Novartis AG v Bayer Animal Health GmbH

Case •

[2011] APO 67

•

29 August 2011

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Novartis AG v Bayer Animal Health GMBH [2011] APO 67

Patent Application:                2001279664

Title:Endoparasiticidal agents for voluntary oral ingestion by animals

Patent Applicant:                   Bayer Animal Health GmbH

Opponent:  Novartis AG

Delegate:  Dr B. Akhurst

Decision Date:  29 August 2011

Hearing Date:  30 May 2011, in Canberra

Catchwords:  PATENTS - section 59 - opposition to grant of a patent - novelty - claims to a combination - features found to be inherently present in a prior art product - other prior art did not disclose all of the features of the claims - inventive step - documents directed to a different problem would not have been ascertained - one of two foreign language documents would not have been understood and regarded as relevant - evidence in respect of obviousness influenced by hindsight - manner of manufacture - no evidence that the claims are to a mere collocation with no working interrelationship - utility - whether broad claims necessarily lack utility - no product identified within the claims that would not be useful - full description - examples provide sufficient disclosure - claims defining the invention - claims are present defining the monopoly - clarity - opposition succeeds on ground of lack of novelty.

Representation:  Patent applicant:  Katrina Howard Senior Counsel, instructed by Dr Gavin Recchia and Nigel Lokan of Davies Collison Cave, Sydney.

Opponent:Christian Dimitriadis of Counsel, instructed by Kerry Awerbuch of Blake Dawson, Melbourne.

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                2001279664

Title:Endoparasiticidal agents for voluntary oral ingestion by animals

Patent Applicant:                   Bayer Animal Health GmbH

Date of Decision:                   29 August 2011

DECISION

  1. Claims 1-3 and 6 are not novel.  Bayer has two months from the date of this decision to propose amendments to the claims to overcome this deficiency.  Costs according to Schedule 8 awarded against Bayer Animal Health GmbH.

    REASONS FOR DECISION

    Background

  2. Patent application 2001279664 was filed by Bayer Aktiengesellschaft on 18 June 2001 under the provisions of the PCT, claiming priority from German basic application DE 10031044 filed on 26 June 2000.  After examination, the application was advertised as accepted on 2 March 2006.  Subsequently, Bayer Aktiengesellschaft assigned the rights of the patent application to Bayer Animal Health GmbH (‘Bayer’) and the change of applicant in Australia was advertised on 13 August 2009.

  1. On 27 October 2009, during the evidentiary stages of this opposition, Bayer filed a request under section 104 to amend the accepted specification which amendment was advertised allowed on 10 June 2010.

  1. Novartis AG (‘Novartis’) filed a notice of opposition to grant of the patent on 2 June 2006, followed by a statement of grounds and particulars on 1 September 2006.  On 20 May 2011, Novartis filed a request to amend the statement of grounds and particulars, which was allowed on 10 June 2011.

  1. Evidence in support was completed on 30 May 2008, consisting of statutory declarations by:

    ·     Dr James Stevens Rowe dated 11 June 2007 (Rowe#1) with exhibits JSR-1 to JSR-20

    ·     Dr James Stevens Rowe dated 30 November 2007 (Rowe#2) with exhibits JSR-21 to JSR-25

    ·     Dr James Steven Rowe dated 27 May 2008 (Rowe#3) with exhibits JSR-26 to JSR-29

    ·     Dr Walter Otto Oechslein dated 16 May 2008 with exhibits WO-1 to WO-12

  2. Evidence in answer was served on 29 March 2010, consisting of a statutory declaration by

    ·     Dr Margaret Doherty dated 26 March 2010 with exhibits MD-1 to MD-3

  1. Evidence in reply was completed on 29 October 2010, consisting of a statutory declaration by

    ·     Dr James Stevens Rowe dated 27 October 2010 (Rowe#4), with exhibit JSR-30

    Standard of proof

  2. The onus of proof in opposition proceedings lies with the opponent, who must establish 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 [29], [67]; (2001) 50 IPR 305 at 311 [29], 319 [67]; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; (2009) 79 IPR 426 at 430 [18], 432 [22]).

    Grounds of Opposition

  3. The grounds for opposing the grant of a patent under section 59(b) and (c) of the Patents Act 1990 are identified in the statement of grounds and particulars as including manner of manufacture, novelty, inventive step, utility and section 40 issues.

    The specification and claims

  4. The application is entitled “Endoparasiticidal compositions which are readily ingested by animals”.  The application relates to pharmaceutical presentations for oral administration to animals, which are readily accepted (voluntarily ingested) by the animals.  It was known in the art to increase the palatability of tablets by adding aromas and flavourings, by altering the shape of the tablet, or by laminating it with attractants.  However, such tablet systems can be clearly distinguished from normal feed and do not achieve complete acceptance.  Very good acceptance is achieved by starch-based extruded shaped articles used in the feeds industry.  However, since they contain up to 50% meat, feed products do not comply with the rules of a pharmaceutical presentation, and consequently their suitability as carriers for pharmaceutically active compounds is limited.  Pure starch extrudates are not accepted by animals.  The invention lies in starch-based extruded shaped articles without added meat, which act as carriers for pharmaceutically active compounds, and which are readily accepted by animals.  (See the Description at page 1 to page 2 line 15.)

  5. The specification ends with 9 claims of which claims 1 and 8 are independent. 

  1. The general principles of construction were summarised by Hely J in Flexible Steel Lacing Company v Beltreco Ltd [2000] FCA 890 at [70] - [81]; (2001) 49 IPR 331 at 347 [70] - [81]. Briefly and most relevantly to this opposition: The claims are construed in the context of the specification as a whole. It is not legitimate to vary the boundaries of monopoly as fixed by the words of the claim, by adding words or glosses drawn from other parts of the specification. However reference may be made to the rest of the specification to ascertain the meaning of technical terms and to resolve ambiguities in the construction of the claims. The claim marks out the legal limits of the monopoly granted by the patent. What is not claimed is disclaimed. The construction of the specification is for the Court, not for the expert witness.

  1. Claim 1 defines an article in terms of its composition and the method by which it is produced:

    1.Starch-based extruded shaped articles, comprising specific aromas, bodying agents and pharmaceutically active compounds for animals, wherein the articles are produced by preparing a mixture of starch, the specific aromas, the bodying agents and the pharmaceutically active compounds for animals, and extruding the mixture at a temperature that is less than 150°C.

  2. Preferred starches identified in the application are those from wheat, rice, maize, tapioca, rye, oats and potatoes, or modified starches such as hydroxyethylstarch, hydroxypropylstarch, methylstarch, carboxymethylstarch, starch acetate, hydroxypropylstarch acetate, hydroxyethylstarch acetate, starch phosphates, starch sulphates, or chemically or ionically crosslinked starches such as dye-starch phosphates, phosphates of hydroxypropylated starches, starch dicarboxylic acid diesters or salts of anionic starch derivatives. 

