Merial Limited v Zoetis Services LLC

Case •

[2018] APO 30

•

11 May 2018

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Merial Limited v Zoetis Services LLC [2018] APO 30

Patent Application:                2007343130

Title:Methods of vaccine administration

Patent Applicant:                   Zoetis Services LLC

Opponent:  Merial Limited

Delegate:  Dr S. J. Smith

Decision Date:  11 May 2018

Hearing Date:  Written submissions completed 1 February 2018

Catchwords:  PATENTS – section 59 – final determination – amendments do not overcome deficiencies identified in previous decisions – application refused – costs awarded against applicant

Representation:  Patent attorney for the applicant: Allens Patent and Trade Mark Attorneys

Patent attorney for the opponent: FB Rice

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                2007343130

Title:Methods of vaccine administration

Patent Applicant:                   Zoetis Services LLC

Date of Decision:                   11 May 2018

DECISION

The amendments to the specification do not overcome the deficiencies identified in the earlier decisions; claims 1-18 lack inventive step. 

I refuse the application.

I award costs according to Schedule 8 against Zoetis Services LLC.

REASONS FOR DECISION

Background

  1. Patent application 2007343130 in the name of Pfizer Products Inc. was advertised as accepted on 20 December 2012.  Changes of ownership to Zoetis P LLC then Zoetis Services LLC (collectively Zoetis) were published on 27 June 2013 and 16 July 2015, respectively.  Merial Limited (Merial) opposed the grant of the patent. The matter was heard on 9 May 2015 and 17 February 2016 and on 7 March 2016 a decision that the opposition succeeded on the ground of inventive step was reported as [2016] APO 12 (the first decision). 

  2. In the first decision Zoetis was allowed a period of time in which to propose amendments to the claims, and filed amendments under s 104 (the first amendments) which were allowed unopposed on 15 September 2016. Merial requested to be heard before the final determination of the s 59 opposition. The matter was heard on 24 February 2017 and on 5 May 2017 a decision that the amendments did not overcome the deficiencies identified in the previous decision was reported as [2017] APO 20 (the second decision).

  3. Zoetis was allowed a further period of time in which to propose amendments to the claims, and filed amendments under s 104 (the second amendments) which were allowed unopposed on 26 October 2017.  Merial again requested to be heard before the final determination of the s 59 opposition and a hearing by written submissions was completed on 1 February 2018.

    The law

  4. It is well established that a decision of a delegate in opposition proceedings is final and determines all the issues arising on the notice of opposition so far as they are capable of determination at the time.[1]  The Deputy Commissioner recently considered the law on final determinations, and concluded that:

    “… I cannot revisit any findings that were part of the original decision, but issues that were not considered in the original decision can be decided (for the first time) in a final determination.  However, the decision in the final determination should be consistent with any relevant findings in the original decision.”[2]

    [1] R v Smith; Ex parte Mole Engineering Pty Ltd [1981] HCA 25; (1981) 147 CLR 340 at 348-349.

    [2] Novozymes A/S v DSM IP Assets B.V. [2018] APO 2 at [21].

  5. In a final determination of an opposition the only issues to be considered are whether the amendments overcome the deficiencies identified in the earlier decisions, and whether the amendments introduce any new deficiencies. 

  6. Zoetis submitted that the Commissioner would need to be satisfied that it is clear or practically certain that the presently claimed invention lacks inventive step for the opposition to be successful at this stage[3] and the heavy onus on an opponent in an opposition is well established.[4]  However, I agree with the Deputy Commissioner’s observation in CSR Building Products Limited v United States Gypsum Company[5] that in a final determination that onus must be understood in the context of the earlier decision, which creates a persuasive onus on the applicant to show that the grounds of opposition have been overcome. 

    [3] Zoetis’ written submissions filed 25 January 2018 at [23].

    [4] F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283; 50 IPR 305 at 319, [67]; Commissioner of Patents v Sherman [2008] FCAFC 182; 79 IPR 426 at [18].

    [5] [2017] APO 15 at [12].

    Procedural fairness

  7. The present matter is somewhat unusual, as there has already been a “final” determination of the opposition, following which Zoetis was allowed a further opportunity to amend.  Before considering the matter at hand, I will address submissions made by the parties in relation to the procedural fairness of finally determining the opposition for a second time.

  8. In the second decision the delegate concluded that:

    “…Zoetis has made a genuine attempt to overcome the deficiencies identified in the earlier decision, and there may be subject matter disclosed in the specification that would overcome the defects identified in this and the earlier decision.  Therefore, I will allow Zoetis a further short period in which to file further amendments to the claims.”[6]

    [6] The second decision at [30].

  9. Merial submitted that an applicant should not be allowed multiple opportunities to amend the claims and “[i]f the applicant cannot rectify the deficiencies found by the Delegate in one concerted attempt, it should not be permitted further attempts to do so.”[7]  Merial also submitted that it had been disadvantaged by the introduction of features into the claims that were not present in the claims as accepted and that have not been addressed in the evidence, concluding that “[o]n procedural fairness alone the proposed amendments should be rejected.”[8]

    [7] Merial’s written submissions filed 9 January 2018 at [28].

    [8] Merial’s written submissions filed 9 January 2018 at [31].

