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

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Abbey Laboratories Pty Ltd v Elanco Australasia Pty Ltd [2021] APO 30
Patent Application: 2014280848

Title:Ectoparasitic treatment method and composition

Patent Applicant:                   Elanco Australasia Pty Ltd
Opponent:  Abbey Laboratories Pty Ltd
Delegate:  Cathy Douglas
Decision Date:  26 July 2021
Hearing Date:  17 June 2021 by video conference
Catchwords:  PATENTS – section 59 – final determination - amendments do not overcome deficiencies identified in previous decisions – application refused – costs awarded against applicant

Representation: Counsel for the applicant: Andrew D. B. Fox
Patent attorney for the applicant: Jenny J. Park

Counsel for the opponent: David Larish
Solicitor for the opponent: Jane Owen and Rebecca Currey, Bird & Bird

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2014280848
Title:Ectoparasitic treatment method and composition

Patent Applicant: Elanco Australasia Pty Ltd
Date of Decision: 26 July 2021
DECISION
The amendments to the specification do not overcome the deficiencies identified in the opposition decision; claims 1-10 lack an inventive step.
I refuse the application.
I award costs according to Schedule 8 against the applicant, Elanco Australasia Pty Ltd.
REASONS FOR DECISION
Background

Patent application 2014280848 (the application) in the name of Bayer Australia Ltd was advertised as accepted on 10 May 2018. Abbey Laboratories Pty Ltd (the opponent) opposed the grant of the patent, the matter was heard on 27 February 2020, and a decision issued on 4 June 2020 reported as [2020] APO 25 (the opposition decision). A change to the ownership of the application to Elanco Australasia Pty Limited (the applicant) was published on 17 December 2020.
The opposition decision found that claims 1-10 were not supported according to subsection 40(3) and claims 1 and 4-11 were not novel in view of D1. Furthermore, claims 1-3, 6 and 7 were found to lack an inventive step in view of D1 and the common general knowledge in the art.

The opposition decision allowed the applicant an opportunity to propose amendments to overcome the deficiencies identified, which were allowed unopposed on 22 October 2020. The examiner noted in the comments in his report that he did not consider that the amendments overcame the deficiency of lack of inventive step identified in the opposition decision. I also note that the opponent provided comments on the amendments on 24 July 2020 expressing their view that the amendments did not overcome the lack of inventive step identified in the opposition decision. The applicant asked to be heard in the final determination of the opposition, and a hearing was scheduled.
The opponent filed submissions on 2 June 2021. The applicant subsequently filed their submissions which included new evidence in the form of a Declaration by Mr Kai Kin Lau dated 9 June 2021 (the Lau declaration) and asked that it be considered under the provisions of regulation 5.23 of the Patents Regulations. The opponent wrote to IP Australia on the 11 June 2021 expressing concern about the very late filing of this evidence. I indicated in a responding letter to the parties that I would decide after the hearing whether or not I would admit this evidence, and then would allow the opponent further time to respond if I decided to do so.

The hearing was held on 17 June 2020 by video conference.
The amendments
The claims as amended now include six independent claims, claims 1, 4, 6, and 8-10. All these claims include the following features which represent a narrowing of the previous claims:

·Administration of thiacloprid by topical administration, specifically by backlining in claims 1, 4 and 6;

·Thiacloprid is administered to the animal in an amount of 10 to 30 mg/kg by weight of the animal;
·The animal is a sheep or goat; and

·Thiacloprid is administered in a composition containing 0.5%-2% w/v of thiacloprid.