  3. Specific aromas are defined on page 20a of the description as “those suitable for inclusion in the shaped articles according to the invention which are attractive to animals that these items are to be administered to”.  Preferred aromas are powdered liver from cattle, poultry, sheep or pigs, and in particular the commercially available products BEEF® (Pharmachem) and BAYOPAL® (Haarmann and Reimer). 

  4. Ms Howard submitted that read in context, the claims should be construed to include a specific aroma in the absence of meat.  However, claim 1 contains no explicit limitation that the article is meat free, and it would be impermissible to import this feature into the claim.  Moreover, the specification identifies preferred aromas as including powdered liver, which is meat, albeit processed meat.  It follows that insofar as claim 1 defines a product comprising an aroma that is attractive to animals that the items are to be administered to, this aroma may be provided by meat in the product.

  1. The specification provides no dictionary for the word “shaped”.  Dr Oechslein at [21] interprets the “shaped article” to encompass any article, including “an ear tag, medallion, animal collar, implant, pellet, etc”.  In contrast, at [78]-[79] Dr Doherty construes the “shaped article” to be in “a particular form which may be dictated by its function, for example … assisting in making the article more likely to be voluntarily consumed by an animal”.  Although the claim does not explicitly define the route of administration, Dr Doherty understands the claimed article to be for oral administration.  I consider this a reasonable construction since the presence in the article of an aroma that is attractive to animals is redundant in dosage forms such as an implant, and unnecessary in an ear tag, medallion or collar.  Consequently, I consider the term “shaped article” to encompass an article of any shape suitable for the oral administration of a pharmaceutically active compound to an animal.  

  1. At page 20, the term “bodying agent” is defined as “materials which are especially suitable for shaping and bodying”.  Especially preferred bodying agents are cellulose and its derivatives such as microcrystalline cellulose, hydroxypropylcellulose, methylhydroxypropylcellulose, carboxymethylcellulose, especially cellulose acetate and very especially cellulose-2,5-acetate.  Also preferred are highly-dispersed silicates and titanium dioxide.  The declarants agree that a bodying agent functions to modify the viscosity of a product to which it is added (Dr Oechslein at [42], Dr Doherty at [62], [83]; Dr Rowe at [40]). 

  1. A pharmacologically active compound is defined by Dr Rowe as “any compound that has a biological effect aimed at modifying the course of a disease state (Rowe#4 at [48]).  Dr Doherty at [71] understands the phrase “pharmaceutically active compounds” to mean compounds that “display a drug-like activity, or in other words, pharmacological, pharmacodynamic and pharmacokinetic characteristics”.  These definitions are not inconsistent with each other.  I accept that a pharmaceutically active compound is a compound with these activities.

  2. The term “animals” is ambiguous in that it is not clear whether the term encompasses humans.  Resort to the description reveals on page 1 that the invention relates to pharmaceutical presentation for animals, with preferred animals being dogs, cat and horses.  Reference is made in the next paragraph to an “animal keeper”, which would clearly exclude humans.  The description on pages 1 and 15 distinguishes humans from animals (“extrusion … is known for use in humans, but … acceptance by animals … is insufficient”, and “endoparasites found in humans and in animal keeping…”, respectively).  In addition, the specification on page 3 identifies suitable active compounds as those suitable for use in veterinary (i.e. animal not human) medicine.  A construction of “animals” to exclude humans is supported by the evidence of the experts, who understand the opposed application to relate to veterinary medicines (Rowe#1 at [27], Dr Oechslein at [22], and Dr Doherty at [25]; and Rowe#3 at [7]).  In addition, Dr Rowe explicitly states that he understands the opposed application to relate to the treatment of animals rather than humans (Rowe#3 at [7]).  Consequently, I construe the word “animals” in claim 1 as referring to non-human animals.

  1. Independent claim 8 defines the article by reference to the exemplified subject matter:

    8.Starch-based extruded shaped articles, substantially as herein described with reference to any one of the Examples.

  1. Example 1 describes an article containing in weight/volume amounts: 55% wheat flour, 10% fructose, 10% beef aroma (Pharma-Chemie), 1% Aerosil (“one of a number of silicon dioxide-based products” per Dr Doherty at [38]), 4% depsipeptide, 5% water and 15% glycerol.  Example 2 describes an article containing 45% cornstarch, 10% sucrose, 10% liver aroma (Haarmann & Reimer), 10% cellulose acetate powder, 1% Aerosil, 4% depsipeptide, 5% water and 15% glycerol.  Each article is of a size such that it contains a depsipeptide dose appropriate for 10 kg of the animal’s bodyweight.

  1. The dependent claims are as follows:

    2.Starch-based extruded shaped articles according to Claim 1, wherein the specific aromas are poultry liver aroma or meat aroma.

    3.Starch-based extruded shaped articles according to Claim 1, which have a Shore A hardness of 10-100.

    This range of hardness extends from something quite malleable to something very hard and inflexible and would encompass any starch-based extruded product (Rowe#1 at [22], Dr Oechslein at [24]).

    4.Starch-based extruded shaped articles according to Claim 1 or Claim 2, wherein the pharmaceutically active compounds for animals are cyclic depsipeptides composed of amino acids and hydroxycarboxylic acids as units and having 6 to 30 ring or chain atoms.

    5.Starch-based extruded shaped articles according to any one of Claims 1 to 3, further comprising pulverulent cellulose acetate.

    6.Starch-based extruded shaped articles according to any one of Claims 1 to 4, further comprising ancilliary materials.

    The word “ancilliary” (ancillary) is defined by the Macquarie Dictionary as accessory or auxiliary.  In view of dependent claim 7, the term “ancilliary materials” in claim 6 would include, but is not limited to, emulsifiers, humectants and preservatives.  The description identifies the following as ancillary substances:

    “starch such as, for example, starch from wheat, rice, maize, tapioca, rye, oats and potatoes.  Modified starches can be physically pretreated starches such as precooked or chemically modified starches such as hydroxyethylstarch, hydroxypropylstarch, methylstarch, carboxymethylstarch, starch acetate, hydroxypropylstarch acetate, hydroxyethylstarch acetate, starch phosphates, starch sulphates, or chemically or ionically crosslinked starches such as dye-starch phosphates, phosphates of hydroxypropylated starches, starch dicarboxylic acid diesters or salts of anionic starch derivatives.  Preferred are hydroxypropylated and phosphate-crosslinked starches of maize, wheat, tapioca and potato.  Starch quantities of between 30% and 80%, preferably between 40% and 70%, especially preferably between 40 and 60%, are employed in this context.  The percentages are percent by weight of the finished composition.” (page 18 line 23 to page 19 line 6)

    7.Starch-based extruded shaped articles according to Claim 6, wherein the ancilliary materials are selected from the group consisting of: emulsifiers, humectants and preservatives.

