Allergan, Inc. v Galderma Research & Development

[2015] APO 87

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Allergan, Inc. v Galderma Research & Development [2015] APO 87

Patent Application:                2010252935

Title:Injectable combination of adrenergic receptor agonists with fillers, for decreasing skin reactions due to injection

Patent Applicant:                   Galderma Research & Development

Opponent:  Allergan, Inc.

Delegate:  Dr M-A. Fam

Decision Date:  15 December 2015

Hearing Date:  23 November 2015, in Canberra

Catchwords:  PATENTS – section 59 – opposition to the grant of a patent – grounds of novelty, inventive step, manner of manufacture, utility, fair basis and clarity considered – novelty – citation does not disclose all the features of the claims – inventive step – evidence does not establish that it would be a matter of routine to prepare an injectable composition comprising three active ingredients – claims define a manner of manufacture – claimed invention is useful – claims are fairly based and clear – opposition fails

Representation:  Patent applicant: Bernadette Hawkins of Cullens

Opponent: Christian Dimitriadis SC and Gavin Recchia of Davies Collison Cave

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                2010252935

Title:Injectable combination of adrenergic receptor agonists with fillers, for decreasing skin reactions due to injection

Patent Applicant:                   Galderma Research & Development

Date of Decision:                   15 December 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 Allergan, Inc.

REASONS FOR DECISION

Background

1. The present application was filed by Galderma Research & Development (Galderma) and Symatese on 28 May 2010.  Symatese subsequently assigned its rights in the application to Galderma.  The application claimed priority from US 61/213322 having a filing date of 29 May 2009.  Following examination, the application was advertised accepted on 9 January 2014.  Galderma subsequently filed section 104 amendments on 2 January 2015 and the amendments were advertised allowed on 28 May 2015.

2. A notice of opposition was filed by Allergan, Inc. (Allergan) on 9 April 2014.  A hearing was held in Canberra on 23 November 2015.  Galderma was represented by Bernadette Hawkins of Cullens.  Allergan was represented by Christian Dimitriadis SC and Gavin Recchia of Davies Collison Cave. 

3. It is noted that the request for examination in relation to the application was filed on 23 November 2011.  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.  A similar qualification applies to references to the Patents Regulations 1991.

   Grounds of opposition

4. The original statement of grounds and particulars was filed on 9 July 2014.  A request to amend the statement was filed on 9 November 2015 and subsequently allowed.

5. 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.

6. All grounds were pressed at the hearing, other than the section 40 issue of full description.

   Standard of proof

7. 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

8. The evidence filed is summarised in the table below.

Evidence	Declarant	Exhibits	Date	Reference
Peter Callan	PC-1	8 October 2014	Callan-1
In Support
Mark Magnusson	MM-1	8 October 2014	Magnusson-1
In Answer	Anca Debu	9 January 2015	Debu
Peter Callan	13 March 2015	Callan-2
In Reply	Mark Magnusson	13 March 2015	Magnusson-2

The subject matter of the specification

Background of the invention

1. The specification relates to injectable compositions and their use in aesthetic procedures, in particular cosmetic dermatology.  These procedures include the injection of fillers and botulinum toxin.  Fillers, such as hyaluronic acid, are biomaterials that are able to fill dermal tissues.  Botulinum toxins cause muscle paralysis or contraction.

2. The specification indicates that superficial bruising and bleeding are not uncommon consequences of these cosmetic procedures.  The injection of fillers may also result in secondary immediate reactions, including redness and ecchymosis.  These adverse side effects may be treated through the use of ice packs immediately after the procedure or the use of the herb Arnica to promote healing.  If bruising occurs following a procedure, patients prefer to avoid work and social activities and instead remain at home. 

   Aim of the invention

3. The specification states (page 2, lines 5 – 6):

   “Therefore, there is a need for alleviating bruising/bleeding that occur during aesthetic or surgical procedures, especially when fillers are injected.”

   Nature of the invention

4. The specification indicates that the injection of an adrenergic receptor agonist together with a filler reduces the occurrence of skin reactions due to injection. 

5. Thus, in one aspect, the invention provides a method for diminishing, decreasing or avoiding skin reactions due to injection comprising injecting a composition containing a filler or a botulinum toxin and an adrenergic receptor agonist.  In a further aspect, the composition may be used in the prevention and treatment of skin defects, especially folds, wrinkles, skin depressions and scars (page 2, line 29 – page 2a, line 3 and page 9, lines 1 – 3).

