Boehringer Ingelheim Animal Health USA Inc. v Zoetis Services LLC
[2022] APO 42
•23 June 2022
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Boehringer Ingelheim Animal Health USA Inc. v Zoetis Services LLC [2022] APO 42
Patent Application: 2017203965
Title:Methods of vaccine administration
Patent Applicant: Zoetis Services LLC
Opponent:Boehringer Ingelheim Animal Health USA Inc.
Delegate:Damian Triffett
Decision Date: 23 June 2022
Hearing Date: 1 September 2021, by Video Conference
Catchwords: PATENTS - section 59 opposition to the grant of a patent – method for oral canine vaccination – grounds of novelty, inventive step, clear enough and complete enough disclosure, support and utility considered – opposition successful – description is not clear enough and complete enough with respect to the CPI, CCV, B. bronchiseptica and Leptispora antigens - claims not supported with respect to the CPI, CCV, B. bronchiseptica and Leptispora antigens – grounds of novelty, inventive step and utility not established - opportunity to amend – costs awarded against applicant
Representation: Counsel for the applicant: Mr Patrick Flynn
Counsel for the opponent: Ms Clare Cunliffe, Mr Christian Dimitriadis and Dr Tom Kowalski (US)
Patent attorney for the applicant: Dr Tony Shaw from Allens Patent & Trade Mark Attorneys
Patent attorney for the opponent: Dr Karin Innes and Dr Jenny Petering from FB Rice
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2017203965
Title:Methods of vaccine administration
Patent Applicant: Zoetis Services LLC
Date of Decision: 23 June 2022
DECISION
The opposition succeeds on the grounds of section 40(2)(a) and section 40(3).
I award costs according to Schedule 8 against Zoetis Services LLC.
I allow the applicant two (2) months from the date of this decision to file amendments to
overcome the deficiencies identified in this decision.
REASONS FOR DECISION
Background
Patent application 2017203965 (the opposed application) in the name of Zoetis Services LLC (the applicant) was advertised as accepted on 18 July 2019. Boehringer Ingelheim Animal Health USA Inc. (the opponent) opposed the grant of a patent under section 59 of the Patents Act 1990 (Cth) (the Patents Act).
The opposition
The Statement of Grounds and Particulars (SGP) as amended on 17 April 2020, identified six grounds of opposition: manner of manufacture, novelty, inventive step, clear enough and complete enough disclosure, support and utility. At the hearing, only five grounds were pressed: novelty, inventive step, clear enough and complete enough disclosure, support and utility.
The parties relied upon evidence by several declarants. Evidence in support consists of a declaration by Dr Robert M Nordgren (Nordgren-1). Annexed to Nordgren-1 were two declarations by Richard Bevan dated 19 September 2013 (Bevan-1/RMN-9) and 15 May 2014 (Bevan-2/RMN-10), which were made in relation to a previous opposition. Evidence in answer consists of declarations by Dr Keith Ameiss (Ameiss), Dr Terry Bowersock (Bowersock), Dr Sharon Wappel (Wappel), Dr Steven Holloway (Holloway-4) and Tony Shaw (Shaw). Annexed to Shaw were three declarations by Steven Holloway dated 19 December 2013 (Holloway-1/TS1), 20 February 2014 (Holloway-2/TS2) and 11 August 2014 (Holloway-3/TS3), which were made in relation to a previous opposition. Evidence in reply consists of a declaration by Dr Robert M Nordgren (Nordgren-2).
The request for examination in relation to the patent application was filed on 7 August 2017. Consequently, the amendments of the Patents Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (the Raising the Bar Act) apply to the present application. This includes section 60(3A) of the Patents Act, which provides that the Commissioner may refuse an application if satisfied on the balance of probabilities that a ground of opposition exists. It is the opponent who carries the onus of proof.
The previous opposition
The predecessor of Boehringer Ingelheim, Merial Limited, opposed[1] Australian Patent Application No. 2007343130 (the earlier application), from which this application is ultimately divided. The claims of the earlier application were similar to those of the opposed application, being directed to methods of treatment involving the administration of vaccines containing the same antigens, except that they required a first dose to be given subcutaneously, followed by oral administration of subsequent doses.
In the previous opposition Merial relied upon evidence from Mr Bevan, one of the experts relied on here and on the same prior art (D1) which is relied on here. In the previous opposition, the Delegate, Dr Akhurst concluded that:
“I am satisfied that before the priority date, in all the circumstances (including knowledge of the problem and disclosure of [D1]), the person skilled in the art or team would be directly 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 [D1], in 2-3 does followed by one or more annual boosters, all orally [emphasis added] 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.”
The opponent submits that in the earlier application, the Delegate concluded that all claims lacked an inventive step, Zoetis did not appeal the decision, and the earlier application with very similar claims to those now in suit, did not proceed to grant.[2] The applicant objects to the opponent seeking to submit that the previous decision given on a “substantially similar” claim is “highly persuasive” of the outcome of the present opposition, submitting that “the previous decision, given on different claims, provides no short cut to the outcome of the present application, which must be considered entirely on its merits on the basis of the claims and evidence in this opposition.”[3]
While I have considered the prosecution of the earlier application, I will consider the opposed application entirely on its merits on the basis of the claims and evidence in this opposition, which although they share some similarities as noted above, are different to the previous decision.
The specification
The opposed application is a divisional of patent application 2015255165 which is a divisional of application 2013201732 which is a divisional of 2007343130 which is the Australian national phase entry of PCT/IB2007/003666, which claims priority from US60/877,322 filed on 27 December 2006. The contents of each of these applications is incorporated into the present specification by reference. The specification as accepted comprises description pages from 1 to 21, claims pages from 22 to 24, and drawings pages 1/3 to 3/3. There are 20 claims, including one independent claim (claim 1). The claims in full appear in the ANNEX at the end of this decision.
What is the invention as described?
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd:[4]
“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 background to the invention
The application is titled: “Methods of vaccine administration”.
Vaccines against major canine infectious disease have been available for three to four decades, and they have greatly reduced the incidence of these infectious diseases in dogs. Pfizer Animal Health sells several vaccines for the prevention of diseases associated with various viral and bacterial diseases in dogs, including the VANGUARD® line of vaccines. These vaccines are an aid in preventing canine distemper (CD) caused by canine distemper virus (CDV), infectious canine hepatitis (ICH) caused by canine adenovirus type 1 (CAV-1), respiratory disease caused by canine adenovirus type 2 (CAV-2), canine parainfluenza (CPI) caused by canine parainfluenza virus (CPI), and canine parvoviral enteritis caused by canine parvovirus (CPV).[5]
The Background of the Invention states that while major animal health companies market core canine vaccines for companion animals, all of these vaccines are delivered by the parenteral route, especially subcutaneous injections.[6]
The specification further states 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.”[7]
Summary of Invention
The invention is broadly summarised as “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. The viral antigens comprise one or more of 1) canine distemper virus (CDV), 2) canine adenovirus type 2 (CAV-2), 3) canine parainfluenza virus (CPI), 4) canine parvovirus (CPV), 5) and canine coronavirus (CCV), and wherein the bacterin comprises one or more of Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. pomona, L. bratislava, and Bordetella bronchiseptica; and any combination of viral antigens and bacterin thereof.”[8]
The specification further provides that in one embodiment, the second and third doses are administered from about 7 to about 35 days, inclusive, after the first and second doses respectively.[9]
Examples
The specification provides six examples which I will discuss below.
Example 1 evaluated the ability of a modified live vaccine to cause seroconversion (e.g., going from a state of having no antibodies to a state of having relatively high concentrations of antibodies to specific antigens) when a vaccine was administered subcutaneously in a first dose, then orally in a second and third dose.[10] The vaccines comprised a mixture of antigens from CAV-1, CPV, CDV and CPI,[11] although the immune responses tested were only to CAV-1, CPV and CDV. Thirty-three pups between the ages of 6 and 9 weeks at the initiation of the study that had no antibodies to CAV-1, CPV or CDV were randomly divided into three treatment groups of 11 dogs each. Dogs in treatment group T01 were given placebo vaccine three times, three weeks apart. Animals in treatment groups T02 and T03 were given experimental vaccines first subcutaneously (on day 0), then the same vaccine orally three weeks (day 21) and six weeks (day 42) later. The only difference between T02 and T03 was the amount of virus in the vaccines administered, with T02 receiving a relatively low dose, and T03 receiving a relatively high dose. Blood samples were taken weekly to measure concentrations (e.g., titres) of specific antibodies.
