Merial Limited v Intervet International B.V
[2015] APO 38
•10 July 2015
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial Limited v Intervet International B.V. [2015] APO 38
Patent Application: 2009203180
Title:Compositions and process for delivering an additive
Patent Applicant: Intervet International B.V.
Opponent: Merial Limited
Delegate: Dr M-A. Fam
Decision Date: 10 July 2015
Hearing Date: 17 June 2015, in Canberra
Catchwords: PATENTS – section 59 – opposition to the grant of a patent – grounds of novelty, inventive step and manner of manufacture considered – whether a particular substance acts as an emulsifying agent and a forming agent – emulsifying and forming properties are inherent – not all emulsifying agents act as forming agents – lack of novelty not established – lack of inventive step not established – claims define a manner of manufacture – opposition fails
Representation: Patent applicant: David Myers of Spruson & Ferguson
Opponent:Marcus Caulfield and Jess Smith of FB Rice
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2009203180
Title:Compositions and process for delivering an additive
Patent Applicant: Intervet International B.V.
Date of Decision: 10 July 2015
DECISION
The opposition fails on all grounds. Subject to appeal, I direct the application proceed to grant. Costs according to Schedule 8 are awarded against Merial Limited.
REASONS FOR DECISION
Background
The present application was filed by Intervet International B.V. (Intervet) on 31 July 2009 and claimed divisional status from 2003262643. The application was examined and advertised accepted on 28 July 2011. Intervet subsequently filed section 104 amendments on 19 July 2013 and the amendments advertised allowed on 23 January 2014.
A notice of opposition was served by Merial Limited (Merial) on 28 October 2011. A hearing was held in Canberra on 17 June 2015. Intervet was represented by David Myers of Spruson & Ferguson. Merial was represented by Marcus Caulfield and Jess Smith of FB Rice.
It is noted that the request for examination in relation to the application was filed on 10 December 2009. Consequently, substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. It is further noted that any subsequent references to sections of the Patents Act relate to the Patents Act 1990 prior to amendment by the Raising the Bar Act.
Grounds of opposition
The original statement of grounds and particulars was filed on 27 January 2012. A request to amend the statement was filed on 29 October 2012 and subsequently allowed.
The statement of grounds and particulars specifies the following grounds of opposition:
- novelty
- inventive step
- manner of manufacture
- section 40 issues of clarity, fair basis and full description
- utility.
At the hearing the opposition was limited to the grounds of novelty, inventive step and manner of manufacture.
Standard of proof
The onus of proof in this opposition proceeding rests with the opponent, who must demonstrate that it is clear that a valid patent cannot be granted (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [67]; 50 IPR 305; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18]; 79 IPR 426).
Evidence
The evidence filed is summarised in the table below.
Evidence Declarant Exhibits Date Reference In Support Robert Simon Marov RSM-1 to RSM-8 18 October 2012 Marov-1 In Answer Louise A. Richardson
LAR-1 to LAR-4 6 June 2014 Richardson In Reply Robert Simon Marov
RSM-9 to RSM-10 5 September 2014 Marov-2 Further John Simon Landells
D1 to D5, D7 to D10, D12, D15, D24 and D26 to D28 9 January 2015 Landells The subject matter of the specification
Background of the invention
The specification relates to chewable dosage forms for drug delivery. The process of chewing is known to increase the surface area of the available active ingredient and may increase the rate of absorption by the digestive tract. Chewable dosage forms provide easier drug administration in paediatric and geriatric patients and are also advantageous for making an active ingredient available topically to the mouth or throat for local effects and/or systemic absorption (page 1, lines 9 – 15).
Many active ingredients have a bitter or unpalatable taste, or an unpleasant mouth feel, due to their chalkiness and/or grittiness. Such properties make it difficult to incorporate active ingredients into chewable dosage forms, as the objectionable taste and/or mouth feel make it less likely to obtain compliance by the user (page 1, line 18 to page 2, line 2).
Various approaches have been tried in an attempt to address these problems, including the use of flavourings and sweeteners to mask the taste of the active ingredient. Alternatively, the active ingredient may be encapsulated to mask bitterness. These approaches do not affect the physical structure of the dosage form. Examples of dosage forms include compressed, compacted tablets (page 2, lines 3 ‑ 11).
Such tablets are made by feeding a mixture of ingredients into a die chamber of a tablet press and the tablet then produced by direct compaction. The hardness of the tablet is a direct function of the pressure employed during compaction, with softer tablets formed with reduced pressure. Alternatively, softer tablets may be prepared by including a disintegrant in the mixture (page 2, lines 12 – 18).
The specification indicates that compressed, chewable tablets generally have a less than desirable mouth feel, i.e. chalkiness and grittiness, and a dry, powdery taste. These undesirable properties may be masked by the addition of oils or fats, however the inclusion of these components in the pre-tablet mix can result in adherence of the tablet ingredients to the die chamber and a reduction in the action of any binders present in the mix (page 3, lines 1 – 8).
Aim of the invention
The specification states (page 3, lines 9 – 10):
“Accordingly, the art field is in search of a process of manufacturing a soft chew whereby compression and subsequent product loss may be minimized or lessened.”
The specification further indicates (page 3, line 22 to page 4, line 3) that:
“… the art field has experienced problems with delivering additives/active ingredients to organisms because of palatability issues. Complex guidelines exist along the regulatory framework that make it very difficult to make and/or manufacture a palatable composition with an additive. Accordingly, the art field is in search of a method and/or composition of delivering an additive to an organism in a palatable format.”