    9.Process for the preparation of starch-based extruded shaped articles according to any one of Claims 1 to 4, substantially as herein described with reference to Examples 1 or 2.

  1. Examples 1 and 2 describe a process in which the ingredients listed at para [22] above, except water and glycerol, are homogenised, screened, then the mixture fed to an extruder via a measuring screw.  The water and glycerol is pumped in via a metering pump and extrusion carried out at 120°C.  The extrudate is then cut into pieces containing a dose of depsipeptide for 10 kg of the animal’s bodyweight.

    Novelty

  2. 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]; (1977) 137 CLR 228 at 235:

    “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”

  3. This test is satisfied if the alleged anticipation discloses all of the essential features of the invention as claimed (Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40 at [19]; (1990) 91 ALR 513 at 517). To meet this requirement, the prior art must contain “clear and unmistakable directions” to the claimed invention (Pfizer Overseas Pharmaceuticals v Eli Lilly and Co [2005] FCAFC 224 at [314]; (2006) 68 IPR 1 at 67 [314]). However, if the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in such a way that would not do so, the patentee’s claim will not be anticipated (General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (1971) 1A IPR 121 at 138). 

  1. Where a prior publication does not explicitly disclose all of the integers of the claimed invention, it would still deprive the claimed invention of novelty if (i) the skilled reader understands the disclosures of the prior publication to include a missing integer, or (ii) if the document contains a direction to use a process that inevitably or inexorably results in something within the claim (Bennett J in Danisco A/S v Novozymes A/S (No 2) [2011] FCA 282 at [248]).

  2. There were no submissions or evidence to the effect that any of the features in the claimed combination was inessential.  It was not in dispute that the individual features of the claims were known in the art, and that the invention lay in the combination of these features.  Therefore, it is the claimed combination that must be tested against the prior art:

    “a prior publication does not amount to an anticipation of an invention claimed as a combination if it discloses some, but not all, of the integers of that combination” (Ramset Fasteners (Aust) Pty Ltd v Advanced Building Systems Pty Ltd [1999] FCA 898 at [22]; (1999) 44 IPR 481 at 491 [22])

  3. Novartis relied on 7 published patent documents to establish lack of novelty, as follows: 

    GB 23001032 A (Gilbertson & Page) 30 October 1996
    EP 0796565 A1 (Barbieux, S. et al) 24 September 1997
    US 5663140 A (Scherkenbeck, J. et al ) 2 September 1997
    FR 2702960 (Kerouedan, B. and Bonnet, C) 30 September 1994
    WO 1999/048372 A1 (General Mills, Inc.) 30 September 1999
    WO 1998/018610 A1 (Van Lengerich) 7 May 1998
    EP 0552897 A1 (Colgate-Palmolive Company) 28 July 1993

  4. For each of the above, Novartis identified the claims anticipated by the document and, referring to a “novelty table”, submitted that:

    “As set out in the accompanying table, many features of those claims are expressly disclosed in the document.  Those that are not are either inherent in the disclosure or are common variants that would be added by the skilled person as a matter of course” (Emphasis added)

  1. In referring to common variants that would be added by the skilled person as a matter of course, Novartis is paraphrasing a legal principle referred to earlier in their submissions, which was provided by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 at [181]:

    “If the prior art discloses some but not all integers of a claimed …  product, such as a combination, there is anticipation if the skilled addressee would add the missing information as a matter of course and without the application of inventive ingenuity or undue experimentation (Nicaro at 530-531)”

  2. In the above passage, it is important to note that Bennett J was referring to the addition of missing information to that which is explicitly disclosed by a document, rather than the addition of “common variants”.  Bennett J in the above paragraph was summarising the majority judgement in Nicaro.  I note that in Nicaro, Gummow J observed that where one or more integers of a claimed combination is not disclosed in an alleged anticipation, the addition of a missing feature could not be described as the substitution of an equivalent feature “for there would be lacking that for which the substitution was made” (at 541-542). 

  1. Therefore, I do not believe that the authorities support Novartis’ contention that a claimed combination would lack novelty in light of a prior publication that neither explicitly or implicitly discloses to the skilled addressee all of the essential features of the claimed combination, but where the skilled addressee would add as a matter of course “common variants” of the missing feature(s).  Such an argument is more appropriate under the ground of inventive step.  Therefore, in the context of novelty, I will not further consider Novartis’ submissions in respect of the addition of common variants.

    GB 2300103 (GB’103)

  2. GB’103 describes starch-based, extruded dog biscuits containing creatine to enhance physical performance.  The biscuits also contain conventional ingredients such as cereals, meat and animal products, fats, flavours and appetising substances.  These ingredients are extruded at a temperature below 130°C.  (Rowe#2 at [21], Dr Doherty agreeing at [59])  Novartis submitted that GB’103 anticipates claims 1-3 and 5-7 of the opposed application. 

  1. It was not in dispute that creatine is a pharmaceutically active agent and that the biscuits are starch-based shaped articles as claimed.  However, Bayer submitted that there was no indication that any of the ingredients possessed an aroma and in addition, that GB’103 fails to disclose an ingredient functioning as bodying agent.  Bayer’s submission is supported by Dr Doherty whose entire evidence in respect of this document is as follows:

    “I agree with the comments in paragraph 21 of Dr Rowe's Second Declaration.  I would however add that the dog biscuits of GB 2300103 do not include specific aromas, nor bodying agents as required by claim 1 of The Patent Application.”

  2. The Example in GB’103 provides a method of preparing a dry dog biscuit containing, in w/w amounts, 10% maize, 41% poultry meat, 17.5% fat, 12.5% rice, 5% sugar beet, 2.5% yeast, 3.75% gluten, 2.5% egg, 2.0% supplement of vitamins and 3.25% trace element supplement.  Dr Rowe understands the poultry meat to have an aroma that is attractive to dogs and other carnivorous animals (Rowe#4 at [39]).  While Dr Doherty does not read a specific aroma into the products of GB’103, she has not commented specifically on the exemplified subject matter.  I prefer Dr Rowe’s evidence on this aspect.  Prima facie poultry meat, whether raw or processed, would have an aroma attractive to dogs.  I am satisfied that GB’103 discloses an article comprising a specific aroma, as required by opposed claim 1. 

  3. Dr Rowe understands yeast, fat, rice, gluten and sugar beet to be acting as bodying agents in the exemplified biscuit (Rowe#4 at [39]).  In the absence of any direct evidence from Dr Doherty in respect of these ingredients, I find that the exemplified dog biscuit of GB’103 comprises bodying agents within the meaning of claim 1.

