Gilead Pharmasset LLC v AbbVie Inc
[2015] APO 27
•18 June 2015
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Gilead Pharmasset LLC v AbbVie Inc. [2015] APO 27
Patent Application: 2013201406, 2013201758, 2013201532, 2013201585
Title:Methods for treating HCV
Patent Applicant: AbbVie Inc.
Opponent: Gilead Pharmasset LLC
Delegate: Dr S.D. Barker
Decision Date: 18 June 2015
Hearing Date: Written submissions filed by the Opponent on 24 April 2015, 13 May 2015, and 19 May 2015
Written submission filed by Applicant on 13 May 2015, and 20 May 2015
Catchwords: PATENTS – request to join oppositions – consideration of efficiency and convenience – oppositions not joined – application for extension of time to file evidence in support – not yet apparent that evidence will not be able to be filed despite acting promptly and diligently – extension refused
Representation: Patent applicant: Griffith Hack
Opponent:FB Rice
Patent Application: 2013201406, 2013201758, 2013201532, 2013201585
Title:Methods for treating HCV
Patent Applicant: AbbVie Inc.
Date of Decision: 18 June 2015
DECISION
Oppositions to applications 2013201406, 2013201758, 2013201532, and 2013201585 are not joined.
The request for extension of time to file Evidence in Support for 2013201406, 2013201532, and 2013201585 is refused.
REASONS FOR DECISION
Background
Patent applications 2013201406, 2013201758, 2013201532, and 2013201585 are in the name of AbbVie Inc. (the Applicant). Gilead Pharmasset LLC (the Opponent) has opposed the grant of a patent in relation to all of the applications. On 24 April 2015 the Opponent requested that the Commissioner join the oppositions to applications numbers 2013201406, 2013201758, 2013201532, and 2013201585.
In the letter of 24 April 2015 the Opponent also requested that the time to file the Evidence in Support be extended for three of the oppositions (2013201406, 2013201532 and 2013201585) until the latest due date of Evidence in Support i.e. 27 August 2015 (being the due date in respect of application 2013201758).
On 6 May 2015 a Delegate advised the parties that the Commissioner was not satisfied that the oppositions should be joined, nor that an extension of time was appropriate.
On 13 May 2015 the Opponent provided further reasons in support of the requests to a) join the oppositions, and b) extend the time to file Evidence in Support.
On 15 May 2015 a Delegate advised that the Commissioner was still not satisfied that the oppositions should be joined, nor that an extension of time was appropriate.
On 18 May 2015 the Opponent requested a final determination be made on the joining of oppositions and extension of time.
The relevant dates of the four oppositions are provided in the table below, with italicised dates representing the dates at which evidence is due to be filed:
Application number
Earliest Priority date
Notice of opposition
Statement of Grounds and Particulars
Evidence in Support Due
2013201406 (parent)
21 October 2011
23 December 2014
23 March 2015
23 June 2015
2013201758 (child)
21 October 2011
27 February 2015
27 May 2015
27 August 2015
2013201532 (parent)
21 October 2011
23 December 2014
23 March 2015
23 June 2015
2013201585 (child)
21 October 2011
13 February 2015
13 May 2015
13 August 2015
Consequence of joining oppositions
The joining of oppositions would result in two consequences:
- Evidence in support filed in any one of the joined oppositions be treated as evidence filed in all of the joined oppositions.
- The time for filing any evidence in is kept aligned. Any action that delays one due date for evidence for one opposition (e.g. as a consequence of a stay or extension of time) applies to all joined oppositions.
The law
All of the oppositions were filed after 15 April 2013, so they are governed by Chapter 5 of the Patent Regulations as amended by the Intellectual Property Legislation (Raising the Bar) Regulation 2013 (No 1). Pursuant to regulation 5.22, the Commissioner has a broad power to give directions in relation to an opposition. This power extends to directions that oppositions be joined, given the clear reference to this in the Explanatory Statement (in relation to regulation 5.9):
“… where opposition proceedings are to be: joined; …”
In Ferocem Pty Limited v Commissioner of Patents [1994] FCA 981, 28 IPR 243 the Federal Court said that the exercise of a broad discretion (in that case the now superseded regulation 5.10) should be exercised according to the following principles:
a)A broad discretion cannot be reduced to insistence on imperative compliance with particular requirements;
b)The Commissioner must give proper, genuine and realistic consideration to all the relevant aspects of the case; and
c)The interests of the opponent, the applicant and any other parties are a relevant consideration.