The results of Example 1 indicated that regardless of antigen, animals given experimental vaccine (groups T02 and T03) responded robustly to the first (subcutaneously administered) vaccine dose.[12] Animals are considered protected from disease when they have antibody titres greater than or equal to 1:16 for CAV-1, 1:32 for CDV and 1:80 for CPV.[13]
Figure 1 shows that CDV-specific antibodies peaked at 28 days after the first vaccination, with mean titres of 1:3499 and 1:3668 for T02 and T03 respectively. The specification states that the concentration of antibodies following subcutaneous vaccination with CDV antigens may have been high enough to interfere with the animals’ abilities to subsequently react to orally administered vaccines.[14]
Figure 1
Figure 2 shows that peak antibody titres against CPV occurred two weeks following the first oral vaccination (mean titre of 1:5702 on day 36) for dogs in T02, and one week following the first oral vaccination (mean titre of 1:5613 on day 28) for dogs in T03. The specification states that due to the differences in timing between CDV and CPV peak antibody concentrations, this pattern could be interpreted as an immune response to the oral vaccination, although the initial high antibody titres again make interpretation difficult.[15]
Figure 2
Figure 3 demonstrates that on the day of the first oral vaccination, day 21, animals in T02 had mean titres of CAV-1 specific antibodies of 1:5, and those in T03 had mean titres of 1:16. Two weeks later, dogs had mean antibody titres of 1:25 and 1:118 in groups T02 and T03 respectively. Two weeks following the second orally administered vaccine, on day 56, animals had mean titres of 1:83 and 1:150 in T02 and T03 respectively.[16] The specification states that specific antibodies against CAV-1 clearly indicate that there is a robust immune response to oral dosing for this antigen, and that traditionally CAV-1 antibody titres are lower than the other two antigens, which may have decreased the likelihood of interference caused by subcutaneous vaccination.[17]
Figure 3
Example 2 evaluated the ability of a modified live vaccine to cause seroconversion when a vaccine was administered subcutaneously or orally in a first dose, then orally in a second and third dose.[18] Thirty-nine pups, having no antibodies to CAV-1, CPV, CDV or CPI, were randomly divided into three treatment groups of 13 dogs each.[19] Dogs in treatment group T01 were orally given placebo vaccine three times, three weeks apart, dogs in treatment group T02 were orally given the same experimental vaccine on days 0, 21 and 42, and dogs in treatment group T03 were subcutaneously given the experimental vaccine on day 0, then the same vaccine orally on day 21 and day 42.[20]
Animals were considered positive responders (i.e. protected from disease) if they had antibody titers greater than or equal to 1:16 for CAV-1, 1:32 for CDV, and 1:16 for CPV.[21] Table 5 shows that all animals in the T03 group (SQ, oral, oral) seroconverted against the three measured viruses by day 63, all animals in the T02 group (oral, oral, oral) seroconverted against CPV and CAV-1 by day 63, and approximately half of the animals in the T02 group seroconverted to CDV by day 63.[22]
Table 5
Examples 3-6 are notional examples describing the administration of various canine viral and bacterin antigens to dogs (including those vaccines in the VANGUARD® range.[23] These examples include the preparation and formulation of the vaccines as well as dosing regimes.[24]
The Person Skilled in the Art
The person skilled in the art (PSA) was considered in Root Quality Pty Ltd v Root Control Technologies Pty Ltd:[25]
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”
However, the PSA is not a real person, but an artificial construct that is used as a tool of analysis which is used to make the determination:
“The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – 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.”[26]
The opponent submits that the person skilled in the art is a “person experienced in developing vaccines for companion animals” which includes Dr Nordgren and Mr Bevan.[27] The applicant submits, as Greenwood J pointed out in Novozymes v Danisco (2013) 99 IPR 417 at [11], the skilled person is the person who would put the invention into effect at the expiry of the patent.[28] The applicant further submits that in this case, the skilled person is a veterinarian familiar with the administration of vaccines to dogs and vaccination regimes, and the skilled person should also have some knowledge of vaccine formulation to the extent that they will be aware that certain formulations have been developed for particular administration routes and are not necessarily suitable for delivery by alternate administration routes.[29] The applicant further submits that while the opponent repeatedly emphasises that the opposed application involves no new formulation, the opponent put forward two formulators as their witnesses, in circumstances where a formulator would not put the invention into effect at the expiry of the patent.[30]
I am satisfied that the hypothetical team representing the PSA would comprise both veterinarians with skill in administration of vaccines to dogs as well as canine vaccine formulators. While the claims define methods of administrating vaccines to dogs, in order to perform the invention, the person skilled in the art would need to formulate dosages of different antigens such that the therapeutic effect was achieved.
Hindsight
The applicant submits that due to the leading manner in which he was briefed the evidence of Dr Nordgren was tainted with impermissible hindsight. This hindsight is said to arise for several reasons. Firstly, Dr Nordgren apparently had some recollection of his previous declaration (RMN-8) in which he was asked to specifically consider a deleted sentence at [0057] of the earlier application, which erroneously referred to the VANGUARD label containing a direction for oral administration (RMN-8 [7(b)]).[31] Secondly, Dr Nordgren had already read Mr Bevan’s declarations of 19 September 2013 and 15 May 2014, and thus cannot be said to have considered D1 in light of the common general knowledge only.[32] Thirdly, Dr Nordgren was briefed with D4 (now abandoned) simultaneously with D1 in a manner calculated to further emphasise, and remind him of, the importance of oral administration.[33] As a result, the applicant submits that Dr Nordgren’s evidence is now some mélange of his recollection of Mr Bevan’s declarations and the earlier application.[34]
Dr Nordgren states “I had no clear recollection of what I had said in my previous declaration and thus the technical field of the present opposition.”[35] While some recollection by Dr Nordgren of his evidence to the previous opposition is unavoidable, Dr Nordgren has declared that “[t]he opinions expressed in this Declaration are my own based on my personal knowledge and experience”[36]. As a result, I consider that while the circumstances surrounding the preparation of Dr Nordgren’s evidence were not ideal, I do not consider that this amounts to such an impermissible degree of hindsight as to consider Dr Nordgren’s evidence of no assistance to this opposition, although it may affect the weight I attribute to it.
Construction
The correct approach to the construction of claims was discussed by Bennet J in H Lundbeck A/S v Alphapharm Pty Ltd:[37]
“the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … 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 … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification.”
Construction of claim 1
Claim 1 is the only independent claim. It reads:
“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 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 canine distemper (CD) virus, canine adenovirus type 2 (CAV-2) and canine parvovirus (CPV), and one or more of 1) canine parainfluenza (CPI) virus, and 2) 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.”
Claim 1 defines that the vaccine comprises viral antigens, a bacterin, or both. The word “comprising” is, based on the context of its use, construed as not exhaustive such that the vaccine can also (but does not have to) contain other components. As the vaccine comprises “viral antigens, a bacterin, or both”, I consider that the vaccine could comprise viral antigens (without any bacterin), only a bacterin (without any viral antigens), or both viral antigens and (one or more) bacterins. Claim 1 further defines that the “viral antigens” (if present) must comprise CDV, CAV-2 and CPV, and must also comprise either of CPI or CCV.
I note that the preamble to claim 1 defines a method of treating canine diseases, rather than treating a canine disease. While this plural use of the word disease may appear inconsistent when the claim is construed such that the vaccine only comprises a single bacterin, to take the alternative construction that the claim is limited to treating multiple diseases is inconsistent with the plain meaning of “viral antigens, a bacterin, or both” which provides that a single disease could be treated. I consider the former construction to be preferable as “diseases” accounts for scenarios where more than one antigen is present.
The last line of claim 1 defines that the vaccine may comprise “any combination of viral antigens and bacteria thereof”. There is a question surrounding whether this statement means that the vaccine can comprise any combination of the five defined viral antigens, or can comprise any combination of the six defined bacteria, or whether the vaccine must comprise at least CDV, CAV-2 and CCV, and either of CPI and CCV, and any combination of the six defined bacteria? The former broader construction would appear to contradict the requirement in the claims for requiring at least CDV, CAV-2 and CPV, when viral antigens are present, as it would include a construction comprising only a CCV antigen and a Leptospira canicola antigen for example. As a result, I construe this phrase to mean that the vaccine can only comprise:
(i)any single bacteria or combination of the six defined bacteria
(ii)CDV, CAV-2, CCV and either or both of CPI and CCV, or
(iii)a combination of (i) and (ii)
I note that neither of the parties addressed this construction issue in their written submissions. At the hearing, the opponent agreed with my construction identified above and the applicant did not contest it.
Treating a dog for canine diseases
The specification defines “treating” at [0035] as:
“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.”
Therapeutically effective amount
The specification defines “therapeutically effective amount” as an amount of an antigen or vaccine that would induce an immune response in a subject receiving the antigen or vaccine which is adequate to prevent signs or symptoms of disease, including adverse health effects or complications thereof, caused by infection with a pathogen, such as a virus or a bacterium.[38] The specification further defines an “immune response” as the development of a humoral immune response (one that is mediated by antibodies), a cellular immune response (one mediated by T-lymphocytes or other white blood cells or both, and includes the production of cytokines, chemokines and similar molecules produced by activated T-cells, white blood cells, or both), or a humoral and a cellular immune response to the antigen.
Oral administration
The specification defines “oral” (or “peroral”) administration as introduction of a substance, such as a vaccine, into a subject’s body through or by way of the mouth and involves swallowing or transport through the oral mucosa (e.g., sublingual or buccal absorption) or both.[39]
Novelty
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:
“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 and infringement.”[40]
This test is satisfied if the alleged anticipation discloses all the essential features of the invention claimed.[41]
To meet this requirement, the prior art must contain “clear and unmistakable directions to do what the patentee claims to have invented… A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.”[42]
A prior disclosure will only invalidate a claim if, after having read it, the skilled addressee would, rather than could, have produced all the essential features of the claim. As stated in Canadian General Electric Co., Ltd v Fada Radio Ltd:[43]
“Where the question is solely one of prior publication, it is not enough to prove that an apparatus described in an earlier specification could have been used to produce this or that result. It must also be shown that the specifications contain clear and unmistakable directions to use it.”
