Introduction

IP Australia is providing free extensions of time of up to 3 months if a deadline cannot be met due to the effects of COVID-19.  As reported here https://www.shelstonip.com/news/covid-19-update-ip-australia-now-extended-streamlined-relief-measures-31-january-2021-provide-certainty-holiday-period/, the period for requesting such an extension currently ends on 31 January 2021 with the prospect of the period being further extended. 

A streamlined process has been implemented for requesting COVID-19-related extensions.  No declaratory evidence or fee is required; all that is needed is to check the relevant box on IP Australia’s eServices system to declare that the deadline cannot be met due to disruptions from the pandemic (equating to circumstances beyond control).  Although these COVID-19 extensions of time have so far been routinely allowed, they are nonetheless subject to the Commissioner’s discretion. 

New decision from IP Australia

A recent decision from IP Australia, Shell Internationale Research Maatschappij B.V. v Yara International ASA [2020] APO 55, http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/cth/APO//2020/55.html, relates to a request for a COVID-19 extension in the context of a patent opposition.  It provides a reminder that care is required when requesting COVID-19 extensions at IP Australia, both in terms of the timing of the request and the reasoning.

Shell Internationale Research Maatschappij B.V. (the Opponent) filed a Notice of Opposition and, at the same time, requested a COVID-19 extension of 3 months for filing the Statement of Grounds and Particulars (SGP), which was due to be filed within 3 months of the Notice of Opposition. 

In accordance with usual procedure under Australian law, Yara International ASA (the Applicant) was afforded the opportunity to comment on the Opponent’s request for an extension of time.  The Applicant opposed the Opponent’s request for an extension of time. 

The Opponent’s submissions

The Opponent filed a declaration which provided a general overview of the COVID situation in the UK and at Shell.  The declaration noted that, as a consequence of the pandemic, the responsible in-house attorney had commenced working at home in April 2020, solely with the use of a laptop, without access to printers or desktop monitors, and that he did not have access to numerous physical documents that were required for the opposition.  The declaration also reasoned that, due to COVID-19, obtaining mandates and financial approvals for the opposition at Shell had become more difficult. 

The Applicant’s submissions

The Applicant, however, noted that the Opponent had filed two rounds of third-party observations at the EPO on the corresponding European application.  The Applicant argued that, although another Shell attorney had filed those third-party observations, the Opponent had not provided any reason why that attorney could not have prepared or assisted with the preparation of the SGP or why the task could not have been delegated to the Australian representative.  The Applicant pointed out that preparation of the SGP does not need expert witnesses and that the amount of time required to prepare the SGP is significantly less than that required for the preparation of evidence.  Furthermore, the Applicant argued that an undue delay would lead to an extended period of uncertainty for the Applicant and would not be in the public interest. 

Decision to grant a shortened extension and reasoning

The Commissioner commented that it was “not the existence of the pandemic, but rather the specific impacts on the responsible person, that must be taken into consideration”. 

The Commissioner considered that the extension request was “largely prospective and based on conjecture of circumstances that might arise in the future”.  The fact that the extension request had been filed at the same time as the Notice of Opposition did not work in the Opponent’s favour.  In this regard, the Commissioner observed that “if a party can anticipate on-going delays, and even quantify those delays in requesting an extension upfront, then presumably they can also plan and take action to mitigate their impact”.  The Commissioner expressed concern that “a party obtaining an upfront extension and working to an extended deadline may not be as diligent in completing their work, or as motivated to consider and implement mitigating strategies that could enable them to meet the original deadline”.

In the concluding remarks, the Commissioner adjudged that, whilst there were circumstances that had impacted on the Opponent’s ability to complete the SGP in time, the request was made at the beginning of the period for preparing the SGP when the impacts and the extent of delay were uncertain.  Further, the Commissioner was not satisfied that the Opponent had provided a sufficiently detailed disclosure of the circumstances to justify the request for an extension at that time, including the reasons why no strategies were available to mitigate the impacts. 

On balance, the Commissioner decided to allow an extension but the length of the extension allowed was less than the 3 months requested.

The Commissioner noted that the decision to allow the extension of time of course does not preclude the Opponent seeking a further extension based on current circumstances that may prevent completion of the SGP by the extended due date.

Conclusion

Whilst a shortened extension was granted in this circumstance, this decision serves as a stark reminder that IP Australia’s COVID-19 streamlined extension provisions are not a simple free-for-all.  An element of discretion does apply. 

A requestor must be able to provide genuine reasons and evidence to justify the grant of the extension and the timing of the request can also be of significance. 

In addition, it is worth mentioning IP Australia’s warning that a false declaration could put the validity of an IP right at risk.

For more information, or if you have been affected by the COVID-19 pandemic and require assistance with your IP Rights, please contact us. 

Authored by Serena White, DPhil and Michael Christie, PhD

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

Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477

Summary

Australia’s Federal Court has delivered judgment in a dispute concerning patents covering improvements in vaccines against Streptococcus pneumoniae, a leading cause of serious infections, particularly in children.  The judgment provides the first detailed analysis by a Federal Court judge of the Raising the Bar reforms to Australian patent law concerning sufficiency and support.  The decision demonstrates the profound implications of those reforms for permissible claim breadth in Australian patents.

Key takeaways

  • Australian patent law concerning sufficiency of description and support for claims underwent significant changes in 2012 as a result of the Raising the Bar amendments to the Patents Act 1990 (Cth) (Patents Act).
  • Due to generous transitional provisions, the amended law is only now coming before Australia’s Federal Court for interpretation and application.
  • European and UK authorities provide guidance on how the amended provisions of Australia’s Patents Act are likely to be interpreted and applied. In some cases, the amendments will result in a reduction in permissible claim breadth for Australian patents.
  • As a result of the transitional arrangements, many Australian patent disputes between now and least 2033 are likely to involve both patents subject to the pre-Raising the Bar law and patents subject the post-Raising the Bar Amendments may be required to avoid the latter patents being held invalid under the new, more stringent standards of sufficiency and support.

On 14 October 2020, Justice Stephen Burley delivered the judgment of the Federal Court of Australia in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477.  The case concerned three patents owned by Wyeth LLC (Wyeth) relating to improvements in immunisation against infection by Streptococcus pneumoniae, a bacterium responsible for meningitis, pneumonia and other serious illnesses, especially in children.