6. The preferred filler is hyaluronic acid, which is a non-sulphated glycosaminoglycan found in connective, epithelial and neural tissues.  It plays an important role in the hydration and elasticity of skin.

7. Adrenergic receptor agonists bind and activate the adrenergic receptors.  These receptors may be either a or b type, with a-adrenoreceptors further distinguished as a1 and a2.  Compounds that function as a-adrenergic receptor agonists possess peripheral vasconstrictive activity and include brimonidine and clonidine.

8. The composition may also contain further active ingredients, for example an anaesthetic, preferably lidocaine.

   The examples

9. The examples evaluate irritation and inflammatory response following the injection of a composition containing hyaluronic acid (filler), brimonidine (an a-adrenergic receptor agonist) and lidocaine (anaesthetic) and a control wherein brimonidine is absent.  Following analysis of the results, the specification concludes that by incorporating brimonidine, it is possible to reduce the inflammatory response (page 13, line 3 – page 14, line 22 and Figures 1 and 2).

   The claims of the specification

10. The claims as amended consist of independent claims 1 – 6 and dependent claims 7 – 13, with claim 13 being an omnibus claim.

    The person skilled in the art

11. The person skilled in the art was considered at the hearing.  As stated in Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70] – [71]; 49 IPR 225:

    “He is the person to whom the patent is addressed and who must construe it.  He is the person whose knowledge will determine whether a patent is novel.  He is the person who will judge whether a patent is obvious.  ….

    In Catnic Lord Diplock said (at 242) that skilled addressees are ‘those likely to have a practical interest in the subject matter of [the] invention’.  A variety of people may have that interest.  There are those who might wish to make or construct the invention, those who may wish to compound the invention and those who may wish to use the invention.  The skilled addressee seems to me to be a relative expression which does not identify any specific person.”

12. Dr Callan is a plastic surgeon with a particular interest in facial cosmetic surgery, including the use of dermal fillers.  Dr Magnusson is a plastic surgeon whose non-surgical practice includes the injection of dermal fillers.  Dr Debu has medical and dermatological qualifications and has practical experience in cosmetic procedures such as the injection of dermal fillers.  I consider that Dr Callan, Dr Magnusson and Dr Debu would all have a practical interest in the invention.

13. Allergan stated that Dr Debu is in France and is therefore not in the position to comment on the approach of a skilled person in Australia.  However, I accept Galderma’s submission that the art of dermal fillers is of an international nature.

14. Allergan further submitted that Dr Debu is not independent, being an employee of Galderma.  I will have regard to all of the evidence provided by the three declarants.  Where there is conflicting evidence, I will use the normal practice of evaluating and weighing the evidence in order to resolve any conflict.

    Claims construction

15. 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 …”

    Construction of claim 1

16. Independent claim 1 is as follows:

    A cosmetic method for preventing or treating skin defects by injecting in an individual in need thereof with an injectable composition comprising:

    - hyaluronic acid (HA);

    - an a-adrenergic receptor agonist; and

    - an anaesthetic, wherein the anaesthetic is lidocaine or a pharmaceutically acceptable salt thereof.

17. Adopting the plain meaning of the words, the claim defines a method for preventing or treating skin defects by injecting a composition, i.e. the composition administered must be such that it achieves the result of preventing or treating skin defects. 

18. “Cosmetic” means “serving to beautify; imparting or improving beauty, especially of the complexion” (Macquarie Dictionary).  This is consistent with the discussion throughout the specification of the use of injectable compositions in aesthetic procedures, such as dermal fillers and botulinum toxins.

19. The specification indicates that skin defects include those due to ageing or skin damage.  The former include folds, wrinkles and skin depressions, whilst examples of the latter include scars (page 2a, lines 1 – 3).  It is therefore appropriate to construe “skin defects” as meaning defects of the type mentioned in the specification.

20. Claim 1 is therefore considered to define a method wherein the appearance of the complexion is improved by the injection of an injectable composition comprising hyaluronic acid, an a‑adrenergic receptor agonist and lidocaine, the composition being such that it prevents or treats skin defects.

