A recent YouTube spat over an AI created cover of Britney Spears’ 2004 song “Toxic” demonstrates that AI has now made it possible for one artist to sing a cover of another artist, no human required! In this case, a group called DADABOTS, which describes itself as “a cross between a band, a hackathon team and an ephemeral research lab”, created the rendition using software enabling generation of audio content in the voice of a particular artist, in a particular genre or as a novel fusion. The end result was a Frank Sinatra cover of the Britney Spears song.

Whilst this is a prospect that is bound to be exciting to some, from the perspective of conventional copyright law (and perhaps defamation law), the path to creating such a custom cover track using AI is fraught with complexity and uncertainty.

Yet that didn’t stop DADABOTS rendition being met with something a little more conventional, a copyright takedown notice and subsequent removal from YouTube, as Futurism’s Dan Robitzski recently reported. Futurism noted that GreyZone Inc., a company which offers copyright infringement identification and reporting services, was responsible for the complaint but wasn’t able to identify on whose behalf.

Appeal of YouTube take down

The basis for the original takedown notice is unclear – presumably representatives of either Frank Sinatra or Britney Spears’ respective record labels took the view that their copyright was infringed in some form. In Australia, their songs are likely to be covered by a suite of copyright and related rights, potentially including copyright in the lyrics, the musical work, performance rights and recording rights.

In this case, DADABOTS appealed YouTube’s decision to remove the rendition, calling in aid the US copyright doctrine of fair use. This doctrine is codified in the US Copyright Act and allows “fair use” of copyright works without infringing copyright. Unlike in Australia where the equivalent “fair dealing” is limited to quite specific circumstances, the US Courts have a broad discretion to determine what use is “fair”, depending on factors such as the nature of the copyright work, the purpose of the use and the effect of the use on the potential market for the copyright work. YouTube accepted the appeal and DADABOTS upload was reinstated, albeit with YouTube flagging it as a cover of “Toxic”. YouTube offers a service which allows eligible copyright holders to set up rules dealing with any third party copies of their exclusive copyright content uploaded on YouTube. This might include blocking the uploaded media, taking ad revenue from it or tracking the viewership information. YouTube’s flag of the DADABOTS version presumably makes it subject to any such controls in place in respect of “Toxic”.

Use of copyright works during development of AI powered applications

To make the rendition, DADABOTS used an AI software tool developed by California based OpenAI. Known as “Jukebox”, the software utilises neural networks, a form of machine learning. To become competent, Jukebox was trained by processing various datasets, which in turn allowed it to create the rendition on the basis of what it learnt from that data processing. In this case Jukebox then performed lyrics (of “Toxic”) in the voice and/or genre of the artist on which the software had been trained (Frank Sinatra). According to Open AI’s website, Jukebox was trained on 1.2 million songs, corresponding lyrics and metadata, including artist, genre, year and associated keywords.

Interestingly, Futurism’s article suggests the YouTube appeal arguments were crafted without reference to the use of AI to create the DADABOTS rendition. The fair use arguments were focussed on the end result (i.e. the new rendition) as a fair use in itself, rather than by reference to the method used to create it. Separate to issues around copyright ownership of works created wholly or substantially by AI technologies, the use of copyright works for AI related functions, such as machine learning and datamining is very much a live issue globally. The extent to which such uses are thought to be “fair uses”, is likely to influence the development of the fair use doctrine in copyright, the bounds of which already vary considerably from country to country, if not lead to specific copyright provisions. One notable mover in this space is Japan, which from 1 January 2019 enacted various provisions in its Copyright Act aimed at exempting computer data processing and analysis of copyright works from infringement in certain circumstances. The way in which the law on this topic develops globally may well be a factor which influences where companies with a focus on developing AI powered applications choose to base themselves (if it is not already). Differences in the law on this topic around the globe may also lead to potentially complicated questions of jurisdiction where AI generated material is exported from one country to another.

In Australia, the current law is likely to be less friendly to machine learning and AI powered applications, as a result of the stricter confines on fair dealing, and other limited exceptions to copyright infringement. Certainly where AI applications are used for development which is commercial in nature, it is unlikely that Australian copyright exemptions would apply. While section 40 of the Copyright Act 1968 (Cth) does provide an exemption for fair dealing for research purposes, it has generally been given a narrow reach.

Indeed, extension of the fair dealing provisions in Australia was a topic considered extensively by the Productivity Commission in its review of intellectual property laws in Australia and consequent report issued in 2016. Submissions made on this issue included those from tech companies supporting a broader fair use exception and specifically referring to machine learning in this context. The Productivity Commission ultimately recommended significant reforms in this area paving the way for a US-style fair use exception. However following two years of further consultation, the Government announced in August 2020 only a limited extension of the fair dealing exceptions for non-commercial quotation.

As a consequence, use of datasets to train AI systems in Australia appears likely to carry with it a significant risk of copyright infringement for the foreseeable future, in the absence of an appropriate licence. As the law in this area continues to develop worldwide, this is clearly a space to watch for both copyright owners and anyone using databases of copyright material to power or utilise AI technologies.

Authored by Onur Saygin and Katrina Crooks

Pfizer suffered a setback last week in its Australian battle to protect ENBREL (etanercept), when its preliminary discovery application against Sandoz was dismissed by Justice Burley in the Federal Court. The reasons for the dismissal are not yet public, subject to the parties seeking suppression orders over any confidential information contained in them, but are likely to be released in coming days.

ENBREL is Pfizer’s blockbuster autoimmune disorder therapy, used to treat various chronic diseases including rheumatoid arthritis. Commercially available in Australia since 2003, ENBREL was the only etanercept product registered on the Australian Register of Therapeutic Goods until 2016 when Samsung Bioepis registered BRENZYS, followed by Sandoz’s registration of ERELZI in 2017.

Given ENBREL’s success it is not surprising that patents covering the product are also being litigated elsewhere. In the United States, where Amgen holds the patent rights, ENBREL is its top selling product. The US Federal Appeal Court recently issued its judgment upholding the validity of the ENBREL patents and restraining Sandoz from entering the market there.  Amgen has also filed proceedings against Samsung Bioepis in the US, where Samsung’s ETICOVO is not yet on the market pending the outcome of that litigation.

In Australia, Pfizer launched its preliminary discovery application against Sandoz in November 2019, after winning a similar application against Samsung Bioepis in late 2017. In the Samsung case, Pfizer sought discovery of documents submitted to the Therapeutic Goods Administration in order to ascertain whether BRENZYS infringed three patents covering methods of producing polypeptides and/or proteins in the upstream bioprocessing phase.

The relevant Australian rules provide that preliminary discovery can be sought before a substantive proceeding is commenced, for discovery of documents directly relevant to the question of whether the applicant has a right to obtain relief from the Court. It is necessary to show that the applicant reasonably believes that they may have a right to such relief and that, after making reasonable inquiries, does not have sufficient information to decide whether to start a proceeding to obtain that relief. The Court has a discretion as to whether it makes a preliminary discovery order.