Although the prior art provides “a part solution” in the form of a matrix for carrying an active ingredient, this product is limited to an extrudate and not available in a tablet form (page 4, lines 4 – 16).
Nature of the invention
The specification indicates that it is possible to provide a soft chew formulation for the administration of a pharmaceutical for the control of a parasite of various animals, including horses, dogs, cats and bovines. In particular the formulation, in addition to the active ingredient, contains a flavouring component, a starch component, a sugar component, an oil component and an emulsifying agent that acts as a forming agent. The moisture content of the formulation is between 5.0 and 7.5% weight. An example of an emulsifying agent that is a forming agent is polyethylene glycol (PEG) (page 16, lines 20 – 22).
The formulation is formed by “knockout” and is not an extrudate (page 5, lines 7 – 8). In one embodiment, the soft chew is made by mixing the components to produce a dough which is then heated and formed into a soft chew by means of a knockout (page 17, line 21 to page 18, line 17 and Figure 3).
The examples
The examples describe soft chew formulations for horses or dogs containing active ingredients such as ivermectin, fenbendazole and praziquantel (Examples 1b and 2). The formulations contain 9% PEG and 13% glycerin (an emulsifier, page 13, lines 8 – 10), however no water is added. Further studies indicate that the formulations are palatable to animals.
The claims of the specification
The claims as amended consist of independent claim 1 and dependent claims 2 – 17. Claim 1 is as follows:
“1. A soft chew formulation for oral administration comprising a pharmaceutical for control of a parasite of Equidae, Canidae, Felidae, Bovidae, Ovidae, Capridae, or Suidae organisms in a soft chew formulation, a flavouring component, a starch component, a sugar component, an oil component and an emulsifying agent that acts as a forming agent, wherein the moisture content of the composition is between 5.0 and 7.5 percent wt, the soft chew formulation is formed by knockout and the soft chew formulation is not an extrudate.”
Dependent claims 2 – 12 and 15 define additional features of the formulation, dependent claims 13 and 14 define a process for making the formulation and dependent claims 16 and 17 define the use of the formulation for the control of parasites.
Claims construction
The approach to claims construction was considered by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 at [118]-[120]; 81 IPR 228:
“… the end point is that 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 … However, terms in the claim which are unclear may be defined or clarified by reference to the body of the specification …”
Claim 1
“Emulsifying agent that acts as a forming agent”
The specification indicates that the emulsifier component may act as a forming agent and that the forming agent of choice is polyethylene glycol (PEG) (page 16, lines 19 – 25). Ms Richardson stated that while she was not familiar with the specific term “forming agent”, she viewed this as an alternative term for a binding agent, i.e. an agent used to hold the components of the soft chew together (Richardson at [37]). Mr Marov agreed with this interpretation (Marov-2 at [40]).
The emulsifying agent is therefore considered to be a substance that functions as both an emulsifier and a binding agent.
Typical emulsifier contents in a soft chew are relatively low, in the order of 0 to 1% (Richardson at [69]) or 0.5 to 3% (Marov-2 at [42]). In contrast, the medicated soft chew formulations exemplified in the specification contain PEG in an amount of 9% (Examples 1b and 2). The use of such high quantities suggests that the emulsifier is acting as a forming (binding) agent, in addition to its usual function of stabilising an emulsion (Richardson at [42], [44], [69] and [77]; Marov-2 at [42] and [86]).
During the hearing there was some discussion on whether a particular substance functions as an emulsifier, forming agent or both. Merial submitted that the emulsifying and forming properties are inherent, regardless of whether a substance is labelled as an emulsifier or forming agent. Thus, for example, whilst gelatine may be known for its forming (binding) properties, it functions as both a forming agent and an emulsifier (Marov-2 at [42]; Exhibit RSM-9 at E441; Exhibit RSM-10 at 428). Merial also acknowledged that not all emulsifying agents will act as forming agents (Marov-2 at [50] and [86]).
Intervet agreed that not all emulsifying agents will function as forming agents. With respect to gelatine, Intervet submitted that it was not generally used as an emulsifier, but rather as a gelling, binding and bulking agent (Richardson at [27] and [38]).
I agree with Merial that the emulsifying and forming properties are inherent features of a substance. The key issues are therefore:
i)whether a given substance can function as both an emulsifier and a forming agent (noting that not all emulsifiers are forming agents) and, if so;
ii)whether that substance is used in sufficient quantities to enable it to function as a forming agent;
regardless of whether the substance is labelled as an “emulsifier”, “forming agent”, “binding agent” or otherwise.
Whether a particular substance acts as an emulsifier and/or a forming agent is a key factor when considering the issues of novelty and inventive step and is discussed where appropriate in further detail below.
“Soft chew formulation is formed by knockout and soft chew formulation is not an extrudate”
Merial submitted that “knockout” is not a process or technology per se for preparing a formulation, but rather a term used to describe the step of a forming process which removes the soft chew from the die or mould of the forming machine (Marov-1 at [121]). Intervet agreed that “knockout” involves pushing a product out of a die (Richardson at [49]).
