Merial Limited v Intervet International B.V

Case •

[2018] APO 25

•

3 April 2018

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Merial Limited v Intervet International B.V. [2018] APO 25

Patent Application:                2006289102

Title:PCV-2 vaccine

Patent Applicant:                   Intervet International B.V.

Opponent:  Merial Limited

Delegate:  Dr B. Akhurst

Decision Date:  3 April 2018

Hearing Date:  Written submissions filed on 31 January 2018, 14 February 2018 and 21 February 2018.

Catchwords:  PATENTS – Final determination – the amendment overcomes the ground of opposition and does not introduce new deficiencies – application to proceed to grant.

Representation:  Patent attorney for the applicant:  Spruson and Ferguson.

Patent attorney for the opponent:  FB Rice.

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                2006289102

Title:PCV-2 vaccine

Patent Applicant:                   Intervet International B.V.

Date of Decision:                   3 April 2018

DECISION

The amendments to the specification overcome the deficiencies identified in the first decision in this s 59 opposition and do not introduce new deficiencies.

Subject to an appeal of this decision, I direct the application proceed to grant.

Costs according to Schedule 8 are awarded against Merial Limited.

REASONS FOR DECISION

Background

  1. Patent application 2006289102 was filed by Intervet International B.V. (Intervet) on 8 September 2006, claiming the priority date 9 September 2005.  Acceptance of the application was advertised on 15 December 2011.

  2. Merial Limited (Merial) opposed the grant of a patent under s 59 of the Patents Act 1990 (the Act).  The matter was heard, and in the decision published on 27 June 2016 as Merial Limited v Intervet International B.V. [2016] APO 39 (the first decision), certain claims of the specification were found to lack an inventive step.  As is usual in such matters before the Commissioner, Intervet was allowed a period of time to propose amendments to the claims to overcome this deficiency.  Intervet did so, and the grant of leave to amend was advertised on 5 January 2017.  Merial’s opposition under s 104(4) to allowance of the amendments was unsuccessful - this decision was published on 19 September 2017 as Merial Limited v Intervet International [2017] APO 47 (the amendments decision).  Allowance of the amendment request was published on 30 November 2017.   

  3. Merial asked to be heard before the s 59 opposition was finally determined and the hearing took place by way of written submissions in filed on 31 January 2018, 14 February 2018 and 21 February 2018.

    The first hearing and decision

  4. The accepted specification contained 12 claims.  Most relevant to this current matter, accepted claim 12 is an ‘omnibus’ claim, limiting the subject matter of each one of the earlier claims to being “substantially as herein described with reference to any one of the examples”. 

  5. Merial’s grounds of opposition to the accepted specification are identified in the amended Statement of Grounds and Particulars dated 23 March 2015 as follows:

    · the applicant is not entitled to the invention contrary to s 59(a); and

    · the claimed invention is not patentable under section 59(b) because it does not comply with the requirements of:

    ·     section 18 with respect to manner of manufacture, novelty, inventive step, utility and secret use;

    · section 40(2) with respect to full description, best method and claims defining the invention; and

    · section 40(3) with respect to fair basis, clarity and succinctness.

  6. At the first hearing, the grounds pressed by Merial against accepted claims 1-12 were manner of manufacture, novelty, inventive step, utility and fair basis.  The opposition succeeded on one ground only, with my finding in the first decision that accepted claims 1-6 and 8-11 did not involve an inventive step in light of the document Blanchard et al. (2003) Vaccine 21: 4565-4575 (Blanchard)[1]. 

    [1] Merial Limited v Intervet International B.V. [2016] APO 39 at [83].

  7. Merial did not appeal this decision.

    The amendments

  8. Intervet subsequently proposed amendments to the claims which deleted accepted claim 12 and introduced the omnibus clause into each one of 11 proposed claims.  A ‘marked-up’ indication of the amendments is reproduced below, with added text underlined and deleted text struck-through.

    1. Use of ORF-2 protein of Porcine Circovirus type 2 (PCV-2) for the manufacture of a vaccine that comprises at least 20 microgram/dose of said ORF-2, for the protection of Maternally Derived Antibody-positive (MDA-positive) piglets against PCV-2 infection, said use being substantially as hereinbefore described with reference to any one of the examples.

    2. The Uuse of claim 1, ORF-2 protein of PCV-2 for the manufacture of a wherein said vaccine that comprises at least 50 microgram/dose of said ORF-2, for the protection of MDA-positive piglets against PCV-2 infection.

    3.The use of claim 1, wherein said vaccine comprises up to 80 microgram/dose of said ORF‑2.