Furthermore:
“If … the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but would be at least as likely to be carried out in a way that would not do so, the patentee's claim will not be anticipated.”[44]
WO 2006/038115
WO2006/038115 A1 (designated D1) was published on 13 April 2006. Consequently it is part of the prior art base.
D1 discloses vaccines and methods for protecting dogs against diseases caused by canine pathogens.[45] D1 discloses combination vaccines suitable for administration to dogs including a Bordetella bronchiseptica p68 antigen in combination with at least one other antigen from other canine pathogens, capable of inducing a protective immune response in dogs against disease caused by other pathogen(s).[46] D1 discloses that the other pathogens can be selected from CDV, CAV-2, CPI, CPV, CCV, Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. Pomona and L. Bratislava.[47]
In addition D1 discloses that the:
“p68 antigen and the veterinary-acceptable carrier can be combined in any convenient and practical manner to form a 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.”[48]
With regard to administration of the vaccine, D1 states:
“The combination vaccines can be administered in 2 to 4 doses, preferable in 2-3 doses. The doses can be administered with 2 to 6 weeks between each dose, preferably with 2 to 4 weeks between each dose.”[49]
…
“Preferably, two doses of a p68 vaccine are administered to dogs with an interval of about 2-4 weeks, preferably about 3 weeks, between the two administrations”
…
“Dogs can also be revaccinated annually with a single dose.”[50]
…
“In accordance with the present invention, a p68 vaccine can be administered to a dog 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 needle-free delivery devices. Administration can 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.”[51]
…
“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 needle-free delivery devices.”[52]
…
“said combination vaccine is administered by an intravenous, intranasal, oral, intramuscular or subcutaneous route.”[53]
…
“said dog receives said combination vaccine two or three times with an interval of about 2-4 weeks between the administrations.”[54]
Example 4 of D1 discloses safety and efficacy testing of VANGUARD® Plus 5/CV-L, a freeze-dried preparation of attenuated strains of CD virus, CAV-2, CPV, and inactivated whole cultures of L. canicola and L. icterohaemorrhagiae, plus a liquid preparation of inactivated CCV with an adjuvant.[55] D1 further discloses that product safety was further demonstrated by a backpassage study which included oral administration of multiple doses of the vaccine strain to susceptible dogs, all of whom remained normal.[56]
The opponent notes that oral administration is mentioned first in two of the passages relating to the different treatment routes.[57] The applicant responds by submitting that the disclosure of oral administration in D1 appears as one option in an exhaustive list of all possible routes of administration of a substance to an animal.[58] The applicant further cites Eli Lilly and Company Limited v Apotex Pty Ltd[59] at [272]-[293] as standing for the proposition that a mere inclusion in a list, without any specific direction as to which member of the list to choose, is unlikely to be a novelty-destroying disclosure.[60] I note that the list referred to in the prior art document in Eli Lilly comprised olanzapine as one of the many compounds (probably in excess of 5 x 108 compounds) encompassed by formula (I) and one of the 86,000 compounds in the “most preferred class”.[61]
The opponent further submits that an alleged invention may be anticipated by a documentary disclosure that advances a hypothesis, rather than reporting actual results.[62] The applicant responds by submitting that in Sun Pharma it was the ‘primary hypothesis’ advanced by the prior art document that was relevant to lack of novelty, whereas in D1, the ‘primary hypothesis’ exclusively relates to parenteral administration.[63] I agree with the applicant and consider that Sun Pharma can be distinguished on the current facts as in the present case, D1 provides an explicit exemplification of the parenteral route of administration.
The applicant submits that D1 does not teach the use of oral prime and oral boost, rather D1 teaches that a parenteral prime and mucosal boost is preferred.[64] The applicant further submits that all of the examples, and the substance of the disclosure of D1 as a whole, refer to parenteral administration. With regard to the dosing regime, the applicant submits that the mention of oral dosing in D1 are very much stray phrases in the context of long lists.[65] Furthermore, the applicant submits that there is no disclosure in D1 that oral administration of the disclosed vaccines would provide the requisite therapeutic protection as defined in the claims of the opposed application.[66] The opponent responds by submitting that neither the fact that D1 does not report the actual administration or results of the administration of the vaccine orally, nor the fact that it also records that the vaccine could be administered by other standard and well-established means, undermine its strength as a novelty citation.[67]
In my view, D1 fails to provide clear and unmistakeable directions for a PSA to perform the method defined in claim 1. D1 discloses six possible routes of administration and provides examples of parenteral administration. Although, as pointed out by the opponent, that “oral” administration appears first in the list, it is clear from reading the specification as a whole that the clear preference for administration is subcutaneous and intramuscular. Firstly, the specification states that the preferred routes of administration include subcutaneous and intramuscular administrations.[68] Secondly, while D1 does teach administration by a combination of routes, the exemplified combination of routes referred to a first administration using a parental route and subsequent administration using a mucosal route.[69] Thirdly, all the examples refer to subcutaneous or intramuscular administration with the exception of Example 4, which only used oral administration of the vaccine strain to susceptible dogs in a challenge study rather than a vaccination regimen.[70] As a result, I consider that D1 fails to provide clear and unmistakable directions for a method of treating a dog for canine diseases comprising administering at least three oral doses of a vaccine comprising the antigens defined in claim 1. Therefore claim 1 is novel in light of D1. It follows that dependant claims 2-20 are also novel in light of D1.
Inventive Step
The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V. R. Laboratories (Aust.) Pty Ltd[71] Aickin J stated:
“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 are the steps of the inventor or not.”
More recently, the High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd[72] referred with approval to this approach and further held:
“That way of approaching the matter has an affinity with the reformulation of the ‘Cripps question’ by Graham J in Olin Mathieson Chemical Corporation v BiorexLaboratories Ltd [1970] RPC 157. This court had been referred to Olin in the argument in Wellcome Foundation. Graham J had posed the question:
‘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 invention] in the expectation that it might well produce [the desired result]?’
That approach should be accepted.”
The relationship between the matter of routine test in Wellcome Foundation and the reformulated Cripps question in Alphapharm was discussed in Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73; 222 FCR 336 at [71]:
“We do not think there is a divide here in terms of whether an expectation of success is relevant between a test which refers to routine steps to be tried as a matter of course and the reformulated Cripps question. It is difficult to think of a case where an expectation that an experiment might well succeed is not implicit in the characterisation of steps as routine and to be tried as a matter of course.”
In Nichia Corporation v Arrow Electronics Australia Pty Ltd [2019] FCAFC 2 at [89], Jagot J (with whom Besanko and Nicholas JJ agreed) further elaborated on the expectation of success:
“To my mind, these references suggest that the primary judge strayed from the test of steps taken in an expectation that they might well produce the invention or a useful result towards a test of an expectation of knowing that steps will produce a useful result based on predictive capacity.”
Common general knowledge
Common general knowledge (CGK) is the background knowledge and experience available to all those working in the relevant art:
“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.”[73]
The evidence establishes that the common general knowledge in the art before the priority date includes the following:
· Multivalent canine vaccines including canine parvovirus, canine adenovirus and canine distemper antigens. [74]
· RECOMBITEK canine vaccines which included canine viral antigen combinations as well as Leptospiral combination antigens, [75] which were typically administered via subcutaneous administration. [76]
· Intranasal live vaccine for Canine parainfluenza virus[77] and Bordetella bronchiseptica.[78]
· CAV and CPV are able to reproduce in the intestinal tract, CPV sheds into the faeces and was delivered orally to dogs in viral challenge studies,[79] and CDV was known to transmit through the respiratory tract and digestive tract.[80]
· Oral vaccines for rabies were commercially available in the EU and US.[81]
· Pfizer Vanguard 5 vaccine including canine distemper, canine adenovirus type 2, canine parainfluenza and canine parvovirus antigens,[82] which is ordinarily a subcutaneously administered vaccine.[83]
· Virbac Canigen® DHa2PPI vaccine containing live attenuated canine distemper, canine adenovirus type 2, canine parvovirus and canine parainfluenza vaccines, and which was typically reconstituted with a product which contained inactivated canine parainfluenza and Bordetella.[84]
· B. bronchiseptica vaccine which is delivered intranasally (so-called oronasal administration) has been available since 1990.[85]
Problem
The specification appears to succinctly state the problem at [0004] as:
“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.”
The opponent’s attorneys framed the problem to Dr Nordgren as “if I was tasked to make a parenteral vaccine more convenient for administration for veterinarians or pet owners, how would I go about doing that, particularly in light of D1?” Similarly, Mr Bevan was asked to “consider the problem with administration of vaccines by subcutaneous or intramuscular routes which require administration to the animal by a veterinarian and how I might go about developing more convenient vaccination strategies to avoid this problem just prior to December 2006.”[86] The applicant phrased the problem as the need for a method of vaccine administration that did not require a trained veterinarian to administer a subcutaneous or intramuscular objection.[87]
Therefore, consistent with the specification and the submissions of the parties, I consider the problem to be the need for an efficacious canine vaccine that could be delivered easily and provide increased convenience of vaccine delivery to the pet, the veterinarian, and the pet owner, and allow for delivery by personnel untrained in parenteral administration techniques.
Inventive step in light of the common general knowledge
I consider the relevant question to be considered is: In light of the problem, would the person skilled in the art as of 27 December 2006 be directly led as a matter of course to perform the three-step oral canine vaccination method defined in claim 1 in the expectation that it might well result in a therapeutically effective means of treating a dog for the defined canine diseases?