“Extrudate” means something that has been forced under pressure through an opening (Marov-1 at [123]). Mr Marov further indicated that all forming processes involve some kind of extrudate, i.e. the mixture is moved under pressure through or into some kind of die to form the product. Thus, whether the extrudate is formed on an extruder or as part of a forming process involving a knockout, the product can still be considered to have been extruded at some stage during the manufacturing process (Marov-1 at [123] – [127] and [154]).
Intervet stated that the process of extrusion involves different pressures and temperatures compared with those involved in a knockout process (Richardson at [75] and [79]) and this was acknowledged by Mr Marov (Marov-1 at [125]).
The specification indicates that a knockout is used to form the soft chew of the invention (page 18, lines 6 – 15). Figure 3 illustrates the final “soft chew 40” as a formed product and this is clearly not an extrudate.
I also note that when reviewing the prior art, Mr Marov did not consider a knockout process to be one that involves extrusion (Marov-1 at [175], [181], [195] – [196], [202], [220], [238] and [270]).
Claim 1 is therefore considered to define a soft chew formulation wherein the soft chew is removed from the die or mould of the forming machine by “knockout” to yield a final formed product, and the final soft chew formulation is not in the form of an extrudate.
Novelty
Under subsection 7(1), an invention is taken to be novel unless it is not novel in the light of the prior art base. Information in a document forms part of the prior art base for the purposes of novelty if it was published before the priority date of a claim.
It is well established that the general test for anticipation is the reverse infringement test. The classic formulation of this test is that given by Aicken J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 at [20]; 137 CLR 228:
“The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement”.
This test is satisfied if the alleged anticipation discloses all the essential features of the invention claimed (Nicaro Holdings Pty Limited v Martin Engineering Company [1990] FCA 40 at [19]; 16 IPR 545). In order to meet this requirement, the prior art “must contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486).
Merial submitted that certain claims are not novel in view of US 6387381 (D7), US 5637313 (D12) and WO 99/48372 (D15). In determining whether the prior art documents disclose the claimed invention, emphasis will be given to the emulsifying agent that acts as a forming (binding) agent which, as indicated previously, is a key component of the formulation. The features of a pharmaceutical for control of a parasite, moisture content of between 5.0 and 7.5% weight and the formulation being formed by “knockout” will also be discussed where appropriate.
US 6387381 (D7)
Merial submitted that claims 1, 4 – 9, 13 and 15 – 17 lack novelty in view of D7.
D7 discloses a product matrix for delivering pharmaceuticals or nutraceuticals to a mammal, including ivermectin and fenbendazole (column 3, lines 33 – 42). Merial submitted that D7 describes the use of emulsifiers (column 3, line 43) and in particular glycerol (glycerin) (column 2, line 66 to column 3, line 5 and column 3, line 42). Merial stated that the present specification identifies this substance as an emulsifier (page 13, lines 8 – 10). Merial further submitted that glycerol acts as a forming (binding) agent (Exhibit RSM-9 at E422; Exhibit RSM‑10 at 422) and that the quantities of glycerol used in D7 (10 to 50% by weight) are comparable to those exemplified in the specification (13%).
Intervet submitted that the reference to glycerin at column 3, line 42 is in the context of using “minor amounts” of the substance and that such quantities would be insufficient for it to function as a forming agent. Intervet further stated that glycerin in this context is added as a water activity regulator and that this is its more typical use (Richardson at [26]; Marov-1 at [34]). It also submitted that no emulsifiers are mentioned in the examples in D7.
In considering the use of glycerol (glycerine), Mr Marov stated (Marov-2 at [44]):
“With reference to glycerine, I agree that the inclusion of more glycerine to the composition would lead to a stickier/wetter more liquid composition. This is because glycerine is a liquid and the addition of more liquid would generally cause the composition to be wetter and less firm. I would not expect glycerine to act as a binder in such a circumstance, and I note that the Applicant’s [sic] concede this point by stating: “affect the stickiness of the soft chew. The greater the concentration of glycerin, the stickier the soft chew.”
When asked at the hearing whether glycerol (glycerine) would act as a forming agent, Merial indicated that at higher concentrations the substance would still possess this function, however its binding properties would “be reduced”.
As discussed above, “minor amounts” of an emulsifier are insufficient to enable the component to also function as a forming agent. Regarding the use of glycerol (glycerine), the evidence does not demonstrate that this substance is a suitable forming agent at the concentrations envisaged in D7. Furthermore, none of the formulation examples in D7 contain a substance that acts as an emulsifier.
D7 does not provide clear and unmistakeable directions to use an emulsifying agent that acts as a forming agent and therefore cannot deprive the claims of novelty. Having determined this, it is not necessary to consider the remaining components of the formulation in further detail. Nevertheless, I will comment briefly on the moisture content and knockout aspects of the formulation.
D7 discloses that water is present in about 5 to about 20% by weight of the matrix, such that the moisture content of the final product is 5 to 15% (column 3, lines 17 – 26). This encompasses the moisture content defined in claim 1. However, all of the examples in D7 contain 10% water and 15% corn syrup, the latter component comprising approximately 20 – 25% water (Richardson at [87]). Thus, the final moisture content will be roughly 13%. I do not consider that D7 provides clear and unmistakeable directions to produce a formulation having a moisture content between 5 and 7.5% weight.