  10. Zoetis submitted that a “second final determination is consistent with the application of Procedural Fairness.”[9]

    [9] Zoetis’ written submissions filed 25 January 2018 at [21].

  11. While not common it is certainly not unheard of for an applicant to be provided with a further opportunity to amend after a final determination, and the provision of such an opportunity has typically been based on the nature of the amendments made by the applicant in the first instance and the prospect of amendments being made to overcome the outstanding grounds of opposition.[10]  Those factors were clearly considered by the delegate in deciding to provide Zoetis with a further opportunity to amend.  That opportunity having been provided, I agree with Zoetis that conducting a second final determination hearing is in keeping with the principles of procedural fairness.  I also note that the inclusion of new features into the claims, provided that the amendment is allowable, does not provide any basis for the refusal of amendments.  As submitted by Zoetis, the issue for determination is whether the claims, including any new features, overcome the deficiencies identified in the earlier decisions.[11]

    [10] See, for example, ExxonMobil Upstream Research Company v Shell Internationale Research Maatschappij B.V. [2016] APO 51; ExxonMobil Chemical Patents Inc v Lubrizol Corporation [2003] APO 52; Ericsson Australia Pty Ltd v Aussie L.L.C. Pty Ltd [2004] APO 13; W. Neudorff GmbH KG v Colin Leslie Young [2005] APO 23.

    [11] Zoetis’ written submissions filed 25 January 2018 at [20].

    The amendments

  12. The amended claims consist of two independent claims and 16 appended claims.  Independent claims 1 and 2 and appended claim 3, marked up to indicate the changes relative to the claims introduced in the first amendments, are reproduced below:

    1. A method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of a vaccine;         
    wherein the vaccine comprises viral antigens and a bacterin;
    wherein the viral antigens comprise 1) canine distemper (CD) virus, 2) canine adenovirus type 2 (CAV-2), 3) canine parainfluenza (CPI) virus, and 4) canine parvovirus (CPV);
    wherein the bacterin comprises one or more bacteria selected from Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, L. bratislava, and Bordetella bronchiseptica;
    wherein the vaccine is administered orally in a first dose, orally in a second dose, orally in a third dose, and orally in one or more annual doses;
    wherein the second dose is administered from 7 to 35 days, inclusive, after the first dose; and
    wherein the third dose is administered from 7 to 35 days, inclusive, after the second dose;
    wherein the viral antigens are present in the following ranges of amounts: for CD virus, about 102 TCID50 to about 108 TCID50, inclusive; for CAV-2, about 102 TCID50 to about 108 TCID50, inclusive; for CPV, about 103 TCID50 to about 1010 TCID50, inclusive; for CPI virus, about 103 TCID50 to about 1010 TCID50, inclusive; and
    wherein the dog has an anti-CDV antibody titre of at least 1:3499 and an anti-CPV antibody titre of at least 1:5613 at 28 days after the first dose.

    2. A method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of a vaccine;

    wherein the vaccine comprises viral antigens and a bacterin;

    wherein the viral antigens comprise 1) canine distemper (CD) virus, 2) canine adenovirus type 2 (CAV-2, 3) canine parainfluenza (CPI) virus, and 4) canine parvovirus (CPV);
    wherein the bacterin comprises one or more bacteria selected from Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, L. bratislava, and Bordetella bronchiseptica;
    wherein the vaccine is administered subcutaneously in a first dose, orally or subcutaneously in a second dose, orally in a third dose, and orally in one or more annual doses;
    wherein the second dose is administered from 7 to 35 days, inclusive, after the first dose; and
    wherein the third dose is administered from 7 to 35 days, inclusive, after the second dose;
    wherein the viral antigens are present in the following ranges of amounts: for CD virus, about 102 TCID50 to about 108 TCID50, inclusive; for CAV-2, about 102 TCID50 to about 108 TCID50, inclusive; for CPV, about 103 TCID50 to about 1010 TCID50, inclusive; for CPI virus, about 103 TCID50 to about 1010 TCID50, inclusive; and

    wherein the dog has an anti-CDV antibody titre of at least 1:3499 and an anti-CPV

    antibody titre of at least 1:5613 at 28 days after the first dose.

    3. The method of claim 1 or 2, wherein the vaccine further comprises canine coronavirus (CCV) present in an amount of at least about 100 relative units (RU) per dose.

  13. The claims considered in the second decision and the claims presently under consideration in their entirety are annexed to this decision as Annexes A and B, respectively.

  14. The amounts of viral antigens which were introduced into claims 1 and 2 in the second amendments were present in claim 8 of the claims considered in the second decision.  Claim 8 of the previous set of claims also recited a CCV viral antigen amount of at least about 100 relative units per dose.  The specific anti-CDV and anti-CPV antibody titres at 28 days after the first dose of the vaccine are newly introduced into the claim set, and the values recited in the claims are found in Example 1 of the specification. 

  15. In Example 1 a vaccine was administered subcutaneously in a first dose, then orally in second and third doses.  Tables 1 and 2 of the specification are reproduced below and summarise the details of the experimental design and vaccine (Investigational Veterinary Product).

  16. At 28 days after the first vaccination, CDV-specific antibodies peaked, with mean titres of 1:3499 and 1:3668 for the T02 and T03 groups, respectively.  Dogs in the T03 group exhibited a mean titre of 1:5613 for CPV-specific antibodies on day 28.

