Reliance in patent litigation on experimental work referenced in specification

Reliance in patent litigation on experimental work referenced in specification

Reliance in patent litigation on experimental work referenced in specification

Bristol-Myers Squibb Company v Apotex Pty Ltd (No 4) [2012] FCA 1433

The issue: use of the specification as proof of experimental work referred to in it.

An important issue in the conduct of patent litigation is the use to which statements in the patent specification in suit can be put. In Bristol-Myers Squibb Company v Apotex Pty Ltd (No 4)1, the issue was whether the patent specification in suit could be used as proof of certain experimental work referred to in it.

More particularly, in this case, the applicants, Bristol-Myers Squibb Company (BMS) and Otsuka Pharmaceutical Co., Ltd, sought to rely on Reference Examples 1 and 2 in the specification to prove that the steps referred to in each example had been carried out and that the results referred to were indeed obtained. The respondent, Apotex Pty Ltd, objected to the admissibility of the specification for that purpose, as well as to a passage in an affidavit made by one of the inventors (Mr Aoki) that asserted what Reference Example 2 demonstrated, on the basis that there had been no compliance with rule 34.50 of the Federal Court Rules 2011.

Rule 34.50 of the Federal Court Rules 2011

Rule 34.50 of the Federal Court Rules 2011 is in the following terms:

(1).  If a party (the proponent) proposes to tender, as evidence in a proceeding, experimental proof of a fact, the proponent must apply for orders in relation to the experimental proof, including orders about any of the following:

  • (a) the service on other parties of particulars of the experiment and of each fact that the proponent asserts is, will or may be proved by the experiment;
  • (b) any persons who must be permitted to attend the conduct of the experiment;
  • (c) the time when, and the place where, the experiment must be conducted;
  • (d) the means by which the conduct and results of the experiment must be recorded;
  • (e) the time by which any other party (the opponent) must notify the proponent of any grounds on which the opponent will contend that the experiment does not prove a fact that the proponent asserts is, will or may be proved by the experiment.

(2).  Evidence of the conduct and results of the experiment is admissible in the proceeding, only:

  • (a) if the proponent has complied with subrule (1) and any orders given under that subrule; or
  • (b) with the leave of the Court.

(3). If an order mentioned in paragraph (1) (e) has been made, and the opponent has not complied with the order in relation to a ground, the opponent may rely on the ground only with the leave of the Court.

BMS and Otsuka submitted that, to the extent that leave was required to enable them to rely on Reference Examples 1 and 2 as evidence of experiments carried out and results obtained, leave should be granted.

The Judge (Justice Yates) found that r 34.50 did apply to Reference Examples 1 and 2 and granted leave to BMS and Otsuka to rely on those examples to prove the existence of the facts in them.

Application of r 34.50 to experiments conducted before the litigation commenced

In deciding to grant leave, Justice Yates cited Lucent Technologies Inc v Krone Aktiengesellschaft (No 2)2. In that case, Justice Lindgren held that Order 58 rule 31, the predecessor rule to rule 34.50, applied to experimental proof whether the experiments had been carried out before or after commencement of the relevant proceeding. Justice Yates found that even though rule 34.50(1) refers to prospective steps, that rule is expressed in inclusive terms and thus it also applies to experiments conducted before the commencement of the proceeding.

Matters relevant to the grant of leave

The Judge found that the following factors supported the granting of leave.

  • Importantly, the experiments to which Reference Examples 1 and 2 referred were carried out many years ago and in circumstances unrelated to the conduct of the present litigation.
  • Apotex’s objection was unusual in that parties usually proceed on the basis of the asserted truth of the matters stated in the specification, including the conduct and results recorded in the specification, unless those statements are specifically challenged. The Judge noted that, even then, there is normally no challenge to the admissibility and use of the specification.
  • It was open to Apotex to allege that the Reference Examples contained a false suggestion or misrepresentation in relation to the steps that were carried out or the results obtained (a basis for revocation of the patent) but it did not do so.
  • If any issue was expected to arise out of tender of the specification, and the use to which it would be put, that matter should have been raised at the case management conference before the hearing, if not earlier.
  • Discovery had already been given in relation to reproductions of prior art methods carried out by Otsuka, which the parties seemed to accept included discovery in respect of the Reference Examples.