D7 indicates that a sigma mixer may be used in the formation of the matrix (column 3, lines 49 ‑ 51). Merial submitted that it would be inevitable that a forming machine would be used to produce the final soft chew, i.e. the soft chew would not be subject to extrusion (Marov-1 at [195] – [197]). However, Mr Marov acknowledges that the soft chew is not specifically described as being formed by a process that includes a knockout step (Marov-1 at [198]). Furthermore, I consider that the emphasis in D7 is on extrusion processes (column 1, lines 58 ‑ 60; column 3, lines 46 – 49; Example 1; claim 9). I am not satisfied that D7 contains clear and unmistakeable directions to produce a formulation by knockout.
Conclusion on D7
It has not been established that the claims lack novelty in view of D7.
US 5637313 (D12)
Merial submitted that claims 1, 2, 4, 13 and 15 are not novel in light of D12.
D12 describes soft chew dosage forms containing an active ingredient. Merial submitted that the use of emulsifiers is disclosed and in particular the use of glycerin (column 3, lines 36 – 37; column 4, lines 59 – 60; column 6, line 27; Tables 1 and 2). However, I note that only minor amounts of emulsifiers are used and, as discussed previously, such amounts are insufficient for the emulsifier to also function as a forming agent. Similarly, glycerin is not a suitable forming agent for reasons discussed above.
Merial further stated that D12 discloses the inclusion of water soluble bulking agents, including thickeners and binders, such as gum arabic, carrageenan and polyethylene oxide polymers (i.e. PEG) (column 3, line 65 to column 4, line 7). The latter substance is described in the specification as an emulsifying agent that functions as a forming agent (Marov-2 at [102]), whilst gum arabic and carrageenan are both emulsifiers that function as forming (binding) agents (Exhibit RSM-9 at E407 and E414; Exhibit RSM-10 at 407 and 414). Merial stated that Ms Richardson also describes using carrageenan and other vegetable gums as a binder (Richardson at [27] and [38]).
Merial further submitted that D12 describes the use of dicalcium phosphate and powdered cellulose (column 4, lines 16 – 18). These substances are water insoluble bulking agents that add body and structure to the product (column 4, lines 12 – 13) and therefore function as forming agents (Marov-2 at [103] – [104]). Merial stated that since dicalcium phosphate and powdered cellulose are also emulsifiers (Exhibit RSM-9 at E450 and E460; Exhibit RSM-10 at 450 and 460), these substances meet the requirements of claim 1.
Intervet submitted that whilst polyethylene oxide polymers are mentioned in D12, they are referred to amongst a wide range of other water soluble bulking agents (not as emulsifiers or forming agents). It was further stated that D12 only refers to the water insoluble bulking agents providing body and structure, and that dicalcium phosphate and cellulose are very poor emulsifying agents. In addition, D12 only exemplifies the use of cellulose at low concentrations (about 1%).
I note that the preparative examples in D12 contain only minor amounts of cellulose and/or gum arabic. As discussed previously, such small quantities are insufficient for the substance to function as a forming agent. Although PEG and carrageenan are listed in D12 as possible water soluble bulking agents, they are not preferred agents (column 4, lines 7 – 11) and are not exemplified. Similarly, the use of dicalcium phosphate is not exemplified. Consequently, D12 is not considered to provide clear and unmistakeable directions to use an emulsifying agent that acts as a forming agent.
Although it is not necessary to consider the remaining components of the formulation in further detail, I will comment briefly on the pharmaceutical for control of a parasite and the moisture content.
D12 indicates that the dosage forms may be used for either human or veterinary applications (column 5, lines 1 – 3). However, of the large number of possible active ingredients listed (column 5, lines 5 – 54), none are antiparasitic agents. D12 states that the dosage form “contains little moisture” (column 2, lines 53 – 56), however the exact moisture content is not specified. I do not consider that D12 provides clear and unmistakeable directions to incorporate a pharmaceutical for parasite control into a soft chew formulation, wherein the moisture content of the formulation is between 5 and 7.5% weight.
In relation to the “knockout” aspect of the formulation, Merial stated that D12 discloses mixing the components in a sigma mixer (column 3, lines 23 – 24) which does not involve extrusion. Reference was also made to Example 1 and claim 15, which defines forming the matrix into a dosage form. I note that Example 1 (and also Examples 2 – 11) refers to rolling the matrix into the desired thickness and then cutting the material into tablets. Whilst this does not involve extrusion, the use of a roller does not necessarily mean that the final product is removed from a die using a knockout (Richardson at [30] and [49]) and D12 does not clearly indicate the means used for cutting the material. The reference in claim 15 to “forming said matrix into said dosage form” is similarly unclear. D12 is not considered to provide clear and unmistakeable directions to form a formulation by “knockout”.
Conclusion on D12
It has not been demonstrated that the claims lack novelty in view of D12.
WO 99/48372 (D15)
Merial submitted that claims 1, 2, 4, 5, 8, 9, 11, 13, 15 and 16 are not novel in light of D15.
D15 relates to the encapsulation of active ingredients into edible products. Merial submitted that D15 describes the inclusion of substances such as PEG, carrageenan and gum arabic (page 13, lines 11 – 12) which, as discussed above, are emulsifiers that function as forming agents. It was further stated that D15 discloses the use of gelatine (page 15, line 5) and that this substance functions as both an emulsifier and a forming (binding) agent (Marov-2 at [42]; Exhibit RSM-9 at E441; Exhibit RSM-10 at 428). Merial also submitted that Ms Richardson indicated that she had used gelatine as a binding agent (Richardson at [27] and [38]; Marov-2 at [42]).
