Grounds 1 and 4: did Zoetis know a method of performing the invention which conferred the advantages of the invention?
- It is clear, in our respectful opinion, that Zoetis knew how to make compositions which conferred the advantages identified at [50] above. Example 9 in the specification (p 43) was headed 'Evaluation of M. hyo efficacy of a 1 bottle PCV2/M. hyo Combination Vaccine in 10% SP-Oil'. Under this heading the specification said at p 43 lines 20-25:
This study is a proof of concept designed to evaluate the M.hyo fraction efficacy of four experimental PCV2/M.hyo vaccines (Serials L071 IRK 11, L071 1RK12, L071 1RK13 and L071 1RK14 in Table 11 below) prepared by different M.hyo manufacturing processes which utilize Protein A for IgG removal compared to control vaccines prepared with the standard M.hyo manufacturing process. Each of these four experimental PCV2/M.hyo vaccines included 10% SP-oil as the adjuvant.
- There then followed a description of 8 treatments leading to the vaccines known as T01-T08. Although these were detailed, as will be seen, because the absolute concentration of the antigens was not given it was not possible for a person skilled in the art to produce the IVPs which resulted. After the description of the methods there then appeared Table 11 on p 46:
- The IVPs appear in the second column. The reference to 'RP' is a reference to the reference product against which efficacy was measured. The references to PCV1-2 'Ag' and M. hyo 'Ag' are references to the antigen content of the IVP as measured against the RP. As the primary judge observed, the antigen content of the RP was not disclosed with the effect that the antigen content of the IVPs was not disclosed either.
- Following Table 11 there then appeared at lines 5-22 the following:
Pigs at 3 weeks of age were intramuscularly inoculated with a single dose of the different vaccine formulations described in Table 11 above. There were 18 pigs included in each treatment group. Animals were challenged 21 days after vaccination with a virulent M.hyo field isolate. Animals were necropsied 28 days after challenge and the lungs were removed and scored for consolidation consistent with M.hyo infection. Figure 8 (A & B) show the lung lesion scores for the respective treatment groups. Statistical significance was determined by a Mixed Model Analysis of lung scores for each group.
The lung lesion results depicted in Figures 8A and 8B indicate that of all the treatments, only two (T07 and T08) had 100% of pigs in the <5% lung lesion category. It is noted that strong statistical difference were observed in this study.
The results in the present example demonstrate significant M.hyo efficacy in a 1 -bottle PCV2/M.hyo experimental formulation employing the Protein A-treated M.hyo supernatant and utilizing SP-oil as the adjuvant. Additionally, Example 7 above demonstrated PCV2 efficacy in a 1-bottle PCV2/M.hyo formulation employing the Protein A-treated M.hyo supernatant and utilizing SP-oil as the adjuvant. Taken together, both M.hyo and PCV2 efficacy have been demonstrated in the 1 -bottle PCV2/M.hyo combinations employing Protein A-treated M.hyo supernatant.
- Tables 8A and 8B appeared at the end of the specification. The effect of this is that at least T07 (L0711RK13) and T08 (LK0711RK14) were shown to be significantly effective when administered as a single dose. This demonstrates that Zoetis knew a method of performing the invention which conferred the advantages promised by the invention, viz, efficacy when administered as a single dose and suitability to be used as a platform vaccine in combination with antigens conferring immunity against other porcine viruses. But without knowing what the actual antigen concentration of the IVPs was, the person skilled in the art was left to discover for themselves what the appropriate antigen concentrations were which could deliver the results illustrated in Table 11. It would be necessary for that person to conduct their own work to bring about the result that Zoetis had already accomplished.
- It was therefore clear that there were methods known to Zoetis of performing the invention which delivered on the advantage it promised to confer; i.e. an M. hyo vaccine with single dose combination efficacy.
- Zoetis submits that this does not entail that it had failed to disclose the best method known to it of performing the invention. It argues that to establish the case it had pleaded, Boehringer had to demonstrate that one or other of the ten IVPs was, and was known to Zoetis to be, a better method of performing the invention than any IVP with absolute antigen concentrations falling within the disclosed ranges. Boehringer submits that this was not so because the specification did not disclose any method at all since all that was disclosed was a range of antigen concentrations. Since no method was disclosed, the fact that Zoetis knew that the IVPs were of varying efficacy entailed that it knew which of them was most efficacious. It was not necessary therefore for Boehringer to identify which of the IVPs was known to Zoetis to be the best IVP.
- We accept Boehringer's submission. It would be possible, as Zoetis submits, for Boehringer to prove that one of the IVPs was the best method known to Zoetis and then to demonstrate that that method had not been disclosed. But what is involved is a factual question: did Zoetis disclose the best method known to it of performing the invention? Whilst that fact could be proved in the manner suggested by Zoetis this is not the only way it could be proved. Forensically, it was equally open to Boehringer to demonstrate that Zoetis knew of a best method which it had not disclosed without identifying that best method. The evidence showed that the IVPs varied in efficacy and the logic of this entailed that one of them was most efficacious (or even that two were equally the most efficacious). In that circumstance, there was no need for Boehringer to identify which of the IVPs was best. Zoetis's argument to this effect is embodied in Ground 4 which should be rejected.
- The case, therefore, is indistinguishable from Servier for four reasons. First, in Servier the specification of a classical method of salification was sufficient to allow the person skilled in the art to make the arginine salt of perindopril for use as a pharmaceutical composition. Here the specification is sufficient to allow the person skilled in the art to make a composition suitable for administration in a single dose and as part of a combination vaccine conferring immunity against both M. hyo and PCV-2.
- Secondly, in Servier different methods of classical salification resulted in different forms of the arginine salt of perindopril which were of varying levels of suitability for use as a pharmaceutical composition. In this case, the person skilled in the art could make the composition with varying antigen concentrations (and different balances between the antigens).
- Thirdly, in Servier the patentee had utilised two particular classical methods of salification to produce forms of the arginine salt of perindopril which were suitable to be used as a pharmaceutical composition. In this case, Zoetis produced IVPs some of which were more efficacious than others.
- Fourthly, in Servier the particular classical methods of salification which the patentee had used were not disclosed. In this case, Zoetis did not disclose how to make any of the IVPs because it did not disclose their antigen concentration.
- There is therefore no relevant difference between the facts of Servier and the facts of this case. The short of the matter is that Zoetis knew how to perform the invention so as to produce the IVPs and it knew that some of these IVPs were more efficacious than others. Apart from disclosing the possible range of antigens, it did not disclose how to make any of the IVPs. The primary judge correctly concluded that the best method was not disclosed. Ground 1 of the Notice of Appeal should accordingly be rejected.