    Construction of claim 2

21. Claim 2 is also independent and reads:

    A method for diminishing, decreasing or avoiding skin reactions due to injection, comprising injecting an injectable composition comprising;

    - hyaluronic acid (HA);

    - an a-adrenergic receptor agonist; and

    - an anaesthetic, wherein the anaesthetic is lidocaine or a pharmaceutically acceptable salt thereof,

    to an individual in need thereof.

22. Adopting the plain meaning of the words, the claim defines a method for diminishing, decreasing or avoiding skin reactions by injecting a composition, i.e. the composition administered must be such that it achieves the result of diminishing, decreasing or avoiding skin reactions. 

23. The specification indicates that “skin reactions” include redness, ecchymosis, bruising, bleeding, erythema, oedema, necrosis, ulceration, swelling and inflammation (page 2, lines 33 – 37 and page 9, lines 24 – 27) and the term is construed to mean reactions of this type. 

24. Dr Callan states that in the context of the specification, he understands the reference to skin reactions to mean skin reactions resulting from the injection of fillers or botulinum toxin (Callan‑1 at [16]).  Similarly, Dr Magnusson understands the reference to skin reactions in claim 2 to be a reference to skin reactions resulting from the administration of a botulinum toxin or filler (Magnusson-1 at [34]).

25. These comments were made in respect of the specification prior to amendment, when the claims referred to an injectable composition comprising a filler or botulinum toxin, whereas the amended claims are limited to a composition comprising the filler hyaluronic acid.  The specification indicates that the “injections” are those involving administration of the filler (page 1, lines 23 ‑ 26; page 2, lines 5 – 6; page 9, lines 5 – 7 and the examples). Thus, “skin reactions due to injection” is construed to mean skin reactions arising as a result of the injection of hyaluronic acid.

26. Claim 2 is therefore considered to define a method wherein skin reactions resulting from the injection of hyaluronic acid are diminished, decreased or avoided, by administering an injectable composition comprising hyaluronic acid, an a-adrenergic receptor agonist and lidocaine.

    Construction of claim 3 and claim 5

27. Independent claims 3 and 5 are as follows:

    3.        Use of an injectable composition comprising:

    - hyaluronic acid (HA);

    - an a-adrenergic receptor agonist; and

    - an anaesthetic, wherein the anaesthetic is lidocaine or a pharmaceutically acceptable salt thereof,

    for preventing or treating skin defects.

    5.        Use of an injectable composition comprising:

    - hyaluronic acid (HA);

    - an a-adrenergic receptor agonist; and

    - an anaesthetic, wherein the anaesthetic is lidocaine or a pharmaceutically acceptable salt thereof,

    for diminishing, decreasing or avoiding skin reactions due to injection.

28. Claims 3 and 5 are the “use” versions of method claims 1 and 2 respectively.  The construction of the terms used in claims 1 and 2, as discussed above, applies equally to the corresponding use claim.

    Construction of claim 4 and claim 6

29. Independent claims 4 and 6 read:

    4.        Use of hyaluronic acid (HA), an a-adrenergic receptor agonist and an anaesthetic, wherein the anaesthetic is lidocaine or a pharmaceutically acceptable salt thereof, in the manufacture of an injectable composition for preventing or treating skin defects.

    6.        Use of hyaluronic acid (HA), an a-adrenergic receptor agonist and an anaesthetic, wherein the anaesthetic is lidocaine or a pharmaceutically acceptable salt thereof, in the manufacture of an injectable composition for diminishing, decreasing or avoiding skin reactions due to injection.

30. Claims 4 and 6 are the “Swiss claim” versions of method claims 1 and 2 respectively.  The construction of Swiss type claims was considered by Yates J in Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634; 113 IPR 191. It was held that a Swiss claim defines a method or process for making a medicament, wherein the intended therapeutic use of the medicament qualifies the scope of the claim.

31. Claim 4 is construed to define a method for making an injectable composition containing hyaluronic acid, an a-adrenergic receptor agonist and lidocaine, wherein the intended use of the composition is to prevent or treat skin defects.  Similarly, claim 6 is construed to define a method for making an injectable composition containing hyaluronic acid, an a-adrenergic receptor agonist and lidocaine, wherein the intended use of the composition is to diminish, decrease or avoid skin reactions due to injection.  In addition, the construction of the terms used in claims 1 and 2, as discussed above, applies equally to the corresponding Swiss claim.