    Inventive step

  17. In the first decision the delegate found that all claims lacked inventive step in light of WO 2006/038115 (Pfizer Products, Inc.) 13 April 2006 (WO’115) and her finding is conveniently summarised at [119]-[120]:

    “I am satisfied that before the priority date, in all the circumstances (including knowledge of the problem and the disclosure of WO’115), the person skilled in the art or team would directly be led as a matter of course to try treating a dog for canine diseases by administering the core canine vaccine antigens or combinations of antigens identified in WO’115, in 2-3 doses followed by one or more annual boosters, all orally or in a combination of one or two subcutaneous doses followed by oral doses, with a reasonable expectation that it might well provide an alternative and more convenient administration regimen.

    In its submissions Merial provided a table identifying the WO’115 disclosure relevant to the claims. Relying on that information I am satisfied that WO’115 discloses the additional features of opposed claims 3-20, such that in seeking to solve the problem using the WO’115 disclosure, the person skilled in the art would directly be led as a matter of course to try the additional subject matter encompassed by these claims with a reasonable expectation that it might well solve the problem.”

  18. In the second decision the delegate found all the claims under consideration in that decision also lacked inventive step in light of WO’115, stating at [23]-[27]:

    “The antigen combinations taught by WO’115 encompass those defined in the amended claims (that is, page 13 of WO’115 indicates that CV5 denotes a combination of CD, CAV-2, CPI, CPV and CCV antigens).  This is consistent with my finding that accepted claims 4-6 lack inventive step in light of this document.  Having decided that a skilled addressee would administer the combinations of antigens identified in WO’115 in 2-3 doses, it is a logical conclusion that they would do so in the manner instructed by WO’115.

    … the dosing intervals disclosed in WO’115 accord with what Mr Bevan and Dr Holloway understand to be usual in the art in relation to subcutaneous dosing intervals.  That is, Mr Bevan indicated that he would routinely vaccinate puppies at 6, 10 and 12-13 weeks (as per manufacturer’s instructions), and Dr Holloway at 6-8, 10-12 and 14-16 weeks (Bevan#1 at [9]; Holloway#1 at [4(p)], [4](u)]).  Additionally, Mr Bevan’s evidence in relation to a single component vaccine, which I relied on in the earlier decision, is that the dosing intervals for injectable vaccines could be adopted for oral vaccinations (Bevan#2 at [17]). …

    Insofar as Mr Bevan considers that WO’115 discloses multiple dosing I consider that it is reasonable to infer that he is referring to multiple dosing as disclosed therein, including the disclosed intervals, and expects that such dosing intervals would succeed in the context of oral vaccination with the antigens disclosed in the present application.  Therefore, the available evidence is consistent with the logical extrapolation of the earlier decision to follow the express disclosure of WO’115. …

    While Zoetis raised the question of whether there might be time-dependent interactions associated with oral administration of combination vaccines, they did not point to any evidence of that prospect engendering a lack of expectation of success in a skilled person.  WO’115 expressly discloses dosing schedules in accordance with those defined in the amended claims, and in the absence of evidence, I am not persuaded that any potential there may be for unwanted interactions during oral administration is such that it would prevent the skilled addressee having a reasonable expectation of success in trying the dosing schedule disclosed.  It follows that I do not consider that amended claims 1 and 2 have overcome the inventive step finding in the earlier decision.

    The features of appended claims 3-19 substantially reflect those of the claims as accepted, and therefore as previously identified in the earlier decision at [120], they recite features which are disclosed by WO’115, such that in seeking to solve the problem using the WO’115 disclosure, the person skilled in the art would be directly led as a matter of course to try the additional subject matter encompassed by these claims with a reasonable expectation that it might well solve the problem.”

  19. Merial submitted that the feature of the viral antigen amounts contained in previous claim 8 have already been found to lack inventive step and therefore add nothing inventive to the independent claims considered in the second decision.  I agree with Merial that it is clear that the delegate in the second decision found the method of previous claims 1 and 2 using the presently defined combination of antigens in the presently defined amounts lacked an inventive step. 

  20. Zoetis submitted that it is the combination of the features of the present claims that must be considered, stating that it is:

    “both the features present prior to amendment and the features added by the Amendment which the Opponent must demonstrate does not have an inventive step.  What is required is a rigorous analysis of the amended claims against the findings of the Opposition Decision and the other evidence in the proceeding.”[12]

    [12] Zoetis’ written submissions filed 25 January 2018 at [26].

  21. In particular, Zoetis emphasised the significance of the antibody titres, submitting (references relate to the first decision):

    “The Delegate’s finding at [118] which suggests that administration orally is a matter of trial and error does not establish that any trial and error of the combination of all four antigens in the amounts specified in the present claims, dosed orally in the particular regimen and achieving the antibody titres of the present claims, would be conducted with the requisite expectation of success.

    The Delegate’s finding at [119] refers to an expectation of a provision of an “alternative and more convenient administration regimen”, but it says nothing about whether the combination of all four vaccines, in the amounts specified in the present claims, is likely to be therapeutically effective against all four diseases simultaneously when given in the specific dosing regimen in amended claim 1, which specifies dosing intervals and requires specific antibody titres.  The alternative and more convenient administration regimen is not to the point unless there is an expectation that [the] specific combination given (in the amounts specified) according to the specific dosing regimen will result in the antibody titres recited in the claims and be simultaneously effective against each of the diseases mentioned.”[13]

    [13] Zoetis’ written submissions filed 25 January 2018 at [38].

