W relied on the common general knowledge and two prior art documents: a 2013 HP Manual for Projecta jump starters and a 2014 QTC Brochure describing a lithium polymer jump starters.

On novelty, Justice Moshinsky found neither document anticipated the claims.  The HP Manual described products with manual override features and thus fell outside the scope of the claims of the 223 Patent (which used the “only when” language).  Further, the QTC Brochure was too brief and unclear, merely providing “a list of features” without “any detailed description of how the functionality that it offers is achieved”.

On inventive step, his Honour made extensive findings about the common general knowledge including as to safety concerns with jump starters, the advantages of lithium batteries, USB charging technology, and that safety features were “a key aspect of designing a power electronics circuit”.  The expert evidence demonstrated that implementing sensors for detecting battery presence and polarity would have been “a matter of routine”, with B&W’s expert noting that it would have been “of no difficulty for [his] students”, and NOCO’s expert agreeing that such implementations with lithium batteries were “within the general calling of his profession”.  It followed that Justice Moshinsky held all of the asserted claims to be obvious solely based on the common general knowledge.  His Honour found that even the more complex claims involving lithium batteries and USB charging represented “merely a design choice rather than a barrier crossed or difficulty overcome”.

Best Method

B&W contended that the best method known to a patentee which must be disclosed is that known at the date of filing of the complete application of each of the patents, not at the date of filing of the PCT Application from which priority is claimed, and relied on Dometic Australia Pty Ltd v Houghton Leisure Products Pty Ltd [2018] FCA 1573 (Dometic), Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27 (Servier) and Pfizer Overseas Pharmaceuticals v Eli Lilly and Company [2005] FCAFC 224 (Pfizer).

NOCO argued that the knowledge requirement should be assessed at the PCT Application filing date, which is the first filed application in the chain of divisional applications and the date from which the term of each patent runs.  NOCO relied on the reasoning of Gummow J in Rescare Ltd v Anaesthetic Supplies Pty Ltd [1992] FCA 811 at [135], which it contended was approved by the Full Court in Servier and Pfizer, and submitted that the Court ought not to follow Dometic on the basis that it was inconsistent with these authorities and plainly wrong.

After undertaking a detailed analysis of the authorities, Justice Moshinsky preferred NOCO’s position.  His Honour found that Gummow J’s reasoning in Rescare, that “adequacy of the disclosure should be judged by reference to the time from which dated the monopoly granted the applicant in exchange for the disclosure”, was approved by the Full Court in Pfizer.  The Full Court in Pfizer at [366] and [375] distinguished between two separate dates: “the date as at which the best method known to the applicant is to be identified (the knowledge element)” and “the date by which the specification’s full description of the invention must include a disclosure of the best method”.

Justice Moshinsky observed that the Full Court “accepted as correct that the knowledge element is to be assessed as at the filling date of the complete specification (which was, in that case, the international filing date)”.  His Honour reasoned that section 29A(2) of the Patents Act 1990 provides that “[t]he description, drawings, graphics, photographs and claims contained in a PCT application are to be treated as a complete specification filed in respect of the application”, and consequently, the filing date of a PCT specification is capable of constituting the filing date of the complete specification.  Noting that the Court in Dometic took a different view, his Honour considered that he should follow the Full Court’s reasoning in Pfizer as he understood it, and that it was not necessary to consider whether the holding in Dometic was plainly wrong.

It followed that his Honour found that the relevant date for assessing best method was the filing date of the PCT Application.  Since the earliest date on which NOCO was alleged to have become aware of a better method than that disclosed in the PCT Application was after the date of filing of the PCT Application, this ground failed.

Infringement

Despite his Honour’s validity findings, Justice Moshinsky briefly addressed infringement.  His Honour’s ruling on infringement followed his findings on construction:

1. (i) claims not requiring automatic start were infringed due to B&W’s manual override feature;
2. (ii) claims prohibiting manual override were not infringed; and
3. (iii) USB-C implementation did not avoid infringement given the broad construction of “USB”.

Outcome and Implications

Justice Moshinsky declared all asserted claims invalid and ordered their revocation (subject to any appeal within 28 days), and dismissed NOCO’s infringement claims.  His Honour’s decision is particularly notable for its consideration of the date at which the best method knowledge requirement is assessed for divisional patent applications.

Justice Moshinsky’s finding that the best method knowledge requirement is assessed at the filing date of the earliest complete application from which the patent term runs, rather than each divisional filing date, provides important guidance in the face of competing authorities on this issue.  However, it is important to note that his Honour’s reasons were strictly obiter, and so are not binding on future courts.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.