Joining of oppositions has not been previously considered in any written decision of the Commissioner. Although oppositions are occasionally heard together or on consecutive days at the consent of the parties, this is different to joining the oppositions during the evidentiary stages of the oppositions.
I have drawn guidance from the approach adopted by the Federal Court (as I did in Mobay Corporation v Dow Chemical Co [1992] APO 25, 24 IPR 379). It is well established in the courts that causes of action can be joined. In the Federal Court, the joinder of causes of action is allowed under Rule 9.01.
An applicant may claim relief in the same proceeding in relation to as many causes of action as the applicant has against a respondent, whether or not the applicant is claiming the relief in the same capacity
This Rule is of broad application, but is subject to the power in Rule 9.06 to separate the matters:
A party may apply to the Court for an order that separate trials be held on the ground that a joinder of parties, or causes of action, in a proceeding may:
(a) complicate or delay the trial of the proceeding; or
(b) cause any other inconvenience.This provides an insight into when different actions should be joined:
the parties are the same;
joining would simplify or expedite the proceedings; and
joining would not otherwise cause inconvenience.These issues can be summarised as efficiency matters and convenience matters. I think the same should apply in matters before the Commissioner. In the context of an opposition, this necessarily directs attention to:
- the degree of overlap between the specifications and evidence in the matters
- efficiencies that are likely to arise in the preparation of evidence and the conduct of the hearing
- inconvenience that may arise to either of the parties or the Patent Office
Efficiency Matters
Overlap of scope of claims
The Opponent states at paragraph 26:
“In these submissions, Gilead refers to the combination of PSI-7977 and GS-5885 as the "HARVONI Combination". All of the Opposed Applications have claims that attempt to target the HARVONI Combination, such as:
(1) claims 1 to 24 of the '532 Application;
(2) claims 1 to 24 of the '406 Application (with ribavirin);
(3) claims 1 to 7 and 9 to 14 of the '585 Application; and
(4) claims 1 to 7 and 9 to 14 of the '758 Application (with ribavirin).”The Applicant states:
“There are very significant differences between the claims of the '532 and '406 applications as compared to the '585 and 758 applications, with the '532 and '406 applications containing claims that have no equivalent whatsoever in the '585 and '758 applications, as one example.”
Terminology used in claims:
DAA = direct acting antiviral agents
HCV genotype 1 = one of the three Hepatitis C virus genotypes
Ribavirin = a chemical used to stop viral RNA synthesis
Interferon = signalling proteins which increase cells’ antiviral defences
PSI-7977 = a particular HCV polymerase inhibitor
GS-5885= a particular HCV NS5A inhibitorA table of features of claims of each opposed application is given below:
Co-administered drug
Direct acting antiviral agents
Application number
Treatment of HCV genotype 1
ribavirin
interferon
HCV polymerase inhibitor
HCV NS5A inhibitor
general
PSI-7977
general
GS-5885
2013201406
Yes
Yes
No
No
Yes
Some claims
Some claims
2013201758
Yes
Yes
No
Yes
No
Yes
No
2013201532
Yes
No
No
No
Yes
Some claims
Some claims
2013201585
Yes
No
No
Yes
No
Yes
No
All applications are about administering a combination of direct acting activated agents which inhibit viral replication, optionally with ribavirin but excluding interferon. The difference between the applications is the use of general and specific HCV polymerase and NS5A inhibitors.
I am satisfied that there is significant commonality of subject matter and overlap of scope of claims of all four opposed applications.
Overlap of Evidence
The Opponent states in their letter of 13 May 2015:
“[O]ur client does not submit that evidence in all four oppositions would be identical. To the contrary it has explained why the breadth of the claims of the divisional applications raise their own complex and particular issues (for eg, see paragraph 39 of our client's submissions).”
It is clear that the Opponent intends to file separate evidence in each opposition, however also wants evidence of one opposition to be considered as evidence in all others.