    Construction of claim 13

32. Claim 13 is an omnibus claim and reads as follows:

    Methods or uses involving an injectable composition, according to any one of claims 1 to 6, and substantially as herein described with reference to the Examples and/or Figures, excluding the comparative examples.

33. The construction of omnibus claims was considered in Reckitt Benckiser Healthcare (UK) Ltd v Glaxosmithkline Australia Pty Ltd (No 5) [2015] FCA 486 at [108] – [112]; 112 IPR 273. The word “substantially”, in the context of “substantially as described with reference to the drawings and/or examples” was held to mean the omnibus claim:

    “extends to the substantial idea disclosed by the specification and shown in the drawings, but is not limited to the exact expression or illustration of that idea in the patent.”

34. Allergan submitted that claim 13 lacks clarity for several reasons and I will consider each of these in turn. 

    Composition 10LDEEP010 (Test1)

35. Claim 13 makes reference to the examples, excluding the comparative examples.  Allergan stated that there are inconsistent statements in the specification as to whether the exemplified positive control composition, 10LDEEP010 (Test1), contains the anaesthetic lidocaine in addition to the filler hyaluronic acid.  At page 10, reference is made to Test1 containing the filler alone (lines 9 ‑ 12 and lines 22 – 24).  However, the preparative method for Test1 involves the addition of lidocaine hydrochloride to hyaluronic acid following the crosslinking process (page 11, lines 7 ‑ 14).

36. Galderma submitted that Test1 only contains hyaluronic acid and that the reference to lidocaine in the preparative method on page 11 is a typographical error.  However, there is no evidence to support this assertion.

37. On reading the specification, Dr Magnusson notes that it describes the results of studies in which hyaluronic acid (i.e. Test1), or hyaluronic acid plus lidocaine and brimondine, was administered to rabbits (Magnusson-1 at [35]).  However, later when discussing the results, Dr Magnusson considers the Test1 product to contain both hyaluronic acid and lidocaine (Magnusson-2 at [16]).

38. Thus, Dr Magnusson understands the Test1 composition to contain both hyaluronic acid and lidocaine and this is consistent with the preparative method on page 11.  The method clearly refers to the addition of lidocaine hydrochloride at the end of the crosslinking process and states that it is added in an amount to achieve a concentration of 03%.  I consider that the skilled addressee would give greater weight to the manner in which the Test1 composition is prepared, as opposed to the statements about this substance on page 10.  The presence of both hyaluronic acid and lidocaine in Test1 is also consistent with the use of this composition as a positive control.  Test1 is compared with a composition containing hyaluronic acid, lidocaine and brimonidine in order to evaluate the effect of brimonidine on the inflammatory response (page 14, lines 15 – 22).

39. The Test1 composition is considered to contain both hyaluronic acid and lidocaine.

    Comparative example

40. Allergan submitted that it is not clear whether the comparative example referred to in claim 13 is intended to mean the control, i.e. Test1.  Galderma confirmed that the comparative example is Test1.  This is consistent with the use of a control for comparative purposes.

41. The comparative example is therefore considered to be the positive control Test1.

    “Substantially as herein described”

42. Allergan submitted that it is unclear how a method or use according to any one of claims 1 to 6 is “substantially as herein described with reference to the Examples and/or Figures” in the specification.  In particular, as the examples relate to studies in rabbits, Allergan queried whether the omnibus claim is limited to methods or uses in such animals.

1. The examples and figures in the specification evaluate the potential of brimonidine to reduce inflammation and irritation following intradermal injection of the filler hyaluronic acid in rabbits.  Thus, the examples relate to methods or uses for diminishing, decreasing or avoiding skin reactions due to injection of the filler. 

2. Claim 13 is appended to any one of claims 1 to 6.  A sensible construction is to append claim 13 only to those claims that define methods or uses for diminishing, decreasing or avoiding skin reactions, namely claim 2, claim 5 and claim 6.  I will consider each of these claims in turn.

