Boehringer Ingelheim Animal Health USA Inc.v Zoetis Services LLC - [2020] APO 40

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Boehringer Ingelheim Animal Health USA Inc.v Zoetis Services LLC [2020] APO 40

Patent Application: 2013243535; 2013243537 and 2013243540.

Title:Mycoplasma hyopneumoniae vaccine;
PCV/Mycoplasma hyopneumoniae vaccine;
PCV/Myoplasma hyopneumoniae/PRRS combination.

Patent Applicant:                   Zoetis Services LLC.
Opponent:  Boehringer Ingelheim Animal Health USA Inc.
Delegate:  K. Wagg
Decision Date:  28 August 2020
Hearing Date:  26-27 August 2019 with further submissions filed on 4 September 2019

Catchwords: PATENTS – opposition to grant – s 59 – clarity – inventive step – manner of manufacture – Mycoplasma hyopneumoniae supernatant vaccine – vaccine platform – bivalent and multivalent vaccine – substantially free – whether it was obvious to use a supernatant vaccine in the prior art as a starting point for a platform vaccine – evidence required to establish the problem – removal of IgG and immunocomplexes using protein A or G as common general knowledge – opposition successful on one application but fails on two – costs on one application awarded against the opponent.

Representation: Counsel for the Applicant: Christian Dimitriadis SC and Clare Cunliffe
Patent attorneys for the Applicant: Jenny Petering, Karin Innes and Cameron Smith of FB Rice.
Also in attendance: Judy Jarecki-Black from Merial, Inc./Boehringer Ingelheim and Thomas Kowalski on behalf of Merial, Inc./Boehringer Ingelheim.
Counsel for the Opponent: Patrick Flynn SC of Eleven Wentworth
Ean Blackwell and Katrina Crooks of Shelston IP Lawyers Pty Ltd
Also in attendance: Gloria Szakiel and Sally Mannion of Zoetis Services LLC

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2013243535; 2013243537 and 2013243540

Title:Mycoplasma hyopneumoniae vaccine;
PCV/Mycoplasma hyopneumoniae vaccine;
PCV/Myoplasma hyopneumoniae/PRRS combination.

Patent Applicant: Zoetis Services LLC.
Date of Decision: 28 August 2020
DECISION
Claims 1-2, 4-6, 9-10, 12-18 of patent application 2013243535 do not involve an inventive step. No other grounds made out. Subject to appeal the Applicant is given 2 months to file suitable amendments. The Oppositions on 2013243537 and 2013243540 have not been successful.
Costs for the oppositions on 2013243535; 2013243537 are balanced. The Opponent to pay costs on 2013243540.
REASONS FOR DECISION
Background

This decision relates to three patent applications, 2013243535, 2013243537 and 2013243540 (the ‘535 , the ‘537 (bivalent) and the ‘540 (trivalent), respectively). The ‘535 application is titled Mycoplasma hyopneumoniae vaccine; the ‘537 (bivalent) application is titled PCV/Mycoplasma hyopneumoniae vaccine, and the ‘540 (trivalent) application is titled PCV/Myoplasma hyopneumoniae/PRRS combination. The applications are related, and the parties are the same. I have, therefore, combined them here to decide all three applications.
All three applications were filed on 3 April 2013 and claim a priority date of 4 April 2012. The Applicant for all three applications is Zoetis Services LLC (The Applicant). The Applicant filed requests for full examination on all three applications on 3 August 2016. Consequently, substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar) apply.
Each application was examined by a delegate of the Commissioner of Patents. The ‘535 and ‘540 (trivalent) applications were advertised as accepted on 19 October 2017 and acceptance of the ‘537 (bivalent) application was advertised on 12 October 2017. The Applicant sought leave to amend both the ‘535 and ‘540 (trivalent) applications on 23 November 2017. Those amendments were allowed and incorporated into the specifications on 15 February 2018.
Boehringer Ingelheim Animal Health USA Inc., formerly Merial, Inc., (the Opponent) opposed the grant of all three applications under section 59. The Opponent filed a notice of opposition to grant of the ‘537 (bivalent) application on 12 January 2018. The Opponent also filed notices of opposition to the grant of the ‘535 and ‘540 (trivalent) applications on 19 January 2018.
A hearing was held on the 26^th and 27^th of August 2019 in Canberra to decide the opposition on all three cases.
The Grounds of Opposition
The Statements of Grounds and Particulars identified seven grounds of opposition on all three applications. At the hearing the following grounds were pressed:[1]
[1] Although there are written submissions on Novelty, at the hearing the Opponent dropped this ground.
·Lack of Clarity (section 59(c)−section 40(3)).
·Lack of Manner of Manufacture (section 59(b)−section 18(1)(a))
·Lack of Inventive Step (section 59(b)−section 18(b)(ii))
Onus
The Opponent has the onus to satisfy me, on the balance of probabilities, that a ground of opposition to the grant exists. Then, once satisfied, I may refuse the application[2] or, where appropriate, give the Applicant a reasonable opportunity to amend the relevant specification(s) to remove any ground of opposition.[3]
[2] Subsection 60 (3A).
[3] Subsection 60 (3B).
Evidence
In support of the oppositions, Dr Christopher Chase made the declarations listed in the table below for the Opponent.

‘535 ‘537 (bivalent) ‘540 (trivalent)

Date Reference Exhibits Date Reference Exhibits Date Reference Exhibits

17 July 2017 Chase #1 CC 1 to CC 14 11 July 2017 ‘537 (bivalent)
Chase #1 537CC 1 to 537CC 13 17 July 2017 ‘540 (trivalent)
Chase #1 540CC 1 to 540CC 16

In answer, Prof. Glenn Browning made the declarations listed in the table below for The Applicant.

‘535 ‘537 (bivalent) ‘540 (trivalent)

Date Reference Exhibits Date Reference Exhibits Date Reference Exhibits

22 October 2018 Browning GFB1-GFB9 12 October 2018 ‘537 Browning 537GFB1-537GFB9 22 October 2018 ‘540 Browning 540GFB1-540GFB9

Holly Klink made a declaration on 9 October 2018 in the ‘537 (bivalent) application (Klink). Dr Ean Blackwell, a patent attorney, made declarations on both the ‘535 and ‘540 (trivalent) applications which attached the Klink declaration and the intention to rely on it.
In reply Dr Christopher Chase made the declarations listed in the table below:

‘535 ‘537 (bivalent) ‘540 (trivalent)

Date Reference Exhibits Date Reference Exhibits Date Reference Exhibits

19 December 2018 Chase #2 CC 15 to CC 25 14 December 2018 ‘537 Chase #2 537CC 14 to 537CC 24 19 December 2018 ‘540 Chase #2 540CC 17 to 540CC 27

