River Stone Biotech ApS v Antheia, Inc [2025] APO 38

1. During the period for filing evidence in support, River Stone filed a request for a Notice to Produce (19 May 2025). The request was subject to some exchanges with a delegate of the Commissioner of Patents who was ultimately not convinced that a Notice to Produce should issue. On 28 July 2025, River Stone requested a hearing in regard to the delegate's findings. I also note that evidence in support has been filed and completed. The applicant has chosen not to file any evidence in answer. As such, pending River Stone's request for a notice to produce, the matter is ready to proceed to a hearing of the substantive opposition.

1. The specification[1] describes the background to the present invention as follows:

Medicinal opioids are used for treating moderate to severe pain, but may exhibit addictive properties. Due to the mechanism by which medicinal opioids relieve pain, these medications are among the most effective painkillers in modern medicine. Additionally, however, medicinal opioids are also widely abused. In addressing the use of medicinal opioids, policy makers are tasked with balancing the under-treatment of pain, while mitigating the risk for opioid abuse. Pharmacotherapies have proven effective in treating and preventing opioid addiction but the high cost of these therapeutics is a limiting factor in the scope and reach of treatment programs.

1. Some preliminary consistory clauses describing the invention are as follows:

The present disclosure provides methods for demethylating a first opioid to a second opioid. The present disclosure further provides methods for demethylating an opioid to a nor-opioid. Additionally, the present disclosure provides methods for altering an opioid to a nal-opioid. Further, the present disclosure provides engineered cells for producing a nor-opioid from an opioid present within the engineered cell. The present disclosure also provides engineered cells for producing a nal-opioid from a nor-opioid present within the engineered cell.

An aspect of the disclosure provides a method for demethylating a first opioid to a second opioid. The method comprises contacting the first opioid with at least one enzyme, wherein contacting the first opioid with the at least one enzyme converts the first opioid to a second opioid through loss of an O-linked methyl group, wherein the first opioid is not selected from the group consisting of codeine and thebaine.

Another aspect of the disclosure provides a method of demethylating an opioid to a nor-opioid. The method comprises contacting the first opioid with at least one enzyme, wherein contacting the first opioid with the at least one enzyme converts the first opioid to a second opioid through loss of an O-linked methyl group. The method also comprises contacting the second opioid with at least one enzyme, wherein contacting the opioid with the at least one enzyme converts the second opioid to a nor-opioid through loss of an N-linked methyl group.[2]

1. I note the specification is rather lengthy, constituting 162 pages, and for the purposes of this decision it is not necessary for me to provide a general summary of its contents. River Stone's request for a Notice to Produce is focused on examples 14-16 in the specification. Paragraphs [00345], [00348] and [00351] are relevant to examples 14 (O-demethylation of opioid molecules), 15 (N-demethylation of opioid molecules) and 16 (Modification of nor-opioid compounds to generate nal-opioids) respectively. I have added emphasis to the key aspect of these examples that form the basis for River Stone's assertion that the best method has been withheld.

[00345] To identify engineered enzymes with improved O-demethylation activity, sequences encoding enzymes listed in Table 3 were subjected to random mutagenesis and then screened via a high-throughput colorimetric assay. Initial libraries were generated by error-prone PCR using Mutazyme II (Agilent Technologies), and variants were cloned into the pA24 (or similar) vector by gap repair in the Cen.PK2 screening host. Strains expressing mutated enzymes, with either individual mutations or combinations of mutations introduced by gene shuffling or other methods, were grown in selective medium in 96-well plate format under varying fermentation conditions (different media components, pH, and temperature, for example), pelleted, and lysed by glass bead disruption. Lysates were incubated with substrates (listed in FIG. 23) and assayed for formaldehyde production in the purpald assay. Enzymes with improved O-demethylation activity were verified by directly measuring O-demethylated product (oxymorphone, for example) formation in the culture medium by LC-MS.

[00348] To identify engineered enzymes with improved N-demethylation activity, sequences encoding enzymes listed in Table 4 were subjected to random mutagenesis and then screened via a high-throughput colorimetric assay. Initial libraries were generated by error-prone PCR using Mutazyme II (Agilent Technologies), and variants were cloned into the pA24 (or similar) vector by gap repair in the Cen.PK2 screening host. Strains expressing mutated enzymes, with either individual mutations or combinations of mutations introduced by gene shuffling or other methods, were grown in selective medium in 96-well plate format under varying fermentation conditions (different media components, pH, and temperature, for example), pelleted, and lysed by glass bead disruption. Lysates were incubated with substrates (listed in FIG. 24) and assayed for formaldehyde production in the purpald assay. Enzymes with improved N-demethylation activity were verified by direct measurement of N-demethylated product (noroxymorphone, for example) formation in the culture medium by LC-MS.