Would the person skilled in the art be directly led to try canine oral vaccination?
Dr Nordgren’s evidence is that when his team were thinking about alternative administration routes prior to 2006, he considered transdermal patches or topical gels because the skin is a great and efficient organ for drug delivery,[88] and needle-less intradermal vaccines with reduced dose.[89] Having conceded that transdermal patches and topical gels are not good for companion animals like dogs as they lick or chew off anything applied to the skin, Dr Nordgren concluded that the only other alternative administration routes were up the nose or down the throat of the animal. [90]
In his first declaration, when asked what administration route he would have used to deliver a canine vaccine, Mr Bevan stated that he “would have formulated the vaccine so as to provide the easiest way of administration to the dog (not necessarily the most efficacious route of administration), i.e by subcutaneous (SC) or intramuscular (IM) administration.”[91] Later on in his first declaration, Mr Bevan was asked to consider “the problem with administration of vaccines by subcutaneous or intramuscular routes which require administration to the animal by a veterinarian and how he might go about developing more convenient vaccination strategies to avoid this problem just prior to December 2006.”[92] Mr Bevan responded by stating that he would have considered formulations in which the vaccine could be administered by the pet owner, either by bait or by some other means in which the vaccine antigens could be delivered to the oral mucosa and tonsils of the animal.[93]
Dr Holloway was not directly asked how he would go about solving the problem. However, Dr Holloway understands Mr Bevan’s evidence is that vaccination by injection was most efficacious because of ease of administration.[94] With regard to Mr Bevan’s evidence that bait vaccines could be used to deliver vaccine antigens to the oral mucosa and tonsils, Dr Holloway’s opinion was that a bait vaccine approach is not a method that a dog owner may wish to use and the rabies bait vaccinations were never considered an option for pet animals.[95] Furthermore, Dr Holloway states that he does not consider oral vaccines for rabies as being relevant technology for protecting domestic dogs against common canine infections such as CPV2, CDV, CAV2 and CPiV.[96] Regarding intranasal vaccines, Dr Holloway states that the CPiV/BB intranasal vaccine was administered by a veterinary surgeon via a special nasal delivery device attached to a syringe containing the CPiV/BB containing liquid and then dripped into the dogs nose.[97] Presumably, such special nasal delivery devices would not be easily available to the average pet owner.
I consider that on balance, when looking to address the problem of an alternative canine vaccination method that could be delivered easily and was convenient for the pet, veterinarian and pet owner, a person skilled in the art would consider oral or intranasal administration. I come to this conclusion for a couple of reasons. Firstly, Dr Nordgren’s and Mr Bevan’s evidence is that they would have considered administering a vaccine orally or intranasally, or to the oral mucosa and tonsils respectively. Secondly, Mr Bevan’s evidence is that while subcutaneous or intramuscular injection would be the easiest method of delivery to the dog, these methods would not be able to be administered by a pet owner. Furthermore, this evidence was not contested by the applicant’s experts.
Would the person skilled in the art have the requisite expectation of success?
The next question is, would the person skilled in the art have the requisite expectation that an oral vaccination might well result in a therapeutically effective means of treating a dog for the defined canine diseases?
Mr Bevan concludes his evidence by answering the question of whether he would be “reasonably confident” that the oral-based delivery approaches would work with canine vaccines other than rabies vaccines? Mr Bevan responded by stating that although the parenteral route of administration is typically the quickest form of antigen delivery, the fact that a B. bronchiseptica vaccine delivered intranasally (so-called oronasal administration) has been available since about 1990, suggests to him that non-injectable routes of administration are certainly feasible.[98] After reviewing some literature on rabies vaccines being delivered through baits, fish vaccines being added to water, and live poultry vaccines being delivered through drinking water, Mr Bevan stated that he would be “optimistic” that oral based delivery approaches would work with a range of canine viral and bacterin antigens.[99]
While Mr Bevan refers to bait vaccines for rabies that are eaten by dogs as an example of a vaccination strategy that allows more convenient vaccination compared to subcutaneous or intramuscular injection, Dr Holloway notes that oral rabies vaccines are not administered to wild animals by a set vaccination regime and rabies bait vaccinations were never considered an option for pet animals.[100] Dr Holloway further notes that that he had concerns with the “difficulty in finding a dose that would be effective and sufficiently stimulate the immune system but would not cause clinical signs of disease.”[101] Dr Holloway further states 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.[102]
Dr Nordgren’s evidence is that oral vaccines were already available including an oral Bordetella bronchiseptica vaccine delivered to the buccal pouch.[103] Dr Nordgren also provided that oral vaccines for rabies were commercially available in the EU and US.[104] While I accept that it is Dr Nordgren’s understanding that he was aware of an oral B. bronchiseptica vaccine delivered to the buccal pouch, it is not apparent to what extent such vaccines were commercially available or whether they formed part of the common general knowledge.
Regarding the efficacy of a canine oral vaccine, Dr Nordgren stated that:
“it was known in late 2006 that intranasal and oral administration of vaccines via the nose or mouth could elicit a similar response as the oral and nasal openings communicate via the tonsils and hence vaccines administered by these routes pass through the tonsils which is an important site for immune cell (dendritic cell) processing of antigen.”
…
“Accordingly, one would reasonably predict that administration of many of the strains of antigen, particularly viral antigens such as CDV, CAV, CPV and CCV… via the oral route would stimulate an effective immune response.”[105]
Dr Nordgren further stated that he would be reasonably confident that an injectable vaccine would be effective as an oral vaccine as the antigens in the injectable vaccine had an affinity for a mucosal tissue type.[106] Since CAV-2 is a respiratory virus and CDV is transmitted via the respiratory tract, Dr Nordgren’s evidence is that he would have predicted that these antigens might work orally given the junction of the oral and nasal passages at the tonsils.[107] Similarly, as CPV is designed to pass through the stomach to the gut and CCV is a known intestinal pathogen, Dr Nordgren would predict oral administration could provide effective protection against these viruses.[108]
Dr Ameiss notes that Lauterslager et al.[109] states that:
“Oral vaccination is an attractive but not very efficient way to induce immunity. Despite considerable effort, only a few active oral vaccines are commercially available at the moment.”[110]
Dr Ameiss states that this is consistent with his view at 4(i)-(k) that due to the diverse immunological characteristics of different parts of the mucosa it is not possible to predict whether a particular vaccine would be effective or not when delivered orally.[111]
The declaration of Dr Bowersock, particularly 4(c) and (d), indicates that Dr Nordgren’s assertion that oral and intranasal vaccination would likely elicit a similar response is flawed as it fails to account for the known anatomical and physiological barriers presented by the gastrointestinal tract, and the physiological differences between species.[112]
Similarly, Dr Wappel’s evidence contradicts that of Dr Nordgren:
“While Dr Nordgren is correct that the pharyngeal tonsils in the dog intersect both the respiratory (nasal passages) and gastrointestinal (mouth) tracts, it is an over-simplification to assume that antigen or virus introduced into the nose or the mouth would elicit the same immune response as he claims.”[113]
…
“Additionally, Dr Nordgren specifically mentions the importance of dendritic cells in immune cell processing of antigens. Dendritic cells are prominent in the lymph nodes, skin and mucosal surfaces. The nasal passages have much more mucosal surface area than the mouth and there is therefore much more potential for antigen to be taken up by dendritic cells in the nasal passages and presented to the adaptive immune system to produce antibodies.”[114]
Dr Wappel concludes by stating that due to the very different environments and defences of the upper respiratory tract and the mouth,[115] she would not expect oral and intranasal vaccination to elicit the same immune response, at least due to the relatively short mucosal contact time in the oral cavity and the natural function of saliva.[116]
Consideration
I give less weight to Mr Bevan’s evidence that he would be “optimistic” and “reasonably confident” that oral based delivery approaches would work with a range of canine viral and bacterial antigens. Mr Bevan comes to this conclusion predominantly based on the success of rabies vaccines being delivered through baits, which as pointed out by Dr Holloway, raises concerns with the difficulty in finding a dose that would be effective and sufficient to stimulate the immune system but would not cause clinical signs of disease. I consider that dosage would not be so much of a problem when vaccinating wild dog populations to control a disease such as rabies when compared to vaccinating domestic animals, as in a domestic pet vaccination regime, pet owners would not tolerate dosage errors resulting in their dogs presenting with clinical signs of disease.
Similarly, I give less weight to Dr Nordgren’s evidence that vaccination via the oral route, as opposed to the intranasal (or oro-nasal) route, would be expected to stimulate an effective immune response. Firstly, as pointed out in the evidence of Dr Wappel, there are known anatomical and physiological barriers presented by the gastrointestinal tract when compared to the nasal passages, including the short mucosal contact time in the oral cavity and the natural function of saliva. Secondly, as noted by Dr Ameiss, due to the diverse immunological characteristics of different parts of the mucosa, it is not possible to predict whether a particular vaccine would be effective or not when delivered orally.[117] This position is further supported by Billen et al.[118] which notes that the location of the canine tonsil makes it a potentially useful target for intranasally delivered immunogens not orally delivered antigens.[119] Thirdly, there is less potential for antigen to be taken up by dendritic cells in the mouth than the nasal passages, as the nasal passages have much more mucosal surface area than the mouth.[120] Fourthly, a vaccine virus administered by one route may replicate faster and cause fatal disease when compared to a different delivery route or replicate inefficiently and therefore not provide adequate protection.[121] For example, Ramsay et al.[122] disclose that African painted dogs receiving repeated oral administration of a CDV vaccine failed to produce measurable antibody titres.[123] On the balance of probabilities, I consider that a skilled person would not draw any expectation of success of oral vaccination from the existence of intranasal/oro-nasal vaccinations.