  22. I agree with Zoetis that it is the presently amended claims that must be considered and that analysis of the claims is to be undertaken in the context of the findings already made by the delegate in the first and second decisions.  In the second decision the delegate found that WO’115 discloses the claimed combinations of antigens[14] and that oral administration or a combination of oral and subcutaneous administration of the claimed antigen combinations in the amounts and time intervals defined in the present claims lacks inventive step.  I note that in the second decision the delegate considered the meaning of “therapeutically effective amount” in the context of the claims under consideration at that time, concluding that Zoetis’ construction, requiring the vaccine to be effective against all the diseases associated with the antigens and bacterins specified in the claims, should be adopted.[15]  It was with this understanding that the claims were found to lack inventive step and I cannot revisit this finding.  Accordingly, when the findings of the first decision are considered together with those of the second decision, Zoetis’ submissions to the effect that the first decision does not adequately address the present claims in relation to the requisite expectation of therapeutic efficacy against all four diseases (and the fifth, CCV as defined in claim 3) are not persuasive. 

    [14] Second decision at [21]-[23].

    [15] Second decision at [8]-[9].

  1. Zoetis’s submissions are predicated on a view that, for the claims to be obvious, a skilled person would have to have an expectation of achieving the specific claimed antibody titres at 28 days.[16]  Merial appears to have accepted this proposition.[17]  However, in the first decision the delegate formulated the problem as “the provision of an alternative and more convenient administration regimen for canine vaccines.”[18]  The same problem remained apposite in the second decision[19] and I am satisfied that this remains a reasonable characterisation of the problem addressed by the specification.  I can see no basis for concluding that the problem addressed by the specification includes the feature of specific antibody titres – while it is apparent that the specification identifies antibody titre measurement as a means for assessing immunogenic response[20] and there is a requirement for therapeutic efficacy, the specification is silent as to any particular desired antibody titre level.  Accordingly, while this is a feature of the claim, I do not agree with Zoetis that this is a feature that must form part of the expected solution to the problem when considering the Cripps question.

    [16] Zoetis’ written submissions filed 25 January 2018 at [29], [35]-[39].

    [17] Merial’s written submissions filed 1 February 2018 at [6].

    [18] First decision at [79].

    [19] Second decision at [19].

    [20] Page 5, [024]; page 7, [034].

  2. What I must determine is whether what is now claimed, that is, the claimed regimens limited by the defined resulting antibody titres, lacks inventive step.  That is, whether a skilled worker would directly be led as a matter of course to try the regimen defined in the present claims (including the claimed antigen doses and resulting in the claimed antibody titres) with a reasonable expectation of arriving at an alternative and more convenient administration regimen for a combination canine vaccine.

    Parametritis

  3. Merial submitted that the inclusion of the antibody titre parameters into claims 1 and 2 represents parametritis and cannot confer inventive step.  Parametritis was discussed by Laddie J in Raychem Corp.’s Patents[21]:

    “This is the practice of seeking to repatent the prior art by limiting claims by reference to a series of parameters which were not mentioned in the prior art. Sometimes it includes reference to parameters measured on test equipment which did not exist at the time of the prior art. The attraction of this to a patentee is that it may be impossible to prove now that the prior art inevitably exhibited the parameters and therefore it is impossible for an opponent to prove anticipation. Even if that is what has happened here, it does not alter the task of the court. It must decide whether the opponent has proved anticipation or some other statutory ground of invalidity.  Parametritis may make the court’s task more difficult, but at the end of the day the test of invalidity must be the same, whatever the form of the claims.”

    [21] [1998] RPC 31 at 37.

  4. Laddie J then stated in relation to the parameter S/D volume ratio in question:

    “It is essentially arbitrary and has little technical significance.  The selection of a group of compositions by reference to such a parameter does not involve any inventive step.  Although it may not be obvious, in the common use of that word, to limit a claim by reference to this particular meaningless and arbitrary parameter, that has nothing to do with patentability.  Patents are not given for skill in inventing technically meaningless parameters.”[22]

    [22] [1998] RPC 31 at 46-47.

  5. I agree with the conclusion of the delegate in Sandoz Pty Ltdv Euroceltique S.A.[23] that the critical question to be considered is whether the parameter chosen achieves a technical effect or whether it is an arbitrary convenience and this is the basis on which the parties have advanced their arguments.

    [23] [2009] APO 21 at [112].

  6. Merial submitted that the antibody titres defined in the claims are arbitrarily chosen parameters.[24]  Generally in support of the position that the antibody titre parameters are arbitrary choices, Merial submitted that:

    i. the titres were not achieved by the dosing regimen of claim 1 – Example 1 includes a subcutaneous first dose, whereas the regimen of claim 1 involves an oral first dose;[25] and

    [24] Merial’s written submissions filed 9 January 2018 at [71].

    [25] Merial’s written submissions filed 9 January 2018 at [62]-[64].

