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

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.

Authored by Michael Christie, PhD

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Authored by Michael Christie, PhD and Ean Blackwell

Australia’s Full Federal Court recently delivered judgment in an appeal in a significant patent case: Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116.  The case concerned three patents relevant to Mylan’s oral lipid-lowering agent, Lipidil® (fenofibrate).

An enlarged Full Court bench comprising 5 judges (Middleton, Jagot, Yates, Beach and Moshinsky JJ) was appointed to hear and decide Mylan’s appeal.  This was because Mylan sought to clarify the Full Court’s previous statement in Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91; 154 FCR 31 that the characterisation of an alleged anticipation as a “suggestion” in relation to the invention, is “not necessarily fatal to a novelty argument”.  Mylan submitted this statement by the Full Court did not countenance “mere speculation” or “the presentation of no more than a reasoned hypothesis” as an anticipatory disclosure.  On this basis, Mylan submitted to the Full Court (unsuccessfully, as explained below) that the trial judge (Nicholas J) had erred in finding that a hypothesis stated in a prior art document relating to a clinical study deprived methods of treatment claims of novelty.

The Full Court’s decision also provided important guidance in relation to the approach taken by Australian courts in considering obviousness, the construction and infringement of ‘Swiss-style’ claims under Australian patent law and the extent to which consistory clauses alone can provide fair basis for a claim.

Method of treatment and Swiss-Style claims lack novelty in light of clinical trial protocol

The Full Court considered whether method of treatment and Swiss-style claims could be anticipated by prior art comprising a protocol for a clinical trial of the claimed method.

Mylan argued that such a protocol could not be novelty-defeating, because at most it identified a hypothesis that required testing, and could not be understood as teaching or recommending that the claimed method be put to clinical use.  The Full Court rejected that analysis and upheld the trial judge’s finding that Mylan’s method of treatment and Swiss-style claims lacked novelty.

The Full Court held that, in assessing novelty, the key question is whether the information disclosed in the prior art is sufficiently specific and complete to be equal to the invention that is later claimed.  If so, then even a protocol for a trial to test the claimed method could be novelty-defeating.  The Full Court acknowledged that, in this respect, Australia’s law on novelty differs from the law applied by UK courts in cases such as Regeneron Pharmaceuticals Inc v Genentech Inc [2012] EWHC 657 (Pat) and Hospira UK Limited v Genentech Inc [2015] EWHC 1796 (Pat), which hold that the prior art must disclose actual achievement of the relevant therapeutic effect to be novelty-defeating.

This aspect of the Full Court’s decision arguably fails to give due consideration to the proper meaning and importance of words such as “treat” and “prevent” in method of treatment and Swiss-style claims.  As Mylan contended, at the stage of disclosing the protocol for a clinical trial, it is not known whether the product or method under consideration does in fact “treat” or “prevent” the particular condition or illness of interest, and there is a significant prospect that it will later prove ineffective or unsafe.  The approach of the Full Court and the primary judge makes clear that the nature and extent of the prior-published clinical trial protocol or other document will be critical in each case.  Those case-specific factual issues will be especially important in future cases, as it would seem a harsh outcome for patentees for statements of unproven hypotheses, theories, ideas or suggestions to anticipate and invalidate (for lack of novelty, putting aside considerations of obviousness which depend on the common general knowledge and availability of prior art) claims to a method that the patentee has subsequently proven effective and safe in “treating” or “preventing” the particular condition or illness.

Obviousness of formulation and method of treatment claims

Australian Courts generally assess obviousness by asking whether, before the priority date, a skilled person presented with the same problem as the patent owner would have been “directly led to try the claimed subject matter with a reasonable expectation of success” (referred to as the “modified Cripps question”).  Historically, that test has been applied in a strict manner by Australian courts, leading a number of patents to be upheld in Australia that have been invalidated on obviousness grounds in other jurisdictions.