Justice Burley’s decision provides the first detailed analysis by the Federal Court of Australia concerning amendments made in 2012 to Australian patent law on the topics of sufficiency of description and support for claims.  The decision highlights the significant implications of those amendments for patent validity and claim scope.

The technology

Streptococcus pneumoniae (also referred to as “pneumococcus”) has an outer capsule that incorporates complex sugars known as polysaccharides.  Differences in capsular polysaccharides distinguish variants of pneumococcus, called “serotypes”.  More than 90 distinct serotypes have been described.  A more limited group of virulent serotypes are responsible for most serious pneumococcal infections.

The antibody response to capsular polysaccharides is generally poor in young children.  As a result, they are particularly susceptible to pneumococcal infections, which globally account for around 1 to 2 million childhood deaths each year.

To address this problem, “polysaccharide-protein conjugate vaccines” were developed with the aim of stimulating immunity against serotypes of pneumococcus known to be responsible for a high proportion of human infections.  In such vaccines, capsular polysaccharides are joined (“conjugated”) to a carrier protein, leading to a stronger antibody response than is achievable with vaccines based on capsular polysaccharides alone.

A polysaccharide-protein conjugate vaccine against pneumococcus developed by Wyeth, known as Prevnar 7®, was in clinical use before the priority date of the Composition Patents.  That product is a “7-valent” vaccine.  It comprises capsular polysaccharides from 7 different pneumococcus serotypes, in each case conjugated to a single protein (known as “CRM197”).  Evidence led in the case indicated that, before the priority date, steps had been taken to develop 9-valent and 11-valent polysaccharide-protein conjugate vaccines against pneumococcus, but no such products had yet been licensed or launched.

The patents

Three patents were at issue in this proceeding.  Two of them, referred to by Burley J as the “Composition Patents”, were related members of the same patent family.  The more senior family member (referred to here as the “Parent Composition Patent”) was subject to the provisions of Australia’s Patents Act as they stood prior to the Raising the Bar amendments.  The more junior family member (referred to here as the “Child Composition Patent”) was subject to the post-Raising the Bar Patents Act.  The body of the specification was substantially the same in the parent and child patents.  It described multivalent immunogenic compositions (that is, vaccines) comprising 13 distinct polysaccharide-protein conjugates, thereby providing increased coverage of pneumococcal serotypes compared to the existing Prevnar 7® vaccine.

A third patent asserted by Wyeth in the proceeding, referred to by Burley J as the “Container Patent”, disclosed siliconized container means for the stabilization of polysaccharide conjugates.  The issues raised in the proceeding in relation to the Container Patent are not discussed here.

The proceedings

Merck Sharp & Dohme (MSD) sought revocation of Wyeth’s Composition Patents on a variety of grounds, including lack of novelty, lack of inventive step (i.e., obviousness), false suggestion, lack of clarity, lack of fair basis (in relation to the pre-Raising the Bar Parent patent) and lack of support (in relation to the post-Raising the Bar Child patent).

By a cross-claim, Wyeth alleged that a 15-valent pneumococcal vaccine which MSD proposed to launch and market in Australia would infringe selected claims of all three of the asserted patents.

Wyeth’s allegation that the Composition Patents would be infringed by marketing of MSD’s 15-valent vaccine in Australia gave rise to a critical issue of claim construction in the proceeding, namely, whether the claims of those patents were limited to 13-valent vaccines (as MSD contended) or extended to vaccines covering 13 or more serotypes (as Wyeth submitted).

The construction issue

Claim 1 of the Parent Composition Patent was in the following terms:

A multivalent immunogenic composition, comprising: 13 distinct polysaccharide-protein conjugates, together with a physiologically acceptable vehicle, wherein each of the conjugates comprises a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to a carrier protein, and the capsular polysaccharides are prepared from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and wherein said carrier protein is CRM197.

Insofar as is presently relevant, claim 1 of the Child Composition Patent was in similar (although not identical) terms.

The specification of each of the Composition Patents included text (standard in Australian patents) indicating that “comprising” is used in an inclusive sense (“including”) rather than an exhaustive sense (“consisting of”).  That text provided the basis for Wyeth’s submission that, because MSD’s 15-valent vaccine included the 13 serotypes identified in the claims of the Composition Patents, it fell within those claims.  On Wyeth’s construction, the presence of two additional serotypes in MSD’s 15-valent vaccine was irrelevant to infringement.

Arguing to the contrary, MSD submitted that its construction (limiting the claims to 13-valent vaccines) was the only construction consistent with the description of Wyeth’s invention in the specification taken as a whole.  A corresponding submission, based on similar (but not identical) claim language, had been accepted in related UK proceedings between MSD and Wyeth (see Merck Sharp & Dohme Limited v Wyeth LLC [2020] EWHC 2636 (Pat) at [251]-[270]).

However, on this key issue, Burley J preferred Wyeth’s construction.  In his Honour’s analysis, the inclusive definition of “comprising” was decisive.  Provided that a vaccine included each integer of Wyeth’s claims (including, relevantly, the 13 specified serotypes), it would infringe – a conclusion not altered by the presence in the infringing product of additional serotypes.

What is notable for present purposes is the very substantial breadth given to Wyeth’s claims on the construction adopted by Burley J.  On that construction, the range of valences covered by Wyeth’s claim would appear to have no upper bound.

Unsurprisingly, in view of this broad construction, a question arose as to whether the claims were fairly based on, or supported by, the disclosure contained in the body of the Composition Patent specification.  On that legal issue, the Raising the Bar amendments have brought about a profound shift in Australian law, as Burley J’s judgment demonstrates.

Raising the Bar reforms

The Raising the Bar reforms were introduced to address concerns that Australia’s patent standards were lower than those of its major trading partners, causing Australia’s innovation landscape to become cluttered with unduly broad patents.  The amendments were expressly directed at aligning key aspects of Australian patent law, including on sufficiency of disclosure and support for claims, with the standards applied by UK courts and the European Patent Office (EPO) Boards of Appeal.

Although the Raising the Bar amendments were enacted in April 2012, lengthy transitional provisions mean that many of the key reforms, including those concerning sufficiency and support, are only now coming before the courts for interpretation and application.