  1. In summary, GB’103 discloses at the Example, starch-based extruded shaped articles (dog biscuits), comprising a specific aroma (provided by poultry meat in the article), bodying agents (yeast, fat, rice, gluten and sugar beet), and a pharmaceutically active compound for animals (creatine), wherein the articles are produced by preparing a mixture of these ingredients, and extruding the mixture at a temperature that is less than 150°C.  It follows that GB’103 anticipates all of the features of claims 1 and 2.

  1. I have found at [23] above, that the person skilled in the art understands all starch-based extruded articles to fall within the Shore A hardness range of 10-100. Consequently, GB’103 anticipates the matter in claim 3. Claim 6 adds further unspecified ancillary materials. I note that maize starch is specifically identified in the opposed application as an ancillary substance. Given that the exemplified biscuit contains 10% maize I consider claim 6 to be anticipated.

  1. GB’103 does not explicitly disclose an article comprising pulverulent cellulose acetate, and Novartis have led no evidence that this feature is inherent to the disclosed biscuit.  I have no evidence before me that any of the ingredients listed at the example is an emulsifier, humectant or preservative.  Consequently, GB’103 does not disclose, or provide directions to produce, an article that would anticipate claims 5 and 7 of the opposed application.

  1. In summary, I find the subject matter of claims 1-3 and 6 to lack novelty in the light of GB’103.

    EP 0796565 (EP’565)

  2. An English translation of this application in the French language is in evidence as JSR-29 and WO‑10.  The document is entitled “Oral treatment product for animals” and describes a chewable starch-based extruded product containing “treatment active substances” for the local treatment of oral hygiene in pets.  The product contains an attractant to make it appealing to animals such as meat meal or coarse bone powder, and may also contain preservatives, abrasive substances, substances promoting intestinal transit and good digestion, and high energy substances.  The produced is produced by extrusion below 150°C.  (Rowe#3 at [14], Dr Doherty agreeing at [62], Dr Oechslein at [56]). 

  3. Novartis considered this document to anticipate opposed claims 1-3 and 5-7.  However, Bayer submitted that the chew does not include specific aromas, bodying agents or a pharmaceutically active substance for animals.

  4. Dr Doherty at [70], states that EP’565 provides “no indication that the appetite-stimulating substance is, or has an aroma”.   However, Dr Rowe believes an aroma is inherent in the idea that an attractant is appetite-stimulating, and supported by the need identified in EP’565, for it to “encourage consumption” (Rowe#4 at [46]).  Dr Rowe understands meat meal and bone powder to have an aroma detectable by animals (Rowe#4 at [46]).  Although not explicitly disclosed by EP’565, I am satisfied the pet chew of EP’565 comprises an aroma that is attractive to the animal to which it is to be administered.

  5. Dr Doherty at [70] states that EP’565 does not teach that the chew contains a bodying agent.  Dr Doherty notes the references in EP’565 to gums in the product and states that “gums may serve a variety of functions in pharmaceutical formulations”.  Although EP’565 provides no indication as to what function the gum is fulfilling in the formulations, Dr Doherty at [70] expects that it acts to enhance mouthfeel rather than functioning as a bodying agent.  I infer from Dr Doherty’s evidence that gum may function as a bodying agent in some circumstances. 

  1. Dr Rowe’s view is that the gum performs more than one function in the product of EP’565.  While he accepts that the gum contributes to mouthfeel and provides a chewable substance, he states that it is also a bodying agent (Rowe#4 at [47]).  I note that Dr Oechslein, in reviewing EP’565 makes no express reference to a bodying agent (Dr Oechslein at [55]-[56]).

  1. On balance, I am not satisfied that the skilled reader understands the pet chew of EP’565 to contain a substance functioning as a bodying agent.  It follows that EP’565 does not anticipate the opposed claims.

    US 5663140 (US’140)

  2. Novartis submitted that US’140 anticipates claims 1-7 of the opposed application on the basis that where features are not expressly disclosed by US’140 they are inherent in the disclosure.  It was not in dispute that US’140 discloses the use of cyclic depsipeptides, bodying agents and preservatives in shaped veterinary formulations for combating endoparasites.  However, Bayer submitted that the document does not disclose the production of starch-based articles by extrusion, nor the inclusion of specific aromas. 

  1. The expert evidence relied upon by Novartis to establish lack of novelty merely indicates that the products of US’140 may contain ingredients having an aroma (Rowe#4 at [51]) and that they may be produced by extrusion (Rowe#4 at [51]; Dr Oechslein at [47]).  Dr Oechslein’s statement at [49], that he “would have considered producing the articles described by US’140 with the addition of … aroma” (emphasis added) indicates that he, like Dr Doherty at [85], did not understand the compositions of US’140 to include an aroma.  I note also that no submissions were made or evidence adduced in regard to the extrusion temperature.  Therefore, I consider US’140 to fall short of providing clear and unmistakable directions to produce the starch-based extruded articles of the opposed claims.  Consequently, the claims are not anticipated by this document.

    FR 2702960 (FR’960)

  2. An English translation of this document is in evidence as exhibit JSR-18.  FR’960 is entitled “Lure for the oral administration of veterinary medicines”.  Novartis submitted that FR’960 anticipates claims 1-3 and 5-7 of the opposed application.

  1. Bayer accepted that the product discloses an extruded starch-based shaped article comprising specific aromas, bodying agents and ancillary materials.  However, Bayer contended that the pharmaceutical agents are not present in the extruded mixture as required by the opposed claims. 

  1. The evidence does not support Novartis’ submissions at the hearing that their experts understood the pharmaceutically active ingredient to be included in the mixture of ingredients prior to extrusion.  Both Drs Rowe and Oechslein describe FR’960 as disclosing an extruded starch-based article for the oral administration of medicines to animals (JSR#1 at [51]-[52]; Dr Oechslein at [58]).  However, in describing the individual ingredients of the matrix material, Dr Rowe does not include the pharmaceutically active ingredient (Rowe#1 at [51]).  Dr Oechslein at [58] states that the articles of FR’960 “can contain” among other things, a pharmaceutically active compound.  However, he follows this statement with a passage from FR’960 stating that the edible extruded compositions “may be made, for example, into cylindrical containers having a cavity for holding the active ingredient” (emphasis added).  I conclude from this evidence that neither of Drs Rowe or Oechslein understand the lure to contain a pharmaceutically active agent in the extruded excipient-carrier composition.

  1. FR’960 does not expressly disclose the production of a starch-based extruded article as claimed, by preparing a mixture of starch, the specific aromas, the bodying agents and the pharmaceutically active compounds for animals, and extruding the mixture.  The evidence does not establish that the person skilled in the art would understand the disclosure of FR’960 to include this process.  It follows that FR’960 does not anticipate the claimed subject matter. 