Recently, however, Australian courts have adopted a more flexible interpretation of the Cripps test.  This Mylan case continues that trend.  The trial judge held two of Mylan’s patents (one relating to nanoparticulate formulations of fenofibrate, the other relating to methods of preventing or treating retinal damage associated with diabetes by administering fenofibrate) invalid on obviousness grounds, and the Full Court upheld those findings.

The following aspects of the Court’s obviousness analysis are notable:

  • Mylan’s patent for a nanoparticle formulation of fenofibrate included claims which required the use of specified surface stablizers.  The trial judge did not find that the skilled person would have been directly led to select those specific stabilizers with an expectation that they would be effective. Rather, he found that the claimed stabilizers were logical to try and that routine, trial-and-error testing would have demonstrated their suitability.  The Full Court agreed this was sufficient to support an obviousness finding.
  • In relation to Mylan’s method of treatment patent, an expert gave evidence that, before the priority date, his expectation of success with the claimed method would have been less than 50%.  The trial judge held that evidence was not inconsistent with a finding of obviousness, because the Cripps test does not require a numerical assessment.  Again, the Full Court agreed with that analysis.

The test for obviousness applied by Australian courts remains more demanding upon the party seeking revocation than the approach taken by (for example) the European Patent Office or the UK courts.  However, the Mylan decision continues a trend in Australian patent cases towards a more flexible application of the obviousness test that is somewhat closer to the approach taken by the European Patent Office and UK courts.  This serves to emphasise the importance of careful preparation of the obviousness defence in close collaboration with inventors and key expert witnesses.

Defining the scope of Swiss-style claims

The claims asserted by Mylan included Swiss-style claims.  Swiss-style claims are typically drafted in the form “Use of [active ingredient] in the manufacture of a medicament for the treatment of [disease or disorder]”.  They came about from the need to satisfy particular requirements for patentability which formerly applied under the European Patent Convention.  Although these requirements do not exist in Australia, Swiss-style claims are routinely included in Australian patents as their scope is different from that of method of treatment claims, which are also permitted under Australian law.

The Full Court in this Mylan case examined the interpretation of Mylan’s Swiss-style claims, having regard to the decision of the UK Supreme Court in Generics (UK) v Warner-Lambert [2018] RPC 2, and provided guidance on determining the scope of such claims under Australian law.

One of the Swiss-style claims asserted by Mylan recites:

 “Use of fenofibrate or a derivative thereof for the manufacture of a medicament for the prevention and/or treatment of retinopathy, in particular diabetic retinopathy”.

The Full Court confirmed that the claim, if valid, conferred a monopoly in respect of the method or process of making the medicament, and that the method or process is complete upon manufacture.  The monopoly did not extend to a method of treatment – that being the province of method of treatment claims.  The Full Court also confirmed that Swiss-style claims are purpose-limited in the sense that the medicament resulting from the method or process is characterised by the therapeutic purpose for which it is manufactured, as specified in the claim.  The Full Court rejected the “outward presentation” test that was favoured by Lords Sumption and Reed in the UK Warner-Lambert case.

In the first instance decision, the primary judge said that the the crucial question concerning the infringement of a Swiss-style claim was whether the manufacturer had made or will make the medicament with the intention that it be used in the treatment of the designated condition.  On this basis, to prove infringement of a Swiss-style claim, it would not be enough to show that it was “reasonably foreseeable” that a generic product would be put to the use referred to in those claims (although foreseeability could be relevant in the overall analysis).  The trial judge held that, to prove infringement of Swiss-type claims, it would be necessary to show that the generic intended that its product be put to the use referred to in the Swiss-style claims.

The Full Court disagreed with this approach, instead finding that infringement of a Swiss-style claim is concerned with what the allegedly infringing manufacturer has done, not what it intended to do.  That is, not what a generic manufacturer intended, but what the generic product is for.  According to the Full Court, a single factual question arises when considering infringement:  as the product of the claimed method or process, is the medicament for the specified therapeutic purpose?  The question, the Full Court said, is answered having regard to “all the circumstances of the case”.