The key issue in the Samsung case was whether Pfizer had the requisite belief that it may have a right to obtain substantive relief; that is, in this case, a belief that Samsung was infringing its patents. The parties filed extensive affidavit evidence, including from experts on this topic. Pfizer advanced six contentions which it argued supported its reasonable belief, including the fact that BRENZYS had been registered on the basis of its biosimilarity with ENBREL, that specific characteristics of BRENZYS were similar to ENBREL, in particular it had similar glycosylation profiles, and that since ENBREL fell within the scope of the relevant patent claims, so must BRENZYS. Considering these arguments in detail, and noting that he had not had the benefit of cross examination of the witnesses, Justice Burley ultimately found that he was not convinced that there was a “reasonable basis” for Pfizer’s belief of patent infringement, as opposed to a mere suspicion (see Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA 285). However, an appeal by Pfizer to the Full Federal Court was upheld (see Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCFCA 193). The Full Court emphasized that the inquiry was not to determine the dispute between the experts, or who was more persuasive, but rather whether Pfizer had a reasonable basis for a belief that it may have a right to obtain relief. Noting the very substantial evidence filed on the application, Allsop CJ emphasised that “these are summary applications not mini-trials”. The High Court subsequently refused special leave for a further appeal. After the matter was remitted to the primary judge to determine the final form of orders, those orders were made in May 2019 and the proceeding still continues after orders were made earlier this year for any application for further discovery to be filed.

In light of the more generous approach to preliminary discovery applied by the Full Court in the Samsung case, it will be interesting to see the reasons for Justice Burley’s decision in the Sandoz case. It certainly seems plausible that another appeal to the Full Court is on the horizon. More generally, we expect to see more preliminary discovery applications in patent disputes in years to come, given the increasing significance in Australia (as elsewhere) of biosimilar patent litigation. In that sphere, patents covering manufacturing processes are likely to assume greater importance in light of the additional complexities at play in claiming active biological molecules per se, and the significance of specific manufacturing processes in the production of biologics. Given the likely lack of available information as to a competitor’s manufacturing processes, preliminary discovery may be an essential weapon in many such cases. It also remains to be seen whether we will see more applications to be released from the general undertaking only to use information obtained in an Australian proceeding for the purpose of that proceeding, in order to allow, for example, preliminary discovery obtained in Australia at an early stage to be used for the purpose of corresponding US proceedings.

We look forward to providing a further update when the judgment is released in this case.

Authored by Katrina Crooks

Shelston IP assisted Legal 500 in their recent launch of The Legal 500: Patent Litigation Country Comparative Guide.

Our highly experienced litigation team have provided their expertise for the Australian Patent Litigation Chapter.

The aim of this guide is to provide its readers with a pragmatic overview of the law and practice of patent litigation law in Australia.

Each chapter of this guide provides information about the current issues affecting patent litigation in Australia and addresses topics such as direct and indirect patent infringement, patent invalidity, post-grant opposition proceedings and injunctions, and future patent litigation growth areas.

Authored by Duncan Longstaff, Katrina Crooks, Mark Vincent and Stuart Hughes

Boehringer Ingelheim Animal Health USA Inc. v Intervet International B.V. [2020] FCA 1333

Key takeaways:

  • For novelty purposes, expert evidence does not make up for a lack of sufficiently clear and unambiguous directions in the prior art or for a lack of teaching that would inevitably result in the invention
  • Invention was a “substantial departure” from known formulations, particularly in the face of a long-standing need for combination anthelmintic treatments and was thus not obvious
  • Lack of utility was not established in the circumstances

Background

Merial Inc (now Boehringer Ingelheim Animal Health USA Inc (Boehringer)) appealed from an opposition decision in respect of Australian patent application AU 2011268899 (the application).

The invention described in the application relates to injectable formulations comprising a macrocyclic lactone and levamisole for controlling parasites in animals, and the use of such formulations in the preparation of a medicament for controlling parasites.

The problem addressed by the application was that some parasites develop a resistance to anti-parasitic drugs. Combinations of known drugs had been used in the art to overcome this resistance, but it was desirable to develop an injectable formulation for a combination of a macrocyclic lactone and levamisole, two of the most widely used and effective antiparasitic (anthelmintic) drugs.

However, such combinations have been difficult to formulate, for three main reasons:

First, levamisole and macrocyclic lactones are chemically incompatible and tend to react with each other when combined.  Secondly, levamisole and macrocyclic lactones are stable under different pH conditions (levamisole requires a pH of about 3.0-4.0 to be stable, while macrocyclic lactones require a pH of around 6.0-7.0).  Finally, levamisole salts are soluble in water, whereas macrocyclic lactones are not water soluble but are soluble in organic solvents, and are commonly formulated in oils and organic solvents.

The invention in the application addressed these issues by adopting a non-aqueous solvent system comprising oil and an organic solvent, in which the macrocyclic lactone is in solution, and the levamisole is a salt in particulate form (that is, in suspension).  This type of formulation achieves a separation of the macrocyclic lactone and the levamisole, thus addressing the issue of chemical incompatibility.

Claim 1 of the application is as follows:

  1. An injectable formulation of a macrocyclic lactone and levamisole in a non-aqueous solvent system comprising oil and an organic solvent, wherein the macrocyclic lactone is in solution and the levamisole is a salt in a particulate form, and wherein the levamisole salt is present in the range of between 10-35% w/v.

The Appeal

Boehringer was unsuccessful in its opposition in the Patent Office and appealed on various grounds:

(a)          Lack of novelty.  Boehringer contended that various claims were not novel in light of Chinese patent application CN 1375291A (CN 291).

(b)          Lack of inventive step.  Boehringer contended that the claims did not involve an inventive step because they were obvious in the light of the common general knowledge considered alone, or the common general knowledge combined with CN 291.

(c)           Lack of utility.  Boehringer contended that the invention claimed in each of the claims was not useful, in that the claims of the application include embodiments that do not achieve the promise of a physically and chemically stable suspension formulation of a macrocyclic lactone and levamisole.

Novelty

CN 291 was a patent application published on 23 October 2002 for an invention titled “Veterinary Compound Injection Containing Levamisole or Salts thereof”.

Example 3 of CN291 set out an oil injection containing a combination of ivermectin (a macrocyclic lactone) and levamisole hydrochloride.  However, it was clear that the concentration of levamisole HCl in Example 3 at 5% w/v did not fall within the scope of claim 1 of the application, which specified 10-35% w/v.  Further, Example 3 did not set out any manufacturing steps, or any description of what was intended to be made.  Moreover, it did not describe the levamisole HCl as being in particulate form (or in a suspension).

