Merial Limited v Zoetis Services LLC
[2016] APO 12
•7 March 2016
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial Limited v Zoetis Services LLC [2016] APO 12
Patent Application: 2007343130
Title:Methods of vaccine administration
Patent Applicant: Zoetis Services LLC
Opponent: Merial Limited
Delegate: Dr B. Akhurst
Decision Date: 7 March 2016
Hearing Date: 9 May 2015 and 17 February 2016, in Canberra
Catchwords: PATENTS – section 59 opposition to grant of a patent – manner of manufacture – obvious on the face of the specification – whether a statement in the description is factually incorrect – whether amendment of the description overcomes the manner of manufacture ground of opposition – manner of manufacture ground not established – novelty – no clear and unmistakable directions to the claimed combination of features – lack of novelty not established – inventive step – the claims lack an inventive step – utility – lack of utility not established
Representation: Patent applicant: Patrick Flynn of Counsel, instructed by Tony Shaw, patent attorney of Allens Patent & Trade Mark Attorneys, Sydney.
Opponent: In May 2015, Dr Jenny Petering and Dr Karen Innes, patent attorneys of FB Rice, Melbourne. In February 2016, Jonathon Gottschall, barrister, instructed by Dr Jenny Petering and Dr Karen Innes.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2007343130
Title:Methods of vaccine administration
Patent Applicant: Zoetis Services LLC
Date of Decision: 7 March 2016
DECISION
Claims 1-20 lack an inventive step.
Zoetis has 2 months from the date of this decision to propose amendments to the claims.
Costs are awarded according to Schedule 8 against Zoetis Services LLC.
REASONS FOR DECISION
Background
Patent application 2007343130 was filed by Pfizer Products Inc. on 23 November 2007, via the PCT, claiming priority from application US 60/877332 filed on 27 December 2006. After examination, acceptance of the application was advertised on 20 December 2012. Changes of ownership first to Zoetis P LLC then Zoetis Services LLC (collectively Zoetis) were published on 27 June 2013 and 16 July 2015, respectively.
Merial Limited (Merial) served a notice of opposition on 20 March 2013 and filed a statement of grounds and particulars (SGP) on 20 June 2013. Amendments to the SGP were allowed on 5 December 2013 and 16 June 2014. Evidence in support was completed on 20 September 2013, evidence in answer on 20 February 2014 and evidence in reply on 20 May 2014. A request by Zoetis on 11 August 2014 for leave to serve further evidence under reg. 5.10(4) was granted unopposed on 10 September 2014. Merial filed responding evidence on 9 October 2014.
The opposition to grant of a patent was heard on 11 May 2015 in Canberra (the 2015 hearing). Merial opposed a request by Zoetis at the hearing for further evidence under reg. 5.10(4) in order to address the manner of manufacture ground of opposition. The matter was heard and on 7 July 2015, I granted leave to Zoetis to file the evidence. After a request by Merial, the Commissioner issued a Notice under s 210(1)(c) requiring the production of documents by Zoetis, which it filed on 25 September 2015. Merial filed responding evidence on 9 November 2015. In view of matters raised in Merial’s correspondence and evidence, on 24 November 2015 a delegate requested, among other things, that Zoetis confirm that it had complied with the Notice to Produce. Zoetis advised on 8 December 2015, that:
“… the applicant confirms that there are no product labels or product statements falling within the terms of the Notice to Produce dated 25 August 2015 in the applicant's possession, custody or power (including labels or statements used in Australia or elsewhere), that it has not produced. In this regard, the applicant attaches a declaration of S Mannion dated 7 December 2015 to the same effect.”
At para 1 of her declaration, Ms Mannion, identifies herself as Senior Corporate Counsel for Zoetis. She states that in order to find relevant documents she accessed older physical archives in the US and UK and the applicant’s newer electronic document registry (para 6). In addition she asked employees at the relevant time if they had any relevant documents in their possession (para 7). Ms Mannion states that she found no indication from her investigation that a relevant vaccine was registered outside the USA at the relevant time (para 7).
On 16 June 2015, Zoetis filed a request to amend the specification under section 104, which was allowed unopposed on 19 October 2015. The hearing was resumed in relation to the manner of manufacture ground only on 17 February 2016 (the resumed hearing).
The Evidence
Evidence in support consisted of a declaration by:
Richard E. Bevan dated 19 September 2013 (Bevan#1) with Exhibits REB 1-16
Evidence in answer consisted of declarations by:
Steven A. Holloway dated 19 December 2013 (Holloway#1) with Exhibits SAH-1 and SAH-2
Steven A. Holloway dated 20 February 2014 (Holloway#2) with Exhibits SAH-3 to SAH-5
Evidence in reply consisted of a declaration by:
Richard E. Bevan dated 15 May 2014 (Bevan#2) with Exhibits REB-17 to REB-19
Zoetis’s further evidence consisted of a declaration by:
Steven A. Holloway dated 11 August 2014 (Holloway#3)
Merial’s responding evidence consisted of a declaration by:
Richard E. Bevan dated 7 September 2014 (Bevan#3)
Zoetis’s further evidence filed at the hearing consisted of a declaration by:
Michele Brettmann dated 8 May 2015 and Annex A (Brettmann)
Merial’s responding evidence consisted of a declaration by:
Robert M. Nordgren dated 6 November 2015 (Nordgren) with Exhibit ###1
The Nordgren declaration
Zoetis objected to paras 6(d) and (e), 7(c) and (d), 15-29, 31 and 32-37 of the Nordgren declaration as raising new matter which is not directly responsive to the Brettmann declaration or the documents filed in response to the Notice to Produce (the produced documents).
Paragraphs 6(d)-(e) and 7(c)-(d) simply identify the Bevan declarations and Dr Nordgren’s instructions and are of little probative value. At the resumed hearing, Merial agreed to adopt the matter in paras 15-28 of the Nordgren declaration as submissions. Paragraph 31 of the Nordgren declaration relates to the construction of para 57 of the opposed specification in the context of the Brettmann declaration and the produced documents, and as such I consider it responsive to these documents.
For the reasons provided later in this decision, para 29 of the Nordgren declaration is not relevant to Merial’s manner of manufacture ground of opposition for which it was relied on. Merial acknowledged that paras 32-37 were not strictly in response to the Brettmann declaration. It did not formally request that these paras be admitted as further evidence, but in any event I consider their content to be of little relevance.
The documents filed in response to the Notice to Produce
The documents filed by Zoetis in response to the Notice to Produce under s 210(1)(c) were not formally adduced in evidence. However, Dr Nordgren refers to them in his evidence, as do both parties in their submissions. Consequently, I notified the parties at the resumed hearing that I intended to inform myself by reference to the produced documents under the provisions of Chapter 5 of the Patents Regulations 1991 (in this case, specifically reg 5.11 as it stood immediately before 15 April 2013). I am satisfied that each party had a copy of, or access to, the documents and had the opportunity at the hearing to make representations about them.
Additional matter
A declaration by David McGavin attached to Zoetis’s submissions is not in evidence in this opposition.
Grounds of opposition
The grounds of opposition pressed at the hearing were manner of manufacture, novelty, inventive step and utility.
Onus of Proof
The request for examination in relation to the patent application was filed on 29 April 2009. As a consequence, the substantive amendments of the Patents Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present patent application. This includes the amendment to subsection 60(3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition has been made out. Instead, the onus of proof in this opposition proceeding lies with the opponent, who must establish that it is clear that a valid patent cannot be granted (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29], [67], 50 IPR 305; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22], 79 IPR 426).
The specification
In construing the specification I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214, 100 IPR 451 at [139]:
“It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”
The opposed specification is titled “Methods of vaccine administration”. At para 1, it is stated:
“This invention relates to a method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of vaccine, wherein the vaccine comprises viral antigens, a bacterin, or both, and wherein the vaccine is administered subcutaneously or orally according to the schedules provided herein.”
The description states at para 2 that vaccines against major canine infectious diseases have been available for decades and have greatly reduced the incidence of these diseases. At para 4, the observation is made that the core canine vaccines marketed by major animal health companies are all delivered by the parenteral route, especially by subcutaneous injections. The conclusion is drawn that:
“A canine vaccine that could be delivered easily would provide increased convenience of vaccine delivery to the pet, the veterinarian, and the pet owner, and allow for personnel untrained in parenteral administration techniques to deliver canine core vaccines to animals.”
Under the heading “Description of the invention”, the invention is broadly summarised as follows:
“Provided herein is a vaccination regimen that reduces morbidity and mortality in animals, and provides increased ease of administration of vaccines for pets, veterinarians, and animal owners. It is highly desirable to administer vaccines using methods that do not require injection when animals are older. Also, oral vaccines are probably less likely to induce undesirable side effects that may be seen after parenteral vaccinations. Oral vaccines can be administered by individuals untrained in administering materials parenterally (i.e., via a needle and syringe), thereby increasing the probable frequency of vaccination and protection from disease.” (para 39)
The methods of the invention comprise administering to the dog a therapeutically effective amount of a first dose, a second dose, and optionally a third dose of an immunogenic composition, either all orally or in a combination of first and optionally the second dose subcutaneously, followed by oral administration of subsequent doses (paras 41-42, 44-45). An annual booster may be administered orally, with further annual boosters at the discretion of the veterinarian (vet) (paras 43, 45).
