Biosimilars Deals 2021

Nufarm Australia Limited v Corteva Agriscience LLC [2023] APO 40

30 June 2023

Australian Patent Office

Felix White

The common law doctrine of issue estoppel requires that a dispute arising between parties should be decided once and for all¹.  On occasion, the Commissioner of Patents may be tasked with examining issues that have emerged in earlier proceedings before it concerning the same patent application, or a closely related application.  In these instances, issue estoppel does not bind the Commissioner.

Background

This unappealed decision involves an opposition filed by Nufarm Australia Limited against the seventh application (of eight) in a patent family filed by Dow Agrosciences, now known as Corteva Agriscience LLC, directed to low vapour drift herbicides.  The patent family has a history of oppositions and divisional applications, with the present opposition relating to Australian patent application no. 2019253885 (Application) claiming compounds derived from herbicidal carboxylic acids and ammonium hydroxides having reduced volatility compared to commercially available carboxylic acid herbicide salts.

Key Issues

The opponent Nufarm initially submitted a Statement of Grounds and Particulars covering various grounds for opposition and providing 62 prior art documents, however the only grounds pressed were novelty and inventive step based on one prior art document (a Japanese patent referred to as D2).

Of the six earlier filed applications, Nufarm opposed the parent application (1) which was subsequently withdrawn; two divisionals (2 and 3) proceeded unopposed to grant with a narrower claim set; Nufarm’s oppositions against further divisionals were unsuccessful (4) and partially successful (5) in a combined decision handed down in 2020 (unrelated to the present challenge); and Nufarm’s opposition to the sixth application (6) was successful on the grounds of novelty and inventive step based on D2 in a decision handed down in July 2022, following which the sixth application was amended.

The opposed application, as a divisional application (7), shares substance with its predecessors but diverges in specific claims.    A further divisional application (8) remains pending.

Both parties provided written submissions on issue estoppel arising from the earlier opposition decisions.

Both parties concurred that the Commissioner is not bound by estoppel, with Nufarm suggesting that the correct approach had been prescribed by the earlier Patent Office decision in SNF as follows:

“The Delegate should start with the findings of fact made in the previous decisions, and then ask whether there is any evidence that contradicts those findings of fact.  Where there is contradictory evidence, the Delegate will need to decide how much weight to give to each”.² 

The Delegate noted that SNF involved a finding of fact in the Federal Court, unlike the present case which involved previous findings of fact by another delegate.  In any event, he was careful to distinguish findings of fact in previous decisions from both findings of law and the application of the law to the facts.  He considered that questions of construction and of disclosure by the prior art are not questions of fact in the sense referred to in SNF.  The Delegate concluded:

“To sum up, my understanding is there [is] no estoppel before the Commissioner, which as an administrative tribunal is not part of the court system and not part of jurisprudence as such.  While it is no doubt desirable for there to be consistency between decisions, it is inevitable that there will be occasional inconsistencies in decisions delivered by different delegates….. Be that as it may, I will make my decision in this case on the evidence before me.”

Outcome

The Delegate stated his understanding that there is no estoppel before the Commissioner, clarifying that the Commissioner functions as an administrative tribunal that is not part of the court system and nor part of jurisprudence.  While consistency of in office decisions is desirable, differences are inevitable, as there is in fact no duty on the delegates to follow findings of fact from earlier Patent Office decisions.

Ultimately, consistent with the 2022 opposition decision, the opposed claims of the Application were found to lack novelty and inventive step in view of D2 as that document disclosed the specific chemical process central to the reduced volatility of the claimed compounds

Implications

The Delegate affirmed that there is no issue estoppel before the Commissioner in relation to prior Patent Office decisions.  If prior decisions of a delegate are to be relied upon, drawing inferences to similar findings in Court decisions may strengthen their impact.

Given there is an eighth application pending in this family, the parties may find themselves in another dispute over closely related subject matter as issue estoppel will not act to prevent it.

___
[1] See SNF (Australia) Pty Ltd v Ciba Specialty Chemicals Water Treatments Ltd [2016] APO 8 (SNF)
[2] Paraphrasing SNF at [52].

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.

MGP Ingredients, Inc v Manildra Milling Corporation [2023] APO 32

31 May 2023

Australian Patent Office

Dr S. J. Smith

In this first in class case, the Patent Office considered the circumstances in which the inclusion of a trade mark in a claim may not result in a lack of clarity.  Notwithstanding the registered Novozymes mark for ‘Alcalase’, the use of ‘alcalase’ in the claims was held to be ‘generic’ – referencing a protease preparation that included but was not limited to the Novozymes ‘Alcalase’ protease product – providing a sufficiently certain meaning.

Background

Manildra Milling Corporation sought to claim a method of producing gluten-free starch comprising a series of steps, one of which included treatment with ‘alcalase’, while the description referred to both ‘alcalase’ and ‘Alcalase’.  Alcalase® is a proprietary name, owned by Novozymes, and applied to its products containing a proteolytic enzyme produced by submerged fermentation of a selected strain of Bacillus licheniformis.