Intervet stated that D15 does not describe an emulsifier that also functions as a forming agent. In particular, emulsifiers such as mono- and diglycerides are mentioned only as optional minor components (page 7, lines 12 – 19) and these small levels are insufficient to act as a forming agent (Richardson at [102]). It was further submitted that PEG, carrageenan and gum arabic are described in D15 as examples of optional plasticiser components (page 13, lines 9 ‑ 12).
I agree that the emulsifier described in D15 is used in amounts that are insufficient for the substance to function as a forming agent. I also note that D15 does not provide any clear indication of the quantities of PEG, carrageenan, gum arabic or gelatine used in the products and that these substances are one of several optional ingredients. Mr Marov also indicates that low molecular weight PEGs are often used as plasticisers and he does not consider that these substances could act as forming agents, since they are liquid at room temperature (Marov-2 at [10], [52] and [88]). Furthermore, the use of PEG, carrageenan, gum arabic or gelatine is not exemplified. Consequently, D15 is not considered to provide clear and unmistakeable directions to prepare a formulation containing an emulsifying agent that acts as a forming agent.
Having established that D15 does not deprive the claims of novelty, I will not consider the remaining components of the formulation further, other than to note that the document does refer to the use of the parasite control agents albendazole, levamisole hydrochloride, praziquantel and pyrantel pamoate. However, these agents are only a few of the many possible active ingredients described (the full list extends to more than 7 pages) and it is doubtful whether such a disclosure amounts to clear and unmistakeable directions to incorporate an antiparasitic into the formulation.
Conclusion on D15
It has not been established that the claims lack novelty in view of D15.
Conclusion on novelty
It has not been demonstrated that the claims lack novelty.
Inventive step
Under subsections 7(2) and 7(3), an invention is taken to involve an inventive step unless it would have been obvious to the person skilled in the art in the light of the common general knowledge, either considered alone or together with the prior art. The prior art is information that the skilled person could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant.
The test for whether an invention is obvious is whether it would have been a matter of routine to proceed to the claim invention.
“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.” (Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12 at [45]; 148 CLR 262)
More recently, in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59 at [53]; 212 CLR 411, the High Court accepted the approach taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at [187] where Graham J posed the reformulated Cripp’s question:
“Would the notional research group at the relevant date, in all the circumstances, …. directly be led as a matter of course to try [the claimed combination] in the expectation that it might well produce a [useful or better result]?” (emphasis in original)
The problem
Merial submitted that the problem to be overcome is to provide a palatable soft chew that can deliver an active ingredient. Intervet stated that the problem to be overcome is to provide a more readily accepted soft chew containing a parasitic agent that will treat the animals listed in claim 1.
As discussed previously, the specification states that there have been problems in the prior art with delivering active ingredients to organisms due to palatability issues. In particular, “the art field is in search of a method and/or composition of delivering an additive to an organism in a palatable format” (page 3, line 22 to page 4, line 3).
The specification indicates that such an organism may be any organism, with livestock, pets and farm animals being preferred (page 9, lines 8 – 10). Additives may be pharmaceuticals, nutraceuticals, vitamins and minerals (pages 14 – 15). However, the emphasis in the specification is on providing an active ingredient for the control of parasites in livestock, pets or farm animals (page 9, lines 10 – 13; page 19, lines 13 – 16; Examples 1a, 1b and 2) and this is reflected in claim 1.
The problem to be overcome therefore relates to the provision of a palatable soft chew for delivering an active ingredient for the control of parasites in livestock, pets or farm animals.
Merial submitted that the claimed invention lacks an inventive step in light of the common general knowledge and also the prior art when considered in conjunction with the common general knowledge. I will firstly consider the common general knowledge and then the prior art.
Common general knowledge
Merial submitted that claims 1 – 11, 13 and 15 – 17 are not inventive based on the common general knowledge alone. Merial stated that all of the components of the formulation of claim 1 are common general knowledge, as is forming the soft chew formulation by “knockout”.
Merial submitted that the use of flavourings, starch, sugar and oil in soft chew formulations is common general knowledge (Marov-1 at [114] – [119]) and Intervet did not object to this. Therefore, in determining whether the components of the formulation of claim 1 form part of the common general knowledge, I will only consider the moisture content of between 5.0 and 7.5% weight, the emulsifying agent that acts as a forming agent and the pharmaceutical for control of a parasite.
Moisture content between 5.0 and 7.5% weight
In relation to the moisture content of between 5.0 and 7.5% weight, Mr Marov stated (Marov-1 at [120]):
“… I take this to mean that the composition cannot contain more than 7.5% water and that the lower limit of the water concentration is 5.0%. I believe that this is a very tight range, but depending on the other components, it would not be unreasonable. To deliver such a tight moisture content, steps would need to be taken to ensure that the process and the ingredients deliver such a tight range, but I do not consider preparing a product to such a specification as being anything unusual as most, if not all, commercially prepared soft chews would be produced to a reproducible composition.”
Ms Richardson stated (Richardson at [36]):
“… the moisture content (between 5.0 and 7.5 wt%) is very low in my experience. In fact, according to the examples, no water appears to be added to the formulations at all. Presumably, therefore, all moisture is imported into the formulation via moisture inherent in the formulation components. In my experience, the moisture contents of soft chews is typically significantly higher, of the order of 15 to 30%. The medicated chew formulation I had developed had a moisture content of the order of 20%, and I understand that HeartGard® had a moisture content of the order of 37 wt%.”