The declarations of Dr Chase and Prof. Browning are mostly identical with differences only occurring where they are discussing issues particular to an application. The parties submissions, and at the hearing utilised and referred to the declarations of Chase #1, Browning and Chase #2. I see no reason to depart from this, however, where necessary I will refer to the declarations specific to each application.
The Specifications
Before commencing to construe the specification, I note what Middleton J said:
“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.”[4]
[4] Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214, 100 IPR 451 at [139]
With common sense generously measured, I must place myself in the position of a person skilled in the art. In order to do this I must first characterise the person skilled in the art. The first step in doing this is the identification and characterisation of the field of the invention.[5]
[5] Aktiebolaget Hassle v Alphapharm P/L (2000) CLR 411, [153].
‘535
The specification is entitled “Mycoplasma hyopneumoniae vaccine”. The specification ends with 18 claims. Both claim 1 and claim 18 are independent claims.
The field of the invention is said to relate to Mycoplasma hyopneumoniae (M. hyo) and more particularly to the soluble portion of an M. hyo whole-cell preparation and its use in a vaccine for protecting pigs against enzootic pneumonia.[6]
[6] ‘535 page 1 lines 4-6.
‘537 (bivalent)
The specification is entitled “PCV/Mycoplasma hyopneumoniae combination vaccine”. The specification ends with 24 claims. Both claim 1 and claim 24 are independent claims.
The field of the invention relates to porcine circovirus (PCV) and M. hyo. A multivalent immunogenic composition comprising a soluble portion of an M. hyo whole-cell preparation and a PCV2 antigen. This composition is useful as a vaccine for protecting pigs against enzootic pneumonia and Post-weaning Multisystemic Wasting Syndrome (PMWS).[7]
[7] ‘537 (bivalent) page 1 lines 4-8.
‘540 (trivalent)
The specification is entitled “PCV/Mycoplasma hyopneumoniae/PRRS combination vaccine”. The specification ends with 25 claims. Both claim 1 and claim 24 are independent claims.
The field of the invention is said to relate to porcine circovirus, M. hyo and porcine reproductive and respiratory syndrome (PRRS) and more particularly to a trivalent immunogenic composition including a soluble portion of an M. hyo whole-cell preparation, a PCV2 antigen, and a PRRS virus antigen and its use in a vaccine for protecting pigs against at least enzootic pneumonia and Post-weaning Multisystemic Wasting Syndrome (PMWS).[8]
[8] ‘540 (trivalent) page 1 lines 4-9
In Summary
The ‘535 provides a vaccine for pigs against M. hyo. It uses the soluble portion of a whole-cell preparation and the ‘537 (bivalent) and ‘540 (trivalent) use this in combination with other antigens to provide combination vaccines. With this in mind, I will proceed to characterise the person skilled in the art.
The person skilled in the art
The person skilled in the art (PSA) has been considered previously with Finkelstein J saying:
“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.” [9]
[9] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; 49 IPR 225 at [70]
However, the PSA is not a real person, but an artificial construct used as a tool of analysis by the Court. This concept was discussed by the High Court in AstraZeneca[10]:
[10] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30
“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.”[11]
[11] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]
The understanding of the PSA is, therefore based on evidence. The evidence is from persons with knowledge of the relevant art, experts, as to the things they know and do, and what they understand to be commonly known and done. The weighing and evaluating of this evidence is the normal work of a delegate of the Commissioner.
The Opponent submitted that the PSA is a skilled, but not inventive, worker with training as a veterinarian and with particular experience with swine. Based on the field I am confident the PSA would have experience in the development of vaccines for bacterial pathogens in swine.
The key experts, in this case, are Dr Chase, for the Opponent, and Prof. Browning and Klink for the Applicant. Prof. Chase holds a degree in veterinary medicine and a PhD. Prof Chase is a Professor in the Department of Veterinary and Biomedical Science at South Dakota State University. Prof. Browning holds a Bachelor of Veterinary Science with first-class honours, a Postgraduate Diploma of Veterinary Clinical Studies and a PhD. Prof. Browning is a Professor in Veterinary Microbiology at the Faculty of Veterinary Science at Melbourne Veterinary School, The University of Melbourne.
The PSA is likely to have a practical interest in the subject. This practical interest was discussed by Lord Diplock[12] and approved by the Full Federal Court in Australia with Heerey, Emmett and Dowsett JJ stating:
[12] Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183 at 243.
“The uninventive but skilled worker is likely to have a practical interest in the subject matter of the claimed invention.”[13]
[13] Minnesota Mining & Manufacturing Co v Tyco Electronics Pty Ltd [2002] FCAFC 315; 56 IPR 248 at [91], 271.
The Opponent submitted that Dr Chase has experience in developing vaccines for swine at the priority date.[14] Dr Chase made comments in reply that Prof. Browning does not appear to have significant experience with vaccines against bacterial infections, nor with swine vaccines more generally.[15] The Applicant responded to this by stating that Prof Chase’s experience before the priority date was in the development of vaccines to viral pathogens of livestock with a focus on virology as well as swine health.[16] The Applicant went on further, submitting that Prof Chase did not appear to have specific experience in Mycoplasmology or the formulation of M. Hyo.[17] Prof. Browning has published concerning Mycoplasmas[18] and worked on bovine vaccine development and has consulted for the Australian Pesticides and Veterinary Medicines Authority on veterinary vaccines.[19]
[14] Chase #2 at [6] and [7].
[15] Chase #2 at [7].
[16] CC-1
[17] Ibid.
[18] Browning at [11].
[19] Browning at [9].
Both Prof. Chase and Prof. Browning are Professors in Veterinary fields, and both appear to have practical experience that is relevant to the current field. Although it seems that Prof. Chase might have more experience in viral vaccines and the application is focused on a bacterial vaccine, he none the less has an understanding of vaccines. Prof. Browning appears to have experience in Mycoplasmas; his experience in vaccine development might not include vaccines for pigs. In my view, the expert’s experience does overlap with the field of the current application and can be weighed accordingly. I, therefore, accept both of them as experts who can comment on the PSA.
The invention described in the ‘535 specification
Under the heading “Background of the Invention” the specification starts by stating that enzootic pneumonia in swine is also called mycoplasmal pneumonia and it is caused by M. hyo.[20] The disease affects the respiratory tract and causes lesions. Although this disease is non-fatal and only causes minor symptoms, it has a significant economic impact due to reduced feed efficiency and reduced weight.[21] Pigs with mycoplasmal pneumonia can also have secondary infections.[22] M. hyo is transmitted from pig to pig as an airborne pathogen, and the specification states that surveys of slaughtered animals revealed lesions in 30 – 80% of swine and further results from 37 herds in 13 states indicated 99% of the herds had hogs with pneumonia lesions typical of enzootic pneumonia.[23]
[20] ‘535 page 1 line 13.
[21] ‘535 page 1 lines 14-15.
[22] ‘535 page 1 line 18.
[23] ‘535 page 1 lines 31- page 1a line 1.
The ‘535 specification then discusses M. hyo stating that:
“M. hyo is a small, prokaryotic microbe capable of a free living existence, although it is often found in association with eukaryotic cells because it has absolute requirements for exogenous sterols and fatty acids. These requirements generally necessitate growth in serum-containing media. M. hyo is bounded by a cell membrane, but not a cell wall.”[24]
[24] ‘535 page 1 lines 21-24.
The specification then discusses that antibiotic treatment is expensive and requires prolonged use[25] , and reinfection can still occur.[26] The specification then states:
[25] ‘535 page 1a lines 4- page 2 line 2.
[26] ‘535 page 2 lines 1-2.
“Due to the economic consequences of swine pneumonia, vaccines against M. hyo have been sought.”
The specification then elaborates on vaccines with the following:
“Vaccines containing preparations of mycoplasmal organisms grown in the serum-containing medium have been marketed, but raise concerns regarding adverse reactions induced by serum components (such as immunocomplexes or non-immunogenic specific proteins) present in the immunising material. Other attempts to provide M. hyo vaccines have been successful, but the disease remains widespread.”[27]
[27] ‘535 page 2 lines 3-9.
The ‘535 specification then goes on to introduce two other porcine pathogens. These are porcine circovirus type 2 (PCV2), which causes Post-weaning Multisystemic Wasting Syndrome,[28] and Porcine Reproductive and Respiratory Syndrome (PRRS)[29]. PCV2 and M. hyo are said to be the two most prevalent pathogens that are encountered in the pig industry[30] and M. hyo is said to have also been implicated as one of the significant cofactors in the development of Porcine Circovirus Associated Disease (PCV AD).[31] PRRS is said to be caused by arterivirus which has an affinity for the macrophages found in the lungs.[32] Up to 40% of the macrophages are destroyed, allowing bacteria to colonise and do damage.[33] A typical example of this is that pig with PRRS will have a noticeable increase in the severity of enzootic pneumonia.[34] It is said that more than half of weaning-age PRRS virus negative pigs will become infected by the time they go to market.[35]
[28] ‘535 page 2 lines11-13.
[29] ‘535 page 2 lines 12.
[30] ‘535 page 2 line 11.
[31] ‘535 page 2 lines 18-20.
[32] ‘53’ page 2 lines 23-25.
[33] ‘535 page 2 lines 27-28.
[34] ‘535’ page 2 lines28-29.
[35] ‘535 page 2 lines 30-31.
The ‘535 specification then sets out an object of the invention stating that:
“It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.”[36]
[36] ‘535 page 2a lines 1-2.
The specification says that the M. hyo vaccine will be compatible with other porcine antigens. These can be given concurrently or as separate single vaccines or combined in a ready-to-use vaccine. The other porcine antigens include PCV2 and PRRS virus.[37] The ‘535 specification states that it would be desirable to provide a ready-to-use single-dose M. hyo/PCV2 combination vaccine.[38]
[37] ‘535 page 3 lines 1-3.
[38] ‘535 page 3 lines 3-4.
Following on the ‘535 specification provides a summary of the invention. This summary sets out four aspects of the invention. The first one is similar to claim 1, the second similar to the kit claim and the third one is similar to the method claim. The first aspect relates to:
“an immunogenic composition comprising the supernatant of a Mycoplasma hyopneumoniae (M. hyo) culture, wherein the supernatant of the M. hyo culture has been separated from insoluble cellular material by centrifugation, filtration, or precipitation and is substantially free of both (i) IgG and (ii) immunocomplexes comprised of antigen bound immunoglobulins.”[39]
[39] ‘535 page 3 lines 7-11.
The kit is a bottle comprising the composition.[40] The method involves five steps.[41] The steps are culturing M.hyo, inactivating it and then harvesting the inactivated culture. The inactivated culture includes soluble and insoluble material. The insoluble material is then separated by centrifugation, filtration, or precipitation to form a supernatant of the M. hyo culture. The final step; step five, involves:
[40] ‘535 page 3 line 13.
[41] ‘535 page 3 line 20 et seq.
“substantially removing both the IgG and antigen/immunoglobulin immunocomplexes the supernatant of the M. hyo culture.”[42]
[42] ‘535 page 3 lines 1-2.