Boehringer submitted that Example 3 of CN 291 was to be read in conjunction with claim 3 of CN 291, which discloses levamisole HCl in the amount of 10-20% w/v, and with page 3 of the specification, which discloses that preferably the levamisole HCl is present in the amount of 10-20% w/v.  Further, Boehringer submitted that a skilled person reading CN 291 as a whole would understand that CN 291 contained a direction, recommendation or suggestion to make the Example 3 formulation using 10-20% w/v levamisole HCl, because they would consider the 5% w/v concentration of levamisole HCl stated in Example 3 to be far too low for cattle, particularly in light of the other teaching in CN 291.

Based upon expert evidence, Boehringer further argued that the skilled person would expect the levamisole HCl in Example 3 to be suspended in the solvent system and to be present in particulate form, because the skilled person would expect that levamisole HCl will not dissolve in the solvent system of Example 3.  To support this view, Boehringer provided details of two formulations prepared by its expert witnesses following the guidance of CN 291 that fell within the scope of claim 1 of the application.

However, Moshinsky J was not convinced, finding that there was no sufficiently clear and unambiguous direction to modify Example 3 by applying the higher concentration level described elsewhere.  Further, the Court emphasised that Example 3 did not describe the intended formulation as one in which the levamisole HCl is in particulate form.

In addition, the appellant’s expert formulator conceded under cross-examination that the formulation in Example 3 could be a suspension or a solution.

The Court was not swayed by the experiments conducted by the appellant as they involved a number of departures from the teaching of Example 3, and did not establish that any steps used to manufacture a formulation having the composition of Example 3 would inevitably contain levamisole HCl in particulate form.

Inventive Step

Boehringer contended that that it would have been obvious to the notional skilled person or team, based on the common general knowledge alone, or in light of the common general knowledge together with CN 291, to make a suspension formulation using an oil or organic carrier as a base and a co-solvent such as benzyl alcohol (an organic solvent), in which the macrocyclic lactone was in solution and the levamisole salt was in suspension.  It submitted that the skilled person would appreciate that, in such a composition, the levamisole salt would be in particulate form, and that they would know to use a concentration of levamisole salt sufficient to achieve the desired dose in a product for cattle having a dose volume rate of 1 mL/25 kg, which results in a formulation in accordance with claim 1 of the application.

However, the Court found that an oily formulation with levamisole present as a particulate was a substantial departure from known formulations, particularly (and most significantly) in respect of levamisole.  The expert evidence had also shown that, in order to be effective, levamisole needed to reach a high peak concentration in the animal’s gut rapidly, and preferably underwent similarly rapid clearance from the animal to meet regulatory requirements.  As there were no existing formulations of levamisole as a particulate in oil, a carrier often used to slow down absorption of a drug, it was not clear in the common general knowledge whether an effective peak concentration of levamisole could be reached in the animal using such a formulation.  Further, the evidence showed that there is a risk that an active ingredient formulated as a suspension will not be dispersed evenly throughout the formulation, or may result in agglomeration of the particles.

Based upon the evidence, it was held that a solution appeared to be preferable to a suspension for an injectable formulation, and that the above uncertainties as to efficacy, as well as others, would point away from the adoption of such an approach.

Secondary evidence such as the long-standing need for combination treatments of levamisole and a macrocyclic lactone and the desirability of having such a combination in injectable form were also held to support the existence of an inventive step.

Moreover, it was held that CN 291 would not provide any direct assistance to the notional skilled team in addressing the known chemical incompatibility of levamisole and macrocyclic lactones, a finding that was conceded by experts for Boehringer during cross-examination.

Lack of Utility

Boehringer submitted that the stability data in Intervet’s patent application WO 2017/108954 A1 (WO 954) (which Intervet accepted disclosed formulations falling within the scope of claim 1 of the application in suit) demonstrates that not all formulations falling within the scope of the claims of the application achieve the promise of being physically and chemically stable.  In particular, Boehringer relied on data in Table 4 of WO 954 for 2 months, at which point a loss of stability was shown.

However, the figures in Table 4 for 3 months – this being the relevant period for the purposes of the promise – did not show such a loss of stability.  Accordingly, it was held that the data in Table 4 did not establish that the invention failed to meet the promise of stability (that is, stability for 3 months under accelerated conditions).  Moreover, it was found that the data in Table 4 was inherently unreliable, and, even if it had shown a loss of stability as at 3 months, the Court would not have been satisfied that the invention failed the promise of stability.

Costs of amendment applications

In a subsequent judgment (Boehringer Ingelheim Animal Health USA Inc. v Intervet International B.V. (No 2) [2020] FCA 1433, The Court dealt with the costs of two interlocutory amendment applications.

In respect of each interlocutory application to amend, the Court found that “Intervet sought something in the nature of an indulgence.”  Referring to Les Laboratoires Servier v Apotex Pty Ltd (2010) 273 ALR 630 at [59]; cf Eli Lilly and Co v Pfizer Research and Development Co NV/SA (2003) 59 IPR 234, the Court held that in such cases, the patentee may be ordered to pay the costs of the amendment application, regardless of the outcome.

Accordingly, Boehringer’s request that each party bear its own costs was appropriate, particularly in circumstances where there was no adjudication on the merits of either application because Boehringer had ultimately consented to the amendments.

Ono Pharmaceutical Co., Ltd. et al [2020] APO 43 (16 September 2020)

Background

Australia’s Patents Act provides a patent term extension (PTE) to account for the delays that can occur when obtaining regulatory approval for a pharmaceutical substance.   The extension can last for up to five years and is available when the following requirements are met:

  • the patent, in substance, discloses and claims a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology;
  • goods containing or consisting of the pharmaceutical substance are included in the Australian Register of Therapeutic Goods (ARTG); and
  • the first regulatory approval for the pharmaceutical substance occurred more than five years after the filing date of the patent.

The length of a patent term extension is equal to the period between the filing date of the patent and the date of the earliest first regulatory approval, reduced by five years.

The decision

Ono Pharmaceutical Co., Ltd. et al [2020] APO 43 concerned a request to extend the term of a patent covering anti-PD-1 antibodies.  The patent included claims for two blockbuster drugs; Merck Sharp & Dohme’s KEYTRUDA and the patentee’s OPDIVO, both of which received regulatory approval in Australia, but on different dates.  The question at issue, then, was which regulatory approval date was relevant for deciding the patentee’s PTE request.

The patentee hedged its bet, filing two PTE requests; one based on KEYTRUDA, which received regulatory approval on 16 April 2015, and another based on OPDIVO, which received regulatory approval on 11 January 2016.  From the patentee’s perspective, the request based on OPDIVO was preferred as it would result in a longer extended term (an additional 8 months, 26 days).  However, the Patent Office refused that request, finding that KEYTRUDA was included on the ARTG first and therefore should form the basis of the request.  The patentee disagreed and requested to be heard.

In the hearing, the patentee submitted that the “first regulatory approval date” should be the approval date of their own product, OPDIVO.  This, they argued, was consistent the purpose of the extension of term provisions, that being to restore the time lost by patentees in gaining marketing approval, and to compensate the patentee for the additional time, expense and difficulty in developing and commercialising a new drug.

