August 2022
1. Patents
Fonterra’s Opposition Brings Perfect Day’s Accepted Application Down To (and below) Ground
In Fonterra Co-operative Group Ltd v Perfect Day Inc [2022] APO 59 an application relating to dairy substitutes was successfully opposed in a case where more careful drafting could have avoided that outcome.
Perfect Day’s patent application relates to dairy substitutes, methods of manufacturing them, compositions comprising animal-free milk fats and proteins for food applications such as milk, butter, cheese, yoghurt, and cream. The Australian patent office accepted the application in September 2019 and Fonterra opposed it on the grounds of lack of inventive step, inutility, insufficiency and lack of support.
The specification states that the current plant and nut based substitutes for dairy milk fall short in terms of flavour and almost universally fail to form derivative products such as cheese, yoghurt, cream or butter when subjected to the same processes used on dairy milk. The specification claims to disclose compositions having a similar taste, mouth feel, aroma, and nutritional value to a mammal-based milk, but which lack one or more undesirable components of a mammal-produced milk (e.g., allergens, lactose, antibiotics, stress hormones and/or growth hormones, heavy metals, bacteria such as E. coli, viruses, and prions). It also claims that the disclosed compositions have an improved shelf-life and aroma profile compared to mammal-produced milk. Claim 1 is as follows:
A food composition comprising:
(i) a recombinant β-lactoglobulin and a recombinant α-lactalbumin, 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).
Construction: Noting that “food composition” is not defined in the specification Fonterra argued that the claim is over-broad as it could include compositions that would not be considered foods on account of qualities such as not being sufficiently palatable. The Delegate accepted Perfect Day’s submission that the phrase should be given its ordinary meaning of being a substance that is eaten or taken into the body for nourishment. The Delegate went on to construe claim 1 as defining dairy substitute products that possess one or more characteristic properties of a corresponding dairy product.
Obviousness: Regarding lack of inventive step Fonterra argued that it would be routine for the skilled person to arrive at the claimed compositions for use as dairy food substitutes as a matter of course as the common general knowledge included the use of recombinant β-lactoglobulin and α-lactalbumin to create whey food compositions. It was also argued that the common general knowledge in conjunction with one of two pieces of prior art would establish obviousness. The Delegate rejected the argument based on common general knowledge alone as the evidence did not establish that the requisite information was known and accepted widely enough in the art to be considered common general knowledge. Obviousness was also rejected in relation to the first piece of prior art as it was held that the skilled person at the priority date would not have chosen the claimed combination from amongst the large number of proteins disclosed therein for use in a food product. Finally obviousness was also rejected in relation to the second piece of prior art, which centred around the use of modified α-lactalbumin in food compositions, as the motivation for its modification pointed away from it being combined with β-lactoglobulin.
Lack of Support: Claim 1 does not define the invention in terms of a principle of general application, but instead is very specific in relation to the milk proteins β-lactoglobulin and α-lactalbumin and other ingredients. However, the applicant sought to establish support for the claims based on broad reference to a subset of milk proteins together with various general references to β-lactoglobulin and α-lactalbumin throughout the description, rather than any specific embodiments of such compositions. Instead, the specific embodiment in the specification is directed to compositions containing casein, and highlights the importance of micelles, which the application does not show can be produced using β-lactoglobulin and α-lactalbumin. Consequently, because the applicant has not enabled the invention across the full scope of the claims, the Delegate found the claims do not reflect the technical contribution of the application to the extent of being supported thereby. During examination a consistory clause was added to the specification which mirrored the language of claim 1. However, at [94] the Delegate held that this did not contribute to enablement:
“The mere presence of a consistory clause that mirrors the language of Claim 1 does not address this deficiency. As noted in Regeneron the technical contribution to the art is the product which is enabled by the disclosure, in this case compositions containing specific milk components (including casein), and not the invention itself (or the idea), as set out here in the claims and in the consistory clause.”
Insufficiency: Fonterra argued that in order to make anything within the scope of the claims process steps which are not disclosed in the specification and are not part of the common general knowledge needed to be developed. In particular, the products rely on the use of PD cream as a base, but there is no discussion of this base product in the specification, and the examples neither use nor result in a product like the PD cream. The Delegate agreed, finding that the specification provides no guidance, or even a suggestion, that α-lactalbumin and/or β-lactoglobulin could be used as a replacement for casein and would provide the structure, texture, mouthfeel and aggregation properties traditionally attributed to casein. In order to work the invention research involving trial and error would be required to the extent that it would constitute an undue burden on the person skilled in the art.