The fourth aspect of the invention is a method of immunising pigs using the composition.[43]
[43] ‘535 page 3a lines 4-5.
The specification then states that the present invention relates to the same immunogenic composition as outlined in the first aspect above.[44] This statement then follows:
[44] ‘535 page 3a lines 7-10.
“In one aspect, the soluble portion of the M. hyo whole-cell preparation has been treated with protein-A or protein-G prior to being added to the immunogenic composition.”[45]
[45] ‘535 page 3a lines 10-13.
The specification then sets out embodiments of the invention which can include additional antigens[46] with PCV2 and PRRS virus set out.[47] Additional adjuvants, including oil-in-water adjuvants, are also set out in some embodiments.[48] Other embodiments also include the vaccine as a single dose or two-dose administration.[49]
[46] ‘535 page 3a lines 21-page 4 line 2.
[47] ‘535 page 4 lines 4-7.
[48] ‘535 page 4 lines 15-19.
[49] ‘535 page 4 lines 21-27.
The specification provides a detailed description of the invention which is said to be:
“The present invention provides an immunogenic composition including a soluble portion of a M.hyo whole cell preparation, wherein the soluble portion of the M. hyo preparation is substantially free of both (i) IgG and (ii) antigen-bound immunocomplexes.”[50]
[50] ‘535 page 8 lines 15-17.
This description is followed by:
“Applicants have surprisingly discovered that the insoluble fraction of the M. hyo whole cell preparation is non-immunogenic. In contrast, the IgG-free M. hyo soluble preparation is immunogenic and can be effectively combined with antigens from other pathogens, such as PCV2, without analytical or immunogenic interference between the antigens. This makes the M. hyo soluble preparation of this invention an effective platform for multivalent vaccines, including one-bottle, ready-to-use formulations. Applicants have also surprisingly discovered that removing the immunoglobulins and the insoluble cell debris enhances the safety of the immunogenic composition.”
Definitions then follow this. The ‘535 specification states that all available vaccines are made from killed whole-cell mycoplasma preparations (bacterins). The current invention is distinguished from these in that it only uses the soluble portion substantially free of IgG and immunocomplexes bound to immunoglobulin.[51]
[51] ‘535 page 13 lines 5-9.
The ‘535 specification states that M. hyo has absolute requirements for exogenous sterols and fatty acids and that a serum-containing media is necessary.[52] It then states:
[52] ‘535 page 13 lines 11-12
“Separation of the insoluble material from the soluble portion of the M. hyo whole cell preparation (e.g. by centrifugation, filtration, or precipitation) does not remove the porcine IgG or immune complexes. In one embodiment of the present invention, the M. hyo soluble portion is treated with protein-A or protein-G in order to substantially remove the IgG and immune complexes containing the culture supernatant.”[53]
[53] ‘535 page 13 line 13-17.
The ‘535 specification states that:
“Methods for purifying/removing total IgG from crude protein mixtures, such as tissue culture supernatant, serum and ascites fluid are known in the art.”[54]
[54] ‘535 page 13 lines 21-23.
This is followed by details of the prior art and the strains of M.hyo, stating that any strain can be used and suitable strains and commercial sources are listed.[55]
[55] ‘535 page 14 lines 26-28.
The invention is said to be both safe and efficacious and is suitable for a single-dose administration. It is also said to be an effective platform for multivalent vaccines.[56]
[56] ‘535 page 15 lines 25-30.
I note that PCV2/M.hyo combination vaccines exist, but they are provided as either two-dose or as single dose but two bottle—requiring simultaneous administration of separate vaccines.[57] The present invention is said to be compatible with other antigens such that all antigens can be administered in a single dose.[58]
[57] ‘535 page 16 lines 29-32.
[58] ‘535 page 17 lines 1-2.
The examples
Example 1 involves inoculating a porcine serum medium with M. hyo and then inactivating the culture[59] and example 2 discloses the production and inactivation of chimeric porcine circovirus.[60]
[59] ‘535 pages 28-29
[60] ‘535 pages 29-31.
Example 3 involves the treatment of the inactivated serum material of example 1 to give supernatants, and a cell-free supernatant is treated with protein-A. These are evaluated for the presence of the M.hyo p46 antigen, the presence of other immunological compounds, and, the PCV2 antibody. All showed the presence of the p46 antigen. I will come back to this example later; however, it shows that:
“the following treatments successfully removed PCV2 antibody: 10x UF concentrated and centrifuged, 10x centrifuge, 10x centrifuge and heated and Cell-free supernatant (protein A treated).”[61]
[61] ‘535 page 33 lines 4-6.
The following statement is made, in example 3:
“Since it is known in the art that Protein A binds IgG, it is understood by those of ordinary skill in the art that not only PCV2 antibody, but other swine antibodies, including PRRS antibody, HPS antibody, and SIV antibody will be effectively removed by the Protein-A treatment. This makes the Cell-free Protein-A treated M.hyo supernatant of this invention compatible not only with PCV2 antigen, but also with other porcine antigens due to the lack of immunological interference between the antigens. Additionally, the removal of the non-protective cell debris and removal of the immunoglobulin and antigen/immunoglobulin complexes is reasonably expected to make a safer vaccine.”[62]
[62] ‘535 page 33 lines 13- 20.
It is clear from the above passage that the use of protein A is to remove IgG and antibodies and immunocomplexes that are likely to be present in swine serum. By removing these they will not bind to any further antigens added. In other words any added antigens are not neutralised by antibodies that might be present in the swine serum. It also states that this will like be a safer vaccine.
Example 4 then uses the treated supernatants of example 3 to make vaccine formulations with adjuvants. In example 5, these vaccines were given to pigs (16 in each group), and the pigs were challenged with M. hyo.[63] All of the vaccines appeared to offer some protection based on lung lesions; however, T04 differed substantially from placebo.[64]
[63] ‘535 page 34 lines 17-20.
[64] ‘535 page 34 line 9.
Example 6 evaluated the compatibility of the M.hyo vaccines with PCV2 antigen. This involved combining the treated M.hyo compositions above with the PCV2 antigen of example 2. It concludes that:
“only the M.hyo preparations from the following downstream processes were compatible with the PCV2 antigen: Ultrafiltration and centrifugation (T04 and T05), centrifugation (T06 and T07), Centrifugation plus heat (T08) and Protein A-treated Supernatant (T10).”[65]
[65] ‘535 page 36 lines 23-25
Examples 7-11 test the combination as a 1-bottle vaccine with different adjuvants and a proposed manufacturing method. Examples 12 and 13 evaluate PRRS virus vaccine and the addition of it to the M.hyo/PCV2 vaccine made earlier.[66]
[66] ‘535 page 38-51.
The ‘535 specification ends with 18 claims. Claims 1 and 18 are independent. With claims 1-8 being claims to an immunogenic composition for M.hyo, claims 9-15 to methods of immunising a pig using the composition and claims 16 and 17 being kit claims. Claim 18 is to a method of preparing the immunogenic composition. I note that claims 3 and 12 (and dependent claims) include an additional antigen.
The ‘537 (bivalent) specification
The ‘537 (bivalent) application is almost identical to the ‘535 application; however, this application is focused on the bivalent vaccine of M.hyo and PCV2. The document states:
“the invention relates to a multivalent immunogenic composition including a soluble portion of an M. hyo whole cell preparation and a PCV2 antigen and its use in a vaccine for protecting pigs against enzootic pneumonia and Post-weaning Multisystemic Wasting Syndrome (PMWS)”[67]
[67] ‘537 (bivalent) page 1 lines 5-8.
I note that PMWS is a syndrome exhibited by pigs infected with PCV2.[68]
[68] ‘537 (bivalent) page 2 lines 14-15.
The examples in the ‘537 (bivalent) are the same as those in the ‘535 application but include a further example: example 14. This further example evaluates the PRRS virucidal activity.
The ‘537 (bivalent) application ends with 24 claims. Claims 1 and 24 are independent. Claims 1-13 are to the multivalent immunogenic composition similar to that in the ‘535. The difference is the inclusion of the PCV2 antigens. Claims 14-20 are to a method of vaccinating a pig with the multivalent composition. Claims 21-23 are to kits for carrying out the method and claim 24 is to the method of preparing the immunogenic composition having both the M.hyo preparation and the PCV2 antigen. I note that both claim 8 and claim 17 (and dependent claims) include an additional antigen and that the PRRS antigen is not listed.
The ‘540 (trivalent) specification
Again the ‘540 (trivalent) specification is mostly identical to the ‘535 and the ‘537 (bivalent) applications. The ‘540 (trivalent) is trivalent vaccine including the M.hyo preparation, the PCV2 antigen, and unlike the ‘537 (bivalent) application, the ‘540 (trivalent) also includes the PRRS antigen. The ‘540 (trivalent) specification states that:
“the invention relates to a trivalent immunogenic composition including a soluble portion of an M. hyo whole cell preparation, a PCV2 antigen, and a PRRS virus antigen and its use in a vaccine for protecting pigs against at least enzootic pneumonia and Post-weaning Multisystemic Wasting Syndrome.”[69]
[69] ‘540 (trivalent) page 1 lines 4-10.
The examples in the ‘540 (trivalent) are primarily identical to the ‘537 (bivalent) and ‘535 application but include examples 14-16 which further evaluate the trivalent formulation.
The ‘540 (trivalent) specification ends with 25 claims. Claim 1 and claim 24 are independent claims with claims 2-23 dependent on claim 1 and claim 25 dependent on claim 24. Claims 1-13 are to the trivalent immunogenic composition and have the M.hyo culture preparation, PCV2 antigen and the PRRS virus antigen. Claims 14-18 are to a method of immunising a pig using the trivalent preparation. Claims 19-23 are to kits for carrying out the method. Claims 24-25 are to a method of preparing the trivalent composition using the M.hyo preparation with PCV2 antigen, and PRRS virus antigen added.
Construction of the Claims and Clarity
It is useful to pair my construction of the claims with ground of clarity.
Bennett J discussed the correct approach to the construction of claims in H Lundbeck A/S v Alphapharm Pty Ltd:[70]
[70] [2009] FCAFC 70, 81 IPR 228 at [118] – [120]
“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.”
It is also a requirement of subsection 40(3) of the Act that the claims must be clear. The public must be able to know the “exact boundaries of the area within which they will be trespassers”[71] or put another way “whether or not what he proposes to do falls within the ambit of the claim”[72].
[71] Electric & Musical Industries Ld v Lissen Ld (1939) 56 RPC 23 at 39.
[72] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59
If a construction cannot be reached and the scope of the claims cannot be determined, it will follow that the claims are unclear. As I have done above, I will start with the ‘535 application. Claim 1 of the ‘535 application reads:
An immunogenic composition comprising the supernatant of a Mycoplasma hyopneumoniae (M. hyo) culture, wherein the supernatant of the M. hyo culture has been separated from the insoluble material by centrifugation, filtration, or precipitation and is substantially free of both (i) IgG and (ii) immunocomplexes comprised of antigen bound to immunoglobulin.
This claim starts with “an immunogenic composition”. The Applicant submitted that this refers to a composition of matter that comprises at least one antigen which elicits an immunological response in the host of a cellular and or antibody-mediated immune response to the composition or vaccine of interest.[73] This is reflected in the specification[74]. The Opponent noted that this construction catches any composition which elicits any immunological response and does not necessarily confer protection. I agree with the Opponent; this claim is not to a vaccine and does not have to have lasting protection.
[73] Applicant’s submissions at 94.
[74] ‘535 page 9 lines 16-18.
Claim 1 of the ‘537 (bivalent) application reads:
“A multivalent immunogenic composition comprising the supernatant of a Mycoplasma hyopneumoniae (M. hyo) culture; and a porcine circovirus type 2 (PCV2) antigen, wherein the supernatant of the M. hyo culture has been separated from the insoluble material by centrifugation, filtration, or precipitation and is substantially free of both (i) IgG and (ii) immunocomplexes comprised of antigen bound to immunoglobulin.”
Claim 1 of the ‘537 (bivalent) application is to a multivalent immunogenic composition. The Applicant defined multivalent in terms of a vaccine containing more than one antigen, which can be from the same species or different species or genera. In my view this claim is to a multivalent immunogenic composition, rather than a vaccine. The composition of this claim contains antigens from two different viruses M. hyo and PCV2 and may contain more.
Claim 1 of the ‘540 (trivalent) application reads:
“A trivalent immunogenic composition comprising the supernatant of a Mycoplasma hyopneumoniae (M. hyo) culture; and a porcine circovirus type 2 (PCV2) antigen; and a porcine reproductive and respiratory syndrome (PRRS) virus antigen, wherein the supernatant of the M. hyo culture has been separated from the insoluble material by centrifugation, filtration, or precipitation and is substantially free of both (i) IgG and (ii) immunocomplexes comprised of antigen bound to immunoglobulin.”
The Applicant again defined trivalent in terms of a vaccine containing three antigens which can be from the same species or different species or genera. Again, in my view this claim is to a multivalent immunogenic composition, rather than a vaccine. The composition of this claim contains antigens from three different viruses M. hyo, PCV2 and PRRS.
The composition is followed by the word “comprising” which I consider to be non-exhaustive as is the usual practice when construing claims.
The composition comprises the “supernatant of a M. hyo culture”. The Applicant submitted that the supernatant is the soluble liquid fraction of an M.hyo whole cell preparation after separation of the insoluble material and removal of IgG and antigen-bound immunocomplexes. Indeed the following clauses put limitations on the supernatant to be separated by either centrifugation, filtration, or precipitation. When centrifugation, filtration or precipitation is conducted, the insoluble material is separated from the soluble material. The soluble material, for example in the case of centrifugation, is on top, this is the supernatant. It is that soluble material or supernatant that has been separated from the insoluble material by either centrifugation, filtration or precipitation.
The supernatant is said to be “substantially free” of both (i) IgG and (ii) immunocomplexes comprised of antigen bound to immunoglobulin. The Opponent submitted that the use of the term substantially free is vague and imprecise, and particularly when read in the context of the examples, they submitted, the term is unclear. They contended that it is unclear how much IgG and immunocomplexes needs to be removed. The Opponent submitted that there is no “workable standard suitable to the intended use” citing Minnesota Mining & Manufacturing Co v Beiersdorf (Aust) Ltd.[75] The Opponent cited Chase who said:
[75] (1980) 144 CLR 253 at 274.
“Claim 1 refers to the composition being “substantially free” of IgG and immunocomplexes. The term “substantially free” is not defined in the ‘535 application. I understand that some IgG immunocomplexes may be retained in the immunogenic composition, but it is not clear how much.”[76]
[76] Chase #1 at 100.
The Applicant turned to example 3 and 6, which had comparative examples where the amount of PCV2 ab using S/P ratio, g1TTV and g2TTV were measured. This table is repeated below.
Browning said that table 3 can be used to determine what is meant by “substantially free:
“This is a reasonable method of definition because in practice, it would be extremely difficult if not impossible, to guarantee that all traces of immunoglobulin and/or immunocomplexes have been removed from a serum-derived biological composition. Looking at Table 3 for the example, it is reasonable to say that those compositions comprising a detected titre of less than 0.099 S/P ratio are “substantially free” of antibodies.”[77]
[77] Browning at 158.
The Opponent’s pointed out in the hearing that Browning’s construction causes issues because in example 3 PCV antibody is removed below an S/P ratio of 0.099 for 10x UF concentrated and centrifuged, 10x centrifuge, 10x centrifuge and heated and Cell-free supernatant (protein A treated).[78]
[78] ‘535 page 33 lines 14-16.
The Applicant responded to this stating that those examples are not cell-free supernatants and therefore are not the supernatants as claimed. Indeed the claim is to the supernatant that has been separated from the insoluble material so if you compare the last two entries in the table it is clear that the protein-A treated cell free supernatant has a lower S/P ratio than the cell free supernatant. I therefore accept that this does provide a workable standard and that those with a low titre, less than 0.099 S/P are “substantially free”.
Furthermore, I note that the use of the word “substantially” was discussed in Leonardis v Sartas No 1 Pty Ltd[79] where “substantially” merely indicated an intention that the term it qualifies should not be read too literally. Indeed the use of qualifier terms like “substantially” are common in drafting patent specifications but the rules of construction should still be applied to each case. In this case I have found that table 3 provides a workable standard to determine what is meant.
[79] (1996) 67 FCR 126 at 134.
Claim 1 therefore requires the supernatant to have a low titre, less than 0.099 S/P ratio. This can be achieved by any means. The means of achieving this is not limited in claim 1. In claim 2 however, a separate step is required, i.e. the treatment with protein A or G.
The Opponent made similar submissions on the use of the term “substantially removing” used in the other independent claims.
Claim 18 of ‘535 reads:
A method for preparing an immunogenic composition, the method comprising:
i)Culturing M. hyo in a suitable media over periods ranging from 18-144 hours;
ii)Subsequently inactivating the M. hyo culture;
iii)Harvesting the inactivated culture fluid, wherein the inactivated culture fluid comprises both a soluble liquid fraction and insoluble cellular material;
iv)Separating the soluble liquid fraction from the insoluble cellular material by centrifugation, filtration, or precipitation to form a supernatant of the M. hyo culture; and
v)Substantially removing both IgG and antigen/immunoglobulin immunocomplexes from the supernatant of the M. hyo culture.