The patentee argued that the reference to “first” regulatory approval in the Act was only important when multiple regulatory approval dates existed for the same substance, such as for different delivery forms (e.g. capsules, gel capsules, tablets, slow-release, different amounts, etc) that manifested in different ARTG registrations.  According to the patentee, it was only logical, given that the regime is intended to be beneficial and remedial, that it can only be about rewarding patentees for their work and, by implication, not the work of others.  If not, the patentee would not receive the full extension of term for their product.

The Delegate accepted that the PTE regime was designed to encourage the development of new drugs, but rejected the patentee’s broader purposive construction of the Act.  Such a construction, the Delegate noted, would encourage companies to develop a substance that is not new and seek regulatory approval as late as possible, secure in the knowledge that a PTE will be granted for the (not new) substance.  According to the Delegate, this type of scheme would not incentivise new drugs. Rather, it would incentivise new extension applications.

The Delegate acknowledged that there is some ambiguity in the words of the Act insofar as they do not say one way or the other whether the relevant pharmaceutical substance is only that belonging to the patentee, or whether it includes other, equivalent substances owned by third parties.  But the Delegate also noted that this ambiguity had been dealt with previously by the Patent Office in G.D. Searle LLC [2008] APO 31.  In that case, the Patent Office held that an application for PTE must be based on the earliest inclusion on the ARTG of a pharmaceutical substance falling within the scope of the claims, irrespective of the sponsor of the goods.  Moreover, in Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176, the Federal Court of Appeals held that “the term of the extension is based on the earliest inclusion, regardless of the identity of the sponsor. It is not open to the Commissioner to calculate the term of the extension only on the basis of goods sponsored by the Patentee.”

The Delegate therefore found that the substance with the earliest regulatory approval date for the purpose of the PTE request was KEYTRUDA, not OPDIVO.  As such, the patentee’s request for a PTE based on OPDIVO was refused.

Conclusion

In circumstances where a patent claims more than one registered pharmaceutical substance, this decision confirms that the earliest registered substance will be used to determine eligibility for a PTE and to calculate the length of the extension, irrespective of whether the registered substance is owned by the patentee or by a third party.  Patentees should therefore be aware of all pharmaceutical substances covered by their claims, not just those they are seeking to commercialise. If a patent application covers more than one pharmaceutical substance, an applicant may be well-advised to file one or more divisional applications to ensure that each registered substance is quarantined within its own patent, thus enabling maximum extensions to be sought for each patent separately.

In the recent decision, CSIRO v BASF Plant Science GmbH [2020] FCA 328, the Federal Court of Australia considered the allowability of amendments to patent specifications under s 102(1) of the Patents Act 1990, as amended by the ‘Raising the Bar’ Act[1]. In overturning a decision of the Commissioner of Patents, Beach J decided that BASF’s proposed amendments were impermissible because they claimed and disclosed matter that extended beyond the specification as filed. In so doing, the Court decided that the same strict test used by UK Courts should also be applied in relation to added matter in Australia.

The Background

At issue is a patent application filed by BASF Plant Sciences GmbH (BASF) entitled “Process for the production of polyunsaturated fatty acids in transgenic organisms”, which relates to genes from a species of unicellular algae that code for enzymes which can be employed for the recombinant production of polyunsaturated fatty acids (PUFAs) in plants. Specifically, the invention relates to a pathway for the synthesis of long-chain PUFAs, that involves a sequence of enzymatic reactions to convert shorter-chain PUFAs into commercially desirable long-chain PUFAs. The claims relate to isolating the genes for those enzymes in a species of unicellular algae, Ostreococcus lucimarinus, and introducing those genes into suitable oil-producing crops. Performing the invention enables the production of the valuable fatty acids in transgenic commercial crops.

CSIRO opposed BASF’s accepted application, and during the opposition proceedings BASF applied to amend its patent and introduce new dependent claims. The Australian Patent Office initially refused the proposed amendments on the basis that, as a result of the proposed amendments, the specification would not comply with the requirements of s 40(3). However, a second set of proposed amendments was submitted, which a Delegate of the Commissioner of Patents subsequently allowed. CSIRO then lodged an appeal to the Federal Court against that decision under s 104(7) of the Patents Act 1990.

The amendments

In a passage referred to by the parties as the “bridging paragraph”, the specification as filed stated that:

      “The invention, the subject of the present application, is directed to the following:

  • a CoA-dependent delta-6 desaturase having the substrate specificity of the delta-6 desaturase shown in SEQ ID NO:14 [referred to by Beach J as Feature A]and
  • the above CoA-dependent delta-6 desaturase which has a preference for conversion of alpha linolenic acid compared to linoleic acid [referred to by Beach J as Feature B].” (emphasis added)

The experts agreed that the words “the above” in the statement in the second bullet point of the bridging paragraph meant that this statement (i.e., the “conversion preference”) must be read together with the statement in the first bullet point of the bridging paragraph (i.e., the “substrate specificity”). In other words, the invention is directed to the claimed enzyme having the substrate specificity shown in amino acid “SEQ ID NO:14”, and having a certain conversion preference. The bridging paragraph is the only place in which a conversion preference is disclosed in the body of the specification of the application as filed. The invention described in each bullet point of the bridging paragraph is claimed in claims 1 and 2 respectively of the application as filed.

BASF removed the bridging paragraph and deleted corresponding claims 1 and 2 by amendment during prosecution and replaced it with a description that defines the invention as:

  • a process for the production of a substance of general formula I … wherein the process comprises the cultivation of (i) a host cell … or (ii) a transgenic non-human organism comprising … “an isolated polynucleotide comprising a nucleic acid sequence coding for a CoA-dependent delta-6 desaturase having at least 75% identity to a nucleotide sequence which codes for a polypeptide as shown in SEQ ID NO: 14” [referred to by Beach J as “Feature C”]; and
  • use of an isolated polynucleotide … (or vector, host cell, or transgenic non-human organism comprising said nucleic acid sequence) … for the production of an oil, lipid or fatty acid composition.

In light of the amendments to the bridging paragraph and the deletion of the corresponding claims, the application as accepted did not refer to Feature A, Feature B or Feature A combined with Feature B.

As Beach J noted at [130], Feature C captures a broader range of polypeptides than Feature A. That is, Feature A (substrate specificity of the Δ6-desaturase shown in SEQ ID NO:14) is a subset of Feature C (at least 75% identity to SEQ ID NO:14).

In a further round of post-acceptance amendments BASF sought to insert new dependent claims, to a process for production of, and use of, a CoA-dependent Δ6-desaturase:

a) having at least 75% identity to a nucleotide sequence which codes for a polypeptide as shown in SEQ ID NO:14 [Feature C]; and

b) that preferentially converts alpha linolenic acid compared to linoleic acid [Feature B].