Opponent MGP Ingredients submitted that the use of a proprietary name din the claims gave rise to a lack of clarity as the Novozymes product may change over time creating a movable target such that the scope of the claims are indeterminate.

Manildra submitted that ‘alcalase’ referred unambiguously to any food grade Alcalase product, ie a productcontaining the protease enzyme derived from Bacillus licheniformis.

MGP’s opposition was ultimately unsuccessful on the ground of lack of clarity, and on its other pressed grounds (support, inventive step and support). No appeal was filed, and the patent has now been granted.

Key Issues

Whilst there is no express prohibition on the use of trade marks in a patent claim, Australian and New Zealand patent examiners typically frown upon such use.  A trade mark is a sign that denotes origin, and a trade mark-branded product may vary from jurisdiction to jurisdiction and over time.  Therefore inclusion of a trade mark in Australian and New Zealand claims will typically result in clarity objections during examination.

With a claim directed to or encompassing a pharmaceutical substance, it is often possible to amend the claim to replace the brand name of a drug with its generic name (i.e. the International Non-Proprietary Name or INN) without triggering an added matter objection.  However, in some circumstances (e.g. where there is no INN), an alternative amendment strategy may be required to overcome the objection.

Whilst there has been no relevant case to date, according to IP Australia’s Patent Manual of Practice and Procedure:

A claim that uses a trade mark to identify an element of an invention may not be clear through an inability to establish the precise scope of the claim.  Where the scope of a claim is uncertain or ambiguous as the result of the use of a trade mark, examiners should object that the claim lacks clarity [2.11.5.7A].

Further:

A trade mark is used to identify the source of origin of a good, not its properties.  For example, the composition of laundry detergents sold under a particular trade mark or proprietary name are likely to vary in different regions of Australia (due to differences in the ‘hardness’ of local water supplies), as well as change over time [2.11.3.8A]

Is a Trade Mark a Moveable Target?

In determining whether the use of ‘alcalase’ in the claim resulted in a lack of clarity, the hearing officer looked quoted the decision of Hely J in Flexible Steel Lacing Company v Beltreco Ltd¹:

“Lack of precise definition in claims is not fatal to their validity, so long as they provide a workable standard suitable to the intended use.  The consideration is whether, on any reasonable view, the claim has meaning. In determining this, the expressions in question must be understood in a practical, commonsense manner. Absurd constructions should be avoided and mere technicalities should not defeat the grant of protection.”

The hearing officer summarised MGP (the opponent’s) concern as ‘a feature defined by a trade mark is indeterminate over time given that the manufacturer may change the product sold under the trade mark, creating a movable target such that the scope of the claim cannot be determined’.

Outcome

Here because the hearing officer accepted that the term ‘alcalase’ was used in the claim in a generic manner, reflecting use in the field ‘over an extended period’, the hearing officer rejected the MGP challenge based on lack of clarity.    The hearing officer said:

‘In this case, neither the claims nor the description refer explicitly to a specific product….. but the specification refers to Alcalase in a more general manner as a protease.  It appears based on the contemporaneous evidence that there has been, over an extended period, an understanding that the term Alcalase refers to a commercially available protease preparation from Bacillus licheniformis and there was no evidence before me that this has ever been otherwise.  The opponent noted that the apparent generic use of ‘alcalase’ in the specification and in other documents does not mean that the term has in fact become generic.  Such a conclusion is clearly outside the scope of this decision, but it is necessary to understand how the skilled person would understand the term Alcalase.  The use of this term, particularly in contemporaneous documents, is necessarily indicative of how the skilled person would understand it, and I consider the use in the specification to be part of the context within which the understanding arises.  In the context of this application and based on the evidence of the experts and other documents discussed previously, I consider that the skilled person would understand Alcalase to refer to a protease preparation (specifically, serine protease) derived from Bacillus licheniformis.”

MGP’s support and inventive step challenges were also unsuccessful.

Implications

Prudent applicants will ensure that all claimed terms are broader than any registered mark.  However, where a trade mark is used more broadly in the specification than as a reference to the goods supplied under that mark, such use may not be terminal to registration in Australia.  Use of a proprietary name in a claim may not be terminal to validity of the claim where a reference to a trade mark-protected product is clearly defined within the specification to include a specific disclosure of the claimed features of the proprietary product (eg properties of the product and/or its function(s)).

Whilst amendments to replace a trade mark in patent claims may be possible, they may not be straightforward.  Laws in Australia and New Zealand limit the ability to amend a patent specification after filing by precluding the addition of matter that extends beyond that disclosed in the specification as originally filed.  Except where there is broad disclosure in the specification such an amendment application will likely trigger an ‘added matter’ objection which will result in rejection of the amendment application.

Such broad disclosure is vital in the case where the patent applicant may be forced to amend the claims to remove reference to the trade mark.  Providing clear basis for an amendment will avoid triggering an added matter objection on amendment, and as it did for Manildra here, and may obviate the need for such an amendment entirely.

¹ [2000] FCA 890; (2001) 49 IPR 331 at [81]

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.