Amgen Inc. v ImmunoGen, Inc
[2011] APO 7
•3 February 2011
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Amgen Inc. v ImmunoGen, Inc. [2011] APO 07
Patent Applications 2003241580
Title:Anti-IGF-I Receptor Antibody
Patent Applicant: ImmunoGen, Inc.
Opponent: Amgen Inc.
Delegate: Dr S. K. Aggarwal
Decision Date: 3 February 2011
Submission Filed: 16 December, in Canberra
Catchwords: PATENTS – request under subregulation 5.10(2) – request for extension of time to serve evidence in support – no satisfactory explanation of delay – lack of diligence by the opponent – interests of parties offsetting – public interest in determining opposition on its merits marginally outweighs other considerations
Representation: Patent applicant: Griffith Hack, Brisbane
Opponent:Phillips Ormonde Fitzpatrick, Melbourne
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2003241580
Title:Anti-IGF-I Receptor Antibody
Patent Applicant: ImmunoGen, Inc.
Date of Decision: 3 February 2011
DECISION
I grant the extension of time to serve evidence in support in respect of the patent application until 19 February 2011.
I make no award of costs.
REASONS FOR DECISION
Background
Patent application 2003241580 directed to Anti-IGF-I Receptor Antibody was filed on 12 June 2003 by ImmunoGen, Inc. (“ImmunoGen”). The patent application proceeded to acceptance and was advertised accepted on 19 November 2009.
Amgen Inc. (“Amgen”) filed a notice of opposition to the patent application 2003241580 on 19 February 2010. A statement of grounds and particulars was served on 19 May 2010. The service of evidence in support was due on 19 August 2010.
On 19 August 2010, Amgen filed an application for extension of time to serve evidence in support from 19 August 2010 to 19 November 2010 which was granted on 1 September 2010.
On 18 November 2010, Amgen filed a further application for extension of time to serve evidence in support from 19 November 2010 to 19 February 2011 which was opposed by ImmunoGen.
On 2 December 2010, the Patent Office advised the parties that an oral hearing was not required and that the hearing will be based upon written submissions. Consequently, the parties were invited to file written submission in relation to the above matter to the Commissioner and to the other side within fourteen days from the date of advice. The parties were also given seven days (after the fourteen days time) to provide submission-in-response to the Commissioner and to the other side.
Amgen and ImmunoGen filed their written submissions on 16 December 2010 and submission-in-response on 23 December 2010 via their respective patent attorneys.
Application for Extension of Time
The circumstances in which, and the grounds upon which, the application for extension of time is made are stated to be as follows:
“Relevant citations and evidence required in support of this opposition are continuing to be collated and analyzed. In our previous extension period, we identified and contacted an expert to assist us in the preparation of the evidence. However, the selected expert has just indicated that they are unavailable to assist. We have had numerous discussions and email exchanges with one of our inventors, and with our Australian Attorney about the potential suitability of another expert. An alternative expert was immediately sought and discussion have been undertaken to assess their suitability and availability to act as an expert in the preparation of the evidence. After contact and discussion with this alternative expert, it was considered that their expertise in the area at the time may not be suitable although he is currently an expert in the field. This has required us to seek yet another expert. We have immediately identified another potential expert and we are currently in the process of determining their suitability. Further time is therefore required to contact the newly identified expert for discussions to determine their suitability and availability and for preparing and finalising the Evidence-In-Support.”
I will discuss the written submission of the parties as necessary in the reasons for my decision.
Law relating to extension of time
The time for serving evidence in support can be extended under subregulation 5.10(2) of the Patents Regulation 1991 which provides that:
(2)The Commissioner may extend the time within which the party may take a step prescribed in this Chapter (not being a step that is taken under regulation 5.3 or 5.3AA, paragraph 5.4(a), subparagraph 5.8(1)(a)(i) or regulation 5.9A):
(a) on the application of a party in the approved form; and
(b)on such reasonable terms (if any) as the Commissioner specifies; and
(b)after the party has served a copy of the application on the other party.
The above provision must be read in conjunction with subregulation 5.10(5) which provides that:
(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 or her 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, an extension of time or the serving of evidence is appropriate in all the circumstances.
Consequently, it is a prerequisite to any decision that the Commissioner must ensure that the other party has been notified, and that both parties have had the opportunity to make representations. In the present case the other party has been notified, and both parties have been given the opportunity to make representations.
An extension can only be granted if the Commissioner is reasonably satisfied that it is appropriate. In exercising this discretion, I am guided by the decisions of Burchett J in Ferocem Pty Ltd v Commissioner of Patents (1994) AIPC 91-057; 28 IPR 243, Sackville J in A Goninan & Co Ltd v Commissioner of Patents (1997) AIPC 91-330; 38 IPR 213 and Goldberg J in National Starch & Chemical Co v Commissioner of Patents (2001) AIPC 91-697, 50 IPR 398. These decisions establish that:
(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 party: 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 Patent Office. (Ferocem at AIPC 38,208; IPR 247, Goninan at AIPC 39, 436; IPR 222).
Explanation of the delay
Amgen cited their inability to engage an expert as the sole reason for the delay in completing the evidence in support. It was submitted that discussion between Amgen and their Australian attorneys relating to potential experts were conducted on 3 August 2010 and the name of a first potential expert was cited for further consideration to determine suitability. However, the first potential expert declined their invitation to assist in the opposition. A second potential expert was identified in late October 2010, who also declined to assist. Subsequently, a third potential expert was contacted by 30 November 2010, who despite indicating his initial availability, advised Amgen that his employer did not allow its employees to engage in legal proceedings. A fourth potential expert was contacted on 8 December 2010, who immediately advised Amgen of his unavailability. A fifth potential expert was also contacted on 8 December 2010, who has indicated his preliminary availability and is seeking clearance from his institute to assist in the opposition. It was stated that further efforts have been made to progress the opposition and conduct a teleconference on 15 December 2010 to begin the early stages for the preparation of evidence. Amgen further submitted that the proceedings were not unreasonably protected because at all times they were seeking experts and that they could not expedite the process due to reasons beyond their control.
