Pharmalink International Ltd v Pharmazen Ltd
[2025] NZHC 2657
•12 September 2025
IN THE HIGH COURT OF NEW ZEALAND WELLINGTON REGISTRY
I TE KŌTI MATUA O AOTEAROA TE WHANGANUI-A-TARA ROHE
CIV-2025-485-000053
[2025] NZHC 2657
UNDER the Patents Act 2013 and Parts 20 and 22 of the High Court Rules 2016 IN THE MATTER OF
an appeal against a decision of the Commissioner of Patents
BETWEEN
PHARMALINK INTERNATIONAL LIMITED
Appellant
AND
PHARMAZEN LIMITED
First Respondent
COMMISSIONER OF PATENTS
Second Respondent
Hearing: 11 – 12 August 2025 Counsel:
GF Arthur KC for Appellant
JM Glover and JP Rogers for First Respondent
Judgment:
12 September 2025
JUDGMENT OF DOWNS J
This judgment was delivered by me on Friday, 12 September 2025 at 3 pm pursuant to r 11.5 of the High Court Rules 2016.
Registrar/Deputy Registrar
Solicitors/Counsel: Buddle Findlay, Auckland. James & Wells, Auckland. Crown Law, Wellington.
GF Arthur KC, Wellington. JM Glover, Auckland.
PHARMALINK INTERNATIONAL LTD v PHARMAZEN LTD [2025] NZHC 2657 [12 September 2025]
Table of Contents
The appeal [1]
Appellate approach [2]
Background [3]
Synergy [6]
Example 2 [9]
Example 3 [16]
Do examples 2 and 3 exhibit synergy? [21]
Does the specification disclose the invention in a manner clear and complete enough for the invention to be performed by a person skilled in the art? Is the application supported by the material disclosed in
the specification? [33]
Patient study (example 4) [55]
Is amendment of a claim permissible on appeal? [59]
Krill species [63]
Mussel species [65]
The definition of “about” [66]
Is the invention novel? [84]
It is obvious to combine the ingredients in the claimed ratios? [96]
Summary of conclusions [108]
Result [109]
Costs [110]
The appeal
[1] This judgment addresses a patent appeal. As is so often the case, the subject matter is technical. In what follows, I attempt to explain, as simply as possible, the applicable science. Some technical language is, however, unavoidable, including in relation to patent law.
Appellate approach
[2] An appeal in this context is a rehearing but, as appellant, Pharmalink International Ltd1 must identify error on the part of the Commissioner of Patents or persuade me to a different conclusion from him.2
1 Pharmalink.
2 Austin, Nichols & Co Inc v Stichting Lodestar [2007] NZSC 103, [2008] 2 NZLR 141 at [16].
Background
[3] Pharmalink applied for a patent in relation to an alleged invention: the anti-inflammatory effect of green-lipped mussel lipid extract with krill oil. Each ingredient has long been recognised as having anti-inflammatory properties. No one, however, had seemingly contemplated the two being combined or taken together to reduce inflammation beyond the sum of their parts. This introduces the key concept: synergy arises when ingredients produce just such an outcome. For example, an ingredient that reduced inflammation by two units with another that reduced it by three would produce a synergistic effect if together, the reduction were six units. A reduction of five units would be additive, not synergistic.
[4] Pharmazen Ltd3 opposed Pharmalink’s application on a multiplicity of grounds. The Assistant Commissioner4 dismissed several objections but upheld five, and therefore declined the application.5 The decision is comprehensive; it occupies 264 paragraphs across 89 pages. As foreshadowed, Pharmalink appeals. Its stated appeal grounds ultimately produce these:
(a)Do examples 2 and 3 exhibit synergy?
(b)Does the complete specification6 disclose the invention in a manner clear and complete enough for the invention to be performed by a person skilled in the art? Is the application supported by the material disclosed in the specification?
(c)Is amendment of a claim permissible on appeal?
(d)Is the invention novel?
(e)It is obvious to combine the ingredients in the claimed ratios?
3 Pharmazen.
4 The Commissioner.
5 Pharmalink International Ltd v Pharmazen Ltd [2024] NZIPOPAT 15 [the decision].
6 The specification.
[5] All are best understood against the backdrop of the evidence, beginning with synergy. A summary of what this judgment holds is at [108].
Synergy
[6] Three experiments were performed to assess synergy, two in the laboratory, and one using patients. The specification to the application refers to these as examples 2, 3, and 4. Example 4, a patient study, is best discussed later.
[7] Some explanations first. An inflammatory marker is a substance in the body that indicates the presence of inflammation, or level of inflammation. NO, Tumour Necrosis Factor-alpha,7 Interleukin-6,8 and Prostaglandin-E29 are several types of inflammatory marker. NO is a molecule of nitric oxide produced during inflammation. TNF is a protein released by the body that causes inflammation. So too IL-6. PGE2 is a fatty acid molecule which causes blood vessels to widen, in turn increasing blood flow.
[8] RAW264.7 cells10 are derived from mice, and widely used in scientific research. RAW cells mimic some behaviours of human immune cells.
Example 2
[9] RAW cells were stimulated to produce the four inflammatory markers identified: NO, TNF, IL-6 and PGE2. Three mixtures were tested on the markers to assess each mixture’s apparent anti-inflammatory effect:
(a)The first contained 90 percent PCSO-524® and 10 percent enriched krill oil.11 PCSO-524® comprises lipid oil extracted from the green-lipped mussel. The first mixture was tested against NO, TNF, and IL-6.
7 TNF.
8 IL-6
9 PGE2.
10 RAW cells.
11 The krill oil used in the experiments was enriched to produce a high phospholipid percentage of 62.
(b)The second contained 75 percent PCSO-524® and 25 percent enriched krill oil. It was also tested against NO, TNF, and IL-6.
(c)The third contained 50 percent PCSO-524® and 50 percent enriched krill oil. It was the only mixture tested against all four markers and, therefore, encompassed PGE2.
[10] The specification tabulates the results for each test, as below. PCSO-524® is referred to as LY, presumably because it is the major component of Lyprinol®:
Table 2-3: IC50 for NO Inhibition
LY Krill 90%LY 75%LY Olive Oil 1400W IC50 ~107 ~286 44.8 40.9 Not active 1.6
Table 2-4: IC50 for TNFα Inhibition
LY Krill 90%LY 75%LY Olive Oil Dexa IC50 ~238.7 ~103.3 89 57 DNF* 3.328e-005 * Did not fit mathematical model of a dose response curve
Table 2-5: IC50 for IL-6 Inhibition
LY Krill 90%LY 75%LY Olive Oil Dexa IC50 22.4 13.4 11.5 10.4 ~106.8 1.19
Table 2-6: IC50 for PG-E2 Inhibition
LY Krill 90%LY 75%LY 50% LY Diclofenac Olive Oil Not active Not active ~112 ~118 55.3 0.12 DNF* * Did not fit mathematical model of a dose response curve
[11] Readers will notice each table refers to IC50. IC50 stands for half-maximal inhibitory concentration, a measure to determine how much of a substance is needed to inhibit something by 50 percent. A low IC50 concentration means the substance is potent, whereas a high IC50 means the substance is weak.