At para 47, the vaccines can contain antigens to protect dogs against or to treat diseases including those caused by canine distemper (CD) virus; canine adenovirus type 1 (CAV-1); canine adenovirus type 2 (CAV-2) or canine respiratory coronavirus (CCV); canine parainfluenza virus (CPI); canine coronavirus or canine parvovirus (CPV); Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, or L. Bratislava; and Bordetella bronchiseptica. One vaccine may be combined with other vaccines to produce a polyvalent vaccine product that can protect dogs against a wide variety of diseases caused by other pathogens (para 47). Examples of suitable vaccines include those in Pfizer’s VANGUARD® product line, “including but not limited to VANGUARD® Plus 5, VANGUARD® Plus 5 L4, and VANGUARD® Plus 5 L4 CV” (para 47).
There is no exemplification of preparing a vaccine, but at para 56 it is stated “One skilled in the art can readily formulate a vaccine”. The vaccines are provided sterile and pyrogen-free and can be made in various forms depending on the route of administration, storage requirements, “and the like”, for example as sterile aqueous solutions or dispersions suitable for injectable use, or in lyophilised form (para 56).
Claims construction
The specification was accepted with 20 claims, which are reproduced at Annex A to this decision. Claims 1 and 2 are the only independent claims.
The principles to be applied in construing the claims are well settled in law and were summarised by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228 at [118]-[120]. Most relevantly, the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear. Words used in a specification, including the claims, are to be given the meaning which the person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification. While the claims define the monopoly claimed in the words of the patentee’s choosing, the specification should be read as a whole. It is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification. However, terms in the claims which are unclear may be defined or clarified by reference to the body of the specification. The construction of a specification, including the claims, is ultimately a question of law for the Court.
“treating” a dog
The claims are to a method of treating a dog. “Treating” is defined on at para 35 of the description as referring to:
“preventing a disorder, condition, or disease to which such term applies; or to preventing one or more symptoms of such disorder, condition, or disease; or to reversing, alleviating, or inhibiting the progress of such disorder, condition, or disease”.
Oral administration
Merial submitted that the reference to oral administration in the opposed specification encompasses nasal routes of delivery which would achieve vaccine delivery to the oral mucosa. However, the dictionary definitions at paras 26 and 28 of the description explicitly distinguish oral from intranasal administration in that these terms refer to the introduction of a substance into a subject’s body “through or by way of” the mouth, or nose, respectively. It follows that insofar as they recite oral administration of vaccine, the opposed claims require the substance to be introduced through, or by way of, the mouth.
Vaccine formulation
At the hearing, Zoetis submitted that the opposed claims should be understood as defining a method of treatment in which the vaccine is formulated in such a way that it can be administered subcutaneously or orally, as a matter of convenience. Merial disagreed, noting that Zoetis’s construction is not explicitly mentioned in the claims and there is no clear disclosure to this effect in the specification. None of the claims explicitly requires that the vaccine is formulated or adapted to be suitable for both oral and subcutaneous delivery, and for the reasons that follow, I am not satisfied that it is permissible to read this feature into the claims.
Insofar as the claims may be ambiguous in this regard, the body of the specification does not support a construction that the same vaccine formulation is administered both orally and parenterally in carrying out the claimed methods. The stated “field of the invention” in para 1 of the description is consistent with the invention residing in the route and schedule for vaccine administration, rather than the suitability of the vaccine for both oral and parenteral delivery. While the definition of “vaccine” at para 37 of the description includes that the vaccine may be introduced directly into the subject by various routes of administration, other passages in the specification contradict Zoetis’s construction. At para 22, a “dose” is defined as “a vaccine or immunogenic composition given to a subject”. Notably, after a first dose, subsequent vaccine doses “may or may not be the same vaccine or immunogenic composition as the first dose” (para 22). Similarly, at para 46, the “first, second, third, and annual doses may be the same or a different vaccine or immunogenic composition and each comprises, independently, one or more antigens”. At paras 44-45, the description refers to adaptation of the vaccine for oral or subcutaneous administration.
Turning to the evidence, both experts understood the opposed application to describe and claim methods for vaccinating a dog against one or more of the common infectious agents in current vaccines by administering a vaccine in two or three doses and an annual booster, either orally or in a combination of subcutaneous then oral delivery (Holloway#2 at para 3(a)-(b); Bevan#1 at [22]). Both experts consider that a key issue in preparing a vaccine is its formulation (Holloway#2 at 4(k); Bevan#2 at [20]). However, they disagreed on whether the invention includes formulating the vaccine. It is apparent from Mr Bevan’s evidence that he did not think so, because the specification provides no information relevant to formulating a vaccine - in his second declaration at [20], Mr Bevan states:
“There is nothing mentioned in the opposed application as to how the oral vaccines were formulated for oral administration (if at all). From my reading of the opposed specification, it merely suggests that a suitable vaccine, such as the VANGUARD® 5 or VANGUARD® 5 L4 which are listed at paragraph [047] of the opposed application and which are ordinarily subcutaneously administered vaccines, can simply be administered orally without any further modification or alternatively as suggested at paragraph [056] can be readily formulated by a person skilled in the art.”
In contrast, since the claims refer to a combination of injection and oral vaccine delivery, Dr Holloway understood the specification to relate to methods and protocols for replacing or adapting some or all of the known parenteral vaccines, with vaccines that can be administered orally or in a combination of oral and subcutaneous routes (#2 at paras 3(b) and 4(h)). However, nowhere in his evidence does Dr Holloway refer to information in the opposed specification relevant to formulating a vaccine for oral and subcutaneous delivery (#2 at paras 3(a)-(g)). Consequently, I accord Dr Holloway’s evidence on this point less weight.
On balance, given the disclosure of the specification, supported by Mr Bevan’s evidence, I construe the claims as not requiring the use of a vaccine composition that is necessarily formulated in a manner such that it can be administered both orally and subcutaneously.
TCID50
The abbreviation “TCID50”, in claims 9-11, refers to “tissue culture infective dose” and means “that dilution of a virus required to infect 50% of a given batch of inoculated cell cultures” (para 33 of the description).
Manner of Manufacture
Section 18(1)(a) of the Act provides that an invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. The threshold requirement for a patentable invention is that it must not be apparent on the face of the specification that the subject matter of the claim lacks the necessary quality of inventiveness for it to be a proper subject of letters patent under the Statute of Monopolies (NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 at [9], (1995) 183 CLR 655 at 663).
Obvious on the face of the specification - the reference to oral administration in para 57
Merial’s submissions that the claimed methods for vaccine administration are obvious on the face of the opposed specification, were based on a statement at para 57 of the specification as filed, and at acceptance, that relevant known vaccines could be administered orally. Paragraph 57 is reproduced below, with “the oral administration direction” emphasised:
“[057] The subjects suitable for vaccination would include dogs that are about four weeks of age or older. Thus, the first dose would be given to a dog at about four weeks of age, followed by subsequent doses according to the timetable given herein. Certain commercially prepared vaccines provide directions for the timing of administration and number of doses based on the potential for maternal antibody interference. For example, the product label for VANGUARD® Plus 5 L4 (Pfizer Inc) indicates that dogs receiving the first vaccine at less than 9 weeks of age should be administered a third orally administered one-ml dose at about three weeks after a second dose.”
It was not in dispute that the VANGUARD® Plus 5 L4 vaccine was known and commercially available before the priority date. Thus, prima facie, the statement in para 57 that its product label indicated that a dose should be administered orally renders the oral administration of this vaccine obvious on the face of the specification.
Zoetis has since amended the specification to remove the words “orally administered” from para 57, which it submitted renders the manner of manufacture ground unsustainable. I am not satisfied that this is necessarily correct because, as noted by Merial, earlier versions of the specification containing the admissions are on the public record, including the PCT and accepted specifications and the priority document. There appears to be little judicial authority in Australia on this point. However, in Gerber Garment Technology Inc v Lectra Systems Ltd (Gerber) [1995] FSR 492 at 494-5 the UK Court of Appeal found that:
“… a recital [of the prior art] constituted an admission which must necessarily carry great weight, but that it did not estop the patentee or debar him from leading evidence to contradict it. … It would be contrary to all principles to hold a party to be estopped as against another party by an erroneous statement on which the other party has not relied.”
In Gerber, the specification incorrectly stated that the use of an item was known, which rendered the claims obvious. The Court of Appeal found at page 495 that if the other party had been disadvantaged by relying on the admission (most relevantly, it may have led them to apply for revocation of the patent), then the patentee might well be estopped from resiling from it. However, even in those circumstances the majority expected the patentee to be able to amend the specification for the future to delete the erroneous recital (page 495). The reasoning in Gerber supports a conclusion that Zoetis’s amendment alone does not resolve this ground of opposition. However, that if a statement in the specification can be shown to be in error, then the applicant can amend the specification and not be bound by the content of the earlier versions.
The question is whether Merial relied on the oral administration direction in para 57 to oppose grant of a patent for application 2007343130 and in doing so has been disadvantaged? Merial raised three grounds of opposition in addition to manner of manufacture, from which I infer that the admission in para 57 was not the sole factor it relied on in deciding whether to oppose grant of a patent. In these circumstances, it is reasonable to conclude that Merial has not been disadvantaged by taking a step it would not have taken had it not relied on the admission. It follows that Zoetis should not be estopped from disputing whether the reference to oral administration in para 57 is, in fact, correct.
Zoetis submitted that before the priority date the VANGUARD® Plus 5 L4 product label did not indicate that it should be administered orally. To establish this it relied on the Brettmann declaration and subsequently produced documents. Ms Brettmann identifies herself in her declaration as the applicant’s manager of regulatory affairs (para 1). She states at para 2 that the “VANGUARD® PLUS 5 L4 vaccine has been sold in the USA continuously since 2005”. At para 5 Ms Brettmann states:
“At all times since they were first sold, VANGUARD® Plus 5 L4 has been sold in the USA with containers, box labels and inserts which are in the approved form for administration by subcutaneous or intramuscular injection.”