The Full Court pointed to several such “circumstances” that will be relevant in determining the therapeutic purpose of the medicament as defined by a Swiss-style claim.  First, the court noted that the physical characteristics of the medicament as it emerges as a product of the manufacturing process, including its formulation and dosage, packaging and labelling, and its patient information, will be an important consideration.  So too will evidence of the manufacturer’s actual intention in making the medicament, where such evidence is available.  Both factors are relevant considerations, but neither is determinative.

On the facts of this case (which included “skinny labelling” confining the approved indications of the generic product to indications outside the conditions within Mylan’s method of treatment claims), the Full Court held that Mylan had not proved that Sun’s fenofibrate products were “for” the second medical use covered by Mylan’s Swiss-type claims.

The Full Court also gave consideration to the reasonably foreseeable use or uses to which the medicament would be put after manufacture.  But while a reasonably foreseeable use may be relevant in deciding the therapeutic purpose of a medicament, it is also not determinative:  it might be reasonably foreseeable that a product might be put to a particular use, but it does not necessarily follow that the product, as manufactured, is for that use.

The Full Court agreed with the primary judge that mere suitability of a medicament for a claimed purpose cannot be determinative of the question of infringement of a Swiss-style claim.  The fact that the patent has been granted on the basis of a second medical use means that there are multiple uses to which the medicament could be put.  Evidence of suitability for use was therefore considered ambiguous and could not alone answer the question whether the medicament, as manufactured, is one for the specified therapeutic purpose.

Ultimately, the Full Court found that the Swiss-style claims, if valid, would not have been infringed by the manufacture of Sun’s competing product.  Of particular relevance to the Full Court’s decision was the fact that the competing product could be used in a large number of diseases other than retinopathy.

The decision validates the importance of including both Swiss-style claims and method of treatment claims when protecting a therapeutic use in Australia.  Both types of claim are permitted in Australia, and although their scope is limited to the specified therapeutic use, each will directly capture a different infringer.  In particular, Swiss-style claims provide a more direct avenue than method of treatment claims for pursuing manufacturers of competitive pharmaceutical products, rather than the medical practitioners who perform the treatment.

Consistory clauses may not provide fair basis if too broad 

Mylan’s third patent, relating to an immediate-release micronized formulation of fenofibrate, was found by both the primary judge and the Full Court to be invalid for lack of fair basis.  The Full Court endorsed the primary judge’s reasoning that the disclosure elsewhere in Mylan’s patent specification made clear that the invention was to the immediate release fenofibrate composition and a method for preparing it, whereas Mylan had advanced a construction of a consistory clause and corresponding claims to the effect that the invention extended to any composition of fenofibrate which satisfies the specified dissolution profile.  The Full Court affirmed that, as Sun Pharma had submitted, this is “a paradigm example of claims which travel beyond the matter disclosed in the specification”, amounting to invalidity for lack of fair basis.

The fair basis test considered in this case still applies to Australian patents for which examination was requested prior to 15 April 2013, when the “Raising the Bar” amendments came into effect.  The ‘fair basis’ requirement is generally considered to be a lower standard for patentees than the ‘support’ requirement that replaced it from 15 April 2013, which Australian Parliament expressly intended to align more closely with requirements under European law.  Therefore, if a consistory clause alone will not necessarily provide fair basis, that risk is likely to be even more significant for more recent patents and pending future patent applications required to meet the higher standard of support (such as an “enabling disclosure”).

Authored by Duncan Longstaff and Michael Christie, PhD

The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 was introduced in Australia with the intention of aligning Australia’s written description requirements with those in the UK and Europe. Under the new Act, a specification must disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art (section 40(2)(a)) and the claims must be supported by the matter disclosed in the specification (section 40(3)).