Furthermore, the absence of any oral vaccination regimes for domestic dogs on the market provides further evidence of the difficult and non-routine nature of administering oral vaccines to dogs. For example, Lauterslager et al. states that “oral vaccination is an attractive but not very efficient way to induce immunity” which helps to explain why oral vaccination is “notoriously famous for dead-end leads”.[124] Also, while Dr Nordgren asserts that the only useful alternative administration routes for dogs and cats are nasal and oral, he fails to explain why those routes were not widely adopted for commercially available vaccines such as VANGUARD.[125]
As such, due to the number of differences between oral and intra-nasal vaccination as outlined above, I consider that the evidence fails to establish that there would be the necessary reasonable expectation of success that an entirely oral vaccination regime would result in a therapeutically effective means of treating a dog for the defined canine diseases. I do not consider that the evidence provided in relation to intra-nasal vaccination can be extrapolated to suggest that oral vaccination would have the same expectation of success. As a result, claims 1-20 are inventive in light of the common general knowledge.
Inventive step in light of the prior art
WO 2006/038115 (D1)
As discussed above, D1 discloses that vaccines can be administered to dogs by a variety of known routes including oral, intranasal, mucosal, topical, transdermal, and parenteral. I acknowledge that, absent some reason to the contrary, it will often be obvious for a skilled person to implement what is taught or disclosed in a document as a matter of routine and without invention. However, for the same reasons given above for inventive step in light of the common general knowledge, I consider that here the evidence establishes that this would not be the case. That is, notwithstanding the reference to oral administration in D1, the evidence fails to establish that a person skilled in the art would be directly led as a matter of course to perform the three-step oral canine vaccination method defined in claim 1 in the expectation that it might well result in a therapeutically effective means of treating a dog for the defined canine diseases. There is nothing in the disclosure of D1 that alters my conclusion for inventive step in light of the common general knowledge. As a result, claims 1-20 are inventive in light of D1.
Clear enough and complete enough disclosure
Paragraph 40(2)(a) as amended by the Raising the Bar Act requires that the claimed invention be described in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art.
It is clear that this provision requires that the PSA must be able to perform the invention across the scope of the claim without undue burden or inventive skill.[126] In Evolva SA[127] (Evolva), the Deputy Commissioner considered paragraph 40(2)(a), and having drawn guidance from European and UK decisions, adopted the following approach to assessing a clear and complete enough disclosure:
What is the scope of the invention as claimed?
What does the specification disclose to the skilled person?
Does the specification provide an enabling disclosure of all the things that fall within the scope of the claims, and in particular:
Is it plausible that the invention can be worked across the full scope of the claim?
Can the invention be performed across the full scope of the claim without undue burden?
This approach has subsequently been adopted by delegates of the Commissioner,[128] and the approach of the Deputy Commissioner was affirmed by the Federal Court in Cytec Industries Inc. v Nalco Company [2021] FCA 970. I will adopt the Deputy Commissioner’s approach to considering this ground.
What is the scope of the invention as claimed?
The claimed invention defines a method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of vaccine, wherein the vaccine comprises either (i) CDV antigen, CAV-2 antigen and CPV antigen, and one or more of CPI virus antigen and CCV antigen, or (ii) one of more bacterial antigens selected from Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. Pomona, L. Bratislava and Bordetella bronchiseptica, or (iii) both.
What does the specification disclose to the skilled person?
As discussed above under construction, I consider the specification broadly discloses a method of treating a dog for canine disease 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, and orally in one or more annual doses.[129]
More specifically, the specification discloses by way of exemplification:
·Antibody titres to CDV antigen, CPV antigen and CAV-1 antigen in a canine in response to a vaccine administered subcutaneously in a first dose, then orally in a second and third dose (Example 1)
·Seroconversion in a canine in response to CPV, CDV and CAV-1 antigens delivered (i) both subcutaneously in a first dose, then orally in a second and third dose, or (ii) orally in all three doses (Example 2)
·Formulation of various canine combination vaccines (Examples 3-6)
Plausibility
The first limb of the test outlined in Evolva asks: Is it plausible that the invention can be worked across the full scope of the claim?
With regard to the threshold of plausibility, I note the comments made by Lord Sumption (with whom Lords Reed and Briggs agreed) in Warner-Lambert Company LLC v Generics (UK) Limited (t/a Mylan) and ors[130] who stated:
“The principle is that the specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true.”
In Gary B Cox v MacroGenics, Inc. [2019] APO 13, the Delegate considered the U.K cases on plausibility as well as Evolva and considered that the consideration of plausibility is:
“one of technical credibility or believability. Plausibility may be a low threshold, but it is a threshold nonetheless, and is not satisfied by mere speculation or assertion.”[131]
The opponent submits that the effect of the evidence is that it is not plausible to assert that the invention will work across the claim, as the opposed application does not demonstrate effectiveness.[132] The applicant responds by submitting that it is not necessary to prove, with experimental data, every embodiment of the claim.[133] The applicant further submits that the evidence does not support the assertion that the invention working across the scope of the claims is not plausible or credible.[134] The opponent provides several reasons for their attack on plausibility and I’ll consider each of these in turn.
No data in Example 2 on antibody titres
Firstly, the opponent submits that the opposed application does not include any data in Example 2 as to antibody titres, rather seroconversion was used as a de-facto measure of protection.[135] Dr Holloway notes that seroconversion is used in many vaccine trials initially to show that the vaccine stimulated the immune system and there is a very high correlation between antibody levels and protection from challenge for CAV, CDV and CPV.[136]
Paragraph [0066] of the specification states:
“Animals were considered positive responders (i.e., protected from disease) if they had antibody titres greater than or equal to 1:16 for CAV-1, 1:32 for CDV, and 1:16 for CPV.”
Dr Nordgren states:
“These figures are generally considered to be representative of protection although this would need to be confirmed by challenge. These “expected protective titres” are based on historical experience with parenteral administration.”[137]
Dr Holloway appears to agree stating that “[i]t is widely accepted by the scientific community that proof of a serological immune response to a live virus will often correlate with a memory response being present such that subsequent challenge with wild type virus would result in a rapid response.”[138] Dr Holloway goes on to say that the invention has shown that sufficient immune response has been produced to infer that protection would most likely occur at challenge.[139]
I consider that the evidence fails to establish that it is not plausible that the seroconversion data provided in Table 5 could be used as a de-facto measure of protection. While both Dr Nordgren and Dr Holloway agree that using seroconversion as a de-facto measure of protection would ultimately need to be confirmed by challenge, I do not consider that data on antibody titres or challenge studies needs to be disclosed to meet the plausibility threshold.
Insufficient response to CDV
Secondly, the opponent submits that the opposed application does not show that there will be a sufficient response elicited to CDV antigen.[140]
Dr Nordgren states that:
“For the CDV antigen, the protocol involving entirely oral vaccinations (T02) resulted in seroconversion in only 6/13 dogs at day 63. The results for CDV are not clear as a local IgA response could have been stimulated and not detected by circulating antibodies, or otherwise the three times oral administration was an insufficient means of protecting dogs against distemper.”[141]
Dr Holloway disagrees submitting that the fact that 6/13 dogs seroconverted suggests that entirely oral vaccinations are feasible.[142] Dr Holloway compared these results to those in Connolly et al.[143] where only 2/8 dogs seroconverted to the degree of the protective titre after the first oral vaccination but the protection was short lived and disappeared at the time of the second vaccination, which was not the case here where 5/13 dogs seroconverted at the time of the second vaccination (See day 21, T02 for CDV in Table 5).[144]
Dr Nordgren also states that “a seroconversion of 6 of 13 dogs for CDV is a very low rate and could also have been impacted by the maternally derived antibody status of the animals.”[145] Dr Holloway disagrees submitting that the dogs were free of antibodies at the start of the experiment and therefore concluded that maternally derived antibodies were also absent.[146] The specification also states in Example 1 that the thirty-three pups used in the study had no antibodies [emphasis added] to CAV-1, CPV or CDV at the initiation of the study.[147] Dr Holloway concludes that if maternally derived antibodies were present, he would have expected higher levels of antibodies at first measurement, and that the low rate of seroconversion for CDV may be related to other issues such as the dose of the virus given and the oral route of administration.[148]
In the situation where dogs are free of maternally derived antibodies, Dr Nordgren’s evidence provides that the very low rate of seroconversion is quite indicative that the data does not demonstrate [emphasis added] that there will be a sufficient immune response elicited to CDV.[149] At the hearing, the applicant emphasised that to reach the threshold of plausibility under the test outlined in Evolva, all that is required is that it is plausible that a sufficient immune response is achieved. In the present case, I consider that this threshold is reached. While the evidence establishes that a seroconversion rate of 6/13 is not “optimal”, it fails to establish that it is not at least plausible that such a rate would offer sufficient protection. Indeed, as pointed out by Dr Holloway, the seroconversion rates achieved against CDV antigen in Example 2 are higher than expected based on other rates achieved in the prior art (See Connolly et al.).