The amendments also sought to introduce the following description after the consistory clause:

“According to an embodiment of the abovementioned process and use, the CoA-dependent desaturase preferentially converts alpha-linolenic acid compared to linoleic acid.” [Feature B]

CSIRO argued (at [166]) that the post acceptance amendments were not allowable as they would introduce a claim combining Feature C with Feature B, when the only disclosure of Feature B in the specification as filed was in the context of Feature A (a much narrower subset of Feature C) in the bridging paragraph.

Issues and Decision

Section 102(1) relevantly provides:

(1) An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim or disclose matter that extends beyond that disclosed in the following documents taken together:

(a) the complete specification as filed;

(b) other prescribed documents (if any).

Beach J noted that that the Raising the Bar provisions were intended to mirror other jurisdictions, such as the UK and Europe, and that it was intended that Australian courts would have regard to the developments of case law in those jurisdictions when interpreting the Raising the Bar provisions. More specifically, he noted the intention disclosed in the explanatory memorandum to the Raising the Bar amendments that the operation ss40(2) and (3) as amended (which deal with sufficiency and support) be as close as practicable to that given to the corresponding provisions in the UK Patents Act and the European Patent Convention,

Beach J therefore commenced a review of the UK authorities and in coming to his decision, noted two “conceptual themes permeate the UK authorities”, namely “added matter” and “intermediate generalisation”.

In terms of the former, and with reference to several landmark UK decisions on added matter (including Bonzel[2]Richardson-Vicks[3], and European Central Bank[4]), it was noted that subject matter will be impermissible added matter “unless it is clearly and unambiguously disclosed in the application as filed”, having reference to what has been disclosed both explicitly and implicitly.

As to intermediate generalisations, it is useful to consider the EPO guidelines[5], which explain:

“…the content of the application as filed must not be considered to be a reservoir from which individual features pertaining to separate embodiments can be combined in order to artificially create a particular combination.

When a feature is taken from a particular embodiment and added to the claim, it has to be established that

  • the feature is not related or inextricably linked to the other features of that embodiment and
  • the overall disclosure justifies the generalising isolation of the feature and its introduction into the claim.

… it has to be ensured that the skilled person is not presented with information which is not directly and unambiguously derivable from the originally filed application, even when account is taken of matter which is implicit to a person skilled in the art using his common general knowledge”

In other words, the concept of “intermediate generalisation” requires that an amendment is not allowable if it takes a feature which is only disclosed in a particular context and seeks to introduce it into a claim deprived of that context.

Beach J found that there was “no good reason not to follow the UK authorities” to apply these analogous concepts for the purposes of construing the present form of s 102(1) of the Act.[6] In doing so, Beach J confirmed that, after Raising the Bar “the test is a strict one” in Australia, and that the concept of intermediate generalisation applies to s 102(1).

BASF argued that the relevant amendments, including the addition of new claims, were narrowing amendments. Beach J accepted this insofar as the comparison was with the accepted claims, however he noted that this did not resolve the issue of whether the amended specification would claim or disclose matter extending beyond that disclosed in the specification as filed.

BASF further argued that there was disclosure of Feature C in a particular paragraph of the specification as filed. However, Beach J decided that this paragraph could only be read in the context of the description of ‘the invention’ in the bridging paragraph. In this regard, Beach J considered that the bridging paragraph did not provide disclosure of a delta-6 desaturase with Feature B (the “conversion preference”) in the absence of Feature A (the “substrate specificity”).  As mentioned above, Justice Beach also considered that Feature A was not the same as the 75% homology requirement that BASF sought to introduce into the claims (Feature C).  This was because two enzymes can have different substrate specificities and still have 75% homology to each other at the DNA level.

Justice Beach concluded that BASF’s amendment sought to remove Feature B from the context in which it was disclosed in the application as filed (namely, in conjunction with Feature A) and introduce it into the specification and the claims deprived of that context.  The amendments generalised the originally disclosed technical information (applying Feature B in the broader context of Feature C, as opposed to Feature A), thereby introducing subject-matter extending beyond the content of the application as filed. This was an example of an impermissible intermediate generalisation.

As a result, BASF’s amendment was refused, and CSIRO’s appeal was upheld.

Commentary

In the first Federal Court decision on “added matter” under the Raising the Bar Act, Beach J has confirmed that the test in Australia for added matter is strict, and that subject matter will be impermissibly added “unless it is clearly and unambiguously disclosed in the application as filed”. Importantly, until now it has not been clear whether the prohibition on “intermediate generalisation”, a familiar concept in European patent law, would be adopted in Australia. Beach J has confirmed that an intermediate generalisation is not permissible, where a feature which is only disclosed in a particular context (e.g. a particular example) is introduced into a claim deprived of that context.

At the time of filing a patent application, it is important to provide a full disclosure of your invention as adding subject matter later will not be allowable. It is also important to ensure that your patent application discloses your invention in terms that encompass all variants of the invention that you may later wish to claim.

Such limitations should also be borne in mind if seeking to limit granted claims in pre-litigation or litigation to avoid prior art brought to the attention of the patentee.

Shelston IP is well placed to advise its clients on how to best draft a patent specification to satisfy these important requirements and on related issues in a litigation context. If readers have any questions, please do not hesitate to contact any of our Shelston IP patent attorneys or lawyers.


[1] Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (the Raising the Bar Act)

[2] Bonzel v Intervention Ltd (No 3) [1991] RPC 553 (Bonzel)

[3] Richardson-Vicks Inc’s Patent [1995] RPC 568 (Richardson-Vicks)

[4] European Central Bank v Document Security Systems Inc [2007] EWHC 600 (European Central Bank)

[5] https://www.epo.org/law-practice/legal-texts/html/guidelines/e/h_v_3_2_1.htm

[6] Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH [2020] FCA 328 at [214]

In an unprecedented decision, the Federal Court of Australia has considered and dismissed a claim by the Commonwealth Government for compensation from sponsors of innovator pharmaceutical products, pursuant to undertakings as to damages given in exchange for an interlocutory (preliminary) injunction restraining the launch of the first generic product: Commonwealth of Australia v Sanofi (No 5) [2020] FCA 543.

Notwithstanding this first-instance decision against the Commonwealth, given some of the findings in the case, the potential for Commonwealth damages claims would appear to remain a relevant factor to be taken into account by innovators in their risk assessment, prior to commencing any application for an interlocutory injunction to restrain the launch of a first generic or biosimilar competitor product.

The judgment also provides a number of other “takeaways” for both innovators facing generic launch during the term of a patent, and generics defending their position in such circumstances, which are discussed further below.

