Drawing the Line Between a Request for a Notice to Produce and a Request for Discovery
During the evidentiary period of a patent opposition matter before IP Australia, there may be a need for one party to request further information from the other party, but only if the documents requested are necessary and relevant to the matter in dispute. The request filed by the party seeking to obtain such further documents is called a Notice to Produce, which is subject to the Hearing Officer’s discretion.
In the case of River Stone Biotech ApS v Antheia, Inc [2025] APO 38, River Stone filed a request for a Notice to Produce during the period for preparing Evidence in Support. The patent application in dispute was owned by Antheia, Inc, which was an accepted divisional application (AU2022203267) concerning methods for demethylating an opioid to a nor-opioid and to produce nal-opioid from a nor-opioid within engineered cells.
The Notice to Produce related to examples provided in the specification, specifically examples 14-16 for which River Stone contended that the best method was not provided, placing an undue burden on a skilled person to perform the invention as claimed. The Notice to Produce requested that the Applicant provide details and evidence of the enzymes sequences that were verified as having improved activity, as well as the sequences of those enzymes that were reported to exert an efficient bioconversion of substrate molecules to nal-opioid compounds, as disclosed in the specification.
The Hearing Officer was not convinced that the request for a Notice to Produce should issue, which led to River Stone filing a request for a hearing to challenge the decision.
The Patents Act & Case Law on Requests for Notice to Produce
Section 210 of the Patents Act outlines the Commissioner’s powers for exercising discretion to issue a Notice to Produce, which is applicable in cases filed after 15 April 2013 and thus those that fall under the post-raising the bar Act. This requires the Commissioner to be satisfied on the balance of probabilities that there is substantial interest in the matter. The documents should also likely be of substantial relevance to the proceedings, meaning that there is a realistic expectation that the documents are likely “to be of substantial probative value in the determination of a matter before the Commissioner”, with the document itself being either in or out of the patent area. Crucially, this means that unless a document can be assessed for its relevancy, it cannot otherwise be subject to the requirement to produce under the Act.
In Australia, the Notice to Produce under the Act is distinguished from discovery in other jurisdictions, in that the Notice to Produce “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”.” Rather, there needs to be 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”.” (Domino’s Pizza Enterprises Limited v Precision Tracking Pty Ltd [2016] APO 13 at [32]). The documents must also already be in existence. Otherwise, mere speculation that the documents exist is likely considered to an exercise of discovery.
With the exercise of discretion, some factors that might influence whether this power is exercised may include whether “any order made would be onerous” for example if it may delay resolution of the proceedings and/or grant of the patent (Domino’s Pizza Enterprises Limited v Precision Tracking Pty Ltd at [33]).
The Hearing
In the present case, the request for Notice to Produce by River Stone noticeably did not specify a date range for the documents sought, contending that the documents requested concern a very specific set of data. The Hearing Officer pointed out that when establishing whether the best method has been applied, the relevant time at which this must be assessed is the time of filing the complete application. For divisional applications, this would be the filing date of the earliest application. Given this, this date limitation should have been included in the request. Nevertheless, it was deemed clear that the Applicant did have a substantial interest in the proceedings. However, it was left to be determined whether on balance, a notice should be issued and whether the documents requested are likely to be of substantial relevance.
The Hearing Officer acknowledged that the specification was deficient in the requested information. However, whilst it would be “highly complex” and time consuming to determine the steps of producing and identifying the improved enzymes, it would first be necessary to assess whether the request for a Notice to Produce is actually one for discovery.
Request for Notice to Produce vs Request for Discovery
As per above, the production of existing documents is distinct from an exercise of discovery for documents that might exist. Since section 210 (4) relies on the balance of probabilities, it ultimately could not be determined whether the requested documents were even in existence, as the Applicant had not deposited the relevant engineered yeast cells under the Budapest Treaty, which is one way to satisfy the requirements for a clear enough and complete enough disclosure for microorganism inventions.
River Stone argued that in the absence of the biological deposit, it would be necessary to disclose the enzyme sequences. Conversely, this would mean that if the deposit was accessible, there would not be a need to disclose the relevant sequences. Thus, it was considered by the Examiner that had the cells been deposited (in the absence of sequences), the cells could be used to perform the invention. Consequently, it was unclear whether the Applicant was in possession of the requested information (the enzyme sequences) in the first place.
There were also other instances where the Hearing Officer was not satisfied that the requested documents even existed. For example, it was noted that the method for identifying the improved enzymes was disclosed to occur through use of Liquid Chromatography – Mass Spectrometry (LC- MS) and not by sequencing individual colonies, as per the method for identifying capable enzymes. This and other reasons led to the Hearing Officer to conclude that the requirements for issuance of a Notice to Produce were not satisfied, since it was uncertain whether the requested documents existed.
The Hearing Officer contended that rather than focusing on whether the application contained the best method, the more appropriate question would be whether there is a clear and complete enough disclosure of the invention as provided by the specification. Much of the Opponent’s arguments centred around the lack of enablement as the claims were argued incapable of being worked without the knowledge of the sequences and/or due to the absence of a relevant biological deposit under the Budapest Treaty. These arguments were deemed not directly applicable to the case at hand, which concerned best method. Therefore, the request for issuance of a Notice to Produce was refused, as it was deemed to fall under a request for discovery, rather than one for the production of existing documents.
Closing Comments on Requests for a Notice to Produce
The Hearing Officer’s closing comment stated that even if the Opponent was able to prove that the relevant improved enzymes were sequenced, it was unclear how production of these requested documents would provide substantial assistance in resolving the matter concerning whether the best method was used. For example, if the performance of the relevant enzymes is crucial to the best method and the enzymes on balance have been sequenced, then it would be likely that the best method attack would succeed, even if the precise sequences are not disclosed.
In other words, the decision to refuse the Notice to Produce did not result in any decision being handed down concerning the Opponent’s ground of lack of best method. Rather, if River Stone wished to pursue the matter, then the arguments for lack of best method must be presented in the absence of the requested enzyme sequences.
Key Takeaways
This case emphasises the need to give proper consideration towards the preliminary issue of whether a request for a Notice to Produce is truly one for the production of existing documents, or whether it is a request for discovery. This is because the provisions under Section 210 of the Patents Act cannot be relied on if the requested documents simply do not exist. Opponents must therefore put forward sufficient evidence, not speculation, that the Applicant is in possession of the requested documents. The Commissioner must then be satisfied on the balance of probabilities that the documents do exist and that they contain information of substantial relevance to the case at hand. This means that the document requested must be likely to materially affect the outcome of the issue that is being examined.
The present case further emphasises that should Opponents wish to raise a case for lack of best method, the arguments must be based on what has already been disclosed in the specification, highlighting what should have been disclosed the time of filing the complete application and why the skilled person cannot do without said information.
Readers should take away from this decision that Applicants are not automatically taken to have sequence data for every improved variant, unless the specification contains evidence to show that such information is available. If it is apparent from reading the specification that the Applicant had possession of these sequences, then it would become necessary for the Applicant to disclose this information. Caution must therefore be taken when drafting patent specifications to avoid implying possession of specific embodiments that are not actually characterised.
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