ImmunoGen, on the other hand, termed Amgen’s statements regarding procurement of experts as mere conjecture and unsupported by any form of proof. They indicated that there was no explanation as to why the first, second and fourth experts declined to assist. ImmunoGen put the view that absent any explanation and supporting evidence from Amgen for each of the experts who declined, a possible explanation was that no expert was willing to agree to the allegation of unpatentability put by Amgen. ImmunoGen also submitted that there appeared to be a delay in identifying the first expert which was not explained.
I note that Amgen have had six months for engaging a suitable expert to assist them in preparing the evidence in support. I also note that it is not unusual for experts to decline participation in legal proceedings and for the parties to contact many experts for assistance which can be time consuming. However, it is clear from the evidence on file that Amgen did not even start looking for an expert until two weeks prior to the first deadline for serving evidence in support. Furthermore, they took over two months in contacting the second expert. In view of this, I cannot conclude that the time taken so far by Amgen in procuring a suitable expert is reasonable and that they have been diligent. In my opinion, Amgen have failed to provide a satisfactory explanation of the delay. However, it is noteworthy here that while a satisfactory explanation of delay is a relevant consideration, it is not a mandatory requirement for granting an extension of time.
The public interest
The public interest in opposition proceedings calls for a balance between said opposition being dealt with on its merits and expeditious processing. In order to determine the extent to which a correct and just determination of the opposition on its merits can be made, I need to assess the nature and the significance of the evidence that will be served.
Amgen submitted that objections relating to sufficiency and clarity raised in other jurisdictions were not fully considered in the examination of the opposed application in Australia. It was indicated that while the claims were limited in other jurisdictions, the claims that were granted in Australia are substantially the same as those submitted under Article 34 of the PCT during international phase, and that it was in the public interest to have the claims of the opposed application properly considered. Amgen further submitted that the prior art cited in the statement of grounds and particulars were not raised in the examination of the opposed application in Australia, and that the evidence will be served to discuss the prior art as outlined in the statement of grounds and particulars both for the purpose of lack of novelty and inventive step.
In reply, ImmnuGen argued that it was unreasonable to expect the claims to be identical to those granted elsewhere given that the laws of each jurisdiction are unique. They submitted that each of the prior art documents raised in the opposition was disclosed under the provisions of Section 45(3), and while the documents were not cited in an examination report, it is not correct to say that they were not considered in the examination. They submitted that Amgen’s allegations are unsupported by the law or fact and that the opposition to the application is not serious.
Amgen have not filed any evidence in support of their opposition so far and from the submissions on file, I can see that they intend to address the grounds of opposition with the assistance of an expert. Following a brief review of the case file, I note that the prior art documents raised by Amgen in the statement of grounds and particulars were considered in the examination. However, that does not diminish the seriousness of the opposition to the application because in assessing the relevance of earlier documents, the examiner does not have the benefit of knowing the precise level of common general knowledge in the field and the benefit of evidence from people working in the field.
Therefore, I am of the opinion that the evidence to be served is significant in that without it there will be no serious challenge to the patent application. Although a considerable period has passed since the filing of statement of grounds and particulars by Amgen, in my view the public interest in the present case that an opposition be determined on its merits overrides the consideration that the opposition be swift. Consequently, I conclude that the public interest favours extension of time.
The interests of the party seeking the exercise of discretion
Amgen have an interest in submitting their evidence in support. At this juncture, they have not filed any evidence in support, and their case will be clearly prejudiced if I were to refuse the extension. I conclude that Amgen’s interests lie in obtaining the extension of time.
The interests of the party opposing the exercise of discretion
ImmunoGen submitted that their interests lie in ensuring that the opposition to their application is determined with reasonable expedition. In my view, any unnecessary protraction of the opposition proceedings is to ImmunoGen’s disadvantage and their interests clearly lie in a timely determination of the validity or otherwise of the patent application and a clear indication of the monopoly grounds that they can not encroach upon. Therefore, I conclude that ImmunoGen’s interests lie in disallowing the extension of time.
Interests of the Patent Office
The interests of the Patent Office, although of no major significance, are in having the opposition matters resolved in a timely manner without undue delay. Considering that significant time has already elapsed since the statement of ground and particulars was served, the interests of the Patent Office favour disallowing further extension of time.
Balance of Considerations
The interests of Amgen and ImmunoGen are largely offsetting. The Public interest favours an extension of time. Had I been provided a satisfactory explanation of the delay, then the balance of consideration would have clearly favoured the extension. However, the absence of a satisfactory explanation of the delay leaves the considerations finely balanced. Overall, I am of the view that the public interest marginally outweighs the other considerations.
Conclusion
I conclude that it is appropriate to grant extension in all the circumstances.
I grant the extension of time to serve evidence in support in respect of the patent application until 19 February 2011.
Costs
Ordinarily in proceedings such as these, costs follow the event. In the present case, Amgen have not provided a satisfactory explanation of the delay and have not demonstrated that they have been diligent in preparing their evidence in support. While Amgen have been granted the extension they sought, they should not be rewarded by an award of costs in this situation. Furthermore, I consider that ImmunoGen is not entitled to an award of costs as they have been unsuccessful in opposing the extension.
Therefore, I make no award of costs.
Dr S. K. Aggarwal
Delegate of the Commissioner of Patents
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