{"id":7582,"date":"2025-05-12T14:00:17","date_gmt":"2025-05-12T02:00:17","guid":{"rendered":"https:\/\/www.jamesandwells.com\/?p=7582"},"modified":"2025-05-12T14:02:41","modified_gmt":"2025-05-12T02:02:41","slug":"perfect-days-imperfect-outcome-patent-drafting-and-opposition-lessons","status":"publish","type":"post","link":"https:\/\/www.jamesandwells.com\/au\/perfect-days-imperfect-outcome-patent-drafting-and-opposition-lessons\/","title":{"rendered":"Perfect Day\u2019s imperfect outcome \u2013 patent drafting and opposition lessons"},"content":{"rendered":"

When drafting patent applications at each stage of the process \u2013 from provisional applications to complete \u2013 it can be difficult to predict the future opportunities and challenges faced by a business, which may result in a divergence between the early technology focus and the later commercial realities. Prior art can also influence decision-making on what to focus on as the key inventive concept, and often this only comes to light after the application is filed. The history of Perfect Day\u2019s first patent application in Australia, which lead to the decision of the Australian Federal Court in Perfect Day, Inc. v Commissioner of Patents<\/em> [2025] FCA 270, illustrates a clear case-in-point.<\/p>\n

Perfect Day, Inc. (\u201cPerfect Day\u201d) was established in 2014 to produce animal-free milk proteins and dairy-like food products such as ice cream from those proteins. The animal-free milk proteins are produced by precision fermentation, a process that uses microbial cells (such as fungi) for the required protein production within the cell structure. Using precision fermentation to produce the proteins that are traditionally sourced from animal milk is associated with an improved environmental impact (reduced water use, methane production, etc.), and adds to the range of animal-free food products available to consumers. While soy, oat, almond and coconut \u201cmilks\u201d are useful as milk-substitute beverages, they do not form satisfactory substitutes for dairy-derivative products, such as cheese, ice-cream, yogurt, cream and butter, which require the particular physical properties of milk (and the proteins present in milk) that enable those derivative products to be made.<\/p>\n

Perfect Day filed its first US provisional patent application in August 2014, describing an \u201canimal-free dairy substitute that has desirable flavor characteristics, e.g., replicates dairy flavours\u2026, while retaining the downstream applications of dairy milk\u201d. The examples demonstrated the production of some key dairy proteins present in milk \u2013 notably casein<\/strong> and the major whey proteins<\/strong> including \u03b1-lactalbumin (\u201cALA\u201d) and \u03b2-lactoglobulin (\u201cBLG\u201d), through precision fermentation. These precision-fermented proteins were then combined with lipids, sugars, an inorganic component (\u201cash\u201d) and water, taken from non-dairy sources, to engineer a \u201cmilk\u201d and downstream milk-derived dairy products, all without milking a cow.<\/p>\n

While the general concept was a clever one, the challenge that arose was \u201cwhat to claim\u201d as the invention. The provisional patent application was entitled \u201cdairy substitute foods and method of manufacture\u201d and described many broad general concepts, but the specification did not set out a clearly articulated core inventive concept that was novel and distinct from the prior art. A year later, Perfect Day filed an International patent application, which matured into Australian patent application 2015305271. At the time of filing the international application, the specification was updated and most of the original broad general concept statements removed.\u00a0 Focus was placed instead on \u201ccompositions comprising a casein<\/strong> and methods of producing the same\u201d (emphasis added), which became the title of the international application. Then, through later <\/em>amendments filed in August 2019, there was an apparent re-thinking of the desired claim scope, and the accepted claims of the application were directed to \u201cthe\u00a0combination\u00a0of \u03b1-lactalbumin and \u03b2-lactoglobulin<\/strong> (along with ash, sweetener and (optional) lipid) in a \u201cfood composition [that] does not comprise any other milk proteins than those\u201d two. So, there was a shift from casein to the whey proteins ALA and BLG as the key proteins in the claimed products, and the presence of only those <\/em>two specified whey proteins.<\/p>\n

Today, the leading products in Perfect Day\u2019s commercial range are based on whey protein<\/strong>, rather than casein.\u00a0 Having obtained acceptance of patent claims in Australia covering the combination of the two key whey proteins in food compositions, despite the earlier focus in the patent application on casein, Perfect Day must have been pleased.<\/p>\n

However, Perfect Day is only one of a number players to have emerged in animal-free dairy protein space, and their competitors were watching this patent application closely. The major New Zealand dairy co-operative Fonterra co-established Vivici in Denmark in 2022, which also produces the whey protein BLG by precision fermentation, and has an interest in food products comprising the whey protein BLG. Fonterra filed an opposition against Perfect Day\u2019s Australian application 2015305271 directed to the whey proteins ALA and BLG, and succeeded on the grounds of lack of support and sufficiency.1<\/sup> \u00a0The Delegate found that the claims failed to disclose how a dairy substitute food product having the functional characteristics specified in the claims could be made without casein<\/em> (i.e. the claims lacked support under s 40(3) Patents Act 1990 (Cth)).2<\/sup>\u00a0 The Delegate also found that the specification did not provide clear or complete enough guidance on how the whey proteins ALA and BLG could be used to replace casein whilst delivering properties traditionally attributed to casein (i.e. the disclosure was insufficient under s 40(2)(a)).3<\/sup><\/p>\n