In some cases, patent applicants can submit data not included in the specification as filed (so called post-filing data) in an effort to overcome section 40 objections. But there are currently no guidelines in Australia’s Patent Manual of Practice and Procedure concerning the use of post-filing data.  A recent decision in BASF Corporation [2019] APO 34 confirms that post-filing data can assist in overcoming section 40 objections provided the data is confirmatory in nature.

Background

The decision in BASF relates to two patent applications – Application No. 2017204400 (the 400 application) and Application No. 2017204506 (the 506 application) – filed by BASF Corporation (the Applicant).  The 400 application relates to synergistic mixtures of Bacillus subtilis MBI600 and a second compound selected from a range of fungicidal or insecticidal compounds and plant growth regulators. The 506 application relates to synergistic mixtures of Bacillus pumilus INR7 and a second compound selected from a wide range of fungicidal or insecticidal compounds and plant growth regulators, or Bacillus subtilis MBI600. The applications describe several strategies by which synergy may be assessed and disclose data demonstrating synergistic mixtures, none of which were claimed.

The issues and findings  

In maintaining support and sufficiency objections against both applications, the Examiner adopted the two-step enquiry set out in Evolva SA [2017] APO 57:

Does the specification provide an enabling disclosure of all the things that fall within the scope of the claims, and in particular:

(a) Is it plausible that the invention can be worked across the full scope of the claim?

(b) Can the invention be performed across the full scope of the claim without undue burden?

The Examiner was satisfied that there would be no undue burden for the skilled person to perform the claimed invention as the claims were substantially narrowed during prosecution. However, the Examiner alleged that the applications failed the plausibility test (step (a)). In response, the Applicant submitted post-filing experimental data showing synergistic activity of some of the claimed mixtures. This was rejected by the Examiner who alleged that the specifications were speculative, and in the absence of a principal of general application supporting broad applicability of synergy at the filing date, the post-filing evidence of synergy cannot be used to demonstrate sufficiency (and support) of the specifications. The Examiner referred to the UK Supreme Court judgement in Warner-Lambert v Generics & Anr [2018] UKSC 56 (Warner-Lambert; previously reported here) which states (emphasis added):

“Sufficiency of disclosure must be satisfied at the effective date of the patent, ie on the basis of the information in the patent application together with the common general knowledge then available to the skilled person. Acknowledging sufficiency of disclosure on the basis of relevant technical information produced only after this date would lead to granting a patent for a technical teaching which was achieved, and, thus, for an invention which was made, at a date later than the effective date of the patent…”

The Applicant requested the matter be heard by the Patent Office. With regard to the role of post-filing data, the Delegate noted the absence of authority on this issue and observed “This is a matter which has not received attention following the implementation of the Raising the Bar Act, and so, in accordance with the guidance in the Explanatory Memorandum, I will have regard to UK and European case law as to the role of such evidence in relation to questions of support and sufficiency.”

Turning then to UK authorities, the Delegate cited Lord Sumption in Warner-Lambert at [72]:

“This does not mean that subsequent data is never admissible in a dispute about sufficiency, but the purpose for which it is admitted is strictly limited.  Where the asserted therapeutic effect is plausible in the light of the disclosure in the patent, subsequent data may sometimes be admissible either to confirm that or else to refute a challenger’s contention that it does not actually work … it cannot be a substitute for sufficient disclosure in the specification.”

The Applicant argued that the post-filing evidence submitted in this case: 1) supplemented the evidence contained in the specifications; and 2) refuted the contentions of the Examiner regarding the unpredictability of synergy. The Applicant submitted declaratory evidence from an inventor attesting that the disclosure in the specifications of synergy between a particular Bacillus and a chemical pesticide having a given mechanism of action makes it more or less likely that synergy will be observed with a different chemical pesticide with a different mechanism of action. Accepting the Applicant’s evidence, the Delegate found that the post-filing data confirmed the expectation of the skilled person having regard to the specification as filed and the common general knowledge as at the filing date.  Accordingly, the claims were found to be fully supported and sufficiently enabled by the specification as filed.