Claim 24 of the ‘537 (bivalent) application is identical to claim 18 of the ‘535 application with the additional step:
vi) subsequently combining the supernatant of the M. hyo culture with a PCV2 antigen.
Claim 24 of the ‘540 (trivalent) application is identical to claim 18 of the ‘535 application with the additional step:
vi)subsequently combining the supernatant of the M. hyo culture with a PCV2 antigen and PRRS virus antigen.
In the context of this method, it is clear that there is an extra step where removing takes place. I consider that the term substantially removing means removing them such that the S/P ratio is less than 0.099.
I am therefore not satisfied that a lack of clarity has been made out.
Inventive step
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art.
Subsection 7(3) states that the information for the purposes of subsection (2) is:
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.
In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd[80] Aickin J stated:
[80] [1981] HCA 12; 148 CLR 262 at 286
“The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.”
In Alphapharm,[81] the High Court endorsed the use of the reformulated “Cripps question”:
[81] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411
“Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and the facts”… “directly be led as a matter of course to try [the invention as claimed] in the expectation that it might well produce a useful alternative or better [product] or a body useful for any other purpose?”[82]
[82] Alphapharm at [53]
This test has been elaborated on in the Full Federal Court’s decision Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft:
“We do not think that the plurality in Alphapharm were saying that the reformulated Cripps question was the test to be applied in every case. Rather, it is a formulation of the test which will be of assistance in cases, particularly those of a similar nature to Alphapharm. The plurality did not reject as an alternative expression of the test the question whether experiments were of a routine character to be tried as a matter of course (The Wellcome Foundation Limited v VR Laboratories (Aust) Proprietary Limited (1981) 148 CLR 262, at 280‑281, 286, per Aickin J). 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.”[83]
[83] 2014 FCAFC 73 at [71]
It is clear that this test requires routine steps to be undertaken and that there is an expectation is that something or anything useful might come from them. In Nichia Corporation v Arrow Electronics Australia Pty Ltd (Nichia) the Full Federal Court said the expectation does not mean that it is necessary to know or be able to predict that useful thing and a useful alternative is one which is useful when compared to the prior art in the field of the invention.[84] I note that more than one thing may be obvious too, and other steps or solutions might be tried first.[85]
[84] Nichia Corporation v Arrow Electronics Australia Pty Ltd [2019] FCAFC 2 at [80]; [89]; [99].
[85] Nichia Corporation v Arrow Electronics Australia Pty Ltd [2019] FCAFC 2 at [94].
Where the invention is a combination of integers obviousness is to be determined by reference to the combination as a whole and not each integer individually. As stated in Alphapharm at [41]:
“The claim is for a combination, the interaction between the integers of which is the essential requirement for the presence of an inventive step. It is the selection of the integers out of ‘perhaps many possibilities’ which must be shown by Alphapharm to be obvious, bearing in mind that the selection of the integers in which the invention lies can be expected to be a process necessarily involving rejection of other possible integers.”
In the current case the modified Cripps question was discussed at the hearing as well its use in Nichia so I will use that test here. Inventive step requires light to shine from the common general knowledge so I will now determine how that light shines.
The Common General Knowledge (CGK)
Emmett J considered the common general knowledge in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc[86]:
[86] [1999] FCA 345; 45 IPR 577 at [112]
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled worker's mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·           standard texts and handbooks;
·           standard English dictionaries;
·           technical dictionaries relevant to the field;
·           magazines and other publications specific to the field.”
The common general knowledge must be established by evidence as stated by Emmett J in Dynamite v Aruze[87]:
“It is necessary to establish common general knowledge by appropriate evidence. Evidence that consists of generalised and sweeping statements of opinion or recollection, unsupported by secondary materials such as textbooks, trade journals and technical publications, should be treated with caution and given litter weight.”
In Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) the High Court stated that admissions to CGK in the specification may be made, however, when used as evidence, they would always need to be weighed with evidence, if it exists, from the PSA who is naïve to the solution.[88]
[87] [2013] FCA 163 at [104]
[88] (2007) 235 CLR 173 at 105.