Apotex alleged that it was unable to test the evidence of the experiments in the Reference Examples without access to supporting documentation. In response to this, Justice Yates said that “it was always within its (Apotex’s) power to seek specific discovery on that issue or, perhaps, to endeavour to obtain documents by issuing a notice to produce.”

The Judge also pointed out that as Apotex had elected to test the evidence of the experiments described in the discovered prior art documents by cross-examining Mr Aoki, it was equally able to test the evidence of the experiments referred to in the Reference Examples by cross-examining him.

Earlier in the proceedings, Apotex applied under Order 58 rule 31 (the predecessor to rule 34.50) to tender its own experimental evidence. The Judge noted that had Apotex wished to challenge Reference Examples 1 and 2, it could have conducted its own experiments and applied under Order 58 rule 31 or rule 34.50 to tender proof of those experiments.

The Judge concluded by noting that any disadvantage which Apotex perceived it had suffered could have been remedied by Apotex itself. Apotex must have known that the specification (including a description of the invention and the best method of performing it) would be tendered.

Other objections to admissibility: hearsay and unfairly prejudicial evidence

The Judge noted that the specification was admissible as evidence in the proceeding, and for a variety of purposes. He also noted that the statements in the specification concerning Reference Examples 1 and 2 were hearsay. However, he found that the hearsay rule did not apply to those statements because section 60 (1) of the Evidence Act provides that the hearsay rule does not apply to evidence of a previous representation that is admitted because it is relevant for a purpose other than proof of an asserted fact.

Section 136 of the Evidence Act provides:

The court may limit the use to be made of evidence if there is a danger that a particular use of the evidence might:

  • (a) be unfairly prejudicial to a party; or
  • (b) be misleading or confusing.

The Judge found that there was no danger that the evidence would be misleading or confusing or that use of the Reference Examples as experimental proof would be unfairly prejudicial to Apotex.

Section 135 of the Evidence Act provides that the Court may refuse to admit evidence if its probative value is substantially outweighed by the danger that the evidence might be unfairly prejudicial to a party, or be misleading or confusing, or cause or result in undue waste of time. The Judge also found that the conditions for the exercise of the discretion under s 135 of the Evidence Act to reject the evidence of the Reference Examples as experimental proof were not present.

Admissibility of the contested passage in Mr Aoki’s affidavit

The Judge did not consider the particular contested passage in Mr Aoki’s affidavit to be experimental proof. When taken together with another passage in his affidavit (to which no objection had been taken), he found that it merely identified the type of crystals referred to in Reference Example 2, about which much evidence had already been given in the proceeding. He accordingly admitted the contested passage into evidence.

Matters to consider in patent litigation

The case illustrates some of the matters that the parties to patent litigation (involving issues of infringement and revocation) should consider at an early stage in the proceeding. These include:

1. in the case of the patentee

  • what use may or will be made of the Examples in the specification in suit
  • whether it is necessary to obtain leave under r 34.50 of the Federal Court Rules 2011 in respect of any of those Examples
  • discovery may have to be given in respect of the Examples

2. in the case of the respondent

  • whether any statement in the specification in suit should be specifically challenged and/or whether there is a basis for asserting that it contains a false suggestion or representation
  • whether specific discovery in respect of any of the Examples should be sought
  • whether it should itself conduct its own experiments, and make relevant application under rule 34.50 of the Federal Court Rules 2011
  • whether, and if so when, there should be an objection to tender of the specification

Endnotes

  1. [2012] FCA 1433
  2. (1999) 94 FCR 124