3. Claim 2 defines a method comprising injecting an injectable composition comprising hyaluronic acid, an a-adrenergic receptor agonist and lidocaine to an individual in need thereof.  Giving the claim a purposive construction, a rabbit is not considered to be an individual in need of treatment with a dermal filler.  For this reason I conclude that claim 13 does not define the method of claim 2 with reference to the examples and/or figures.

4. Claim 5 defines the use of an injectable composition for diminishing, decreasing or avoiding skin reactions due to injection.  The use of the composition necessarily involves its administration to a subject or patient.  In the case of the examples this is a rabbit.  The examples further qualify that the a-adrenergic receptor agonist is brimonidine.  Claim 13, when appended to claim 5, is considered to define the use in rabbits of an injectable composition comprising hyaluronic acid, brimonidine and lidocaine for diminishing, decreasing or avoiding skin reactions due to injection.

5. Claim 6 is the Swiss claim version of claim 5.  Following similar reasoning to that outlined above, claim 13, when appended to claim 6, is considered to define the use of hyaluronic acid, brimonidine and lidocaine in the manufacture of an injectable composition for diminishing, decreasing or avoiding skin reactions due to injection in rabbits.

   Priority date

6. Under regulation 3.12, where a claim is fairly based on matter disclosed in 1 or more priority documents, the priority date of the claim is the date of filing of the priority document in which the matter was first disclosed.

7. Subsection 40(3) requires that the claims must be fairly based on the matter described in the specification.  The test for fair basis was stated by the High Court in Lockwood Security v Doric Products [2004] HCA 58 at [69]; 217 CLR 274 as:

   “Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.”

8. Allergan submitted that the claims are not entitled to the earliest priority date of 29 May 2009.  In particular, the priority document US 61/213322 does not make any reference to an anaesthetic as a component of the injectable composition.

9. US 61/213322 describes the use of a-adrenergic receptor agonists in combination with fillers such as hyaluronic acid.  There is no disclosure of an anaesthetic, either as a component of the injectable composition or otherwise.  Consequently, the earliest priority date of the claims is the filing date, i.e. 28 May 2010.  I note that this finding has no impact on novelty or inventive step considerations, as all of the documents cited in the statement of grounds and particulars are published before 29 May 2009.

   Novelty

10. 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.

11. 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”.

12. 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).

13. Allergan submitted that claims 1 – 12 are not novel in view of US 2009/0130027 (D10).

    US 2009/0130027 (D10)

14. D10 was published on 21 May 2009 and therefore forms part of the prior art base.  D10 describes the use of an a-adrenergic receptor agonist (agonist) to treat vascular extravasation into the skin and in particular purpura. The definition of “purpura” includes ecchymosis, which in turn is a bruise ([0033], [0036]). It is further stated that the agonist may be used to treat ageing of the skin, for example skin wrinkling ([0044]).

15. D10 discloses that the agonist may be used to treat purpura caused by surgical procedures, including the injection of fillers ([0047]).  The agonist may be administered locally (including via injection) during the procedure ([0047], emphasis added).  “During” means “in the course of” (Macquarie Dictionary).  Thus, the agonist and filler could either be administered together in the one composition, or administered as separate compositions.  The person skilled in the art would understand the term filler to include hyaluronic acid (Callan-1 at [9]; Magnusson-1 at [10]; Debu at [6]). 

16. D10 indicates that in a further embodiment, other active agents may be combined with the agonist in a formulation suitable for local administration. These agents include anaesthetics such as lidocaine ([0060] – [0062]). However, an anaesthetic is only one of the 15 possible classes of agent listed and the use of such a substance is not exemplified.

17. I further note that all of the preparative examples in D10 relate to topical compositions wherein the agonist is the sole active ingredient.  The compositions are used to treat laser-induced purpura or solar purpura.

18. The administration of an anaesthetic is also mentioned in the claims of D10.  Claim 27 defines a method for decreasing purpura by administering an agonist to the site of a surgical procedure (which includes the injection of fillers).  Dependent claim 38 defines the method of claim 27 further comprising administering at least one other active agent, including an anaesthetic.  However, this is only one possibility from a list of active agents.  Furthermore, it is not clear that the agonist, filler and anaesthetic are in the one composition.

19. D10 does not provide clear and unmistakeable directions to prepare an injectable composition comprising an a-adrenergic receptor agonist, hyaluronic acid and lidocaine, or use such a composition to prevent or treat skin defects, or diminish, decrease or avoid skin reactions arising from injection of the hyaluronic acid.