100. The Opponent outlined a list which largely matched points in Chase’s first declaration of (a) to (x) which they considered to be common general knowledge. The Applicant responded by discussing some of these aspects. I will discuss aspects relevant to the current opposition.

101. It was not disputed that M. hyo, PCV2 and PRRS were known to be endemic in pigs and that vaccines for M. hyo[89] were on the market. Browning states that:
‘Commercial Mycoplasma hyopneumoniae vaccines were typically produced at 4 April 2012 from Mycoplasma hyopneumoniae organism following growth in broth containing porcine serum, followed by subsequent inactivation.”[90]
[89] ‘535 page 13 line 5-6.
[90] Browning at 49.

102. This inactivated broth was then tested to quantify the presence of the antigen before formulating with adjuvants with Browning stating that:
“To my knowledge, all commercial vaccines directed to Mycoplasma hyopneumoniae by 4 April 2012 comprised the whole cell bacterin in the medium in which it was grown plus an adjuvant.”[91]
[91] Browning at 50.

103. He goes on to state that:
“to the best of my knowledge, when making vaccines against Mycoplasma hyopneumoniae, the antigen was not routinely purified, and other serum-derived components were not routinely identified and removed from the broth.[92]
[92]Browning at 52.

104. When asked how he would increase the immunogenicity of the known M.hyo vaccines, Browning discussed concentrating the bacterial cells, and he said this could be done by centrifugation or filtration to collect the cells and:
“discard the excess supernatant.”[93]
[93] Browning at 56.

105. When asked why he thought this would be effective, he said:
“At 4 April 2012, it was thought by most researchers that most of the important antigenic materials would be associated with the Mycoplasma hyopneumoniae bacterial cell itself and not the growth medium, which generally was provided merely for cultivation of the organism.”[94]
[94] Browning at 56.

106. Browning states that serum vaccines, such as the M. hyo vaccine could lead to adverse reactions because of unaccounted for serum components present in the immunizing material. Browning provided a few examples of what the unaccounted for serum component could be and included immunocomplexes in his list.[95] I accept that this was a known issue.
[95] Browning #1 at 51.
107. It is important to note that Browning stated that he was aware of continuous effort towards experimental and new vaccines to M. hyo. He said that the vast majority of these efforts used rational design, such as recombinant subunits, recombinant vectors or DNA vaccines.[96]
[96] Browning at 48.
108. Chase was asked more broadly about vaccine preparation prior to 2012. He stated that he was aware of:
“Inactivated whole cell preparations (or parts thereof) or culture supernatants could be used to make vaccines.”[97]
[97] Chase #1 at 19.

109. Chase then went on to discuss PCV2 vaccines and M. hyo combination vaccines. Chase did not address the use of a supernatant vaccine for M. hyo. Instead he gave evidence on supernatant vaccines generally and this was not specific to M. hyo. I, therefore, find that the common general knowledge for M. hyo vaccines was of bacterin (whole cell) vaccines.
110. Combination vaccines of both M. hyo and PCV2 existed. The combination vaccines included Circumvent®PCVM and Ingelvac MycoFlex®.[98] These were either two-dose or single-dose 2 bottle with simultaneous administration because of compatibility issues. I accept that these were CGK.
[98] ‘535 page 16 lines 30-33; Chase #1 at 21; Browning at 59;
111. Compatibility brings me to the issue of interference and neutralising antibodies as it is an important feature of the patent applications in suit that these are removed. Browning said:
“In the case of a mycobacterin growth in broth containing porcine serum, components may be present in the broth that interact with another antigen mixed into the same solution. For example, antibodies may be present that bind to the other antigen, and which cause analytical interference.”[99]
[99] Browning at 59.

112. Browning was asked about preparing a bivalent vaccine of M. hyo and PCV2 and he said he would start with:
“My first step would be to review the current literature and in particular the commercially available monovalent vaccines in the field to determine which type of vaccine I would expect to be the most effective in the final bivalent composition, for example, which would be the most immunogenic, provide the most sustained protection, and be economically viable and safe.”[100]
[100] Browning at 60.

113. He then states that:
“I would have selected a bacterin + killed virus combination.”[101]
[101] Browning at 70.

114. He states that:
“There is a prospect of interference between one antigenic fraction and the other”… “For example, antibodies may be present that bind to the other antigen, and that cause such interference.”

115. Browning was then asked what steps he would take to overcome this. He said he would overcome the problem by using fetal serum as it is less likely to contain interfering components.[102] His evidence further focuses on the cellular material, which he believed at the priority date, was the source of the antigen and not the serum and that using the serum component (i.e. the liquid fraction or supernatant) would be counterintuitive.[103]
[102] Browning at 74.
[103] Browning at 75.
116. Chase also knew about the problem of interference when making multi-component vaccines. Chase states that:
“I would then typically further assess interference via serological analysis in-vitro.”[104]
[104] Chase #1 at 32.

117. He says:
“Before April 2012, I was also very familiar with antigen neutralisation which occurs when antibodies in a composition bind to and neutralise one or more of the antigens (i.e. antibody mediated antigen neutralisation.” [105]
[105] Chase #1 at 35.

118. He stated that:
“Before April 2012, it was well known that animal serum contains various antibodies that neutralise antigens(s) in a combination vaccine because serum generally contains antibodies against the antigens the animal has been exposed to.”[106]
[106] Chase #1 at 35.

119. Chase stated that:
“It was well known prior to 2012 that swine serum usually contained antibodies to PCV-2.

120. Chase has a different approach to Browning to deal with neutralising antibodies. He states that he would:
“If I detected interference in any of the above tests, I would then have taken steps to identify the interfering component(s) and remove them from the composition as discussed further below.”[107]
[107] Chase #1 at 33.

121. He stated that, depending on size, if an antigen were smaller than the antibody; for example, he would use filtration, precipitation or centrifugation.[108] I note that here Chase had already been asked about his understanding of supernatant vaccines and how he might go about preparing them.[109] Chase mentions that:
“column-based chromatography and affinity chromatography were also commonly used prior to April 2012 to separate out antibodies from compositions containing serum.[110]
[108] Chase #1 at 39.
[109] Chase #1 at 27.
[110] Chase #1 at 39.

122. Chase was then asked to expand on what he knew about affinity chromatography. He stated:
“For example, one commonly used method of affinity chromatography before April 2012 used ligands with high-affinity for immunoglobulins, such as ligands from Staphylococcus A and Staphylococcus G (also known as Protein A and Protein G). Protein A and Protein G affinity chromatography involve running the sample (e.g. a serum containing composition) through a column loaded with protein A or G ligands. Immunoglobulin binds to the column proteins, allowing the remainder of the sample to pass through the column with the desired immunoglobulin removed. The sample would typically have undergone some pre-treatment prior to loading, for example, concentration by centrifugation, filtration or dialysis. [111]
[111] Chase #1 at 39.

123. It is clear to me that the issue of neutralising antibodies and interference was common general knowledge for vaccines prepared from serum, including the M. hyo vaccines. This was an issue for making combination vaccines when the M. hyo preparation is combined with another antigen.
124. There is a clear difference in approach between the experts when they were asked about the steps they would take to remove the interfering and neutralising antibodies. Browning was starting from a bacterin vaccine and using fetal serum so that other antibodies would not be present and Chase was beginning from the supernatant and then cleaning it up. Chase then expanded on affinity chromatography after being asked. In my view, it would appear that several methods for “cleaning up” a supernatant could be used and affinity chromatography, including protein A or G, was known. I have discussed some of the steps and CGK and it is necessary to now discuss the problem.
The Problem
125. In AstraZeneca AB v Apotex Pty Ltd[112] (AstraZeneca), the court held that in formulating the problem it is not permissible to incorporate information that is not available to the PSA either as common general knowledge or information available under subsection 7(3).
[112] [2014] FCAFC 99; 107 IPR 177.
126. The specification discusses the prior art bivalent vaccines as having disadvantages of being either two-dose or as a single-dose 2-bottle vaccine requiring simultaneous administration.[113] I note that the current invention is described as being compatible with other antigens such that all antigens can be administered in a single dose.[114] Neither declarant discussed this as a problem. The specification also states that the removal of the non-protective cell debris and removal of the immunoglobulin and antigen/immunoglobulin complexes is reasonably expected to make a safer vaccine.[115]
[113] ‘535 page 16 lines 30-33.
[114] ‘535 page 17 lines 1-2.
[115] ‘535 page 33 lines 13- 20.
127. Chase began discussing mulit-agent supernatant vaccines by saying “if a multi-agent supernatant vaccine was being prepared”[116] before discussing the issue of interference. He did not say why he would be preparing one. He did say that before the priority date it was known that swine serum contained PCV-2 antibodies and in order to combine M.hyo supernatant antigen with PCV2 it would be necessary to remove neutralising antibodies.[117] But again he did not discuss why he would combine M.hyo with PCV2 in a single multivalent composition.
[116] Chase #1 at 31.
[117] Chase #1 at 38.
128. Browning’s evidence was presented similar to that of Chase. He discusses the known combination vaccines[118] when asked about multivalent combination vaccines. He went on to say that:
“At 4 April 2012 it was known that multiple antigenic fractions contained in one solution could interact with each other for many reasons and could sometimes result interference” … “For example, antibodies may be present that bind to the other antigen, and which cause analytical interference.”[119]
[118] Browning at 58.
[119] Browning at 59.