Implications

This decision confirms that post-filing experimental data can help establish sufficiency and support provided the data confirms the information disclosed in the specification as understood by a skilled person in the art.  In our experience, post-filing data can be, and has been, persuasive in overcoming written description objections.

Authored by Michael Christie, PhD

Biological molecules, including polypeptides and, in some cases, nucleic acids, can be patented under Australian law.  The level of disclosure that is required to support and enable a claim to a polypeptide will depend on several factors, including:

i.    the identity of the person skilled in the art;

ii.   the information disclosed in the specification;

iii.  the function of the polypeptide; and

iv.  the specific sequence being claimed.

This article briefly describes how each of these factors contributes to the determination of a claim’s scope under Australian practice.

The person skilled in the art

In considering whether a claim is sufficiently enabled, the Australian Patent Office will ask:

i.   whether it is plausible that the invention could be worked across the full scope of the claim; and

ii.  whether the invention can be performed across the full scope of the claim without undue burden.

The answer to both questions will depend on the identity of the hypothetical person skilled in the art.  The skilled person may carry out ordinary methods of trial and error and may use their common general knowledge to supplement the information contained in the patent specification.[1]  Where the subject matter of the invention is inherently complex – protein engineering may be one example – a substantial amount of work may be required, and indeed expected, for a person skilled in the art to perform the claimed invention.  When seeking to claim a large number of polypeptides, a patent applicant will therefore be well served if they can frame the invention as one which lies within a complex technical field, where the “ordinary” skilled person is highly qualified and capable of complex experimental techniques.

The skilled person played a prominent role in Evolva SA [2017] APO 57 (“Evolva”), a case which concerned the use of uridine-5′-diphospho-dependent glycosyltransferases (UGTs) to glycosylate mogrol.  The specification described only five UGTs, but the claims encompassed the use of polypeptides having at least 90% sequence identity to any one of them.  The examiner rejected the claims, alleging that an undue burden would be placed on the skilled person who would have to produce every polypeptide encompassed by the claims and then perform an assay on each to identify those which exhibited the desired activity.  In arriving at the decision, the examiner characterised the skilled person as being “a single synthetic chemist, perhaps a PhD candidate”.

The matter was heard before a Delegate of the Commissioner of Patents who ultimately allowed the application including claims that defined polypeptides having at least 90% sequence identity to any one of the five UGTs described in the specification.  Crucial to the Delegate’s decision was the characterisation of the person skilled in the art.  Contrary to the examiner’s characterisation, the Delegate considered that a team, comprising biotechnologists and synthetic chemists, would be the “person” to whom the specification is addressed.[2]  Needless to say, the team of people described by the Delegate was considered to have a much wider breadth of skills and knowledge at their disposal when it comes to assessing the plausibility of, and to performing, the invention as claimed.

 The information disclosed in the specification

Australian law does not prescribe a level of experimental data that must be disclosed by a patent specification to enable a polypeptide claim of a certain scope.  Of course, an abundance of experimental data will, in many cases, help to enable a claim that encompasses a broad range of polypeptides, particularly when it comes to demonstrating the plausibility of the claimed invention.  However, plausibility can also be demonstrated by a priori reasoning.[3]  In the absence of extensive experimental data, a broadly drafted claim may be enabled where the specification discloses a technical rationale that makes the claimed invention plausible to a person skilled in the art and provides guidance for the skilled person to perform the invention across the full scope of the claim.

To take a simple example, a claim which defines an antibody solely by reference to its target-binding specificity will typically be enabled provided the target is new and the specification sufficiently describes the epitope and has shown the antibodies can be raised against it.  In such cases, the specification need only disclose one such antibody since raising antibodies against the epitope is considered to be a principle that can be generally applied to produce antibodies across the entire scope of the claim.[4]  In each case, the question to ask is whether, based on the disclosure of the specification, including any a priori reasoning provided therein, a person skilled in the art would find the claimed invention plausible and could work the invention across the full scope of the claim.

