Merial Limited v Intervet International
[2017] APO 47
•19 September 2017
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial Limited v Intervet International [2017] APO 47
Patent Application: 2006289102
Title:PCV-2 vaccine
Patent Applicant: Intervet International B.V.
Opponent: Merial Limited
Delegate: Dr B. Akhurst
Decision Date: 19 September 2017
Hearing Date: 23 August 2017, in Canberra.
Catchwords: PATENTS – section 104 opposition - the claims as proposed to be amended fall within the scope of the accepted omnibus claim – any deficiencies under s102(2) do not arise as a result of the amendment – opposition unsuccessful.
Representation: Patent attorney for the applicant: David Myers.
Counsel for the opponent: Christian Dimitriadis and Claire Cunliffe.
Patent attorney for the opponent: Dr Jenny Petering of FB Rice.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2006289102
Title:PCV-2 vaccine
Patent Applicant: Intervet International B.V.
Date of Decision: 19 September 2017
DECISION
The opposition is unsuccessful.
Costs are awarded according to Schedule 8 against Merial Limited.
At the hearing, I allowed Merial’s request on 9 August 2017 to amend its Statement of Grounds and Particulars.
REASONS FOR DECISION
Background
Patent application 2006289102 was filed by Intervet International B.V. (Intervet) on 8 September 2006. An opposition to grant of a patent by Merial Limited (Merial) was heard and the decision reported as Merial Limited v Intervet International B.V. [2016] APO 39 on 27 June 2016. That decision found that certain claims of the specification lacked an inventive step.
Intervet proposed amendments to the specification under section 104 on 23 August 2016 and after an adverse examination report, proposed further amendments on 27 October 2016. After the grant of leave to amend was advertised on 5 January 2017, Merial opposed allowance of the amendments. No party sought to file evidence and the matter was heard on 23 August 2017 in Canberra. The parties’ summaries of submissions for the hearing were filed on 9 August 2017 and 16 August 2017.
The Law
The request for examination of the patent application was filed before 15 April 2013 and as a consequence the substantive amendments of the Patents Act 1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present application. Instead, the relevant provisions of the Act in this matter is subsection 102(2) as it existed prior to the introduction of the ‘Raising the Bar’ Act, which are set out below:
(1) An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.
(2)An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:
(a)a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or
(b) the specification would not comply with subsection 40(2) or (3).
The ‘relevant time’ for the purpose of s 102(2) is after the specification has been accepted[1]. Subsections 40(2) and 40(3) of the Act as they apply to the present case are set out below:
(2) A complete specification must:
(a) describe the invention fully, including the best method known to the applicant of performing the invention; and
(b) where it relates to an application for a standard patent – end with a claim or claims defining the invention.
(3) The claim or claims must be clear and succinct and fairly based on the matter described in the specification.
[1] Subsection 102(2A) of the Act.
The opposition under s 104
Merial’s original statement of grounds and particulars (SGP) filed on 31 March 2017 identified the grounds of opposition as failure to comply with the allowability criteria set out in subsection 102(1) and paragraphs 102(2)(a) and 102(2)(b). With its submissions for the hearing, Merial proposed amendments to the SGP to remove the s102(2)(a) ground and amend its particulars under s102(2)(b) removing those relating to fair basis, and adding those for full description and best method. Intervet advised that it did not oppose the SGP amendments, and it addressed the additional matters in its submissions for the hearing. Subregulation 5.16(3) does not apply and at the hearing I advised the parties that I made the amendments to the SGP.
Merial’s submissions for the hearing were limited to those under s102(2)(b), specifically that the specification failed to fully describe the invention in the proposed claims and provide the best method of performance, and that the proposed claims lack clarity. Intervet responded that the grounds of opposition cannot succeed in the present case, because all of the subject matter in the claims as proposed to be amended explicitly falls within the scope of accepted claim 12, rather than arising as a result of the amendment.
