Allergan Australia Pty Ltd v Self Care IP Holdings Pty Ltd

[2020] FCA 1530

FEDERAL COURT OF AUSTRALIA

Allergan Australia Pty Ltd v Self Care IP Holdings Pty Ltd [2020] FCA 1530  

Appeal from:

Allergan Inc v Self Care IP Holdings Pty Ltd [2017] ATMO 102

File numbers:

NSD 15 of 2017
NSD 1802 of 2017

Judgment of:

STEWART J

Date of judgment:

22 October 2020

Catchwords:

TRADE MARKS – infringement claim pursuant to s 120 of the Trade Marks Act 1995 (Cth) – whether respondents infringed applicants’ BOTOX marks by using PROTOX as a trade mark – whether use of applicants’ trade mark in composite phrases such as “Instant BOTOX® Alternative” is use as a trade mark – whether PROTOX or composite phrases substantially identical with, or deceptively similar to applicants’ marks – whether goods in respect of which trade mark registered or goods of the same description

TRADE MARKS – whether director of respondents directed, procured or entered into a common design with respondents in any acts of infringement – whether director had “close personal involvement” in any infringing conduct – whether director’s conduct was such as to “go beyond” causing the company to act – whether the director was “standing apart” from the company

TRADE MARKS – cross-claim for removal from the Register of Trade Marks for non-use pursuant to s 92(4)(b) of the Act – whether the BOTOX marks have been used in relation to specified goods in class 3 – whether Botox product is a cosmetic product

TRADE MARKS – cross-claim for rectification of the Register of Trade Marks to cancel registration of BOTOX trade mark pursuant to s 88(1) of the Act – defensive trade marks – whether use of the mark would indicate a connection between those goods and the registered owner of the BOTOX marks – where strong reputation of marks – potential for confusion

TRADE MARKS – registration – opposition – appeal under s 56 of the Act against decision of the Registrar of Trade Marks allowing registration of the mark FREEZEFRAME PROTOX – whether a ground of opposition to registration of the marks is established pursuant to ss 42(b), 44, 58, 59, 60 or 62A of the Act – whether respondent’s mark is deceptively similar to the appellant’s marks in respect of similar goods – whether respondent’s mark likely to deceive or cause confusion because of reputation of appellant’s marks – whether respondent intended to use or authorise use of mark at priority date – whether respondent owner of the opposed mark – whether registration application made in bad faith

CONSUMER LAW – misleading or deceptive conduct – use of allegedly similar trade marks in relation to the sale of cosmetic products –whether respondents intended to mislead or deceive consumers – whether respondents’ mark or marks adopted for the purpose of appropriating the reputation of the applicant – where no relationship between applicants and respondents and use of marks by respondents not authorised by applicants – whether respondents represented by the use of applicants’ trade marks that their goods were provided by or associated with the applicants or provided with the endorsement, approval, licence, authority or sponsorship of the applicants

CONSUMER LAW – misleading or deceptive conduct – efficacy representations – representations as to a future matter – whether representations that product will give similar results, achieve the same performance characteristics or work complementarily with applicants’ product made – whether reasonable grounds for such representations as made – analysis of scientific studies

CONSUMER LAW – whether director should be held personally liable for any contravention – whether the director aided, abetted, counselled or procured any contravention

TORTS – passing off – whether goodwill or reputation attached to Botox product by association with the identifying “get-up” – whether there was a misrepresentation by the respondents leading or likely to lead the public to believe that goods offered by them are the goods of the applicants

PRACTICE AND PROCEDURE – injunctive relief against contravention of statute – whether contraventions of Therapeutic Goods Act 1989 (Cth) – whether claims in relation to respondents’ products are claims of therapeutic use – whether applicants have standing to enforce criminal prohibitions by injunction

Legislation:

Acts Interpretation Act 1901 (Cth) ss 2G, 36(1)

Competition and Consumer Act 2010 (Cth) s 75B and Sch 2 (Australian Consumer Law) ss 2, 4, 18, 29(1)(a), 29(1)(g), 29(1)(h), 236

Evidence Act 1995 (Cth) s 91

Therapeutic Goods Act 1989 (Cth) ss 3, 42DLB, 42DL

Trade Marks Act 1995 (Cth) ss 6, 8, 10, 17, 20, 27, 42, 44, 58, 59, 60, 62A, 88, 92, 100, 101, 120, 187, 219

Federal Court Rules 2011 (Cth) r 22.01

Trade Mark Regulations 1995 (Cth) reg 17A.48D

Trade Marks Act1955 (Cth) ss 66, 93(1)

Trade Marks Act 1938 (UK) s 27(1)

Cases cited:

AFT Pharmaceuticals (Au) Pty Ltd v Reckitt Benckiser (Australia) Pty Ltd [2020] FCAFC 45; 143 ACSR 522

Allergan Inc v Di Giacomo [2011] FCA 1540; 199 FCR 126

Allergan Inc v Self Care IP Holdings Pty Ltd [2017] ATMO 102

AMI Australia Holdings Pty Ltd v Bade Medical Institute (Australia) Pty Ltd (No 2) [2009] FCA 1437; 262 ALR 458

Anheuser Busch v Budejovický Budvar Národní Podnik [2002] FCA 390; 56 IPR 182

Aston v Harlee Manufacturing Co [1960] HCA 47; 103 CLR 391

Australian Competition and Consumer Commission v ACM Group Ltd (No 2) [2018] FCA 1115

Australian Competition and Consumer Commission v Birubi Art Pty Ltd [2018] FCA 1595

Australian Competition and Consumer Commission v Coles Supermarkets Australia Pty Ltd [2014] FCA 634; 317 ALR 73

Australian Competition and Consumer Commission v Giraffe World Australia Pty Ltd (No 2) [1999] FCA 1161; 95 FCR 302

Australian Competition and Consumer Commission v Jetstar Airways Pty Ltd [2015] FCA 1263

Australian Competition and Consumer Commission v Purple Harmony Plates Pty Ltd [2001] FCA 1062

Australian Competition and Consumer Commission v TPG Internet Pty Ltd [2020] FCAFC 130; 381 ALR 507

Australian Competition and Consumer Commission v TPG Internet Pty Ltd [2013] HCA 54; 250 CLR 640

Australian Competition and Consumer Commission v Woolworths Ltd [2019] FCA 1039

Australian Meat Group Pty Ltd v JBS Australia Pty Ltd [2018] FCAFC 207; 268 FCR 624