The function of the polypeptide

A novel polypeptide may be defined in a claim either structurally, such as by its amino acid sequence, or functionally, for example, by its target-binding specificity or its enzymatic activity.  But somewhat paradoxically, a narrower claim which includes both structural and functional limitations can, in some cases, be found insufficiently enabled.

Take, for instance, our antibody example above.  While an antibody defined solely by its target-binding specificity may be fully enabled, further defining the antibody by reference to one or more of its complementarity determining regions (CDRs) will often render the claim insufficiently enabled.  The Patent Office takes the position that the disclosure of the epitope is not a principle of general application that can be applied to generate the antibodies in the claimed subset, to the exclusion of other antibodies not encompassed by the claim.[5]  In performing the claimed invention, a person skilled in the art would have to raise antibodies against the epitope and then perform an additional sequencing step to identify those that fall within the claimed subset.  This, in the Patent Office’s view, would place an undue burden on the person skilled in the art.

There is no general rule, however, prohibiting the inclusion of functional and structural limitations in a claim.  In Evolva, the claims in question defined a method of producing a mogroside compound using a UGT having at least 90% sequence identity to any one of five UGTs described in the specification.  Given what was known about the structure and function of UGTs, including the information disclosed by the specification, the Delegate found that the skilled person would consider it plausible that functional variants to a level of identity of at least 90% could be identified and would be useful in the claimed methods.[6]  On the issue of “undue burden”, the Delegate observed that the specification provided sufficient information about the manner in which UGT variants may be generated and tested.  Although such tests may involve time-consuming experimentation, they did not, it was found, present difficulties that would require the skilled person to undertake any prolonged research or experimentation that would be considered an undue burden in the relevant field of technology.[7]

The decision in Evolva contrasts with the more recent decision in Gary B Cox v MacroGenetics, Inc. [2019] APO 13, where the Patent Office rejected claims directed to deimmunized therapeutic proteins having an extended serum half-life. The therapeutic proteins comprised an albumin-binding domain (ABD) that could bind to serum albumin and thereby extend the half-life of the entire protein.

Claim 1 of the application defined a polypeptide comprising a variant ABD, the variant ABD having an amino acid sequence that differs from wild-type ABD by comprising one of two combinations of amino acid substitutions.  Importantly, the claim also included two functional limitations, namely that the ABD is deimmunized and that it is albumin-binding.

The use of the inclusive term “comprising” in claim 1 allowed for the variant ABD to have any number of mutations, provided it included those specifically recited in the claim. While acknowledging that the level of skill possessed by the relevant person skilled in the art would be high, it was not apparent to the Delegate that the skilled person would appreciate what mutations could be combined with those specified in the claim whilst achieving the functional limitations of the claims.[8]  To the contrary, evidence suggested that combinations of mutations would have an unpredictable effect on albumin-binding and could even introduce immunogenic regions.[9]  The Delegate found that the work required to identify variants having the desired properties, particularly the ability to bind albumin, while systematic and iterative, is unpredictable, with limited guidance provided by the specification.  The effort required to perform the invention across the full scope of the claims was described as being “in the nature of a research project” and therefore constituted an undue burden.[10]

The specific sequence being claimed

Certain polypeptides, and indeed certain regions within a polypeptide, may be more likely than others to tolerate amino acid variation without compromising the functionality of the polypeptide.  Large structural proteins, for instance, may tolerate a greater level of variation compared to smaller antigen-binding proteins or enzymes.