[00351] To identify engineered enzymes with improved BIA modifying activity, sequences encoding enzymes listed in Table 5 were subjected to random mutagenesis and then screened via a high-throughput colorimetric assay. Initial libraries were generated by error-prone PCR using Mutazyme II (Agilent Technologies), and variants were cloned into the pA24 (or similar) vector by gap repair in the Cen.PK2 screening host. Strains expressing mutated enzymes, with either individual mutations or combinations of mutations introduced by gene shuffling or other methods, were grown in selective medium in 96-well plate format under varying fermentation conditions (different media components, pH, and temperature, for example), pelleted, and lysed by glass bead disruption. To detect N-methylation activity in a high-throughput screen, lysates were incubated with substrates (such as noroxymorphone) in the presence of a BM3 variant with demethylating activity, and assayed for formaldehyde production in the purpald assay (for indirect measurement of methylation). In this case, formaldehyde formation can only result from the activity of BM3 on a substrate that has been N-methylated by an enzyme of interest. Enzymes with improved modifying activity were additionally tested for activity in cell lysates using various SAM analogues as cosubstrates (see FIG. 25), and verified by direct measurement of product formation by LC-MS. The best variant enzymes were selected for the efficient bioconversion of substrate molecules to nal-opioid compounds.

1. Turning to the claims, claims 1-3, which reflect examples 14-16, are most relevant, I provide these claims below.

1. A method of demethylating an opioid to a nor-opioid, comprising:

contacting the opioid with an N-demethylase enzyme, wherein contacting the opioid with the enzyme converts the opioid to the nor-opioid through removal of a N-linked methyl group from the opioid,

wherein the nor-opioid is produced by culturing an engineered yeast cell comprising a coding sequence for encoding the N-demethylase enzyme,

wherein the opioid is selected from the group consisting of codeine, oxycodone, thebaine, hydrocodone, dihydrocodeine, 14-hydroxycodeine, codeinone, and 14- hydroxycodeinone, morphine, oxymorphone, oripavine, hydromorphone, dihydromorphine, 14-hydroxy-morphine, morphinone, or 14-hydroxy-morphinone.

contacting a first opioid with an O-demethylase enzyme, wherein contacting the first opioid with the O-demethylase enzyme converts the first opioid to a second opioid through loss of an O-linked methyl group; and

contacting the second opioid with the N-demethylase enzyme, wherein contacting the opioid with the N-demethylase enzyme converts the second opioid to the nor-opioid through loss of an N-linked methyl group,

wherein the nor-opioid is produced by culturing the engineered cell, wherein the cell further comprises a coding sequence for encoding the O-demethylase enzyme.

1. The method of claim 1 or claim 2, further comprising altering an opioid to a nal-opioid, comprising:

contacting the nor-opioid with a N-methyltransferase enzyme, wherein contacting the nor-opioid with the N-methyltransferase enzyme in the presence of a cofactor converts the nor-opioid to the nal-opioid through transfer of a sidechain from the cofactor,

wherein the nal-opioid is produced by culturing the engineered cell, wherein the cell further comprises a coding sequence for encoding the N-methyltransferase enzyme.

1. On 19 May 2025 River Stone made an initial request for a Notice to Produce. That request sought the following:

1. Documents pertaining to Example 14 of the Specification

A document constituting, reporting, recording or evidencing each sequence of the O-demethylation enzymes that was verified by the Applicant and identified in paragraph [00345] of the Specification as displaying improved activity.

1. Documents pertaining to Example 15 of the Specification

A document constituting, reporting, recording or evidencing each sequence of the N-demethylation enzymes that was verified by the Applicant and identified in paragraph [00348] of the Specification as displaying improved activity.