    34. Pharmaceutical composition comprising at least 20 microgram/dose of ORF-2 protein of PCV-2 and a pharmaceutically acceptable carrier, when used as a vaccine for the protection of MDA-positive piglets against PCV-2 infection, said composition being substantially as hereinbefore described with reference to any one of the examples.

    45. The Ppharmaceutical composition of claim 4 comprising at least 50 microgram/dose of ORF-2 protein of PCV-2 and a pharmaceutically acceptable carrier, when used as a vaccine for the protection of MDA-positive piglets against PCV-2 infection.

    6.The pharmaceutical composition of claim 5, comprising up to 80 microgram/dose of said ORF-2.

    57. Pharmaceutical composition according to any one of claims 4 to 6 3 or 4, characterized in that said composition comprises an oil-in-water emulsion as a suitable adjuvant.

    6. Pharmaceutical composition according to claim 5, characterized in that said adjuvant is an oil-in-water emulsion.

    7. Pharmaceutical composition according to claim 5 or 6, characterized in that said adjuvant comprises vitamin E.

    8. Use of ORF-2 protein of Porcine Circovirus type 2 according to any one of claims 1 to 3 or 2, wherein that said ORF-2 protein has been produced by way of expression from a baculovirus expression vector in insect Spodoptera frugiperda Sf21 cells, and wherein the baculovirus expression vector comprises the PCV-2 ORF-2 gene sequence under the control of a suitable the p10 promoter.

    9. Use of ORF-2 protein according to claim 8, wherein said promoter is the p10 promoter.

    109. A method for the protection of MDA-positive piglets against PCV-2 infection, the method comprising administering a vaccine comprising at least 20 microgram/dose of ORF-2 protein of PCV-2 to an MDA-positive piglet, said method being substantially as hereinbefore described with reference to Example 5.

    1110. AThe method of claim 9, for the protection of MDA-positive piglets against PCV-2 infection, the method comprising administering a vaccine comprising at least 50 microgram/dose of ORF-2 protein of PCV-2 to an MDA-positive piglet.

    11. The method of claim 9, comprising administering a vaccine comprising up to 80 microgram/dose of ORF-2 protein of PCV-2 to an MDA-positive piglet.

    12. The use according to any one of claims 1, 2, 8 or 9, the composition according to any one of claims 3 to 7 or the method according to claim 10 or 11, substantially as herein before described with reference to any one of the examples.

  9. In the amendments decision I construed proposed claims 1-11 and concluded that the subject matter of each of these claims is identical in scope to embodiments that were present in accepted claim 12[2].  Accordingly, I found Merial’s opposition to the amendments to be unsuccessful because no deficiencies arose in the claims as a result of the amendment, and I allowed the amendments. 

    [2] Merial Limited v Intervet International [2017] APO 47 at [12], [14], [19], [23], [27] and [28].

  10. Proposed claims 1-11, the subject of the amendments decision, are now the amended claims for consideration in this hearing. 

    The opposition to grant as it now stands

  11. In this hearing before the s 59 opposition is finally determined, Merial sought to pursue grounds of opposition under section 18 and subsections 40(2) and (3) of the Act. Specifically, that the invention of all the amended claims lacks an inventive step in light of Blanchard and the common general knowledge; the specification does not fully describe the invention including the best method of performance; and the omnibus clause renders the claims not clear.

  12. Before commencing to decide this matter, I first must first ask whether it is open to me to consider these submissions in order to finally determine the opposition.  

    The applicable law

  13. There was no dispute that the principles set out in R v Smith (Commissioner of Patents); Ex parte Mole Engineering Pty Ltd [1981] HCA 25; (1981) 147 CLR 340 (Mole Engineering), Iluka Midwest Ltd v Technological Resources Pty Limited [2002] FCA 49; 116 FCR 218 (Iluka 1), and Iluka Midwest Ltd v Technological Resources Pty Limited [2002] FCA 1233; 58 IPR 467 (Iluka 2) Merck Sharpe & Dohme (Australia) Pty Ltd v Genentech Inc [2016] FCA 324; (2016) IPR 498 (Merck) support the Commissioner deciding an opposition with more than one decision.  The parties disagreed, however, as to how these authorities should be applied in this case. 

    Merial’s submissions

  14. Merial submitted that the deficiencies it now raises have not been determined in either the first decision or the amendment decision, and accordingly they fall for determination now.  In this regard, Merial submitted that facts of the present case are distinguished from those considered by the Courts in Mole Engineering, Merck and Ilukas 1 and 2.

  15. Regarding the ground of inventive step, Merial submitted that there has been no determination on the obviousness of accepted omnibus claim 12, for the following reasons:

    Firstly, that in the first decision, no specific findings were made in relation to the obviousness of accepted omnibus claim 12 in light of Blanchard, and in particular no reasoning was provided indicating that the omnibus claim, or the examples it relied on, involved any inventive step.  In the circumstances, Merial concluded that there has been no determination of the obviousness of accepted claim 12 and, it follows, no determination on the obviousness of the amended claims.