[12]The specification captures the results:
Summary of Results
[0135] Mussel lipid extract and krill oil were demonstrated in this assay system at the concentrations tested to individually inhibit NO, TNFα and IL-6, but not PGE2.
[0136] The combination of mussel lipid extract and krill oil was more effective than either mussel lipid extract or krill oil alone in inhibiting NO, TNFα and IL-6. In the PGE2, assay, neither mussel lipid extract or krill oil alone demonstrated inhibitory activity, but in combination, demonstrated inhibition.
[13] Each party engaged independent experts to consider the results and other aspects of the specification.
[14] Mitchell Low is a pharmacologist. Dr Low says example 2 is “suggestive of a synergistic effect”. Frances Wolber and Peter Nichols are microbiologists. Dr Wolber says example 2 “indicates a synergistic effect”. Dr Nichols says the first and second mixtures in relation to NO had a “substantially greater” effect than PCSO-524® or enriched krill oil individually. Dr Nichols says these results “cannot be due solely to an additive effect”.
[15] Pharmazen’s witnesses disagree, somewhat. Colin Barrow, a professor and biotechnologist, says “not all data ... supports a hypothesis of synergism”. Some results are commensurate with krill oil acting alone given margins of experimental error. Paul Davis is a biomedical researcher. Dr Davis says the individual effects of PCSO-524® and enriched krill oil at specific concentrations are not clearly stated, hence it is possible some combinations are additive, not synergistic.
Example 3
[16] As with example 2, example 3 involved mixtures of PCSO-524® and enriched krill oil. A wider range of combinations was tested, including 10 percent PCSO-524® and 90 percent enriched krill oil. The mixtures were tested against NO, TNF, and IL-6, but not the PGE2 marker. The results were entered into a computer programme to generate the Combination Index, which is a mathematical model to assesses synergy.
[17]The specification tabulates the results:12
Table 3-4: IC50s … and Combination Index for NO inhibition of combination LY75 to LY45
LY75 LY70 LY65 LY60 LY55 LY50 LY45 IC50 (μg/mL) 123 68 84 65 86 79 84 95% CI for IC50
(μg/mL)
97–160 65–85 69–96 60–73 70–90 69–89 73–100 Combination Index 0.80 0.50 0.55 0.48 0.54 0.77 0.61
Table 3-6: IC50s and [Combination Index] for LY70-LY35 (n=9) [TNF inhibition]
LY70 LY65 LY60 LY55 LY50 LY45 LY40 LY35 IC50 91 80 78 68 69 90 70 73 95% CI 64–189 60–137 64–98 54–87 60–80 68–128 57–89 59–92 Combination Index 0.14 0.12 0.114 0.097 0.096 0.123 0.094 0.095
Table 3-8: IC50s and Combination Index for IL-6 inhibition
LY70 LY65 LY60 LY55 LY50 LY45 LY40 LY35 LY30 IC50 36 39 34 43 37 49 52 41 41 95% CI 29–45 33–45 27–42 37– 30–44 40–58 44–60 30–54 32–51 Combination Index 0.27 0.23 0.31 0.27 0.37 0.4 0.32 0.32
[18] A result less than one on the Combination Index is indicative of synergy. The specification summarises the results this way:
[0155] Mussel lipid extract and krill oil, used in combination, would demonstrate in this … system to meet the mathematical criteria for synergy in inhibiting NO, TNFα and IL-6.
[19]Pharmalink’s experts consider example 3 commensurate with synergy.
[20] Pharmazen’s experts disagree, again somewhat. Professor Barrow observes the components responsible for the putative synergistic effect are unclear, particularly as PCSO-524® and krill oil contain numerous minor components, some of which
12 For each inflammatory marker, tests were performed in increments of 10 percent (LY90 to LY10) to identify the most synergistic result (the highlighted column). Further tests were then performed in five percent increments to generate the results recorded here.
remain unknown. He and Dr Davis also emphasise the significant differences between laboratory experiments and the effects of substances in the human body. A laboratory experiment typically tests a single mechanism, whereas those in the human body are many and complex.
Do examples 2 and 3 exhibit synergy?
[21] Unsurprisingly, a patentable invention requires an inventive step. A step is inventive if it is not obvious to a person skilled in the art, having regard to the prior art base.13 A person skilled in the art is a hypothetical expert in the applicable field. Put broadly, the prior art base refers to all pre-existing knowledge, that is, what was known before the patent was sought.14
[22] Pharmalink contends the inventive step is the synergetic effect arising from the combination of green-lipped mussel lipid extract and krill oil. As this effect was unexpected by those skilled in the art, it was, by definition, not obvious. This introduces the first issue: do examples 2 and 3 exhibit synergy?
[23] The Commissioner held the answer was no. This conclusion was largely based upon the Commissioner’s own interrogation of the data and attendant concerns. The following paragraphs of the decision afford a glimpse of the Commissioner’s thinking, and the example is merely that:
155.For TNFα inhibition, Table 3-6, CI=0.14 for LY70, deceases to CI=0.114 for LY60, hovers around a least value CI=0.096 for LY50, increases to CI=0.123 for LY45, then somewhat surprisingly decreases to CI=0.094 and CI = 0.095 for LY40 and LY35. According to the tabulated data, the CI for reduction of TNFα has minimums at around LY50 and LY40. CI<1 for LY70 to LY35. The CI values for TNFα for LY90, LY80, and LY30, LY20 and LY10 are not disclosed or tabulated in the specification. Table 3-6 is a refinement of Table 3-5 but the IC50 values for the common LY70: 64 vs 91, LY60: 53 vs 78 and LY50:43 vs 69 are inconsistent. More concerning for the TNFα assays is that the isobologram, Fig 10 is plotted with the IC50 intercepts for K at 966 μg/ml and for LY at 606 μg/ml respectively corresponding to the values listed in Table 3 -5, but Table 3-5 does not list the 95% CI for IC50 μg/ml values so there is no firm error measure for the intercept values. Nor are the IC50 intercepts for K at 966 μg/ml and for LY at 606 μg/ml
13 Patents Act 2013, ss 7 and 14(b)(ii) [the Act].
14 Section 8(1).
anywhere close to the IC50 values for K at 103.3 μg/ml and for LY at
238.7 μg/ml listed in Table 2-4.