    WO 1999/048372 (WO’372)

  2. WO’372 is entitled “Encapsulation of Components into Edible Products” and refers to a mixture containing a component to improve sensory attributes (Rowe#1 at [55], Dr Doherty agreeing at [47]).  Bayer accepted that WO’372 discloses the production of edible extruded starch-based matrix composition comprising a bodying agent, ancillary agents and a pharmaceutically active ingredient for animals, but contended that it did not disclose a product comprising “specific aromas”.  Novartis submitted that WO’372 anticipated opposed claims 1-3 and 5-7, with features such as “specific aromas” inherent in the disclosure. 

  1. Novartis drew my attention to page 15 of the document, which describes the use of additional components to improve sensory attributes, such as taste, texture, aroma, colour, appearance or hydration behaviour of the product.  Preferred components for this purpose are listed as:

    “flavors, sodium chloride, nonfat dry milk, whey protein, high fructose corn syrup, leavening agents, lipids, such as oils or fats, chocolate liquor, chocolate, cocoa powder, compound coatings, concentrated fruit juice, or particulates, such as ground nuts or almonds.”

While Dr Doherty at [47] states that WO’372 makes no reference to a “specific aroma”, Dr Rowe understands the document to disclose articles containing such aromas (Rowe#4 at [29]-[32]).  In any event, the directions in WO’372 are to optionally enhance any of six sensory attributes, only one of which is aroma.  It follows that this publication contains a direction which is at least as likely to be carried out in a way that would not infringe Bayer’s claims.  Consequently, WO’372 does not provide clear and unmistakeable directions to prepare a starch-based extruded article falling within the opposed claims.  

WO 1998/018610 (WO’610)

  1. WO’610 is entitled “Embedding and encapsulation of controlled release particles”.  The particles can include a pharmaceutically active compound for animals encapsulated or embedded in a matrix-forming material such as starch, along with bodying agents such as cellulose.  The particles may also contain flavourings or fragrances, and are manufactured by extrusion between 58-98°C.   (Rowe#2 at [12]-[13], Dr Doherty agreeing at [55])  Novartis submitted that this document anticipates opposed claims 1-3 and 5-7.

  1. Bayer submitted that the teaching in WO’610 of pharmaceutically active compounds and fragrances are separate embodiments of the encapsulated particles, and that the document does not teach the combination of these in one product.  Bayer further argued that the “fragrance” of WO’610 was more in the nature of an air freshener and was distinct from the “specific aroma” as claimed.

  1. Dr Rowe states that the articles described in WO’610 can contain pharmaceutically active compounds (Rowe#2 at [11]-[12]).  In a separate sentence he notes that the articles can also contain fragrances (Rowe#2 at [12]).  At [14], Dr Rowe states that if he were faced with the problem addressed by the application, he would have considered producing the starch-based articles of WO’610 “… to encapsulate the pharmaceutically active compound along with appealing flavours and aromas”.  However, Dr Rowe does not explicitly state that the article he would consider producing is disclosed by WO’610.  I do not believe that Dr Rowe’s evidence supports a firm conclusion that he understands WO’610 to disclose the encapsulation of a pharmaceutically active compound in combination with an aroma.

  2. Although WO’610 exemplifies extruded products containing pharmaceutically active agents, none contain an aroma or fragrance.  WO’610 refers to encapsulated fragrances on pages 7, 11, 14 and claim 18.  In each case the encapsulated fragrance represents an embodiment distinct from those containing pharmaceutically active compounds.  Consequently these references cannot contribute to a finding of anticipation.

  1. Claim 21 of WO’610 is to an encapsulated product wherein the encapsulant is “at least one member selected from” thirty five listed components some of which represent broad classes of compounds.  While many of the components could be considered pharmaceutically active, others, such as detergents and surface-active components are not.  Therefore, irrespective of the nature of the fragrance, I do not consider WO’610 to provide clear and unmistakable directions to prepare starch-based extruded articles comprising a pharmaceutically active compound and a fragrance in combination.

  1. I am satisfied that the opposed claims are novel in the light of WO’610.

EP 0552897 (EP’897) 

  1. EP’987 describes a starch-based pet chew containing an oral care additive, cellulosic fibrous material, humectant and proteinous binder.  The admixture is extruded at a temperature below 150°C.  The chew may also contain flavouring agents including meat and fish extract.  (Rowe#1 at [58], Dr Doherty at [50] agreeing.) 

  1. Novartis submits that this document anticipates claims 1-3 and 5-7 of the opposed application.  In contrast, Bayer argued that the oral care compounds are not “pharmaceutically active compounds”, and that flavours, which act after ingestion to improve palatability, are distinguished from aromas which can be smelt before ingestion. 

  1. I note that Dr Doherty does not dispute that the oral care additives referred to by EP’897 are “pharmaceutically active agents”.  Rather, she distinguishes the additives because the pharmaceutically active compounds referred to in the opposed application are systemically assimilated in contrast to those of EP’897 which act locally (Dr Doherty at [50]).  However, the opposed claims are not restricted to systemically active agents and therefore I conclude that the oral care agents described by EP’897 are encompassed by the term “pharmaceutically active compounds” in claim 1. 

  2. With regard to aromas, Dr Rowe understands the pet chew to contain specific aromas in order to increase the palatability and therefore acceptance for ingestion by animals (Rowe#1 at [59]).  On page 4, EP’897 lists preferred flavouring materials as garlic, wood smoke, meat and fish extracts and fermentation residues.  Dr Rowe considers that these flavourings, particularly meat, would carry an aroma that must act as an attractant (Rowe#4 at [33]-[34]).

  3. EP’897 does not explicitly disclose the starch-based extruded article comprising the combination as presently claimed.  However, opposed claim 1 will be anticipated if the person skilled in the art, following the directions provided by EP’897, would inevitably and inexorably arrive at the starch-based extruded articles comprising specific aromas as presently claimed.  However, flavouring is an optional feature of the pet chew taught by EP ‘897 - the exemplified subject matter does not include flavouring at all.  Consequently, while EP’897 contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, I consider it to be at least as likely to be carried out in such a way that would not do so.  It follows that the claims are not anticipated by this document.

  1. In summary, Novartis have established that the invention of claims 1-3 and 6 is not novel.

    Inventive step

  2. Under the provisions of subsections 7(2) and 7(3) of the Patents Act 1990, an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art. “Obvious” means “very plain” (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21 at [51]; (2007) 72 IPR 447 at 461 [51]). The relevant prior art is the common general knowledge, considered on its own or together with information in a document that the person skilled in the art could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant.

  3. The test for obviousness was provided by Aicken J in Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12 at [45]; (1981) 148 CLR 262 at 286 as whether it would have been a matter of routine to proceed to the claimed 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.”