Key Findings

  • In principle, the Commonwealth is not precluded from claiming compensation under a patentee’s usual undertaking as to damages, where it can be established that the Commonwealth’s loss would not have occurred but for the grant of the interlocutory injunction, the loss was a direct legal consequence of the grant of the injunction, and the loss was reasonably foreseeable.
  • However, the Court found that the Commonwealth’s losses were not a direct consequence of the interlocutory injunction granted in this case which, although restraining infringement of Sanofi’s patent generally, did not explicitly restrain listing on the Commonwealth’s Pharmaceutical Benefits Scheme (PBS) (instead, Apotex gave a separate undertaking, not supported by any undertaking as to damages, to refrain from listing its products on the PBS pending the outcome of the patent case). This finding calls into question future Commonwealth damages claims based on interlocutory injunctions that do not explicitly restrain PBS listing.
  • Compelling evidence (supported by contemporaneous documents) from the ultimate decision-makers at the generic party and the Commonwealth is likely to be required to convince the Court that, but for the grant of the interlocutory injunction, the generic product would have been launched and listed on the PBS in the face of the significant damages risk if the patent owner ultimately succeeded in establishing infringement of a valid patent claim. In the present case, the Commonwealth failed to lead evidence from those key decision-makers and, in those circumstances, the Court was not prepared to draw inferences favourable to the Commonwealth, or accept the evidence given by subordinates without the relevant decision-making authority.
  • The Court found that it was more likely than not that the Commonwealth would have been prepared to reverse statutory reductions in the reimbursed price for Sanofi’s products triggered by the generic listing on the PBS, if sale of the generic product was subsequently restrained by a permanent injunction.

Background to the litigation

The case concerned the blockbuster blood-thinning (platelet-inhibiting) medication clopidogrel, sold in Australia by Sanofi as PLAVIX and by Bristol-Myers Squibb (BMS) as ISCOVER, under a global co-marketing arrangement. Apotex proactively commenced proceedings in August 2007 against Sanofi seeking revocation of Sanofi’s Australian Patent No. 597784 (the Patent), relating to clopidogrel and various of its salts. The litigation progressed relatively quickly, compared to more recent cases in the Federal Court. An interlocutory injunction was granted in late September 2007, the trial on validity was conducted in April 2008 and a first-instance decision upholding the validity of some claims of the Patent was delivered in August 2008. A Full Court appeal decision, revoking all claims of the Patent, was delivered in late September 2009 and an application by Sanofi for special leave to appeal to the High Court was refused in March 2010. Apotex’s clopidogrel products were listed on the PBS from 1 May 2010. In 2010, Apotex and other generic companies commenced damages proceedings, seeking compensation from Sanofi and BMS pursuant to the undertaking as to damages. Those claims were settled in 2014. The Commonwealth brought its claim for damages in 2013.

The interlocutory injunction obtained by Sanofi in September 2007 restrained Apotex from infringing the Patent, including by importation and sale of pharmaceutical products which had clopidogrel as their active ingredient. Sanofi gave the usual undertaking as to damages in connection with the interlocutory injunction. Importantly, the interlocutory injunction did not expressly prevent Apotex from applying for inclusion of its products on the PBS. However, on the same date (and noted in the same set of orders as gave effect to the interlocutory injunction) Apotex gave the Court a voluntary undertaking (the Apotex Undertaking) that it would not apply to list its clopidogrel products on the PBS until the determination of the patent proceeding. Sanofi did not provide any cross-undertaking as to damages for the Apotex Undertaking.

The Commonwealth’s claim

The Commonwealth claimed losses in respect of the supply of clopidogrel products under the PBS, said to result from the delay in the Commonwealth’s ability to reduce the subsidised price for those products via statutory price reductions triggered by first generic entry and subsequent price disclosure-related reductions. The various components that made up the claimed price difference amounted to a sum of approximately AU$325 million, excluding interest:

AU$51 m

Mandatory statutory price reductions that would have occurred if generic clopidogrel products had been listed on the PBS on 1 April 2008 (then a 12.5% reduction), with a further 2% reduction on 1 August 2009.

AU$216 m

Price disclosure-related price reductions that would have occurred between 1 April 2010 and 31 December 2014.

AU$58m

Payments made by the Commonwealth to subsidise supply of clopidogrel plus aspirin combination products in the period 1 December 2009 to 31 March 2016.

This is the first case in which judgment has been given on a Commonwealth claim for damages pursuant to a pharmaceutical patentee’s undertaking as to damages given in connection with grant of an interlocutory injunction. The Commonwealth has previously settled claims for compensation against Wyeth,[1] relating to extended release formulations of the antidepressant venlafaxine (EFFEXOR-XR) (a decision in that case concerning damages claims by generic suppliers issued in late 2018), and against AstraZeneca relating to the “super statin” rosuvastatin (CRESTOR) (in that case, both the Commonwealth and the generic parties reached a settlement with AstraZeneca).[2] A Commonwealth claim for damages pursuant to undertakings given by Otsuka and BMS in relation to the antipsychotic aripiprazole (ABILIFY) is continuing.[3]

The guidance provided to the Australian pharmaceutical industry by this clopidogrel decision complements the recent (late 2018) Federal Court decision relating to venlafaxine, in which generic party claims arising from an undertaking as to damages were upheld: Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2018] FCA 1556. In the venlafaxine case, the Court found that the unsuccessful innovator patentee should pay compensation to both the generic companies party to the litigation, and third party generic companies who were affected by the interlocutory injunction. The Commonwealth settled its claim with the patentee Wyeth before trial, but its evidence and submissions were referred to in the decision on the generic party claims, with an intimation that the Commonwealth could, in the right circumstances, have a sound claim to compensation. However, Nicholas J’s decision in the present clopidogrel case highlights the need to satisfy the threshold requirement for the Commonwealth’s loss to flow directly from the interlocutory injunction itself, and the significant circumstantial and evidentiary hurdles the Commonwealth will often face in proving what would have happened if there had been no interlocutory injunction.

The Court’s reasoning

The Court’s findings regarding the complex issues, arguments and evidence led by the parties can be distilled as follows:

  • Did the interlocutory injunction restrain Apotex from PBS-listing? – Nicholas J found that the Apotex Undertaking, which had been given voluntarily, was not a necessary or natural consequence of the making of the interlocutory injunction. His Honour did however accept the Commonwealth’s position that the Apotex Undertaking would not have been proffered but for the interlocutory injunction, and that the interlocutory injunction had the practical (indirect) effect of preventing Apotex from applying for PBS listing of its generic clopidogrel products.
  • Would Apotex have PBS-listed “but for” the interlocutory injunction? – Despite Apotex’s Australian Managing Director giving evidence that Apotex would “almost certainly” have launched “at risk”, Nicholas J was not satisfied that Apotex’s CEO and ultimate decision-maker would, in September 2007, have authorised such a launch in the circumstances where:
    • hypothetically, no interlocutory injunction had been granted;
    • a judgment in the validity trial was expected within 1 year, given that the presiding judge was due to retire; and
    • significant financial consequences would result if the challenge to the validity of the Patent failed, because Apotex “…could find itself having to cease any further sales following the grant of a final injunction shortly after obtaining a PBS listing that triggered a price reduction that might not be reversed or, at least, might not be reversed for some significant period of time”.
  • Was the Commonwealth’s loss a direct consequence of the interlocutory injunction, or too remote? – Nicholas J found that the interlocutory injunction did not directly affect the legal rights, obligations or interests of the Commonwealth as it did not prevent the Commonwealth receiving applications for PBS listing from Apotex or any other generic supplier. His Honour also considered that the fact that Sanofi’s undertaking as to damages did not extend to the Apotex Undertaking gave strong contextual support to the view that the undertaking as to damages should not be interpreted as extending to loss suffered by the Commonwealth due to Apotex being prevented from applying for PBS listing as a result of its voluntary undertaking.
  • Could the Commonwealth’s loss have been foreseen at the time the interlocutory injunction was granted? – Nicholas J found that all losses claimed by the Commonwealth, including the operation of the price disclosure price reduction regime and the pricing of the clopidogrel plus aspirin combination products, were reasonably foreseeable. His Honour rejected Sanofi’s contention that it could not have reasonably foreseen that the Commonwealth would be affected, as no legal right or liability of the Commonwealth was affected by the interlocutory injunction.
  • Was the loss claimed by the Commonwealth compensable (in principle)? – Nicholas J found that the Commonwealth was in principle entitled to seek compensation under Sanofi’s undertaking because its circumstances were not different from those of a natural person, notwithstanding that it had control over the PBS regime.
  • Would the statutory PBS price reductions have been reversed? – Nicholas J considered it more likely than not that the Commonwealth would have de-listed Apotex’s clopidogrel products from the PBS, and reversed the 12.5% statutory price reduction for PLAVIX and ISCOVER, if (in the counterfactual) Apotex’s products had been PBS-listed but their supply was later restrained by a final injunction. His Honour was strongly influenced by evidence of two previous examples of (discretionary) PBS price reductions for other products having been reversed and lamented the lack of evidence from the senior Commonwealth decision-maker to support its contentions that it would not have reversed the 12.5% price reduction.

Implications for the conduct of pharmaceutical patent litigation in Australia

The implications for the conduct of pharmaceutical patent litigation flowing from this long-awaited decision are multi-faceted and can be summarised as follows:

  • Commonwealth damages claims are possible in principle – This decision is consistent with the view that loss incurred by the Commonwealth as a result of delayed PBS-listing of generic products due to patent litigation is compensable, in principle, where the necessary elements are established, and reinforces comments to that effect made in the recent venlafaxine case. Patentees seeking interlocutory injunctions must therefore continue to take into account a possible Commonwealth claim as an incident of obtaining an interlocutory injunction.
  • Remoteness of loss may be an impediment to claims for compensation under the usual undertakings as to damages – The Court’s findings on the question of whether the connection between the interlocutory injunction and the alleged loss is sufficiently direct may present an impediment to future Commonwealth claims for compensation based on interlocutory injunctions that do not expressly restrain PBS-listing of generic products. It will be of interest to see how the Full Court views this question of remoteness of loss, should an appeal take place. It will also be interesting to observe whether the Commonwealth becomes more actively involved in the hearing of interlocutory injunction applications and specifically presses for the issue of PBS listing to be addressed in the terms of any interlocutory injunction granted and the associated cross-undertaking as to damages.
  • Evidentiary hurdles for the Commonwealth and other third-party compensation claims exist – On this occasion, the Commonwealth failed to establish on the evidence that Apotex would have launched “at risk” if no interlocutory injunction was granted, demonstrating the difficulties faced by the Commonwealth and other third parties in making good this proposition, particularly in circumstances where the generic involved has settled its claim. The Commonwealth’s failure to call key decision-makers from the restrained generic party and its own PBS-pricing authority were significant factors. The Commonwealth’s case was further hampered by the need to obtain documents from Apotex by subpoena, many of which were produced in heavily redacted form, to preserve privilege. Such evidentiary difficulties could potentially be lessened where both the Commonwealth and the generics are parties to the claim for compensation from the innovator. However, even where the generic parties pursue their own damages claims under a patentee’s undertaking at the same time as the Commonwealth, the Commonwealth and other third parties will be dependent on the generic parties’ evidence and therefore potentially vulnerable.
  • Contemporaneous records or communications must establish the generic decision maker’s intent to PBS list in the counterfactual – For generic parties, the Commonwealth or any third parties to claim compensation under the “usual undertakings” given by an innovator, they must be able to establish by contemporaneous business records, and if necessary by calling evidence from the ultimate decision makers, that they would, in all the circumstances, have made the decision to launch and supply their generic product to the Australian market, if not restrained by grant of an interlocutory injunction. It will be important for parties planning to launch “at risk” in circumstances where they may be the subject of an interlocutory injunction to consider what contemporaneous records will be available to establish the course they would have pursued had no injunction been granted.
  • Innovators and generics should consider carefully the terms of an interlocutory (preliminary) injunction and any voluntary undertakings sought – Where an innovator is able to obtain voluntary undertakings from a generic party, to the effect that it will not take steps to PBS-list pending the resolution of patent enforcement proceedings, this may reduce the likelihood of a successful Commonwealth damages claim. In light of this decision, innovators can be expected to seek interlocutory injunctions that restrain infringement of their patent(s) generally, without any express refence to the generic party’s ability to list their products on the PBS (while noting the possibility that a court could nevertheless find that the injunction had the practical effect of preventing PBS-listing because the generic will not be able to give the required “guarantee of supply”). The decision also sounds a warning to generic parties to carefully consider any voluntary undertakings they may provide to the Court, where such undertakings are not supported by any cross-undertaking as to damages given by the innovator. In the latter circumstances, the generic party is unlikely to be compensated for losses flowing from its undertakings, even if ultimately successful in the patent proceedings.
  • Statutory price reduction(s) may be reversed – The Court’s finding that, on the balance of probabilities, it was likely that any statutory reduction in the PBS-price for Sanofi’s products would have been reversed had an interlocutory injunction been refused and final judgment subsequently delivered in Sanofi’s favour, may have implications for future interlocutory injunction applications in pharmaceutical patent cases. It has previously been suggested that such price reductions would be effectively irreversible, even if the innovator was ultimately successful in obtaining a final injunction. The finding of Nicholas J in this case has the potential to contribute to the trend away from the routine granting of interlocutory injunctions in pharmaceutical patent disputes, observable in a number of recent judicial decisions.[4]

Given the size of the Commonwealth’s claim and the novel legal issues raised in the case, it appears likely the Commonwealth will consider an appeal.


[1] Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth (2018) 136 IPR 8.

[2] AstraZeneca AB v Apotex Pty Ltd; AstraZeneca AB v Watson Pharma Pty Ltd; AstraZeneca AB v Ascent Pharma Pty Ltd (2015) 323 ALR 605.

[3] Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd [2015] FCA 848

[4] See the reasons of the Full Court  comprising Jagot, Yates and Moshinsky JJ in Sanofi-Aventis Deutchsland GmbH v Alphapharm Pty Ltd (2019) 139 IPR 409; Jagot J in Sigma Pharmaceuticals (Australia) Pty Ltd (ACN 004 118 594) v Wyeth (2009) 81 IPR 339 and H. Lundbeck A/S v Sandoz Pty Ltd (2018) 137 IPR 408; Yates J in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd (No 2) (2019) 141 IPR 26.

