Biosimilars Deals 2021

Wrays Solutions Pty Ltd v Zhejiang Zhuji United Chemicals Co., Ltd. [2024] APO 44 (29 October 2024)

Highlight

In a straw man opposition, Wrays Solutions (Wrays) has successfully opposed all claims (apart from claim 11) of AU2019446196 (the Patent Application) held by Zhejiang Zhuji United Chemicals (Zhejiang).  The opposition to the grant of the Patent succeeded on the grounds of novelty (claims 1, 2 and 9), inventive step (claims 1, 2, 9 and 10), clarity (claim 2), utility (claim 3) and lack of support and sufficiency (claims 3 to 7).  While Wrays filed expert evidence in support of its opposition, Zhejiang filed no expert evidence, relying solely on legal submissions to answer the opposition.  Zhejiang was given two months to propose amendments.  Zhejiang has appealed the opposition decision to the Federal Court of Australia, and in those proceedings has given notice that it intends to seek to amend the Patent Application.  Zhejiang now has until 20 March 2025 to file an application in the Federal Court proceedings for an order for amendment of the Patent Application.

The Patent Application claimed an allegedly new high-purity thermostable crystalline form, or polymorph, of an existing herbicide, bixlozone, detailing its space group, lattice parameters and melting point.  The claims also covered the crystal structure with a specific powder X-ray diffraction (PXRD) pattern, methods for preparing it using specific solvents and conditions, and its application in agrochemical formulations.

Key Issues

Construction – Melting Point Temperature Range

One of the key disputes between the parties that impacted several of the grounds related to the claimed melting point temperature range of 83°C to 85°C in claim 1.  Wrays argued that the skilled person would not understand the defined temperature range of 83°C to 85°C to be a hard and fast cut-off.  Zhejiang disagreed, arguing that the claimed temperature range was based on their experimental results and already factored in a margin for experimental error.  While the Delegate noted that the claimed lower limit was set at the precise temperature of one of the exemplified products in the specification, the Delegate ultimately concluded that the specific upper and lower limits of the temperature range were essentially arbitrary.  Further, the Delegate considered that, based on the terminology used in the claim, the temperature range defined in claim 1 would be understood as being 83°C to 85°C.  There was no qualification or imprecision imposed on the defined range, either explicitly in the claim or implicitly through any definition given in the specification or purposive reading by the skilled person.

Novelty

At the hearing, Wrays argued that claims 1, 2 and 9 to 11 were anticipated by WO2019030177 (D1), or alternatively, in light of the combination of D1 and US4405357 (D2).  The Delegate found claims 1, 2 and 9 to lack novelty in light of D1 on the basis that:

1. D1 disclosed the polymorph claimed in claims 1 and 2.  On this point, the Delegate noted that the PXRD patterns were relevantly identical, even though D1 did not disclose the claimed melting point range.  The Delegate accepted Wray’s expert evidence which established that two different polymorphs of the same material could have similar melting points, but stated that the suggestion that two different polymorphs could have almost identical PXRD was not plausible based on the expert evidence as well as the data derived from Zhejiang’s own experiments.
2. D1 also enabled the skilled addressee to be able to make the polymorph defined by claims 1 and 2.  On this point, the Delegate stated that it was not enough for the prior art simply to disclose the invention – it must also enable the invention.  The Delegate therefore analysed the disclosure in D1 to determine (and ultimately conclude) that, following the instructions given in D1, a crystal according to claims 1 and 2 would inevitably be obtained.

The Delegate found that D1 did not anticipate claims 3 to 7, 10 and 11 as the specific methods defined by these claims were not disclosed by D1.

Inventive Step

Wrays argued that the invention claimed in claims 1, 2 and 9 to 11 were obvious is light of the common general knowledge in combination with D1 alone or D1 together with D2.  As the Delegate had found that the inventions in claims 1, 2 and 9 lacked novelty, the Delegate considered that it followed that they were also obvious.  So, the Delegate limited his consideration of this ground to claims 10 and 11.

The Delegate found claim 10 to be obvious.  The Delegate considered that the skilled person would arrive at the claimed combination of formulation and use defined in claim 10 without the exercise of any inventive faculty and in the expectation that it would provide a useful result.  In reaching this conclusion, the Delegate relied on the fact that the replacement of one form of bixlozone with another in known herbicide applications would present no apparent difficulty or barrier to the person skilled in the art.

The Delegate did not, however, find claim 11 to be obvious, stating that based on the evidence before him he was unable to conclude that the specific use of the claimed formulations of bixlozone in wheat or corn was a mere choice from a number of equally useful alternatives that would have been obvious to the skilled person at the relevant time.

Clarity

Wrays argued that claim 2 was unclear because relative peak intensity was one of the parameters used to define the claimed polymorph.  Wrays argued that, as the relative intensities of peaks in a PXRD spectrum will depend on a range of factors during sample preparation, the same crystal form might show different intensities for peaks in its PXRD depending on how the sample was prepared.  This meant that the skilled person would not know whether a crystal form they had produced would fall within the scope of claim 2, particularly given that the Patent Application provided no guidance as to what relevant parameters should be used in the sample preparation for producing the required spectrum.