The law pre-Raising the Bar

Prior to the Raising the Bar reforms, the relationship between the disclosure in the body of a patent specification and the breadth of the claims was governed by the legal requirement for “fair basis”.  The leading authority on that requirement (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274) established that fair basis does not turn on any inquiry into the patentee’s “technical contribution to the art”, but rather on whether each claim corresponds textually with what the patentee has described as their invention in the body of the patent specification.

The practical effect of Lockwood’s permissive interpretation of the fair basis requirement was amplified by the equally permissive interpretation of the sufficiency requirement given in the leading authority pre-Raising the Bar (Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1).  That case stands as authority for the proposition that a patent specification will have adequately described the invention if it would enable a person skilled in the relevant art to produce “something” falling within each claim (referred to colloquially as the “one way rule”).

That body of law is of continuing relevance for Australian standard and innovation patents for which examination was requested before 15 April 2013.  In the present case, that “old” body of law applied to the Parent Composition Patent.

Applying those authorities, Burley J found little difficulty in concluding that, notwithstanding his Honour’s broad interpretation of the claims of the Parent Composition Patent, those claims were fairly based.  Reflecting the essentially textual nature of the pre-Raising the Bar test for fair basis, that conclusion followed from the fact that the description of the invention in the body of the Parent Composition Patent employed the same inclusive language (“comprising”) as appeared in the claims.

The law post-Raising the Bar

Following the Raising the Bar amendments, the provisions of Australia’s Patents Act dealing with sufficiency and support are in substantially the same terms as the corresponding provisions of the European Patent Convention and the United Kingdom’s Patents Act 1977.  Parliamentary records make clear that those provisions were intended to have substantially the same effect as their European and UK counterparts, and that Australia courts are expected to have regard to decisions of the EPO Boards of Appeal and of UK courts in interpreting those provisions.

Burley J reviewed a number of EPO and UK authorities, including the recent decision of the UK Supreme Court in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27, to interpret the post-Raising the Bar requirement that the claims be “supported by matter disclosed in the specification”.

Referring to the landmark decision of the House of Lords in Biogen Inc v Medeva Plc [1997] RPC 1, Burley J observed that the claim support obligation has come to be understood as falling “under the umbrella of the requirement that the patent specification contain an enabling disclosure”.  His Honour noted that, although the requirement for sufficient description is directed to the specification as a whole, while the requirement for support is directed specifically to the claims, both requirements serve to ensure that a person skilled in the relevant art, armed with the patentee’s specification, is enabled to perform the invention over the whole area claimed without undue burden.

Referring to the decision of the EPO Board of Appeal in Exxon/Fuel Oils (T 409/91) [1994] EPOR 149, Burley J noted that the requirement for enablement across the full claim scope has been recognised as reflecting the general legal principle that the scope of a patent monopoly, as defined by the claims, should correspond to the patentee’s technical contribution to the art, as disclosed in their specification.

Applying those authorities, Burley J concluded that the claims of the Child Composition Patent were not supported by the matter disclosed in the specification.  On the construction advanced by Wyeth and accepted by His Honour, those claims encompassed any polysaccharide-protein conjugate pneumococcal vaccine comprising 13 or more serotypes (provided the other claim integers were satisfied).  While there was no dispute that the specification of the Composition Patents would enable a skilled person to make and use a 13-valent vaccine, uncontested evidence established that the disclosure of the specification could not be extrapolated to vaccines containing other, additional serotypes.  Manufacture of polysaccharide-protein conjugate vaccines comprising more than 13 serotypes was not enabled.

In the result, the asserted claims of the Parent Composition Patent were held to be valid and infringed, while the asserted claims of the Child Composition Patent were held invalid for lack of support.

Significance of the judgment

The disparate conclusions reached in this case concerning the Parent and Child Composition Patents serve to illustrate the profound changes to Australian law brought about by the Raising the Bar reforms.

Observers in other jurisdictions may find it curious that such starkly different findings could be made on the basis of very closely similar patent specifications.  The principle upon which the Child Composition Patent was held invalid (i.e., the requirement that claim breadth correspond to the patentee’s technical contribution to the art) is said to reflect the “essential patent bargain” whereby the patent holder is granted a time-limited monopoly in return for disclosing their invention in terms sufficiently clear and complete for it to be performed by those skilled in the art.  The fact that this requirement did not apply to the Parent Composition Patent serves to illustrate the extent to which, in the pre-Raising the Bar era, Australian patent law had diverged from the law applied by its major trading partners.

Such disparate outcomes are likely to remain a feature of Australian patent disputes for some years to come.  Australian patents subject to the pre-Raising the Bar law are expected to remain in force until at least 2033.

This decision also demonstrates that the post-Raising the Bar incarnations of Australia’s written disclosure requirements in s 40 of the Patents Act 1990 (Cth) can be a much more powerful weapon in the arsenal of a party seeking to revoke an Australian patent.  Historically, the low thresholds for fair basis and sufficiency have provided relatively wide scope for Australian patentees in advancing positions on claim construction to capture alleged infringements.  This main constraint for patentees in advancing claim construction under the pre-Raising the Bar body of law has been (and will remain) potential novelty and inventive step consequences arising from constructions being so broad as to capture prior art or common general knowledge.  The onerous post-Raising the Bar support and sufficiency requirements will add an extra dimension to these construction “squeezes” and another powerful validity ground which must be fended off.

Furthermore, notwithstanding parliament’s intention that the post-Raising the Bar provisions concerning sufficiency of description and claim support be interpreted so as to have substantially the same effect as the corresponding provisions of European and UK law, lingering disparities between the law of those jurisdictions and the terms of Australia’s Patents Act mean that some independent development of Australian law on sufficiency and support appears inevitable.  Two examples may be noted.

First, under the UK’s Patents Act 1977, although both sufficiency and support are requirements for a valid patent application, only lack of sufficiency is available as a ground of revocation for granted patents.  UK courts have remedied that “logical gap” by recognising both requirements as aspects of a single unifying requirement for an enabling disclosure.  No such logical gap exists in Australia’s Patents Act, where both lack of sufficiency and lack of support are available as grounds for revocation.  Whether this difference will lead Australian courts to seek to disentangle the threads of sufficiency and support in the UK authorities remains to be seen.