ESCO Corporation v Ronneby Road Pty Ltd [2018] FCAFC 46

We previously reported the Federal Court decision in Ronneby Road Pty Ltd v ESCO Corporation [2016] FCA 588  in which all claims of ESCO Corporation’s (“ESCO”) patent application AU 2011201135 for a Wear Assembly were found to lack utility on the basis that none of the claims were for an invention which achieved each and every one of six promised benefits listed in the specification.

By way of background, the claims of the patent application at issue relate to wear members having a certain lock mechanism for attaching to excavating equipment.  The specification includes the following paragraph (“paragraph 6”):

The present invention pertains to an improved wear assembly for securing wear members to excavating equipment for enhanced stability, strength, durability, penetration, safety and ease of replacement.

The specification then proceeds to describe several different aspects of the invention, some directed to the wear assembly and some to components thereof (such as wear members), where each different aspect is described as providing certain benefits – some of which are listed in paragraph 6 and some of which are not.

Ronneby Road Pty Ltd asserted (and it was accepted by the primary Judge) that the list of advantages in paragraph 6 constituted a “composite” promise, and that accordingly, each of the six promises must be achieved by the invention in every claim in order for the invention to be useful.  ESCO’s position was that the list of advantages in paragraph 6 was a statement of purpose and did not constitute a promise at all.  Instead, ESCO submitted that the advantages described specifically in relation to the lock mechanism elsewhere in the specification constituted the true “promises” of the invention.

The Court’s job was thus to find the correct “promise” of the specification and then to ask whether the invention as claimed did what was promised by the patentee.  In the end, their Honours agreed with ESCO and found that the true promises were to be found by looking at the body of the specification and the claims to find what the Court termed “degree[s] of symmetry” between the two. In this case, significance was placed upon the fact that there were two ‘clusters’ of claims, relating to the wear assembly and the wear member respectively, so that the relevant promise for each ‘cluster’ needed to be identified. The specific promise for claim 1 and its dependent claims was identified in other paragraphs of the specification, and that promise was achieved by the invention of the relevant claims.

Interestingly, as part of this decision, the Court reviewed Australian case law on utility and noted that if a specification, when properly construed, contains a composite promise, each and every advantage in that composite promise must be attained by the claims to meet the utility requirement.  That is, under Australian law, a claim will lack utility if the invention fails to attain any one of the elements of a relevant composite promise.

This finding did not substantially influence the outcome of the present case since the composite promises, once correctly identified, were all satisfied by the claimed invention. It is, however, a reminder of the importance of carefully drafting patent specifications (or reviewing and amending during prosecution) to avoid composite promises, and where possible, exercising restraint when promising advantages in a patent specification, as any variation between what is promised and what is achieved could lead to a finding of inutility.

It’s World Intellectual Property Day on April 26 and this year celebrates the brilliance, ingenuity, curiosity and courage of the women who are driving change around the world and shaping our common future.

In that spirit, an invention by three Melbourne schoolgirls has the potential to solve a global problem on the world’s tennis courts: keeping track of the score in social games.

Thirteen year-olds Alice Wilson, Susannah Lutze and Mikayla Lee, who are all in year 8 at Camberwell Girls Grammar School, have developed a simple device that straps to the throat of a tennis racquet that could resolve the constant question that bedevils amateur players everywhere: ‘What’s the score?’

The students, with the guidance of the Girls Invent program and pro bono work from intellectual property specialists at Shelston IP, are well advanced in securing IP protection over their invention, the Score Buddy, which has a potential global market.

Girls Invent runs specifically designed workshops to help guide girls to develop new products, from idea generation through to commercialisation and market entry. They currently operate programs in 150 Australian schools. CEO Mark Glazebrook said, “The Score Buddy team are a great example of the core ingredients for success: passion, determination, smarts and magnetism to bring people along with them. The Girls Invent program in partnership with the school creates the creative space for every girl to thrive and not just accept what others think they can do.”

Shelston IP has supported Girls Invent through its pro bono program since 2016. Senior Associate Allira Hudson-Gofers (herself a mechatronics and biomedical engineer and an Australian representative player in handball and beach handball) said the girls’ development work on Score Buddy was extremely impressive. A provisional patent application has been filed and discussions are underway about which other territories to file for IP protection. “All of the girls I’ve spoken with through the Girls Invent program are incredibly enthusiastic and have some great ideas. They’ve put together prototypes and thought ahead about the next steps in developing their inventions. It’s really encouraging for these girls to be innovating and seeing the potential for STEAM subjects to lead to practical results and opportunities.”

One of the Score Buddy inventors, Susannah Lutze, said, “We are really excited because we recently visited Tennis Australia’s innovation centre and in a few weeks we are visiting an engineering company to possibly help us with the next stage.”

The young inventors are seeking financial backers and, with help from a Dutch industrial design company, hope to have a working prototype completed by the end of the year.

Principal of Camberwell Girls Grammar School, Debbie Dunwoody, believes that an education focused firmly on the future is vital. “We want our students to develop entrepreneurial skills and we know that they will need to create their own opportunities in the future. Girls Invent is a really inspiring and accessible program for our girls to learn about and understand their capacity to be creative innovators. The program really connects them to all elements of STEAM (Science, Technology, Engineering, Arts, Mathematics) and focusses them on ‘design thinking’.

Shelston IP is delighted to congratulate Xialene Chang on receiving full scholarship offerings for both Harvard and Stanford universities, following completion of her year 12 studies.

Xialene is one of the highly successful graduates of the Girls Invent program of which Shelston IP is a proud supporter. Dedicated to inspiring and motivating girls to become successful innovators, Girls Invent runs workshops encouraging girls to generate their own ideas for innovative products using an ideation framework. Girls then work through the process of turning ideas into reality: design, feasibility, market research, intellectual property, resourcing and possible routes to market. The program culminates in a gala Girls Invent pitch session.

In 2015, Xialene and her classmate, Aditi Venkatesh, pitched an idea of a dispenser for adhesive bandages developed through the Girls Invent program.  Their winning entry encouraged the girls to seek mentorship and funding, before attending the Yale Young Scholars global program in July 2016. Returning from Yale, the girls were invigorated to take their product to the market, interacting with experts in engineering, intellectual property, and commercialisation.

At Shelston IP, innovation is our passion.  Since 2016 we have supported Girls Invent through our pro bono program, providing IP materials for use in the program and other intellectual property support.

Girls Invent is keen to partner with corporates to extend its reach across Australia. Its Corporate Supporters Program offers in house workshops for families of employees, to enhance employee engagement and spread the Girls Invent message even further, while allowing companies to support its ongoing efforts to embed innovation in the Australian educational curricula of the future.

If you are interested in becoming a Corporate Supporter of Girls Invent, or would like any further information on its offerings, please visit its website at www.girlsinvent.com.au or contact Katrina Crooks or Caroline Bommer at Shelston IP.