Apotex Pty Ltd v Astrazeneca AB

[2012] APO 95

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Apotex Pty Ltd  v Astrazeneca AB [2012] APO 95

Patent Application:                   2005202392

Title:Pharmaceutical compositions

Patent Applicant:  AstraZeneca AB          

Opponent:  Apotex Pty Ltd

Delegate:  Nicole Howard

Decision Date:  7 September 2012

Submissions Received:             16 April 2012 and 7 June 2012 from Apotex
  31 May 2012 from AstraZeneca

Catchwords:  PATENTS – Reg 5.10  – further evidence application– evidence highly significant to whether citation would be ascertained- explanation of delay unsatisfactory – application allowed – costs awarded against opponent

Representation:  Patent applicant:  Davies Collison Cave

Opponent:Freehills Patent and Trademark Attorneys

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                   2005202392

Title:Pharmaceutical compositions

Patent Applicant:  AstraZeneca AB

Date of Decision:  7 September 2012

DECISION

Application to serve further evidence allowed.  Costs awarded against Apotex.

REASONS FOR DECISION

Background

1.Patent application 2005202392 in the name of AstraZeneca AB (hereafter AstraZeneca) was filed on 2 June 2005 claiming divisional status from Australian Patent 781269.  The application was advertised accepted on 20 November 2008.  The application relates to pharmaceutical compositions comprising (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R, 5S)-3, 5-dihydroxyhept-6-enoic acid or a pharmaceutical salt thereof as the active ingredient, the composition having a ferric oxide light protective coating.  The active ingredient is commonly known as rosuvastatin.

2.Apotex Pty Ltd (hereafter Apotex) filed a notice of opposition under Section 59 of the Patents Act 1990 on 20 February 2009.  The opposition was heard in Melbourne on 4 and 5 April 2012.  During the hearing Apotex indicated that they wished to file further evidence pertaining to whether the person skilled in the relevant art could reasonably be expected to have ascertained the UK Patent citation primarily relied upon.  Apotex requested one week in which to make their application to serve further evidence and were directed to do so by 16 April 2012. 

3.Apotex applied to serve further evidence on 16 April 2012.  AstraZeneca objected to the service of further evidence, and the matter was heard on the basis of written submissions. 

4.Submissions were received from Apotex on 16 April 2012 and from AstraZeneca on 31 May 2012.  Submissions in response were received from Apotex on 7 June 2012.  

The law

5.Further evidence is governed by regulation 5.10(4). 

(4)       The Commissioner may:

(a)on the application of a party; and

(b)on such reasonable terms (if any) as the Commissioner specifies;

permit the party to serve further evidence on the other party.

6. This provision must be read in conjunction with regulation 5.10(5):

(5)The Commissioner must not give a direction under subregulation (1) or grant an application under subregulation (2) or (4) unless the Commissioner:

(a)if he or she proposes to grant an application by a party -  is reasonably satisfied that the other party has been notified of the application;  and

(b)if he or she proposes to act on his own motion -  ensures that the parties are notified of the proposed action;  and

(c)in either case:

(i)gives the parties a reasonable opportunity to make representations concerning the application or proposed action;  and

(ii)is reasonably satisfied that a direction, and extension of time or the serving of evidence is appropriate in all the circumstances.

7.In the present case I am satisfied that AstraZeneca has been notified, and that both parties have had an opportunity to make representations.  The question that must be considered is whether I am satisfied that it is appropriate to allow the service of the further evidence.  In exercising this discretion I am guided by the decisions of Burchett J in Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981; (1994) AIPC 91-057; 28 IPR 243, Sackville J in A Goninan & Co Ltd v Commissioner of Patents [1997] FCA 424; (1997) AIPC 91-330; 38 IPR 213 and Goldberg J in National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33 on the operation of regulation 5.10(5) in relation to extensions of time. The general principles that flow from these decisions are as follows:

a)        The power is discretionary:    Regulation 5.10 confers a broad discretion, which cannot be reduced to imperative compliance with particular requirements.  It is necessary to give genuine and proper consideration to all relevant considerations.  (Ferocem at AIPC 38,208; IPR 247-8,  Goninan at AIPC 39,434; IPR 220)

b)        Explanation of delay: The reasons why the evidence was not served earlier are a relevant consideration, but a satisfactory explanation is not a mandatory requirement.  (Ferocem at AIPC 38,207-8; IPR 247) 

c)        The public interest:     The public interest in determining a serious opposition on its merits is a relevant consideration.  (Goninan at AIPC 39,435-6; IPR 222)