When it comes to antibodies, for example, one might expect that an amino acid change within a CDR would be more likely to affect binding specificity compared with an amino acid change within a framework region. (Of course, amino acid changes within the framework region can still impair the folding within, or the pairing between, the variable domains.)  Given the significant role played by the CDRs in dictating binding specificity, the Patent Office may allow a greater degree of sequence variability within the variable domain than it would within the CDRs themselves.  For claims which define an antibody solely by its heavy and light chain variable regions, the Patent Office has allowed 90% sequence identity.[11]

In some cases, mutations within a polypeptide may have unpredictable effects on the polypeptide’s function.  In Gary B Cox v MacroGenetics, Inc. [2019] APO 13, evidence was adduced showing that mutations would have an unpredictable effect on certain properties of the claimed polypeptide; properties that were included in the claims as functional limitations.[12]  Given the unpredictability in the art, and the lack of guidance provided by the specification, the Delegate found that the work required to perform the invention across the full scope of the claims would constitute an undue burden, and so the claims were found to be insufficiently enabled.[13]

Conclusions

When patenting polypeptides, there is no general rule that dictates the level of sequence variation that may be encompassed by any particular claim.  Certain proteins may be more resilient than others to amino acid changes, or the changes may have predictable consequences on the protein’s function, in which case, a broad range of protein variants may be validly claimed.  A large number of variants may also be claimed in circumstances where the person skilled in the relevant art is highly qualified and capable of complex experimental techniques that could be employed to perform the invention across the full scope of the claims.  Examples in the specification which demonstrate the functionality of protein variants can also help, but so too can a technical rationale which makes the claimed invention plausible and workable across the full scope of the claims.


[1] Eli Lilly & Co v. Human Genome Sciences, Inc [2008] RPC 29, [239]. Evolva SA [2017] APO 57, [24].

[2] Evolva, [54].

[3] Warner-Lambert v. Generics (t/a Mylan) & Actavis [2018] UKSC 56.

[4] The Australian Patent Office Manual of Practice and Procedure, s 2.11A Annex A.

[5] The Australian Patent Office Manual of Practice and Procedure, s 2.11A Annex A.

[6] Evolva, [62].

[7] Evolva, [68].

[8] Gary B Cox v MacroGenetics, Inc. [2019] APO 13, [95].

[9] Gary B Cox v MacroGenetics, Inc. [2019] APO 13, [97]-[99].

[10] Gary B Cox v MacroGenetics, Inc. [2019] APO 13, [107].

[11] See, for example, Australian Patent No. 2015242981.

[12] Gary B Cox v MacroGenetics, Inc. [2019] APO 13, [97]-[99].

[13] Gary B Cox v MacroGenetics, Inc. [2019] APO 13, [107].

Authored by Michael Christie, PhD

IAM Patent 1000: The World’s Leading Patent Professionals 2020 has again listed Shelston IP as Highly Recommended for their patent prosecution.

Congratulations to our ranked practitioners Paul Harrison, Chris Bevitt, Greg Whitehead and Michael Christie.

“The impeccably qualified team of patent attorneys and attorneys at law at Shelston IP has achieved great success in recent years, especially in tapping into the Chinese market. Processing one out of every 15 applications entering national phase in Australia already, the side now represents the greatest number of Chinese entities among Australian IP firms and files the most China-originating patent applications in Australia. Paul Harrison  and Greg Whitehead are fine examples of the group’s first-rate advisers. With a chemical engineering background, Harrison aptly handles building and construction products and systems, material separation, treatment and handling, metallurgy, food processing, medical equipment and process technology briefs. He is also the Asian Patent Attorneys Association Conference chair 2020. Head of the mining team, Whitehead is not just technically excellent, he also has a great track record building up and consolidating the patent portfolios of start-ups for commercialisation. Similarly, Michael Christie, a former senior associate at MinterEllison who joined the firm in May 2020 to head up the life science practice, specialises in molecular biology. Elsewhere, Chris Bevitt is the commercial law team leader who tackles transactional work effortlessly.”