Exhibited to the Brettmann declaration are four instances of vaccine container labels, box labels and pack inserts for VANGUARD® Plus 5 L4 dated June 2005 or January 2006, which were approved by the US Department of Agriculture Animal and Plant Health Inspection Service (APHIS) (Brettmann para 3). Subsequently, the produced documents are correspondence between the applicant and APHIS (submissions and approvals, consistent with Nordgren at [8]) and include further copies of vaccine container labels, box labels and pack inserts for the same VANGUARD® vaccine dated between July 2004 and 8 December 2006, this last being less than 3 weeks before the 27 December 2006 priority date. It was not in dispute that none of this product information includes the direction for oral administration as it occurs in para 57 of the opposed specification. Prima facie, Zoetis’s evidence lies in favour of finding the product label for the specified vaccine did not in fact indicate that a dose of vaccine should be administered orally.
Merial submitted that Zoetis’s evidence falls short of establishing the necessary facts to discharge the onus of establishing an error in the specification. It argued that the produced documents are unpublished copies of correspondence between the applicant and APHIS and that Zoetis has adduced no evidence of actual labels. Conceding that it may be reasonable to infer that the APHIS-approved labels were published, Merial nevertheless submitted that there is no evidence to support the further inference that nothing else was communicated to the public that might contradict the admission in the specification. Relying on Dr Nordgren’s evidence, Merial advanced arguments to the effect that it was logically credible that the oral administration direction in para 57 may have been made, or that it may originate in documentation other than the APHIS-approved script. However, without evidence that such a direction was in fact made, mere speculation that it may have been present in a label that is not presently before me, is not sufficient to counter Zoetis’s evidence that between mid-2004 until just before the priority date, approved labels did not contain the oral administration direction.
Merial also submitted that the “specification refers to the label for VANGUARD® Plus 5 L4 and incorporates it by reference” and then subsequently relied on the referenced label to conclude that “It is beyond doubt that the pack script was included in what was known about VANGUARD® Plus 5 L4 as a commercially available product”. However, para 57 does not explicitly incorporate any label by reference and in the absence of supporting evidence, the factual existence of a relevant label has not been established.
Disputing the adequacy of Zoetis’s evidence to establish that the oral administration direction in para 57 was not made, Merial noted in particular:
· the absence of any information on whether the vaccine was sold in other countries, or whether there were other approved script;
· that Ms Brettmann fails to explicitly confirm or deny whether the oral administration direction was given; and
· there may have been inaccuracy in identifying the provenance of the statement in para 57 and misattribution of the source.
While I accept that it is difficult for Merial to obtain relevant evidence, in the absence of any evidence establishing, on the balance of probabilities, that a VANGUARD® Plus 5 L4 product label existed containing the oral administration direction as it occurs in para 57 of the accepted specification, Merial has not refuted the substance of Merial’s evidence which is that para 57 is factually incorrect.
On balance, I find that the product label for VANGUARD® Plus 5 L4 did not in fact indicate that in the specified circumstances, dogs should be orally administered a third dose of the vaccine. The specification has now been amended to delete the reference to oral administration in para 57 and, consistent with the principles in Gerber, Zoetis is not bound by the erroneous statement in the earlier versions.
Merial advanced no argument that oral administration of vaccine was obvious on the face of the amended specification and I am satisfied that it was not.
Relevance of para 29 of the Nordgren declaration
At the hearing, there was discussion about whether para 29 of the Nordgren declaration was properly in response to the Brettmann declaration, and if not whether it should be admitted as further evidence. In any event, for the reasons that follow I do not consider Dr Nordgren’s evidence at para 29 at all relevant to the manner of manufacture ground of opposition.
At para 29 of his declaration, Dr Nordgren states:
“The Label Circular [i.e. the pack insert] of the 14 April 2006 copy also explicitly describes oral administration of the CPV fraction of VANGUARD Plus 5 L4. This is set out in a description of a backpassage study under the heading “SAFETY AND EFFICACY”. Safety and efficacy are generally established using the same route of administration. The use of oral administration in the backpassage study is mode of [sic] testing safety that is consistent with a vaccine that is suitable for oral administration.”
At the hearing, there was no dispute that a backpassage study is carried out to ensure the safety of a vaccine and not for the purposes of vaccination. Dr Nordgren’s conclusion that the “use of oral administration in the backpassage study … is consistent with a vaccine that is suitable for oral administration” is, in effect, an opinion on the suitability of the CPV fraction of the specified vaccine for oral delivery. This evidence does not address the question of whether or not a VANGUARD® Plus 5 L4 product label at the relevant time, included directions that “dogs receiving the first vaccine at less than 9 weeks of age should be administered a third orally administered one-ml dose at about three weeks after a second dose”. Consequently, Dr Nordgren’s evidence at para 29 is not relevant to the manner of manufacture ground of opposition. It follows that the declaration by David McGavin responding to para 29 of the Nordgren declaration is also not relevant.
Use of a known substance for a purpose for which its known properties make it suitable
Merial submitted that the opposed claims do not define a manner of manufacture because they recite the use of a known material (the antigens) in a vaccine, for the purpose of which its known properties make that material suitable (as in Commissioner of Patents v Microcell Ltd (Microcell) [1959] HCA 71 at [15], (1959) 102 CLR 232 at 251). Responding, Zoetis submitted that it was not previously known that any properties of vaccines previously administered subcutaneously made them suitable for oral administration at all, let alone in the same dosing regimes as had been previously used for subcutaneous administration. Zoetis submitted that this property of the known substance was first discovered and utilised in the opposed specification.
In Microcell, the High Court found claims did not define a manner of manufacture where the specification itself indicated that claimed products were well known articles of manufacture and that the product comprised well known materials. Subsequently, in Novozymes AS v Danisco AS [2013] FCAFC 6 at [218]-[221], (2013) 99 IPR 417 [219]-[222] Jessup J found that where the claims defined a process which involved inactivation of an enzyme, a manner of manufacture argument is only made out if it appears on the face of the specification that a process including enzyme inactivation was known. Similarly, in AstraZeneca AB v Apotex Pty Ltd (AstraZeneca) [2014] FCAFC 99 at [409], 107 IPR 177 at [409], the Full Court distinguished Microcell, in circumstances where the patent specification claimed a known pharmaceutical substance coated with a known commercial coating to improve its stability, and the specification did not admit or disclose on its face that it was known before the priority date that the disclosed commercial coatings could be used to address the stability issues that are discussed in the specification.
I have found above that the single reference to orally administering a third dose of VANGUARD® Plus 5 L4 vaccine in para 57 of the specification is factually incorrect and does not form part of the disclosure. The opposed claims recite methods of treating a dog for canine diseases by administering a therapeutically effective amount of specified vaccine in 2-3 doses followed by annual dose(s), either all orally or in a combination of subcutaneous then oral doses. The specification does not admit on its face that such methods were previously known. Consequently, this aspect of the opposition fails.
Collocation of known components
Merial submitted that the vaccines covered by the claims are a collocation of known integers because each antigen was known before the priority date and each performs its own function independently of the others as was the case in British Celanese v Courtaulds Ltd (1935) RPC 171 at 193-194. However, the claims define a method of treating a dog using a vaccine, not the vaccine per se, and for this reason at least I am satisfied the claims do not define a mere collocation of known components.
Manner of Manufacture summary
Merial has not established that the claims do not define a manner of manufacture.
Novelty
Section 18(1)(b)(i) of the Act provides that an invention, so far as claimed in any claim, must be novel when compared with the prior art base. It is well established that the general test for anticipation is the reverse infringement test. The classic formulation of this test is that given by Aicken J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 at [20], (1977) 137 CLR 228 at 235:
“The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement”
In AstraZeneca at [293], the majority of the Full Court identified the principles in General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (General Tire) [1972] RPC 457 at 486 as the criteria for determining anticipation by a prior publication. Most relevantly, to anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented.
The majority in AstraZeneca at [294], noting the use of the “planting the flag” and “accuracy of a sniper” metaphors in earlier Australian decisions (ICI Chemicals & Polymers Ltd v The Lubrizol Corporation Inc [2000] FCA 1349 at [51], (2000) 106 FCR 214 at [51] and Apotex Pty Ltd v Sanofi-Aventis [2008] FCA 1194 at [91], (2008) 78 IPR 485 at [91]), described them as underlining the importance of the specificity required in order for a prior art document to anticipate a claimed invention.
Priority date
I disagree with Merial’s submission that the priority date of the claims should shift to the date of the amendment removing the reference to oral administration from para 57. Section 114 as it stood immediately before 15 April 2013 provides that where a claim of a complete specification claims matter that was in substance disclosed as a result of amending the specification, the priority date of the claim must be determined under the regulations. Merial advanced no submissions to the effect that the opposed claims claim matter that was not in substance disclosed by the specification prior to the amendment. I am satisfied that they not do so. The priority date of the claims in the amended specification is 27 December 2006.
The prior art
Merial relied on two prior art documents to establish lack of novelty. These are:
WO 2006/038115 (Pfizer Products, Inc). 13 April 2006 (WO’115)
WO 2002/002139 (American Home Products Corporation) 10 January 2002 (WO’139)
WO’115
WO’115 is in evidence as exhibit REB-16. It is titled “Multivalent canine vaccines against Leptospira bratislava and other pathogens”.