Australian Woollen Mills Limited v F S Walton and Company Ltd [1937] HCA 51; 58 CLR 641

Bauer Consumer Media Ltd v Evergreen Television Pty Ltd [2017] FCA 507; 349 ALR 679

Bing! Software Pty Ltd v Bing Technologies Pty Ltd (No 1) [2008] FCA 1760; 79 IPR 454

Butcher v Lachlan Elder Realty Pty Ltd [2004] HCA 60; 218 CLR 592

CA Henschke & Co v Rosemount Estates Pty Ltd [2000] FCA 1539; 52 IPR 42

Cadbury Schweppes Pty Ltd v Darrell Lea Chocolate Shops Pty Ltd [2007] FCAFC 70; 159 FCR 397

Campbell v Backoffice Investments Pty Ltd [2009] HCA 25; 238 CLR 304

Campomar Sociedad Limitada v Nike International [2000] HCA 12; 202 CLR 45

Chief Commissioner of State Revenue v Adams Bidco Pty Ltd [2019] NSWCA 34

Coca-Cola Company v All-Fect Distributors Ltd [1999] FCA 1721; 96 FCR 107

ConAgra Inc v McCain Foods (Aust) Pty Ltd [1992] FCA 176; 33 FCR 302

Cooper Engineering Co Pty Ltd v Sigmund Pumps Ltd [1952] HCA 15; 86 CLR 536

Cummings v Lewis [1993] FCA 190; 41 FCR 559

DC Comics v Cheqout Pty Ltd [2013] FCA 478; 212 FCR 194

Doppstadt Australia Pty Ltd v Lovick & Son Developments Pty Ltd [2014] NSWCA 158

E & J Gallo Winery v Lion Nathan Australia Pty Ltd [2010] HCA 15; 241 CLR 144

E & J GalloWinery v Lion Nathan Australia Pty Ltd [2009] FCAFC 27; 175 FCR 386

E & J Gallo Winery v Lion Nathan Australia Pty Ltd [2008] FCA 934; 77 IPR 69

Food Channel Network Pty Ltd v Television Food Network GP [2010] FCAFC 58; 185 FCR 9

Fry Consulting Pty Ltd v Sports Warehouse Inc (No 2) [2012] FCA 81; 201 FCR 565

Gillette Australia Pty Ltd v Energiser Australia Pty Ltd [2002] FCAFC 223; 193 ALR 629

Global Sportsman Pty Ltd v Mirror Newspapers Pty Ltd [1984] FCA 167; 2 FCR 82

Google Inc v Australian Competition and Consumer Commission [2013] HCA 1; 249 CLR 435

Health World Ltd v Shin-Sun Australia Pty Ltd [2010] HCA 13; 240 CLR 590

Hills Industries Ltd v Bitek Pty Ltd [2011] FCA 94; 214 FCR 396

Irving’s Yeast-Vite Ltd v Horsenail (1934) 51 RPC 110

Insight Radiology Pty Ltd v Insight Clinical Imaging Pty Ltd [2016] FCA 1406; 122 IPR 232

Jafferjee v Scarlett [1937] HCA 36; 57 CLR 115

Johnson & Johnson Australia Pty Ltd v Sterling Pharmaceuticals Pty Ltd [1991] FCA 402; 30 FCR 326

JR Consulting & Drafting Pty Ltd v Cummings [2016] FCAFC 20; 329 ALR 625

J Lyons & Co Ltd’s Application [1959] RPC 120

Keller v LED Technologies Pty Ltd [2010] FCAFC 55; 185 FCR 449

Knott Investments Pty Ltd v Winnebago Industries Inc [2013] FCAFC 59; 211 FCR 449

Kowa Company Ltd v NV Organon [2005] FCA 1282; 223 ALR 27

Kraft Foods Group Brands LLC v Bega Cheese Ltd [2020] FCAFC 65; 377 ALR 387

Lodestar Anstalt v Campari America LLC [2016] FCAFC 92; 244 FCR 557

Lyons & Co Ltd’s Application [1959] RPC 120

Mars Australia Pty Ltd v Sweet Rewards Pty Ltd [2009] FCA 606; 81 IPR 354

Melbourne Chinese Press Pty Ltd v Australian Chinese Newspapers Pty Ltd [2004] FCAFC 201; 63 IPR 38

MID Sydney Pty Ltd v Australian Tourism Co Ltd [1998] FCA 1616; 90 FCR 236

Mond Staffordshire Refining Co Ltd v Harlem [1929] HCA 6; 41 CLR 475

Moorgate Tobacco Co Ltd v Philip Morris Ltd (No 2) [1984] HCA 73; 156 CLR 414

New South Wales Dairy Corporation v Murray Goulburn Co-op Co Ltd (No 1) [1989] FCA 124; 14 IPR 26

Novartis Pharmaceuticals Australia Pty Ltd v Bayer Australia Ltd [2015] FCA 35; 322 ALR 621

Pacific Dunlop Ltd v Hogan [1989] FCA 250; 23 FCR 553

Parkdale Custom Built Furniture Pty Ltd v Puxu Pty Ltd [1982] HCA 44; 149 CLR 191

PepsiCo Australia Pty Ltd v Kettle Chip Co Pty Ltd [1996] FCA 48; 135 ALR 192

Peter Bodum A/S and Others v DKSH Australia Pty Ltd [2011] FCAFC 98; 280 ALR 639

Pfizer v Karam [2006] FCA 1663; 219 FCR 585

Pham Global Pty Ltd v Insight Clinical Imaging Pty Ltd [2017] FCAFC 83; 251 FCR 379

Pioneer Computers Australia Pty Ltd v Pioneer KK [2009] FCA 135; 176 FCR 300

Polo Textile Industries Pty Ltd v Domestic Textile Corp Pty Ltd  [1993] FCA 265; 42 FCR 227

ReApplications by Mobile Oil Corp (1995) 32 IPR 535

Re Application by Pianotist Co Ltd (1906) 23 RPC 774

Re Ferodo Ltd [1945] Ch 334; 62 RPC 111

Reckitt Benckiser (Australia) Pty Ltd v GlaxoSmithKline Australia Pty Ltd [2018] FCAFC 138

Reckitt Benckiser (Australia) Pty Ltd v AFT Pharmaceuticals (AU) Pty Ltd [2018] FCA 1552