Secondly, by contrast to the requirements of European and UK law, Australia’s post-Raising the Bar Patents Act continues to impose a requirement to disclose the “best method”.  European and UK authorities provide no guidance on how that requirement is to be accommodated with the law regarding sufficiency and support.  For such guidance, it may be necessary for Australian courts to look to United States authorities.  Whether they will choose to do so remains to be seen.

Given the significant commercial interests at stake, and the complexity of the legal and factual issues raised by the Prevnar® case, the likelihood of an appeal appears reasonably high.  Whether any appeal judgment casts further light on Australian patent law post-Raising the Bar is likely to depend upon whether the appeal court upholds the broad construction of Wyeth’s Composition Patent claims that was accepted by Burley J.

Authored by Andrew Rankine, Charles Tansey, PhD, Duncan Longstaff

LION

In the recent Trade Marks Office decision of Long Way Home Holdings Pty Ltd v Saroo Brierly Enterprises Pty Ltd [2020] ATMO 109, the issue of whether a film title functions as a trade mark has again been discussed.

The decision concerned a film called Lion, which is based on the story of young Indian man, Saroo Brierly, who grew up in Australia. At the age of five, he lost contact with his family in India when he was at a train station waiting for his brother, who never returned. After surviving three weeks in Calcutta by himself, he was placed in an orphanage and subsequently adopted by an Australian family. He then spent the next 25 years living in Tasmania, Australia. He then went searching for his natural parents in India, eventually being re-united with them and discovering that his original name was Sheru, meaning Lion.

The book, which was called A Long Way Home, received wide acclaim and a film adaptation called Lion, was subsequently produced. The film starred Dev Patel and Nicole Kidman and was nominated for six Academy Awards.

The story was written by Mr Brierly, with some editorial assistance, and he licensed the film rights, but kept musical and theatrical rights separate.

The holder of the licensed film rights, See Saw Films Pty Ltd (“See-Saw”) wished to produce a stage show, but was not granted rights by Mr Brierly, who applied for registration of the trade mark LION in respect of a range of theatre and musical services in Class 41. Long Way Home Holdings Pty Ltd (“LWHH”), a subsidiary of See-Saw then opposed that application.

According to the evidence, See-Saw decided to change the name of the title of the film from A Long Way Home, to Lion. According to them, Mr Brierly was not approving of this name.

In brief, the Hearing Officer found that LWHH did not have any good basis for opposing the acceptance of Mr Brierly’s application because its use of Lion as a film title was not use as a trade mark.

On the further issue of whether Mr Brierley’s application was filed in bad faith, because it was filed at a time when he was negotiating with LWHH concerning theatrical rights, the Hearings Officer decided:

Mr Brierley has rights in the story contained in that book which he may choose to licence to others, or not, as he sees fit. Mr Brierley chose to grant rights to See-Saw to produce a film based on the story in his story. A film was made and was entitled LION—this is not some random title but the meaning of a phonetic equivalent of his first name. Whether Mr Brierley decided on that title for the film or was happy with that title or not is of little import here. Mr Brierley was approached by See-Saw to produce a stage show based on his memoir. That Mr Brierley might have seen monetary value in a trade mark and/or sought, through the Applicant, to improve his bargaining position in negotiations in respect of rights he owns by applying to register LION as a trade mark seems a natural approach, rather than behaviour which is likely to be seen as unscrupulous, underhand or unconscientious in character by persons adopting proper standards. This is especially so in the light of my finding that the Opponent has, at no time, used LION as a trade mark.

Cases concerning Film Titles

Superficially, film titles seem just like trade marks. They are names used to identify a particular product. However, the nature and types of titles vary considerably, as does their function.

In some cases, the film title is derived directly from a prior publication, in others, it directly describes what the film is about. In other cases, it is at best suggestive. The function of names in the title also vary to an extent depending upon whether it is indicative of a series of releases, or a one-off film.

There are few judicial decisions in Australia on this issue. The two that most readily spring to mind concern Disney’s Hunchback of Notre Dame[1] and a television program called Discover Downunder.[2]

In the case concerning Disney’s Hunchback of Notre Dame, it was alleged that Disney’s proposed use of Hunchback of Notre Dame in respect of a musical production was an infringement of a trade mark registration for Hunchback of Notre Dame. As might be expected, the Court found that the word “Disney’s” functioned as a trade mark but that “Hunchback of Notre Dame” was simply being used to describe a musical based on a book commonly referred to as The Hunchback of Notre Dame. Hence there was no infringement.

In the case of Discover Downunder, it concerned an application to register that trade mark in respect of the “production of television programs”. In that case, the Court did not need to decide whether Discover Downunder functioned as a trade mark. This is because it decided that use and intended use as the name of a television program was not intended use for the “production of television programs”. The business of producing television programs was to be carried out by the production company, whose name was Evergreen, not Discovered Downunder.

With this paucity of judicial consideration, it is useful to look at decisions at the level of the Trade Marks Office. Here we find that film and television program titles have not typically been considered use as a trade mark. Decisions in respect of Braveheart,[3] Veronica’s Closet,[4] Thirtysomething[5] and Matrix,[6] found no use as a trade mark. However, Die Hard[7] was distinguished on the basis that it was a name used to identify a series of productions.

In the case of Braveheart, an opposition to registration of BRAVEHEART THE MUSICAL, in respect of theatre musical production services, was nevertheless successful on the basis that, while Braveheart was not considered to have been used as a trade mark, use of the name by a third party would connote an association with the film by virtue of its reputation.

Also, in the Twentysomething case, the Hearings Officer commented that:

By analogy, the television series name is just that. It is not an indicator of the trade source of the goods. Had the opponent applied the name, or licensed others to apply the name, ‘thirtysomething’, to merchandised goods sold in Australia then I would have no hesitation in finding that there was use of the name as a trade mark in relation to those goods.

In the Die Hard case the rationale was explained:

I think that motion pictures, if there is a series of them, fall into the same genus of publication as the newspapers, sound recordings, magazines and newspapers referred to above. By analogy, therefore, the titles of motion picture films should also be capable of functioning as trade marks. Whether particular movie titles do function as trade marks, will, naturally, depend on the evidence how such indicia have been used and whether such indicia have, in fact, developed trade mark significance. 

As regards the decision in the Matrix case, as at the relevant date, only one Matrix movie had been released.