Merial considered this earlier application by Pfizer to disclose the same pathogens, canine subjects, and administration routes and schedules as specified in the opposed claims. It submitted that there would have been no undue experimentation required to perform the claimed methods on the basis of this disclosure. Zoetis submitted that WO’115 provides no directions at all as to the dosing regime to be applied for an oral vaccine.
On page 1 of WO’115, the “Field of the invention” extends to combination vaccines and their use for the prevention of canine infectious disease, as follows:
“This invention relates to vaccines containing a Bordatella bronchiseptica p68 antigen and the use thereof for protecting dogs against infectious tracheobronchitis (‘kennel cough”) caused by Bordatella bronchiseptica. This invention also relates to combination vaccines containing a Bordetella bronchiseptica p68 antigen and one or more antigens of another canine pathogen such as canine distemper (CD) virus, canine adenovirus type 2 (CAV-2), canine parainfluenza (CPI) virus, canine coronavirus (CCV), canine parvovirus (CPV), Leptospira bratislava, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae or Leptospira pomona. Methods for protecting dogs against diseases caused by canine pathogens using combination vaccines are also provided. This invention relates to vaccines containing Leptospira bratislava and the use thereof for protecting dogs against infections caused by Leptospira bratislava. This invention also relates to combination vaccines containing Leptospira bratislava and one or more antigens of another canine pathogen such as canine distemper (CD) virus, canine adenovirus type 2 (CAV-2), canine parainfluenza (CPI) virus, canine coronavirus (CCV), canine parvovirus (CPV), Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae or Leptospira pomona. This invention further relates to combination vaccines of said antigens without Leptospira bratislava. Methods for protecting dogs against diseases caused by canine pathogens using the combination vaccines are also provided.”
The evidence establishes that WO’115 discloses vaccines relevant to the opposed claims and the use of the vaccines for protecting dogs against canine pathogens, which falls within the definition of “treating” a dog for canine diseases (Bevan#1 at [31]; Holloway#1 at [4(z)]). To anticipate opposed claims 1 or 2, WO’115 must also provide clear and unmistakable directions to administer the vaccine in either two or three oral doses followed by one or more oral annual boosters; or the first dose subcutaneously, the second dose orally or subcutaneously, any third dose orally, followed by oral administration of one or more annual doses.
Regarding the administration schedule for relevant vaccines, on pages 14-16 WO’115 discloses preferred vaccination schedules including 2 or 3 doses and optional yearly boosters, as follows:
“In accordance with the present invention, … [relevant] combination vaccines can be administered to healthy dogs … preferably in 3 doses, each administered about 3 weeks apart. Dogs can be revaccinated annually with a single dose.” (page 14, lines 29-33)
“In accordance with the present invention, … [relevant] combination vaccines can be administered to healthy dogs … preferably in 2 doses, each administered about 3 weeks apart. Dogs can be revaccinated annually with a single dose.” (page 15, line 43 to page 16, line 3)
Regarding the route of vaccine administration, the most relevant disclosure in WO’115 is a statement identified by Mr Bevan (#1 at [31]), reproduced below:
“The administration can be done by any known routes, including the oral, intranasal, mucosal topical, transdermal, and parenteral (e.g., intravenous, intraperitoneal, intradermal, subcutaneous or intramuscular). … Administration can also be achieved using a combination of routes, e.g., first administration using a parenteral route, and subsequent administration using a mucosal route. Preferred routes of administration include subcutaneous and intramuscular administrations.” (WO’115 page 13, lines 14-19)
That last paragraph discloses administration of a first vaccine dose parenterally and subsequent dose(s) using a mucosal route. “Parenteral” administration encompasses at least “intravenous, intraperitoneal, intradermal, subcutaneous or intramuscular” routes of administration. I have construed oral administration in the opposed claims, as meaning administration “through or by way of the mouth”. However, the reference to “mucosal” routes in WO’115 encompasses more than just oral administration and includes, for example, delivering a substance to the nasal and nasopharyngeal mucosa by intranasal administration (see for example the definitions at paras 26 and 28 of the opposed specification).
Relevant to the claims requiring oral administration of two or three vaccine doses and one or more annual boosters, Dr Holloway does not understand WO’115 to disclose a method for oral vaccination per se (#2 at [4(z)]). Mr Bevan acknowledges that WO’115 “may not specifically mention a method for oral vaccination per se”, but he considers it to describe all the relevant antigens and to instruct that they can be administered orally (#1 at [31]; #2 at [25]).
In effect, Merial’s case for lack of novelty relies on a mosaic of the options in the WO’115 paragraphs reproduced above in order to anticipate vaccination methods comprising the administration route(s) and schedules set out in opposed claims 1 and 2. However, the evidence is not sufficient to establish that WO’115 discloses the combination of features in opposed claims 1 or 2 with sufficient specificity to provide clear and unmistakable directions to the methods as presently claimed.
I find the claims novel in light of WO’115.
WO’139
WO’139 is in evidence as exhibit REB-8 (and REB-14). It is titled “Methods and compositions for oral vaccination”. On page 1, WO’139 refers to the benefits of vaccination and explains that oral administration is preferable in large populations of farm animals and domesticated pets, such as dogs and cats, among other things to reduce stress.
It was not in dispute that WO’139 teaches oral administration to animals of a relevant vaccine in one or two doses, but does not explicitly disclose subsequent annual dosing. On this basis, Zoetis submitted that WO’139 does not disclose the invention as presently claimed. Merial submission was essentially that since it was common general knowledge and therefore routine to administer an annual booster vaccine, the person skilled in the art would add annual oral dosing to the WO’139 disclosure as a matter of course. Merial argued that there is no undue experimentation required by the person skilled in the art to perform the claimed methods based on the disclosure of WO’139.
To support its submission, Merial relied on Justice Middleton’s reasoning in Eli Lilly and Company Limited v Apotex Pty Ltd (Eli Lilly) [2013] FCA 214 at [290] which is reproduced below:
“In the end … the question is one of clarity of disclosure. If the prior disclosure is clear and unmistakable enough in making directions and includes all the essential integers of the invention as claimed, then the invention will not be novel. However, there does not necessarily need to be a literal disclosure – see Nicaro Holdings Pty Ltd v Martin Engineering Co [(Nicaro)[1990] FCA 40] (1990) 91 ALR 513 at 531 per Gummow J. If there is not literal or exact disclosure, then if the skilled addressee would add the missing information as a matter of course (without the application of inventive ingenuity or undue experimentation), that would lead to anticipation.”
The difficulty arises in considering that paragraph in isolation. When it is read in the context of what follows in Eli Lilly, it is clear that Justice Middleton’s reference to “missing information” that might be added by the skilled addressee refers to the implicit disclosure of the prior document. An implicit disclosure is confined to what is in fact disclosed to the skilled addressee by the prior document and does not extend to the addition of an integer (AstraZeneca at [347]-[350]). Justice Middleton’s subsequent paragraphs in Eli Lilly, relevantly reproduced below, confirm that he is not departing from the disclosure of the prior art as informed by the expert evidence:
“[292] The correct approach, not constrained by any presumption, … is that described by Bennett J in H Lundbeck [v Alphapharm Pty Ltd [2009] FCA 70 at [191]], (2009) 177 FCR 151 at 194 [191]:
Where the prior disclosure is of large numbers of compounds by reference to a chemical formula, evidence will establish whether or not such a form of disclosure in the context of the examples and the discussion in the specification is disclosure of any particular subsequently claimed compound.
[293] Therefore, evidence will establish whether there is sufficient disclosure to the skilled reader of olanzapine in prior art documents. … Thus, it becomes necessary to investigate the prior documents said to give rise to the anticipation, and to take into account the expert evidence as to what those prior documents disclose.”
In Nicaro, Gummow J confirmed at [34]-[35] that the law on novelty does not extend to finding a prior art document novelty-destroying where it does not include an integer of a claim and what was required of the skilled addressee to produce the claimed combination was the taking of an obvious and non-inventive step.
As indicated above, WO’139 does not explicitly disclose annual dosing. I did not understand Merial to be relying on an implicit disclosure of oral annual dosing in WO’139, and in any event, there is no evidentiary support for such a conclusion. In the absence of clear and unmistakable directions to a method including oral annual dosing, I find the claims novel in light of WO’139.
Novelty summary
Merial has not established that any claim lacks novelty.
Inventive Step
Section 18(1)(b)(ii) of the Act provides that an invention, so far as claimed in any claim, must involve an inventive step when compared with the prior art base. Under the provisions of subsections 7(2) and 7(3) of the Patents Act 1990, an invention is taken to involve an inventive step when compared with the prior art base unless it would have been obvious to a person skilled in the art. ‘Obvious’ means ‘very plain’ (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21 at [51] - [52], (2007) 72 IPR 447 at 461 [51] - [52]). The invention must be obvious in the light of the common general knowledge as it existed in the patent area before the priority date, either on its own or together with information in a document, or combination of documents, that the person skilled in the art could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant and, where necessary, combined.
The test for obviousness was provided by Justice Aicken in Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12 at [45]; 148 CLR 262 at 286 as follows:
“The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.”
The High Court in Aktiebolaget Hässle v Alphapharm Pty Ltd (Alphapharm) [2002] HCA 59 at [51]- [53], 212 CLR 411 at [51]-[53] approved this approach, in addition to that taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at 187 in which Graham J had posed the “reformulated” Cripp’s question, which can be summarised as follows:
Would the notional research group at the relevant date, in all the circumstances, directly be led as a matter of course to try the claimed combination of integers, in the expectation that it might well produce a useful or desired result.