Inutility: Fonterra also argued that a composition that includes only one (or less than all) characteristics of a dairy food product would not meet the promise made, and that some of the food compositions falling within the scope of the opposed application would not fulfil the promise made. While the Delegate had similar concerns it was held that Fonterra had not provided sufficient evidence to substantiate those allegations.
Conclusion: The Delegate found the application’s claims to lack support and that the disclosure was insufficient for a skilled person to work the claimed invention without undue effort. The Delegate allowed the applicant 2-months to make amendments, but expressed doubt that suitable amendments would now be possible.
Montenegro Changing from EPC Extension State to EPC Member State
From the 1st October 2022 Montenegro (ME) will be an EPC member state, thereby bringing the total number of EPC member states to 39. Since the 1st March 2010 Montenegro has been an extension state of the EPC. Montenegro’s joining of the EPC does not also extend to joining the forthcoming Unitary Patent system.
The other current EPC extension state is Bosnia & Herzegovina (BA). The following non-EPC states have enacted validation agreements with the EPO, thereby allowing European patents to be validated therein: Cambodia (KH); Morocco (MA); the Republic of Moldova (MD); and Tunisia (TN). Georgia (GE) has signed a validation agreement with the EPO, but it has yet to bring the agreement into force. Historically, extension agreements were made with European states that were not members of the EPC. However, since 2010 the EPO has used validation agreements, which are not limited to European states that are not members of the EPC.
In addition, while not having a validation agreement with the EPO, the following non-EPC states allow the re-registration of European patents: the Democratic Republic of Congo (CD); Ethiopia (ET); Guernsey (GG); Macao (MO); and Nepal (NP). There are also numerous Commonwealth countries that allow for the re-registration of European patents that have been validated in the UK.
PCT Fee Changes for New Zealand
Effective from 1st September 2022 the International Filing fees will change for New Zealand. The table below gives the changes in the equivalent amounts in NZD: (PCT Newsletter; 2022/08)
PCT Intl Filing Fees / Intl Filing Fee / Fee per sheet over 30 / PCT-EASY Reduction (Varies according to electronic format)
Current Fee (NZD) / 2,060 / 23 / 310 – 465
Fee from 01/09/2022 / 2,208 / 25 / 332 – 498
CAFC Finds Eagle Doesn’t Drift Into Par’s Infringement Trap
In Par Pharmaceutical Inc v Eagle Pharmaceuticals Inc 21-2342 the Court of Appeals for the Federal Circuit (CAFC) affirmed a District Court’s finding that fluctuations in pH levels in a generic composition would not inevitably result in infringement.
Par obtained two patents 9,744,209 and 9,750,785 relating to its vasopressin injection product used to treat patients with critically low blood pressure. The ‘785 patent concerns vasopressin compositions, while the ’209 patent concerns methods of increasing blood pressure with those compositions. The claims of both patents require the vasopressin composition to have a rounded pH between 3.7–3.9, i.e., a pH between 3.65–3.94 before rounding. Following FDA approval in April 2017 of that product it was added to the Orange Book and marketed under the brand Vasostrict®.
In 2018 Eagle filed an abbreviated new drug application (ANDA) with the aim of manufacturing and selling a generic version of Vasostrict®. It sought to avoid infringing Par’s patents by specifying a different pH range. In particular, Eagle’s ANDA specified that the pH range of its product both when released for distribution and during its shelf life would be between 3.4-3.6 (after rounding) or 3.35-3.64 (before rounding).
Par claimed infringement would inevitably be more likely than not based on the combination of evidence showing that the pH of Eagle’s product drifts up over time and Eagle seeking to manufacture with a pH around the 3.64 level. The District Court rejected Par’s infringement allegation, finding that the evidence only established minor fluctuations in pH, not a discernible upward drift. The District Court also rejected Par’s request for a declaratory judgment to the effect that Eagle will infringe in the future, again finding Eagle’s post-release pH data did not establish basis for that.