129. Browning followed this by stating that the known combination had separate vials, Ingelvac FLEXcombo, and this allowed the farmer flexibitity of separate administration.[120] This flexibility sounds like a good thing which is different to the disadvantages the specification states it overcomes.
[120] Browning at 60.
130. I accepted evidence as CGK that immunocomplexes were known to be present in serum vaccines and that these could lead to side effects. I note that Browning was naïve to the solution when he made those comments so accept that the use of serum in the M. hyo vaccine had known issues of unaccounted for serum components.
131. Therefore, although combination vaccines were known and interference and neutralisation was known these were not backed up by evidence to be problems. Nor is the problem of making a single dose single administration vaccine backed up by evidence. The evidence does however, give weight to a known problem that unaccounted for serum components could cause adverse reactions at the priority date.
132. The Opponent submitted that the claims lack an inventive step when compared to three documents combined with the common general knowledge. These documents are referred to as the Okada publications:
Okada 1999: Okada et al. Evaluation of Mycoplasma hyopneumoniae Inactivated Vaccine in Pigs under Field Conditions. J. Vet. Med. Sci. 61:1131-5 (1999). [121]
Okata 2000a: Okada et al. Protective Effect of Vaccination with Culture Supernate of M. hyopneumoniae against Experimental Infection in Pigs. J. Vet. Med. B. Infect. Dis. Vet. Public Health. 47:527-533 (2000).[122]
Okada 2000b: Okada et al. Cytological and immunological changes in bronchoalveolar lavage fluid and histological observation of lung lesions in pigs immunised with Mycoplasma hyopneumoniae inactivated vaccine prepared from broth culture supernate. Vaccine 18 2825-2831 (2000).[123]
[121] Exhibit CC-10.
[122] Exhibit CC-11.
[123] Exhibit CC-13.
Could the PSA be reasonably expected to combine these three documents?
133. The Opponent says that the PSA could, before the priority date, be reasonably expected to have combined each of the Okada documents for three reasons. Firstly they are all published by the same group of authors. Secondly, that they are each concerned with the same supernatant vaccine for M.hyo and thirdly that Okada 2000b explicitly refers to Okada 1999.

134. The Applicant notes that Chase (the Opponent’s declarant) was shown the documents together and thus the Opponent’s submission amounts to speculation. Browning stated that he would start by reviewing the literature for a suitable vaccine.[124]
[124] Browning at 60/

135. It is clear to me that the three documents are closely related. Indeed they relate to the same supernatant vaccine for M. hyo, and there is cross-referencing in Okada 2000b to both Okada 1999 and 2000a. Given that they are so closely related and show a progressive set of research on the relevant topic, M. hyo, by the same group I am satisfied that the person skilled in the art could be reasonably expected to combine them.

Disclosure of Okada 1999
136. Okada 1999 is a paper testing a vaccine for M. hyo in field conditions where a pathogen-free herd, a high health status herd and a low health status herd were tested. The vaccine is said to be:
“marketed as Mycobuster”… “and was an inactivated vaccine prepared from broth culture supernatant of M. hyopneumoniae 1986-1-1 strain with an aluminium hydroxide adjuvant.”[125]
[125] Okada 1999 page 1131.

137. Each herd is separated into a vaccinated and control group, and there was a significant reduction of lung lesions in the vaccinated groups relative to control groups.[126] I note that the low health herd came from a region with a history of M. hyo and, along with other diseases, porcine reproductive and respiratory syndrome.[127] Pigs were vaccinated twice, first at 3-7 weeks of age and then repeated 4 weeks later.[128]
[126] Okada 1999 page 1134.
[127] Okada 1999 page 1131.
[128] Okada 1999 page 1131-1132.
138. Okada 1999 concludes that
“It is suggested that inactivated vaccine prepared from broth culture supernatant of M. hyopneumoniae not only reduces the prevalence of pigs with pneumonia, the extent of lung lesions, and colonisation of M. hyopneumoniae, but also improves ADG, FCR, and day to market weight in herds where clinical and economic losses are significant. It is expected that the use of this vaccine may help to control MPS in conventional pig herds.”[129]
[129] Okada 1999 page 1135.

Disclosure of Okada 2000a
139. In Okada 2000a, the efficacy of vaccines from sedimented whole cells was compared to supernatant vaccine and placebo.[130] Each pig was inoculated twice at two-week intervals.[131] It showed that the supernatant vaccine protected against M.hyo infection in small groups.[132] Okada 2000a states that in the prior art:
“centrifugation used in the preparation of the supernate does not remove all the mycoplasma cells or membranes; therefore, it is possible that whole cells or membranes also contributed to protection.”
[130] Okada 2000a abstract.
[131] Okada 2000a page 528 experimental design.
[132] Okada 2000a page 529.

140. They then state that:
“In this study, we prepared inactivated vaccines from sedimented whole cells and cell-free supernates and evaluated each.”

141. They found that M. hyo specific antigens were found in both the whole cell preparation but also in the culture supernates and that some of these antigens in the supernates may be closely related to the reduction in lung lesions. They suggest that the antibodies against these should be further investigated.[133] Antibody responses to the cell-free supernate were low but gross lesions were significantly reduced.[134] It concludes that:
“In the present study, vaccination with the supernate of M. hyopneumoniae cultures protected against M. hyopneumoniae infection. Our results indicated that vaccination with culture supernate is a good tool for the control of MPS and offers a foundation for the further investigation of protective antigens.[135]
[133] Okada 2000a page 531.
[134] Okada 2000a page 532.
[135] Okada 2000a page 532.

142. This study was in small groups.[136]
Disclosure of Okada 2000b
[136] Browning at 91.
143. Okada 2000b studies the Mycoblaster vaccine[137] and refers to Okada 1999 and 2000a.[138] In its experimental design, Okada 2000b pigs are vaccinated twice at 2-week intervals.[139]
[137] Okada 2000b page 2826.
[138] See references 3 and 4 of Okada 2000b.
[139] Okada 2000b page 2826.
144. Okada 2000b discloses how the Mycobuster vaccine is prepared. It involves growing the M. hyo in serum overnight followed by centrifugation. The supernate is collected and treated with formalin to deactivate it, and aluminium hydroxide adjuvant added.[140]
[140] Okada 2000b page 2826 vaccine product.

145. This study demonstrates that the infiltration of inflammatory cells causes lesions in the lungs.[141] They show that the supernate vaccine led to decreased TNF-a and this may have resulted in a decreased inflammatory response to infection.[142] They state that:
“In this study, we used whole cell antigen for ELISA to determine the level of local IgA and IgG antibodies, because culture supernate antigen prepared for vaccine contained large quantities of swine serum components, which may elicit nonspecific reactions.”[143]
[141] Okada 2000b page 2830.
[142] Okada 2000b page 2830.
[143] Okada 2000b page 2830.

Consideration of the Okada documents
146. The Applicant discussed the steps a PSA would take and relied on the evidence of Browning who did not start from a supernatant vaccine. The Applicant’s position was that the Okada documents would not have used for further development. Browning was unaware of the Okada documents when he gave his evidence on vaccine development. When he was shown the documents Browning criticised the Okada documents for their small group sizes.[144] This meant he gave little weight to them. Browning was then asked:
“whether, in light of the Okada papers, I would choose to use or develop a supernatant vaccine as disclosed therein in preference to the standard bacterin vaccine available for vaccinating commercial swine.[145]
[144] Browning at 87; 91; 94.
[145] Browning at 96.

147. He comments again on the small group sizes and states:
“I could certainly not conclude that it was more effective than the bacterin vaccines already available at the time.”[146]
[146] Browning at 97.

148. Browning also comments that the vaccines in the Okada documents require additional production steps and that they use two doses before he concludes that he would not have chosen to start with them.[147]
[147] Browning 100.
149. The Opponent submitted that Browning had failed to answer the question. Indeed the Applicant’s submissions focused on the step first of why start with the Okada vaccine. It is clear to me that the Mycobuster vaccine was not common general knowledge. However, the Okada documents are viewed as prior art documents under s 7(3), which states that a claim is taken to involve an inventive step if it is not obvious in the light of the documents and the common general knowledge. Browning dismisses the documents at an early stage and does not discuss any steps he would have taken from them.
150. The evidence of Chase states that:
“I was asked what I would do if I was tasked with adding another antigen to an M. hyo supernatant vaccine (such as those described in Okada 1999 and Okada 2000a) to produce a multivalent immunological vaccine.”[148]
[148] Chase #1 at 54.

151. I note that the question asked involved the addition of another antigen.
152. Chase then states in reply, and therefore not naïve, that:
“The protective efficacy demonstrated in the Okada studies paired with the advantages of supernatant vaccines known before April 2012 would have motivated me to use the supernatant of M. hyo culture as a starting point for the preparing an effective vaccine against M. hyo.”[149]
[149] Chase #2 at 31.