Reckitt & Colman Products Ltd v Borden Inc [1990] UKHL 12; [1990] 1 WLR 491

Registrar of Trade Marks v Woolworths Ltd [1999] FCA 1020; 93 FCR 365

Reliance Water Controls Ltd v Altecnic Ltd [2001] EWCA Civ 1928

Ricegrowers Ltd v Real Foods Pty Ltd [2008] FCA 639; 77 IPR 32

Sheldon and Hammond Pty Ltd v Metrokane Inc [2004] FCA 19; 135 FCR 34

SMASolar Technology AG v Beyond the Building Systems Pty Ltd (No 5) [2012] FCA 1483

Southern Cross Refrigerating Co v Toowoomba Foundry Pty Ltd [1954] HCA 82; 91 CLR 592

Stuart Alexander & Co (Interstate) Pty Ltd v Blenders Pty Ltd [1981] FCA 169; 37 ALR 161

Suyen Corporation v Americana International Ltd [2010] FCA 638; 187 FCR 169

Sydneywide Distributors Pty Ltd v Red Bull Australia Pty Ltd [2002] FCAFC 157; 234 FCR 549

Sykes v Reserve Bank of Australia [1998] FCA 1405; 88 FCR 511

Telstra Corporation Ltd v Optus Communications Pty Ltd [1996] FCA 1035; 36 IPR 515

Telstra Corporation Ltd v Singtel Optus Pty Ltd [2018] VSCA 347

Shell Company of Australia Ltd v Esso Standard Oil (Australia) Ltd [1963] HCA 66; 109 CLR 407

Tivo Inc v Vivo International Corporation Pty Ltd [2012] FCA 252

Trade Practices Commission v Telstra Corp Ltd [1993] FCA 567; ATPR 41-256

Unilever Australia Ltd v Beiersdorf Australia Ltd [2018] FCA 2076

Wingate Pty Ltd v Levi Strauss & Co [1994] FCA 163; 49 FCR 89

Yorke v Lucas [1985] HCA 65; 158 CLR 661

Division:

General Division

Registry:

New South Wales

National Practice Area:

Intellectual Property

Sub-area:

Trade Marks

Number of paragraphs:

627

Date of hearing:

3, 4, 5, 6, 12, 13, 14 June 2019

In NSD 15 of 2017

Counsel for the Applicants/Cross-Respondent:

SJ Goddard SC with EE Whitby

Solicitor for the Applicants/Cross-Respondent:

Griffith Hack Lawyers

Counsel for the Respondents/Cross-Claimant:

RP Lancaster SC with AR Lang and GS Tsang

Solicitor for the Respondents/Cross-Claimant:

Minter Ellison

In NSD 1802 of 2017

Counsel for the Appellant: 

SJ Goddard SC with EE Whitby

Solicitor for the Appellant: 

Griffith Hack Lawyers

Counsel for the Respondent 

RP Lancaster SC with AR Lang and GS Tsang

Solicitor for the Respondent 

Minter Ellison

ORDERS

NSD 15 of 2017

BETWEEN:

ALLERGAN AUSTRALIA PTY LTD (ACN 000 612 831)

First Applicant

ALLERGAN INC

Second Applicant

AND:

SELF CARE IP HOLDINGS PTY LTD (ACN 134 308 151)

First Respondent

SELF CARE CORPORATION PTY LTD (ACN 132 213 113)

Second Respondent

MS SONIA AMOROSO

Third Respondent

AND BETWEEN:

SELF CARE IP HOLDINGS PTY LTD (ACN 134 308 151) (and another named in the Schedule)

First Cross-Claimant

AND:

ALLERGAN INC (and another named in the Schedule)

First Cross-Respondent

order made by:	STEWART J
DATE OF ORDER:	22 October 2020

THE COURT ORDERS THAT:

1.Within 14 days of these orders or such further period as may be allowed, the parties are to confer and bring in:

(a)orders that dispose of the proceeding and, so far as relevant, deal with its further conduct, in accordance with the reasons published today;

(b)orders that deal with the costs of the proceeding thus far;

(c)proposed redactions of the reasons published today with reference to the suppression orders in the proceeding; and

(d)failing agreement on the above, competing orders, redactions (if necessary) and short submissions in support of their respective positions.

2.Until further order, the text of the reasons for judgment published today is to be published and disclosed only to the external lawyers (solicitors and counsel), including foreign lawyers, of the parties who may then disclose the substance of the reasons to their respective clients (the parties) without disclosing any facts or information in the reasons which may be the subject of suppression orders in respect of the evidence in the proceeding from which the facts or information is drawn.

Note:   Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

ORDERS

NSD 1802 of 2017

BETWEEN:

ALLERGAN INC

Appellant

AND:

SELF CARE IP HOLDINGS PTY LTD (ACN 134 308 151)

Respondent

order made by:	STEWART J
DATE OF ORDER:	22 October 2020

THE COURT ORDERS THAT:

1.The appeal be dismissed.

2.The appellant is to pay the respondent’s costs of the appeal as agreed or taxed.

3.In terms of r 36.03(b) of the Federal Court Rules 2011, the time for the filing of a notice of appeal from these orders shall be 28 days after final orders are entered in proceeding NSD15/2017 as contemplated by order 1(a) of the orders in that proceeding made on 22 October 2020.

[Note:  Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.]

REASONS FOR JUDGMENT

STEWART J:

INTRODUCTION	[1]
Background	[1]
The applicants, their product and their trade marks	[5]
The respondents, their products and their trade marks	[25]
The proceedings	[36]
NSD15/2017	[38]
NSD1802/2017	[52]
SELF CARE’S MARKET, PRODUCTS AND PACKAGING	[54]
The market	[54]
Protox product	[62]
Inhibox product	[76]
Night (tube) product	[86]
Night (tub) product	[96]
Boost Product	[100]
SELF CARE’S IMPUGNED STATEMENTS AND ITS UNDERTAKINGS	[107]
THE REPUTATION OF BOTOX	[117]
TRADE MARK INFRINGEMENT	[154]
Infringement of BOTOX trade mark under ss 120(1) and 120(2) of TM Act	[154]
Section 120 of the TM Act	[155]
(1)  Use as a trade mark – principles	[159]
(2)  Deceptive similarity – principles	[164]
1.     Surrounding circumstances	[173]
2.     Reputation	[178]
3. Section 120(2)	[183]
(3)  The “goods in respect of which the trade mark is registered” or “goods of the same description” – principles	[185]
PROTOX as a word mark	[190]
(1)  Use as a trade mark	[190]
(2)  Deceptive similarity	[200]
(3)  The registered goods or goods of the same description	[214]
(4)  Conclusion: trade mark infringement claim with regard to PROTOX	[227]
BOTOX in composite phrases	[228]
(1)  Use as a trade mark	[228]
(2)  Deceptive similarity	[256]
(3)  The registered goods or goods of the same description	[259]
(4)  Conclusion: trade mark infringement claim with regard to BOTOX phrases	[262]
CROSS-CLAIM: REMOVAL OR CANCELLATION OF TRADE MARKS	[263]
Removal of the 655 mark	[266]
(1)  The law	[266]
(2)  Consideration	[274]
Cancellation of the 426 defensive mark	[293]
(1)  Introduction	[293]
(2)  The law	[296]
(3)  Submissions	[316]
(4)  Consideration	[324]
TRADE MARK OFFICE APPEAL	[340]
INTRODUCTION	[340]
Section 60 – likely to deceive or cause confusion	[344]
Section 42(b) – contrary to law as misleading and deceptive	[354]
Section 44 – deceptively similar in respect of similar goods	[355]
Section 58 – ownership of the opposed mark	[359]
Section 59 – intention to use	[388]
Section 62A – application made in bad faith	[405]
Conclusion on the Trade Mark Office appeal	[413]
AUSTRALIAN CONSUMER LAW AND PASSING OFF	[414]
Framework principles: ACL claims	[416]
Generally	[416]
With regard to efficacy in particular	[435]
Framework principles: passing off	[445]
Affiliation representations	[454]
INTRODUCTION	[454]
Consideration	[461]
Efficacy representations	[481]
INTRODUCTION	[481]
The representations	[494]
Reasonable grounds?	[510]
Formulations, active ingredients and studies	[510]
Expert witnesses	[513]
The structure of skin and wrinkles	[523]
Self Care’s identified support for the claims	[529]
Allergan’s submissions	[539]
Prolonging the effect of Botox specifically	[573]
Conclusions on reasonable grounds	[577]
LOSS AND DAMAGE	[581]
LIABILITY OF MS AMOROSO	[588]
THERAPEUTIC GOODS ACT CLAIM	[610]
CONCLUSION	[618]

INTRODUCTION

Background

1. The eternal human interest in reducing the appearance of ageing underlies the disputes in these cases.  The opposing parties have both respectively developed and promoted products with very different modes of action to attract customers who have this Sisyphean interest. 

2. This litigation has spawned sprawling testimony and documents before the Court.  Standing out amongst the vast number of exhibits are two short segments from the well-known television series and film, Sex and the City.  In each, the character Samantha Jones tries to persuade Carrie Bradshaw to submit to treatment with Botox to lessen the appearance of wrinkles on her face and thereby to maintain her apparent youth despite her chronological age.  The extracts were tendered as proof of the ubiquitous reputation of Botox.

3. The applicants – who have rights to BOTOX trade marks – contend that the respondents have sought to sell their products by unlawfully leveraging off the reputation of Botox.  That includes by way of trade mark infringement, misrepresentations in contravention of the Australian Consumer Law (ACL) and passing off.  The second applicant also appeals against a decision of a delegate of the Registrar of Trade Marks to allow one of the respondents’ trade marks – which includes the word PROTOX – to proceed to registration.  The respondents, by way of cross-claim, contend that certain of the applicants’ trade marks should be removed from the register or restricted to a smaller class of goods.

1. It is useful to make a note on nomenclature at the outset.  Where in these reasons reference is made to a word as a trade mark, e.g., BOTOX and PROTOX, the word is in capital letters.  However, when a word is used as the name of a product, it is used as a proper noun and hence has only the first letter capitalised, e.g., Botox and Protox.  That, at least, is the approach that has been sought to be followed.

   The applicants, their product and their trade marks

2. Allergan Inc is the manufacturer of Botox and the owner of trade marks including for the word BOTOX.  BOTOX is an invented portmanteau word, derived from the active ingredient in Botox, namely botulinum toxin, type A.  It was first registered as a word trade mark in the United States of America in 1990. 

3. Allergan Australia Pty Ltd is the Australian subsidiary of Allergan Inc.  It is the sponsor of the Botox products on the Australian Register of Therapeutic Goods and (the applicants contend) is the authorised user of the BOTOX marks in Australia.

4. I shall refer to Allergan Inc and Allergan Australia together simply as Allergan save where it is necessary to distinguish between them.

5. The Botox product is a particular botulinum toxin type A purified neurotoxin complex, supplied as a powder in vials of 50 ml/units, 100 ml/units and 200 ml/units.  In use, the product is reconstituted with sterile saline for injection, usually intramuscularly.  Botox is used for numerous therapeutic indications (including for the treatment of overactive bladder, cervical dystonia and hyperhidrosis) as well as the following cosmetic indications: temporary improvement in the appearance of upper facial rhytides – glabellar lines (frown lines), lateral canthal lines (crow’s feet) and forehead lines in adults.  The present case is concerned with the cosmetic indications. 

6. When Botox is injected into the muscle it is expected that most of the Botox will remain close to the site of injection.  The core neurotoxin is surrounded by accessory proteins which protect it as it enters the body.  The Botox core then dissociates from its accessory protein and enters the nerve cell.  Botox blocks the release of acetylcholine, which is a chemical released by the nerve cells to send signals to other cells.  When the release of acetylcholine is stopped, muscle contraction cannot occur.

7. Once the Botox is injected, it inhibits the nerve and within roughly 50 hours (or about 2-3 days) the Botox is removed from the body by passing urine.  Over time the nerve heals itself and starts releasing acetylcholine again.  This gives movement back to the muscle.

8. The effects of Botox may take a few days to manifest.  It has effect by relaxing the muscles at the site of injection.  Full results may take up to 10-14 days to be seen.  The effects will usually last up to four months, then dramatically decrease.  Treatment may be repeated every six months.

9. Botox does not moisturise or tighten the skin.  People who have been treated with Botox may feel that their skin looks smoother, shiny and moisturised after the treatment due to the fact that the underlying muscle has been relaxed and cannot move.  There is, however, no clinical data to show that Botox has these effects on the skin.  Important for present purposes is that Botox has a therapeutic effect, i.e., it has a physiological or pharmacological action.