Consideration
The construction of s102, and in particular the effect of the phrase “as a result of the amendment” in subsections 102(1) and 102(2), has been conveniently summarised by Moshinsky J in United States Gypsum Company v CSR Building Products Ltd[2]. Relevant to the case Merial is presently pursuing, are the following principles:
[2] [2017] FCA 595.
“34. The language used by the Patents Act directs attention to the effect of the amendment being considered. Thus, it has been said that the application of s 102(1) involves a two stage process. In RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd [1998] FCA 1358; (1998) 89 FCR 458, the Full Court of this Court (Burchett, Carr and Goldberg JJ) said at 466:
“That subsection requires one first to identify precisely what is the amendment. In this case that is done by identifying the difference between the specification as accepted (and as it stood at the hearing of the motion at first instance) on the one hand and, on the other hand, as the specification would read if amended in the manner sought. … The subsection [i.e. 102(1)] focuses on the amendment proposed and it must be that amendment which has the result of pushing the claimed matter over the line defined by the expression “matter not in substance disclosed in the specification as filed”. The key point to keep in mind is … that the words “as a result of the amendment” are not to be confused with the expression “after the amendment”. …
35. In Bristol-Myers Squibb Co v Apotex Pty Ltd [2010] FCA 814; (2010) 87 IPR 516 at [38], Yates J reiterated that the analysis undertaken pursuant to s 102(1) must be confined to a consideration of the result of the proposed amendments:
[T]he key point is that the words “as a result of the amendment” in s 102(1) are not to be confused with the expression “after the amendment”. The amendment is identified by considering the specification as it stands with how it would stand after the proposed amendment. It is only by that step that one can determine what matter results from the amendment. … If by reason of the amendment proposed, and for no other reason, the specification would then claim matter not in substance disclosed in the specification as filed, the amendment would not be allowable.
36. The phrase “if, as a result of amendment” has the same meaning when used in s 102(2). In this respect, it has been observed in Bodkin C, Patent Law in Australia (2nd ed, Thomson Reuters, 2014) at [13230] that:
The expression “as a result of the amendment” has the same meaning in the context of s 102(2) as it does in the context of s 102(1) (see [13220]); that is, in s 102(2)(b) the appropriate question is whether any failure to comply with s 40(2) or (3) would arise because of an amendment that is proposed, and did not exist before.”
Thus, in order to decide the allowability of amendments proposed to the complete specification under section 104, I must first identify the effect of the proposed amendments on the scope of the claims as they currently stand. Only then can I determine whether the proposed amendments result in the specification failing to comply with the allowability criteria set out in subsection 102(2).
The effect of the proposed amendments on the scope of the accepted claims
The accepted specification included 12 claims reproduced in Annex A to this decision. The amendments proposed on 23 August 2016 and 27 October 2016 reduces this to the 11 claims reproduced in Annex B to this decision – I will refer to these claims as the proposed claims. The combined effect of the proposed amendments is indicated below, with the additional text in a claim underlined and the deletions 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 awherein said vaccinethatcomprises 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. ThePpharmaceutical composition of claim 4 comprising at least 50 microgram/dose of ORF-2 protein of PCV-2and 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 63 or 4, characterized in that said composition comprises an oil-in-water emulsion asa suitableadjuvant.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, whereinthat said ORF-2 protein has been produced by way of expression from a baculovirus expression vector ininsectSpodoptera frugiperda Sf21 cells, and wherein the baculovirus expression vector comprises the PCV-2 ORF-2 gene sequence under the control ofa suitablethe 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 methodcomprising 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.Submissions
Intervet submitted that all of the proposed claims fall within the scope of accepted claim 12, which contained an ‘omnibus’ clause explicitly limiting the subject matter of each and every accepted claim to being “substantially as hereinbefore described with reference to any one of the Examples”. It noted that in the specification as proposed to be amended there is no use of new terms in the claims other than the restriction of “insect cells” to the specific insect Spodoptera frugiperda Sf21 cells; narrowing if anything of the scope of the independent claims; and no alteration of the examples in the specification.