153. Although the Okada studies are on small group sizes, Mycobuster was commercially available in Japan.[150] Its sales were not known, but Chase provides evidence that it was first offered for sale in 1997 and then was subject to successful re-examination in 2006 as required by Japanese law. It was reformulated as a combination vaccine with other pathogens.[151] Given this, it is my view that Mycobuster would be considered as a starting point for further development.
[150] See Okada 1999 page 1131 vaccine; Okada 2000b page 2831 2.2 vaccine product.
[151] Chase #2 at 20.
154. It is clear from the disclosures above that the Okada documents disclose a cell-free supernatant vaccine for M. hyo. There is no disclosure in them involving the removal of IgG and immunocomplexes.
Claim 1 of ‘535
155. The first difference between the Okada documents and claim 1 of ‘535 is that the Okada documents do not disclose a method of removing the IgG and immunocomplexes. The Opponent argued that substantially free was unclear. However, I have found this not to be the case. Furthermore, example 3 of the applications, which the Opponent relied on, compares both a cell-free supernatant and a cell-free protein A treated supernatant, and there is a clear difference, see the last two entries in the table above.[152] In my view, the Mycobuster vaccine in the Okada documents would need some sort of purification/removal step to arrive at the current claims.
[152] ‘535 page 33 table 3 last two entries.
156. The question is thus whether the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and the facts, directly be led as a matter of course to try removal of the IgG and immunocomplexes in the expectation that it might well produce a useful alternative or better vaccine.[153]
[153] Alphapharm at [53]

157. I have found above, based on the evidence of Browning, that unaccounted for components in serum could cause adverse reactions and these included immunocomplexes. Furthermore the presence of antibodies in serum prepared vaccines were known. Chase said these could be removed by filtration, precipitation and several chromatography techniques, including affinity chromatography.[154]
[154] Chase #1 at 39.

158. Browning responds to this by saying that:
“These methods were generally used to capture antibodies for further study and were not used to remove antibodies in the standard process of preparing a veterinary vaccine composition for commercial use. I am not aware of any paper or other material describing the use of this process in vaccine preparation.”[155]
[155] Browning #2 at 194.

159. He goes on to state that affinity chromatography was used in the laboratory to isolate antibodies but he was not aware of it being used in the production of commercial swine vaccines.[156]Chase replied to this with several examples of the use of protein A in human vaccines.[157] I note that claim 1 of the ‘535 relates to an immunogenic composition and is not limited to large scale vaccines. Indeed Browning was aware of the techniques listed by Chase. Furthermore, when asked what he would do to overcome the problem of interference, Browning stated that he would start with fetal serum. If fetal serum were used in the production of the Mycobuster vaccine in the Okada documents, on Browning’s evidence, this would be substantially free of IgG and other immunocomplexes.
[156] Browning #2 at 195.
[157] Chase # at 116.
160. I, therefore, find that from Mycobuster either using a separate step to remove immunocomplexes and IgG or to start with fetal serum would have been a routine step that the person skilled in the art would have done. Claim 1 of the ‘535 application does not involve an inventive step in light of the Okada documents and the common general knowledge.
Claim 2 of ‘535
161. This claim is dependent on claim 1 and reads:
The composition of claim 1, wherein the soluble portion has been treated with protein-A or protein-G prior to being added to the immunogenic composition.

162. Unlike claim 1, this requires the specific step of protein-A or protein-G treatment. I note that in Nichia, more than one thing may be obvious too, and other steps or solutions might be tried first.[158] Chase gave evidence on the use of protein-A or protein-G when he was asked to expand on affinity chromatography.
[158] Nichia Corporation v Arrow Electronics Australia Pty Ltd [2019] FCAFC 2 at [94].
Is the use of protein-A or protein-G routine?
163. I have noted above that Browning was not aware of protein-A being used in swine vaccine production. However, Chase gave evidence of its use in human vaccines. Indeed there needs to be an expectation of a useful alternative of a vaccine. However, the claim itself is not limited to a vaccine and includes any immunogenic composition. Browning was aware of protein-A being used in a laboratory setting for antibody capture. In my view, use of protein-A on the Mycobuster vaccine in the Okada documents in a laboratory setting to try a useful alternative or to try the Mycobuster as a platform vaccine would still lead to the claim.
164. Chase stated:
“I knew before April 2012 that affinity chromatography could be used to remove a neutralising antibody(ies) from compositions containing serum.” (my emphasis).

165. He then goes on to say:
“For example, one commonly used method of affinity chromatography” …involved using protein-A or protein-G.

166. When Chase was shown the Okada documents, he has stated that if he was tasked adding a further antigen to Mycobuster he would ensure there were no neutralising antibodies. If there were neutralising antibodies, he would attempt to remove them.[159] He then goes on to say:
“As I explained, neutralising antibodies could be removed using an affinity chromatography column loaded with protein-A or protein-G which bind IgG (immunoglobulin G a type of antibody). This was a particularly selective method.”[160]
[159] Chase #1 at 58.
[160] Chase #1 at 59.

167. The specification states:
“Since it is known in the art that Protein A binds IgG, it is understood by those of ordinary skill in the art that not only PCV2 antibody, but other swine antibodies, including PRRS antibody, HPS antibody, and SIV antibody will be effectively removed by the Protein-A treatment. This makes the Cell-free Protein-A treated M.hyo supernatant of this invention compatible not only with PCV2 antigen, but also with other porcine antigens due to the lack of immunological interference between the antigens. Additionally, the removal of the non-protective cell debris and removal of the immunoglobulin and antigen/immunoglobulin complexes is reasonably expected to make a safer vaccine.”[161]
[161] ‘535 page 33 lines 13- 20.

168. In Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) the High Court stated that admissions to CGK in the specification may be made, however, when used as evidence, they would always need to be weighed with evidence, if it exists, from the PSA who is naïve to the solution.[162] I am satisfied that the use of protein-A was known to bind IgG by the PSA. Although other methods could have been used more than one thing may be obvious too, and other steps or solutions might be tried first.[163]
[162] (2007) 235 CLR 173 at 105.
[163] Nichia Corporation v Arrow Electronics Australia Pty Ltd [2019] FCAFC 2 at [94].
169. I am satisfied on the balance of probabilities that the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and the facts would directly be led as a matter of course to try protein-A for the removal of the IgG and immunocomplexes in the expectation that it might well produce a useful alternative or better vaccine.[164] Claim 2 of the ‘535 application does not involve an inventive step.
[164] Alphapharm at [53]

Claim 3 of ‘535
170. Claim 3 of the ‘535 application is to the composition of claim 1 or 2, which further comprises at least one additional antigen which is protective against a microorganism selected from a long list. I note that PCV2 is not included in this list; however, PRRS is. Chase stated that:
“If a multi-antigen supernatant vaccine was being prepared, then other antigens would be added to the supernatant. For example, Streptococcus suis, PCV2 or PRRS virus antigen could be added to the supernatant.”

171. He then went on to discuss the problem of antigen interference. It was established the PRRS virus was endemic in pig populations. There is little evidence on its use in combination with M. hyo. Chase stated that M. hyo had been combined with other combinations including H. parasuis PRRS virus and Erysipelothrix rhusiopathiae had been used in a combination vaccine with an M. hyo bacterin vaccine and provided an article where this had been done.[165] There is no further discussion about doing this or if it would have been routine to add one of these viruses to the Mycobuster vaccine in the Okada documents. Instead, there is evidence on PCV-2. I also note that the documents provided by Chase include combinations of bacterins[166] and combination with a live attenuated virus[167] and little information or no information is given on how these are prepared. Chase merely stated that these are mostly enteric diseases and it appears to be a shopping list and that he wasn’t sure if they would work.[168] I, therefore, do not have enough evidence about the antigens in claim 3 to satisfy me that their addition would be routine.
Claims 4 and 5 of ‘535
[165] Chase #1 at 12 and CC-3; CC-4 and CC-5
[166] CC-3; CC-5.
[167] CC-4.
[168] Chase #1 at 103.
172. Claims 4 and 5 are to the compositions of claims 1-3 which further comprises an adjuvant and claim 5 lists adjuvants including aluminium hydroxide. Aluminium hydroxide is the adjuvant used in the Mycobuster vaccine in the Okada documents.[169] As I have found claims 1 and 2 not inventive, it follows that claims 4 and 5 do not involve an inventive step.
Claim 6 of ‘535
[169] Okada 1999 page 1131 vaccine; Okada 2000a page 528 vaccine preparation; Okada 2000b page 2826 vaccine product.
173. Claim 6 of ‘535 is to the composition of claims 1-5 which further comprises a pharmaceutically acceptable carrier. I consider that the Mycobuster vaccine in the Okada documents had water as the carrier. It follows that claim 6 does not involve an inventive step.
Claims 7, 8 and 11 of ‘535
174. These claims both involve the composition being administered as a single dose. The Okada all involve a two-dose vaccination administration with an interval.[170] There is no evidence of what steps would be taken to achieve a single dose administration from the Mycobuster vaccine. Chase merely said that this was desirable.[171] It has, therefore, not been established that these claims do not involve an inventive step.
Claims 9 and 10 of ‘535
[170] Okada 1999 page 1131 -1132 experimental design; Okada 2000a page 528 experimental design; Okada 2000b page 2826 experimental design.
[171] Chase #1 at 107.
175. These claims are dependent claims (with claim 9 being dependent on claim 1) to a method involving administration of the composition to pigs. In the Okada documents, the vaccine is administered to pigs intramuscularly. It follows that these claims do not involve an inventive step.
Claim 12 of ‘535
176. Claim 12 of ‘535 is a method claim similar to claim 3 and lists the same diseases. In this claim, the composition is administered in conjunction with at least one additional antigen rather than the composition further comprising the additional antigen. This could involve the composition being administered to pigs at the same time as another vaccine rather than being formulated together. Some of the known PCV2 and M. hyo vaccines used this method.[172] It appears that the administration of one vaccine in conjunction with another was well known. I am therefore satisfied that this claim does not involve an inventive step.
Claims 13, 14 and 15
[172] Chase #1 at 112.
177. These claims involve methods of administering the composition to pigs with maternally derived M. hyo antibodies (claim 13) and at least one other microorganism and administration at 3 weeks of age or older. The Opponent said that these are standard practice.[173] In the Okada documents, pigs were vaccinated at 3 to 7 weeks[174] if the mothers were exposed to M. hyo or were vaccinated then the pigs would have maternally derived antibodies. It does appear that this would be standard practice. Therefore these claims do not involve an inventive step.