156.For IL-6 inhibition, Table 3-8, the CI values are tabulated for LY65 through to LY30 in 5% increments, for LY65, CI=0.27, CI=0.23 is a minimum at LY60, then sits between 0.27 and 0.4 for LY55 to LY30. The CI values for IL-6 for LY90, LY80, LY70, and LY20 and LY10 are not disclosed or tabulated in the specification. The IC50 measures for the common ratios LY70, LY60, LY50, LY40 and LY30 are consistent between Tables 3-7 and 3-8. The axes intercepts for the additive line on the IL-6 isobologram Fig 13 do not correspond to the IC50 values for K, 114 μg/mL and LY, 173 μg/mL listed in Table 3-7. If the 95%CI (μg/mL) figures are accounted for the additive line cuts right through the IC50 data points for the combinations, which would not be indicative of a synergistic effect.
[24] On behalf of Pharmalink, Mr Arthur KC argued examples 2 and 3 exhibit synergy to the modest standard required in this context. Mr Arthur noted an applicant need not prove “the invention will work or explain why the invention will work”. Mr Arthur said the Commissioner, “of his own volition … dissected the examples” to conclude synergy had not been demonstrated. Mr Arthur said the Commissioner’s analysis went beyond that of any expert and was, therefore, unsupported by the evidence, particularly as the Commissioner, rather than any expert, treated apparent anomalies as “disconcerting” and “concerning”.15
[25] On behalf of Pharmazen, Ms Glover argued the examples do not support synergy. Ms Glover said, “many of the results” in examples 2 and 3 are inconsistent:
• Table 3-3 shows an IC50 value of 105 μg/ml for LY90 for NO inhibition. In Table 2-3 the equivalent value is 44.8 μg/ml.
• Table 3-4 shows an IC50 value of 123 μg/ml for LY75 for NO inhibition. In Table 2-3 the equivalent value is 40.9 μg/ml.
• Table 3-5 shows a nil IC50 value for LY90 for TNF inhibition. In Table 2-3 the equivalent value is 44.8 μg/ml.
• Table 3-7 shows an IC50 value of around 100 μg/ml for LY90 for IL-6 inhibition. In Table 2-3 the IC50 value for LY75 for IL-6 inhibition is 40.9μg /ml.
• Table 2-5 shows an IC50 value of 10.4 mg/ml LY75 for IL-6, while LY70 and LY80 are 36 μg/ml and 53 μg/ml, respectively, in Example 3 (Table 3-7). The LY75 result would be expected to lie between LY70 and LY80.
15 The decision, above n 5, at paras 154 and 155.
48.These discrepancies are significant. No error levels are provided for the data, but these discrepancies demonstrate that they must be high. A difference from 40.9 μg/ml to 123 μg/ml reflects a discrepancy of about 300%. An error level of 300% on 40 μg/ml is “40 plus or minus 80”. In addition, AC Luiten noted that some of the figures in the Tables differ from the corresponding isobolograms.
49.It is submitted that these inconsistencies cast significant doubt on the reproducibility of the assay results - particularly as the applicant carried out each assay in Examples 2 and 3 three times, but only one set of results was disclosed. In the absence of information about the error levels, the usefulness of the IC50 numbers is unknown.
[26] Ms Glover also emphasised the expertise of the Commissioner, observing it should attract deference.
[27] I have found this issue difficult, as I am not a scientist or mathematician. Plainly, the Commissioner has expertise I do not. It follows Ms Glover was right to counsel deference. That said, I conclude, in respectful disagreement with the Commissioner, the examples exhibit synergy. My reasoning is threefold.
[28] First, our system is adversarial. Significant challenges to an aspect of a party’s case should emanate from the opposing party, not the Judge. A related process point is that the Commissioner’s concerns do not appear to have been put to Pharmalink for it to respond.
[29] Second, the Commissioner went beyond the evidence in finding synergy was not exhibited by the (two) examples. As I observed earlier, Professor Barrow and Dr Davis disagree somewhat with Pharmalink’s experts on this issue; their more searching criticism arises in relation to the next grounds of appeal, to which I come shortly. Their primary criticism of synergy at this juncture is that not all data exhibits it, or necessarily exhibits it, but this is not the same as saying synergy is not exhibited at all. The importance of this distinction is obvious. While Ms Glover stressed the criticisms of Professor Barrow and Dr Davis, a close reading of their evidence reveals the argument really lies at the margins, not that synergy is not exhibited. All of which is to emphasise that the Commissioner’s concerns were not identified by either Professor Barrow or Dr Davis.
[30] Third, as Mr Arthur submitted, proof of synergy is not required in this context. It is enough that synergy is plausible. Taken together, examples 2 and 3 meet that relatively modest standard on the evidence.
[31] Before leaving this topic, I acknowledge the Commissioner’s concerns may be correct. Again, I accept he has expertise I do not. But as I have explained, our system is adversarial, and conclusions must ultimately reside in the evidence.
[32]This ground of appeal succeeds.
Does the specification disclose the invention in a manner clear and complete enough for the invention to be performed by a person skilled in the art? Is the application supported by the material disclosed in the specification?
[33] A patent application must be supported by a complete specification, which describes how the invention is made or reproduced.16 The complete specification must disclose the invention sufficiently clearly so it can be reproduced by someone skilled in the art, without undue burden, across the breadth of the claim. The requirement for support is just that; the application must be supported across its breadth by the complete specification. These obligations are sometimes described as two sides of the same coin, and can, in practice, be indistinguishable.17
[34] The requirements of sufficiency and support can be illuminated by an admittedly contrived hypothetical. Imagine a scientist applies for a patent for a drug directed at the treatment of every type of cancer known to humankind but supported by data confined exclusively to one cancer type. Such an application would almost certainly be declined unless there was reason to believe the invention involved a mechanism, technique, or effect reproducible to all other forms of cancer. Absent that, the application would not be supported or sufficient.
[35] The case law offers somewhat different formulations of what I have described as the “reason to believe”. “Sound prediction” or “fair basis” is one;18 another offered
16 The Act, ss 36(1) and (39).
17 Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2023] FCAFC 178, (2023) 300 FCR 408 at [155]; citing Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477, (2020) 155 IPR 1 at [543]. See also Ardelyx, Inc [2023] NZIPOPAT 17 at [77]–[89].
18 Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 (Ch) at 193.
by the United Kingdom Supreme Court is plausibility. Is it “plausible” the invention will work across the breadth of the application.19 Readers will note I used the same term in relation to whether synergy was demonstrated by the examples.
[36] Precise linguistics matter not. As observed, an applicant need not prove the invention works. However, an applicant must identify a plausible reason for believing the invention works across the matters claimed by the patent. This reflects what is known as “the patent bargain”, a concept at the heart of patent law.20 An inventor receives a monopoly in return for their contribution to the art, but the monopoly is no broader than the extent of the inventor’s contribution to the art.