1. Document pertaining to Example 16 of the Specification

A document constituting, reporting, recording or evidencing each sequence of the best variant enzymes that were verified and selected by the Applicant for the efficient bioconversion of substrate molecules to nal-opioid compounds identified in paragraph [00351] of the Specification

1. River Stone supported this request by noting that:

• They assert in the statement of grounds and particulars that the specification does not describe the best method known to the applicant at the time of filing.
• The claimed invention is directed to methods using N-demethylase enzymes, O-demethylase enzymes, and N-methyltransferase enzymes.
• The specification at examples 14-16 suggests that enzymes with improved activity were verified and the best enzymes for efficient bioconversion were selected.
• Absent the disclosure of sequence listings for these enzymes, the best method for reproducing the invention is not present.
• The requested documents will identify the improved sequences and are thereby determinative of the best method matter.

1. The request was considered by a delegate who considered that the relevant question was whether the applicant had knowledge of the improved enzymes at the relevant date, and not the identity of the enzymes themselves. He was not satisfied that a notice should issue on the basis that it appeared an exercise of discovery noting there was no certainty that the documents actually existed.

1. River Stone responded by expanding their arguments along the lines I have summarised above. Notably they suggested that:

• The documents sought by the request were expected to reveal with very high probability that the applicant has withheld the best method.
• The selected documents only relate to sequence listings and are easily produced
• Identifying the improved sequences requires incredible time and research effort thus it is necessary they be disclosed to satisfy the requirements of the ground of best method.

1. The delegate remained unsatisfied of the merits of the request for fundamentally the same reasons as already provided.

1. River Stone requested to be heard. Antheia did not wish to be heard.

1. Section 210 of the Act provides:

(1) The Commissioner may, for the purposes of this Act:

(b) receive written or oral evidence on oath or affirmation; and

(c) require the production of documents or articles; and

(d) award costs against a party to proceedings before the Commissioner.

(2) The Commissioner must not summon a witness under paragraph (1)(a) unless:

(a) the Commissioner is satisfied, on the balance of probabilities, of the following matters:

(i) the witness has a substantial interest in the proceedings before the Commissioner;

(ii) the witness is likely to provide oral evidence of substantial relevance to a matter before the Commissioner;

(iii) receiving oral evidence from the witness is necessary or desirable in all the circumstances; and

(b) the Commissioner notifies the witness of the actions the Commissioner may take under section 210A if the witness fails or refuses to comply with the summons.

(3) The Commissioner may summon a witness under paragraph (1)(a) whether the witness is in or out of the patent area.

Exercise of power to require production of document or article

(4) The Commissioner must not require a person to produce a document or article under paragraph (1)(c) unless:

(a) the Commissioner is satisfied, on the balance of probabilities, of the following matters:

(i) the person has a substantial interest in the proceedings before the Commissioner;

(ii) the document or article is likely to be of substantial relevance to a matter before the Commissioner; and

(b) the Commissioner notifies the person of the actions the Commissioner may take under section 210A if the person fails or refuses to comply with the requirement.

(5) The Commissioner may require a person to produce a document or article under paragraph (1)(c) whether the person is in or out of the patent area.

Exercise of powers in relation to bodies corporate

(6) The Commissioner's powers in subsection (1) to make a requirement of a person extend, if the person is a body corporate, to making that requirement of any person who is an officer, agent or employee of the body corporate.

1. A central consideration is the fact that the Commissioner must not issue a notice to produce unless the document or article is likely to be of "substantial relevance" to the matter. Notably, the Commissioner must be satisfied of this requirement on the balance of probabilities.

1. These provisions apply to the exercise of the Commissioner's powers on or after the commencement of Schedule 3 of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar Act), that is, after 15 April 2013. Substantially the changes brought about at that time were the insertion of subsections (2) to (6). The effect of these changes to section 210 was discussed by the Deputy Commissioner in Domino's Pizza Enterprises Limited v Precision Tracking Pty Ltd[3]:

"...in my view 'substantial relevance' means more than just 'substantive relevance' or 'not of limited relevance' as suggested by Mr Cordiner. It must be something that is likely to be, if not determinative, highly significant in the determination of a relevant issue in dispute in the proceedings."

1. The Deputy Commissioner drew a clear distinction between production under the Act and discovery (at [32]):

"It follows that section 210 as amended is unlike the scheme for discovery and production in other jurisdictions. It is not to be invoked by one party as a general means of exploring the other party's case and particularly is not to be used in a fishing expedition or a hunt for a 'smoking gun'. Usually it will be necessary to identify a real and specific factual issue in dispute, not merely speculation that production or summons might reveal such a matter and a plausible basis for concluding that the order will in some way be likely to provide substantial assistance in resolving the matter. Otherwise the Commissioner cannot be satisfied on the balance of probabilities that what is sought is 'likely to be of substantial relevance'."

and pointed out that the power is discretionary (at [33]):

"The power exercised by the Commissioner is discretionary and must only be exercised after considering the respective interests involved and the purpose of the legislation. Some relevant factors will include fairness to the respective parties, whether any order made would be onerous, delay in the resolution of the proceedings and in the granting of the patent, the correctness of the determination of the proceedings and the efficiency of IP Australia in administering the process."