Both approaches require that the person skilled in the art has a reasonable expectation of success, which is explicit in the expectation that an approach “might well” succeed and implicit in steps characterised as routine and to be tried as a matter of course (Generic Health Pty Ltd v Bayer Pharma Aktiengessellscaft [2014] FCAFC 73 at [71]). Where, as in this case, the invention lies in a combination of features, the question is whether the combination, not each individual feature, is obvious when compared to the prior art base (Alphapharm [2002] HCA at [41], 212 CLR at [41]; Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd (Minnesota Mining) [1980] HCA 9 at [116], (1980) 144 CLR 253 at 293).
The usual approach to determining inventive step is the problem-solution approach. Once the problem has been formulated and the common general knowledge and the prior art base has been determined, the question of whether the claimed solution is obvious must be addressed.
The problem
Merial considered the problem addressed by the application to be the provision of an alternative administration regimen for vaccines. Zoetis identified the problem as the need to address the key disadvantage with the prior methods of administration, specifically that they required a trained vet to administer a subcutaneous or intramuscular injection. The parties submissions are not inconsistent with the need in the art identified in para 4 of the specification for a canine vaccine “that could be delivered easily” to “provide increased convenience of vaccine delivery to the pet, the veterinarian, and the pet owner, and allow for personnel untrained in parenteral administration techniques to deliver canine core vaccines to animals”. On balance, I consider a reasonable formulation of the problem addressed by the application to be the provision of an alternative and more convenient administration regimen for canine vaccines.
The person skilled in the art
The notional “person skilled in the art” is an artificial construct that is used as a tool of analysis “which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step” (AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23], (2015) 89 ALJR 798 at [23]). In general, the skilled person or addressee is the person who works in the art or science with which the invention is connected. He or she is a person, or team, likely to have a practical interest in the subject matter of the invention. While the skilled person may be assumed to be well-versed in the relevant art, such a person must be taken to be non-inventive. (Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [71] - [72], 49 IPR 225 at [71] - [72] referring to Catnic Components Ltd v Hill &Smith Ltd [1982] RPC 183 at 242 and General Tire [1972] RPC 457 at 485; Minnesota Mining [1980] HCA 9 at [115], 144 CLR 253 at 293).
There was no dispute and I agree that the person skilled in the art or team would include a practicing vet. Thus, the evidence of Zoetis’s expert, vet Steven Holloway, is relevant. The parties disagreed on whether the person skilled in the art would also have expertise in formulating vaccines. In this regard, the specification states at para 56, that “One skilled in the art can readily formulate a vaccine”. Consistent with this, Dr Holloway states that “a key issue in preparing a vaccine or vaccination method relates to the formulation of the vaccine” (Holloway#2 at [4(k)], emphasis added). It is reasonable to conclude that the person skilled in the art would possess skills in vaccine formulation.
Zoetis submitted that Merial’s expert Richard Bevan did not represent the person skilled in the art, because his experience was in quality assurance not formulation of vaccines. Mr Bevan graduated in 1970 with a B. Sc. in Agriculture, specialising in microbiology (Exhibit REB-1 page 1). Between 1970 and 1997, he was involved in the quality assurance of pharmaceutical products, including the production and testing of veterinary vaccines (Bevan#1 at [2] and Exhibit REB-1). Between 1998 and the priority date, Mr Bevan worked as a consultant to the industry, with respect to the production and quality assurance of veterinary vaccines (Bevan#1 at [2] and Exhibit REB-1). Since Mr Bevan’s experience broadly extends to the production of veterinary vaccines, I consider his evidence relevant to the opposition.
In summary, the person skilled in the art in this opposition has expertise in the production and administration of vaccines. The evidence of both Mr Bevan and Dr Holloway is relevant.
The common general knowledge in the art
A definition of common general knowledge was provided by Aitken J in Minnesota Mining [1980] HCA 9, (1980) 144 CLR 253 at 292:
“The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”
Before the priority date, the oral route of administration for canine vaccines was not known in small animal veterinary practices (Holloway#2 at [3(h]), consistent with Bevan#2 at [15]). However, the concept of oral vaccination was known (Holloway#2 at [4(jj)], consistent with Bevan#2 at [15]).
The evidence establishes that the common general knowledge in the art before the priority date also included the following:
· Canine vaccines for CD, CPV, CAV-2, CPI, CCV, Bordetella Bronchiseptica (BB) Leptospira icterohaemorrhagiae and L. canicola were available and used in Australia (Holloway#1 at [4(b)])
· Canine vaccines were typically multivalent in order to prevent or treat a number of canine diseases simultaneously (Bevan#1 at [7]; Holloway#1 at paras 4(c), (i), (w)). The “core” viral constituents are CD, CPV, CAV-2 and CPI (Bevan#1 at [6]; Holloway#1 at [4(b), (e)-(f)]). The VANGUARD®5 vaccine including these antigens was used in Australia and administered subcutaneously to dogs (Bevan#1 at [10]; Holloway#1 at [4(b)])
· Leptospira antigen such as L. icterohaemorrhagiae and L. canicola was also included in vaccine compositions. (Bevan#1 at [7]; Holloway#1 at paras 4(b), (h)). Bordetella Bronchiseptica or CCV antigen preparation was often used as a diluent to reconstitute other canine vaccines (Bevan#1 at [7], [10]). A combined BB and CPV vaccine for intranasal administration was in use (Bevan#1 at [14]; Holloway#1 at paras 4(h), (i), (n))
· The core canine vaccines were typically administered by a vet parenterally by subcutaneous or, less commonly, intramuscular injection (Bevan#1 at [8]; Holloway#1 at paras 4(b), (m), (o)).
· A vaccination strategy for dogs would typically involve vaccinating immunocompetent puppies two or three times, followed by annual booster vaccinations (Bevan#1 at [9]; Holloway#1 at paras 4(p)-(v)).
· Bait vaccines against rabies were used outside Australia where rabies is endemic (Bevan#1 at [6], [14]; Holloway#1 at [4(aa)]).
The prior art base
Merial submitted that claims of the application lacked an inventive step in light of each of the following documents:
WO’115
WO’139
Baer, G.M. et al. (1989) American Journal of Veterinary Research 50(6): 836-837 (Baer)
Ascertained, understood and regarded as relevant
“Ascertained” means found or discovered (Commissioner of Patents v Emperor Sports Pty Ltd [2006] FCAFC 26 at [29]-[30], (2006) 67 IPR 488). The person skilled in the art could be expected to have regarded a prior disclosure as relevant if it is directed to solving a particular problem or meeting a long-felt want or need as the patentee claims to have done (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (Lockwood (No 2))[2007] HCA 21 at [152], (2007) 235 ALR 202). The question of what a person skilled in the relevant art would regard as relevant, when faced with the same problem as the patentee, is to be determined on the evidence (Lockwood (No 2) at [153]).
Patent literature
Relying on Dr Holloway’s evidence (#1 paras 4(dd)-(ee)), Zoetis submitted that as a vet, the person skilled in the art would not look to patent documents to solve a problem in vaccine delivery. However, I have found above that the person skilled in the art or team includes a person with expertise in the production of vaccines. Mr Bevan’s evidence (#1 at para 18) establishes that such a person would have regard to the patent literature when seeking information to solve a problem.
WO’115 is titled “Methods of vaccine administration” and the abstract refers to subcutaneous or oral administration of a vaccine to a dog. WO’139 is titled “Methods and composition for oral vaccination” which the abstract states encompass methods and compositions for oral vaccination of healthy animals. Given the content of each title and abstract, it could be reasonably expected that WO’115 and WO’139 would have been ascertained before the priority date by the person skilled in the art seeking information with which to provide and alternative and more convenient administration regimen for canine vaccines. Both documents are in English and could be reasonably expected to have been understood.
Although Dr Holloway states that WO’139 and WO’115 are not relevant to the opposed claims (#2 at [4(w)] and [4(z)]), it is not apparent that he considered the relevance of the documents to the problem identified above. Later in this decision I find that, faced with the problem at the priority date, the person skilled in the art would have considered oral delivery strategies. As such, I am satisfied that the person skilled in the art could be reasonably expected to have regarded WO’115 and WO’139 as relevant.
Baer
Merial considered it reasonable to expect that Baer would have been ascertained by the person skilled in the art conducting an on-line search for information regarding alternative and more convenient canine vaccination regimes. Zoetis submitted that there is no evidence that Baer would have been ascertained without the benefit of hindsight, particularly since it did not appear until Mr Bevan’s second declaration. However, the late appearance of Baer is not determinative of the matter because Mr Bevan’s evidence contains no suggestion that he did in fact perform a literature search, or that having done so he failed to locate the document.
Both experts conduct scientific literature searches using on-line database search facilities such as PubMed (Bevan#1 at [18]; Holloway#3 at para 3(b)). PubMed provides access to the published veterinary literature. Baer was published in English in a mainstream veterinary journal and is titled “Oral vaccination of dogs fed canine adenovirus in baits”. On this basis, it can reasonably be expected that the document would have been ascertained, understood and regarded as relevant by the person skilled in the art seeking information with which to provide alternative and more convenient vaccine delivery regimes.
Summary
I am satisfied that before the priority date, the person skilled in the art could be reasonably expected to have ascertained, understood and regarded as relevant each of WO’115, WO’139 and Baer.
Is the invention obvious?
Would the person skilled in the art directly be led to try oral administration?