Merial disagreed that the proposed claims are within the scope of those accepted, submitting that the amendments introduce language differences into the claims which change their scope. Relying on proposed claim 2 as an example of its concerns, Merial submitted that none of the proposed claims referred to an ORF-2 dose of “at least 50 micrograms” that is limited by reference to any one of the examples.
For the reasons that follow, proposed claims 1-11 are identical in scope to embodiments present in accepted claim 12, and for this reason any potential deficiencies in these claims do not arise as a result of the proposed amendments.
Proposed claims 1, 4 and 9
The amendments Intervet seeks to independent claims 1, 3 and 10 in the accepted specification is to explicitly incorporate all or part of the omnibus clause from dependent claim 12. The net effect of these amendments is evident in proposed claims 1, 4 and 9. In proposed claims 1 and 4 the claimed subject matter is limited to “being substantially as hereinbefore described with reference to any one of the examples”. In proposed claim 9 the subject matter is limited to “being substantially as hereinbefore described with reference to Example 5”.
Thus, proposed claims 1, 4 and 9 are of precisely the same scope as accepted claim 12 when dependent on accepted claims 1, 3 and 10, respectively.
Proposed dependent claims 2, 5, 7 (in part), and 10
Proposed claims 2, 5 and 10 each refer to either a vaccine or pharmaceutical composition comprising PCV-2 ORF-2 protein at a dose of at least 50 microgram, and are based on amendments to accepted independent claims 2, 4 and 11 which recite the same dose range.
Specifically, claims 2, 5 and 10 have been appended to proposed independent claims 1, 4 and 9, respectively, with duplicated text deleted. Proposed claim 2, 5 and 10 commence with the following words:
2. The use of claim 1 … ;
5. The pharmaceutical composition of claim 4 … ; and
10. The method of claim 9… ’.
As noted above, proposed independent claims 1 and 4 explicitly require “said use” and “said composition” of those claims, to be “substantially as hereinbefore described with reference to any one of the examples”, and proposed independent claim 9 limits “said method” to “being substantially as hereinbefore described with reference to Example 5”. In contrast to Merial’s submission, I construe the preamble to proposed claims 2, 5 and 10 reproduced above, as importing all of the details relating to the use, composition or method from proposed claim 1, 4, or 9, respectively, including the omnibus clause. As did the corresponding accepted claim, each of proposed claims 2, 5 and 10 encompasses a narrower range of doses than the independent claim to which they are appended, and otherwise remain subject to the omnibus clause. No further features are added to these claims. On this basis, I find proposed claims 2, 5 and 10 to be identical in scope to accepted omnibus claim 12 when dependent on accepted claims 2, 4 and 11.
Proposed claim 7 requires the pharmaceutical composition of the claims to which it is appended to comprise “an oil-in-water emulsion as adjuvant”. Insofar as it is dependent on proposed claims 4-5 in which the PCV-2 ORF-2 dose is at least 20 or 50 micrograms, respectively, I consider the scope of proposed claim 7 to be identical to that of accepted omnibus claim 12 when dependent on accepted claim 3 (at least 20 micrograms ORF-2/dose) or 4 (at least 50 micrograms ORF-2/dose), via accepted claim 6 (in which the pharmaceutical composition is “characterized in that said adjuvant is an oil-in-water emulsion”).
In summary, in the proposed claim set, claims 2, 5 and 10, and claim 7 when appended to claims 4-5, are identical in scope to embodiments present in accepted claim 12.
Proposed claim 8 (in part)
In the accepted claim set, claim 8 is dependent on claims 1 or 2, and explicitly requires the ORF-2 protein of the earlier claims to have been expressed in insect cells from a baculovirus expression vector comprising the PCV-2 ORF-2 gene sequence under the control of a suitable promoter. Dependent on claim 8, accepted claim 9 limits the promoter to the p10 promoter.