On appeal the CAFC also declined to find infringement. It noted that under § 271(e)(2) it is an act of infringement to submit an ANDA seeking FDA approval to make and sell a patented drug. Where the terms of the ANDA clearly show that the generic drug will fall outside the scope of the patent’s claims there will be no infringement. It is only if the ANDA does not speak clearly and directly to the question of infringement that courts may look to other relevant evidence, such as data or samples the ANDA filer has submitted to the FDA. Given that the release and stability undertakings in Eagle’s ANDA directly and unambiguously address the pH range the CAFC found no basis for infringement. In the absence of evidence that Eagle would not comply with its undertakings the CAFC considered Par’s allegations to be unsupported conjecture.
Par also challenged the District Court’s denial of declaratory judgment, arguing that the District Court was wrong to find no discernible upward drift or to reject the relevance of the fluctuations and to find that Eagle was not engaged in, or making meaningful preparation for, infringing activity. However, the CAFC found no clear error in the District Court’s findings in any of those respects.
2. Trade Marks
Unfair Advantage Ruling Upheld
In Monster Energy Company v Red Bull GmbH 2022 EWHC 2155 a UK High Court Judge upheld a Hearings Office decision that allowed an opposition based on taking unfair advantage of a well-known mark without requiring a subjective intention to do so.
Monster Energy’s class 32 application to register RED DAWG in respect of non-alcoholic beverages was opposed by Red Bull on the basis of their class 32 registrations for RED BULL, a stylised version thereof and a device mark, also in respect of non-alcoholic beverages, including energy drinks. Red Bull’s grounds of opposition were that the opposed mark is confusingly similar to theirs (section 5(2)(b)) and that it takes unfair advantage of their well-known marks (section 5(3)).
Although the goods are identical and the marks share the word ‘RED’, the Hearings Officer rejected the section 5(2)(b) direct confusion opposition, finding that average consumers would not overlook non-negligible differences between the marks even when taking into account imperfect recollection. The Hearings Officer also rejected the section 5(2)(b) indirect confusion opposition. Indirect confusion occurs where the relevant consumer recognises that the mark is different to another mark but assumes it has common ownership with the other mark on account of a distinctive shared element that creates a link between the two marks that is more than mere association. The Hearings Officer found that the shared element RED is not distinctive of the opponent and that the mark RED DAWG does not simply add or remove non-distinctive elements or amount to a brand extension of a mark of the opponent.
However, the Hearings Officer upheld the opposition under section 5(3), which protects well-known marks from uses of marks that take unfair advantage of or would be detrimental to the distinctive character or the repute of the well-known mark. The determination of section 5(3) centred on the well-known status of the RED BULL mark. Given that mark and the opposed mark begin with the same word, are two words long, reference animal names and involve the same goods, the distinctive character of the RED BULL mark and its well-known status led the Hearings Officer to find that it would be called to mind by a consumer encountering the RED DAWG mark. The Hearings Officer then found that unfair competition was established as the calling to mind of the RED BULL mark in respect of the same goods meant the opposed mark did not require as much investment in advertising as it would be riding on the coattails of Red Bull’s marketing efforts. The Hearings Officer made that finding on an objective basis and declined to find that Monster subjectively intended to benefit from the reputation of Red Bull’s mark. Nonetheless, Monster’s lack of evidence explaining why it chose the RED DAWG mark meant it failed to establish due cause for adopting the mark.
On appeal Monster argued that the onus was on Red Bull to provide evidence showing that there was a serious risk of unfair advantage being taken of its mark, and that in the absence of such evidence the Hearings Officer should not have inferred unfair advantage from the existence of a link or calling to mind of the opponent’s mark. The Judge rejected that contention. The Judge found that the Hearings Officer’s analysis regarding Monster’s adoption of the RED DAWG mark only required an intention to adopt an impactful brand, it did not require an intention to take advantage of Red Bull’s mark. While evidence of a subjective intention to take advantage of the reputation of another parties mark would be highly relevant to a finding of unfair advantage, it is not a necessary requirement under section 5(3). While merely obtaining a commercial advantage is not sufficient to engage section 5(3), the unfair advantage finding was based on the impact of the choice of that brand on consumer behaviour with the effect of Monster selling more while paying less. The Judge considered the Hearings Officer was entitled to infer from the link that consumers would likely make between the marks that unfair advantage would thereby be taken of Red Bull’s well-known mark. The inference was considered to be permissibly drawn based on inherent probabilities in the relevant context and not a mere supposition.