·In order to do this, it is necessary for the Commissioner to form a view as to the nature of the evidence that it is sought to adduce, and the significance of that evidence for the opposition proceedings.  (Goninan at AIPC 39,438; IPR 225-6)

·The significance of the evidence is assessed having regard to any relevant material available, not just the evidence itself.  (National Starch at [33])

·The public interest is not protected merely because some evidence has already been served.  (Goninan at AIPC 39,438; IPR 225)

d)        The interests of the party seeking the exercise of discretion: The interests of the party seeking the exercise of discretion are a relevant consideration.  (Ferocem at AIPC 38,208; IPR 247)

e)        The interests of other parties: It is relevant to consider the disadvantage to the other party of delays in determining the opposition, and the effect of delays on the efficient and orderly administration of the Patents Office.  (Ferocem at AIPC 38,208; IPR 247,  Goninan at AIPC 39,436; IPR 222)

8. These considerations are equally relevant to the determination of the present request for further evidence.  Previous decisions of the Commissioner on further evidence illustrate different aspects of these considerations, but do not represent binding rules.

The evidence

9. The statement of grounds and particulars includes grounds related to novelty and inventive step.  At the hearing Apotex explicitly indicated that under these grounds they would be relying on UK Patent application document 2 262 229 (UK Patent) as their sole citation. The key expert evidence provided by the opponent at the time of the hearing comprised three declarations by Dr Philip Marshall.  The Marshall declarations do not specifically address whether he would have found the UK Patent.  Apotex seek to ‘file further evidence addressing the question of whether the person skilled in the relevant art could reasonably be expected to have ascertained the UK patent at the priority date’.

10.The evidence now sought to be adduced consists of four Statutory Declarations:

·Statutory Declaration of Dr Philip Marshall made on 13 April 2012

·Statutory Declaration of Dr James Rowe made on 16 April 2012

·Statutory Declaration of Dr Emma Lees made on 16 April 2012

·Statutory Declaration of Dr Nicole Watling made on 16 April 2012

11. The Marshall declaration expands on his originally filed comments and informs that he would have searched the patent literature.  He identifies the search terms he would have used and Chemical Abstracts as the principal database. 

12. Apotex explain that the Rowe declaration addresses submissions foreshadowed by AstraZeneca ‘at the hearing that Dr Marshall’s evidence was affected by his prior knowledge of the existence of the UK patent’.  Apotex submitted:

‘Dr Rowe was not shown or provided with the UK patent at any stage, nor was it described to him or identified in any way.  Dr Rowe provides evidence of how he would have gone about searching the literature when faced with the problem of trying to formulate the compound identified in the claims of the Opposed Application when faced with the problem that it was known to be susceptible to degradation.  Dr Rowe proposes a handful of searches.  The searches he proposed were then conducted and the results are exhibited in his declaration.  Dr Rowe then identified which of those results he considered to be relevant to his task and would have reviewed in more detail by, for example, ordering a copy of the full document.  Among the documents selected by Dr Rowe is the UK Patent.’

13. The Lees declaration sets out the results of a search conducted by Dr Lees using the SciFinder database  identified by AstraZeneca’s expert witness Dr Williams.  Dr Lees uses the search terms identified by Dr Marshall and Dr Rowe.  The Watling declaration details her communications with Dr Rowe and instructions to the searcher who carried out Dr Rowe’s searches. 

The objection

14. AstraZeneca’s objection can be summarised as;

• The significance and weight of the evidence is not such that it will add to the opponent’s case because the evidence does not support the proposition that the skilled artisan could have been reasonably expected to have ascertained the UK Patent before the priority date without reference to material not part of the common general knowledge.

• If the evidence were admitted and taken at its highest, the requisite standard of practical certainty would not be made out because there would remain a conflict of evidence with Dr Williams who conducted his own search and did not identify the UK Patent.

• The request was made after conclusion of the hearing and it cannot be said that the evidence was unavailable or unable to be prepared at the time of filing the opponent’s evidence in support.  There is no substance to the opponent’s contention that the so-called ‘absence of evidence’ on the s7(3) point only became critical at the hearing.

• To permit the further evidence promotes delay and is contrary to the fair, orderly and efficient conduct of pre-grant opposition proceedings. 

Explanation of the delay

15.In explaining their reasons for the request, Apotex submit that prior to the hearing, they were of the view that a finding in their favour could be made in the absence of evidence and that in high technology areas such as pharmaceuticals it would be routine to search the patent literature.  They further submit

‘AstraZeneca, however, relied upon the absence of evidence on this issue as meaning that it could not be determined in favour of Apotex.’