Conclusion

Whether a film title, or words in a film title function as a trade mark, depends upon the circumstances. Currently, it seems that a one-off film title will not usually be considered use as a trade mark. However, where there is a series, for example Harry Potter and Star Wars, the identifying name used consistently across the series will usually function as a trade mark.

There is also likely a distinction to be drawn between use in respect of films and use in respect of merchandise, and the merchandising of a film title may also enhance its prospects of being considered a trade mark, even in respect of the film.

Similar considerations are relevant in respect of book titles and song titles, and it is worth noting that even if the title is not being used “as a trade mark”, there may still be protectable property, as indicated by the decision in the Braveheart case.


[1] Christodoulou v Disney Enterprises Inc [2005] FCA 1401 (4 October 2005).

[2] Bauer Consumer Media Ltd v Evergreen Television Pty Ltd [2019] FCAFC 71 (3 May 2019)

[3] Twentieth Century Fox Film Corporation v Michael F Durkan [2000] ATMO 5 (19 January 2000).

[4] Time Warner Entertainment Company LP v Cosmopolitan Enterprises Pty Limited [2001] ATMO 83 (6 September 2001).

[5] Metro-Goldwyn-Mayer Studios Inc v Andrea Margaret Higgs [2007] ATMO 44 (6 August 2007).

[6] Time Warner Entertainment Company LP v Just Spectacles Pty Ltd [2003] ATMO 43 (29 July 2003)

[7] Twentieth Century Fox Film Corporation v Die Hard [2001] ATMO 43 (25 May 2001).

On 1 March 2020, the Vanuatu Trade Marks Office (“VTMO”) announced the introduction of a new annual maintenance fee (“the AM Fee”) for all Vanuatu trade mark registrations.

The AM Fee has currently been set at US$35 and is due on or before the “anniversary date” of the trade mark. The anniversary date is taken from the date of the receipt of the file in the Vanuatu Office (i.e. the filing date). For older Vanuatu marks, which were based on re-registrations of United Kingdom registrations, the anniversary date is calculated from the filing date of the UK mark.

The AM Fee is payable for nine (9) consecutive years before the renewal fee applies. It is not payable on renewal.

The VTMO will issue a reminder notice and invoice for the AM Fee to the agent of record, however, according to present advice, there are delays in the implementation process. As a result, issuance of reminders for the AM Fee may not commence until 2021.

There is currently no official grace period for payment of the AM Fee and no penalty fee for late payment.

The new requirement is an unexpected development that presently seems to be administratively burdensome for international owners of registrations, and we wait to see if there will be some revision once actually operational.

Shelston IP deals directly with the Vanuatu Trade Marks Office and various other South Pacific intellectual property offices with respect to trade mark rights.

If you require further information regarding the Vanuatu AM Fee or assistance with other IP rights in South Pacific jurisdictions, please let us know.

There was no sweet victory for the owners of the WICKED SISTER trade mark, used mostly for dairy desserts, in their attempt to prevent use of the WICKED trade mark for dipping sauces and related products.

The recent Federal Court case of PDP Capital Pty Ltd v Grasshopper Ventures Pty Ltd [2020] FCA 1078 (30 July 2020), heard by Markovic J, involved numerous issues relating to competing registrations, infringement and validity, but ultimately PDP was unsuccessful in its claims against Grasshopper for trade mark infringement, misleading and deceptive conduct under the Australian Consumer Law and passing off under the common law.

PDP also failed in its claim to cancel Grasshopper’s trade mark registration, although it partially succeeded in its challenge to the registration on the basis of non-use.

Grasshopper’s cross claim to cancel the Wicked Sister registrations also failed, but it partially succeeded to restrict the registrations on the basis of non-use.

Background

PDP has manufactured and sold a range of chilled dairy desserts and snacks under the Wicked Sister brand since 2008.

PDP owns registrations for WICKED SISTER in plain word and stylised forms which cover various goods in classes 29 and 30 (collectively “the Wicked Sister marks”). The earlier stylised mark

dates from 2008 and is owned by PDP Fine Foods Pty Ltd (“PDP Fine Foods”). The later stylised mark

and plain word mark WICKED SISTER both date from 2016 and are owned by PDP Capital Pty Ltd (“PDP Capital”), a related IP holding company. PDP Capital’s marks achieved registration by consent from PDP Fine Foods.

Grasshopper is an IP holding company which has authorised the use by various entities selling dipping sauces since 2002 under the WICKED brand.

Grasshopper owns a registration dating from 2005 for

(“Wicked tail mark”) in class 30. The WICKED brand was modified in 2014 to

(“new Wicked mark”) with the original branding phased out by early 2016. Grasshopper also owns a pending application for the new Wicked mark, and an accepted application for the plain word WICKED (which has, since these proceedings, been successfully opposed by PDP in proceedings before the Trade Marks Office, on the basis of a lack of distinctiveness. In that case, the Hearing Officer expressed the view that “the ordinary signification of the trade mark is a colloquial word for ‘excellent’ and when applied to the goods there is an implication of decadence”).

Grasshopper extended its product range to include waffle dippers in 2018.

The Wicked Sister and Wicked products are sold through Coles supermarkets.

The products sold under the Wicked Sister marks are flavoured rice puddings, custard, tiramisu and panna cotta, made from fresh ingredients and found in the refrigerated section of the dairy aisle.

The Wicked dipping sauces are not made from fresh ingredients and therefore do not require refrigeration, although they are still sometimes placed with frozen berries in the fresh food section of the supermarket.

Common Issues

Markovic J initially considered two main issues common to the parties’ various claims in the proceedings:

»  whether the new Wicked mark is substantially identical or deceptively similar to the Wicked Sister marks; and

»  whether the goods covered by the respective marks are the same or of the same description.

The marks were not found to be substantially identical. In making her determination that the marks were also not deceptively similar, her Honour considered a number of factors including:

  • the new Wicked mark and the Wicked Sister marks are not visually or aurally similar;
  • the adjective “wicked”, when used on its own, is an abstract concept which could describe anything. In contrast, the word “wicked”, used in conjunction with the noun “sister”, is not a strongly distinguishing feature of the Wicked Sister marks;
  • despite her Honour agreeing that the goods are fast moving consumer goods sold at a low price point, based on the evidence, the goods are found in different parts of the supermarket, consumers are able to view the products and their associated trade marks, and confusion is unlikely; and
  • the evidence of confusion advanced by PDP was ultimately given little weight as it was not evidence of an “ordinary person”, but of people who have a personal or trade affiliation with PDP.