Ms Richardson also indicated that typical moisture contents for soft chews are from about 10% to about 30% (Richardson at [69]). Mr Marov stated that a soft chew would typically have a moisture content of 10% to 20% (Marov-2 at [39]).
The evidence does not demonstrate that it is common general knowledge to formulate a soft chew such that the moisture content is between 5.0 and 7.5% weight. Therefore, it would not have been a matter of routine for the skilled addressee, faced with problem of producing a soft chew for delivering an active ingredient for parasite control in livestock, pets or farm animals, to produce a formulation with a moisture content of between 5.0 and 7.5% weight. Consequently, it has not been established that the claims lack an inventive step based on the common general knowledge alone.
Given the finding above, it is not necessary to consider whether an emulsifying agent that acts as a forming agent and a pharmaceutical for control of a parasite are part of the common general knowledge. However, I will nevertheless provide comment on these issues, as they are important considerations in the discussion that follows.
Emulsifying agent that acts as a forming agent
As discussed above under novelty, polyethylene glycol (PEG) (other than low molecular weight PEGs), carrageenan, gum arabic, gelatine, dicalcium phosphate and powdered cellulose are substances that inherently function as both emulsifiers and forming (binding) agents. It is therefore necessary to consider whether any of these substances are used routinely in soft chew formulations in amounts sufficient for them to function as forming (binding) agents, regardless of whether the substance is labelled as an emulsifier, forming (binding) agent or otherwise.
Ms Richardson stated that she was not aware of the use of PEG in animal foods or treats, including soft chews (Richardson at [40], [41], [65] and [78]). Mr Marov stated that although he was aware that PEG had some emulsifier capability, he did not consider it to be a standard choice (Marov-2 at [6] and [46]). He further indicated that he was aware that PEGs were used in the pharmaceutical industry as fillers, lubricants and for their solvent acting ability (Marov-2 at [46]).
The evidence does not demonstrate that it is common general knowledge to include PEG in soft chews for animals.
Ms Richardson indicated that typical binders used in animal chews include vegetable gums, such as carrageenan, and gelatine. Ms Richardson further stated that gelatine and carrageenan were used as binders in the soft chews that she worked with (Richardson at [27] and [38]).
The use of gelatine and carrageenan in soft chew formulations for animals is therefore considered to be common general knowledge.
In regard to gum arabic, dicalcium phosphate and powdered cellulose, the evidence does not establish that it is common general knowledge to use these substances in soft chew formulations for animals.
Pharmaceutical for control of a parasite
Merial submitted that it is common general knowledge that soft chews can be used to deliver active ingredients that treat parasites (Marov-1 at [131]). Reference was also made to the fact that soft chew formulations for delivering active ingredients to treat parasites in animals existed before the priority date, including Heartgard 30 Chewables and Heartgard 30 Plus (Marov-1 at [131] and [135]; Exhibit RSM-7 at page 246).
Ms Richardson also indicated that she was aware of Heartgard (Richardson at [12] and [16]).
The use of soft chew formulations to deliver a pharmaceutical for the control of parasites in animals is considered to be common general knowledge.
Conclusion on common general knowledge
It has not been established that the claims lack an inventive step based on the common general knowledge alone.
Prior art – ascertained, understood and regarded as relevant
Merial submitted that certain claims are not inventive in view of US 6387381 (D7), US 5637313 (D12), WO 99/48372 (D15), US 4997671 (D27), US 4284652 (D28) and EP 0075443 (D5) when considered together with the common general knowledge.
The first question to consider is whether these documents would have been ascertained, understood and regarded as relevant. The evidence indicates that the skilled addressee would consult the patent literature in order to solve the problem (Marov-1 at [8]; Richardson at [8]). Therefore the prior art would have been ascertained.
D7 and D15 discuss the preparation of soft chew formulations wherein possible active ingredients are parasite control agents. D12 describes medicated soft chews for veterinary purposes. D7, D12 and D15 are therefore regarded as relevant. D27 discloses soft chew formulations specifically for dogs, whilst D28 relates to soft chews for pets. D27 and D28 are also relevant documents for inventive step considerations.
D5 relates to a product comprising a bob syrup component (generally containing a substantial amount of sugar) and a frappe component for formulation into nougat-type confectionary. The product may contain a medicament, however only an antacid is mentioned and exemplified. The products described in the examples are all very high in sugar and therefore appear to be designed for human consumption (Richardson at [88]). Merial submitted that claim 4 of the present specification allows for up to 75% weight of a sugar component. However, Mr Marov indicates that the levels of sweeteners (sugars) employed in soft chews are generally up to 40% (Marov-1 at [38]) and I note that this is consistent with the examples in the specification.
I am not satisfied that it has been demonstrated that the skilled addressee, in the context of solving the problem of providing a palatable soft chew for delivering an active ingredient for the control of parasites in livestock, pets and farm animals, would regard D5 as relevant.
The prior art documents for inventive step considerations are therefore D7, D12, D15, D27 and D28. I will firstly consider D12, D27 and D28 and then D7 and D15.