10. In Australia, Botox has been supplied for certain therapeutic indications under the BOTOX marks since November 1993 when approval by the Therapeutic Goods Administration (TGA) was granted.  In 2002, Botox received approval for cosmetic indications and it has been available for sale in Australia for that purpose since about April 2002. 

11. In Australia, Botox must be administered by a registered medical practitioner (or registered nurse under the direction of a registered medical practitioner) or other authorised health professional under the relevant state or territory legislation. Allergan supplies Botox to approved medical practitioners and other health professionals that hold an account with Allergan Australia. Botox is not advertised or supplied directly to retail customers as the advertising of therapeutic goods, and poisons, is prohibited: s 42DL, Therapeutic Goods Act 1989 (Cth) (TG Act).

12. The evidence is that one 100 ml vial of Botox is sold for approximately $500 (excl. GST).  As the product is reconstituted in saline, one vial can apparently be used for more than one treatment.  A single treatment, which is to say five or six injections in a single site (e.g., frown lines), including the health professional’s charges, is in the range of $200-$720.

13. In Australia, Allergan Inc is the registered proprietor of the following pending or registered Australian trade marks (which I will refer to as the BOTOX marks):

    (1)Trade Mark No. 551279, for the word BOTOX, registered (court action pending) in class 5 and having a priority date of 28 February 1991;

    (2)Trade Mark No. 860785 for the composite mark , registered in class 5 and having a priority date of 14 December 2000 (the 785 mark);

    (3)Trade Mark No. 860786, for the word BOTOX, registered (court action pending) in class 5 and having a priority date of 14 December 2000 (the 786 mark);

    (4)Trade Mark No. 1008655 (International Registration 826203) for the word BOTOX, registered (court action pending) in class 3 and having a priority date of 8 March 2004 (the 655 mark); and

    (5)Trade Mark No. 1578426 for the word BOTOX, registered (court action pending) in classes 1, 3, 5, 9, 10, 16, 35, 41, 42, 44, and 45 and having a priority date of 4 September 2013 (the 426 defensive mark).

14. Each of the class 5 registrations is in respect of pharmaceuticals. Relevant to the claim for trade mark infringement under s 120(2) of the TM Act is that the 785 and 786 marks include the following goods: “Pharmaceutical preparations for the treatment of … wrinkles …”.

15. The class 3 registration in respect of the 655 mark is for “cosmetics, face creams and lotions; skin creams and lotions.”

16. The class 3 registration in respect of the 426 defensive mark is for the following:

    After sun lotions and preparations; after-shave lotions and creams; anti-ageing creams; anti-wrinkle cream; anti-cellulite preparations; antiperspirant deodorants and preparations; aromatherapy preparations; artificial tanning preparations; astringents for cosmetic purposes; barrier creams and preparations for the skin; bath salts, crystals, oils, lotions and preparations (not medicated); bath soap; beauty care preparations; beauty preparations; beauty care products; beauty products; beauty creams; bleaching preparations (decolourants) for cosmetic purposes; bleaches in the form of creams; bleaching preparations for the hair; body care preparations (non-medicated); body lotions (other than for medical purposes); body moisturisers; body scrubs; breath fresheners; bubble bath preparations; cleaners (preparations) for cleaning surgical instruments; cleaning oils for cosmetic purposes; cleaning preparations; cleaning preparations containing sterilising substances; cleaning preparations for medical and laboratory instruments; cleaning preparations for personal and sanitary use; cleaning preparations for the hands and the skin; cleansers for the face; cleansing facial masks and lotions; cleansing products for removing make-up; collagen preparations for cosmetic application; colouring preparations for cosmetic purposes; conditioners for use on the hair; cosmetic acne creams; cosmetic articles for personal use; cosmetic articles and preparations; cosmetic kits; cosmetic skin care products; cosmetics; deodorant preparations for personal use; deodorants for the body; depilatories; depilatory preparations and products; depilatory wax; dermatological cosmetic preparations; dermatological preparations (other than medicated);  detergents having anti-bacterial and disinfecting properties (other than for medical use or for use in manufacturing processes); essential oils; essential oils for cosmetic purposes; exfoliants for the care of the skin; eye make-up; eye wrinkle lotions; facial care products (cosmetic); fragrances; hair care products; hair conditioner; hair colouring preparations; hair cosmetics; hair cream and lotions; hair gel and mousse; hair permanent treatments; hair perming products; hair preparations; hair products; hand cream; impregnated cloths for cosmetic use; impregnated pads for removing make-up; lipsticks; lip gloss; lip pencils and liners; make-up; make-up preparations and products; make-up removing preparations; massage oils and creams (not medicated); moisturisers (cosmetics); mouth washes (not for medical purposes); nail care preparations; nail preparations (cosmetics); non-medicated toiletries; perfumes; perfumery preparations and articles; preparations for care of the teeth; products for cleaning; sanitary preparations (other than for medical purposes); serum (cosmetic preparations); shampoos; shaving soap, creams and gels; skin care preparations and creams (cosmetic); skincare cosmetics; soaps; soap products; sun screen preparations (cosmetics); suntan preparations (cosmetics); tanning preparations (cosmetics); toilet preparations; toiletries; toothpaste

17. The relevance of the details of the class 3 registration, as opposed to all the other classes of registration of the 426 defensive mark, is that the respondents’ challenge to the registration by way of the cross-claim is only to class 3.

18. As dealt with further at [117]-[153] below, sales of Botox have been considerable and BOTOX has achieved significant success as a trade mark and brand, both internationally and in Australia. As at the date of commencement of the proceedings, Botox had a significant and valuable reputation amongst consumers in Australia, including as a highly effective injectable product in reducing the appearance of wrinkles.

19. Allergan maintains a distinction in its business model between the use of Botox for medicinal therapeutic indications and for cosmetic indications.  In respect of the cosmetic indications for the Botox product, Allergan uses the website which provides information about the product when used for cosmetic purposes.  A different website, provides information about all uses of the Botox product.  That website displays a separate tab to redirect browsers seeking information on its cosmetic uses to the Botox cosmetic website. 