20. It has not been demonstrated that the claims lack novelty.

    Inventive step

21. 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.

22. 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)

23. 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

24. The problem addressed by the specification is the need to alleviate bleeding or bruising that occurs during aesthetic procedures, such as the injection of dermal fillers.

    Common general knowledge

25. The parties agreed that hyaluronic acid, lidocaine and a-adrenergic receptor agonists are part of the common general knowledge.  It was also acknowledged that hyaluronic acid and lidocaine are known to function as a filler and an anaesthetic respectively.  a-Adrenergic receptor agonists are known to mediate peripheral vasoconstriction.

    Prior art – ascertained, understood and regarded as relevant

26. Allergan submitted that claims 1 – 12 are not inventive in light of US 2009/0130027 (D10) when considered together with the common general knowledge. 

27. The first question to consider is whether this document would have been ascertained, understood and regarded as relevant.  None of the evidence indicates that the skilled addressee would conduct a search of the patent literature in order to solve the problem.  However, Allergan submitted that given the technical nature of the field, it would be reasonable to expect the person skilled in the art to consult the patent literature.  Allergan stated that there is no evidence to the contrary and further that Galderma does not dispute the fact that D10 would have been ascertained.

28. I agree that the technological nature of the invention is such that it would be reasonable to expect the person skilled in the art to conduct a search of the patent literature.  Therefore D10 would likely have been ascertained.  As discussed previously, D10 relates to the use of an a-adrenergic receptor agonist (agonist) to treat purpura (ecchymosis, bruising) and the use of agonists in surgical procedures including the injection of fillers.  D10 would therefore be regarded as relevant.

    US 2009/0130027 (D10)

29. Allergan stated that in view of D10 it would have been obvious to combine hyaluronic acid, an agonist and lidocaine in an injectable composition for the prevention or treatment of bruising caused by cosmetic procedures such as the use of dermal fillers.  This is particularly so given the common general knowledge, which includes knowledge of the use of each of the three components of the composition for their individual purposes.

30. The disclosure of D10 is discussed above.  Thus, D10 describes methods for treating purpura (bruising) wherein an agonist may be administered during surgical procedures, which include the injection of fillers.  An anaesthetic may also be administered during the procedure.  However, whilst the agonist, the anaesthetic and the filler could be in the same composition, D10 does not clearly indicate that the active ingredients are combined in this manner.  As previously noted, all of the examples in D10 relate to topical compositions containing only the agonist.  Furthermore, these compositions are commercially available, i.e. no methods for the preparation of compositions are exemplified in D10.

31. Therefore, the question to consider is whether it would be a matter of routine for the person skilled in the art to prepare an injectable composition containing an agonist, a filler (hyaluronic acid) and an anaesthetic (lidocaine). 

32. Dr Debu states that there are potential problems and obstacles that need to be overcome in developing a single formulation having all three actives.  Such problems relate to the safety, stability and efficacy of the composition (Debu at [6] – [7]).  Thus:

    “Combining three actives is not a straightforward process.  It is not possible to predict that combining three actives in a composition would result in a safe and stable formulation, whilst preserving the activity of the components.  Combining actives in a single formulation will always raise issues of stability, safety and efficacy of the combination.” (Debu at [24])

33. Dr Magnusson notes that no such problems or obstacles are referred to in either the specification or Dr Debu’s declaration (Magnusson-2 at [17]).  However, neither Dr Magnusson or Dr Callan comment on whether it would be a matter of routine for the skilled addressee to combine an agonist, hyaluronic acid and lidocaine into an injectable composition.  Although it may be possible to combine the three active ingredients, the assertion that the skilled addressee would do so as a matter of routine appears to be made with the benefit of hindsight.

34. The evidence does not establish that it would be a matter of routine for the person skilled in the art to prepare an injectable composition comprising hyaluronic acid, an a-adrenergic receptor agonist and lidocaine. 

35. It has not been demonstrated that there is a lack of inventive step in light of D10.

    Manner of manufacture

36. 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).

37. Allergan submitted that on the face of the specification the invention lacks the necessary quality of newness or inventiveness.  However, from reading the specification, there is no indication that it was known that an injectable composition comprising hyaluronic acid, an a-adrenergic receptor agonist and lidocaine could be used to prevent or treat skin defects, or diminish, decrease or avoid skin reactions due to injection.