[37] Pharmalink’s patent application is not confined to PCSO-524® and the krill oil used in the experiments, or to the range of combinations examined in examples 2 and 3. Pharmazen argued the application is, therefore, unsupported as overbroad, and relatedly, the specification does not disclose the alleged invention in a manner clear and complete enough for it to be performed by a skilled person, as the specification is narrower than the application. Reproducibility beyond experimental parameters is thus in doubt.
[38] The hypothetical mentioned earlier helps frame the argument. Those attempting to reproduce the alleged invention across all other types of cancer would fail unless the invention were adequately identified, and supported, across the breadth of the field.
[39] Some reasonable trial and error on the part of the person skilled in the art is acceptable within this context.21 But the application must identify the essential features of the invention in sufficient detail for the skilled person to put the invention into effect.22
19 Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27, [2021] 1 All ER 475 at [27].
20 See Warner-Lambert Co LLC v Generics (UK) Ltd [2018] UKSC 56, [2019] 3 All ER 95 at [17].
21 Regeneron Pharmaceuticals Inc v Genentech Inc [2013] EWCA Civ 93, [2013] RPC 28 at [97], quoting Novartis AG v Johnson & Johnson Medical Ltd [2009] EWHC 1671 (Pat), [2009] All ER (D) 129 (Jul) at [236].
22 Edison and Swan Electric Light Co v Holland [1889] 6 RPC 243 (CA) at 282; and Regeneron Pharmaceuticals Inc v Kymab Ltd, above n 19, at [56].
[40]The Commissioner accepted Pharmazen’s contentions.
[41] Mr Arthur argued the Commissioner erred to do so. Mr Arthur emphasised green-lipped mussel lipid extract is effective in reducing inflammation because of its non-polar lipids, likewise krill oil because of its polar lipids (phospholipids) and triglycerides.23 Mr Arthur said any combination of the two would, therefore, contain the requisite anti-inflammatory properties, hence it was “a sound prediction” synergy would be exhibited across the application.
[42] Some interpolation is desirable, however brief. A lipid is a broad class of biological molecule, largely made of carbon, hydrogen, and oxygen. Lipids are insoluble in water. Polar lipids have heads that carry full or partial electrical charges, allowing them to attract water. Non-polar lipids have no such charge and therefore repel water. Triglycerides are a type of non-polar lipid, primarily used for the (long-term) storage of energy.
[43] Krill oil contains high levels of phospholipids and triglycerides. A phospholipid has a polar head and non-polar tail, enabling it to form part of a cellular membrane. By contrast, a triglyceride is entirely non-polar, and functions as an energy-store.
[44] Mr Arthur said Pharmalink’s experts endorse the contention synergy is anticipated across the application. Drs Nichols and Wolber consider differences arising from the use of: (a) other green-lipped mussel lipid extracts; (b) other krill oils; or (c) different extraction methods in relation to either or both oils; are unlikely to generate significant differences in chemical profile. Both experts therefore anticipate synergy despite such differences, while acknowledging causation remains unknown. Both also say synergy should arise for combinations beyond those tested, given the apparent strength of the synergistic effect in the tested combinations.24 Consequently, Mr Arthur argued the Commissioner erred in concluding the application lacked
23 Triglycerides are also known as triacylglycerols.
24 Dr Nichols says “[e]ach of Tables 3-4, 3-6 and 3-8 ... demonstrate a substantial synergistic effect”. Dr Wolber says “[e]xamples clearly do demonstrate that a small amount of one component, either 10% mussel lipid extract or krill oil, demonstrates substantial synergism.”
support across its breadth and did not sufficiently disclose the invention for it to be performed by a person skilled in the art.
[45] I accept extraction methodology is unlikely to be significant in this context for the reason identified by Mr Arthur: the extractor is a skilled person. She or he should, therefore, be able to reproduce the techniques identified in the application, and consequently, the active ingredients. So, I see this issue as relatively unimportant. But I otherwise depart from Mr Arthur and Pharmalink’s experts for five overlapping reasons.
[46] First, and to begin with the obvious, no one knows why the apparent synergy arises. This is not a reason to decline the application, but the knowledge-gap necessarily increases the unknowns. Because causation is not understood, any departure from the underlying experimentation risks unsuccessful replication of the purported invention across a new variable or variables.
[47] Second, the application is broader in scope than the underlying experimentation. The application anticipates other compositions of lipid extracts from green-lipped mussels, as well as the use of krill oils with lower phospholipid percentages than that used (down to 40 percent). The experiments used mixtures from 90 percent PCSO-524® and 10 percent krill oil, to 10 percent PCSO-524® and 90 percent krill oil, whereas the application approaches the boundary of conceivable ratios of each combination. These additional variables assume heightened significance when, as observed, causation remains elusive.
[48] Third, the bioactive ingredients of green-lipped mussel lipid extract and krill oil are similar. This matters for the reason identified by Professor Barrow: a synergistic reaction typically arises when ingredients have differing bioactive compositions; like-plus-like does not typically result in synergy. Consequently, extrapolation of the alleged invention across the proposed scope of the application (by a skilled person) is likely to be fraught, particularly as even the experimental ingredients contain multiple minor components.
[49] Fourth, synergistic reactions are frequently dependent on dose, ratio, or both. The “window” for such a reaction is typically narrow. Doses or ratios outside the window may produce an additive effect only, even an antagonistic one. As observed above, the application is broader than the scope of the experimentation. All experts agree synergy is surprising. That Pharmalink’s experts expect to see synergy reproduced regardless is, therefore, incommensurate with existing science which, again, recognises the constrained nature of any synergistic window. Pharmalink’s experts respond to this point by saying the results of the experiments justify their view. With respect, this is question begging.
[50] Fifth, as Professor Barrow and Dr Davis emphasise, laboratory success does not necessarily mean a product will work in the human body, particularly given the sophistication and complexity of our bodily processes. As Professor Barrow explains, synergy in the body would normally occur due to the activation of two separate mechanisms, which is not accounted for in the experiments. Without understanding the mechanism of synergy, it would be “very uncertain” to extrapolate the results of any laboratory experiments into the body.
[51] I attempt to draw these threads together in a different way. The application depends on a chain of assumption: (a) that the results of the laboratory experimentation are likely to be replicated in the human body; (b) that untested ingredients and ratios are likely to produce results consistent with those in the laboratory experimentation; and (c) that untested ingredients and ratios are likely to produce outcomes similar in the human body to those in the laboratory experimentation. Assumption (a) is plausible. But the same is not true of (b), which is speculative for the reasons explained above. Even more so is (c), which is another step removed from (b).