20. Consistent with the distinction between the two principal different uses of Botox, Allergan Australia has different sales teams, marketing strategies and marketing material for the Botox product where it is sold for medicinal therapeutic indications and for cosmetic indications.  Sales and marketing teams for therapeutic indications target medicinal requirements and treatment of disease as opposed to sales and marketing for cosmetics which focus on the desire for the temporary improvement of appearance.  Allergan Australia keeps its business units, including its lists of account holders and records of sales, for the two principal different uses of Botox separate.

21. Other botulinum toxin type A products with therapeutic and cosmetic indications similar to Botox are available in Australia (and overseas), including a product sold under the trade mark DYSPORT manufactured by Ipsen Biopharm Ltd and another under the trade mark XEOMIN manufactured by Merz Pharma GmbH & Co. KGaA.

    The respondents, their products and their trade marks

22. Self Care IP Holdings Pty Ltd and Self Care Corporation Pty Ltd are companies incorporated in Australia.  When it is not relevant to distinguish between them, I shall refer to them together simply as Self Care.  Ms Sonia Amoroso, the third respondent, is a citizen and resident of Australia.  Since 24 November 2008, Ms Amoroso has been the sole director and secretary of Self Care IP.  Since 14 July 2008, Ms Amoroso has been the sole director and secretary of Self Care Corp.

23. Ms Amoroso was Self Care’s principal witness.  She deposed to several affidavits which were read as her evidence in chief, and she was cross-examined for approximately two days.  She was a careful witness, by which I mean she was cautious not to be caught out or to give matters away in cross-examination; she required that the questions put to her be clear and understandable by her.  I did not get the impression that she was trying particularly to assist the Court, but I also did not get the impression that she was dishonest in her answers.  I accept her evidence as honest and, for the most part, as accurately reflecting the facts as they occurred.  Where I have reservations as to the reliability of her evidence, I will address those directly.  I otherwise accept her evidence.

24. Ms Amoroso founded the Self Care business in about 2008.  Self Care supplies cosmetic products, including, in particular, topical anti-wrinkle skincare products under the trade mark FREEZEFRAME.

25. Ms Amoroso came up with the FREEZEFRAME brand and decided that it would be used as an umbrella brand and that various products would form part of the brand.  With the Freezeframe products, Ms Amoroso was interested in developing products that could be used as an alternative to botulinum toxin injections. 

26. Self Care’s first flagship product was called Freezeframe with Inhibox which was launched in July 2009.  The product enjoyed significant retail success.

27. Over subsequent years, Self Care became an award-winning and successful Australian business by reference to the FREEZEFRAME brand.  Over time, more than 30 products were developed and sold under that brand, including five that are the subject of these proceedings.  Each is dealt with in detail below (at [62]-[106]).

28. Since at least October 2014, Self Care Corp has been the registered owner of the domain name (Freezeframe website), which it uses to promote its Freezeframe range of products.

29. Since at least July 2015, Self Care Corp has been the registered owner of the domain name (Self Care website).  Since at least around August 2017, the Self Care website has automatically redirected to the Freezeframe website.

30. In October 2014, Self Care IP lodged an application to the Australian Trade Marks Office to register the trade mark FREEZEFRAME PROTOX.  The goods and services in respect of which the FREEZEFRAME PROTOX trade mark is applied for are “anti-ageing serum, anti-wrinkle serum” in class 3.

31. Allergan opposed the registration of the mark, but that opposition was dismissed by a decision of a delegate of the Registrar of Trade Marks on 19 September 2017.  That decision is the subject of the appeal in proceeding NSD1802/2017 referred to below (at [340]-[413]).

32. Self Care has a number of other trade marks that are either registered or pending registration, each of which has the word FREEZEFRAME followed by a particular product name.  These trade marks thus, relevantly, include FREEZEFRAME NIGHT and FREEZEFRAME BOOST.

    The proceedings

33. There are two proceedings that were heard together.  There were orders that the evidence in one proceeding is evidence in the other.

34. The parties helpfully agreed a detailed statement of facts which constitutes a substratum of common ground facts which has to be supplemented by factual findings.  In that respect, four factual witnesses were cross-examined and two expert witnesses gave evidence concurrently during the course of which they were also cross-examined.  There was evidence from several other witnesses, by way of affidavit, who were not required for cross-examination.

    NSD15/2017

35. In proceeding NSD15/2017, Allergan Australia is the first applicant and Allergan Inc is the second applicant.  Self Care IP is the first respondent, Self Care Corp is the second respondent, and Ms Amoroso is the third respondent.

36. Allergan claims that Self Care:

    (1)has infringed the BOTOX registered trade marks by use of the word BOTOX in various forms (including, e.g., “instant Botox alternative”, “overnight Botox alternative” and “long term Botox alternative”) on the Freezeframe products and packaging, as well as in promotion and advertising contrary to the Trade Marks Act 1995 (Cth) (TM Act).  It also claims that use of the trade mark PROTOX is deceptively similar to and infringes the BOTOX mark;

    (2)has contravened the ACL by making representations of affiliation with the applicants or their Botox product (the affiliation representations) and representations concerning the efficacy of the respondents’ products (the efficacy representations);

    (3)has engaged in passing off; and

    (4)has infringed various sections of the TG Act.

37. Allergan contends that Ms Amoroso authorised the infringements of the BOTOX marks, procured or entered into a common design as a joint tortfeasor with Self Care to infringe the BOTOX marks and to engage in passing off, and aided, abetted, counselled, or procured Self Care’s conduct in contravention of the ACL.  Allergan relies on Ms Amoroso’s close involvement in the creation, promotion, sale and offer for sale of Self Care’s products. 

38. In respect of the trade mark infringement, ACL and passing off claims, Allergan seeks declarations, injunctions, equitable compensation and damages, including exemplary damages, or an account of profits. In respect of the trade mark infringement claim, Allergan also seeks delivery up of the relevant stock of products, packaging and promotional and advertising material. In respect of the TG Act claim, Allergan seeks injunctions.

39. In December 2017, it was ordered that the quantification of the loss and damage suffered by Allergan be heard separately from and after all questions of liability.  The questions of liability were identified as including:

    (1)Self Care’s liability, if any, for particular heads of loss or damage, the burden falling on Allergan to prove at least one instance of the loss or damage claimed; and

    (2)Self Care’s liability, if any, for additional damages.

