For many years the pre-grant patent opposition process has been a useful, but somewhat problematic mechanism for a person to challenge the validity of a patent application. As a specialist tribunal, the Patent Office could decide oppositions efficiently. Despite this, some patent oppositions became excessively protracted, due to numerous grants of extensions of time during the evidence preparation stages. There is now a new paradigm in Australia that seeks to avoid this problem, which parties to an opposition would be wise to observe.

In a recent decision, apparently key evidence relating to novelty and inventive step was excluded, due to failure to meet the requirements of the new regime. Although at the time of writing the fate of the patent application remains to be seen, this exclusion of evidence may have a substantial influence on the probability of the patent application being refused.

Key points

Patent oppositions have changed in Australia, requiring a much more assiduous approach by the parties. Parties should now:

  1. Inquire of their staff, experts and patent attorneys what commitments they have that may interfere with the preparation of evidence and what steps will be taken to avoid any consequent periods of inactivity or reduced activity.
  2. Create an evidence plan to meet all original deadlines in the opposition process and take all reasonable steps to implement and complete that plan.
  3. Carefully prioritise the preparation of evidence and consider filing evidence that has been prepared before the deadline, even if an extension of time is required to complete the evidence.
  4. If the progress on evidence preparation is not proceeding to plan, immediately consider alternatives that will allow the deadline to be met.
  5. Keep detailed records of all actions taken during evidence period and difficulties faced during the evidence preparation, in case an extension of time is required.
  6. Carefully prepare evidence in support of any application for an extension of time, to ensure that the Patent Office is given sufficient information to be satisfied an extension is warranted.

Failure to make all reasonable efforts to meet the deadlines and failure to act promptly and diligently at all times can result in critical evidence being excluded from the opposition.

It is expected that patent oppositions will now become a more specialised area of practice, requiring careful strategic analysis and project management skills by parties and their attorneys, beyond those previously required.

The legislative reform and consequences of failure to meet the new requirements

In recent wide-ranging legislative reform, the requirements for a party in an opposition to obtain an extension of time were amended. While previously the Patent Office had a broad discretion to grant an extension of time, there are now specified mandatory pre-requisites that the Patent Office must be satisfied have been met before the Patent Office can exercise its discretion. In addition, if an extension of time is refused, any evidence filed after the deadline will now be disregarded. The Patent Office has exercised this power in a recent decision, discussed below.

While the exclusion of relevant evidence that a party has gone to the trouble and expense of preparing and filing, potentially within a relatively short period after the deadline, may seem harsh, the decision demonstrates that oppositions in Australia should now become a much more streamlined and consequently more attractive option. The decision of the Patent Office also requires a substantial change in practice by opponents, applicants and experts. A party to an opposition needs to ask new questions of the skills and availability of their patent attorney before selecting the attorney to represent them in an opposition.

The decision of Merial v Novartis

In Merial Limited v Novartis AG [2013] APO 65, Novartis was seeking a second extension of time of 3 months to file evidence in answer to the evidence of Merial. Merial had met the original deadline to file its evidence in support and the period for completing evidence in answer expired on 29 July 2013.

Novartis undertook substantial work to prepare evidence in answer. A timeline of the main events is at the end of this article. A first request for an extension of time of 3 months was requested and granted unopposed. It appears that Novartis was actively pursuing the preparation of evidence during the entire six month period, other than during a period of late July to 22 September 2013, when Dr Rowe was on extended leave. During this time it appears that (understandably) only a relatively very small amount of progress was made by Dr Rowe.

Even though the Hearing Officer could not reconsider the decision to grant the first extension of time, he was of the view that he must consider whether Novartis had acted promptly and diligently at all times, including during the original period for preparing evidence. The Hearing Officer noted there was no or insufficient evidence before him of:

  • The plan developed for the obtaining of evidence.
  • The reasons for choosing Dr Rowe.
  • The difficulties that were actually encountered in the obtaining of the evidence.
  • The steps taken to accommodate Dr Rowe’s extended leave.

In light of this, the Hearing Officer found ‘it difficult to conclude the persevering with Dr Rowe in the knowledge that he would be taking extended leave was consistent with acting promptly and diligently.’ The Hearing Officer was of the view that ‘it would have been reasonable for another expert to be considered or, if Dr Rowe was the only reasonable option and if circumstances allowed, making better use of the expert during his absence from Australia or on his return.’

The Hearing Officer therefore found that he could not be satisfied Novartis had acted promptly and diligently at all times.

Despite this finding, the legislation provides that Novartis could still obtain an extension of time if there were exceptional circumstances that warrant the extension. The Hearing Officer found that he could not be satisfied of this either, because there was insufficient evidence before him of:

  • The period of Dr Rowe’s extended leave.
  • Dr Rowe’s work commitments subsequent to the leave that could not have been anticipated.
  • The effect of the above on the preparation of evidence.

Having refused the extension of time, the Hearing Officer directed that declarations filed by Novartis in November are not evidence in answer in relation to the opposition. This evidence related to the tasks of Dr Rowe of reviewing the prior art documents, comparing them to the claims of the opposed application (presumably for novelty and inventive step), and commenting on the declaration of the expert engaged by Merial. Evidence on these matters is often not only highly relevant, but critical in an opposition. This demonstrates how seriously the Australian Patent Office is taking the new extension of time provisions.

Potential alternative avenues if evidence is excluded

The Hearing Officer noted in his conclusion that it is open to Novartis to request that the excluded evidence be admitted as ‘further evidence’, but did not comment on the prospects of such a request succeeding. It appears that Novartis made such a request in January 2014.

The provision for further evidence applies only to oppositions commenced before 15 April 2013. This option is not available for later oppositions. For these, there is a provision for the Commissioner to consider other documents, including declarations.

It remains to be seen how the Australian Patent Office applies these alternative avenues for putting evidence before the Commissioner of Patents when an extension of time for filing the same or similar evidence has been refused. On the one hand, it seems that using these provisions for filing excluded evidence risks rendering the new extension of time provisions ineffective by a side-wind. On the other hand they may provide a mechanism for allowing evidence when the Patent Office is of the view that in the circumstances of the case before it, the mandatory requirements have not achieved the objectives of the opposition procedure.

Timeline of main events

February 2013

Novartis engages Dr Rowe, who informs Novartis that he would be absent overseas ‘from July/August’.

Feb-March 2013

Novartis commences preparation of evidence with Dr Rowe.

27 April 2013

Period for preparing evidence in answer commenced – original deadline 29 July 2013.

May 2013

Dr Rowe given tasks 1 and 2 of nine for evidence in answer.

July 2013

Dr Rowe given tasks 3 to 5 of nine. Dr Rowe, goes on holiday, saying he will not return until 22 September 2013.

18 July 2013

Novartis files a first declaration of Dr Rowe (tasks 1 and 2).

29 July 2013

Novartis requests a first 3 month extension of time, which is granted unopposed. Extended deadline 29 October 2013.

August 2013

Dr Rowe further progresses evidence preparation.

September - October 2013

Dr Rowe given tasks 6-8 of nine.

24 October 2013

Novartis files Dr Rowe’s 2nd to 4th declarations (tasks 3 to 5).

29 October 2013

Extended period for filing evidence in answer expires.

November 2013

Novartis files Dr Rowe’s 5th and 6th declarations (tasks 6 to 9).

 

 

Topics:  Australia, Australian Patent Office, Inventive Concept Test, Lack of Novelty, Novartis, Obviousness, Patent Applications, Patent Litigation, Patent Oppositions

Published In: Civil Procedure Updates, Intellectual Property Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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