Apotex Pty Ltd v Warner Chilcott Company LLC - [2013] APO 51

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Apotex Pty Ltd v Warner Chilcott Company LLC [2013] APO 51

Patent Application: 2005330654

Title: Dosage forms of risedronate

Patent Applicant:  Warner Chilcott Company, LLC
Opponent:  Apotex Pty Ltd
Delegate:  Dr S.D.Barker
Decision Date:  5 September 2013
Hearing Date:  Written submissions completed on 26 July 2013
Catchwords:  PATENTS – application for extension of time to file evidence in support – inadequate explanation of delay – nature and significance of evidence supports extension – extension allowed – no award of costs

Representation: Patent applicant: Pizzeys
Opponent:Freehills

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2005330654

Title:Dosage forms of risedronate

Patent Applicant: Warner Chilcott Company, LLC
Date of Decision: 5 September 2013
DECISION
The time for filing evidence in support is extended to 23 September 2013.
I make no award of costs.
REASONS FOR DECISION

Patent application 2005330654 filed by Warner Chilcott Company, LLC (Warner) was advertised as accepted on 26 November 2011. A notice of opposition to the grant of a patent was filed by Apotex Pty Ltd (Apotex) on 23 September 2011.
Apotex filed its Statement of Grounds and Particulars on 23 December 2011. Apotex has obtained extensions of the time for serving evidence up to 23 June 2013. To date evidence in the form of a declaration by Associate Professor Robert Milne and a declaration by Sarah Catherine Hennebry have been served and filed. On 23 June 2013 Apotex filed a request for an additional 3 month extension of time to 23 September 2013, which has been objected to by Warner and is the subject of this decision. A hearing was conducted on the basis of written submissions. Submissions were filed by the parties on 19 July 2013. Submissions in response were received on 26 July 2013.
The relevant law
As a consequence of the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 there are substantial changes to Chapter 5 of the Patents Regulations 1991. In the case of the present application and the present extension of time, the extension is governed by reg. 5.10 as in force immediately before 15 April 2013. One relevant consequence of the amendments to Chapter 5 is that evidence that is required to be served on or after 15 April 2013 is to be filed with the Commissioner rather than served. Consequently in this decision I will make reference to the filing of evidence where that is to happen on or after 15 April 2013.
Regulation 5.10(2) of the Patents Regulations gives the Commissioner the power to extend the time for filing evidence in support. The Commissioner must not grant an extension unless satisfied that the parties have been notified of the application for extension (reg. 5.10(5) (b)), has given the parties a reasonable opportunity to be heard (reg. 5.10(5)(c)(i)), and is reasonably satisfied the extension is appropriate (reg. 5.10(5)(c)(ii)). In the present case the parties have been notified and have had an opportunity to be heard. The only remaining question is whether it is appropriate to extend the time.
The considerations relevant to this question have been considered several times by the Federal Court (Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981; 28 IPR 243, A Goninan & Co Ltd v Commissioner of Patents [1997] FCA 424; 38 IPR 213 and National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33; 50 IPR 398). In summary, the power to extend time is discretionary, so it is necessary to give genuine and proper consideration to all relevant considerations. (Ferocem at 247-8, Goninan at 220). Relevant considerations include:
Explanation of delay
In its submissions Apotex explained that “evidence from experts from a number of different fields” is required to assist in preparation of evidence in support. They note there are few experts in the relevant fields in Australia relative to other jurisdictions and identification and retention of experts took longer than initially anticipated. In addition to Assoc Professor Milne, Apotex is also preparing evidence from Professor Zajac.
Apotex explained that the serious and reoccurring illness of the first expert witness along with the professional and overseas travel commitments of both witnesses has exacerbated the delay in completing evidence in support. Apotex advises in its submission of 19 July 2013 that it expects Professor Zajac to sign his declaration "within a week". It is not apparent that this happened.
Apotex also emphasised the necessity of a step-wise approach to preparing evidence in respect of inventive step. Accordingly, Assoc. Professor Milne’s evidence in relation to inventive step was obtained in absence of his knowledge of the opposed application. Apotex explained that he is yet to be provided with a copy because “he left on a 2 month holiday overseas holiday shortly before the previous deadline.” Apotex indicated that on his return to Australia in August 2013, Assoc. Professor Milne would then be provided with a copy of the opposed application. Apotex submitted “only one further month is required once Assoc. Professor Milne returns to Australia” to complete its evidence in support.
In reply, Warner noted that the opponent had over six months since 21 December 2012 to finalise its evidence in support. The applicant argued that Apotex has not provided a satisfactory explanation for the whole period of delay with respect to either witness.