40. In summary, Self Care says the following with respect to the claims.

41. With regard to the trade mark infringement claims, it says that there has been no infringement of Allergan’s BOTOX trade mark because Self Care’s use of that word on its products is not use “as a trade mark” within the meaning of s 120 of the TM Act. It says that the function of the word BOTOX on the packaging or in the advertising of Self Care’s creams is to say what the product is not – it is not Botox, but an alternative to Botox; it is not an expensive injectable you receive from your medical practitioner, but a modestly priced self-administered cream. It says that Self Care’s branding shows the origin of the goods to be Self Care. It says that the function of the use of the word BOTOX is to compare and contrast its goods to the goods of another trader, which contrast is magnified by the use of the ® symbol with the word BOTOX. Self Care also says that PROTOX is not used “as a trade mark” and is not deceptively similar to BOTOX because the mark is used only in combination with the word FREEZEFRAME.

42. With regard to the ACL claims alleging affiliation and passing off, Self Care says that there is no doubt that consumers associate the word BOTOX with an injectable product used to reduce the appearance of wrinkles.  It says that Self Care’s creams/serums are presented as products that reduce the appearance of wrinkles, but explicitly as a “Botox alternative”.  It says that the word “alternative” is powerful enough in itself to tell all reasonable consumers that the products are not Botox and are distinct from Botox and the makers of Botox.

43. Self Care says that that distinction from Botox and the makers of Botox is reinforced by other aspects of the context, including Self Care’s own branding on its creams and in its advertising (in which FREEZEFRAME is always prominent), the character of the goods as creams rather than a formulation to be injected, the method of administration being by the consumer themselves rather than by a medical practitioner, and a substantial difference in price.  They say that a consumer could not reasonably think that Self Care’s products were affiliated with the makers of Botox, or that the products were in fact Allergan’s goods.

1. With regard to the ACL claims alleging misleading representations about the efficacy of Self Care’s creams, Self Care says that there is a problematic lack of clarity in Allergan’s case in this respect.  It says that the claims should be rejected either because the alleged representations are not conveyed by the product packaging or the advertising, or because such representations as were conveyed are not misleading and there were reasonable grounds to make them.  In particular, it relies on a number of in vivo studies which, it says, demonstrate that Self Care’s creams reduce the appearance of wrinkles, which is the central message about efficacy.

2. With regard to the claims seeking injunctions against the alleged commission of offences under the TG Act, Self Care says that Allergan has no standing to prosecute criminal offence proceedings or civil penalty proceedings under the TG Act, and that it has not done so. It says that Allergan’s invocation of the exceptional jurisdiction of a civil court to restrain by injunction the commission of an offence should be rejected, including because Allergan has no standing to seek such an injunction and, in any event, there is no contravention of the TG Act because Self Care is not advertising therapeutic goods.

3. Self Care IP and Self Care Corp, as cross-claimants, allege that Allergan has sought to extend its trade mark rights beyond the field of actual use of the trade mark in relation to injectable anti-wrinkle products, to a different and broader field of skin-care creams by way of the class 3 goods specified for the 655 mark and the 426 defensive mark (see [17]-[19] above for the relevant specified goods).  It is claimed that those specifications are not valid.  It is accordingly sought by Self Care that the 655 mark in relation to those goods be removed and for the 426 defensive mark to be cancelled.

4. With regard to the claims against Ms Amoroso, she says that her actions relevant to the proceeding are squarely within her roles as director and officer of Self Care.  She says that they involve, in particular, making and participating in decisions concerning the marketing of Self Care’s products and the claims made about them in marketing materials.  Ms Amoroso accepts that her role involves having ultimate responsibility over the operations of Self Care, including over what goes out to consumers and the public, although she is not involved in every decision.

5. Ms Amoroso says that the activities of Self Care of which Allergan complains are squarely activities within the ordinary course of Self Care’s business, which is the supply to the Australian market of topical cosmetics.  She says that this is not a case in which she caused Self Care to divert from the usual course of its business.

   NSD1802/2017

6. In proceeding NSD1802/2017, Allergan Inc, as appellant, appeals from a decision of a delegate of the Registrar of Trade Marks to allow Self Care IP’s Trade Mark Application No. 1653383 for the words FREEZEFRAME PROTOX to proceed to registration in respect of goods in class 3 (being anti-aging serum and anti-wrinkle serum). Allergan Inc raises ss 42(b), 44, 58, 59, 60 and 62A of the TM Act as grounds of opposition.

7. In summary, Self Care says that each of the numerous grounds on which Allergan opposes the registration of FREEZEFRAME PROTOX ought to be rejected, including because its trade mark is not misleadingly similar to the word BOTOX.

   SELF CARE’S MARKET, PRODUCTS AND PACKAGING

   The market

8. Ms Amoroso gave evidence that in her experience people who are concerned to reduce the appearance of wrinkles fall into two separate markets, those who are prepared to undergo procedures such as injections which may be painful, invasive and involve the risk of potentially serious side-effects, and those who are interested in the use of anti-wrinkle creams and lotions.  Obviously, there are people in the first category who will also use products of interest to the second category.

9. Ms Amoroso also accepted in cross-examination that the market can be split in three ways, namely those who use injectables such as Botox, those who are undecided about whether they will use injectables and those who will not use injectables. 

10. In Ms Amoroso’s experience, the term Botox (or botox) is most frequently used to refer to any brand of botulinum toxin injection and not necessarily the particular product traded by Allergan under the BOTOX name.  Thus, people refer to “having Botox” even when they are having a different brand of botulinum toxin injection.  BOTOX is to a significant degree like marks such as HOOVER, XEROX or BAND-AID which have gained use to describe a whole category of product rather than specifically a particular brand within the category.  Ms Amoroso was not challenged on this evidence, and I accept it.

11. The Freezeframe range of products has been sold to retail outlets such as department stores Myer and David Jones and retail chemists such as Priceline, Terry White Chemists, My Chemist and Chemist Warehouse, and to some online stores such as Adore Beauty and AMCAL Pharmacy Online. 

12. Self Care’s FREEZEFRAME brand has many competitors in the skincare market.  The competitors specialise in cosmetic creams and lotions.  They do not manufacture or distribute anti-wrinkle injections.  There is no brand which has a skincare product such as skin creams or lotions as well as botulinum toxin injections. 