    [26] Merial’s written submissions filed 9 January 2018 at [65]-[71].

    ii. the specification does not suggest that the specific antibody titres are part of the invention.[26]

  7. In support of the asserted unimportance of the antibody titre parameters, Merial also submitted that there is no evidence that if the specified titre levels are not reached the animal will suffer the disease when infected, stating that that can only be ascertained by challenge trials, which are not described in the specification.[27]

    [27] Merial’s written submissions filed 9 January 2018 at [68].

  8. In response, Zoetis submitted that the specification clearly discloses the antibody titres in Example 1 and that the technical effect of the parameter is that a dog is effectively treated by the claimed method.[28]  Zoetis refuted Merial’s submission in relation to challenge trials, stating that “there is a well-established link between the generation of antibodies in response to administration of an antigen and protective immunity.”[29]  In support of this, Zoetis referred to Dr Holloway’s statement that “serology is more than adequate for proof of concept.”[30]

    [28] Zoetis’ written submissions filed 25 January 2018 at [48]-[52].

    [29] Zoetis’ written submissions filed 25 January 2018 at [33].

    [30] Holloway #2 at [4(ee)].

  9. The specification identifies antibody titres as a means of evaluating the immunogenic response of an animal to an immunogenic composition and therefore relevant to identification of the therapeutically effect amount of an antigen.[31]   Further, the specification states that “animals are considered protected from disease when they have antibody titers greater than or equal to 1:16 for CAV-1, 1:32 for CDV and 1:80 for CPV.”[32]  Dr Holloway indicated that the antibody titres in the specification provide an indication that vaccination has been effective[33] and Mr Bevan stated that the antibody titres identified in Example 1 and now defined in the claims are “as one would expect from an initial subcutaneous administration of live antigens to immunologically competent susceptible dogs”.[34]  While I accept that challenge trials are necessary for product registration,[35] I am satisfied that antibody titres are not an arbitrary or technically meaningless parameter, but are of technical significance in the context of this invention given that they provide an indication of vaccination efficacy. 

    Desideratum/result to be achieved

    [31] Page 7, [034].

    [32] Pages 14-15, [061].

    [33] Holloway #2 at [4(bb)], [4(ee)].

    [34] Bevan #1 at [23].

    [35] Holloway #2 at [4(ee)].

  10. Merial also submitted that the antibody titres claimed are the inevitable result of administering the vaccine according to a method the steps of which have been found to lack inventive step and represent mere desideratum.[36]  While ‘inevitable result’ is language typically associated with novelty rather than inventive step, I agree with Merial’s general proposition that if a method has been found to lack inventive step then defining an outcome of that method does not in itself necessarily render the method inventive, notwithstanding that the outcome has technical significance.   

    [36] Merial’s written submissions filed 9 January 2018 at [72].

  11. Zoetis submitted that the antibody titres defined in the present claims do not represent mere desiderata, and, referring to the decision in CCOM Pty Ltd v Jiejing Pty Ltd[37], that in any event desiderata is not an independent ground of objection where all other objections have been overcome.[38]

    [37] [1994] FCA 1168; 28 IPR 481 at [125]-[126].

    [38] Zoetis’ written submissions filed 25 January 2018 at [54]-[56].

  12. It is apparent from the specification that administration of CDV, CAV-2, CPV and CPI antigens at doses within the scope of present claim 2 in a first subcutaneous dose followed by oral doses at three weeks and six weeks does, in fact, give rise to antibody titres as defined in claim 1 (i.e. Example 1 and Figures 1 and 2 illustrate that this result is achieved).  Given that this example relates to a regimen involving subcutaneous vaccination followed by oral vaccination, there is no direct evidence that this is the case for the regimen defined by claim 1 (and appended claims), which define an all oral dosing regimen.  However, for the claims to have any scope at least some vaccination regimens within the scope of each of the claims must give rise to the defined result and therefore I will proceed on the basis that this is the case.  The alternative would appear to be that there are section 40 deficiencies in the claims which arise as a result of the amendment.

  13. It is important to understand what has been decided in the first and second decisions, since as discussed previously, I cannot revisit any findings and my decision must be consistent with relevant findings in the earlier decisions.  The delegate found that regimens including administration of the amounts of antigens defined in present claims 1 and 2 lack inventive step in the earlier decisions, particularly insofar as claim 8 was found to lack inventive step in the second decision.  However, a finding that a claim lacks inventive step does not necessarily mean that the entirety of the subject matter defined by that claim lacks inventive step and so I need to consider what subject matter was found to be lacking in inventive step in the earlier decisions.  That is, was the finding in the second decision that the entire scope of claim 8 lacks inventive step and is what is now claimed merely a subset of subject matter already found to lack inventive step?

  14. In the first decision the delegate concluded, referring to WO’115, that “it is reasonable to expect that [the person skilled in the art] would consider not only the preferred embodiments in a prior disclosure, but also any other options that could be applied to solve the problem.”[39]  Consistent with that finding, the delegate relied on information provided by Merial in its submissions identifying the passages of WO’115 relevant to the defined features when concluding that each of the dependent claims lacked inventive step.[40]  Accordingly, I understand the delegate’s finding in the first decision to be that a person skilled in the art would directly be led as a matter of course to try any options disclosed in WO’115 with a reasonable expectation that they might solve the problem, which is consistent with the delegate’s comments in the second decision.[41]  I consider that the reasonable understanding of the earlier decisions is that the regimens according to the claims which utilise the doses disclosed in WO’115 lack inventive step in light of that document. 