US 5637313 (D12), US 4997671 (D27) and US 4284652 (D28)
As discussed previously, D12 discloses dosage forms that may be used for either human or veterinary applications (column 5, lines 1 – 3). However, of the large number of possible active ingredients listed (column 5, lines 5 – 54), none are agents used for the control of parasites in livestock, pets or farm animals.
D27 relates to soft chew formulations for dogs, however these are not used for the delivery of active ingredients. D28 describes soft chew formulation for pets. Although this document indicates that the formulation may be supplemented with vitamins and minerals (column 7, lines 55 – 57), there is no mention of active ingredients for the control of parasites.
Merial submitted that the inclusion of active ingredients in soft chews is well known and common general knowledge in the field. Merial stated that the person skilled in the art would have been directly led as a matter of course to try the use of a pharmaceutical agent for the control of a parasite in conjunction with the formulations disclosed in the prior art in the expectation that it might produce the desired result.
Mr Marov stated (in relation to D28; Marov-1 at [269]):
“I would use this type of formulation as the basis for development when looking to incorporate other ingredients such as medicaments, nutraceuticals or biologically active components. I do not foresee any difficulties in incorporating other ingredients into such a base formulation, taking into account any incompatability, stability, palatability and efficacy issues with these additional ingredients.”
Intervet submitted that the introduction of a pharmaceutical is not trivial. Ms Richardson indicated (Richardson at [18]):
“An important aspect for consideration in preparing a medicated treat for domesticated animals is the need for the antiparasitic agent to be stable in the formulation and therefore to have a long shelf-life and therefore, typically, low water activity.”
Ms Richardson further stated (Richardson at [28]):
“… the active agent also needs to be considered. In fact, in my opinion, design of the formulation needs to be centred around the active agent, especially where the active agent is a bitter active agent with low specific activity (activity per gram of active), such as praziquantel and benzimidazoles. Praziquantel, for example, is typically present in bite-sized chews as about 16% of the chew. This significantly affects the palatability, texture and colour of the product, producing a whiter, chalkier and bitter product.”
In response, Mr Marov considered this amount of praziquantel to be very high. He considered that typically the active would make up only a small portion of the chew and made reference to Example 2 of the specification, wherein praziquantel is present in an amount of 1.09% (Marov-2 at [34]).
Notwithstanding this difference in opinion regarding the amount of praziquantel, Mr Marov indicated that as the pharmaceutical is of significant importance, its properties must be considered from the outset (Marov-2 at [64]). For example, the pH and heat stability and light sensitivity of the pharmaceutical must be a primary consideration (Marov-2 at [34]).
There are two issues that require consideration. Firstly, is it routine to use an agent for parasite control in a soft chew formulation? As discussed previously, it is common general knowledge that soft chews can be used to deliver active ingredients for parasite control. Therefore this aspect is considered to be a matter of routine. Secondly, having made the decision to incorporate an agent for parasite control, is it routine to produce a soft chew formulation as defined by claim 1? The evidence indicates that the properties of the antiparasitic agent are an important consideration and formulation of the soft chew needs to be adjusted to take the agent into account. I am not satisfied it has been established that these adjustments to the soft chews of D12, D27 and D28, which are required to arrive at a formulation that falls within the scope of the claims, would be a matter of routine.
Although it is not necessary to consider whether the remaining components of the formulation lack an inventive step in light of D12, D27 and D28, I will comment briefly on certain aspects as indicated below.
D12 – moisture content and emulsifying agent that acts as a forming agent
D12 states that the soft chew dosage form “contains little moisture” (column 2, lines 53 – 56), however the exact moisture content is not specified. As discussed previously, typical moisture contents for soft chews are in the range of about 10% to about 30% (Richardson at [69]) or 10% to 20% (Marov-2 at [39]). Whilst “little moisture” could refer to a moisture content less than 10%, I am not satisfied that the skilled addressee would be directly led to produce a soft chew formulation wherein the moisture content is between 5.0 and 7.5% weight.
Possible bulking agents that may be included in the soft chew are gum arabic, carrageenan, PEG, dicalcium phosphate and powdered cellulose. As previously indicated, these substances are inherently able to function as emulsifiers and forming agents. However, the amounts of cellulose and gum arabic exemplified in Table I are insufficient to act as forming agents. The use of dicalcium phosphate, carrageenan or PEG is not exemplified and the latter two substances are not preferred bulking agents (column 4, lines 7 – 11). I do not consider that the skilled addressee would be directly led to utilise gum arabic, carrageenan, PEG, dicalcium phosphate or powdered cellulose in quantities sufficient to act as a forming agent in a soft chew formulation.
As discussed previously, it is common general knowledge to use gelatine and carrageenan, which can act as emulsifiers and forming agents, in soft chew formulations. It could therefore be argued that it would be routine for the person skilled in the art to incorporate gelatine or carrageenan into a soft chew. However, the evidence does not demonstrate that there would be any motivation for the skilled addressee to alter an existing formulation by the addition of gelatine or carrageenan, or substitute these substances for another.
D27 – moisture content
D27 states that the moisture (water) content of the soft chews is about 10 to about 25% weight (abstract; column 2, lines 66 – 67) or about 10 to about 20% weight (column 3, lines 58 – 59). The water level required significantly hydrates the gelatine (an emulsifier and forming agent), which is used in amount of from 12 to 30% weight (column 4, lines 2 – 3; column 5, lines 17 ‑ 19).