This conclusion had significant implications for a number of the claims brought by the parties, but perhaps most significantly meaning that there could be no finding of trade mark infringement.

Her Honour then determined that dipping sauces and waffle dippers are not similar to desserts, rice pudding or any of the other goods covered by the earlier stylised Wicked Sister mark owned by PDP Fine Foods. However, dipping sauces were specifically covered by the later Wicked Sister registrations owned by PDP Capital, and waffle dippers being bakery products, were also encompassed by those registrations.

Grasshopper’s cross-claim for rectification

Grasshopper sought rectification under section 88 of the Trade Marks Act for cancellation of the registration of the Wicked Sister marks.

There was a difference in ownership between the later WICKED SISTER registrations and the first registration, which was principally for tax minimisation reasons. This conflict was resolved at the examination stage by the owner of the earlier registration providing a letter of consent to the subsequent applicant. However, interestingly, her Honour upheld Grasshopper’s claim under the section 58 ownership ground finding that PDP Capital was not the owner of the later registered Wicked Sister marks because PDP Fine Foods, which owned the earlier registered Wicked Sister mark, was also the true owner of the later marks. Despite this finding, her Honour decided not to exercise discretion to cancel the registrations because there was no risk of consumer confusion due to the “unity of purpose” between PDP Fine Foods and PDP Capital being related companies [applying the principle enunciated in the Full Federal Court case of Trident Seafoods Corporation v Trident Foods Pty Ltd [2019] HCAFC 100]. This nevertheless leaves open the possibility of a similar claim in succeeding opposition proceedings, since the discretion exercised by the Court in this case does not exist in those proceedings.

Grasshopper’s non-use applications

PDP was able to establish use of the earlier stylised Wicked Sister mark for dairy desserts, yoghurt desserts, creamed rice, rice puddings, rice tapioca and cheesecakes. PDP also sought to rely on use of flavoured rice puddings to retain “sauces for rice”, but this was not accepted and these goods were removed together with all other goods for which use could not be shown.

Regarding the challenge to the later registered Wicked Sister marks under section 92(4)(a) for lack of intention to use, her Honour found evidence of actual use for various goods including, dairy products, dairy-based desserts panna cottas; crème caramels, custard, cheesecakes, cakes, frozen yoghurts, creamed rice. She also held that use of the marks for panna cotta was sufficient to retain the broad claim for “all other desserts in this class including prepared desserts”. However, as there was no intention to use or actual use of the trade marks for bakery products, confectionery, ice cream confections, dipping sauces and yoghurt products, these goods were removed.

PDP’s claim for trade mark infringement

For trade mark infringement, PDP needed to establish the threshold issue that the new Wicked mark is substantially identical or deceptively similar to the Wicked Sister marks and that dipping sauces and waffle dippers are the same as or of the same description as the goods for which the Wicked Sister marks are registered.

As the marks were not found to be substantially identical or deceptively similar, PDP’s infringement claim failed at the first hurdle and it was therefore not necessary to consider whether Grasshopper had any defences to infringement. However, in case her Honour was wrong in relation to her conclusions to PDP’s infringement claim, she went on to consider the threshold issue – whether Grasshopper’s authorised use of the new Wicked mark is capable of constituting trade mark infringement.

While Grasshopper did not deny that it authorised use of the new Wicked trade mark to other entities within the meaning of the Trade Marks Act, it argued that it could not be subject to direct liability for infringement under section 120 because there is no statutory tort of authorisation in the Act. Her Honour agreed and indicated that the threshold issue would have been decided in Grasshopper’s favour. She did add, however, that this does not mean that no cause of action could have succeeded against Grasshopper as a joint tortfeasor, had that been pleaded.

PDP’s claim under the Australian Consumer Law (ACL)

PDP alleged that Grasshopper’s conduct breached sections 18 and 29 of the Australian Consumer Law. Grasshopper argued that (1) as a mere IP holding company it could not have made any of the alleged misrepresentations and (2) there was no real likelihood of confusion. Her honour rejected Grasshopper’s first contention which indicates that Grasshopper could have been liable under the ACL if the marks were otherwise found to be sufficiently similar and PDP had an established reputation in the Wicked Sister marks as at 2014 when use of the new WICKED trade mark commenced. However, ultimately her Honour found that there was no real likelihood of confusion and, consequently, PDP’s claim under the ACL failed.

PDP’s claim for passing off

PDP’s passing off claim followed her Honour’s findings in relation to the ACL. While Grasshopper’s conduct may amount to conduct for the purposes of establishing passing off, PDP had not established a sufficient reputation in the Wicked Sister marks as at 2014, nor that a sufficient number of consumers were likely to be deceived by Grasshopper’s use of the new Wicked mark.

PDP’s non-use application

PDP sought removal of the Wicked tail mark on the grounds of non-use under sections 92(4)(a) and 92(4)(b). As her Honour had found that Mr Valentine had an intention to use the mark, the section 92(4)(a) ground was dismissed. In relation to the section 92(4)(b) ground, Mr Valentine could establish use during the non-use period for dips including chocolate dips, but conceded that the mark had not been used for dessert toppings and sauces and confectionery products. Despite this, her Honour exercised discretion to retain the registration for all goods except savoury dips.

Takeaways

When comparing marks for the purpose of determining deceptive similarity, whether the combination has a meaning that differs from that of the word alone can impact on whether that word is determined to be an essential feature of the mark.

The case also provides a timely reminder to business owners, who wish to protect and enforce their marks, to ensure that they are filed in the name of the legal entity who will use or authorise use of the mark. Further, it confirms that there is no statutory tort of authorisation in the Trade Marks Act with the result that an IP holding company which merely authorises use of a mark cannot be subject to liability for direct infringement, although it may be liable as a joint tortfeasor.

Gliknik, Inc. v CSL Behring Lengnau AG [2020] APO 46 (“Gliknik”) concerned a patent application for engineered proteins intended for use as replacements for intravenous immunoglobulin.  The application included claims directed to methods of treating autoimmune or inflammatory diseases as well as a Swiss-style claim directed to the same diseases.  Gliknik, Inc. opposed the application on several grounds including that the specification did not sufficiently disclose the invention as claimed.