    [39] First decision at [105].

    [40] First decision at [120].

    [41] For example, second decision at [23], [25].

  15. Notably, WO’115 discloses the ranges of amounts of antigens defined in the present claims:

    ·      CD about 102 to about 109 TCID50 per dose, preferably about 104 to about 106 TCID50 per dose;

    ·      CAV-2 about 102 to about 109 TCID50 per dose, preferably about 104 to about 106 TCID50 per dose;

    ·      CPI about 102 to about 109 TCID50 per dose, preferably about 106 to about 108 TCID50 per dose;

    ·      CPV about 102 to about 109 TCID50 per dose, preferably about 107 to about 109 TCID50 per dose; and

    ·      CCV at least about 100 relative units per dose, preferably in the range of 1000-4500 relative units per dose.[42] 

    These ranges are overlapping in scope with present claims 1-3 with the exclusion of the amounts of 109 to 1010 TCID50 per dose for CPI and CPV which are included in the claims but not disclosed in WO’115.  However, these doses are not exemplified or claimed in appended claims, suggesting that they are not preferred doses, and the ranges disclosed in WO’115 are entirely overlapping with present claims 8 and 9 (and the doses used in the Examples). 

    [42] Page 16, lines 21-31; claims 19-22.

  16. I conclude that the subject matter found to lack inventive step in the earlier decisions is the regimen having the currently claimed antigen combination, administration routes and dosing intervals, wherein the amounts of antigens are as disclosed in WO’115 and identified above.  The second amendments have the result of narrowing the scope of the claims to those methods which were already found to lack inventive step in the previous decisions but which result in the specific claimed antibody titres.  That is, the amendment does not add anything to the method previously found to lack inventive step, but instead limits the methods claimed to those which achieve the claimed result.  Zoetis has not pointed to, and I have not identified, anything in the evidence[43] or the specification that would support a view that the selection of methods resulting in the claimed antibody titres from the broader group of methods found to lack inventive step confers an inventive step.  It would be inconsistent with the delegate’s previous decision to conclude that the present claims, which define, albeit more narrowly, subject matter which has previously been found to lack inventive step, have an inventive step.  That is, the claims define subject matter that it has already been decided a person skilled in the art would be directly led to in seeking to provide an alternative and more convenient administration regimen for a combination canine vaccine.  I must therefore conclude that claims 1 and 2 in their present form lack inventive step in light of WO’115 for the above reasons and those given by the delegate in the first and second decisions.

    [43] As noted previously, Mr Bevan indicated that the response to vaccination shown in Figures 1 and 2 (which reflect the claimed antibody titres) is as would be expected from initial subcutaneous administration of live antigens (Bevan#1 at [23]; Bevan#2 at [12]) and Dr Holloway did not disagree (Holloway#2 at [3(d)], [4(bb)]).

  17. As in the first and second decisions, this finding applies to all claims, as the features of appended claims 3-18 substantially reflect those of the appended claims considered in the second decision, the features of which are disclosed in WO’115,[44] such that in seeking to solve the problem using the WO’115 disclosure the person skilled in the art would be directly led as a matter of course to try the subject matter encompassed by these claims with a reasonable expectation that it might well solve the problem.

    Conclusion

    [44] First decision at [120], second decision at [27].

  18. The inventive step deficiencies identified in the second decision have not been overcome.  Claims 1-18 lack inventive step in light of WO’115.

    Conclusion

  19. I have found that the amendments do not overcome the inventive step deficiencies identified in the first and second decisions.  In the circumstances, while I am satisfied that Zoetis has made a genuine attempt to overcome the deficiencies identified in the previous decisions, Zoetis has not requested a further opportunity to amend, and given the disclosure of WO’115 there appears to be little utility in providing any further opportunity for Zoetis to propose amendments.  I will refuse the application.

    Costs

  20. Neither party made submissions on costs.  It is normal in matters before the Commissioner that costs should follow the event.  Merial has been successful in this matter, and therefore I will award costs according to Schedule 8 against Zoetis.

    Dr S. J. Smith
    Delegate of the Commissioner of Patents

    Annex A: The claims considered in the second decision

    1. A method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of a vaccine; wherein the vaccine comprises viral antigens and a bacterin;

    wherein the viral antigens comprise 1) canine distemper (CD) virus, 2) canine adenovirus type 2 (CAV-2), 3) canine parainfluenza (CPI) virus, and 4) canine parvovirus (CPV);
    wherein the bacterin comprises one or more bacteria selected from Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, L. bratislava, and Bordetella bronchiseptica;
    wherein the vaccine is administered orally in a first dose, orally in a second dose, orally in a third dose, and orally in one or more annual doses;
    wherein the second dose is administered from 7 to 35 days, inclusive, after the first dose; and
    wherein the third dose is administered from 7 to 35 days, inclusive, after the second dose.

