A recent Federal Court decision in Merck Sharp & Dohme Corp. v Ono Pharmaceutical Co., Ltd [2016] FCA 1015 sheds some light on experimental evidence in patent cases.

In patent cases, it is not uncommon to conduct preliminary experiments on a confidential and privileged basis prior to deciding whether or not to seek to rely on experimental evidence at trial. It is also not uncommon that not all of the experiments in the preliminary trial will be relevant to the issues in the case, as those issues become refined during case preparation.

Where a party puts forward to the other party preliminary experimental results, for example in an effort to persuade the other party to provide consent to introduce the results into evidence without repeating the experiments (as would otherwise be required by the court rules), is the other party entitled to have discovery of experimental results relating to matters no longer in issue?

THE FACTS OF THE CASE

In a recent Federal Court decision – Merck Sharp & Dohme Corp. v Ono Pharmaceutical Co., Ltd [2016] FCA 1015 – the Court refused to require discovery of experimental data relating to certain prior art antibodies no longer in issue because the experiments on the asserted prior art antibodies were fully controlled and the results of the other experiments were not necessary to understand the experimental data relied on.

The patent in dispute concerned monoclonal antibodies and the use of immunotherapy to treat cancer. Specifically, the patent provided a method of inhibiting the growth of tumour cells in vivo using identified monoclonal antibodies, and monoclonal antibodies that 'cross-compete' with the identified monoclonal antibodies for binding to a target protein. The applicants commenced proceedings to revoke the 'cross-compete' claim, and claims dependent thereon, on various grounds, including lack of novelty.

At the time of conducting the preliminary experiments, the applicants' pleaded case was that seven prior art antibodies anticipated the 'cross-compete' claim. The applicants later refined their pleadings and removed three prior art antibodies from their pleaded case.

The applicants sought the respondents' consent to leave to rely on the experimental results. Without leave, the experiments would have needed to be repeated and an opportunity provided to the other party to be present to observe the experiments (see r 34.50(2) (b) of the Federal Court Rules 2011).

The applicants provided to the respondents documents and data relating to the experiments on the pleaded prior art antibodies and excluded, by redaction, information relating to non-pleaded antibodies in relation to which experiments had also been conducted. The respondents consented to the applicants having leave to rely on the provided data and documents, subject to the applicants providing certain additional laboratory notebooks. The respondents later sought discovery of documents and data relating to all seven prior art antibodies referred to in the pleadings before they were amended.

THE FEDERAL COURT'S DECISION

The Court found that the respondents' consent to leave was informed by the content of the provided documents and data from which information had been redacted at the time conditional consent was provided.

Also, relevant control data had been provided so that it was not put by the respondents' expert that the data was necessary to understand the results obtained on the asserted antibodies only that the data 'may provide information' on the interpretation of the results or the behaviour of the antibodies relied on.

Nothing had been put forward by the expert on the information provided to suggest that the experimental system was not behaving as expected, and this would have been expected if there was a reason to doubt the reliability of the experimental system.

In the result, the Court denied the additional discovery requested, as follows (at para 76):

"In light of the evidence given and the observations I have made above, I am not persuaded that discovery should be given of all the documents that record the conduct of and results of the..experiments conducted as part of the [trial] experiments. Without being in any way critical of [the respondents' expert], it seems to me that his evidence on this issue raises no higher than an understandable desire to see other information and documents in relation to the..experiments, simply because it is known that other information and documents exist. The utility of the other information and documents for the resolution of the issues to be determined in this proceeding seems to me to be, at best, speculative. I am not persuaded that the general order for discovery that is sought in relation to the...experiments would facilitate the just resolution of the proceedings as quickly, inexpensively and efficiently as possible."

While only an interlocutory decision on the facts of a particular case, the decision provides guidance on matters that arise in practice and are important but do not always come before the courts.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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