1. The Deputy Commissioner also focused on the idea that the distinction between production and discovery is supported by section 210 (at [35]):

"Rather [section 210] is intended to allow existing documents to be produced in limited circumstances where they would provide significant assistance in a determination by the Commissioner." (emphasis added)

1. Such an understanding appears consistent with the approach of the Federal Court of Australia as articulated in a relevant practice note[4] issued by then Chief Justice Allsop concerning subpoenas and notices to produce before the court, where recognition was given to the importance of avoiding "fishing" exercises as follows:

"The subpoena must specify, with reasonable particularity, the documents to be produced and must avoid becoming a mechanism for "fishing" for evidence or documents. Broad subpoenas that contain imprecise or ambiguous terms may fail to obtain leave."

1. Thus, it appears clear that if the Commissioner cannot be satisfied that documents sought by a requested notice exist then they cannot be satisfied, on balance of probabilities, that the relevant threshold of section 210(4) is passed. It follows that in circumstances where it is merely speculation that the documents exist then this will likely be considered an exercise of discovery.

1. The reasoning and conclusions of Deputy Commissioner Spann in Domino's were adopted by Deputy Commissioner Barker in Sanofi v Amgen Inc.[5] and Norbrook Laboratories Limited v Bayer New Zealand Limited[6]. In Sanofi the Deputy Commissioner stated that "substantial relevance" is not to be understood as merely relevant to a substantial issue that is in dispute. Rather, he noted that it is the degree of relevance that must be considered, and it is the high threshold set out in Domino's that applies. The Patent Manual of Practice and Procedure at 7.6.3[7] summarises the principles neatly:

"Likely to be of substantial relevance" means that the documents or articles required are likely to be of substantial probative value in the determination of a matter before the Commissioner. This goes beyond evidence that may be merely relevant to the Commissioner's determination. It requires a realistic expectation that the documents or articles are of such significance that they may be determinative of a matter before the Commissioner.

Unless a document or article is identified with sufficient particularity for its relevance to be determined it cannot be the subject of a requirement to produce. Section 210 is not an opportunity to discover what relevant documents are in possession of another party or to obtain documents of potential relevance. Requests of this nature will be refused."

1. The opponent made a submission that the Deputy Commissioner in Domino's devised a test that went beyond the intent of the explanatory memorandum when suggesting that documents should be "likely to be ... highly significant in the determination" in order for a notice to issue. While not an important aspect of the present decision, my reading of the Deputy Commissioner's approach is that his language merely represents an alternative formulation of the fundamental consideration that is present in section 210 that a document must, on balance, be likely to be of substantial relevance. As the Patent Manual of Practice and Procedure puts it, a document will be considered likely determinative where it would provide substantial assistance in resolving the issue and/or dispute.

1. As an initial point discussed at the hearing, I identified that the present request from River Stone seeks documents with no limitation to a range of dates. While River Stone suggests in their submissions that they seek a very specific set of documents with "surgical precision", I note that the relevant time for establishing the ground of best method has recently been clarified by the Federal Court in The NOCO Company v Brown and Watson International Pty Ltd[8]. In this regard, the best method requirement is assessed on the basis of the applicant's knowledge at the filing of a complete specification qualified by the fact that for a divisional application, the relevant date is the filing date of the earliest application, being the date from which the patent term is calculated. Thus, such a limitation should be present in the requested notice. River Stone agreed this was the case at the hearing and noted that they would seek to amend their request if required.

1. The applicant clearly has a substantial interest in the proceedings in the context of the requested notice to produce, notwithstanding an indication of intent to not pay continuation fees. In turn, section 210(4)(a)(i) is satisfied. The question that remains to be answered is whether, on balance, a notice should issue including, if necessary, considering whether the documents requested are likely to be of substantial relevance.