    Secondly, Merial construed the first decision as making no explicit finding that the deficiencies found to exist were capable of being overcome by amendment.  Noting that in Mole Engineering, Merck, and the Iluka cases more direct statements were made that the deficiencies identified could be overcome by amendment, Merial submitted that no such finding was made in this case, with the first decision merely stating at [115] that (accepted) claims 1-6 and 8-11 lacked an inventive step, followed by:

    “It is usual in matters before the Commissioner that in the event that an opposition to grant is successful, the applicant is allowed the opportunity to propose amendments to the claims.  I will allow Intervet a period of time to propose suitable amendments.”

    Merial concluded that in the absence of a positive finding that the claims could be amended to overcome the deficiencies identified, the first decision cannot be taken to have determined the issue of the obviousness of the subject matter of accepted omnibus claim 12. 

    Thirdly, Merial submitted that various findings in the first decision in relation to common general knowledge and the approach of the skilled person provide a firm basis for a conclusion that the amended claims do not involve an inventive step in light of Blanchard.  On this basis, Merial submitted that the amendments did not overcome deficiencies that were found in the first decision to exist. 

  16. Finally, Merial submitted that the amended claims do not comply with ss 40(2) and 40(3) of the Act, in that the deficiencies it now raises have not been determined in either the first or the amendments decision and accordingly fall for determination now.

    Intervet’s submissions

  17. Intervet considered Merial to be seeking to re-visit the ground of inventive step in relation to subject matter that was already considered, or was open to consideration, in the earlier substantive opposition hearing.  Intervet submitted that in the first hearing, it was open to Merial to deal more specifically with omnibus claim 12, and to deal more specifically with the examples disclosed in the patent specification.  In this regard, Intervet noted that there is no expert evidence on whether accepted claim 12 or the examples disclosed in the patent application encompassed subject matter that is obvious, although its own expert provided positive views in relation to the disclosure in the examples.  

    Consideration

    The relevance of positive statements as to patentable subject matter when providing the opportunity to amend

  18. I will first address Merial’s second submission, which seeks to distinguish the present circumstances from those considered in Mole Engineering, Iluka 1 and 2 and Merck, in that the first decision included no explicit statement that the deficiencies identified were capable of being overcome by amendment.  This submission is of little merit.  In an opposition to grant of a patent, it is necessary for the hearing officer to decide whether or not a ground is made out – i.e. whether there are deficiencies in the specification and/or claims.  The corollary is that the application complies with those grounds that are not made out.

    Merial’s additional submissions

  19. Regarding Merial’s first, third and final submissions, I will first address what was decided in the first decision, and then determine whether it is open to me to consider these submissions.

    What was decided in the first decision?

  20. Merial’s primary submission is essentially that only the matters explicitly decided in the first decision form part of that decision and other aspects of the case not explicitly dealt with are now open for consideration in this final determination of the opposition.  For the reasons that follow, Mole Engineering and Ilukas 1 and 2 do not support such a conclusion.

  21. As indicated above, in the first decision, I explicitly concluded that accepted claims 1-6 and 8-11 did not involve an inventive step.  Accordingly, in the conclusion to the first decision at para [114], and under the heading “DECISION” on page 1, it is recorded that the opposition was successful in that (accepted) claims 1-6 and 8-11 lack an inventive step.  No explicit statement is made with respect to accepted claims 7 and 12.   

  22. Merial relied on statements in Mole Engineering to support its submission that a decision is final only with respect to the matters that it explicitly specifies.  In particular, Merial relied on the statements that an interim decision conclusively determines the position “in relation to such matters as the decision may specify”[3] and that a “decision is final with respect to the issues which it determines”[4] (emphases added).

    [3] [1981] HCA 25; (1981) 147 CLR 340 Mason J at 350 [24] referring with approval to Lloyd-Jacob J.’s statement in Oertling Ltd’s Application (1959) RPC at 148.

    [4] [1981] HCA 25; (1981) 147 CLR 340 Wilson J at 356 [7].

  23. In my view, Merial’s interpretation is unduly restrictive.  In Mole Engineering, the High Court dealt with an application for an order prohibiting the Commissioner of Patents from rehearing an opposition to grant of a patent[5].  Most relevant to Merial’s submission, both Mason J and Wilson J cited with approval the following statement by Lloyd-Jacob J in relation to patent opposition proceedings in the UK[6]. 