  4. In Aktiebolaget Hässle v Alphapharm Pty Ltd (‘Alphapharm’) [2002] HCA 59 at [51]-[53]; 212 CLR 411 at [51]-[53], the High Court noted Aickens J’s reasoning in respect of what was “routine”, and the affinity of his approach with that of Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd[1970] RPC 157 at 187, who posed the question:

    “Would the notional research group at the relevant date, in all the circumstances, … directly be led as a matter of course to try [the invention claimed] in the expectation that it might well produce a [useful or desired result]?” (Emphases in original)

    The High Court held that this approach should be accepted.

  1. A “scintilla of inventiveness” is sufficient to support a finding of inventive step in a claimed invention (Lockwood (No 2) at [52]).  A step, if otherwise inventive, will not lose its inventiveness because once the idea is conceived, is very simple to put into effect (Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 at [52]; (1977) 137 CLR 228 at 249).

  1. While Mr Dimitriadis favoured the “problem-solution” approach used in ApotexPty Ltd v Sanofi-Aventis [2009] FCAFC 134; (2009) 82 IPR 416, Ms Howard submitted that inventive step in this case should be considered using the approach taken in Alphapharm, in which the High Court considered the inventiveness of a combination of integers in a pharmaceutical composition.  In Lockwood (No 2), the High Court at [65] supported the use of the “problem-solution” approach to obviousness in situations where it was appropriate, observing that the approach may overcome difficulties in ex post facto analysis of an invention.  However, the High Court reiterated that such an approach may be unfair to the inventor of a combination, or of a simple solution.  In the present case, I believe the approach advocated by Ms Howard is apposite.

  1. Where the invention lies in a combination of features, the question is whether the combination, not each individual feature, is obvious when compared to the prior art base:

    “The claim is for a combination, the interaction between the integers of which is the essential requirement for the presence of an inventive step.  It is the selection of the integers out of “perhaps many possibilities” which must be shown … to be obvious, bearing in mind that the selection of the integers in which the invention lies can be expected to be a process necessarily involving rejection of other possible integers.” (Alphapharm at [41])

    The person skilled in the art

  2. In this case the person skilled in the art is a person with a practical interest in the administration of pharmaceutically active compounds in the field of veterinary medicine.

  1. Novartis relied on two experts, Dr James Stevens Rowe and Dr Walter Otto Oechslein.  Bayer submitted that Dr Oechslein is not independent, having worked for Bayer in the area of commercial veterinary formulations, and has made several inventions in the area.  That the declarants may not be independent or are themselves inventors may effect the weight given to parts of their evidence.  However, there is no requirement for a person to be unconnected with the parties in an opposition in order to give evidence, nor is the evidence of an inventor inadmissible, provided that it is relevant.

  2. Bayer relies on evidence by Dr Margaret Doherty, who they state is Australian, independent and has experience in veterinary formulation.  Novartis submitted that Dr Doherty has limited relevant experience.  Dr Doherty’s declaration and curriculum vitae (in evidence as MD-1) states that she has a Bachelor of Pharmacy and a PhD in the field of pharmaceutics.  In addition, Dr Doherty has industrial, research and teaching experience in the pharmaceutical area, including in pharmaceutical formulation.  Dr Doherty has recently spent 2 years as a Science Fellow in Biopharmaceutics to the Australian Pesticides and Veterinary Medicine Authority and states that she has extensive experience in the field of veterinary medicine.  I have no reason to believe that Dr Doherty is not qualified to provide evidence as a skilled addressee in the present proceedings.

    Inventive step in light of the common general knowledge alone

    Common general knowledge

  3. The assessment of inventive step is carried out in light of the common general knowledge in the art.  A definition of common general knowledge was provided by Aitken J in Minnisota Mining and Manufacturing Company v Beiersdorf (Australia) Ltd [1980] HCA 9 at [115]; (1980) 144 CLR 253 at 292:

    “The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade.  It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”

  4. It was not in dispute that the individual features of the claimed articles and the process of extrusion formed part of the common general knowledge of the person skilled in the art prior to 26 June 2000.  Nor was it in dispute that the problem facing the person skilled in the art before the priority date was the reluctance of animals to accept veterinary medicines.  Novartis submitted that “having regard to the fact that the problem was known and the features of the claimed invention were in common use before June 2000, it is clear that it was obvious to include them in the articles as claimed”.

  1. The question to be asked at this point is would the non-inventive person skilled in the art faced with the above problem before the priority date, have taken as a matter of routine, the steps necessary to arrive at starch-based extruded shaped articles comprising a combination of specific aromas, bodying agents and pharmaceutically active compounds for animals, wherein the articles are produced by preparing a mixture of these ingredients and extruding the mixture at a temperature that is less than 150°C?

  1. Both Dr Rowe at [31] and Dr Oechslein at [59] state that if they had been required before the priority date to address the problem of oral acceptance by animals of pharmaceutically active compounds, they would have found it obvious to combine the ingredients as claimed, and to have produced the starch-based article by extrusion.  In contrast, Dr Doherty at [25], states that faced with the same problem, she would have considered an alternative route of administration for the pharmaceutically active compound.

  1. Both Drs Rowe and Oechslein provide their evidence in respect of the claimed invention having first read the opposed application (Rowe#1 at [4]; Dr Oechslein at [10]).  In Alphapharm at [21], the High Court warned against the misuse of hindsight in situations such as the present, where what is claimed is a new and inventive combination for the interaction of integers, some or all of which were known. Given that they knew the contents of the opposed specification at the time they gave evidence, I do not consider the evidence of Drs Rowe and Oechslein to be a reliable indicator of what the person skilled in the art would have done to overcome the problem before the priority date. In particular, the evidence of both declarants is essentially that faced with the problem before the priority date it would have been obvious to them to formulate the claimed combination. However, neither expert considers the state of the art before the priority date, including what other possible ingredients or production processes may have been available, nor why they would have rejected such alternatives in favour of the claimed combination. Dr Doherty has identified one such alternative, which Novartis’ declarants have not addressed, even in the evidence in reply.

  1. Consequently, I find that Novartis have not discharged their burden of establishing that the person skilled in the art, faced with the problem I have identified above, would have taken as a matter of routine the steps that led from the prior art to the claimed invention.  It follows that the claimed invention is not obvious in light of the common general knowledge in the art.

    Inventive step in the light of the common general knowledge and prior art information

  2. Novartis relied on 8 published patent documents to establish a lack of inventive step in the claimed subject matter, as follows:

    GB 2300103 A (Gilbertson & Page) 30 October 1996
    EP 0796565 A1 (Barbieux, S. et al) 24 September 1997
    US 5663140 A (Scherkenbeck, J. et al ) 2 September 1997
    FR 2702960 (Kerouedan, B. and Bonnet, C) 30 September 1994
    WO 1999/048372 A1 (General Mills, Inc.) 30 September 1999
    WO 1998/018610 A1 (Van Lengerich) 7 May 1998
    EP 0552897 A1 (Colgate-Palmolive Company) 28 July 1993
    AU 678577 B (Astra Aktiebolag) 21 November 1994

    Ascertained

  3. “Ascertained” simply means discovered or found out (Lockwood (No 2) at [132]).  Bayer submitted that there is no evidence that the documents relied on by Novartis could reasonably be expected to be ascertained because the evidence does not establish that the person skilled in the art in Australia routinely read patents.