    2. A method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of a vaccine; wherein the vaccine comprises viral antigens and a bacterin;

    wherein the viral antigens comprise 1) canine distemper (CD) virus, 2) canine adenovirus type 2 (CAV-2, 3) canine parainfluenza (CPI) virus, and 4) canine parvovirus (CPV);
    wherein the bacterin comprises one or more bacteria selected from Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, L. bratislava, and Bordetella bronchiseptica;
    wherein the vaccine is administered subcutaneously in a first dose, orally or subcutaneously in a second dose, orally in a third dose, and orally in one or more annual doses;
    wherein the second dose is administered from 7 to 35 days, inclusive, after the first dose; and
    wherein the third dose is administered from 7 to 35 days, inclusive, after the second dose.

    3. The method of claim 1 or 2, wherein the vaccine further comprises canine coronavirus (CCV).

    4. The method according to claim 1 to 3, wherein the bacteria in the bacterin are Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, and L. pomona.

    5. The method according to any one of claims 1 to 3, wherein the bacterium in the bacterin is Bordetella bronchiseptica.

    6. The method according to claims 1 to 3, wherein the canine diseases comprise one or more of 1) CD caused by CD virus; 2) infectious canine hepatitis caused by CAV-1; 3) respiratory disease caused by CAV-2 or respiratory CCV; 4) CPI caused by CPI virus; 5) enteritis caused by CCV or CPV; 6) leptospirosis caused by Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, or L. Bratislava; and 7) infectious tracheobronchitis ("kennel cough") caused by Bordetella bronchiseptica.

    7. The method according to claim 6, wherein the canine diseases comprise 1) CD caused by CD virus; 2) infectious canine hepatitis caused by CAV-1; 3) respiratory disease caused by CAV-2; 4) CPI caused by CPI virus; 5) and canine parvoviral enteritis caused by CPV.

    8. The method according to any one of claims 1 to 3, wherein the viral antigens are present in the following ranges of amounts: for CD virus, about 102 TCID50 to about 108 TCID50, inclusive; for CAV-2, about 102 TCID50 to about 108 TCID50, inclusive; for CPV, about 103 TCID50 to about 1010 TCID50, inclusive; for CPI virus, about 103 TCID50 to about 1010 TCID50, inclusive; and for CCV, at least about 100 relative units (RU) per dose.

    9. The method according to any one of claims 1 to 3, wherein the viral antigens are present in the following ranges of amounts: for CD virus, about 103 TCID50 to about 106 TCID50, inclusive; for CAV-2, about 103 TCID50 to about 108 TCID50, inclusive; for CPV, about 106 TCID50 to about 109 TCID50, inclusive; for CPI virus, about 105 TCID50 to about 109 TCID50, inclusive; and for CCV, about 1,000 RU to about 4,500 RU per dose

    10. The method according to any one of claims 1 to 3, wherein the viral antigens are present in the following ranges of amounts: for CD virus, about 104 TCID50 to about 105 TCID50, inclusive; for CAV-2, about 104 TCID50 to about 105 TCID50, inclusive; for CPV, about 107 TCID50 to about 108 TCID50, inclusive; and for CPI virus, about 106 TCID50 to about 108 TCID50, inclusive.

    11. The method according to any one of claims 1 to 3, wherein each Leptospira is present in a range of amounts from about 100 nephelometric units (NU) to about 3,500 NU per vaccine dose, and wherein the Bordetella bronchiseptica is present in a range from about 3 x 106 to about 3 x 1011 cells inclusive.

    12. The method according to any one of claims 1 to 3, wherein each Leptospira is present in a range of amounts from about 200 NU to about 2,000 NU per dose, and wherein the Bordetella bronchiseptica is present in a range from about from about 3 x 107 to about 3 x 1010 cells inclusive.

    13. The method according to any one of claims 1 to 3, wherein the Bordetella bronchiseptica is present in a range from about 3 x 108 to about 3 x 109 cells inclusive.

    14. The method according to any one of claims 1 to 3, wherein the second dose is administered about 3 weeks after the first dose.

    15. The method according to any one of claims 1 to 3, wherein the third dose is administered about 3 weeks after the second dose.

    16. The method according to any one of claims 1 to 3, wherein the annual dose is administered about one year after the first dose.

    17. The method according to claim 16, wherein annual doses administered after the annual dose are administered repeatedly about one year after the immediately prior annual dose.

    18. The method according to claim 2 or 3, wherein the second dose is administered orally.

    19. The method according to claim 2 or 3, wherein the second dose is administered subcutaneously.

    Annex B: The claims presently under consideration

    1. A method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of a vaccine;
    wherein the vaccine comprises viral antigens and a bacterin;
    wherein the viral antigens comprise 1) canine distemper (CD) virus, 2) canine adenovirus type 2 (CAV-2), 3) canine parainfluenza (CPI) virus, and 4) canine parvovirus (CPV);
    wherein the bacterin comprises one or more bacteria selected from Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, L. bratislava, and Bordetella
    bronchiseptica;
    wherein the vaccine is administered orally in a first dose, orally in a second dose, orally in a third dose, and orally in one or more annual doses;
    wherein the second dose is administered from 7 to 35 days, inclusive, after the first dose; and
    wherein the third dose is administered from 7 to 35 days, inclusive, after the second dose;
    wherein the viral antigens are present in the following ranges of amounts: for CD virus, about 102 TCID50 to about 108 TCID50, inclusive; for CAV-2, about 102 TCID50 to about 108 TCID50, inclusive; for CPV, about 103 TCID50 to about 1010 TCID50, inclusive; for CPI virus, about 103 TCID50 to about 1010 TCID50, inclusive; and
    wherein the dog has an anti-CDV antibody titre of at least 1:3499 and an anti-CPV antibody titre of at least 1:5613 at 28 days after the first dose.