[52] In summary, it is one thing to conclude the experiments plausibly support synergy in the body if the same ingredients and ratios are used; it is another to go beyond the experimentation altogether, particularly in the absence of (reliable) in-body testing.25 The reasoning is too remote, the unknowns too many, for a conclusion of “sound prediction” or plausibility across the breadth of the application. Or in terms of
25 See below at [55]–[57].
the patent bargain, the application goes beyond the contribution to the art. It follows the application is not supported by the material in the specification, and the specification does not disclose the invention in a manner clear and complete enough for the invention to be performed by a skilled person.
[53] My thinking is admittedly a little different from the Commissioner’s, who thought a prediction of synergy across the application was not merely speculative, but “probably wrong”.26 I would not go that far, and it is not necessary to do so. The Commissioner also described PCSO-524® and the krill oil used in the experiments as “atypical”,27 which Mr Arthur argued was wrong. I suspect the Commissioner really meant each ingredient was particular and extrapolation to the general from a combination of each was therefore fraught. As will be apparent, that idea informs my reasoning even though I do not treat the ingredients as atypical.
[54]This leaves example 4.
Patient study (example 4)
[55] Twenty-nine patients suffering a variety of pain-related conditions were given capsules containing green-lipped mussel lipid extract and krill oil (with a phospholipid percentage of 61 percent). I say more about the ingredients shortly. All patients had been taking pharmaceuticals to relieve pain. All reported improvement in their condition after taking the capsules.
[56] Mr Arthur did not rely upon example 4 to demonstrate synergy (either propositionally or across the claim), which is why I have not discussed it earlier. Mr Arthur was right not to do so. Example 4 measured pain as a proxy for inflammation, the pain’s cause. Pain is real, but also subjective.28 Notably, no control group involving a placebo was used. This has particular importance as, unsurprisingly, pain-based studies attract a high placebo effect. Some patients took more capsules each day than others, which adds another variable. The capsules’ ingredients adds yet
26 The decision, above n 5, at para 142.
27 At para 17.
28 The study does not identify whether the patients ceased taking their regular, pharmaceutical pain relief.
another. The study identifies olive oil as an ingredient. PCSO-524® does not contain olive oil, but Lyprinol® does.29 Why might this matter? Olive oil demonstrates anti-inflammatory activity.
[57] Mr Arthur said example 4 nonetheless supported the invention’s efficacy. I respectfully disagree. The factors above combine to compromise the experiment’s utility in addressing Professor Barrow’s concerns in translating laboratory results to the body. The breadth of the claim includes replicability in human subjects. Example 4 cannot support that claim.
[58]These grounds of appeal fail.
Is amendment of a claim permissible on appeal?
[59] This ground of appeal evolved during the hearing. It began as a contention the Commissioner erred in concluding the claim was unclear, with appellate amendment offered as a fallback, but ended as an oral application to amend the claim. Additional background is needed, including in relation to principle.
[60] A patent claim must be clear.30 A claim must be supported by “the matter disclosed in the complete specification”.31 As observed earlier, the complete specification describes the “how to”; it must include the best method for performing the invention.32 The complete specification must conclude with a claim defining the scope of the invention.33
[61] Examples 2, 3 and 4 are in the specification. As required, the claim appears thereafter. Paragraphs 1–11 of the (much larger) claim give a sense of how it is drafted:
1.A combination comprising mussel lipid extract and krill oil, wherein the weight ratio of mussel lipid extract to krill oil is in the range of about
29 Ms Glover contends the green-lipped mussel lipid extract used in examples 2 and 3 was also Lyprinol®, because those examples refer to “LY”. Mr Arthur says “LY” is merely shorthand for PCSO-524®, which does not contain olive oil. As will be apparent by my reference to PCSO-524® in relation to examples 2 and 3, I have assumed, without deciding, in favour of Mr Arthur’s position.
30 The Act, s 39(2)(b).
31 Section 39(2)(c). Section 5 defines “claim” to mean “a claim of the complete specification”.
32 Section 39(1)(b).
33 Section 39(1)(c).
5:95 to 99:1, and wherein the combination is adapted for separate or simultaneous administration.
2.The combination according to claim 1 wherein the krill oil has a phospholipid content of at least about 40% w/w.
3.The combination according to claim 2 wherein the krill oil has a phospholipid content of at least about 50% w/w.
4.The combination according to claim 2 wherein the krill oil has a phospholipid content of at least about 60% w/w.
5.The combination according to any one of claims 1–4 wherein the krill oil has a water content of about 5% w/w or less.
6.The combination according to claim 5 wherein the krill oil has a water content of about 3% w/w or less.
7.The combination according to claim 5 wherein the krill oil has a water content of about 1% w/w or less.
8.the combination according to any one of claims 1–7 wherein the krill oil has an extraction solvent content of about 5% w/w or less.
9.The combination according to claim 8 wherein the krill oil has an extraction solvent content of about 3% w/w or less.
10.The combination according to claim 8 wherein the krill oil has an extraction solvent content of about 1% w/w or less.
11.The combination according to any one of claims 1 – 10 wherein the krill oil is prepared from Euphausia superba (Antarctic krill), Euphausia pacific (Pacific krill), Maganycitiphanes norvegica (Northern krill), Euphausia crystallorophias (ice krill), Euphausia frigida, Euphausia Longirostris, Euphausia triacantha or Euphausia vallentini.
…
[62]The Commissioner held the claim was unclear because of three matters.34
Krill species
[63] Paragraph 11 defines the species of krill. Earlier paragraphs, however, contain no reference to species. The Commissioner considered this problematical for the reason identified by Pharmazen:
106.The … objection is that the krill oil encompasses a very broad range of oils the compositions of which will vary substantially depending
34 And because of the way the claim dealt with combinations, as against compositions, of ingredients. This aspect received little attention on appeal, and it is not necessary to explore it, particularly as the ground of appeal ultimately concerns amendment.
on the krill species from which it is extracted, and the techniques used to extract the oil, and the Applicant has not shown that the invention is workable with any sort of krill oil. I agree, it seems to me that the term krill oil is so general as to cover krill oils that simply would not achieve the requisite therapeutic effects in combination with [green- lipped mussel] oil.
[64] The Commissioner considered similar problems arose in relation to the phospholipid content of krill oil as described in the specification.