As yet, it is unclear what evidence will be filed in the oppositions. The Statements of Grounds and Particulars in all oppositions are similar which suggests that the Opponent’s evidence will be similar. However, there are notable differences. For example, although the Statement of Grounds and Particulars for 2013201585 relies on many of the same documents as 2013201406 ground of novelty it additionally relies on G42, G43 and G44.
The Applicant’s evidence will be in response to the Opponent’s evidence. Thus the divergence in the Opponent’s evidence between oppositions will dictate the divergence in the Applicant’s evidence between oppositions.
Although I expect there will be differences in the evidence provided by the parties, I am satisfied that there will be significant commonality and overlap between evidence in the oppositions.
Although finely balanced, I am satisfied that there is sufficient overlap between the claims and the evidence in the oppositions such that they could be joined.
Efficiency for the Office
Joining the oppositions will simplify and reduce the amount of administration and considerations that arise in the evidentiary stages of the oppositions. For example, if any requests for directions or extensions of time are made, then dealing with this collectively rather than on four separate occasions will reduce the time and effort processing and considering the requests. However, I consider this a minor consideration.
Convenience
The Opponent is in favour whereas the Applicant is against the proposed joining of the oppositions. They point to the fact that the four oppositions could get out of alignment, and that ultimately four different hearings might be required.
The Applicant provides several reasons as to why they are against joining the oppositions:
“It would be improper for the patent applicant, in relation to one of its patent applications, to have to search across three other opposition files to identify which piece of evidence filed on another opposition is intended to be applied against the patent application under consideration.”
“It is possible that for reasons not presently foreseen, necessary delay is caused to the progress of the opposition to one case. The patent applicant is opposed to any case management regime whereby necessary delay in respect of one case results in corresponding but unnecessary delay in respect of all other cases.”
I believe there is the potential for inconvenience to the Applicant that more than offsets the interest of the Opponent. The inconvenience that the Opponent refers to can be managed when the evidence stages for the oppositions have been completed. The oppositions can be set for hearings on consecutive days by a single hearing officer even if the oppositions have not been joined (if that is the sensible course of action at the time). In other words, joining the oppositions is not the only way to achieve a sensible end to the process of the oppositions.
Conclusion on joining oppositions
I have found that there is overlap in the specifications (and, in particular, the claims) and of the expected evidence, and thus it could be more efficient that the oppositions be joined. I have also found that the interests of Opponent and Applicant are opposed, but they are not of equal weight. There is the potential for inconvenience to the Applicant which outweighs convenience to the Opponent, and this argues against joining the oppositions.
I do not believe that I should join the oppositions unless the balance of considerations lies in favour of doing so. In the present case the considerations are finely balanced, and I am not persuaded that the balance lies in favour joining the oppositions. Consequently, I am not satisfied that the oppositions should be joined and I will refuse this request.
Extension of time
The principles that apply to an extension of time to file evidence are covered in many decisions of the Commissioner, and I do not need to repeat them here. I will simply focus on the points made by the Opponent.
Reasonable efforts and prompt and diligent action
The Opponent states at paragraphs 66 and 67:
“Gilead has already engaged several independent experts to provide evidence in the Oppositions. In respect of all but one of the engaged experts, Gilead's Australian legal team has already conducted at least 3 and as many as 6 interviews of each expert. Further details of the steps taken by Gilead in preparing its evidence, and the particular difficulties encountered in doing so, are set out in the O'Brien Declaration.
The existence of the foreign disputes between Gilead and AbbVie and the high value of foreign pharmaceutical markets such as the USA, requires Gilead's legal team in Australia to be cognisant of the impact elsewhere of actions taken in Australia. Dealing with the international dimensions of this dispute entails an additional layer of complexity to the preparation of evidence which means that that task is likely to take longer than it would in case that does not have such international considerations.”
The O’Brien declaration states at paragraphs 62 and 63:
“To date, each of these experts has allotted us approximately one hour every 2 to 3 weeks for us to interview that expert about issues arising in respect of the Opposed Applications. Sometimes an expert has given us more than one hour every 2 to 3 weeks but that has happened about 4 times in total (ie, across all of these experts).
In addition to the usual limited availability to which I refer in paragraph 62, there have been periods of time in which Gilead's Australian legal team has had particular difficulty in obtaining time to interview these experts, including:
(1) in February and March 2015, during which period a number of the experts informed us that they were unavailable because they were involved in writing applications for research grants;
(2) a number of the experts have taken extended periods of leave for research or long service and have informed us that they were unavailable to be interviewed, or their availability was more limited, during that period; and
(3) at least three of the experts are unavailable for between 1 to 3 weeks due to their attendance at, or organisation of, professional conferences.”