1. River Stone generally submitted along the following lines:

• The selected documents concern three different enzyme sequences referenced in the specification as having improved activity with respect to the claimed invention. They note that the "importance of the enzyme sequences is recited in the claims in that the invention defines the use of 'a coding sequence' in an engineered yeast cell encoding a particular enzyme function".
• The specification does not list these improved enzyme sequences
• This information has been withheld by the patentee, and the evidence on file in support of the section 59 opposition demonstrates that it would take decades to repeat the relevant methods. They add that the steps described in the specification for producing and/or identifying the verified enzymes are highly complex and time-consuming, and that without those sequence listings the skilled addressee cannot possibly repeat the invention.
• The documents are highly likely to reveal that the patent applicant withheld improved sequence listings and as such, they would be sufficiently relevant to the allegation that the best method of performing the invention has been withheld.

1. River Stone noted that the applicant did not deposit the relevant engineered yeast cells under the Budapest Treaty (being a mechanism that may be used to provide a clear enough and complete enough disclosure in relation to microorganisms), and that accordingly they must disclose the enzyme sequences. The converse would suggest that if the applicant had deposited the cells, they would not need to disclose the sequences. To the extent that the cells (rather than the corresponding identified sequences) may be used to perform the invention, it is prima facie not clear whether the applicant possessed the relevant information - that is, whether they had sequenced the enzymes.

1. To address this, River Stone focusses upon the idea that the specification itself provides clear circumstantial evidence that the applicant has withheld the best method at the relevant date. They submit:

"In Example 19, the Patent Applicant describes the biological production of N-demethylated opioid molecules... For the purposes of the Notice, River Stone refers the delegate to the first 4 lines of [00358] which state:

Enzymes described in Example 15 and listed in Table 4, that displayed N demethylase activity on BIA molecules (such as those listed in Table 2), were incorporated into a microbial strain (either Saccharomyces cerevisiae or Escherichia coli) which biosynthesizes morphinan alkaloids de nova. (Emphasis added)

This passage presents clear circumstantial evidence that the Patent Applicant was in possession of the sequences at the time of filing the Patent Application, for the following reasons:

(a) First, the above passage refers to the use of enzymes that displayed "N-demethylase activity on BIA molecules". The only enzymes that were tested for N demethylase activity on BIA molecules were the improved enzymes identified in paragraph [00348]. The enzymes produced in paragraph [00346] were not tested for the identified enzyme activity; they were merely isolated, verified by PCR and sequenced.

(b) Second the Enzymes were then "incorporated" into the select microbial strain. Without knowing the sequence of the enzyme, it would not have been possible to incorporate the sequence into the strain.

Therefore, the circumstantial evidence would strongly suggest that the Patent Applicant must have been in possession of the sequences with N demethylase activity on BIA molecules revealed in Example 15."

1. Finally, with specific focus on the specificity of the request and the relevance of the requested documents, River Stone assert that the documents sought are specific and not an act of discovery.

1. Firstly, as I reflect upon the submissions summarised at paragraph 25 above, it is clear to me that the issues compress into some rather straightforward points. The focus of the request is that it is clearly the case that "improved" enzymes are in some way identified. It is also clearly the case that the specification does not list what those enzymes are in terms of their sequencing. The documents that are sought are essentially those which are considered to contain the identity of those sequences. While it is the case that the steps of producing and identifying the improved enzymes may be highly complex and time consuming and that the requested documents may be highly relevant to the ground of best method, it is relevant to first consider whether the request is one for production or for discovery.

1. As I have noted above in discussing the relevant legal principles, s210(4) operates to enable the production of existing documents. This is distinct from discovery, or the conduct of a "fishing expedition" for documents that might exist. Subsection 210(4) also operates generally on the on the balance of probabilities. Thus, it appears plain to me that if the Commissioner cannot be satisfied that the documents exist then he cannot be satisfied, on the balance of probabilities, that the requirements of 210(4)(a)(ii) are made out.

1. The opponent submits that the specification itself provides sufficient evidence of the existence of the requested documents, at least circumstantially. Firstly, the opponent submits that the only way the enzymes could be "identified" is by their sequences. Secondly, the opponent submits that the only way the improved enzymes could be "incorporated" into the microbial strain as per example 19 is by knowing their sequences.

