Merial Limited v Zoetis P LLC
[2015] APO 36
•7 July 2015
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial Limited v Zoetis P LLC [2015] APO 36
Patent Application: 2007343130
Title:Methods of vaccine administration
Patent Applicant: Zoetis P LLC
Opponent: Merial Limited
Delegate: Dr B. Akhurst
Decision Date: 7 July 2015
Hearing Date: Written submissions were filed on 11 and 16 June 2015 and responding submissions on 23 June 2015.
Catchwords: PATENTS – application for further evidence under reg. 5.10(4) as in force immediately before 15 April 2013 - explanation of delay considered - nature and significance of the evidence favours allowing the amendment - further evidence allowed.
Representation: Patent applicant: Allens Patent & Trade Mark Attorneys, Sydney.
Opponent: FB Rice, Melbourne.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2007343130
Title:Methods of vaccine administration
Patent Applicant: Zoetis P LLC
Date of Decision: 7 July 2015
DECISION
I grant leave to Zoetis P LLC to file the Brettmann declaration as further evidence. Merial Limited has two months from the date of this decision to file responding evidence.
Costs according to Schedule 8 are awarded against Merial Limited.
REASONS FOR DECISION
Background
Pfizer Products Inc. filed patent application 2007343130 via the PCT on 23 November 2007, claiming priority from application US 60/877332 filed on 26 December 2006. The application was examined and advertised as accepted on 20 December 2012. A change of ownership to Zoetis P LLC (Zoetis) was published on 27 June 2013.
Merial Limited (Merial) filed a notice of opposition to grant of a patent on 20 March 2013. Evidence in support, answer and reply was completed by 20 May 2014 and subsequently supplemented by further evidence and responding evidence on 11 August 2014 and 9 October 2014, respectively.
At the opposition hearing on 11 May 2015, Zoetis sought leave for additional further evidence. Merial objected and requested a hearing and the matter was heard by written submissions. Submissions in chief were filed by Merial and Zoetis on 11 June 2015 and 16 June 2015, respectively. Both parties filed responding submissions on 23 June 2015.
On 23 June 2015, a request was filed under section 113 for a direction that patent application 2007343130 proceed in the name of Zoetis Services LLC. At the time of issuing this decision, the change of applicant had not yet been recorded.
The Law
On 15 April 2013, the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1) (the RTB Regs) commenced, which significantly amended the Patents Regulations 1991 as they apply to patent oppositions. However, under the transitional provisions of RTB subregulation 23.36(2), where, as in this case, the notice of opposition was filed before 15 April 2013, an application to file further evidence is governed by subregulations 5.10(4) and 5.10(5) as they existed immediately before 15 April 2013.
Subregulation 5.10(4) of the Patents Regulations immediately before 15 April 2013 provides:
(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 evidence on the other party.
Subregulation 5.10(5) immediately before 15 April 2013 relevantly provides:
(5) The Commissioner must not … grant an application under subregulation … (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; …
(b) …; and
(c) … :
(i) gives the parties a reasonable opportunity to make representations concerning the application or proposed action; and
(ii) is reasonably satisfied that … the serving of evidence is appropriate in all the circumstances.
Under the transitional provisions of RTB subregulation 23.36(4), a requirement in regulation 5.10 for a party to serve evidence on a person is taken to be a requirement to file the evidence.
It is clear from the above provisions that for leave to be granted for further evidence the Commissioner must be reasonably satisfied that the filing of further evidence is appropriate in all the circumstances. In exercising this discretion, I am guided by the decisions of Burchett J in Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981; 28 IPR 243, Sackville J in A Goninan & Co Ltd v Commissioner of Patents [1997] FCA 424; 38 IPR 213 and Goldberg J in National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33; 50 IPR 398. 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 FCA at [11], IPR at 247-8; Goninan IPR at 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 FCA at [10], IPR at 247).
c)The public interest: The public interest in determining a serious opposition on its merits is a relevant consideration (Goninan IPR at 222). 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 IPR at 225-6). The significance of the evidence is assessed having regard to any relevant material available, not just the evidence itself (National Starch FCA at [33]). The public interest is not protected merely because some evidence has already been served (Goninan IPR at 225).
d)The interests of the parties: The interests of the party seeking the exercise of discretion are a relevant consideration (Ferocem FCA at [11], IPR at 247). It is also 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 Patent Office (Ferocem FCA at [11], IPR at 247; Goninan IPR at 222).
The application for further evidence
Zoetis’s request for leave to file further evidence was made orally at the substantive opposition hearing and was accompanied by the evidence, which consists of a declaration by Michele Brettmann, the Manager of Regulatory Affairs at Zoetis Inc. in the USA since 2011 (the Brettmann declaration). Annexed to the declaration are US regulatory approvals dated June 2005 and January 2006 for the container label, box label and package inserts for the VANGUARD® Plus 5 L4 vaccine.
