Amending your patent claims in corresponding foreign applications could obligate you to look at your granted Australian claims

Date: 2013-02-26
Authors: Karen Bentley & Milena Dryza

“There is no practice ... that I’m aware of, nor have I ever received advice from my attorneys anywhere in the world[,] that once a particular amendment is made to a patent in any particular jurisdiction ... there is some benefit or gain to be had in reviewing the entire portfolio with that in mind and certainly, we have never done that”.

This statement would fairly summarise the view of many patentee’s counsel. But a recent Australian court decision1 however has confirmed that there may be a ‘benefit or gain’ to be had in reviewing your Australian patent portfolio in light of amendments filed in related foreign applications. This decision, while finding in favour of the patentee on this occasion, sent a clear message that where similarities in patentability requirements and law exist between Australia and another jurisdiction, and the validity of your patent claims in that jurisdiction is questioned, it is advisable to closely review your granted Australian claims.

This will become increasingly important as new law, which seeks to harmonise some of Australia’s patent laws with that of other jurisdictions, comes into effect in April this year.

Background

Australian patent 780330 (the ‘Patent’) relates to pharmaceutical compositions for use as oral contraceptives which are sold in Australia under the brand name ‘Yasmin’. It is the subject of an allegation of patent infringement by the patentee Bayer Pharma AG and the exclusive licensee Bayer Australia Limited (collectively ‘Bayer’) against Generic Health Pty Ltd, Lupin Australia Pty Ltd and Eremad Pty Ltd (the respondents). The respondents have counter-claimed that the patent is invalid on a number of grounds.

This decision relates to an application to amend a number of claims (referred to as the ‘dissolution test claims’) made by Bayer. Bayer sought to amend the claims of the Patent to ‘forestall any argument, particularly in the principal proceeding, that the dissolution test claims … are not fairly based on the matter described in the specification….There is no evidence to suggest that these amendments have been sought …to overcome any prior art or indeed, to address any other asserted, apparent or possible ground of invalidity…’2

Patent amendments made before the Court

Claim amendments must be allowable under s 102 of the Patents Act 1990 (Cth) (the ‘Act’). In addition, amendments to a patent requested before a court are only granted subject to the court’s discretion (in accordance with s 105 of the Act). To this effect, the conduct of the patentee is taken into consideration in accordance with the well-established principles set out in Smith Kline & French Laboratories Limited v Evans Medical Limited.3

The respondents did not object to the allowability of the amendments under s 102 of the Act. The only issue was whether the discretion to allow the amendments under s 105 of the Act should be exercised favourably to Bayer.

In this regard, the respondents relied mainly on the allegation that Bayer had been put on notice as early as March 2003, when the corresponding US application was undergoing prosecution, that their Australian claims may need amending.

Corresponding foreign applications

The Court decided that delay in seeking amendment of the claims was not in itself determinative, and looked to the histories of the related European and US cases, as well as the prosecution history of the Patent itself, to consider whether Bayer should have been prompted to seek amendment of the Patent.

With regard to the related US case, the Court concluded that the objection raised by the US examiner was fundamentally different to the fair basis point at question here.

With respect to Europe, the Court gave consideration at [210] ‘to what are undoubtedly two different legal requirements – one dealing with added subject-matter as applied in EPC jurisdictions, and the other dealing with internal fair basis as understood and applied under Australian law’. The Court concluded at [211] that the existence of the problem in the corresponding EP application was ‘essentially a European issue’ that did not require Bayer Pharma to consider whether ‘patents in jurisdictions operating under quite different legal requirements…might also require amendment’.

The Court concluded that, due to the different contexts in which the claims were amended in Europe and the US, the amendments made in those other jurisdictions were not necessarily determinative of what amendments Bayer should have made to the claims of the Patent.

Interestingly, the finding that discretion under s105 of the Act should be exercised in favour of granting the amendments in this case was in contrast to the decision of the court in CSL Ltd v Novo Nordisk Pharmaceuticals Pty Ltd (‘CSL’).4 This decision followed the same principles as the court in the CSL decision, but came to a different conclusion based on the facts. As we reported in December 2010 "Claim amendment refused as patentee knew of problem well before requesting amendment" the court on that occasion concluded that because examiners in multiple jurisdictions had expressed the view that claim 1 should not be granted in view of substantially the same prior art, the patentees were on notice that claim 1 in the Australian patent was ‘problematic’.

New law – different outcome?

In concluding that the legal requirements between Australian fair basis and European support are different, the Court in this case noted the upcoming change in the Australian law to substitute the phrase ‘fairly based on the matter described’ (the current requirement for internal fair basis) with a test of ‘supported by matter disclosed’. As outlined in the Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth), the rationale for this change is to align the Australian requirement with overseas jurisdictions’ requirements (such as the UK). In light of this, it was suggested by the Court that, had the new law been applicable, the Court may have chosen not to exercise its discretion.

This is consistent with the CSL decision where it was considered that there was sufficient similarity in legal requirements for the issue in question to have put the patentees on notice.

 

1. Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2012] FCA 1510.
2. Ibid [26].
3. [1989] 1 FSR 561 at 566-569.
4. (No 2) [2010] FCA 1251.