Pre-grant patent oppositions in Australia enable interested parties to oppose the grant of a patent application once the Patent Office has completed the examination process and the claims have been found to be patentable. One possible outcome in a successful opposition is that the Delegate may allow the Applicant the opportunity to amend the claims to overcome the deficiencies identified in the decision.  A recent decision of the Federal Court (Merck Sharpe & Dohme (Australia) Pty Ltd v Genentech Inc [2016] FCA 324) highlights the difficulties for the Opponent in effectively challenging such ‘post-decision’ amendments.

The opposition

Merck Sharpe & Dohme (Australia) Pty Ltd (“Merck”) opposed the grant of Genentech Inc.’s (“Genentech”) Australian Patent Application relating to the inhibition of IL-17 production (AU 2003287257). The invention was based on the recognition that IL-23 induces IL-17 production in activated T cells and that IL-23 antagonists are capable of inhibiting this process.

At the hearing held on 12 November 2013, the parties agreed that the opposition could be heard on the basis of the independent claims alone, with the dependent claims falling the same way as the independent claims.

In the decision issued on 6 February 2014, the Delegate found that independent claims 1, 4, 5, 14 and 15 lacked novelty in light of four prior art documents.  In light of the agreement between parties in relation to the dependent claims, the Delegate also found that they lacked novelty.  The Delegate found all claims to be inventive, as the documents relied upon by Merck would not have been ascertained or regarded as relevant.

The Delegate also found that it was possible to overcome the identified deficiencies by amendment of the claims and allowed Genentech two months in which to propose such amendments.

Neither party appealed against the Delegate’s decision within the 21-day period within which an appeal must be lodged under the Federal Court Rules.

Amendments

Genentech subsequently lodged amendments introducing additional limitations into the independent claims.  In particular, the inflammatory diseases to be treated were limited to a subset of the diseases recited in dependent claim 28. Treatment of these diseases was not disclosed in the prior art relied upon at the hearing.

The amendments were allowed unopposed.  However, Merck then sought to pursue the grounds of lack of novelty and inventive step against the amended claims in light of a new prior art document not cited at the original hearing. The issue arose as to whether Merck could raise new prior art at this stage.

Second Patent Office decision and Federal Court appeal

In R v Smith (Commissioner of Patents); Ex parte Mole Engineering Pty Ltd [1981] HCA 25 (“Ex parte Mole”), the High Court made clear that decisions of the Commissioner of Patents cannot be re-opened at a subsequent hearing.

Merck claimed that Genentech, by way of its agreement that the opposition be determined on the basis of the independent claims alone, had acknowledged that where an independent claim lacked novelty, the whole subject matter of the associated dependent claims lacked novelty.  On this basis, Merck argued that the introduction of subject matter from a dependent claim found wholly invalid in the earlier decision could not confer novelty on the independent claims, and to find otherwise would be inconsistent with the earlier decision.

Merck also submitted that as the Delegate had not considered the features of the dependent claims in the earlier decision, a final determination taking account of the new prior art document would not be inconsistent with the previous decision.

Both the Delegate, and subsequently the Federal Court, rejected these arguments.

The Court held that the agreement between the parties in relation to the dependent claims simply involved Genentech accepting that, if the Delegate found that one of the prior art publications fell within the scope of an independent claim, it would also fall within the scope of dependent claims such as claim 28, thus causing it to fail.  Genentech had not accepted that the entire scope of the dependent claims was anticipated and so it was possible to limit the claims to those diseases listed in dependent claim 28 which were not disclosed in the prior art.

The Court further held that, in reality, Merck’s attack on the amended claims was an attack of that part of the first decision that found that the objections to the claims could be cured by amendment. That attack could only be brought by way of an appeal of this aspect of the original decision, and Merck had not brought such an appeal. In such circumstances, it could not seek re-hearing of the issue, as to do so would offend against the principles of Ex parte Mole.

Conclusions

Opponents to patent applications may be justifiably concerned by this decision. The message appears to be that if opponents wish to head off possible validating amendments to the claims, they must either (a) ensure that their arguments at the hearing cover the entire scope of the independent and dependent claims (i.e., prior art which invalidates a claim, but would not invalidate a subset of the claim, is not enough), or appeal the opposition decision in which they have been successful. However even beyond the scope of the current claims, it appears that the Federal Court’s decision could suggest that any potential amendments, even those drawn from matter in the specification and not incorporated into any claim at the time of the opposition hearing, need to be considered and dealt with by the opponent in this manner. This places an extremely high burden on an opponent, and one which could result in lengthier hearings and unnecessary appeals dealing with theoretical amendments which the applicant has no intention of making.

Coupled with the problem of how to cover all relevant matter at the opposition is the fact that the deadline for an appeal of an opposition decision (21 days thereafter) falls well before the customary deadline set by the Patents Office for any curing amendments to be filed (usually 2 months). This means that in an opposition where the opponent has been successful, it must still consider whether there is any possible matter in the specification which could save the application, and if it is interested in blocking claims directed to such matter, appeal the decision to the Federal Court. If an appeal is filed, the Patents Office no longer has jurisdiction to grant any amendments and an amendment application must be made in the Court. One foresees cases where both parties are effectively dragged into the Federal Court in circumstances where the applicant wants to make an amendment that the original opponent has no objection to, causing unnecessary expense for both and wasting valuable Court time.

One way of ameliorating this undesirable position would be for the applicant to be required to file amendments before the opponent is required to file an appeal. If the amendments are not of concern to the opponent, or in their view not challengeable, no appeal would be filed. Otherwise it seems likely that in many cases the parties will simply have to see whether they are in fact still in conflict in the early stages of the appeal and if not, settle that appeal.

More generally, it is clear that opponents need to carefully consider at an early stage all of the claims of the application (and potentially the entire subject matter of the specification) and have a clear view of what subject matter is of concern to them so that an appropriate strategy can be tailored accordingly.