38. Allergan further submitted that the claimed invention involves the known use of known compounds or substances administered in accordance with known medical practices and without application of any inventive faculty.  Thus, it is a mere collocation of known integers each performing its known function.

39. The claims are directed to methods or uses wherein an injectable composition comprising hyaluronic acid, an a-adrenergic receptor agonist and lidocaine is administered in order to prevent or treat skin defects, or diminish, decrease or avoid skin reactions due to injection.  As previously indicated, the injectable composition comprising all three active ingredients is novel and inventive.  It therefore follows that methods or uses involving the administration of the novel and inventive composition meet the manner of manufacture requirement.

40. It has not been established that the claimed invention is not a manner of manufacture.

    Utility

41. Subsection 18(1)(c) requires that the claimed invention be useful.  The requirements for utility were considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd supra at [81]; 81 IPR 228:

    “A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid.  That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility”.

42. Allergan stated that claims 1 – 12 lack utility.  It was submitted that claims 1 – 11 relate to methods and uses involving any injectable composition containing hyaluronic acid, an a‑adrenergic receptor agonist and lidocaine.  As the amounts or relative amounts of these components are not specified, the claims include within their scope embodiments that do not achieve the results promised in the specification.  It was submitted that the claims encompass compositions wherein, for example, the components are included in amounts too low to be effective as a filler, an agent to reduce bleeding or bruising, or an anaesthetic.  In the case of claim 12, it was submitted that the defined ranges are too broad to confer utility.

43. As previously indicated, independent claims 1 – 6 have been construed to define methods or uses wherein the composition administered must be such that it achieves the result of preventing or treating skin defects, or diminishing, decreasing or avoiding skin reactions, i.e. the compositions administered will be those that contain therapeutically effective amounts of hyaluronic acid, an a‑adrenergic receptor agonist and lidocaine to achieve the intended result.  The use of compositions containing quantities of ingredients that are ineffective does not fall within the scope of the claims.  Similar reasoning applies to dependent claims 7 – 12.

44. Allergan has not established that there is a lack of utility.

    Fair basis

45. The test for fair basis was previously considered in the context of determining priority dates.  Allergan stated that claims 1 – 13 are not fairly based as there is no real and reasonably clear disclosure of the claimed invention.  It was submitted that there is no indication that the actual invention resides in methods or uses of a composition comprising hyaluronic acid, an a‑adrenergic receptor agonist and lidocaine.  In particular, there is no consistory clause corresponding to independent claims 1 – 6 and the emphasis in the specification is on the use of the combination of hyaluronic acid and an a-adrenergic receptor agonist.

46. The specification indicates that in an embodiment of the invention, the composition contains an anaesthetic, preferably lidocaine, in addition to hyaluronic acid and an adrenergic receptor agonist (page 6, lines 19 – 27 and page 7, lines 22 – 28).  The anaesthetic is further discussed at page 9, lines 10 – 13.  A composition containing all three components is prepared (RADACT014; Test2) and its ability to reduce irritation and the inflammatory response evaluated (page 11, line 16 to page 14, line 22).  The specification is considered to provide a real and reasonably clear disclosure of independent claims 1 – 6.  Dependent claims 7 – 13 define features that have previously been discussed with reference to the specification.  Consequently, the specification also provides a real and reasonably clear disclosure for these claims.

47. It has not been demonstrated that there is a lack of fair basis.

    Clarity

48. Subsection 40(3) requires that the claims must be clear.  A claim will lack clarity if a third party could not ascertain whether a proposed action would fall within the ambit of the claim (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59).

49. Allergan submitted that claim 13 lacks clarity since it is unclear how a method or use according to any one of claims 1 to 6 is “substantially as herein described with reference to the Examples and/or Figures” in the specification. 

50. I have previously found that claim 13 is capable of construction and therefore its scope is clear.

51. It has not been shown that there is a lack of clarity.

    Conclusion

52. The opposition fails on all grounds.

    Costs

53. Both parties submitted that costs should follow the event.  I award costs in accordance with Schedule 8 against Allergan, Inc. 

    Dr M-A. Fam
    Delegate of the Commissioner of Patents