A marked-up version of the claim set identifying the changes is provided below.
1. A method of controlling lice on an animal, characterised by the step of
administering by backlining ~~externally~~ a pharmaceutically effective amount of
thiacloprid, wherein the amount of thiacloprid administered to the animal is
from 1 10 to 45 30 mg/kg by weight of the animal, wherein the thiacloprid is
administered in a composition containing 0.5%-2% w/v of thiacloprid, and
wherein the animal is a sheep or a goat.
2. The method of claim 1, ~~characterised by the step of topically administering a~~
~~composition containing from 0.0001% to 3.5%~~wherein the composition contains
1% w/v of thiacloprid.
3. The method of claim 1 or 2, wherein the amount of thiacloprid administered to
the animal is from 10 to 30 15 mg/kg by weight of the animal.
~~4. The method of any one of claims 1 to 3, wherein the method includes the step of~~
~~diluting a composition containing from 30% to 60% w/v of thiacloprid with water~~
~~before administering the diluted composition to the animal.~~
~~5. The method of claim 4, wherein the composition is diluted with water to provide~~
~~from 1 ppm to 200 ppm of thiacloprid.~~
6.4. A method of providing persistent control of lice on an animal, characterised by
the step of administering by backlining ~~externally~~ a pharmaceutically effective
amount of thiacloprid, wherein the amount of thiacloprid administered to the
animal is from 1 10 to 45 30 mg/kg by weight of the animal, wherein the
thiacloprid is administered in a composition containing 0.5%-2% w/v of
thiacloprid, and wherein the animal is a sheep or a goat.
7.5. The method of claim 64, wherein persistent control is provided for at least two
weeks following administration.
~~8. The method of any one of claims 1 to 7, wherein the thiacloprid is administered~~
~~to the animal by backlining, dipping or jetting.~~
9.6. Use of thiacloprid in the manufacture of a composition for controlling lice on an
animal, wherein the amount of thiacloprid administered to the animal is from 1
10 to 45 30 mg/kg by weight of the animal, ~~and~~ wherein the composition is
administered by backlining ~~externally~~ to the animal, wherein the composition
contains 0.5%-2% w/v of thiacloprid, and wherein the animal is a sheep or a goat.
~~10. The use of claim 9, wherein the external administration is by backlining, dipping~~
~~or jetting.~~
~~11.~~7. The method of any one of claims 1 to 85, or the use of claim 6~~9 or 10~~, wherein
the animal is a sheep ~~or a goat~~.
8. A method of controlling lice on an animal, characterised by the step of topically
administering a pharmaceutically effective amount of thiacloprid, wherein the
amount of thiacloprid administered to the animal is from 10 to 30 mg/kg by
weight of the animal, wherein the thiacloprid is administered in a composition
containing 0.5%-2% w/v of thiacloprid, and wherein the animal is a sheep or a goat.
9. A method of providing persistent control of lice on an animal, characterised by
the step of topically administering a pharmaceutically effective amount of
thiacloprid, wherein the amount of thiacloprid administered to the animal is
from 10 to 30 mg/kg by weight of the animal, wherein the thiacloprid is
administered in a composition containing 0.5%-2% w/v of thiacloprid, and
wherein the animal is a sheep or a goat.
10. Use of thiacloprid in the manufacture of a composition for controlling lice on an
animal, wherein the amount of thiacloprid administered to the animal is from 10
to 30 mg/kg by weight of the animal, wherein the composition is administered
topically to the animal, wherein the composition contains 0.5%-2% w/v of
thiacloprid, and wherein the animal is a sheep or a goat.
It is uncontroversial that these amendments overcome the findings of lack of support and lack of novelty in the opposition decision. The amendments introduce into the independent claims features from claims that were not found deficient on these grounds. Specifically, the feature of previous claim 11 that the animal is a sheep or goat has been introduced into all the independent claims; claim 11 was not found deficient for lack of support. Also, the feature that the administration method is by backlining or topical administration has been introduced into the independent claims which overcomes the novelty deficiency. However, the opponent submits that the lack of inventive step finding has not been overcome by the amended claims.