1. I am not satisfied on the balance of probabilities that the documents do in fact exist. Firstly, while the disclosed methods at paragraph [00345], [00348] and [00351] discuss "identifying engineered enzymes" I see no information before me that inherently suggests that the relevant enzymes were sequenced. As a general proposition it would appear arguable that identification of improved enzymes may be nothing more than some kind of wet chemical isolation in a test tube, to put it colloquially. More specifically, turning to those paragraphs in full the identification occurs through a method of verification using Liquid Chromatography - Mass Spectrometry (LC-MS). I note that Examples 14, 15 and 16 are supported by methods that identify capable enzymes, wherein these individual colonies are sequenced for identification purposes ([00342], [00346] and [00349], respectively). However, there is nothing in the methods of the improved enzymes (para [00345], [00348] and [00351]) that requires identification methods to be the same, especially when each method clearly identifies the relevant method to be used. Therefore, I am not satisfied on balance that there is a circumstantial argument that the documents requested containing the sequences must exist on the face of the specification.

1. Secondly, the opponent concedes in their submissions that when reading example 15 it is unclear if the improved enzymes have been sequenced. Albeit it, the opponent claims that when this is read together with example 19 (at [00358]) the fact that the improved enzymes are "incorporated" into a microbial strain is evidence that the applicant must have the sequences, otherwise incorporation would be impossible. I further note that at the hearing the Opponent also relied on the term "engineered cell" to emphasise this point that the sequences had to be known to engineer the microbial strain by incorporation. However, these contentions are not supported by any evidence and as such this claim does not rise higher than mere speculation as to the existence of the documents.

1. Furthermore, the opponent acknowledges that they are seeking to identify whether the applicant was in possession of the relevant sequences and submitted at the hearing that if the applicant does not have these sequences, then there would be no burden having allowed the notice to produce. These claims further support my preferred construction of the specification that there is nothing circumstantial or directly leading to the inference that these documents must be more likely than not to exist.

1. In general, the opponent argues that the real and specific factual issue in dispute is best method (s40(2)(aa)) because they claim that the applicant has withheld sequence information relating to the improved enzymes of examples 14-16. I accept that this is a real and specific factual issue. However, I am not convinced that it is being properly relied on. What appears at this stage a more relevant issue, given the evidence already filed in support of the s59 opposition to the application and River Stone's submissions, is that of whether there is a clear and complete disclosure of the invention as required by s40(2)(a). Much of the opponent's submissions refer to the requested notice being necessary because the claimed invention is not repeatable, not enabled (e.g. the opponent asserts that at least claim 1 cannot be performed without knowledge of the "coding sequence for encoding the N-demethylase enzyme) and/or because the N-demethylase engineered yeast cells have not been deposited under the Budapest Treaty. Such arguments are not applicable in the present matter to the ground of best method.

1. Therefore, absent any evidence in areas that amount at this stage to speculation, I am of the opinion that allowing this notice to produce would constitute a "hunt for a smoking gun" in relation to the ground of best method.

1. I need go no further to consider the question of substantial relevance. I consider the request is for discovery as opposed to production. With this in mind I note that the amendments introduced by the Raising the Bar Act merely raised the threshold for relevance required of documents sought to be produced. An important aspect of section 210 was, and continues to be, the need to distinguish between production and discovery as a preliminary matter.

1. In the event that I am wrong in my approach to the nature of the request as a fishing expedition, I will comment on the potential relevance of the documents. As put forward by the delegate in his approach to the matter prior to the hearing, if the case currently put forward by the opponent on the basis of the specification alone satisfied me that the relevant improved enzymes were sequenced, then I cannot see how the production of those documents would provide substantial assistance in resolving the matter. Knowledge of the identity of the sequences as such is not the question to be answered in the context of the ground of best method. Instead, the ground of best method asks whether, at the relevant time, the applicant knew of a better method than that which is disclosed. If one assumes that the performance of the relevant enzymes is critical to the best method and is satisfied on balance that the enzymes have been sequenced, then a best method attack would succeed on that basis, and the identity of the sequences themselves would appear to bring no further determinative force to the matter.

1. For this further reason I do not think a notice should issue.

1. I am not satisfied that I should issue a notice. On the information before me, I consider that the present request is for discovery and not production.

[3] (Domino's) [2016] APO 13 at [31]

[4] Allsop CJ (25 October 2016) Subpoenas and Notices to Produce Practice Note (GPN -SUBP) Federal Court of Australia, https://www.fedcourt.gov.au/law-and-practice/practice-documents/practice-notes/gpn-subp

[5] (Sanofi) [2018] APO 3

[6] [2019] APO 37

[7] https://manuals.ipaustralia.gov.au/patent/7.6.3-basis-for-requiring-production

[8] The NOCO Company v Brown and Watson International Pty Ltd [2025] FCA 887 at [389].