Given the importance of whey proteins to its business, it was perhaps not surprising that Perfect Day appealed that decision to the Federal Court. (Perfect Day also obtained grant of a divisional application in which the claims specify the presence of casein, which did not face any third party opposition.)4<\/sup><\/p>\n

In Australia, appeals to the Federal Court from Australian Patent Office decisions are heard de novo<\/em>. This provided Perfect Day with the opportunity to present new evidence and a new approach in support of its claims covering the whey protein-based products. Better still, if Fonterra was not willing to commit to the expense of defending the appeal in the Federal Court, then there was the theoretical possibility that Perfect Day could win the opposition by default, as occurred in Daiichi Sankyo Company, Limited v Alethia Biotherapeutics Inc.5<\/sup><\/em><\/p>\n

Perfect Day would have been feeling more optimistic when Fonterra withdrew <\/em>from the appeal proceedings at a relatively early stage. That optimism may have been tempered when the Commissioner of Patents chose to participate in the proceedings. Nevertheless, there was still some advantage for Perfect Day at this point, as the Commissioner was not in a position to adduce expert testimony on matters of common general knowledge and other relevant matters, meaning that the Commissioner was somewhat constrained in presenting its case as forcefully as Fonterra may have.<\/p>\n

The Commissioner was able to overcome this constraint by relying on paragraphs from submissions filed on behalf of Perfect Day in the original opposition proceedings as admissions regarding what was, and was not, common general knowledge as at the priority date. Taking that information into account, together with the evidence provided by Perfect Day\u2019s new expert in the appeal, the Rofe J. found that (i) the claimed invention was not supported by the description \u2013 at least because the invention claimed in claim 1 was \u201cdifferent \u2026 to that described in the specification when read as a whole\u201d6<\/sup>, and (ii) the disclosure of the specification was insufficient since \u201cprolonged research, enquiry or experimentation\u201d would be required to make the full range of products across the scope of claim 1.7<\/sup><\/p>\n

Key Take-aways<\/strong><\/p>\n

This case provides a good illustration of the practical realities of patent drafting and how the shifting commercial focus of a company can have major implications for its patent strategy. Where a crystal ball is not available to predict the commercial future, it is important to fully describe all potentially inventive concepts in complete patent applications with absolute clarity and clear delineation between each concept. Also, it may have assisted Perfect Day to have retained more of the content of its provisional patent application in its international patent application \u2013 the provisional application did not contain such a heavy focus on casein, and may well have provided better support for the final claim scope that was pursued.<\/p>\n

Secondly, where a patent applicant is unsuccessful in a patent opposition in Australia, there is considerable merit in filing an appeal to the Federal Court. There was a lot on the line for Perfect Day, and had the Commissioner not stepped in when Fonterra withdrew, Perfect Day could have succeeded in the appeal by default.<\/p>\n

It would appear that this is the end of the line for Perfect Day in seeking protection for casein-free, whey protein-based dairy substitutes in Australia based on its 2014 provisional application, however divisional applications remain pending through which this subject matter may re-emerge, so we will continue to watch this space.<\/p>\n

 <\/p>\n

1<\/sup> Fonterra Co-operative Group Ltd. V Perfect Day, Inc.\u00a0<\/em>[2022] APO 59 \u2013 hereafter \u201cFonterra v Perfect Day<\/em>\u201d<\/p>\n

2<\/sup> Fonterra v Perfect Day<\/em>, at [93] \u2013 [94]<\/p>\n

3<\/sup> Fonterra v Perfect Day<\/em>, at [109] \u2013 [110]<\/p>\n

4<\/sup> Australian patent 2019284081<\/p>\n

5<\/sup> Daiichi Sankyo Company, Limited v Alethia Biotherapeutics Inc.<\/em>\u00a0 [2016] FCA 1540. In this case, Alethia Biotherapeutics Inc. (\u201cAlethia\u201d) had successfully opposed Australian patent application 2008311698 to Daiichi Sankyo Company (\u201cSankyo\u201d), having established that certain claims lacked an inventive step. Sankyo appealed the decision, and while Alethia initially participated in the Appeal, they withdrew before the submission of any evidence.\u00a0 The Commissioner of Patents chose not to take part in place of Alethia. Given the onus on the opponent to establish its case in the opposition (including the de novo<\/em> appeal), and the lack of evidence submitted to the Court in the appeal, the Court disposed of the proceedings and allowed the appeal, resulting in the grant of the patent.<\/p>\n

6<\/sup> Perfect Day, Inc. v Commissioner of Patents<\/em> [2025] FCA 270, at [125]<\/p>\n

7<\/sup> Perfect Day, Inc. v Commissioner of Patents<\/em> [2025] FCA 270, at [156]<\/p>\n","protected":false},"excerpt":{"rendered":"

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