The applicant acknowledged at the hearing that to make good the deficiency identified in the opposition decision with respect to inventive step, the Lau declaration is required, and they requested that this evidence be considered under the provisions of regulation 5.23. The applicant confirmed that the purpose of this new evidence is to show that it would not have been a matter of routine to formulate a backlining composition; they submit that this evidence shines a light on a matter not previously considered in the evidence and thus does not amount to a re-litigation of a previously decided point.
The law
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, as is made clear in R v Smith; Ex parte Mole Engineering Pty Ltd (Ex parte Mole).[1] The Deputy Commissioner in Novozymes A/S v DSM IP Assets B.V.(Novozymes)[2] 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.”[3]
[1] R v Smith; Ex parte Mole Engineering Pty Ltd [1981] HCA 25; (1981) 147 CLR 340 at 348-349.
[2] [2018] APO 2 (5 January 2018).
[3] Ibid at [21].
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.
What were the findings in the opposition decision regarding inventive step?
The opposition decision found that claims 1 and 4-11 are not novel[4], and claims 1-3, 6 and 7 lack an inventive step[5]. The inventive step analysis of the opposition decision only specifically considered the claims that did not fail on lack of novelty,[6] as this was all that was required to address the opponent’s submissions. Claim 2 was specifically considered in the inventive step analysis, even though it was not mentioned in the opponent’s submission on inventive step, because it did not fail for lack of novelty. Implicitly, then, the claims that were found to fail for lack of novelty were also considered to lack an inventive step, despite, regrettably, being omitted from the summary in relation to inventive step .
[4] Opposition decision [172].
[5] Opposition decision [231].
[6] Opposition decision [220].
The applicant submitted, on the contrary, that the opposition decision made no finding on the inventiveness of claim 8.[7] However, as above, it is implicit in the opposition decision that since claim 8 failed for lack of novelty, it was also found to lack an inventive step (noting that original claim 8 included dipping as one of the three administration methods recited). This is consistent with the explicit findings in the opposition decision in regard to claim 2 discussed below. These findings are final. As the delegate commented in the final determination in the matter of Merck, Sharpe & Dohme (Australia) Pty Ltd v Genetech Inc, “…regardless of the level of detail involved in considering the validity of each claim, or the merits of my earlier decision, that decision is final insofar as it determines all issues capable of determination at the time”[8].
[7] Applicant submissions [27].
[8] [2015] APO 19 at [20].
The applicant submits there is no finding in the opposition decision that is applicable to presently amended claims 1-7, that include the feature of administration by backlining (one of three alternate administration methods recited in original claim 8). They state:
“…there is no finding in the Opposition Decision to the effect that, and none of the evidence supports the assertion that, there would be the required level of reasonable expectation held on the part of the person skilled in the art that topically administering, e.g. by backlining, a composition containing 0.5%-2% w/v of thiacloprid to a sheep or a goat, such that thiacloprid is administered in an amount of 10 to 30 mg/kg by body weight of the sheep or goat, would be effective to control lice on the sheep or goat, or be effective to provide persistent control of lice on the sheep or goat.”[9]
[9] Applicant submissions [34].
At the hearing, I asked the applicant to further explain their submission. The applicant focussed on the discussion in paragraph [228] about the formulation of actives, and in particular on the last sentence of paragraph [228] of the opposition decision which reads:
“The fact that all the experts agree that backlining (pour on) was common general knowledge at the priority date supports the conclusion that making such a formulation would also be a matter of routine, well known steps.”
The applicant’s submission as I understand it is that this sentence cannot be considered a finding in regard to a claim including the feature of administration by backlining, since it was not based on a proper ventilation of expert evidence on the specific topic of development of backlining formulations; they say that instead this statement should be characterised as an “assertion”. The applicant submitted that a “leap” without evidence was taken in order to draw the conclusion that making a backlining formulation would be a matter of routine, and therefore this statement is not a finding. In the applicant’s view, it follows that the inventiveness of a claim specifically directed to a method of administration by backlining can now be decided for the first time in the final determination hearing process without falling foul of the principle in Ex parte Mole.