The Delegate stated in the Office letter of 6 May 2015:
“Although this may go some way in establishing that the Opponent has been prompt and diligent at all times to ensure the evidence is filed within the period, I am not satisfied that it demonstrates the Opponent is unable to do so. Given that there is still 6 weeks for filing Evidence in Support for two of the oppositions (2013201406 and 2013201532) and more than 3 months for the other two oppositions (2013201758 and 2013201585) there appears prima facie to be enough time to adapt to unexpected changes in the experts’ availability.”
The Opponent further states in the letter of 13 May 2015:
“The reason provided in your letter in support of your conclusion regarding reg. 5.9(2)(a) is that the time left to run on the evidentiary periods "appears prima facie to be enough time to adapt to unexpected changes in the expert's availability". With respect, that misunderstands the position of our client. The problem faced by our client is not its ability to adapt to unexpected changes in expert availability, it is precisely the opposite – Ms O’Brien's statutory declaration sets out what she (a practitioner of more than 25 years' experience) expects will happen given the limited availability of experts to date and the other matters described in her declaration.”
The Delegate states in the Office letter of 15 May 2015:
“I acknowledge that Ms O’Brien expects that the Opponent will be unable to file the evidence in the prescribed period. However, Reg 5.9(2)(a)(ii) requires that an Opponent is unable to file the evidence, in other words it is impossible the evidence will be filed. Given the amount of time remaining to file the evidence for the oppositions, and without a clear statement as to why it would be impossible, I am not satisfied that the Opponent is unable to file the evidence in the prescribed period. I note that my assessment at this stage does not preclude the Opponent from making another request for an extension of time when more information about the Opponent’s actions in preparation of evidence is available.”
I agree with the Delegate's reasoning. There is simply not enough information at this stage to establish that the Opponent will not be able to file the Evidence in Support despite acting promptly and diligently in the three earliest oppositions.
Exceptional circumstances
The Opponent states at paragraphs 52 and 53 of their submissions:
“There are unusual features of these Oppositions, other than the proposed joinder of them, which render them exceptional, including:
(1) the fact that there are 4 Opposed Applications with overlapping claims, most of which attempt to target HARVONI and not AbbVie's VIEKIRA PAK treatment;
(2) the complexity of the legal and technological issues, the volume of material to be considered and the nature of the evidence likely to be required;
(3) the significant commonality in legal and factual issues that arise; and
(4) the nature and significance of the Oppositions.
This combination of circumstances is not encountered in a typical patent opposition.”
In TRED Design Pty Ltd v Julie-Anne McCarthy and Bradley McCarthy [2013] APO 57 (the TRED decision) I stated that exceptional circumstances were:
"matters outside the normal evidentiary process, and outside the control of the party, where it would be unreasonable to insist on a party filing their evidence"
Addressing each of the Opponent's four points, I consider none of them represent exceptional circumstances.
That there are four opposed applications with overlapping claims is not outside the normal evidentiary process. However, as I said in Mineral Technologies Pty Ltd v Orekinetics Pty Ltd [2014] APO 63, it might influence the time available to prepare evidence (and thus be relevant in considering whether a person has been prompt and diligent).
The legal and technological issues may indeed be complicated, however at this stage there is not enough information to establish that they can be considered exceptional according to the approach in the TRED decision.
Similarly, the fact that there is commonality in legal and factual issues between oppositions is not considered exceptional.
The “nature and significance” of the oppositions appears to be referring to the significant revenues currently being generated from the sale of pharmaceuticals mentioned in the Opponent’s request (HARVONI and VIEKIRA PAK for the Opponent and Applicant respectively). Large revenues or potentially lucrative patent rights do not constitute a circumstance where it would be unreasonable to insist on a party filing their evidence in the time specified in the Regulations.
Conclusion
I find that the Opponent has not made out a sufficient case, and consequently an extension of time to file evidence in support is refused.
The Opponent may be able to obtain an extension of time closer to the due dates, if needed.
Dr S.D. Barker
Delegate of the Commissioner of Patents
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