The Delegate agreed, finding that claim 2 lacked clarity, noting that:

• the evidence showed that peak intensity was not a reliable means of distinguishing between polymorphs because of orientation effects and sample preparation effects; and
• if an unusual or “special” parameter was used in a claim to characterise an invention, then detailed information must be given to enable the skilled person to determine whether they were working within the scope of the invention.  This would include sufficient information such that any factors, including orientation effects and sample preparation effects, could be taken into account in the comparison.  Without these details the skilled person would not be able to determine with any certainty whether they were working within the scope of claim 2.

Sufficiency and Support

The Delegate considered claims 3 to 7 to be insufficient and lacking support.  Section 40(2)(a) of the Patents Act requires that the complete 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(3) requires that the claims are supported, that is, that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified.

The Delegate considered that claims 3 to 7 were both insufficient and lacked support because of the limited teaching in the Patent Application regarding how to make the seed crystal from which the claimed polymorph would be recrystallised.  The specification taught the preparation of the seed crystals using only a specific method and specific conditions.  This limited teaching did not enable the invention claimed in claims 3 to 7 to be performed across the breadth of the claims.  It also followed that the method claims in claims 3 to 7 exceeded this limited technical contribution in the specification.  In reaching this conclusion, the Delegate considered that the evidence showed that:

• the conditions required to obtain the seed crystal were more specific than the general process of simply heating, cooling and re-heating in order to obtain the specific mixture of polymorphs in the specific arrangement; but
• once the seed crystal was obtained, the skilled person would be able to determine appropriate conditions and solvents for its use in recrystallization by routine trial and error.

Utility

The Patents Act requires that a claimed invention be useful.  This means that an invention must do what it is intended by the patentee to do, in that it meets the promise of the invention.  Wrays argued that the invention claimed in claim 3 was not useful as claim 3 required a solvent selected from “alkanes and cycloalkanes”, but the specification stated that hexane, an alkane, would not perform the method of the claim.  The Delegate agreed with Wray’s submission, on the basis that it included matter that did not work, and for which the specification did not provide additional information by which the skilled person could make the process work.

Outcome

Wrays succeeded in opposing the grant of all claims except claim 11.  Zhejiang was given two months from the date of the decision to propose amendments.  Costs were also awarded against Zhejiang.

Implications

The decision of the Patent Office provides guidance on a number of key areas.

On novelty, the Delegate’s decision reinforces that a prior art document can anticipate a claimed invention where the features of the claimed invention are inherent (although not explicitly disclosed) in the prior art document.  This led the Delegate to find that D1 anticipated the claimed polymorph based on identical PXRD patterns, despite not disclosing the melting point range.  For inventive step, the decision emphasises that the mere substitution of equivalents lacks inventiveness unless it yields unexpected results, finding that replacing one bixlozone form with another in herbicide applications was an obvious choice.  However, claim 11 survived as its specific use in wheat and corn was inventive.

Regarding clarity, the decision underscores that claims relying on specialised parameters (like PXRD peak intensity) must provide enough detail for skilled persons to determine whether they fall within the claim.

On sufficiency and support, the decision confirms that broad claims must be justified by the patent’s technical contribution, finding that the limited teaching on seed crystal preparation meant claims 3-7 could not be performed across their full scope.

Finally, on utility, the decision reinforces that claims covering inoperative embodiments lack utility.  Claim 3 failed as it encompassed solvents (like hexane) that the specification admitted would not work, without explaining how to fix the issue.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Juno Pharmaceuticals Pty Ltd v Janssen Pharmaceutica NV [2024] APO 48

Highlight

In a December 2024 decision, the Australian Patent Office has dismissed Juno Pharmaceuticals’ (Juno) opposition to amendments sought by Janssen Pharmaceutica NV (Janssen) for its patent covering dosing regimens for long-acting injectable paliperidone esters.  The Delegate allowed the amendments and awarded costs against Juno, finding that the proposed amendments complied with sections 102(1) (amended claims falling within the scope of the ‘as filed’ specification), 102(2)(a) (amended claims falling within the scope of the ‘accepted’ claims), and 102(2)(b) (the amended claims being fairly based on the specification) of the Patents Act 1990.

Background

In December 2008, Janssen filed patent AU2008340101 (the Patent) entitled ‘dosing regimen associated with long acting injectable paliperidone esters’.  The Patent outlines a dosing regimen for injectable paliperidone palmitate, based on research demonstrating that the drug exhibits “flip-flop kinetics” and achieves better results with injections into the deltoid muscles.  The specification recommends a regimen involving two initial deltoid injections on day one and between days 6-10 (loading doses of 100 – 150 mg-eq), followed by monthly maintenance doses of 25-150 mg-eq.

The Patent was granted in December 2015, and Janssen sought leave to amend the specification in February 2023, with those amendments being superseded by further amendments in May 2023.  Juno subsequently filed an opposition in August 2024.