The standard for “sufficient” disclosure was raised in Australia following the commencement of the Intellectual Property Laws Amendments (Raising the Bar) Act 2012 and its assessment has been approached by the Australian Patent Office with the following two-step enquiry:

  1. Is it plausible that the invention can be worked across the full scope of the claim?
  2. Can the invention be performed across the full scope of the claim without undue burden?

In Gliknik, the Patent Office considered for the first time the plausibility of a Swiss-style claim. Following the principles recently set out by the Full Federal Court in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116, the Delegate observed that Swiss-style claims confer a monopoly in respect of a method of making a medicament.  They are not product claims, nor are they method of treatment claims – the monopoly extends to the point where the medicament is made.

Nevertheless, Swiss-style claims are purpose-limited in the sense that the medicament resulting from the method is characterised by the therapeutic purpose for which it is manufactured, as specified in the claim.  Unlike method of treatment claims, however, a Swiss-style claim does not require that the therapeutic effect be achieved. Our analysis of Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116, including the court’s construction of Swiss-style claims, is available here.

Having construed the claims, the Delegate in Gliknik then considered whether the plausibility standard of therapeutic effectiveness (for method of treatment claims) differed from that of therapeutic purpose (for Swiss-style claims).  In the absence of Australian jurisprudence, the Delegate turned to UK authorities, and in particular, the principles set out by Sumption LJ in Warner-Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56.  Although that case concerned the plausibility of efficacy rather than purpose, the Delegate reasoned that, if the efficacy of a product is not plausible, then it would follow that an intention to treat would not be plausible.  The Delegate concluded that substituting the word “efficacy” for “purpose” in Sumption LJ’s comments would not provide any substantial difference to the plausibility analysis.

Turning then to the disclosure of the specification, and the evidence of the common general knowledge in the field, the Delegate found it plausible that the engineered proteins of the invention could effectively treat some, but not all, conditions specified in the claims.  For certain conditions, the specification provided no more than a speculative assertion and so the claims were found to be insufficiently enabled.

This decision shows that the Australian Patent Office will apply a similar standard of plausibility to method of treatment claims as it will to Swiss-style claims. For each type of claim, the disclosure of the specification, supplemented by the common general knowledge, must make the efficacy of the treatment plausible.

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 of Ceramiche Caesar S.p.A. V Caesarstone Ltd [2020] FCAFC 124 (28 July 2020) the Full Federal Court decided that the primary judge had erred in finding “honest concurrent” use of the CAESARSTONE mark.  The decision also considers the requirements for “quality control” and a finding of “authorised use”.

Proceedings

The decision involved Ceramiche Caesar S.p.A’s (Ceramiche Caesar) appeal of the primary judge’s decision to allow Caesarstone Ltd’s (Caesarstone) Australian Trade Mark Application No 1058321 for the word mark CAESARSTONE (CAESARSTONE Mark) to proceed to registration for certain class 19 floor and wall goods on the basis of honest concurrent use.

The decision also involved proceedings in Ceramiche Caesar’s appeal of the primary judge’s decision to allow Caesarstone’s Australian Trade Mark Application No 1211153 for

to proceed to registration for certain goods and services in classes 19, 35 and 37 (Caesarstone Device Mark) and to allow Caesarstone’s Australian Trade Mark Registration No 1211152 for the word mark CAESARSTONE to remain registered for services in classes 35 and 37 (Caesarstone Services Word Mark).

The parties agreed that the result in the first proceeding would determine the results in the second proceedings and almost entirely determine the result in the third proceeding.  The discussion below therefore relates only to the first proceeding.

Facts

The appellant, Ceramiche Caesar, has manufactured ceramic tiles for indoor and outdoor flooring and wall cladding in Australia since 1988. Effective from 23 November 2004, Ceramiche Caesar has had a registration in class 19 covering  “ceramic tiles for indoor and outdoor use” for a CAESAR device mark:

The respondentCaesarstone, is an Israeli company that manufactures and sells large quartz slabs which have been labelled on the underside of the slab with the mark “CAESARSTONE” since 1987.

Caesarstone’s slabs were distributed in Australia from 2003 by two distributors: Caesarstone’s licensee, Tessera Stones and Tiles Pty Ltd (Tessera) and Tessera’s sub-licensee, Carsilstone Pty Ltd (Carsilstone). In 2006, Caesarstone incorporated an Australian subsidiary, Caesarstone Australia Pty Ltd (Caesarstone Australia).

From 2003 the distributors, Tessera and Carsilstone, sold the slabs to stonemasons in Australia who would then convert them into finished products, including benchtops and countertops, vanities and surrounds and splashbacks, which would then be sold on to customers.

Ceramiche Caesar’s CAESAR device mark registration was cited against the  application to register the CAESARSTONE mark on 2 June 2005.  To overcome this citation, Caesarstone amended its goods specification to disclaim “tiles” as follows:

Panels for floors, floor coverings, wall cladding, ceilings; non-metallic covers for use with floors and parts thereof; profiles and floor skirting boards; none of the foregoing being in the nature of tiles.”

The CAESARSTONE application was subsequently successfully opposed by Ceramiche Caesar, with the Registrar’s delegate deciding that the CAESARSTONE mark was deceptively similar to the CAESAR device mark and that, based on the facts, the exception for “honest concurrent use” under s 44(3)(a) and/or “prior continuous use” under s 44(3)(4) of the Trade Marks Act 1995 should not apply.

Caesarstone appealed the decision and the primary judge in Caesarstone Ltd v Ceramiche Caesar S.p.A. (No 2) [2018] FCA 1096 (Caesarstone (No 2)). found that there had been “honest concurrent use” of the CAESARSTONE mark on floor panels and wall cladding and that the use of the CAESARSTONE mark by Caesarstone’s distributors was “authorised use”.

On the appeal the two main issues in dispute in the first proceedings were whether the primary judge erred in concluding that:

(1) there was honest concurrent use of the CAESARSTONE mark on the designated Class 19 goods;

(2) the prior use of the trade mark was authorised use under Caesarstone’s control”.  [1]

Honest concurrent use

The interpretation of the disclaimer of “tiles” in the goods description was crucial to the question of whether there was honest concurrent use.