Insufficient response to CAV
Thirdly, the opponent submits that the opposed application does not show that there will be a sufficient response elicited to canine adenovirus antigen.[150]
Dr Nordgren’s evidence questions the seroconversion results for CAV-1 in Table 5 saying that the results are spurious as even the control (T01) group seroconverted (10/13 dogs).[151] Dr Holloway agrees that the seroconversion in the control group would prevent interpretation of the CAV-1 aspect of the experiment.[152] Dr Holloway then suggests that the most likely cause of the control group seroconverting was contamination from the T02 or T03 groups with oral virus administration and shedding of the vaccine virus which has then spread to the T01 group.[153]
Dr Nordgren suggests that “the results shown for the control (T01) group of the CAV-1 antigen reflects poorly on the containment for the entire study … We do not know whether the dogs in groups T01, T02 or T03 were in contact or common airspace with each other but the results shown for group T01 for the CAV-1 antibody test suggest that this may have occurred.”[154] However, Dr Holloway does not agree that these results call into question the integrity of the entire study because if the integrity of the entire study had been compromised he would expect to see control groups in other arms of the study show seroconversion.[155]
The declarants appear to be in agreement that the seroconversion results for CAV-1 in Table 5 cannot be used as evidence for protection in dogs by three oral vaccinations of the CAV-1 antigen. However, the specification states, in relation to Example 1 that “specific antibodies against CAV-1 clearly indicate that there is a robust immune response to oral dosing for this antigen (see Figure 3).”[156]
When Dr Nordgren was asked whether Figures 1-3 and the results in paragraph [0063] of the opposed specification are relevant to vaccine protocols involving entirely oral dosage forms he replied:
“In my view they are not. This study only looked at protocols involving a first subcutaneous dose and subsequent oral doses, and cannot be extrapolated to protocols involving a first dose and subsequent oral doses. Therefore, these results are of limited relevance to a vaccine strategy involving oral administration.”[157]
Dr Holloway disagrees with this statement submitting that “I note that as shown on Table 5 on page 18 of the opposed application the treatment group T02 was given three oral doses and seroconversion was identified for CPV, CAV-1 and CDV”.[158] However, as noted above, the results of Table 5 are inconclusive in relation to CAV-1.
While as noted by Dr Nordgren, the results from Figures 1-3 are of little relevance to a vaccine strategy involving all oral administration, my view is that when Figures 1-3 are read in conjunction with Table 5, there is sufficient disclosure to say it is at least plausible that a three oral dose vaccination regime with CAV-1 would be protective in dogs. I come to this conclusion for two reasons. Firstly, the specification itself states that Figure 3 indicates a robust immune response to oral dosing for CAV-1.[159] Secondly, it can also be seen from Figure 3 that there is very little raise in antibody titres after the initial subcutaneous dose, whereas mean antibody titres peaked at both day 35 and day 56 in response to oral doses of CAV-1 antigen at days 21 and 42 respectively. I consider it clear from Figure 3 that two oral doses significantly raised antibody titres after a limited raise in antibody titres in response to a first subcutaneous dose. Therefore, I consider that Figure 3 when read in conjunction with the specification provides a technically credible theory that oral vaccination with CAV-1 in dogs results in seroconversion levels reflective of protection against CAV.
The opponent makes a further argument that the tested antigen was CAV-1, yet the claims (and Examples 1 and 2) relate to CAV-2.[160] The specification however, states that “[a]nimals vaccinated with CAV-2 generate antibodies cross-reactive with CAV-1.”[161] As a result, I consider that in the absence of evidence to the contrary, that the results provided in the opposed application for CAV-1 would be representative of the results that would be obtained if the animals were vaccinated with CAV-2.
Protection from bacterin antigens
The opponent further submits that there is no information suggesting that bacterins had been used or successfully evaluated.[162]
Dr Holloway submits that:
“My understanding is that the claims of the Opposed Application are made in relation to combining the current invention with bacterins in a new format. In my opinion, the efficacy of those existing bacterins is not relevant in determining the overall efficacy of an orally given vaccine for CDV, CPV and CAV.”[163]
Dr Holloway’s evidence above was made in relation to the previous opposition where the invention is combining bacterins with CDV, CPV and CAV in an orally administered vaccination regime. However, as discussed above, the scope of claim 1 of the current claims includes a method of treating a dog by administering three oral doses of a therapeutically effective amount of any one of the defined bacterins alone.
Dr Nordgren further submits that “[t]he bacterin antigens that are mentioned in claims 4-7 were known prior to 2006”.[164] Even if these bacterin antigens were known, the opposed application provides no efficacy data on whether these antigens would provide protection to dogs when delivered in a three-dose oral vaccination regime. While the specification does provide some disclosure on how such bacterins could be used in the preparation of vaccines,[165] the specification is silent as to whether such vaccines as formulated would be efficacious in protecting dogs when delivered three times orally. Similarly, the specification fails to disclose any data or examples regarding the efficacy of a three-dose oral vaccination regime for dogs with CPI or CCV.
Mr Bevan states that “a B. bronchiseptica vaccine which is delivered intranasally (so-called oronasal administration) has been available since about 1990”.[166] However, this evidence fails to establish that oral delivery of B. bronchiseptica was part of the common general knowledge as of 27 December 2006. As a result, there is nothing in the evidence or the common general knowledge that indicates that a B. bronchiseptica antigen delivered three times orally in a canine vaccination regime would be effective. As noted by Dr Ameiss, due to the diverse immunological characteristics of different parts of the mucosa, it is not possible to predict whether a particular vaccine would be effective or not when delivered orally.[167] Therefore, I consider that the evidence fails to establish that it would be plausible that that a B. bronchiseptica antigen delivered three times orally in a canine vaccination regime would be effective. Furthermore, I consider that the evidence fails to establish that it would be plausible that the remaining Leptospira antigens defined as well as the CPI and CCV antigens when delivered three times orally in a canine vaccination regime would be effective, for the same reasons given above. As a result, the invention defined by claims 1-20 is not disclosed in a clear enough and complete enough manner with respect to the CPI, CCV, B. bronchiseptica and Leptispora antigens.
Undue burden
The second limb of the test outlined in Evolva asks: Can the invention be performed across the full scope of the claim without undue burden?
The concept of an undue burden was discussed in Evolva. Having considered UK and European authorities the Deputy Commissioner concluded:
“My understanding of these authorities is that the emphasis in relation to undue burden has been on the nature of the work that is required by the skilled person in view of the guidance in the specification. To this end, one approach has been to ask whether the skilled person would be required to undertake a ‘research programme’ in order to perform the invention.”[168]
The consideration of what constitutes an undue burden is necessarily dependent upon the nature of the technology, and factors relevant to the consideration include the level of predictability in the art and the level of guidance in the specification.[169]
The opponent submits that the effect of the evidence is that it would require a research program to carry the invention out across its scope.[170] The opponent further submits that there is no demonstration of lack of interference across the breadth of the claims, and one cannot tell if, for the various possible subsets of viral antigens and bacterins, whether the multitude of combinations encompassed by the claims will indeed be efficacious as to all of the canine diseases to be treated or prevented by administration of the viral antigens and bacterins.[171]
With regard to Example 1, Dr Holloway states:
“In the sense of a new invention or method of vaccination then CAV1 results provide a proof of concept of oral vaccination being effective in dogs for generating antibody responses against these three agents.”
…
“These two experiments confirm proof of principle that the oral method worked for CAV1 and is likely effective for CPV also”
Dr Holloway states, regarding Examples 1 and 2, “[t]aken together the two experiments provide proof of a method that may be utilized to orally vaccinate against these canine viruses.”[172] Dr Holloway expressly acknowledges that the opposed application has not demonstrated efficacy over all the agents it claims.
Dr Nordgren states that “… from my own experience I would know how to repurpose [the parenteral vaccine] for these alternative administration routes and how to test it.”[173] Dr Holloway responds by stating “[i]t is not possible to know how the vaccine would work as there are issues related to reformulation, safety and efficacy that are not predictable.”[174]
I consider that the evidence of Dr Holloway is that Examples 1 and 2 when taken together, provide a proof of concept that oral vaccination is effective in providing an antibody response to CDV, CPV and CAV-1(CAV-2). Although some optimisation may be required with regard to dosimetry for possible combinations and subsets of these antigens, I consider that such optimisation would be predictable and would not amount to an undue burden being placed on the person skilled in the art.
As a result, I consider that the invention defined in claim 1-20 with respect to CDV, CPV and CAV-2 antigens, can be performed across the full scope of the claims without undue burden or the need for further invention.
Conclusion
In summary, claims 1-20 with respect to the CPI, CCV, B. bronchiseptica and Leptispora antigens, do not meet the requirements of s 40(2)(a) of the Patents Act as the invention defined by claims 1-20 is not disclosed in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art.