    2. A method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of a vaccine;
    wherein the vaccine comprises viral antigens and a bacterin;
    wherein the viral antigens comprise 1) canine distemper (CD) virus, 2) canine adenovirus type 2 (CAV-2, 3) canine parainfluenza (CPI) virus, and 4) canine parvovirus (CPV);
    wherein the bacterin comprises one or more bacteria selected from Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, L. bratislava, and Bordetella bronchiseptica; wherein the vaccine is administered subcutaneously in a first dose, orally or subcutaneously in a second dose, orally in a third dose, and orally in one or more annual doses;
    wherein the second dose is administered from 7 to 35 days, inclusive, after the first dose; and
    wherein the third dose is administered from 7 to 35 days, inclusive, after the second dose;
    wherein the viral antigens are present in the following ranges of amounts: for CD virus, about 102 TCID50 to about 108 TCID50, inclusive; for CAV-2, about 102 TCID50 to about 108 TCID50, inclusive; for CPV, about 103 TCID50 to about 1010 TCID50, inclusive; for CPI virus, about 103 TCID50 to about 1010 TCID50, inclusive; and
    wherein the dog has an anti-CDV antibody titre of at least 1:3499 and an anti-CPV antibody titre of at least 1:5613 at 28 days after the first dose.

    3. The method of claim 1 or 2, wherein the vaccine further comprises canine coronavirus (CCV) present in an amount of at least about 100 relative units (RU) per dose.

    4. The method according to claim 1 to 3, wherein the bacteria in the bacterin are Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, and L. pomona.

    5. The method according to any one of claims 1 to 3, wherein the bacterium in the bacterin is Bordetella bronchiseptica.

    6. The method according to claims 1 to 3, wherein the canine diseases comprise one or
    more of 1) CD caused by CD virus; 2) infectious canine hepatitis caused by CAV-1; 3) respiratory disease caused by CAV-2 or respiratory CCV; 4) CPI caused by CPI virus; 5) enteritis caused by CCV or CPV; 6) leptospirosis caused by Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, or L. Bratislava; and 7) infectious tracheobronchitis ("kennel cough") caused by Bordetella bronchiseptica.

    7. The method according to claim 6, wherein the canine diseases comprise 1) CD caused by CD virus; 2) infectious canine hepatitis caused by CAV-1; 3) respiratory disease caused by CAV-2; 4) CPI caused by CPI virus; 5) and canine parvoviral enteritis caused by CPV.

    8. The method according to any one of claims 1 to 3, wherein the viral antigens are present in the following ranges of amounts: for CD virus, about 103 TCID50 to about 106 TCID50, inclusive; for CAV-2, about 103 TCID50 to about 108 TCID50, inclusive; for CPV, about 106 TCID50 to about 109 TCID50, inclusive; for CPI virus, about 105 TCID50 to about 109 TCID50, inclusive; and for CCV, about 1,000 RU to about 4,500 RU per dose.

    9. The method according to any one of claims 1 to 3, wherein the viral antigens are present in the following ranges of amounts: for CD virus, about 104 TCID50 to about 105 TCID50, inclusive; for CAV-2, about 104 TCID50 to about 105 TCID50, inclusive; for CPV, about 107 TCID50 to about 108 TCID50, inclusive; and for CPI virus, about 106 TCID50 to about 108 TCID50, inclusive.

    10. The method according to any one of claims 1 to 3, wherein each Leptospira is present in a range of amounts from about 100 nephelometric units (NU) to about 3,500 NU per vaccine dose, and wherein the Bordetella bronchiseptica is present in a range from about 3 x 106 to about 3 x 1011 cells inclusive.

    11. The method according to any one of claims 1 to 3, wherein each Leptospira is present in a range of amounts from about 200 NU to about 2,000 NU per dose, and wherein the Bordetella bronchiseptica is present in a range from about from about 3 x 107 to about 3 x 1010 cells inclusive.

    12. The method according to any one of claims 1 to 3, wherein the Bordetella bronchiseptica is present in a range from about 3 x 108 to about 3 x 109 cells inclusive.

    13. The method according to any one of claims 1 to 3, wherein the second dose is administered about 3 weeks after the first dose.

    14. The method according to any one of claims 1 to 3, wherein the third dose is administered about 3 weeks after the second dose.

    15. The method according to any one of claims 1 to 3, wherein the annual dose is administered about one year after the first dose.

    16. The method according to claim 15, wherein annual doses administered after the annual dose are administered repeatedly about one year after the immediately prior annual dose.

    17. The method according to claim 2 or 3, wherein the second dose is administered orally.

    18. The method according to claim 2 or 3, wherein the second dose is administered subcutaneously.


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Cases Citing This Decision

1

Abbey Laboratories Pty Ltd v Elanco Australasia Pty Ltd [2021] APO 30
Cases Cited

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Statutory Material Cited

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Merial Limited v Zoetis Services LLC [2016] APO 12
Merial Limited v Zoetis Services LLC [2017] APO 20
R v Smith (Commissioner of Patents); Ex parte Mole Engineering Pty Ltd [1981] HCA 25