Caesarstone argued that the exclusion of “tiles” from its specification was of no significance because it did not limit the goods specifically listed in the specification.  They relied on the primary judge’s finding that the disclaimer did not “subtract all content from” the words “panels for floors” and “wall cladding”.  [2]

Ceramiche Caesar argued that the disclaimer effectively excluded tiles.  As the primary judge found that the goods in honest concurrent use were floor panels and wall cladding in the nature of tiles, there was therefore no honest concurrent use of the mark in respect of the goods covered by the application.

Their Honours considered that “as a matter of plain English, the words “none of the foregoing being in the nature of tiles” operate to limit the class 19 goods to include only panels for floors, floor coverings and wall claddings which are not in the nature of tiles”.  They said that “the primary judge’s conclusion that the tile disclaimer did not “subtract all content” from the words “[p]anels for floors, floor coverings, and wall cladding” which are not “in the nature of tiles” was a statement of the obvious” and “not a statement which supports the conclusion that the tile disclaimer was “ineffectual” in the sense contended for by the respondent”.  [3]

The Full Court held that the primary judge erred in finding honest concurrent use because honest concurrent use must be in respect of the goods covered by the application. In this case, the finding of honest concurrent use was for goods which were all “in the nature of tiles”.  As tiles had been expressly excluded from the specification they were not covered.

The Full Court also refused Caesarstone’s request to remove the disclaimer, because this would effectively widen the scope of the registration to include tiles.

Authorised use

While the Full Court found that there had not been honest concurrent use, and the second question of whether Caesarstone’s use would have been “authorised use” did not therefore strictly arise, the judges considered the question briefly.

Section 8(1) of the Trade Marks Act 1995 states that a person is an authorised user “if the person uses the trade mark under the control of the owner of the trade mark” and section 8(3) provides that:

(3) If the owner of a trade mark exercises quality control over goods or services:

(a) dealt with or provided in the course of trade by another person; and

(b) in relation to which the trade mark is used;

the other person is taken, for the purposes of subsection (1), to use the trade mark in relation to the goods or services under the control of the owner.

The primary judge’s finding that Caesarstone’s prior concurrent use was authorised use under Caesarstone’s control and therefore use in accordance with section 8(3) of the Trade Marks Act was on the basis that Caesarstone:

“(1) gave instructions regarding slab transport and storage to the Australian distributors;

(2) provided technical and marketing support services to the Australian distributors;

(3) sought to exercise quality control by ensuring that the Australian distributors provided fabrication and installation manuals to the stonemasons, and contributing to the content of these manuals.”  [4]

However, on appeal their Honours decided that the evidence did not support this and that the primary had judged erred in finding authorised use.

The Full Court stated that “Authorised use requires the trade mark applicant to establish “control as a matter of substance”: Lodestar Anstalt v Campari America LLC [2016] FCAFC 92(2016) 244 FCR 557 (Lodestar) at [97]. What constitutes control as a matter of substance is informed by the function of the trade mark, which is to indicate a connection in the course of trade with the registered owner – see PioneerKabushiki Kaisha v Registrar of Trade Marks [1977] HCA 56(1977) 137 CLR 670 (Pioneer) at 683 per Aickin J”. (pgh 39).  [5]  The court also noted “the critical enquiry is whether there was quality control with respect to the designated goods”.

The court held that Caesarstone did not exercise quality control because the control was not in relation to the designated goods, being panels for floor covering and wall covering.  Further the quality control was not in relation to the work of the stonemasons who fabricated the slabs into the finished products and were therefore responsible for the ultimate quality of the designated goods.  Their honours found that “not only did Caesarstone not have any contractual relationship with the stonemasons, but there was no evidence that Caesarstone ever inspected the stonemasons’ work or conducted any quality control regarding the final product.” [6]

In relation to the evidence on which the primary judge based his finding of quality control, the court noted that:

  1. Caesarstone’s storage and transport instructions only ensured that the slabs were not damaged, they did not enforce quality control over the finished products covered by the application being the panels for floor covering and wall cladding;
  2. The installation and fabrication manuals provided by the distributors to stonemasons were for guidance only and the “provision of technical information is not, at least of itself, the exercise of quality control”. [7]
  3. There were no terms relating to “quality control standards, brand guidelines, marketing approval mechanisms or rights of inspection of fabricated product” in Caesarstone’s distribution agreement with Tessera. [8]

Authorised use on a wider basis

The primary judge had also found that there had been control “on a wider basis than… exercising quality control”.  However, their Honours held that this was not the case because “the application of the mark to a slab is not indicative of control over the designated goods” [9] and the various claims of wider control, such as Caesarstone’s website listing ideas on possible uses for the slabs did not “operate to constrain or demand the stonemasons to use the slabs in any particular way or require fabrication in any particular way” [10].  Further, the general communications between Caesarstone and its distributors did not include reporting back to Caesarstone on the ultimate application of the slabs and did not “translate into a finding of “control” over the designated goods”.  [11]

Decision

Their honours found that the primary judge erred in concluding that there had been honest concurrent use in respect of the goods covered by the amended application. They also found the claimed use was not authorised use under Caesarstone’s control and that Caesarstone did not exercise quality control and general control on a wider basis.

The second proceeding was resolved in the same way as the first and third proceeding also went the same way as the first.

The appeals in all three proceedings were allowed, the primary judge’s orders were set aside, Ceasarstone’s application numbers 1058321 and 1211153 were refused and registration number 1211152 was cancelled.

Takeaway

The decision is an important reminder that quality control must be exercised as a matter of substance. This is essential if the use of the trade mark is to be considered authorised use that can be relied upon by a registered owner for the purposes of defending a non-use removal action, or to support an applicant’s claim to registration based on use.

It serves as useful clarification that disclaimers in goods specifications are to be interpreted as a matter of plain English and is a reminder that to establish “honest concurrent use”, it is necessary to prove use on the goods covered by the application.


[1] Ceramiche Caesar S.p.A. V Caesarstone Ltd [2020] FCAFC 124 (28 July 2020), paragraph 22.

[2] Ibid, paragraph 27.

[3] Ibid, paragraph 29

[4] Ibid, paragraph 45.

[5] Ibid, paragraph 39.

[6] Ibid, paragraph 60.

[7] Ibid, paragraph 52.

[8] Ibid, paragraph 58.

[9] Ibid, paragraph 64.

[10] Ibid, paragraph 70.

[11] Ibid, paragraph 75.