Support
Section 40(3) as amended by the Raising the Bar Act requires that the claims must be supported by matter disclosed in the specification. The requirement of support can be summarised as requiring that the scope of the claims “should correspond to the technical contribution to the art”.[175]
The requirement of support has been more fully explained as follows:
“in other words it is the definition of the invention in the claims that needs support. In the Board’s judgement, this requirement reflects the general legal principle that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified. This means that the definitions in the claims should essentially correspond to the scope of the invention as disclosed in the description. In other words, as was stated in Decision T 26/81, the claims should not extend to subject-matter which, after reading the description, would still not be at the disposal of the person skilled in the art. Consequently, a technical feature which is described and highlighted in the description as being an essential feature of the invention, must also be a part of the independent claim or claims defining this invention.”[176] (emphasis in the original, citations omitted)
To determine whether the requirements of support are satisfied the following steps were set out in CSR Building Products Limited v United States Gypsum Company (CSR):[177]
(i)construe the claims to determine the scope of the invention as claimed,
(ii)construe the description to determine the technical contribution to the art, and
(iii)decide whether the claims are supported by the technical contribution to the art.
There is substantial overlap in the submissions of the opponent in relation to section 40(3) and section 40(2)(a), in relation to whether there is an enabling disclosure. I have already considered these submissions above and will not revisit them here.
The opponent cites the proposition in Merck Sharp and Dohme Corporation v Wyeth LLC (No 3)[178] at [502]-[577] where Burley J held that a claim which caught a 15 valent vaccine composition was not supported by a disclosure which only disclosed a 13-valent vaccine composition.[179] The applicant submits that the reliance on Merck Sharp and Dohme Corporation is misplaced, as the finding in that case was based on the fact that there was no technical contribution sufficient to justify a monopoly over a 15 valent vaccine. The applicant argues that it is not enough simply to assert, that the claims are broader than the experimental data, otherwise claims broader than the specific experimental examples would always fail the test.[180]
In Merck Sharp and Dohme Corporation, Justice Burley found that there is no disclosure of the conjugation of additional serotypes [beyond the 13 serotypes defined] to the protein CRM197, as the evidence established that it is not “possible to extrapolate the data in the composition to other serotypes because it is focussed on the serotypes covered by the patents.”[181] Justice Burley also found that the common general knowledge revealed that adding serotypes to the composition claimed would be a complex and difficult process.[182] While the opposed application does indeed focus on the three exemplified antigens, CDV, CAV-1 and CPV, in contrast to Merck Sharp and Dohme Corporation, the evidence here does not establish that it would be a complex and difficult process to add additional antigens to the canine vaccine. Example 5 describes the formulation of a Canine Distemper-Adenovirus Type 2-Coronavirus-Parainfluenza-Parvovirus Vaccine containing a Leptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterin. Similarly, Example 6 describes the formulation of a Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus Modified Live Virus Vaccine containing a Bordetella bronchiseptica Bacterin. Therefore it is considered that while there would be no difficulty adding additional antigens to the canine vaccine, there still remains a question on the efficacy of such a vaccine.
The claimed invention defines a method of treating a dog for canine diseases comprising administering to the dog therapeutically effective amounts of vaccine, wherein the vaccine comprises either (i) CDV antigen, CAV-2 antigen and CPV antigen, and one or more of CPI virus antigen and CCV antigen, or (ii) one of more bacterial antigens selected from Leptospira canicola, L. grippotyphosa, L. icterohaemorrhagiae, L. Pomona, L. Bratislava and Bordetella bronchiseptica, or (iii) both.
As can be seen from CSR, the technical contribution is determined by construing the description of the opposed application. From a construction of the opposed application, I consider the technical contribution to be a method of treating a dog for canine disease comprising administering to the dog therapeutically effective amounts of vaccine, wherein the vaccine comprises CDV, CAV-1(CAV-2) and CPV, and wherein the vaccine is administered subcutaneously or orally in a first dose, orally in a second dose, and orally in one or more annual doses.[183] I come to this conclusion for two reasons. Firstly, while I agree with the statement made by the applicant that “a technical contribution does not universally require “demonstration” by experimental data or testing across the full breadth of the claims”, here the specification is silent with regards to any data to support whether the antigens other than CDV, CAV-1(CAV-2) and CPV would be able to effectively treat a canine using the defined oral vaccination regime. Secondly, there is nothing in the evidence to persuade me that the technical contribution should extend to these further antigens. It follows that claim 1 to the extent that it defines CPI, CCV or any of the defined bacterin antigens is broader than the applicant’s technical contribution to the art. As such claim 1 lacks support insofar as the claim defines antigens other than CDV, CAV-2 and CPV. Furthermore, as claims 2-20 also include the use of such unsupported antigens in their scope, claims 2-20 also lack support.
Utility
Section 18(1)(c) of the Patents Act requires that for an invention to be patentable it must be useful. This requirement was expressed in the following manner at [141] of Ranbaxy Australia Pty Ltd (CAN 110 781 826) v Warner-Lambert Company LLC [2008] FCAFC 82:
“Under ss 138 and 18(1)(c) of the 1990 Act, it is a ground of invalidity if the claimed invention is not useful "so far as claimed in any claim". If the claimed invention does what it is intended by the patentee to do and the end obtained is itself useful, the invention is useful within the meaning of s 18(1)(c) (see Rehm Pty Limited v Webster’s Security Systems (International) Pty Limited (1981) 81 ALR 79 at 96; Welcome Real-Time SA v Catuity Inc [2001] FCA 445; (2001) 113 FCR 110 at 144; and Fawcett v Homan (1896) 13 RPC 398 at 405). As to the first aspect, the invention as claimed must attain the result promised by the patentee (Advanced Building Systems Pty Limited v Ramset Fasteners (Aust) Pty Limited [1998] HCA 19; (1998) 194 CLR 171 at 187).”
The principles of utility were summarised by the Full Court of the Federal Court in Artcraft Urban Group Pty Ltd v Streetworx Pty Ltd [2016] FCAFC 29 at [120]-[121] (with references omitted):
“The ‘basic principle’ of inutility is that if an invention ‘does what it is intended by the patentee to do, and the end attained is itself useful, the invention is a useful invention’. What the invention is ‘intended’ to do is a matter to be gathered from ‘title and the whole of the specification’.
Put another way, the two questions are: first, what is the promise of the invention derived from the whole of the specification?; second, by following the teaching of the specification, does the invention, as claimed in the patent, attain the result promised for it by the patentee? Further, ‘everything’ that is within the scope of a claim must be useful, that is, attain the result promised for the invention by the patentee.”
The opponent submits that on the basis of the evidence in the specification of the opposed application itself, it can be concluded that the vaccines are not useful at least in relation to canine distemper.[184] The applicant submits that this conclusion ignores the statement at [0064] of the opposed specification which states that although “high titres of antibodies specific for CDV and CPV following a subcutaneous vaccination make clear interpretation of the efficacy of oral dosing for CDV and CPV difficult …, oral vaccination is a practical and potentially effective route of vaccine administration in dogs.” The applicant further submits that the opponent’s argument quibbles with experimental design rather than anything remotely approaching proof that the invention as claimed does not work in relation to canine distemper.[185]
As discussed above in relation to clear enough and complete enough disclosure, I found that while the evidence establishes that the level of seroconversion against CDV is not optimal, it is plausible or credible that such a seroconversion rate would offer sufficient protection. As noted by Jagot J in Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162 at [352], lack of utility requires evidence, not just speculation:
“Ultimately, an asserted lack of utility must be established by appropriate evidence, not by mere speculation that the invention will not work or meet the promise set out in the specification.”
The opponent has not furnished evidence to establish that the level of protection against CDV acquired using the claimed vaccination method, is insufficient to attain the result promised by the patentee i.e. a method of treating a dog for CDV comprising administering a therapeutically effective amount of vaccine. It follows that the opponent has not made out this ground.
Conclusion
The opposition succeeds on the grounds of section 40(2)(a) and section 40(3) and fails on all other grounds.
I consider that these matters can be overcome by amendment. I will allow the applicant an opportunity to propose amendments.
Costs
It is normal in matters before the Commissioner that costs should follow the event. I see no reason to depart from that approach in the present case. I will award costs according to Schedule 8 against the applicant.
Damian Triffett
Delegate of the Commissioner of Patents
ANNEX
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 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 canine distemper (CD) virus, canine adenovirus type 2 (CAV-2) and canine parvovirus (CPV), and one or more of 1) canine parainfluenza (CPI) virus, and 2) 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.
A method according to claim 1, wherein the vaccine comprises canine distemper (CD) virus, canine adenovirus type 2 (CAV-2), and canine parvovirus (CPV).
A method according to claim 1 or 2, further comprising CPI virus.
A method according to claim 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.
A method according to claim 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.
A method according to claim 3, wherein the bacterin is Bordetella bronchiseptica.
A method according to claim 1, 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.
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.
A method according to claim 1 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 claim 1, 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 claim 1 or 3, wherein the viral antigens are present in the following ranges of amounts: for CD virus, about 104 TCID50 to about 105 TCID50, inclusive; for CAV-2, about 104 TCID50 to about 105 TCID50, inclusive; for CPV, about 107 TCID50 to about 108 TCID50, inclusive; and for CPI virus, about 106 TCID50 to about 108 TCID50, inclusive.
12.A method according to claim 1, 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 claim 1, 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 claim 1, 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 claim 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 claim 1, 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 claim 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.
[1] Merial Limited v Zoeitis Services LLC [2016] APO 12 (the previous opposition).
[2] Opponent’s Written Submissions at [13]-[15].
[3] Applicant’s Written Submissions at [62].
[4] [2013] FCA 214, 100 IPR 451 at [139].
[5] Specification at [0002].
[6] Specification at [0004].
[7] Specification at [0004].
[8] Specification at [0005].
[9] Specification at [0011].
[10] Specification at [0059].
[11] Specification at Table 2.