I do not find this argument persuasive. As the opponent submitted, the opposition decision made clear findings on the matter of inventive step. In particular, the opposition decision specifically found that previous claim 2, characterised by the feature “topically administering”, lacked an inventive step, as is clear from the following excerpt of paragraphs [228]-[230]:
“228. I am mindful of these comments, however I have noted previously from the decision in AstraZeneca that the “need to work towards the invention is not inconsistent with the conclusion that the invention was obvious”. A step that is routine may still require some degree of effort on the part of the PSA; routine is not synonymous with “trivial”. I agree that the skill and effort required to overcome difficulties in formulating thiacloprid referred to by the professors is not trivial, but nevertheless can be categorised as routine steps working “towards the invention”. The fact that all the experts agree that backlining (pour on) was common general knowledge at the priority date supports the conclusion that making such a formulation would also be a matter of routine, well known steps.
229. I have already found above that determining a dosage is a matter of undergoing routine testing. A similar conclusion applies to the concentration of thiacloprid specified in claim 2. I consider that finding the appropriate concentration range specifically for a topical application method is likewise a matter of routine optimization.
230. Therefore, I consider that the skilled person, armed with the teaching of D1, and seeking alternative methods for controlling lice including using varied application methods would formulate thiacloprid for topical application using the common general knowledge in the art, thus arriving at the matter of claim 2 by routine steps. It follows that claim 2 lacks an inventive step.”
I accept that a finding that a claim lacks inventive step does not necessarily mean that the entirety of the subject matter defined by that claim lacks an inventive step, as pointed out by the delegate in Merial Limited v Zoetis Services LLC (Merial)[10]. However, in this case, I consider that “administering by backlining” as a subset of “topically administering” was addressed by the finding given the context of the expert’s evidence quoted in the opposition decision. Dr Playford’s evidence that “…it is a matter of taking routine steps to formulate the same active ingredient for topical application…”[11] was made after his earlier statement that backlining is an example of topical application.[12] The conclusion of paragraph [228] of the opposition decision that making a backlining formulation would be a matter of routine follows from this evidence. Furthermore, the finding of fact upon which this conclusion is based, that backlining formulations are common general knowledge, is clearly applicable to a claim specifically reciting a method of administration by backlining.
[10] [2018] APO 30 (11 May 2018) at [35].
[11] Playford 1 [83]-[84] quoted at [224] of the opposition decision.
[12] Playford 1 [51].
In my view, the applicant’s submission that there was not enough evidence to conclude that a backlining composition would be arrived at as a matter of routine by the skilled person goes to the merit of the finding, rather than being a question of whether a finding was actually made. The applicant can challenge the issue of merit on an appeal from the opposition decision, but it is not relevant to the final determination process. I cannot revisit these issues by consulting new evidence to come to another decision on the question of inventive step that would clearly be inconsistent with the original opposition decision.
Regulation 5.23
In Reflex Instruments Asia Pacific Pty Ltd v Minnovare Limited[13] a delegate stated that the considerations that are relevant to the operation of regulation 5.23 are:
- The circumstances leading up to the evidence not being filed earlier;
- What does the evidence show;
- Is the information likely to be crucial to the delegate’s decision;
- The public interest in having the information considered; and
- The balance of convenience of the parties if the information is considered
As I have explained above, I am not permitted to revisit the finding in the original decision that it would have been a matter of routine to formulate a composition for administration by backlining. Therefore, I cannot consider the evidence provided by the applicant which seeks to address this point. As stated by the Deputy Commissioner in Novozymes[14], if the evidence cannot be considered, it follows that the information is not critical, and in fact is not relevant to my decision. There is no justification to invoke regulation 5.23.
[14] Novozymes A/S v DSM IP Assets B.V. [2018] APO 2 (5 January 2018) at [4].
At the hearing I indicated that should I decide to allow the regulation 5.23 request, I would allow the opponent further time to make representations regarding that evidence. As I have decided not to allow the request, the additional opportunity is now not necessary.
Do the amended claims overcome the inventive step finding?
The applicant submits:
“… to date there has been no consideration of the invention having all of
the features as combined in the amended claims. The Opposition Decision considered
[15] Applicant submissions at [34].
each feature of the claims separately, and the findings in respect of each of those features cannot be applied to the invention as defined by the amended claims.”[15]
As stated above, the presently amended claims now include the following features:
·Administration of thiacloprid by topical administration, specifically by backlining in claims 1, 4 and 6;
·Thiacloprid is administered to the animal in an amount of 10 to 30 mg/kg by weight of the animal;
·The animal is a sheep or goat; and
·Thiacloprid is administered in a composition containing 0.5%-2% w/v of thiacloprid.