Key Issues and Consideration

The Delegate’s analysis centred on two main categories of amendments: (i) Extension of Loading Dose Ranges; and (ii) Method of treatment claims.

Extension of Loading Dose Ranges

Janssen sought to amend claim 1 as follows:

a first loading dose of from about 100mg-eq. to about 150 mg-eq. of paliperidone”

and

“a second loading dose of from about 100mg-eq. to about 150 mgeq. of paliperidone.

Juno argued that prior to amendment, the skilled person would understand claim 1 to include administration of a first and second loading dose of at least 100 mg eq. (but not less than that) up to no more than 150 mg eq.  However, post-amendment, Juno argued that claim 1 would be understood as allowing doses above and below 150 and 100 mg eq., so broadening the scope of the claim.  Janssen submitted that “about” in the original claims meant “approximately”, arguing this interpretation was logical since any other reading would make the word “about” redundant.  The expert evidence was divided on this issue:  Juno’s expert, Professor Keks, interpretated the range as having strict limits due to the word “from”, while Janssen’s expert, Professor Singh, viewed “about” as consistently meaning “approximately” throughout the specification, allowing for marginal variations above and below the stated values.

The Delegate agreed with Janssen, noting that the Full Court in Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCAFC 167 observed that it is “axiomatic that a claim term should be construed consistently throughout the claim set”, and that giving “about” different meanings when used in a range (or prefaced by “from”) versus specific integers would be an unnatural construction.  As such, this amendment could not have the effect of broadening the scope of the claims.

Juno also argued that the specification did not disclose the selection of the two specific doses to which the amendments were directed (where the first loading dose was amended to the upper limit and the second to the lower limit of their original ranges).  Juno further submitted that the amended claims would allow maintenance dosing (25-150 mg eq.) to exceed the second loading dose (100 mg eq.), contradicting both the specification’s statement about doses “dropping to” maintenance levels and the dictionary definition of “loading dose”, being “an initial dose of a drug which is higher than subsequent doses, intended to rapidly achieve a therapeutic concentration in the body”.  The Delegate preferred Janssen’s position, finding that, since the specific doses fell within the original ranges, they represented a permissible narrowing amendment, and there was no clear indication in the specification that a maintenance dose must be lower than a loading dose, irrespective of the dictionary definition.

Finally, Juno argued that amended claims 6 and 7, which specified a 100 mg eq. first loading dose for renally impaired patients, lacked support in the specification, which stated that renally impaired patients’ loading doses “should be reduced to 75 mg eq. for the first two loading doses”.  However, the Delegate found against Juno on the basis that the administration of a first loading dose of about 100 mg eq. of paliperidone to a renally impaired patient was not introduced by Janssen’s amendment.

Method of treatment claims

The second major category of amendments concerned new method of treatment claims (claims 45-54).  These claims defined methods of treating psychiatric patients by administering paliperidone palmitate according to selected preceding claims.  Juno argued that these amendments exceeded the scope of both the original dosing regimen claims (discussed above), and claim 25 prior to amendment (a “use” claim), which reads:

Use of paliperidone palmitate in a dosage regimen according to any one of claims 1 to 23 for treating a psychiatric patient, or a renally impaired psychiatric patient.

In support, Juno submitted that:

• a dosing regimen is not a method of treatment, but a list of instructions for administration (which in and of itself did not treat the patient).  Based on this distinction, Juno argued that the amendment broadened the scope of the claims such that an infringement would occur which would not have occurred pre-amendment; and
• the original claim 25 was limited to cases where paliperidone was used with the regimen instructions (even suggesting that “use” could be satisfied by merely writing paliperidone on a list of drugs to be used according to the regimen), rather than requiring actual administration to patients.

In response, Janssen submitted that:

• “use” constitutes an act of exploitation;
• the dosing regimen claims properly construed are method claims as they define administration steps;
• the appropriate comparison is between each amended claim and the unamended claims as a whole; and
• following the decision in AMP Incorporated v Commissioner of Patents (1974) 3 ALR 283, “it is not necessary before an amendment is allowed to find that the amended claim would actually fall within the scope of one or all of the other claims.  It need only fall in substance within that scope”, and there was no basis in the specification or evidence to understand claim 25 prior to amendment to require the exclusive use of the defined dosage regimen for treating a psychiatric patient.

The Delegate considered it unnecessary to turn to the dosage regimen per se claims to decide this issue.  The Delegate found that claim 25 prior to amendment, which covered “use … for treating a patient”, must include actual drug administration since it referenced regimens specifically designed for administering the drug and detailed specific administration steps.  The Delegate also took the opportunity to confirm that, in any event, the intention of the person carrying out the administering is irrelevant to the scope of method of treatment of dosage regimen claims.

Outcome and Implications 

The Delegate denied the opposition, finding that Juno failed to establish that the amendments did not comply with ss 102(1), 102(2)(a) or 102(2)(b) of the Patents Act.  The Delegate’s decision reinforces the fundamental principles of claim construction, with the Delegate giving a logical and consistent interpretation to the claims before and after amendment.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.