Mussel species
[65] The specification identifies the mussel species as the New Zealand green-lipped mussel. Readers will note paragraph 1 of the claim says nothing about mussel species. Many of the other paragraphs in the claim build on paragraph 1. The Commissioner said:35
104. I agree with the Applicant that the specification discloses using lipids extracted solely from the New Zealand green lipped mussels and not from other species of mussels. However, it is common practice that claims are framed using broader terms than used in the description of the invention, so the Opponent and the Opponent’s experts are not necessarily incorrect. At the hearing the applicant agreed that as a condition for grant if this opposition were to be dismissed any reference in the claims to “mussel lipid extract” is to be replaced by “New Zealand green-lipped mussel (Perna canaliculus) lipid extract”. That concession reinforces my impression that the present claims are “framed with avoidable ambiguity” so are not clear. In the claims the general term “mussel” is used when in fact, on the Applicant’s own admission, the mussel species is restricted to the New Zealand [green-lipped mussel] Perna canaliculus) only. A deceptive claim does not “clearly define the protected field so others may fairly know where they cannot go”, so does not comply with the clarity requirement under s 39(2)(b). A closely related alternative objection is legitimate. This objection is that there is no disclosure of using mussel oil extracted from any species of mussel other than Perna canaliculus so the claims requiring mussel lipid extract or mussel oil without limitation to the particular species of mussel from which the oil is extracted are not supported so do not comply with the support requirement under s 39(2)(c). The expert witnesses Barrow, Davis, and Virtue each observe independently that the claims are not supported or are “too broad” for this reason. Drs Nichols and Wolber both discuss around but do not refute this particular objection.
35 Footnote omitted.
The definition of “about”
[66] The specification qualifies the range of identified ratios with the word “about”. Paragraph 54 says:
[0054] As used herein, “about” refers to a quantity, value or parameter that may vary by as much as 10%, 5%, or 2-1% of the stated quantity, value or parameter, and includes at least tolerances accepted within the art. When used in reference to a stated whole number value, “about” may include variation of one whole number either side of the stated value, for example “50%”, may include 49% and 51%. When prefacing a recited range of values, it is intended to apply to both upper and lower limits of the range.
[67]The Commissioner said:
93.The weight ratios of [green-lipped mussel] oil to krill oil are not whole number values so the second clause of the definition does not apply. Exactly how the first clause of the definition is to be applied to the ratios is not clear. Are the ratios converted to percentages then the variation applied? What size of variation is appropriate, 10% or 5% or only 1%? Is the variation plus or minus either side of the value or just a certain percentage centered on the value? In the context of the claims would any variation of the ratios at the periphery of the range make any practical difference.
94.The ambiguities arising from the qualification of the end ratios of the range of weight ratios with the adjective “about” are entirely avoidable. Consequently, the claims are unclear.
[68] Mr Arthur initially argued the Commissioner erred to conclude these aspects meant the claim was unclear. He noted Drs Nichols and Wolber, Pharmalink’s independent experts, were not confused by the matters identified by the Commissioner. Mr Arthur emphasised the claim is addressed not to a lay person, but a person skilled in the art. So, it is through expert eyes that a claim must be understood. Doing so, he said, addressed all perceived difficulties. Mr Arthur said in any event, it was open to me to amend the claim, if I concluded it would otherwise be unclear.
[69] Ms Glover argued the Commissioner was correct to conclude the claim was unclear. But she emphasised a process point: it was not open to Mr Arthur to rely on conditional amendment if his primary argument failed. Ms Glover said the Commissioner does not permit such an approach at first instance, and there is no
reason for it to be permissible on appeal.36 Otherwise, respondents have no certainty as to what an applicant is claiming, contrary to the imperatives of precision and predictability necessarily emphasised by this area of law. Ms Glover said Mr Arthur should elect between arguing error or applying for amendment; pursuing both as alternative outcomes constituted impermissible “back-pocket” amendment.
[70] In reply, Mr Arthur acknowledged the force of Ms Glover’s process point, disavowed “back-pocket” amendment, and said it was Pharmalink’s case the perceived difficulties could and should be cured by amendment. Mr Arthur said Pharmalink, therefore, applied to:37
(a)Employ the definitions at paragraph 11 throughout, so “krill oil” referred to oil extracted from the species identified in paragraph 11.
(b)Replace references to “mussel lipid extract” with “New Zealand green-lipped mussel (Perna Canaliculus) lipid extract”.
(c)Delete the term “about”.
Mr Arthur said these amendments were consistent with the true nature of the claim and Pharmazen would not be prejudiced by amendment.
[71] This admittedly laboured introduction reveals the issue: is amendment of a claim available on appeal when amendment was not sought below?
[72] Mr Arthur says it is, relying on r 20.19(1)(a) of the High Court Rules 2016.38 This rule affords the Court power to make “any decision it thinks should have been made”. Rule 20.19(5) extends the power to “any interlocutory or similar decision” even when the decision has not been appealed. But r 20.19(1)(a) lies in a part of HCR “subject to any express provision in the enactment under which the appeal is brought”.39 Rule 20.19(1)(a) is also subject to r 22.26 of HCR, which recognises
36 Resmed Ltd v Fisher & Paykel Healthcare Ltd [2016] NZIPOPAT 21.
37 Pharmalink was also willing to introduce the word “synergistic” into the claims, if the Court were to conclude that the claim does go beyond its proper scope.
38 HCR.
39 HCR, r 20.1(3).
r 20.19(1)(a) may be modified by the Patents Act 2013 (the Act), or displaced when inconsistent with it.
[73] The Commissioner contends appellate amendment is not possible; absent objection, he offered a (succinct) written submission on the topic. Ms Glover supported that submission, which, essentially, is that an amendment power in these circumstances is inconsistent with the Act. And so, to it.
[74] Section 5(1) of the Act defines “claim” to mean “a claim of the complete specification”. Section 40 permits amendment of a complete specification before it has been accepted by the Commissioner. Once accepted, s 83 contains “general rules” in relation to amendment. Amendment is not allowable if it “would claim or describe matter that was not in substance disclosed” before the amendment,40 or if amendment “would not fall wholly within the scope” of the pre-existing claim.41 But these rules do not prevent amendment “for the purpose of correcting an obvious mistake”.42
[75] Section 85 permits the Commissioner to amend a complete specification on a request by a patentee or applicant for a patent “at any time after the acceptance of the complete specification”,43 unless any “relevant proceeding” is pending.44 A “relevant proceeding” is defined as a court proceeding in relation to a patent “(a) for infringement of the patent; or (b) for the revocation of the patent; or
(c) in which the validity of the patent, or of a claim, is in dispute.”45
[76] Section 88(a) expressly ousts s 85 “in a proceeding in opposition to the grant of a patent”. I, therefore, accept Mr Britton’s submission on behalf of the Commissioner that Pharmalink could not have relied upon s 85 to amend its application when it was before the Commissioner. Rather, any such application would have been governed by guidelines issued by the Commissioner.46
40 The Act, s 83(1)(a)
41 Section 83(1)(b).
42 Section 83(2).
43 Section 85(1).
44 Section 85(2).
45 Section 5(1).
46 New Zealand Intellectual Property Office “Amendments during the course of a patent proceeding” office/amendments-during-the-course-of-a-patent-proceeding/.
[77] The guidelines provide that parties may request to amend their complete specification, pleadings or other hearing documents at any time prior to the hearing. Further, on receiving a request for amendment the Commissioner will:
(a)Halt the proceeding.