‘When it became clear during the hearing that this could be a critical point, given the position taken by AstraZeneca and given that the issue of whether there is an inventive step in light of the UK Patent could determine the outcome of the proceedings, Apotex sought leave from the Hearing Officer (during the hearing) to make this request to serve further evidence.’ 

16.The Patent Act clearly sets out the provisions of s7(3) as requiring citations to be ascertained by the skilled artisan and it is well established in the courts that this point can be contentious during revocation proceedings.  I agree with AstraZeneca in that the evidence was available at the time of filing evidence in support.  It is not the case here that ‘new’ information came to light (in the form of a new citation or the like).  Rather, Apotex have decided at a very late stage to add evidence which in my view should have been adduced well before the hearing.  Indeed, as stated in their submissions ‘Apotex freely acknowledged at the hearing that it would have been preferable to have evidence on this point, and indicated that it was probably an oversight during evidence preparation.’ While an explanation for the delay has been provided I do not consider it to be satisfactory.  However, the discretion to grant extensions under Regulation 5.10 is a broad one, and while a satisfactory explanation is a relevant consideration, it is not a mandatory requirement.

The interests of the parties

17.It is in Apotex’s interest to allow the further evidence.  The UK Patent is the primary document they rely on in their opposition.  Should the claims be found novel, the UK Patent will only be available under 7(3) if it is established that it would have been ascertained by the skilled artisan.  While it may be the case that this could be established without the further evidence, the opponent could potentially be severely compromised without it.  

18.AstraZeneca’s interests are opposed to those of Apotex.  I agree with them in that the application for serving further evidence affects the orderly conduct of opposition proceedings.  (I also note that their objection to the application (and any subsequent filing of further evidence in response) has also extended the timeframe.)  Further, if the content of the further evidence could change the outcome of the opposition then allowing it would clearly not be in the interest of AstraZeneca. 

The public interest

19.The public interest in determining a serious opposition on its merits is assessed by considering the nature and significance of the evidence that will be served (Goninan at AIPC 39,438; IPR 225-6).  The nature of the evidence that Apotex is serving is readily  apparent and is clearly related to the ground of inventive step, in particular to whether the UK Patent would have been ascertained by the skilled artisan.  For example, Dr Rowe is an independent expert and , as a pharmaceutical formulator, is considered a relevant skilled person.  He is a qualified to give evidence in support on this matter.

20.AstraZeneca have made strong submissions that the evidence does not support the proposition that the skilled artisan would have ascertained the UK Patent.  If they are correct, then allowing the further evidence should make no difference to the outcome of the opposition and therefore would not affect the public interest.  They also submit that if the evidence is admitted and taken at its highest it would be in conflict with the Williams declaration.  While I understand this criticism, it does not mean that the declarations are not capable of being given weight by a hearing officer.

21.Without in any way foreshadowing matters to be addressed in the substantive decision, in my view the public interest strongly favours allowing the further evidence.  It is particularly significant because without it, the ground of lack of inventive step may not be fully considered by the Delegate. 

The balance of considerations

22.The public interest and the interests of Apotex favour allowing the further evidence.  The interests of AstraZeneca lie in the refusal of the application.  Although Apotex  have not  provided a reasonable explanation for the delay, the outcome of the opposition hinges on only one highly relevant document.  While I am sympathetic to AstraZeneca’s submissions on the timing of the application for further evidence, I believe the public interest in determining a correct outcome for the opposition weighs heavily in favour of granting the extension.

23.I allow the application for further evidence.

Other matters

24.The Opposition Officer has indicated to the parties that it is normal practice to allow one month from the date of a decision to allow the serving of evidence in response.  While I am aware that a number of submissions have been made in this regard, in this case the normal practice seems appropriate.

25.I allow AstraZeneca one month from the date of this decision to serve evidence in response.

Costs

26.Costs normally follow the event.  However, on this occasion I have found the explanation for the delay to be unsatisfactory.  In addition, it does not do anything for the orderly disposition of oppositions before the Commissioner if one party waits until flaws in their evidence have been exposed at the hearing and then attempt to correct those flaws with further evidence after the hearing.  The Commissioner expects all parties to have reviewed their evidence and arguments well before the hearing takes place.  Apotex’s conduct in this opposition is not to be encouraged.  I award costs against Apotex. 

Nicole Howard
Delegate of the Commissioner of Patents