In the claims as proposed to be amended, claim 8 is dependent on any one of claims 1, 2 or new claim 3. The reference to “a suitable promoter” in accepted claim 8 has been explicitly limited to “the p10 promoter” and accordingly, claim 9 as accepted is deleted.
The term “insect cells” in accepted claim 8 has been explicitly limited in the proposed claim set to “Spodoptera frugiperda Sf21 cells”. The question is whether the inclusion of this specific embodiment arises in the claims as a result of the amendment and did not exist before? There was no dispute that omnibus claims should be construed narrowly and the details of the example(s) incorporated as part of the claims, rather than the scope of the claim being extended to the ‘substantial idea’ disclosed in the specification and shown in the drawings in accordance with the principles set out in Reckitt Benckiser Healthcare (UK) Ltd v Glaxosmithkline Australia Pty Ltd (No 5)[3]. Omnibus claim 12 in the accepted claim set encompasses, among other things, the use according to claims 8 or 9 substantially as herein before described with reference to any one of the examples. Example 3 of the specification is titled ‘production of PCV-2 antigen’ and describes the production of PCV-2 ORF‑2 protein by way of expression from a baculovirus expression vector (designated ‘BacPCV-2-ORF-2’) in Spodoptera frugiperda Sf21 cells.
[3] [2015] FCA 486; (2015) 112 IPR 273 at [79]-[89].
It follows that the combination of features now present in proposed claim 8 when dependent on proposed claims 1 or 2, were present in the accepted claim set - specifically, in the embodiment of omnibus claim 12 reciting the use according to claim 9, when ultimately dependent on claims 1 or 2 via claim 8.
Proposed claims 3, 6, 7(in part), 8 (in part) and 11
The proposed amendments introduce three additional dependent claims - claims 3, 6 and 11 - which each refer to either a vaccine or pharmaceutical composition comprising “up to 80 micrograms/dose” of the PCV-2 ORF-2 protein. Proposed claims 7 and 8 also include this feature when appended to claims 6 and 3, respectively. Thus, the effect of dependent claims 3, 6 and 11 is to impose an upper limit of 80 micrograms for the ORF-2 protein dose. The question is whether the reference to “up to 80 micrograms/dose” of PCV-2 ORF-2 protein arises in the claims as a result of the proposed amendments?
Accepted claims 1-11 refer to ORF-2 doses of “at least 20” or “at least 50” micrograms but impose no explicit upper limit on the dose amount. Notwithstanding, relevant to the ORF-2 doses encompassed by the various embodiments of omnibus claim 12, Example 5 is titled ‘Influence of the amount of PCV-2 ORF-2 on vaccine take in MDA positive young piglets’. Example 5 discloses a vaccination strategy in which the highest administered dose of ORF-2 protein is 80 micrograms. Thus, accepted omnibus claim 12 necessarily imposes an upper limit for the ORF-2 protein dose, restricting it to no more than 80 micrograms/dose. However, for the reasons that follow, I conclude that Example 5 more broadly discloses a preferred vaccination strategy using an ORF-2 protein dose between 20 and 80 micrograms.
Example 5 discloses a group of piglets, designated Group 2, which were administered 2 doses of PCV-2 ORF-2 protein 3 weeks apart within the range 20‑80 micrograms/dose, and explicitly states that sufficient seroconversion for herd protection was achieved in the group[4]. I agree with Merial’s submission that Example 5 uses inconsistent language regarding the precise ORF-2 doses administered to each piglet, variously referring to vaccination of the 85 piglets in Group 2 “with 20 and 80” micrograms/dose[5], “20-80” micrograms/dose[6] and “20 micrograms per dose or more”[7]. This raises the question of which dosages within the range of 20 to 80 micrograms are disclosed by the Example. The language used in Example 5 in relation to Group 1 is consistent in suggesting doses equal to or less than 14 micrograms. This suggests to me that those for Group 2 should be understood the same way, i.e. doses throughout the range 20 to 80 micrograms. Thus, I construe Example 5 as disclosing an embodiment in which adequate herd protection against PCV‑2 virus is achieved in a group of MDA-positive piglets by vaccinating with two doses of PCV-2 ORF-2 protein between 20 and 80 micrograms/dose. It follows that this feature was present in accepted omnibus claim 12.