Merial submitted that Example 1 contains 8% water and Example 4 indicates that moisture contents of 5 to 6% weight produce a dough with better characteristics.
However, I note that the amounts of water referred to in the Examples are the quantities added to the soft chew and not the moisture content of the final formulation. Thus, in Example 1 the final dog snack contains about 14% weight water (column 12, lines 48 – 49), whilst the water content (where specified) for the remaining examples is 13.75% (Examples 5, 6 and 11). The higher moisture content of the final formulation takes into account the moisture content of the corn syrup and honey components (Richardson at [112]).
It has not been demonstrated that the skilled addressee would be directly led to produce a soft chew formulation having a moisture content of between 5.0 and 7.5% weight based on the disclosure of D27.
D28 – emulsifying agent that acts as a forming agent
D28 indicates that glycerol (glycerine) may be included in the soft chew formulation (column 5, lines 44 – 56). However, as discussed previously, this substance is not considered to be a suitable forming agent. D28 does not disclose or exemplify the use of any other substance that could function as an emulsifier and a forming agent. Furthermore, the evidence does not establish that the skilled addressee would be motivated to incorporate gelatine or carrageenan (emulsifiers that act as forming agents) into an existing formulation.
It has not been demonstrated that the skilled addressee would, as a matter of routine, incorporate an emulsifying agent that acts as a forming agent into a soft chew formulation based on the disclosure of D28.
Conclusion on D12, D27 and D28
It has not been demonstrated that the claims lack an inventive step in view of any one of D12, D27 and D28.
US 6387381 (D7)
As discussed previously, D7 discloses a product matrix for delivering pharmaceuticals to a mammal. Ivermectin and fenbendazole are listed as possible active ingredients (column 3, lines 33 – 42). D7 indicates that glycerol (glycerine) may be a component of the matrix in amounts of about 10 to about 50% weight (column 2, line 66 to column 3, line 5). However, as indicated previously, glycerol is not considered to be suitable forming agent. D7 does not mention any other substance that could function as both an emulsifier and a forming agent. Similarly, none of the preparative examples contain such a substance.
D7 states that the moisture content of the final product is 5 – 15% (column 3, lines 22 – 26). However, as discussed previously, all of the preparative examples contain 10% water, such that the final moisture content is roughly 13% once the moisture content of the corn syrup component is taken into consideration (Richardson at [87]).
It has not been demonstrated that the skilled addressee would, as a matter of routine, add an emulsifying agent that acts as a forming agent to the product matrix described in D7, such that the moisture content is between 5.0 and 7.5% weight, and thereby arrive at a formulation that falls within the scope of the claims.
Conclusion on D7
It has not been established that the claims lack an inventive step in the light of D7.
D15 (WO 99/48372)
D15 discloses the encapsulation of pharmaceuticals, nutraceuticals and live microorganisms into edible products. Of the many possible active ingredients listed, these include the antiparasitic agents albendazole (page 17, line 6), levamisole hydrochloride (page 20, line 1), praziquantel (page 21, line 19) and pyrantel pamoate (page 22, line 4). Optional components include PEG, carrageenan, gum arabic and gelatine (page 13, lines 9 – 12; page 15, line 5). These substances, as discussed previously, can function as emulsifiers and forming agents.
PEG is mentioned in the context of a plasticiser and is therefore a low molecular weight substance unsuitable for use as a forming agent (Marov-2 at [10] and [52]). The amounts of carrageenan, gum arabic and gelatine used in the product are not clearly specified. Consequently, I am not satisfied it has been established that these components, if they were to be included, would be in amounts sufficient to function as forming agents.
The three Examples in D15 all relate to the encapsulation of a microorganism. The final product is derived by mixing ground cookies, water, citrus juice, oil and the microorganism. The composition of the ground cookies is not stated and therefore it cannot be determined whether an emulsifier that acts as a forming agent is present.
It has not been established that the person skilled in the art, in seeking to provide a palatable soft chew for delivering an active ingredient for the control of parasites, would be directly led to incorporate an emulsifying agent that acts as a forming agent and thereby arrive at a formulation falling within the scope of the claims.
Conclusion on D15
It has not been demonstrated that the claims lack an inventive step in view of D15.
Conclusion on inventive step
It has not been demonstrated that there is a lack of inventive step in light of the prior art.
Manner of manufacture
Subsection 18(1)(a) requires that an invention must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. Manner of manufacture is assessed by asking whether the claimed invention lacks the necessary quality of inventiveness on the face of the specification (NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 at [9]; (1995) 183 CLR 655).
Merial submitted that the claimed invention is nothing more than a mere collocation of known integers. In particular, claim 1 merely defines the following:
i)a formulation for oral administration; and
ii)forming of the formulation by a “knockout” step and not by extrusion.
It was submitted that both integers i) and ii) are known to the person skilled in the art and furthermore that there is no working interrelationship or potential working interrelationship between the integers.
I have previously found that the soft chew formulation defined by the claims is novel. It therefore follows that the claimed “collocation” meets the manner of manufacture requirements as the formulation integer is new.
It has not been demonstrated the claimed invention is not a manner of manufacture.
Conclusion
The opposition fails on all grounds.
Costs
Both parties submitted that costs should follow the event. I award costs in accordance with Schedule 8 against Merial Limited.
Dr M-A. Fam
Delegate of the Commissioner of Patents
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