(b)Give the other party 10 working days to make submissions on the proposed amendment.
(c)Pass the request for amendment, supporting documents and any submissions from the other party to the patent examination team who will consider whether the amendments comply with the requirements for amendment after acceptance.
(d)Report on the allowability of the proposed amendment.
[78]Next is s 89, which reads:
89 Amendment of specification with leave of court
(1)In any relevant proceeding in relation to a patent, the court may, by order, allow the patentee to amend the patentee’s complete specification in the manner and subject to the terms as to costs, publication, or otherwise that the court thinks fit.
(2)If, in any proceeding for the revocation of a patent, the court decides that the patent is invalid, the court may allow the specification to be amended under this section instead of revoking the patent.
(3)If an application for an order under this section is made to the court,—
(a) the applicant for that order must give notice of the application to the Commissioner; and
(b) the Commissioner may appear and be heard on the application; and
(c) the Commissioner must appear if he or she is directed by the court to appear.
(4)This section is subject to section 83 (which contains general rules about amendments of specifications).
[79] Mr Britton said s 89 is confined to any “relevant proceeding” as defined above, and this proceeding does not engage the definition. I agree. Section 89 is directed at situations in which a patent has already been granted. That is why it refers to the “patentee”, which s 5(1) defines as “the person entered in the patents register as the grantee or owner of a patent at the relevant time”. This conclusion is supported by the authors of James & Well Intellectual Property Law in New Zealand:47
Under s 89 of the Act, amendments with leave of the court only arise in an action for infringement or revocation of patent before the court and must be on notice to the Commissioner (so that the Commissioner has the option to appear and be heard in respect of the amendment application).
[80] Sections 50, 66, 98(2), and 202 address amendments in other distinct scenarios. For example, s 98(2) provides the Commissioner may not refuse a patent in the context of re-examination under s 94, without first giving the applicant an opportunity to amend the application.
[81] The Act contains no express power of amendment on appeal. Given its scheme, this appears deliberate. Consequently, I am unable to accept Mr Arthur’s submission r 20.19(1)(a) permits the proposed amendments.
[82] This conclusion is consistent with the nature of an appeal, which is directed at the correctness of what happened below.48 It does not compromise the ability of an appellant to challenge the correctness of a decision by the Commissioner declining an amendment.49 But that is not what happened. At most, Pharmalink told the Commissioner if a patent were granted, it should be confined to the New Zealand species of green-lipped mussel. Pharmalink did not, however, lodge an amendment application in relation to the amendments now sought, hence the procedure anticipated by the Commissioner’s guidelines was not employed for the proposed amendments.
47 Ian Finch (ed) James & Wells Intellectual Property Law in New Zealand (3rd ed, Thomson Reuters, Wellington, 2017) at [2.9.3].
48 Telecom Corporation of New Zealand v Commerce Commission [1991] 2 NZLR 557 (CA) affords an example of the principle, albeit in a specific context.
49 In the context of an appeal of a decision declining a patent.
[83] For completeness, I discern no error in the Commissioner’s conclusion the claim was unclear given the principles articulated by the Supreme Court in Lucas v Peterson Portable Sawing Systems Ltd.50
Is the invention novel?
[84] A patentable invention must be novel.51 It is not if it forms part of the prior art base.52 Again, the prior art base comprises pre-existing knowledge.
[85] An often-cited test in this context comes from General Tire & Rubber Co v The Firestone Tyre & Rubber Co Ltd, a decision of the English Court of Appeal forming part of global litigation in relation to oil-extended rubber used in tyres. For that Court, Sachs LJ said:53
If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent, the patentee’s claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated … if carrying out the directions contained in the prior inventor’s publication will inevitably result in something being made or done which, if the patentee’s patent were valid, would constitute an infringement of the patentee’s claim, this circumstance demonstrates that the patentee’s claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated … To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented … A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.
[86] Pharmazen argued six items of prior art vitiated novelty in relation to some of Pharmalink’s claims. The Commissioner dismissed the objection in relation to five items but upheld it relation to one: “D15”. He, therefore, concluded claims 1, 2, 13, 15, 26, and 48–54 were not novel.
50 Lucas v Peterson Portable Sawing Systems Ltd [2006] NZSC 20, [2006] 3 NZLR 721 at [28].
51 The Act, s 14(b)(i).
52 Section 6.
53 General Tire & Rubber Co v The Firestone Tyre and Rubber Co Ltd [1972] RPC 457 (CA) at 485-486.
[87] Pharmalink accepted D15 formed part of the prior art base. It now wishes to argue otherwise. This strikes me as problematical, given this is an appeal. For now, I assume D15 comprises part of the prior art base and continue the narrative.
[88] D15 is a US-originated patent application primarily about krill and krill oil. D15 extends to a related invention: a nutritional supplement comprising green-lipped mussel oil and krill oil, the two ingredients in Pharmalink’s claim. D15 is silent, however, on the ratio of mussel oil to krill oil.
[89] Pharmazen argued a person skilled in the art following D15 would make the invention claimed by Pharmalink because its claim encompassed a broad spectrum of green-lipped mussel lipid extract and krill oil: any ratio between 5:95 to 99:1. This, it was said, occupied the field, particularly as Professor Barrow considered a person skilled in the art, applying D15, would look to use similar amounts of each ingredient rather than mixing at the margins.
[90] Pharmalink argued D15 did not vitiate novelty, as a person (skilled in the art) applying D15 could produce a combination of green-lipped mussel lipid extract and krill oil at, for example, a ratio of 4:96. Pharmalink noted the test was inevitability, not probability. It said its argument was not strained, as similar products do exist with a large amount of one ingredient and a small amount of another at or about the ratio offered as an example.
[91] The Commissioner upheld the objection, essentially for the reasons identified by Pharmazen, and one other. The Commissioner held as Pharmalink’s application was unsupported across its breadth, novelty should be assessed without reference to the qualifying ratios in the claim. Ms Glover said this aspect of the Commissioner’s reasoning was without precedent, but superfluous, as novelty was vitiated on an orthodox basis.
[92] In General Tire, Sachs LJ said the prior art must “inevitably result in something being made or done which … would constitute an infringement of the patentee’s
claim.”54 The language of inevitability appears in other leading decisions too, including those of the House of Lords.55 Novelty then is vitiated if, and only if, the skilled person following the prior art would inevitably make something within the patent claimed. An objection based on novelty must, of course, be established as more likely than not.56 But that standard of proof does not qualify or colour what must be proved: the objector must establish inevitability of performance within the patent claimed. Transposed to the facts, Pharmazen had to establish the skilled person, following D15, would make a composition within the claim. Or to repeat the convenient tautology offered earlier: would inevitably make something within the claim.
[93] I respectfully disagree with the Commissioner on this issue. A skilled person might make, following D15, a composition of green-lipped mussel oil and krill oil other than with the ratios identified in the claim. Inevitable means that.