Before he was given the opposed specification, Mr Bevan was asked how, before the priority date, he might have gone about developing more convenient vaccination strategies than those requiring administration by a vet. This question is consistent with the problem I have identified above. Mr Bevan answered that he would have considered strategies where the pet owner could administer the vaccine, including oral administration or other means for mucosal delivery, as follows:
“I would most likely have considered formulations in which the vaccine could be administered by the pet owner as opposed to requiring administration by a veterinarian which can be inconvenient, particularly for persons living some way from a veterinary surgery. The rabies vaccine which I referred to earlier was administered to dogs in bait which the dogs ate. It was generally understood with these types of bait vaccines that the antigen was absorbed through the mucosa and tonsils of the animal and effected seroconversion in the dogs. Therefore, formulations in which the vaccine could be administered either in a bait or by some other means in which the vaccine antigens can be readily delivered to the mucosa of the animal would be preferred.” (Bevan#1 at [12])
Having identified three reports referring to oral rabies vaccines (#1 at [13]), Mr Bevan was asked if he would have been reasonably confident that these approaches would work with canine vaccines other than rabies vaccines (#1 at [14]). In response, Mr Bevan identifies published reports demonstrating the efficacy of intranasal and oral vaccines, as follows:
“Although the parenteral route of administration is typically the quickest form of antigen delivery, a B. bronchiseptica vaccine which is delivered intranasally (so-called oronasal administration) has been available since about 1990 and suggests to me that non-injectable routes of administration are certainly feasible. Also, parvovirus challenge in dogs generally involves oral administration of faeces from infected dogs. With regard to the rabies vaccine which was administered in bait fed to the animals, given the widespread nature of this disease, there was certainly a number of published reports as well as journal publications on the effectiveness of this vaccine.” (#1 at [14])
In his first declaration at [15], Mr Bevan refers to oral vaccines he was aware of used in non-canine species. Based on the prior literature he describes (#1 at [13]-[14]) and the vaccines he was aware of, Mr Bevan concludes at [16] that he “would be optimistic that oral-based delivery approaches would work with a range of canine viral and bacterins”. Similarly, in his second declaration at [16], Mr Bevan confirms that the state of the art at the priority date, including WO’115, suggests to him that “oral vaccination was certainly feasible” and he “would have expected it to succeed”.
Dr Holloway was not asked how he would have gone about solving the problem. However, having read the opposed specification and in that context, he considers the opportunity for oral vaccination an advantage, as follows:
“Having the opportunity to carry out a vaccination regime for dogs against the major pathogens using oral vaccination or a combination of subcutaneous and oral vaccination would be an advantage to the veterinarian and the dog owner when compared to the available vaccination regimes that I understand were available before 27 December 2006.” (Holloway#2 at 3(j))
Dr Holloway nevertheless disagrees with Mr Bevan’s optimism that prior published oral-based delivery approaches would work with a range of canine and viral bacterins (#2 at [4(n)]). In particular, he has concerns with the mortality and morbidity associated with prior art vaccines for commercial animals (#2 at [4(o)]) and with the efficacy of the antigens identified in the claims when administered according to the methods used for rabies or other prior art vaccines (#2 at [4(q)]). Dr Holloway considers that each oral vaccine requires special conditions to be manufactured to be effective and safe, including a significant level of attenuation, antigenicity and capacity to replicate via the oral route if a live vaccine (#2 at [4(l)]). Considering his evidence as a whole it is not unreasonable to conclude that, before the priority date, if he had been faced with the problem of providing an alternative and more convenient administration regime for canine vaccines, Dr Holloway would not be averse to oral routes of vaccine administration, provided their safety and efficacy could be assured.
In summary, I am satisfied that, before the priority date, if he were seeking an alternative and more convenient administration regimen for canine vaccines, Mr Bevan would in all the circumstances directly be led as a matter of course to try oral routes of administration, with a reasonable expectation of success. Furthermore, that Dr Holloway would not be averse to oral routes of administration, providing the safety and efficacy of the vaccine could be assured.
WO’115
There was no dispute that WO’115 discloses relevant canine vaccine compositions. I have found above that WO’115 also discloses:
·administration of relevant vaccines in 2-3 doses with the option of yearly boosters;
·that administration can be done by any known route including oral, intranasal, mucosal topical, transdermal, and parenteral (e.g., intravenous, intraperitoneal, intradermal, subcutaneous or intramuscular); and
·that administration can also be achieved by combination of routes, with the example provided of a “first administration using a parenteral route, and subsequent administration using a mucosal route”.
What must be determined is whether, in all the circumstances, the person skilled in the art would directly be led as a matter of course to administer a relevant vaccine according to a route and schedule set out in at least opposed claims 1 or 2, with a reasonable expectation that it might well produce an alternative and more convenient administration regimen for the vaccine.
Merial submitted that based on the disclosure of WO’115, the person skilled in the art would be motivated to treat dogs according to the claimed methods because WO’115 teaches that vaccines encompassed by the opposed claims can be used for this purpose and that a combination of routes can be used, including subcutaneous and oral dosing. Merial submitted the vaccine doses would have been scheduled in accordance with opposed claims 1 or 2 based on conventional vaccination practices known in the art. Furthermore, that the person skilled in the art would have expected the approach to succeed based on the expectation that live virus and bacterins would replicate when administered by the oral route (consistent with Holloway#2 at [3(g)]; Bevan#2 at [13]).
In contrast, Zoetis submitted that the person skilled in the art reading WO’115 would have no cause at all to even attempt to arrive at a method of oral administration of core canine vaccines, let alone to do so with a reasonable expectation of success. It argued that the substance of the WO’115 disclosure accords with the common general knowledge in the art which provides no motivation to choose oral delivery. Relying on Dr Holloway’s evidence (#2 at 4(z)), Zoetis described the references in WO’115 to oral administration of vaccine as an ‘omnibus disclosure’ and ‘stray phrases’, which appear in an ‘exhaustive list’ of all possible routes of administration. Zoetis submitted that the preferred methods of administration and exemplified methods are all parenteral.
In my view it is not reasonable to necessarily read down the WO’115 disclosure to that which forms the common general knowledge in the art or the preferred embodiments. The person skilled in the art is seeking to provide an alternative and more convenient administration regimen for canine vaccines. Consequently, it is reasonable to expect that they would consider not only the preferred embodiments in a prior disclosure, but also any other options that could be applied to solve the problem.
Dr Holloway acknowledges the references in WO’115 to oral administration but he interprets them as “simply an add on … to encompass all uses” of the antigens to vaccinate dogs, based on there being no disclosure of “a method for oral vaccination per se” and “no discussion or demonstration of the method of preparing the vaccine for oral use or its efficacy if administered orally” (#2 at [4(z)]). Dr Holloway considers that the reference in WO’115 to oral delivery “is not supported by any response data or antibody data” and “the doses of virus are wide” (#2 at 4(ii)). Dr Holloway’s statements are consistent with his caution identified above, regarding the safety and efficacy of an oral vaccine.
Mr Bevan understands WO’115 to describe vaccination with relevant antigens and combinations of antigens (#1 at [31]-[32]). Mr Bevan places more weight than Dr Holloway on the references to oral administration of relevant antigen(s) (#1 at [32]). Responding to Dr Holloway’s concerns, Mr Bevan states that while WO’115 “may not specifically mention a method for oral vaccination per se, it nevertheless describes all the antigens listed in claims 1 and 2 and tells the reader that these antigens can be administered orally” (#2 at [25]).
Vaccine formulation and safety/efficacy testing
The experts agree that formulation of the vaccine is crucial to ensure it is robust and to ensure an accurate dosage and delivery to the oral mucosa (Bevan#1 at [12]; Holloway#2 at [4(i)]). They also agree that a key issue in preparing a vaccine or vaccination method relates to formulation of the vaccine to ensure appropriate presentation of the antigen to the immune system (Holloway#2 at [4(k)]; Bevan#2 at [20]). Both experts understand that an oral route of delivery would require live virus and bacterins, rather than inactivated antigen (Bevan#1 at [26]; Holloway#2 at [3(g)]; Bevan#2 at [13]).
Dr Holloway states that WO’115 contains no information relevant to preparing a vaccine for oral use and he believes there would be considerable intellectual endeavour involved in developing and formulating effective oral vaccines for the relevant viruses (Holloway#2 at [4(q)]). However, since it is unlikely that as a vet Dr Holloway has experience in vaccine formulation, I accord his evidence less weight on this point than Mr Bevan’s.
Based on his own experience in vaccine production, Mr Bevan states that vaccine formulation typically follows standard protocols (#2 at [25]). Mr Bevan describes his preferred approach to formulating a vaccine for oral administration:
“Preferably, the vaccine formulation is delivered in some form of stable matrix (e.g. a gel adjuvant like aluminium hydroxide or stable gel/sugar suspension like the human live Polio vaccine) which is robust and allows accurate dosage to the animal and which is designed so that the antigens are delivered into the oral mucosa and in the tonsular area of the dog.” (#1 at [12])
On being asked what steps he would have taken before the priority date to formulate a canine vaccine for oral administration, Mr Bevan states:
“I would most likely have formulated the antigens in a gel (eg. sodium hydroxide gel) or viscous GEL-solution (e.g. such as an oil-in-water emulsion) to allow the antigens maximum exposure to the oral mucosa.” (#1 at [17])
Supporting Mr Bevan’s view that there would be little difficulty in formulating an appropriate vaccine, under the heading “Combination vaccines” WO’115 refers to combining vaccine antigens and a veterinary-acceptable carrier ...