  1. I note that Drs Rowe and Oechlein, both drug formulators, in the context of their practice with regard to the literature before the priority date, state that they review the patent literature in areas of interest related to their work (Rowe#1 at [6], Dr Oechslein at [9]).  Dr Doherty makes no comment on this point.  Bayer argued that Dr Oechslein’s evidence is of little value as he works in a commercial pharmaceutical company that can be expected to keep an eye on the competition, and that as he is located in Switzerland his practice may not reflect what a skilled person in Australia would do.  I cannot agree with the submission that as Dr Oechslein is an employee of a commercial company, this means that his practice should be considered not to reflect that of the average person skilled in the relevant art.  Many skilled drug formulators would similarly be employed by drug companies.  Moreover, the pharmaceutical field is a global one, and Dr Oechslein’s evidence at [9] accords with that of Dr Rowe who has worked in the field in Australia for many years (JSR-1).  I conclude from the evidence before me that the person skilled in the art could be reasonably expected to search the patent literature.

  1. Prima facie, the person skilled in the art wishing to overcome the reluctance of animals to voluntarily ingest dosage forms comprising pharmaceutically active compounds, could be reasonably expected to search for documents that address the same problem.

  1. FR 2702960 in English is entitled “Lure for the oral administration of veterinary medicines”, and is directed to overcoming difficulties in the administration of veterinary medicines (Rowe#1 at [52]).  Similarly, EP 0796565, entitled “Oral treatment product for animals” addresses the problem of voluntary acceptance and ingestion of treatment active substances by animals (Rowe#3 at [18], supported by Dr Oechslein’s statements at [56]).  I have no evidence before me to indicate that the person skilled in the art researching the problem would confine their enquiry to patent documents in the English language, and therefore prima facie I consider that FR’960 and EP’565 would have been ascertained by the person skilled in the art investigating the problem of voluntary ingestion of veterinary dosage forms.

  2. US 5663140 relates to the use of cyclic depsipeptides in veterinary formulations, but does not address the problem of voluntary ingestion.  The document might have been ascertained if the person skilled in the art, investigating a problem relating to voluntary ingestion, would have investigated the problem by searching in the area of a specific compound.  I have no evidence before me on this point.  Consequently, I am not satisfied that a person skilled in the art would have ascertained US’140. 

  1. Bayer submitted that WO 1999/048372, WO 1998/018610, EP 0552897 and GB 2300103 are each directed to a different problem than that addressed by the present application.  On the face of these documents this appears to be the case, and Novartis led no evidence to the contrary.  Consequently, I am not satisfied that these documents could, before the priority date of the relevant claim, be reasonably expected to have been ascertained by the person skilled in the art seeking to overcome the reluctance of animals to voluntarily ingest dosage forms comprising pharmaceutically active compounds.

  1. Both Drs Rowe and Doherty distinguish AU 678577 in that it deals with the problem of voluntary ingestion of a pharmaceutical agent by humans, rather than animals (Rowe#3 at [7], Dr Doherty at [65]).  I have no evidence before me that would establish that the person skilled in the art, investigating the problem I have identified above, would search beyond the veterinary field to ascertain this document.  It follows that Novartis have not established that that the person skilled in the art could be reasonably expected to have ascertained AU’577.

  1. In summary, I consider that FR 2702960 and EP 0796565 would have been ascertained by the person skilled in the art seeking information on overcoming the reluctance of animals to voluntarily ingest dosage forms comprising pharmaceutically active compounds.

Understood and regarded as relevant

  1. “Understood” for the purposes of section 7(3) means that the skilled addressee would have comprehended the information or appreciated its meaning or import (Lockwood (No 2) at [132]).  In order to be “relevant” the prior art document should be relevant to solving the particular problem or long-felt want or need that the patentee claims to have done (Lockwood (No 2) at [152]).  In this case, this means solving the problem of the reluctance of animals to voluntarily ingest dosage forms comprising pharmaceutically active compounds (Rowe#1 at [27], Dr Oechslein at [45], Dr Doherty at [9]-[10]).

  1. Patent applications FR 2702960 and EP 0796565 are both in the French language and do not contain an English language abstract.  While I have been provided with an English translation, it has not been suggested that the translation was included in the prior art base. 

  1. As noted by the delegate in Euroceltique S.A. v Sandoz Pty Ltd [2009] APO 21 at [86]; (2010) 84 IPR 172 at 190 [86], where a person has a reason to consider a document could likely be relevant, it is reasonable to expect that they would obtain a translation, if this was required to make the full content of the document understandable. In the present case, I consider that the French title of FR’960 “Leurre pour l’administration orale de médicaments vétérinaires”, is sufficiently recognisable at least to English speakers, to motivate the person skilled in the art to obtain a translation of the document.  Having done so, I believe the document would have been understood and regarded as relevant by the person skilled in the relevant art.

  1. A motivation to obtain a translation of EP 0796565 is not apparent from the face of the document.  None of the experts have indicated that they considered the French language document relevant.  Consequently, I can only conclude the skilled person would not have understood EP’565, and considered it relevant to the problem in this case.

Inventive step in view of the common general knowledge and FR 2702960

  1. FR’960 discloses the composition and the production of a lure for the oral administration of veterinary medicines.  The lure may contain starch as a carrier, a specific aroma, bodying agents and ancillary materials (Dr Doherty at [46], Dr Rowe at [51]-[52]).  The lure may be extruded at a temperature less than 150°C into containers (Dr Oechslein at [58], Dr Doherty at [46]), or a moldable paste (Dr Doherty at [46]), for holding the pharmaceutically active compound. 

  1. This prior disclosure must be used for:

    “the purpose of looking forward from the prior art base to see what a person skilled in the relevant art is likely to have done when faced with a similar problem which the patentee claims to have solved with the invention.” (Lockwood (No 2) at [127])

  1. In order to anticipate the claims of the opposed application, it would at least need to be shown that before 26 June 2000, the person skilled in the art having read FR’960 would, as a matter of routine, have modified the lure of FR’960 to incorporate the pharmaceutically active ingredient into the lure formulation prior to extrusion.  Novartis have served no evidence in this regard.  Consequently, Novartis have not established that the claimed invention is obvious in the light of the common general knowledge in the art and the information in FR 2702960.

    Manner of Manufacture

  2. Section 18(1)(a) requires that an invention must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.  Whether an invention is a 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 at 655).