[94] This conclusion is not strained for the reason identified by Pharmalink earlier; similar products exist with a large amount of one ingredient and a small amount of another. Moreover, that Pharmalink cannot support its claim across its breadth is irrelevant to this issue; that comprises an unrelated objection, albeit one properly upheld by the Commissioner.
[95] As this ground of appeal succeeds, it is not necessary to address whether Pharmalink may revisit D15’s inclusion as prior art.
It is obvious to combine the ingredients in the claimed ratios?
[96] The final ground of appeal entails a return to the inventive step. The Commissioner upheld Pharmazen’s objection there was no inventive step even if synergy were exhibited, as it was obvious to combine the ingredients in the ratios claimed for a reason or reasons other than synergy. Pharmalink challenges this conclusion too.
54 General Tire & Rubber Co v The Firestone Tyre and Rubber Co Ltd, above n 53, at 486 (emphasis added).
55 Merrell Dow Pharmaceuticals Inc v Penn Pharmaceuticals Ltd [1996] RPC 76 (HL); and
Synthon BV v SmithKline Beecham plc [2005] UKHL 59, [2006] 1 All ER 685.
56 Synthon BV v SmithKline Beecham plc, above n 55, at [23].
[97]The legal framework is uncontroversial. One must identify:57
(a)The notional person skilled in the art.
(b)The common general knowledge possessed by the skilled person.
(c)The inventive concept.
(d)Differences, if any, between the “state of the art” and the inventive concept.
(e)Whether those differences, absent knowledge of the inventive concept, constitute steps which would be obvious to the skilled person (or do they require invention?).
[98] Following these steps produces this question: is the combination of green-lipped mussel lipid extract and krill oil in the claimed ratios an obvious step to take for the skilled person? Readers will note the question does not refer to synergy, even though all experts say synergy was surprising, hence not obvious. This is because “[i]f it is an obvious step for one purpose it is not inventive to do the same thing for another”.58 Thus, if it was obvious to the skilled person to combine green-lipped mussel lipid extract and krill oil in the claimed ratios for a purpose other than synergy, that synergy occurred is a “golden bonus” but irrelevant.59
[99] The Commissioner considered a skilled person might blend marine oils to produce a composition with a well-defined and controlled lipid profile or set of compounds. Another reason might be to obtain the best effect for least cost. A combination product might also have a marketing advantage.
[100] Mr Arthur contends this approach offends the rule against hindsight; the assessment of obviousness must not inject thinking based on subsequent developments
57 Pozzoli Spa v BDMO SA [2007] EWCA Civ 588, [2007] FSR 37 at [23], citing Windsurfing International Inc v Tabur Marine [1985] RPC 59 (CA) at 73–74.
58 Lucas v Peterson Portable Sawing Systems Ltd, above n 50, at [62].
59 Hallen Co v Brabantia (UK) Ltd [1991] RPC 195 (CA) at 216.
or ideas. Mr Arthur also contends the approach goes beyond the evidence, as no witness had offered these justifications, or any like them. Mr Arthur says no one had combined the products in the claimed ratios because no one had thought to do so. Combining them (in the claimed ratios) was not obvious to the skilled person. Mr Arthur says the appearance of numerous “copycat” products shortly after Pharmalink launched its combination product affirms this analysis.
[101] Mr Arthur’s copycat submission concerns the appearance, within two months of the publication of the patent (on 27 June 2019), of eight products containing green-lipped mussel and krill oils within the claimed ratios. Ms Glover says the short timeframe implies the alleged copycats must have already been under development, in turn supporting obviousness.
[102]I make four points.
[103] First, the copycat evidence is overall, equivocal, as there is no evidence as to how long it takes to typically prepare, make, or market products of this nature on a commercial scale.60 Some or all products may be copies — or not.
[104] Second, while the question of obviousness ultimately requires a determination that may not be crystallised in the evidence (given the nature of the inquiry), the Commissioner’s reasoning presents as somewhat speculative. But because of what follows, it is not necessary to resolve Mr Arthur’s criticisms of that reasoning.
[105] Third, the balance of the expert evidence provides support for the proposition that combining the products in the claimed ratios might have an additive effect, albeit the experts were not commenting upon obviousness. Dr Nichols was the most guarded; he says he would expect an additive effect “at best”. Dr Davis says he “might suspect … at least additive effects”. Professor Barrow says he would expect an additive effect, not a synergistic one. These observations fold into the next point.
60 Nathan McLean, a director of Pharmalink, gave compressed evidence about the timeline in connection with this product, but not more general evidence.
[106] Fourth, because each product had such well-known anti-inflammatory properties, combining the two in the claimed ratios was, I conclude, an obvious step to maximise their therapeutic effect, irrespective of synergy. Ms Glover captures the point well:61
Krill oil and mussel lipid extract are individually known to be safe and efficacious in treating inflammation and pain and improving joint mobility. It is submitted that this knowledge, in combination with the other common general knowledge, would give the person skilled in the art a strong motive to combine them, and to use the combination or composition to treat inflammation and pain and to improve joint mobility.
...
The data shows that [green-lipped mussel] and krill both have anti- inflammatory effects and different therapeutic strengths/advantages. The natural and obvious thing to do is to use both [green-lipped mussel] and krill oil to attain maximum therapeutic effect There is no reason to depart
from the usual dosage regime (or to reduce the dosage of each oil proportionately).
[107] Contrary to Mr Arthur’s submission, this reasoning does not involve or promote hindsight. Rather, it recognises the obviousness inherent to putting the two products together in usual dosage ratios, and hence those claimed, for the reason identified. It follows the application fails the inventive step hurdle even though synergy was not obvious.
Summary of conclusions
[108] Synergy is exhibited by examples 2 and 3 to the relatively modest standard of plausibility. But the specification does not disclose the patent sufficiently or support the breadth of the application. The claims were — and remain — unclear, given amendment is not permissible on appeal. The alleged invention is novel. However, it contains no inventive step even though synergy is not obvious. This is because it is obvious, irrespective of synergy, to combine green-lipped mussel lipid extract and krill oil in the ratios claimed to maximise therapeutic effect.
61 Ms Glover also cited the copycat products in support of her submission; so too the Commissioner’s reasoning. As will be evident, I do not place weight on either.
Result
[109]The appeal is, therefore, dismissed.
Costs
[110] Some grounds of appeal succeeded, but Pharmazen remains the successful party. I am inclined to award Pharmazen costs for just that reason. If the parties disagree or cannot otherwise agree costs, they should file memoranda of not more than five pages each, in this sequence:
(a)Pharmalink on or before 17 October 2025.
(b)Pharmazen on or before 31 October 2025.
[111]I thank counsel for their excellent submissions.
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Downs J
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