“… in any convenient and practical manner to form a combination vaccine composition, e.g., by admixture, solution, suspension, emulsification, encapsulation, absorption and the like, and can be made in formulations such as tablets, capsules, powder, syrup, suspensions that are suitable for injections, implantations, inhalations, ingestions or the like.” (page 12 lines 33-38)
Dr Holloway states that in preparing vaccines for oral use each infectious agent must be considered individually (#2 [4(z)]) and each oral vaccine requires special conditions to be manufactured to be effective and safe, including obtaining a significant level of attenuation, antigenicity and capacity to replicate via the oral route if a live vaccine (#2 at [4(l)]). Consistent with this, both experts agree that once formulated, oral vaccines would undergo a variety of tests to ensure safety and efficacy (Bevan#1 at [19], #2 at [22]; Holloway#2 at [4(v)]). Mr Bevan expands on this in his first declaration at [19]:
“Once formulated, the oral vaccines would need to go through all efficacy testing as is required for SC or IM vaccines. Indeed, the same efficacy tests would be employed and would involve the standard trial and error approach of testing dosages to determine optimal dosage of each component. Standard methods of vaccine testing include stability, safety, in vitro efficacy, in vivo efficacy including reversion to virulence, challenge, duration of immunity, all of which are part of the development of any vaccine.”
Given that the safety and efficacy of any formulated vaccine must be assured by testing, Mr Bevan states that “one would not expect a difference in mortality rates regardless of the method of administration” (#2 at [22]). This was not disputed by Dr Holloway.
I am satisfied that it would be a matter of routine for the person skilled in the art to formulate an appropriate vaccine for oral delivery containing the antigens and combinations of antigens disclosed by WO’115, and then subsequently test the formulation to ensure safety and efficacy prior to its use to vaccinate dogs.
Administration schedule
I have found above that WO’115 discloses an administration schedule comprising 2 or 3 doses with the option of yearly boosters. The evidence establishes that it is common general knowledge to administer core canine vaccines 2-3 times followed by annual boosters (Bevan#1 at [9]; Holloway#1 at 4(p)-(v)). Mr Bevan explains the reason for multiple dosing:
“… it is known to give multiple doses of vaccines to effect proper immunisation, whether the vaccine is administered parenterally or orally. The point of vaccination is to generate an immune response in the animal and this may typically require administration of more than a single dose of the vaccine.” (Bevan#3 at [22]).
It is reasonable to conclude that regardless of the route of administration, the person skilled in the art would directly be led as a matter of course to administer core canine vaccine antigens in accordance with the common general knowledge in the art; that is in 2-3 doses followed by one or more yearly boosters.
Route of administration
The question remains whether the person skilled in the art would directly be led as a matter of course to administer the vaccines either all orally, or in a combination of one or two subcutaneous doses followed by oral administration. Dr Holloway does not dispute Mr Bevan’s statement that:
“Whether the vaccine should be administered orally or s.c [i.e. subcutaneously] in a first dose (or subsequent doses) is a matter for trial and error by the vaccine tester according to standard protocols.” (Bevan#2 at [24])
Conclusion
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.
WO’139
WO’139 is directed to “methods and composition for the oral vaccination of healthy animals through drinking water or syrups as an aid in the prevention of disease” (page 1). Relevant to treating a dog for canine diseases, on pages 1 and 2 of WO’139, it is stated that domesticated animals such as dogs and cats would benefit from oral vaccines to reduce the stress caused by injectable vaccines. The “Summary of the invention” on page 4, relevantly includes a method of providing protection against disease, essentially involving admixing a water soluble palatable flavorant, a soluble vehicle and one or more bacterial or viral antigens, and administering the vaccine to an animal to provide protection against the disease. The invention further encompasses an orally administered vaccine formulation containing bacterial or viral antigens, and water soluble palatable flavourant and vehicle (page 4).
On page 5, fruit and meat flavourants are particularly preferred for administration dogs. On page 9, the suggested antigens for dogs include L. canicola, L. grippotyphosa, L. hardjo, L. Pomona, L. ictero, and B. bronchiseptica, as well as canine viral antigens canine distemper, canine adenovirus, canine coronavirus, canine parainfluenza virus, and canine parvovirus (consistent with Bevan#1 at [29]).
On page 10, when administering the oral vaccines to a domesticated pet, the vaccine may be administered in drinking water, or more preferably, a syrup. Syrups are preferably administered into the mouth via a syringe, most preferably at the back of the throat (page 10). Regarding administration via drinking water, on page 13:
“To formulate the orally administered vaccines of the invention, an initial determination of the quantity of water (based on body weight) to be administered to the animals is made. The total weight of the animal(s) to be vaccinated is determined by calculating the total number of animals to be vaccinated multiplied by the average weight of the animal. The quantity of water needed for the weight of animal(s) is determined and the vaccine formulation is calculated based on the required water and time span over which the vaccine formulation is to be administered.
The average quantity of water to be administered to the animals of the invention can be determined by those of ordinary skill in the art. Non-limiting examples of the average quantity of water administered to: … 5) small animals such as dogs and cats require approximately 250-1500 ml of water per day.”
Examples demonstrate the effectiveness of mass oral vaccination of pigs with Erysipelothrix Rhusiopathiae vaccine and the improved protection with a flavoured vaccine formulation (pages 14-32).
As indicated above in the context of novelty, it was not in dispute that WO’139 teaches oral administration to animals, including dogs, of a relevant vaccine in one or two doses, but that it does not explicitly disclose subsequent annual dosing. The question is whether in seeking to provide an alternative and more convenient administration regimen for canine vaccines at the priority date, the person skilled in the art would directly be led as a matter of course to try a vaccine taught by WO’139 in a route and schedule within opposed claims 1 and 2, in the expectation that it might well produce a useful or desired result.
Merial submitted that the skilled person would have administered the vaccine described in WO’139 in manner now claimed based on conventional vaccination practices known in the art. It submitted that both experts provide evidence that it is routine to provide an annual booster, and the person skilled in the art would select an oral vaccination route of administration. Responding, Zoetis submitted that WO’139 implicitly assumes as part of a disclosure focused on pigs, and without any demonstration, that it is possible to formulate a core canine vaccine that is suitable and effective for oral administration in dogs. It argued that the WO’139 disclosure would have been confusing in that it assumes the effectiveness of oral administration of core canine vaccines but being confused the person skilled in the art would have no expectation of success.
Dr Holloway’s evidence with respect to WO’139 is contained in the following two paragraphs:
“[WO 2002/02139] is an application filed in 2001 from American Home Products Corporation relating to ‘methods and composition of oral vaccination for healthy animals through drinking water or syrups as an aid in the prevention of disease’. The summary of the invention of this application indicates that it relates to the admixing of a water soluble palatable flavorant with a soluble vehicle for administration of an orally administered vaccine, further admixing an antigen selected from the group consisting of a bacterium and a virus as an active component of the orally administered vaccine and administering the vaccine to an animal to provide protection against the disease.
The main focus of [WO’139] is the administration of a “flavourant” and then this is broadly applied to multiple agents in multiple scenarios in multiple species. However, no optimization of dose or testing has occurred in dogs and only on pages 35 to 36 of [WO’139] are dogs mentioned. Furthermore there is no data in [WO’139] to support the dose rate or even the effectiveness of having the dog drink the vaccine with flavourant.” (Holloway#2 at paras 4(w)-(x))
Dr Bevan’s evidence on WO’139 is confined to his first declaration at [29]:
“… this document describes oral vaccines for administration to different animals, including dogs. I see that pages 8 and 9 of the document refers to examples of preferred antigens for various animals. In terms of the antigens described for administration to dogs, I see that suggested antigens include L. canicola, L. grippotyphosa, L. hardjo, L. Pomona, L. ictero, and B. bronchiseptica, as well as canine viral antigens canine distemper, canine adenovirus, canine coronavirus, canine parainfluenza virus, and canine parvovirus. These are the antigens which are referred to in claim 1 of the opposed application. I also note that the document states that any infectious, attenuated or inactivated, live or dead bacterial or viral agent may be formulated in a vaccine. Additionally, the document describes a method of providing protection against disease by orally administering the vaccine.”
A key issue in preparing a vaccine or vaccination method relates to formulation of the vaccine to ensure appropriate presentation of the antigen to the immune system (Holloway#2 at [4(k)]; Bevan#2 at [20]) and an oral route of delivery would require live virus and bacterins, rather than inactivated antigen (Bevan#1 at [26]; Holloway#2 at [3(g)]; Bevan#2 at [13]). The evidence establishes that very little or no immunological response would result from oral administration of inactivated antigen (Bevan#1 at [26]), which would also appear to encompass dead bacterial or viral agents, all of which the WO’139 disclosure encompasses as the vaccine agent. Prima facie, there are also potential difficulties in accurate dosing of vaccine insofar as it is administered in drinking water, which have not been addressed by the evidence.
Both experts simply summarise the WO’139 disclosure. Their evidence does not support a conclusion that in seeking to solve the problem at the priority date they would directly be led as a matter of course to try a canine vaccine disclosed by WO’139 with a reasonable expectation of success. In the absence of clear evidence in that regard, I am not satisfied that the claims lack an inventive step in light of WO’139.
Merial has not established that any claim lacks an inventive step in light of WO’139.
Baer
Baer is in evidence as exhibit REB-17. It is titled “Oral vaccination of dogs fed canine adenovirus in baits”. In the context of testing CAV-2 as a candidate for a recombinant adenovirus-rabies vaccine the authors carried out a study which is summarised on the first page of the document, as follows:
“Six groups of 5 dogs were each fed dilutions of canine adenovirus-2, either as raw liquid or after insertion into cornmeal baits. By the fourth week after vaccination, 29 of the 30 dogs developed high titres of serum-neutralizing antibodies to the virus.”