    “An interim decision, no less than a final decision, conclusively determines the position of the Comptroller General in relation to such matters as the decision may specify.  It is the means whereby the Comptroller notifies the parties of his decision in relation to so much of the dispute as is susceptible of present determination and his decision also as to the manner in which the remaining matters in dispute may be dealt with.” (emphasis added)

    [5] [1981] HCA 25; (1981) 147 CLR 340 Mason J at 342.

    [6] Mole [1981] HCA 25; (1981) 147 CLR 340 Mason J at page 350 [24] and Wilson J at page 355 [5] referring to Lloyd Jacob J in Oertling Ltd’s Application (1959) RPC 148 at page 148.

  24. In that statement, the emphasised text explicitly qualifies one phrase in Mole Engineering that Merial relied on to establish that the first decision decides only such matters as it explicitly specifies.  In fact, Mole Engineering establishes that the first decision is a final decision on the original unamended application, which dealt with all the issues arising on the notice of opposition so far as they were capable of final determination[7].  Supporting this broader conclusion, in their decisions both Mason J and Wilson J relied on the following statements by Fullagar J relating to opposition proceedings:

    “… despite the description "Interim Decision" the Commissioner had actually decided as much of the opposition proceedings as was susceptible of decision at the time and had decided it once and for all.”[8] (emphasis added)

    “… I see no reason why the opposition proceeding should not be decided by several decisions provided that each of them can be said in a real sense to decide ‘the case’ as presently constituted as far as that case is at the time susceptible of present decision.”[9] (emphasis added)

    [7] Mole [1981] HCA 25; (1981) 147 CLR 340 Mason J at 349 [21], with Murphy and Aicken JJ agreeing at 350 [26].

    [8] Mason J at p349 [22], referring to Fullagar J in Broken Hill Proprietary Co. Ltd. v. American Can Co. [1980] VicRp 17; (1980) VR 143.

    [9] Mason J at p349 [23] & Wilson J at p356 [8], referring to Fullagar J in Broken Hill Proprietary Co. Ltd. v. American Can Co. [1980] VicRp 17; (1980) VR 143 at page 147.

  25. In Iluka 1 and Iluka 2, Merkel J confirmed that the first decision in a substantive opposition is to be taken as dealing with and generally deciding the opponent’s grounds of opposition, rather than only the specific grounds of opposition particularised, argued or pressed by the opponent at the hearing[10]. 

    [10] Iluka 1 [2002] FCA 49 at [50] and reiterated in Iluka 2 [2002] FCA 1233 at [17], [37].

  26. In this final determination of the s 59 opposition, Merial’s submissions are directed to establishing (i) that the invention claimed in each of the amended claims 1-11 does not involve an inventive step; (ii) that the specification does not comply with the requirements that the claimed invention is fully described including the best method of performance; and (iii) that the claims are not clear. All of the grounds Merial now relies on were included in its statement of grounds and particulars for the s 59 opposition and either were, or could have been, pursued in the first hearing against accepted claim 12.

  27. The question remains as to what was decided in the first decision?  I note that in Iluka 1, Merkel J construed the Commissioner’s decision by what was concluded “expressly or by necessary implication”[11].  As indicated above, the first decision found that claims 1-6 and 8-11 did not involve an inventive step.  Since no adverse findings were made in the first decision against claims 7 and 12, by necessary implication the subject matter of these claims was found to involve an inventive step.  No other ground of opposition was established against any of the accepted claims.  

    [11] Iluka 1 at 46 & 48.

    What is the nature of the amendments to the claims?

  28. As indicated above, in the amendments decision I found that the subject matter of each of proposed claims 1-11, which are now the amended claims the subject of this decision, is identical in scope to embodiments that were present in accepted claim 12[12].  

    [12] Merial Limited v Intervet International [2017] APO 47 at [12], [14], [19], [23], [27] & [28].

    The implications for Merial’s opposition to grant of a patent

  1. In the first decision, no adverse findings were made against accepted claim 12.  In the amendments decision the subject matter of each of the amended claims was found to fall wholly within the scope of accepted claim 12.  It logically follows that the amendments overcome the deficiencies identified in the first decision and no new deficiencies arise as a consequence of the amendments.  

    Conclusion

  2. The opposition fails.

    Costs

  3. Both parties to this opposition submitted that costs should be awarded against the other party.  It is normal in matters before the Commissioner that costs should follow the event.  Intervet has been successful in this final determination of the opposition and I see no reason to vary the normal practice.

  4. It is appropriate to award costs according to Schedule 8 against Merial Limited.

    Barbara Akhurst
    Delegate of the Commissioner of Patents


Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

6

Statutory Material Cited

0

Merial Limited v Intervet International B.V [2016] APO 39
Merial Limited v Intervet International [2017] APO 47
R v Smith (Commissioner of Patents); Ex parte Mole Engineering Pty Ltd [1981] HCA 25