  3. Novartis submitted that the alleged invention is a mere collocation of components known to be used in starch-based extruded articles, with no new working interrelationship between the components.  However, no evidence was presented by Novartis to support this last proposition.

  1. I consider the specification to describe an article comprising a new combination that is useful for the administration of pharmaceutically active compounds to animals.  While the individual components of the articles are known, the specification asserts that the claimed combination has an advantage over previous dosage forms.  In my view, this is sufficient for there to be an invention on the face of the specification.  It follows that Novartis have not established that the invention is not a manner of manufacture.

    Utility

  2. When assessing utility, the test to be applied is:

    “to judge of utility the directions in the specification must be followed, and if the result is that the object sought to be obtained can be attained, and is practically useful at the time when the patent is granted, the test of utility is satisfied … ‘Useful for what?’ is a question which must always be asked, and the answer must be useful for the purposes indicated by the patentee” (Lane Fox v Kensington and Knightsbridge Electric Lighting Co (1892) 9 RPC 413 at 416)

  1. More recently, the issue of utility was considered by the Full Court of the Federal Court, which applied the test:

    “If the claimed invention does what it is intended by the patentee to do and the end result obtained is itself useful, the invention is useful within the meaning of s 18(1)(c) … As to the first aspect, the invention as claimed must attain the result promised by the patentee” (Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC [2008] FCAFC 82 at [141]; (2008) 77 IPR 449 at 479 [141]).

  1. In construing the claims for the purposes of utility, the claims must be construed from the perspective of a skilled addressee in a commonsense way, and not in such a way that any such addressee would appreciate would lead to an unworkable result (SNF (Australia) Pty Ltd v Ciba Specialty Chemicals Water Treatments Limited [2011] FCA 452 at [293]).

  1. In summary, lack of utility is established when a claim includes subject matter that will not produce the desired result.  In this case the desired result is to provide pharmaceutical presentations for oral administration to animals, which are readily accepted (voluntarily ingested) by the animals. 

  1. Novartis’ case on lack of utility is essentially that the claims are not limited to articles that are readily accepted by animals and the articles are so broadly defined that the claims must necessarily encompass subject matter that would not be readily accepted.

  1. In support of the ground of inutility, Novartis rely on the evidence of Dr Rowe as follows:

    ·not all pharmaceutically active compounds would in fact be suitable for inclusion in the articles defined by the claims of the opposed application (Rowe#4, paras [25], [53]).

    ·there is no information in the body of the specification or the claims which directs him to which other ingredients can be added to give the articles characteristics that are attractive to animals, let alone the quantity of such ingredients (Rowe#4, paras [54]).

    ·a substantial amount of testing would be required in order to select the relevant ingredients (including which pharmaceutically active substances are best suited to which excipient, or which bodying agent is best suited to achieve a certain texture) and to produce an article that would be readily accepted by an animal (Rowe#4, paras [55]).

    ·the requirements affecting whether an article will be “readily accepted” by an animal will be “specific to the animal and the nature and/or taste of the pharmaceutically active compound” (Rowe#4, paras [25]). 

    ·there may be incompatibility between an excipient and a pharmaceutically active compound, which means that they cannot be combined; and that pharmaceutically active compounds may be heat labile, which means that they are likely to alter when heated to particular temperatures (Rowe#4, paras [2]).

  2. Novartis’ submissions based on Dr Rowe’s evidence summarised above are speculative.  Novartis did not identify, or demonstrate either by evidence or argument, any specific combination falling within the claims that would not be not readily accepted by an animal to which it is administered.  Therefore, Novartis have not established that the claimed invention lacks utility.

    Section 40 issues

  3. Section 40(2) of the Patents Act relevantly requires that a complete specification must (a) describe the invention fully, including the best method known to the applicant of performing the invention and (b) end with a claim or claims defining the invention.  Section 40(3) requires that the claim or claims in a patent specification must be clear and succinct and fairly based on the matter described in the specification. 

Section 40(2): Lack of full description and claims defining the invention

  1. Novartis’ submissions based on lack of full description and failure to define the invention were underpinned by the same facts that support the inutility ground summarised above at [107]. Novartis submissions were:

    “In short, if … the claims require that the articles be “readily accepted” by animals, then the specification does not enable the skilled person to produce such articles without new inventions or additions or prolonged study of matters presenting additional difficulty, and therefore fails to comply with s 40(2)(a). Further, in that event, the claims do not adequately define the composition of such articles in terms of the nature and relative amounts of pharmaceutically active compounds and other components they contain, and therefore fail to meet the requirement that they “define the invention” pursuant to s 40(2)(b).”

  2. The High Court in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at [25]; (2001) 207 CLR 1 at 17 explained the test for full description as:

    “The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?”

  1. The specification contains examples with sufficient information for the skilled person to prepare a starch-based extruded article falling within the present claims.  The requirement for full description is therefore satisfied.

  1. The requirement in section 40(2)(b) that a complete specification for a standard patent shall end with a claim or claims defining the invention is simply that there must be a claim or claims and that they should define the monopoly for which the application has been made (AMP Inc v UtiluxPty Ltd (1971) 45 ALJR 123 at 128). I consider that the specification meets this requirement.

Section 40(3): Clarity

  1. A claim is lacking in clarity if a third party could not ascertain whether an act would fall within the scope of the claim (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59 at 60).

  1. Novartis pressed only that the term “bodying agent” is not clear because the term is not clearly defined in the specification.  In support, Novartis referred to Dr Rowe’s evidence in which he identifies the preferred bodying agents as cellulose and derivatives and highly dispersed silicates and titanium, but notes that in starch-based extrusion the starch acts as a bodying agent (Rowe#4 at [52]).  As a result he states that:

    “… I do not believe it is clear from a reading of claim 1 or any of the claims for that matter, that the starch and the bodying agents are separate ingredients.”  

  2. However, since all of the declarants agree that starch is capable of acting as a bodying agent, in addition to acting in other capacities (Rowe#4 at [52], Dr Oechslein at [16], Dr Doherty at [74], [83]), I do not believe the experts found difficulty with interpreting the term “bodying agent” as potentially encompassing starch.  Consequently, I find the claims are clear.

    Conclusion

  3. Novartis has succeeded in its opposition.  The subject matter of claims 1-3 and 6 is not novel.  It is possible to overcome this deficiency by amendment of the claims.  I therefore allow Bayer two months from the date of this decision to propose such amendments.

    Costs

  4. At the hearing, both Novartis and Bayer submitted that costs should follow the event.  I see no reason to vary this practice.  Novartis have succeeded in the opposition on the ground of novelty.  I award costs according to Schedule 8 against Bayer Animal Health GmbH.

    Barbara Akhurst

    Delegate of the Commissioner of Patents

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