[12] Specification at [0061].
[13] Specification at [0061].
[14] Specification at [0062].
[15] Specification at [0063].
[16] Specification at [0063].
[17] Specification at [0063].
[18] Specification at [0065].
[19] Specification at [0066].
[20] Specification at [0066].
[21] Specification at [0066].
[22] Specification at [0067].
[23] Specification at [0068]-[0076].
[24] Specification at [0068]-[0076].
[25] [2000] FCA 980; 49 IPR 225 at [70].
[26] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30; 257 CLR 356 at [23].
[27] Opponent’s Written Submissions at [26].
[28] Applicant’s Written Submissions at [76].
[29] Applicant’s Written Submissions at [76] and [98].
[30] Applicant’s Written Submissions at [77].
[31] Applicant’s Written Submissions at [91](a).
[32] Applicant’s Written Submissions at [91](b).
[33] Applicant’s Written Submissions at [91](c).
[34] Applicant’s Written Submissions at [90].
[35] Nordgren-1 at [6].
[36] Nordgren-1 at [7].
[37] [2009] FCAFC 70, 81 IPR 228 at [118]-[120].
[38] Specification at [0034].
[39] Specification at [0028].
[40] Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; 137 CLR 228 at 235.
[41] Nicaro Holdings Pty Ltd v Martin Engineering Company [1990] FCA 40; 16 IPR 545 at 549.
486.
[43] (1930) 47 RPC 69, 90.
[44] General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457, 485-486; See also AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 (12 August 2014) at [293].
[45] D1 at Page 3, lines 20-21.
[46] D1 at Page 3, lines 38-42.
[47] D1 at Page 3, line 42 – Page 4, line 8.
[48] D1 at Page 10, lines 5-9.
[49] D1 at Page 13, lines 11-13.
[50] D1 at Page 10, line 44 – Page 11, line 1 and Page 16, line 7.
[51] D1 at Page 10, lines 29-36.
[52] D1 at Page 13, lines 14-17.
[53] D1 at Claim 28.
[54] D1 at Claim 29.
[55] D1 at Page 52, lines 7-9.
[56] D1 at Page 52, lines 27-29.
[57] Opponent’s Submissions at [60]-[62].
[58] Applicant’s Written Submissions at [81]-[82].
[59] [2013] FCA 214 (Eli Lilly).
[60] Applicant’s Written Submissions at [82].
[61] Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214 at [321].
[62] As made clear by the Full Court in Mylan v Sun Pharma [2020] FCAFC 116; 279 FCR 354; 380 ALR 582; 153 IPR 199 (Sun Pharma) at [104]-[111]; See Opponent’s Submissions at [68].
[63] Applicant’s Written Submissions at [94].
[64] Applicant’s Written Submissions at [83].
[65] Applicant’s Written Submissions at [88].
[66] Applicant’s Written Submissions at [86].
[67] Opponent’s Written Submissions at [68].
[68] Specification at Page 10, lines 35-36.
[69] D1 at Page 10, line 32-34.
[70] Specification at Page 52, lines 27-29.
[71] [1981] HCA 12 at [45]; 148 CLR 262 at 286 (Wellcome Foundation).
[72] [2002] HCA 59; 56 IPR 129 at 142-143 (Alphapharm).
[73] Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9; 144 CLR 253 at 292.
[74] Nordgren-1 at [10]; Holloway-1 at [4(c)].
[75] Nordgren-1 at [12].
[76] Nordgren-1 at [15].
[77] Holloway-1 at [4(h)].
[78] Holloway-1 at [4(h)].
[79] Nordgren-1 at [17].
[80] Nordgren-1 at [17].
[81] Nordgren-1 at [17]; Bevan-1 at [12]; Holloway-1 at [4(aa)].
[82] Bevan-1 at [10].
[83] Becan-1 at [20].
[84] Bevan-1 at [10].
[85] Bevan-1 at [14].
[86] Bevan-1 at [11].
[87] Applicant’s Written Submissions at [13].
[88] Nordgren-1 at [16].
[89] Nordgren-1 at [16].
[90] Nordgren-1 at [16].
[91] Bevan-1 at [8].
[92] Bevan-1 at [11].
[93] Bevan-1 at [12].
[94] Holloway-2 at [4(c)].
[95] Holloway-2 at [4(h)].
[96] Holloway-1 at [4(bb)].
[97] Holloway-1 at [4(n)].
[98] Bevan-1 at [14].
[99] Bevan-1 at [16].
[100] Holloway-2 at [4(f)]-[4(h)].
[101] Holloway-4 at [24].
[102] Holloway-2 at [4(l)].
[103] Nordgren-1 at [17].
[104] Nordgren-1 at [17].
[105] Nordgren-1 at [18].
[106] Nordgren-1 at [40].
[107] Nordgren-1 at [45]-[46].
[108] Nordgren-1 at [45]; Nordgren-2 at [6].
[109] Lauterslager et al., Vaccine, 2003, Vol. 21, pages 1391-1399. Annexed to Holloway-4 as exhibit SAH-7.
[110] Ameiss at 6(a)-6(b).
[111] Applicant’s Written Submissions at [134].
[112] Applicant’s Written Submissions at [137].
[113] Wappel at [4(a)].
[114] Wappel at [4(e)].
[115] Wappel at [4(f)].
[116] Wappel at [4(g)].
[117] Ameiss at 4(a)-(k); See also Kiyono and Fukuyama, Nature Reviews – Immunology, 2004, Vol. 4, pages 690-710.
[118] Billen et al., J. Comp. Path., 2006, Vol. 135, pages 63-73. Annexed to Ameiss as exhibit KA-2.
[119] Ameiss at 4(h).
[120] Ameiss at 4(e)-4(h).
[121] Holloway-4 at [58].
[122] Ramsay et al., Journal of Zoo and Wildlife Medicine, 2016, Vol. 47, No. 2, pages 551-557. Annexed to Holloway-4 as exhibit SAH-9.
[123] Holloway-4 at [59].
[124] Silin et al., Expert Opin. Drug Deliv., 2007, Vol. 4, No. 4, pages 323-340. Annexed to Holloway-2 as exhibit SAH-4; Holloway-2 at [4(m)].
[125] Applicant’s Written Submissions at [131].
[126] Novartis AG v Johnson & Johnson Medical Limited [2010] EWCA Civ 1039 at [74].
[127] [2017] APO 57 at [45].
[2018] APO 4; Grant Fisher v ToolGen Incorporated [2018] APO 65; Gary B Cox v MacroGenics, Inc. [2019] APO 13.
[129] Specification at [0005].
[130] [2018] UKSC 56.
[131] Gary B Cox v MacroGenics, Inc at [63].
[132] Opponent’s Written Submissions at [119].
[133] Applicant’s Written Submissions at [146].
[134] Applicant’s Written Submissions at [146].
[135] Nordgren-1 at [61].
[136] Holloway-4 at [72].
[137] Nordgren-1 at [60].
[138] Holloway-4 at [71].
[139] Holloway-4 at [71].
[140] Opponent’s Written Submissions at [119] and [122]; Nordgren-1 at [65].
[141] Nordgren-1 at [62].
[142] Holloway-4 at [72].
[143] Connolly, M. et al., Journal of Zoo and Wildlife Medicine, 2013, Vol. 44, No. 4, pages 882-888. Annexed to Holloway-4 as exhibit SAH-9.
[144] Holloway-4 at [72].
[145] Nordgren-1 at [65].
[146] Holloway-4 at [75].
[147] Specification at [0060].
[148] Holloway-4 at [76].
[149] Nordgren-1 at [65].
[150] Opponent’s Written Submissions at [119] and [122]; Nordgren-1 at [65].
[151] Nordgren-1 at [63].
[152] Holloway-4 at [73].
[153] Nordgren-1 at [73].
[154] Nordgren-1 at [67].
[155] Holloway-4 at [74].
[156] Specification at [0063].
[157] Nordgren-1 at [57].
[158] Holloway-4 at [68].
[159] Specification at [0063].
[160] Opponent’s Written Submissions at [131].
[161] Specification at [0066].
[162] Opponent’s Written Submissions at [119]; Nordgren-1 at [71].
[163] Holloway-4 at [80].
[164] Nordgren-1 at [72].
[165] Specification at Examples 4-6.
[166] Bevan-1 at [14].
[167] Ameiss at [4(i)]-[4(k)].
[168] Evolva at [33].
[169] Evolva at [34] and [35].
[170] Opponent’s Written Submissions at [122].
[171] Opponent’s Written Submissions at [123].
[172] Holloway-2 at [3(g)].
[173] Nordgren-1 at [27].
[174] Holloway-4 at [45].
[175] Fuel Oils/EXXON (T409/91) [1994] OJ EPO 653 at 659.
[176] Fuel Oils/EXXON (T409/91) [1994] OJ EPO 653 at 659 and 660.
[177] [2015] APO 72 at [115].
[178] [2020] FCA 1477; 155 IPR 1 (Merck Sharp and Dohme Corporation).
[179] Opponent’s Written Submissions at [132].
[180] Applicant’s Written Submissions at [150].
[181] Merck Sharp and Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477; 155 IPR 1 at [550].
[182] Merck Sharp and Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477; 155 IPR 1 at [550].
[183] Specification at [0005].
[184] Opponent’s Written Submissions at [138].
[185] Applicant’s Written Submissions at [152].
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10
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