Claims 16-17
[173] Chase #1 at 113-114.
[174] Okada 1999 at page 1131-1132 experimental design.
178. These claims are kit claims. They comprise a bottle with the composition and then an instruction manual. In my view, there is no inventive step in putting a vaccine composition into a bottle and providing instructions. These claims are therefore not inventive.
Claim 18
179. Claim 18 is to a method involving five steps. The Okada documents use the first four steps.[175] The fifth step involves substantially removing both IgG and antigen/immunoglobulin immunocomplexes from the supernatant vaccine. I have decided above that the treatment of the supernatant vaccine of Okada with protein-A was not inventive; it follows that this claim does not involve an inventive step.
Claim 1 of ‘537 (bivalent)
[175] Okada 2000a page 528 vaccine preparation; Okada 2000b page 2826 vaccine product.
180. Claim 1 of the ‘537 (bivalent) application is to a multivalent immunogenic composition. It has the same supernatant composition as claim 1 of the ‘535 application, but with the PCV2 virus, antigen added. PCV2 and M. hyo combination vaccines were known. The Okada documents are silent on it being used as a platform for a multivalent vaccine and silent on multivalent vaccines. Furthermore, the evidence on why the declarants would start from the Okada documents to produce a multivalent immunogenic composition is lacking.
181. Chase was asked directly about preparing a multivalent vaccine from the Okada documents and he said he would have combined it with a PCV2 given its prevalence.[176] He did not say why the he would seek to prepare a multivalent vaccine or why that was a problem he was seeking to solve. He goes onto say that he would have checked for neutralising antibodies and mentions that they could be removed with Protein A or protein G.[177]
[176] Chase #1 at 55.
[177] Chase #1 at 57-58.
182. Browning was also asked about preparing a PCV2/M. hyo combination and his approach to using fetal pigs to avoid neutralising antibodies.[178] He did not see the Okada documents as somewhere to start from given the small group sizes.[179]
[178] Browning at 69.
[179] Browning at 96.
183. Given the above I am not satisfied that the evidence has established that a person skilled in the art would, in all of the circumstances directly be led as a matter of course to try the Mycobuster vaccine in the Okada documents as a mulivalent vaccine and add PCV2 antigen to it. It follows that claim 1 of the ‘537 (bivalent) has not been established as lacking an inventive step.
184. The dependent claims 2-23 all include the features of claim 1. It follows that it has not been established that these claims do not involve an inventive step.
Claim 24 of ‘537 (bivalent)
185. Claim 24 of ‘537 (bivalent) is an independent method claim similar to claim 18 of the ‘535 however it has the additional step of combining the supernatant with a PCV2 antigen. For the same reasons above the evidence has not established that the person skilledin the art would, in all of the circumstances directly be led as a matter of course to try adding a PCV2 antigen to the Mycobuster vaccine of the Okada documents which has had the IgG and immunocomplexes substantially removed.
Inventive step of the ‘540 (trivalent) application
186. Claim 1 and 24 of the ‘540 (trivalent) application are the independent claims. They are to a trivalent immunogenic composition and a method of making it. The trivalent immunogenic composition comprises the M. hyo supernatant of the ‘535 claims and PCV2 antigen and PRRS virus antigen. PRRS was known to be endemic in pig populations, and Chase gave evidence of a PRRS live attenuated virus combination with a bacterin M. hyo vaccine.[180] The experts, however, were not asked about steps they would take to make a trivalent vaccine, and when asked about multivalent vaccines, Chase does not discuss PRRS.[181] I do not have any evidence that this trivalent vaccine would have been routine. Therefore this ground of opposition has not been made out for the ‘540 (trivalent) application.
[180] CC-4.
[181] 540Chase #1 at 55.
Conclusion on inventive step
187. Claims 1-2, 4-6, 9-10, 12-18 of ‘535 do not involve an inventive step. The evidence does not satisfy me on the balance of probabilities that claims 3, 7-8, 11 of ‘535, claims 1-24 of ‘537 (bivalent) and claims 1-25 of ‘540 (trivalent) fail for want of an inventive step.
Manner of manufacture
188. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.
189. The Opponent’s argument focused on the application of the Full Federal Court’s finding in Smith & Nephew Pty Ltd v Wake Forest University Health Sciences (Smith & Nephew).[182] I note that in that case Full Court applied the principle that a mere collocation is not patentable with reference to Minnesota Mining and Manufacturing Co v Beierdorf (Aust) Ltd and Firebelt Pty Ltd v Brambles Australia Ltd[183] and stated:
“A mere collocation of parts, each performing its own separate function, is not patentable. However, a claim may validly combine a number of elements which interact with each other to produce a new result of product. Such a combination may be one constituted by integers each of which are old, or by integers some of which are new, the interaction being the essential element.”[184]
[182] [2009] FCAFC 142; 82 IPR 467
[183] 1A IPR 231 at 237 and 54 IPR 449.
[184] 82 IPR 467 at 16.

190. In Smith & Nephew, the Court found the that a claim to an apparatus for applying pressure to a wound beneath a fluid-impermeable seal had the desired result of the apparatus, i.e. the application of negative pressure.[185] A dependent claim, claim 49 was being considered (this was because it was the claim allegedly being infringed). Claim 49 had the apparatus (the wound covering that applied negative pressure) with the additional feature of it being in an aseptic package. The court construed the feature of the aseptic package in the context of the specification as a whole and found that it was not an optional feature and was part of the consideration in determining whether the claim was a mere collocation.[186] As I mentioned, desired effect of the apparatus was the application of negative pressure to the wound and the court found that the aseptic package did not did not contribute to achieving this desired effect. Consequently, the court found that the primary Judge should have found the claim invalid for want of a manner of manufacture.[187] The Full Court granted leave to appeal which dismissed the interlocutory injunction.[188]
[185] 82 IPR 467 at 24-25.
[186] 82 IPR 467 at 31-32.
[187] 82 IPR 467 at at 44.
[188] 82 IPR 467 at 56.
191. I note that the Smith & Nephew case did not consider whether the features of the claim were new or old as it was dealing with interlocutory injunction for infringement of claim 49. However, the primary Judge noted that the attack on novelty was based on the patent being a “combination patent”.[189] That is, a combination of features which require a working interrelationship. The primary Judge stated that the novelty argument raised “serious questions”.[190]
[189] Wake Forest University Health Sciences v Smith & Nephew Pty Ltd ACN 000 087 508 [2009] FCA 630 at 34.
[190] Wake Forest University Health Sciences v Smith & Nephew Pty Ltd ACN 000 087 508 [2009] FCA 630 at 36.
192. The Opponent’s argument was based on the prinicples in Smith & Nephew and they argued that the kit claims, 16 and 17 of ‘535, 21, 22 and 23 of ‘537 (bivalent) and 19 to 23 of ‘540 (trivalent) have the desired effect of being an immunogenic composition. They contended that the bottle in these claims did not contribute to the desired effect. I note that the kit claims of ‘540 (trivalent) has a first bottle and a second bottle. The Applicant argued that the desired effect was not that of just the immunogenic composition but that it could be a single-dose administration and that it would be ready-to-use one bottle administration for a combination vaccine, which requires no mixing of separate vaccines.
What is the desired effect?
193. As I mentioned above specification discloses that that the prior art has disadvantages of being either two-dose or as a single-dose 2-bottle vaccine requiring simultaneous administration[191] and that the current invention is described as being compatible with other antigens such that all antigens can be administered in a single dose.[192] The’ 535 specification states that it would be desirable to provide a ready-to-use single-dose M. hyo/PCV2 combination vaccine.[193]
Does the feature “a bottle” achieve the desired effect?
[191] ‘535 page 16 lines 30-33.
[192] ‘535 page 17 lines 1-2.
[193] ‘535 page 3 lines 3-4.
194. I consider that the reference to “a bottle” using the article “a” refers to a single bottle, likewise “a first bottle” and “a second bottle” refer to individual separate single bottles. This single bottle meant there is no risk of contamination or additional labour associated with mixing and no requirement to use the mixture within a few hours and that a single bottle cuts waste and storage. The Opponent argued that kit claims in question are not limited to it being a single dose. A single dose is listed as a feature of other claims, indeed this is the case. However, they do provide a ready-to-use vaccine. The benefit of the single bottle is the ease of use and that there is no need for additional labour associated with mixing, the reduction in waste and storage.
Conclusion on Manner of Manufacture
195. Given that the use of a bottle does add to the desired effect and that the claims include new features, I do not consider that claims 16 and 17 of ‘535, 21, 22 and 23 of ‘537 (bivalent) and 19 to 23 of ‘540 (trivalent) are a mere collocation. This ground of opposition fails.
Conclusion
196. The oppositions on ‘535 has been successful on the grounds of inventive step. The opposition on ‘537 and ‘540 has been unsucessful. Subject to appeal, the Applicant is given two months to file suitable amendments on the ‘535 application.
Costs
197. The parties submitted that costs should follow the event. There are three applications under opposition with one successful and two unsuccessful. I therefore consider that costs on the ‘535 and ‘537 application are balanced. However, costs should be awarded against the Opponent under Schedule 8 for the ‘540 application.
K. Wagg
Delegate of the Commissioner of Patents

‘535			‘537 (bivalent)			‘540 (trivalent)
Date	Reference	Exhibits	Date	Reference	Exhibits	Date	Reference	Exhibits
17 July 2017	Chase #1	CC 1 to CC 14	11 July 2017	‘537 (bivalent) Chase #1	537CC 1 to 537CC 13	17 July 2017	‘540 (trivalent) Chase #1	540CC 1 to 540CC 16