The evidence establishes that Baer discloses administration to dogs of a single dose of CAV-2 antigen both as a raw liquid dropped on to the tongue or as baits (Bevan#2 at [21]; Holloway#3 at 3(a)-(c)). The question is whether in seeking to solve the problem and having read Baer, the person skilled in the art would directly be led as a matter of course to try oral administration of the CAV-2 antigen, in two to three doses followed by one or more annual doses, with a reasonable expectation that this might well provide an alternative and more convenient administration regimen for the vaccine.
Merial submitted that Baer demonstrates that attenuated CAV-2 administered orally achieves seroconversion, and the person skilled in the art would simply need to apply the common general knowledge to administer the oral vaccine according to the schedules in the opposed claims. Responding, Zoetis submitted that Baer discloses single dose administration and it would not have been routine to apply “conventional vaccination practices”, because there were no such practices before the priority date for oral vaccines.
Mr Bevan considers Baer to establish the feasibility of oral vaccination to dogs (#2 at [17], [21]) and to demonstrate its efficacy with respect to CAV-2 (#3 at [8]).
Dr Holloway acknowledges that Baer demonstrates that “it is possible to vaccinate a dog by feeding 1 ml of Manhattan strain of CAV-2 vaccine either directly or in baits” (#3 at 6(c), consistent with #3 at 3(a)-(c)). He nevertheless dismisses the document on the basis that the bait vaccine approach is not “directly transposable to create a commercial vaccine for a range of canine diseases that can be used in a vaccination regime that includes oral administration” (#3 at [6(c)]). However, for inventive step purposes this level of disclosure is not necessary. I also accord less weight to Dr Holloway’s statement that he does not consider baits suitable to vaccinate domestic dogs because they regularly fail to eat oral medications (#3 at 4(c)), because it is at odds with his evidence that the opportunity for oral administration would be advantageous (#2 at 3(j)).
As discussed above, Mr Bevan’s evidence supports a conclusion that he would apply a multiple dosing schedule to oral vaccines (Bevan#3 at [22]). In his second declaration at [17], Mr Bevan states that the bait vaccine described by Baer “could merely be administered according to the same vaccination schedule as one would employ for injectable vaccines”. Responding to Dr Holloway’s evidence (#3 para 3(b)) that Baer does not relate to a method involving administering the vaccine according to the route and schedules in the opposed claims, Mr Bevan states:
“… it is well known in the industry to give multiple doses of vaccine and the scheduling frequency would typically be indicated and governed by the vaccine manufacturer to overcome maternal antibody and to provide solid immunity. For example, in my declaration dated 19 September 2013, when asked about vaccine dosing frequency, I mention that a typical vaccination strategy would involve vaccinating a puppy at about 6, 10 and 12-13 weeks, followed by annual booster vaccinations per manufacturer’s instructions.” (#3 at [9])
On balance, I am satisfied that in all the circumstances, the person skilled in the art would directly be led as a matter of course to try oral administration of the CAV-2 antigen taught by Baer, in accordance with the common general knowledge in the art, i.e. by vaccinating two or three times, followed by annual booster vaccinations, with a reasonable expectation that it might well produce a more convenient vaccine regimen. It follows that the subject matter of claim 1 lacks an inventive step.
The subject matter of dependent claim 7, insofar as it encompasses the method wherein the canine disease comprises respiratory disease caused by CAV-2, is also obvious in light of Baer. I also consider the dosing schedules in dependent claims 15, 17-20 obvious in light of Mr Bevan’s evidence above, that these dosing schedules were a matter of routine.
I find claims 1, 7, 15 and 17-20 do not involve an inventive step in light of Baer.
Summary inventive step
Claims 1-20 lack an inventive step.
Utility
Section 18(1)(c) of the Act provides that an invention, so far as claimed in any claim, must be useful. The requirements for utility in a claimed invention were provided by the Full Court of the Federal Court as follows:
“If the claimed invention does what it is intended by the patentee to do and the end result obtained is itself useful, the invention is useful within the meaning of s 18(1)(c) … As to the first aspect, the invention as claimed must attain the result promised by the patentee” (Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC [2008] FCAFC 82 at [141], (2008) 77 IPR 449)
“A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid. That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility.” (H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 at [81], [217], 81 IPR 228)
Merial submitted that the application is concerned with administration of vaccines by individuals untrained in parenteral administration and that the claims do not meet the promise of the invention, insofar as they encompass methods that require subcutaneous administration of the vaccine. Merial identified the promise of the invention at paras 4 and 39 of the opposed specification as follows:
[004] … A canine vaccine that could be delivered easily would provide increased convenience of vaccine delivery to the pet, the veterinarian, and the pet owner, and allow for personnel untrained in parenteral administration techniques to deliver canine core vaccines to animals.
[039] Provided herein is a vaccination regimen that reduces morbidity and mortality in animals, and provides increased ease of administration of vaccines for pets, veterinarians, and animal owners.
Zoetis considered the promise of the invention as the provision of increased convenience of vaccine delivery by allowing untrained individuals to administer some or all of the doses in a vaccine regimen to a dog. It submitted that any reduction in the number of steps requiring trained personnel is advantageous.
The specification as a whole supports Zoetis’s view of the matter. In addition to the passages identified by Merial, on page 1, the invention relates to a method of treating a dog for canine diseases involving, among other things, vaccine administration subcutaneously or orally. On page 2, under the heading “Summary of the invention”, methods are set out that involve administering a number of vaccine doses, initially by the subcutaneous route, followed by oral dosing. Nothing in the specification suggests the invention is necessarily limited to non-parenteral dosing only, such that this could be considered the promise of the invention.
Merial has not discharged the onus of establishing that the subject matter of any claim does not achieve the promise of the invention.
Conclusion
The opposition is successful. Claims 1-20 lack an inventive step.
It is usual before the Commissioner that in the event that an opposition is successful, the applicant is allowed the opportunity to propose amendments to the claims. I will allow Zoetis a period of time to propose suitable amendments.
Costs
It is normal in matters before the Commissioner that costs should follow the event.
Merial made no submissions on costs. Zoetis submitted that it should be awarded costs to compensate for significant legal costs wasted in considering all of the grounds and particularised matter in Merial’s statement of grounds and particulars (SGP), some of which were not pressed at the hearing. However, it is usual in opposition proceeding for the grounds of opposition at the hearing to be more focussed that in the original SGP, and the present case is not unusual. Regarding Zoetis’s submission that it be compensated for additional costs it was forced to incur in considering and responding to additional evidence in the Nordgren declaration, there is no requirement to respond to evidence not properly responsive to further evidence. Therefore, I do not see the need for compensation.
It is appropriate in the circumstances that costs should follow the event. I award costs according to Schedule 8 against Zoetis.
Dr Barbara Akhurst
Delegate of the Commissioner of PatentsAnnex A: The claims
1. A method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of vaccine, wherein the vaccine comprises viral antigens, a bacterin, or both, and wherein the vaccine is administered subcutaneously or orally in a first dose, orally in a second dose, orally in an optional third dose, and orally in one or more annual doses, and wherein the viral antigens comprise one or more of
1) canine distemper (CD) virus,
2) canine adenovirus type 2 (CAV-2),
3) canine parainfluenza (CPI) virus,
4) canine parvovirus (CPV),
5) and canine coronavirus (CCV),
and wherein the bacterin comprises one or more bacteria selected from Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, L. bratislava, and Bordetella bronchiseptica; and any combination of viral antigens and bacteria thereof.
2. A method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of vaccine, wherein the vaccine comprises viral antigens, a bacterin, or both, and wherein the vaccine is administered subcutaneously in a first and in a second dose, and orally in a third dose, and orally in one or more annual doses, and wherein the viral antigens comprise one or more of
1) CD virus,
2) CAV-2,
3) CPI virus,
4) CPV,
5) and CCV,
and the bacterin comprises one or more bacteria selected from Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, L. bratislava, and Bordetella bronchiseptica; and any combination of viral antigens and bacteria thereof.
3. A method according to claims 1 or 2, wherein the viral antigens are CD virus, CAV-2, CPI virus, and CPV.
4. A method according to claims 1 or 2, wherein the viral antigens are CD virus, CAV-2, CPI virus, and CPV, and the bacteria in the bacterin are Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, and L. pomona.
5. A method according to claims 1 or 2, wherein the viral antigens are CD virus, CAV-2, CPI virus, CPV, and CCV, and the bacteria in the bacterin are Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, and L. pomona.
6. A method according to claims 1 or 2, wherein the viral antigens are CD virus, CAV-2, CPI virus, and CPV, and the bacterium in the bacterin is Bordetella bronchiseptica.
7. A method according to claims 1 or 2, 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.
8. A method according to claim 7, wherein the 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.
9. A method according to claims 1 or 2, 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.
10. A method according to claims 1 or 2, 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 106 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
11. A method according to claims 1 or 2, 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.
12. A method according to claims 1 or 2, 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.
13. A method according to claims 1 or 2, 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.
14.A method according to claims 1 or 2, wherein the Bordetella bronchiseptica is present in a range from about 3 x 108 to about 3 x 109 cells inclusive.
15.A method according to claims 1 or 2, wherein the second dose is administered from 7 to 35 days, inclusive, after the first dose.
16. A method according to claim 15, wherein the second dose is administered about 3 weeks after the first dose.
17. A method according to claims 1 or 2, wherein the third dose is administered from 7 to 35 days, inclusive, after the second dose.
18. A method according to claim 17, wherein the third dose is administered about 3 weeks after the second dose.
19.A method according to claims 1 or 2, wherein the annual dose is administered about one year after the first dose.
20. A method according to claim 19, wherein annual doses administered after said annual dose are administered repeatedly about one year after the immediately prior annual dose.
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