[4] Specification Example 5 on page 13, lines 6-9, referring the group of piglets administered 20 micrograms/dose or more of ORF-2 protein, i.e. the Group 2 piglets in Example 5.
[5] Specification Example 5, page 11, line 2.
[6] Specification Example 5, page 12, Table 2.
[7] Specification Example 5, page 13, line 6.
As noted above, each of accepted claims 1-11, either explicitly or by way of a claim to which it is appended, are expressly limited to a lowest dose of PCV-2 ORF-2 protein of at least 20 or at least 50 micrograms. Accepted claim 12 imports the omnibus clause into each of accepted claims 1-11 individually, and I am satisfied that by way of Example 5 this clause imposes an upper limit of “up to 80 microgram/dose” of PCV-2 ORF-2 protein. It follows that this feature now explicitly stated in proposed claims 3, 6, and 11 was implicit in accepted omnibus claim 12 and does not arise as a result of the amendment.
Summary
The amendments proposed to the specification are confined to the claims. I have found above that the subject matter of each of the proposed claims is identical in scope to embodiments that were present in accepted claim 12. It logically follows that for the purposes of s 102, any potential deficiencies in the proposed claims do not arise “as a result of the amendment”, and consequently the opposition under subsection 102(2) must fail.
Conclusion
The opposition is unsuccessful.
Costs
Both parties claimed costs in the opposition. Ordinarily in proceedings such as these, costs follow the event. Merial has been unsuccessful in this opposition. In the circumstances, I see no reason to vary the usual practice. Costs are awarded according to Schedule 8 against Merial Limited.
Barbara Akhurst
Delegate of the Commissioner of PatentsAnnex A: The accepted claims.
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.
2. Use of ORF-2 protein of PCV-2 for the manufacture of a vaccine that comprises at least 50 microgram/dose of said ORF-2, for the protection of MD A-positive piglets against PCV-2 infection.
3. 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 MD A-positive piglets against PCV-2 infection.
4. Pharmaceutical composition 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.
5. Pharmaceutical composition according to claim 3 or 4, characterized in that said composition comprises 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 claim 1 or 2, wherein that said ORF-2 protein has been produced by way of expression from a baculovirus expression vector in insect cells, and wherein the baculovirus expression vector comprises the PCV-2 ORF-2 gene sequence under the control of a suitable promoter.
9. Use of ORF-2 protein according to claim 8, wherein said promoter is the p10 promoter.
10. 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 MD A-positive piglet.
11. A method for the protection of MDA-positive piglets against PCV-2 s 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.
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.
Annex B: The proposed claims.
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 use of claim 1, wherein said vaccine comprises at least 50 microgram/dose of said ORF-2.
3. The use of claim 1, wherein said vaccine comprises up to 80 10 microgram/dose of said ORF-2.
4. 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 MD A-positive piglets against PCV-2 infection, said composition being substantially as hereinbefore described with reference to any one of the examples.
5. The pharmaceutical composition of claim 4 comprising at least 50 microgram/dose of ORF-2 protein of PCV-2.
6. The pharmaceutical composition of claim 5, comprising up to 80 microgram/dose of said ORF-2.
7.Pharmaceutical composition according to any one of claims 4 to 6, characterized in that said composition comprises an oil-in-water emulsion as adjuvant.
8. Use of ORF-2 protein of Porcine Circovirus type 2 according to any one of claims 1 to 3, wherein said ORF-2 protein has been produced by way of expression from a baculovirus expression vector in Spodoptera frugiperda Sf21 cells, and wherein the baculovirus expression vector comprises the PCV-2 ORF-2 gene sequence under the control of the p10 promoter.
9. 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 MD A-positive piglet said method being substantially as hereinbefore described with reference to Example 5.
10.The method of claim 9, 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.
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