Apotex has chosen to adopt a staged approach to the preparation of its evidence. The choice of an inherently slow approach to evidence preparation (which is not required by the Patents Act or Regulations) is not a sufficient justification of delay. I note that although there can be difficulty in identifying and engaging willing experts in the relevant fields in Australia, Assoc. Professor Milne and Professor Zajac were retained by Apotex by 23 June 2012. I appreciate that the illness of the first witness, the busy clinical and professional commitments of the second witness and overseas travel by both, contributed to earlier delays and the consequential grants of extension of time. However, with regard to the present request, I conclude that Apotex has not provided a satisfactory explanation as to why the second expert’s declaration was not completed during the term of the last extension of time to 23 June 2013. Also in my opinion, Apotex has not explained why it did not seek to do so before he undertook his most recent travel. The explanation of delay is clearly inadequate.
Public interest
In its submission on the public interests, Apotex drew upon matters relating to the opposed patent application’s corresponding European patent EP1753395. The opponent submitted that the claims of the opposed patent are similar and “arguably” narrower in scope than the corresponding European patent EP1753395. Apotex advised:
“This European patent EP1753395 was revoked in its entirety following opposition proceedings and was held obvious in light of the prior art.”
Apotex also submitted that if the requested extension of time is not granted, its ability to show how the prior art impacts on the invalidity of the opposed patent application is “significantly compromised”. It follows, Apotex contends, that the public interest is not served if pre-grant opposition processes are not operating to prevent the grant of invalid or “bad” patents.
In reply, Warner noted that the unique claim set of the opposed patent application will be evaluated under Australian law. And further, the public interest is not served by the grant of unlimited extensions of time and “counterpart proceedings in another jurisdiction should hasten matters rather than slow proceedings.”
The opposition in Europe is relevant to the extent that the same matters will be argued in the present opposition. However, different evidence is being prepared in Australia, as can be seen by the lengthy period involved in preparing that evidence. This necessarily reduces the relevance of the European opposition. However, the evidence of the two expert witnesses relates to the ground of inventive step, and is therefore likely to be of assistance to the present opposition.
Interests of the parties
Apotex submitted that the interests of the applicant were not counter to the grant of the extension largely because there were no potential infringement issues because the applicant does not have Therapeutic Goods Administration (TGA) approval for the particular pharmaceutical and consequently no product in the market. Apotex remarked that the applicant had not forewarned of an intention to oppose a further extension when the fifth request was filed and therefore, Apotex concluded, the applicant would not be disadvantaged.
In reply, Warner submitted the lack of TGA approval is a result of the delay and uncertainty in resolution of the opposition proceedings. And as evidence of Apotex’s tardiness and attempts to prolong proceedings, noted that the opponent did not honour its commitment to complete evidence in support by 23 June 2013. Warner also responded that Apotex’s previous commitment to complete evidence by 23 June 2013 was the reason why they did flag an intention to oppose an extension of time.
As is normal in such matters, the parties have differing interests. I recognise that each party has valid reasons to support their differing interests. I can see no logical basis to weigh one interest more than the other. I believe that the interests of the parties are largely offsetting, although not identical.
Conclusion
I am satisfied that there is not an adequate explanation of the delay, but the public interest favours allowing the extension. In its request for a fifth extension of time, the opponent gave an undertaking to complete its evidence by 23 June 2013. This did not happen. There is thus some doubt that the opponent is pursuing the opposition diligently. I consider that the considerations are finely balanced, but I consider that I should give greater weight to the public interest. I will allow the extension of time.
I recognise that granting a sixth extension will introduce a further delay. The opponent indicated in the submission of 19 July 2013 at paragraph 15 that Professor Zajac was expected to sign his declaration within a week and “only one further month is required once Professor Milne returns to Australia, but that is not until August". I anticipate that no further extensions should be necessary, and the opponent should not assume that the balance of considerations will fall the same way if a further extension is requested.
Costs
Both parties made submissions on costs. While it is normal for costs to follow the event, that is not a rule that is applied inflexibly. In this case, the opponent has not provided a satisfactory explanation of the nature of the delay in completing its submissions on evidence in support. The applicant was justified in objecting to the extension, and the award of costs should not penalise them. It is appropriate to make no award of costs.
Dr S.D.Barker
Delegate of the Commissioner of Patents