Both parties have filed submissions in relation to Zoetis’s request and I am therefore satisfied that they have been notified and have made representations.
Explanation of the delay
Zoetis submitted that the delay in filing the evidence was due to Merial raising a new matter at the opposition hearing, in relying on a statement in para [057] of the opposed specification to establish the manner of manufacture ground of opposition. However, Merial’s particulars under sec. 18(1)(a) include that the invention lacks the necessary quality of inventiveness on the face of the specification, which broadly encompasses its submissions at the substantive opposition hearing. Therefore, I am not satisfied that the delay was caused by the opponent.
Relevantly, para [057] of the opposed specification states that the product label of the commercially prepared VANGUARD® Plus 5 L4 vaccine provided directions, among other things, for oral administration of a third vaccine dose. It was not in dispute that Zoetis did not appreciate the significance of para [057] until it was preparing for the substantive opposition hearing. Zoetis explained that having noticed the reference to oral administration between 27‑29 April 2015, it made enquiries regarding the containers, box labels and package inserts for the relevant vaccine, to confirm its method of administration at the relevant time. It had subsequently prepared the Brettmann declation dated 8 May 2015 that it filed at the substantive opposition hearing 3 days later.
I am satisfied that Zoetis has provided a satisfactory explanation of the delay.
The public interest
Zoetis submitted that the Brettmann declaration is directly relevant to establishing the factual correctness of the reference to oral administration in para [057], and the public interest lies in admitting it into the opposition proceedings where it can contribute to a more correct and just result in the substantive opposition proceedings.
Merial relied on criteria in Imperial Chemical Industries PLC v Mitsubishi Gas Chemical Co. Inc. [1994] APO 26 to submit, in effect, that the evidence is directed to showing para [057] is in error and, as such, the credibility of the evidence and the influence it might have on the outcome of the substantive opposition must be considered by reference to whether it establishes the error and thereby overcomes the manner of manufacture ground of opposition. However, this submission would appear to be at odds with Goninan IPR at 225-6, in which Justice Sackville explained that the evidence does not have to be scrutinised in the same way as would occur at a hearing on the merits. Rather, it is necessary to form view as to the issues addressed by the evidence and whether that evidence is likely to be important in the opposition proceedings.
In my view, deciding a ground of opposition on the basis of information in the specification that is factually incorrect would be contrary to the public interest in determining a serious opposition on its merits. Annex A to the Brettmann declaration provides images of the vaccine container label, box label and package insert for the relevant vaccine including information regarding its administration. Prima facie this evidence is relevant to the question of whether the statement in para [057] of the opposed specification referring to oral administration of the prior art vaccine is factually correct. As such I consider it likely to be important in the opposition proceedings.
I am satisfied that the nature and significance of the evidence supports allowing the further evidence.
The interests of the parties and the Patent Office
The interests of Zoetis lie in allowing the further evidence to counter Merial’s manner of manufacture ground of opposition. Merial submitted that if the evidence is admitted into the hearing, it would place the opponent at a forensic disadvantage in its access to relevant information to file responding evidence. As a consequence, Merial’s interests lie against granting leave for the evidence. The Patent Office has an interest in the orderly processing of oppositions.
The balance of considerations
The power to permit the filing of further evidence under reg. 5.10(4) is discretionary. In exercising this discretion I am guided by reg. 5.10(5)(c)(ii) which requires that the Commissioner not grant an application by a party to file further evidence unless reasonably satisfied that it is appropriate in all circumstances.
The interests of the parties are opposed and substantially offsetting. Zoetis has provided a satisfactory explanation of the delay and the public interest favours allowing the further evidence. On balance, I consider it appropriate to grant Zoetis’s application to file the Brettmann declaration as further evidence.
Conclusion
I am satisfied that it is appropriate in all the circumstances to permit Zoetis to file the Brettmann declaration as further evidence. I allow Merial two months from the date of this decision to file responding evidence.
It is apparent from the information on the Patent Office file that Merial has requested a notice under section 210 requiring the production of documents from Zoetis. This request is being separately dealt with by the office, but the time involved in prosecuting the request may impact on the time required to prepare responding evidence. Should Merial require more time to file its responding evidence, it may apply for an extension of time under reg. 5.10(2) as in force immediately before 15 April 2013.
For completeness, Zoetis’s responding submissions included a statutory declaration by S. Mannion. In the absence of any corresponding request by Zoetis for further evidence and grant of leave by the Commissioner, this latest declaration is not in evidence for the purposes of the substantive opposition.
Costs
The parties made no submissions on costs. It is normal practice before the Commissioner for costs to follow the event. In the present case, I can see no reason to depart from the normal practice. I award costs according to Schedule 8 against Merial Limited.
Barbara Akhurst
Delegate of the Commissioner of Patents
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