Whilst I agree with the applicant that it is the presently amended claims with their combination of features which must be considered, I consider that the opposition decision made findings that when taken together are relevant to these claims.
It is helpful firstly to review the reasoning for the inventive step findings. The opposition decision articulated the question to be addressed in the inventive step analysis in the following paragraphs, (noting that D1 disclosed the use of thiacloprid on sheep, so that feature is already taken into account given that the starting point of the analysis is D1.)
“However, for inventive step, the question changes from ‘what would have happened when D1 was put into practice?’, to ‘what would the person skilled in the art do as a matter of routine armed with the disclosure of D1 and faced with the same problem of finding alternative methods for controlling lice using actives that allow for the use of relatively low quantities of actives?’.
The disclosure of D1 provides the PSA with the knowledge that thiacloprid is useful for the control of lice on sheep. D1 also provides the PSA with the knowledge that thiacloprid can be provided in the form of a plunge dip formulation using the active at 48 mg/L. Using the words of the test in Wellcome, I need to determine whether the PSA, faced with the same problem, would have taken as a matter of routine whatever steps might have led from this prior art to the invention, whether they be the steps of the inventor or not.
This test for inventive step requires that the PSA has a reasonable expectation of success. According to the Generic Health decision, it is ‘implicit in the characterisation of steps as routine’ that there is ‘an expectation that an experiment might well succeed’.”[16]
[16] Opposition decision [191]-[193].
The opposition decision concluded “…that the skilled person would undergo routine tests to determine an appropriate dosage of thiacloprid for controlling lice in sheep…”[17] and in relation to the expectation of the PSA, broadly found the following:
“…there is clearly a reasonable expectation on the part of the PSA that conducting trials ‘might well succeed’ in producing an external administration method of treating lice on sheep at an appropriate dosage to be determined by the routine trials.”[18]
[17] Opposition decision [206].
[18] Opposition decision [210].
Clearly, then, a broad finding applies that determining the appropriate dosage of thiacloprid is a matter of routine. This finding extends to further optimizations of the dose, to the determination of the appropriate concentration range of the composition, and to the amounts required to establish persistent control, as indicated in the following passages.
·In relation to previous claim 3 which specified a dose of 10 to 30 mg/kg, the opposition decision stated that “further refining of dose amounts to no more than additional dose optimization” and found that claim 3 with this narrowed dose lacked an inventive step[19];
·In relation to previous claim 2, the opposition decision found that “finding the appropriate concentration range for topical application formulation is likewise a matter of routine optimization”.[20]
·In relation to previous claims 6 and 7 reciting the feature of “providing persistent control of lice”, the opposition decision found that the dosage to achieve this level of control would be determined by routine steps.[21]
[19] Opposition decision [215].
[20] Opposition decision [229].
[21] Opposition decision [216]-[219].
These findings about the significance of dose and concentration in topical methods of treating lice are broadly applicable to claims of various scope, since they flow from the conclusion that the skilled person would have a reasonable expectation of finding the right amounts of thiacloprid for a range of these methods by routine trials. As stated by Dr Playford, “It is standard course to produce efficacious formulations of the same active for multiple administration methods.”[22]
[22] Playford 1 [83]-[84].
Furthermore, as indicated previously, the use of backlining as a topical application method was specifically contemplated within the findings. It would be inconsistent with the opposition decision to conclude that the present claims, which define, albeit more narrowly, subject matter which has previously been found to lack inventive step, to have an inventive step. It follows that it is a matter of routine to optimise the dose and concentration of thiacloprid in methods of controlling and persistently controlling lice on sheep or goats using backlining or other topical administration methods. Therefore, the presently amended claims, which include these features, do not overcome the deficiency regarding inventive step identified in the opposition decision. The presently amended claims lack an inventive step.
I further note that at the hearing, counsel acknowledged that as a matter of logical consequence, if the applicant cannot rely on the Lau declaration which seeks to address a new combination of integers, then there is nothing further that can be submitted other than to ask for another opportunity to amend. I understand this statement to be an acknowledgement that without additional evidence, based on the opposition decision, there is no basis for the applicant to argue that the presently amended claims are inventive.
New deficiencies
The examiner found the claims to be allowable, and the opponent has not identified any other issues which are raised by the amendments. The present amendments do not introduce any new deficiency which should be considered at this stage.
Further opportunity to amend
The applicant urged permission to be allowed a second attempt to amend to overcome the deficiencies should I decide not to consult the Lau declaration under regulation 5.23. 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[23].
[23] See, for example, ExxonMobil Upstream Research Company v Shell Internationale Research Maatschappij B.V. [2016] APO 51 at [38]; Ipsen Pharma S.A.S. v Allergan, Inc 2013 APO 50 at [26]; Ericsson Australia Pty Ltd v Aussie L.L.C. Pty Ltd [2004] APO 13 at [30]; W. Neudorff GmbH KG v Colin Leslie Young [2005] APO 23 at [36]-[37].
The applicant has succeeded in overcoming the deficiencies related to lack of support and lack of novelty by amendment, and they have attempted to overcome the finding of lack of inventive step. However, the applicant was not able to point to any matter that might be included in further amendments in the event that I found the claims still lacking in an inventive step. Considering the broad nature of the findings on lack of inventive step, I am not satisfied that the applicant could propose allowable amendments that would overcome the identified deficiency. I do not believe that there is anything to be gained by providing another opportunity, and it is not in the public interest to allow this matter to be further protracted. I will not provide a further opportunity to amend.
Conclusion
I have found that the amendments do not overcome the inventive step deficiencies identified in the opposition decision. I therefore make a final determination to refuse patent application 2014280848.
Costs
It is normal in matters before the Commissioner that costs should follow the event. The opponent has been successful in this matter, and therefore I will award costs according to Schedule 8 against the applicant.
Cathy Douglas
Delegate of the Commissioner of Patents