Authored by Chris Bevitt, Greg Whitehead, Michael Christie, PhD and Paul Harrison

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]

Authored by Michael Christie, PhD and Katrina Crooks

Under Australian practice, both method of treatment and Swiss-style claims, in the format use of [compound X] in the manufacture of a medicament for the treatment of [condition Y]” are permitted. As reported previously, method of treatment and Swiss-style claims are directed to different infringing acts in Australia. This highlights the importance of pursuing both these claim types in Australian pharmaceutical patents

The construction of Swiss-style claims was recently considered again in Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28. The Federal Court confirmed that infringement of a Swiss-style claim requires the patentee to establish that the manufacturer has made (or will make) the relevant medicament with the “objective intention” that it be used to treat the condition defined in the Swiss-style claim.

In this case, the applicants’ product, fenofibrate (marketed under the name Lipidil), was indicated for the treatment of retinopathy, in particular diabetic retinopathy, and covered by Swiss-style claims of Australian Patent No. 2006313711. The allegedly infringing products, collectively referred to as “the Ranbaxy Products” were originally approved for the same indication as the applicants’ product. However, the product information (PI) for the Ranbaxy Products was subsequently amended to remove reference to diabetic retinopathy.

The infringement case submitted by the applicants relied on the following points at [105]:

(a)    the amended PI for the Ranbaxy Products asserts that the Ranbaxy Products are bioequivalent to Lipidil;

(b)    the PI for Lipidil expressly states that Lipidl is indicated for the reduction in the progression of diabetic retinopathy and includes details of the FIELD and ACCORD trials relevant to that indication; and

(c)    the PI for the Ranbaxy Products does not assert that the Ranbaxy Products are not indicated for diabetic retinopathy or that it is somehow not relevantly bioequivalent for that purpose.

Nicolas J acknowledged that the Ranbaxy Products are suitable to be administered for the therapeutic use designated in the Swiss-style claims yet he rejected the submissions above and said at [106]:

“[i]n my view the evidence does not support a finding that the Ranbaxy products will be manufactured with the intention that they be used for the prevention or treatment of diabetic retinopathy. The infringement case based on the Swiss-style claims must fail.” (emphasis added)

In reaching the decision, Justice Nicolas was guided and accepted the observations of the UK Supreme Court in Warner Lambert Company LLC v Generics (UK) Ltd [2018], including:

  • that a Swiss-style claim is “purpose limited” and that the monopoly claimed is for the preparation or manufacture of a medicament for the treatment of a particular medical condition; and
  • as a matter of construction, a Swiss-style claim required a “mental element” involving an “objective intent” or a “subjective intent” of the manufacturer.

The test of “subjective intent” questions whether the manufacturer made the product with the intention of targeting the patent-protected market while “objective intent” asks whether the alleged infringer knew or could foresee that at least some of the prescriptions for the claimed drug for the claimed indication would actually be fulfilled by their own product. While Nicolas J did not find it necessary to decide in the present case whether the Swiss-style claims are concerned with the objective or subjective intention of the manufacturer, he found the reasons given by the UK Supreme Court who favoured the “objective intention” more persuasive and evidently, he stated at [103]:

“[o]f course, it is for the applicants to establish that the manufacturer has made (or will make) the relevant medicament with the objective intention that it be used to treat the condition designated in the Swiss-style claims. The fact that it may be reasonably foreseeable or even likely that a substantial portion of the product manufactured will be used to treat that condition is certainly not determinative at least not where the product is also used extensively in the treatment of other non-designated conditions.” (emphasis added)

The Court’s decision suggests that establishing the “intention” of a potentially infringing manufacturer may be difficult particularly when the product has a wide range of indications. Importantly, simply because the products are bioequivalents does not establish an intention nor does a lack of disclosure excluding the claimed indication on the PI. As such, innovators should include all possible medical indications of a product in a Swiss-style claim as sufficiently supported and enabled by the specification.

Authored by Michael Christie, PhD