13. Ms Amoroso exhibited photographs of typical in-store displays for the sale of Freezeframe products.  These show the whole range of Freezeframe products being displayed together where the common branding is obvious.  The same is true of the sale of the products on the Freezeframe website – although each product has its own name, some more obviously incorporating the name FREEZEFRAME than others, all appear clearly and unmistakably within the Freezeframe range.  Similarly, products available for sale on the Priceline website are all clearly indicated as being Freezeframe products.

14. Ms Amoroso accepted that some clinics that provide medical treatments also provide cosmetic moisturising products.  But, she said that FREEZEFRAME branded products are not sold at such clinics.  She was not challenged on that evidence, and I accept it.

15. The Freezeframe range of products has been extremely successful – both in terms of annual revenue and in product units sold.  It has been particularly successful at Priceline, which is one of the biggest beauty retailers in Australia. 

    Protox product

16. Since the second half of 2014, Self Care has caused to be manufactured and sold in Australia a skincare product which I will refer to as the Protox product.  It is sold in a 20 ml tube which is packaged in an elongated box.  The packaging includes the word PROTOX prominently on its own, as well as the word FREEZEFRAME® prominently on its own.  It also includes the phrases “prolong the look of Botox®” and “clinically proven to prolong the effect of Botox®”.

17. The packaging relevantly looks like this:

18. The tube itself has the words PROTOX and FREEZEFRAME® in close proximity and the phrase “prolongs the skin smoothing effect of Botox® injections”.

19. Inside the Protox product packaging is a product information sheet which contains information about several of Self Care’s products, including the Protox product.  Generally, the information sheet prominently displays the word FREEZEFRAME and the phrase “injection free alternatives”. 

20. At various times since October 2014, Self Care has sold the Protox product in Australia to various retail outlets and selected pharmacies, as well as through the Freezeframe website.  The recommended retail price of the Protox product is around $69.00, including GST.

21. Since April 2015, advertisements that included the Protox product appeared in publications such as the Body+Soul supplement, Woman’s Day and Marie Claire.  Also, an article or editorial discussing “cosmeceuticals” with accompanying mini-features of select products in the form of panel advertisements was published in Body+Soul supplements that were included in a number of newspapers in the period between November 2014 and October 2016.  The mini-features, or advertisements, on Protox included the following statements:

    (1)“Freezeframe Protox ($69, 1800 662 686), can make Botox last longer, and reduce wrinkles even if you haven’t had injections”

    (2)“Get smoother skin without Botox”

    (3)“IMAGINE A SERUM THAT MAKES BOTOX LAST LONGER

    Introducing freezeframe Protox, the anti-aging serum so powerful, it not only gives you a dramatic skin smoothing without the use of Botox, it can actually make the visual effects of Botox last up to three times longer. See smoother, fresher, younger-looking skin in as little as two-to-four weeks. Call 1800 662 686 or visit freeze-frame.com

    *Botox is a registered trademark of Allergan, Inc.”

    (4)“MAKE BOTOX LAST Imagine a serum that makes Botox® last longer”

    (5)“Better without Botox Freezeframe Protox is clinically proven to make Botox look better and last up to three times longer, but it’s the dramatic results this power serum can produce without Botox that has everyone talking. On its own, Freezeframe Protox has a strong Botox-like effect and is proven to reduce deep wrinkles and smooth skin in just 15 days”.

22. From about October 2014, the Protox product together with the statements below have been included on the Freezeframe website at various times, for various periods of time:

    (1)“At Last! A serum that can prolong the look of Botox®”

    (2)“THE MOST POWERFUL BOTOX® ALTERNATIVE EVER DISCOVERED”

    (3)“Introducing freezeframe PROTOX, the anti-aging serum so powerful, it not only gives you dramatic skin smoothing without the use of Botox, it can actually make the visual effect of Botox injections last up to 3 times longer!”

    (4)“The Accidental Botox Alternative”

    (5)“which could produce a Botox-like visual effect when applied topically to the skin”

    (6)“for the first time ever cosmetic ingredients were tested to see what effects they had on skin that has been administered Botox injections”

    (7)“freezeframe PROTOX’s peptide complex was proven to make the visual skin smoothing effect achieved from Botox injections last up to 3 times longer than they would on their own!”

    (8)“it actually made the visual effect, that lovely smooth skin look achieved with Botox, look even more dramatic than injections alone”

    (9)“In fact, skin looked better 6 months after injections than at 2 months, when Botox injections are still at their peak. Botox injections alone would have worn off by then”

    (10)“Look better without Botox, or make Botox look better for longer – the power is now in your hands!”

    (11)“the ultimate proof: freezeframe PROTOX is so powerful, it can even make Botox look better”

    (12)“freezeframe PROTOX intensified the skin smoothing look achieved by Botox, and had prolonged it even after 6 months.”

23. Ms Amoroso came up with the word PROTOX.  She intended it to be a play on words, where PRO refers to prolonging and TOX refers to botulinum toxin.  She intended the product to be part of the Freezeframe range of products and to be referred to as FREEZEFRAME PROTOX.  She expressly disputed that the play on words was intended to reference Allergan’s product Botox, as opposed to the generic understanding of “botox”, namely botulinum toxin.

24. Ms Amoroso said that she decided to use a capital B for Botox in the packaging and advertising to acknowledge the trade mark owner, Allergan, and to avoid the issues that she had had with Allergan during her time at Cat Media Pty Ltd (Cat Media).  She was the founder of Cat Media and its managing director from March 1997 until December 2006 when she sold her interest in it.

25. Ms Amoroso denied that she had chosen names like BITOX (when she was at Cat Media), PROTOX and INHIBOX because of the closeness to the BOTOX mark or to play on the name BOTOX.  She said that in choosing those names she was interested in communicating an alternative to botulinum toxin, but not that her product had any connection with Botox.  She said that the PROTOX name was intended to convey that the product prolongs the effect of botulinum toxin.

26. It might be thought that that is rather undermined by the use of the ® symbol and the recordal that BOTOX is the registered trade mark of Allergan on the product packaging and in some of the advertising.  However, in view of the general understanding in the market that “botox” refers to anti-wrinkle injections that are not necessarily Allergan’s product, and Ms Amoroso’s prior experience of Allergan complaining of Cat Media having appropriated its BOTOX mark, she could have had the intention to refer to botulinum toxin injections generically and to wish to take the precaution to specifically acknowledge that BOTOX is Allergan’s trade mark.

27. In email correspondence with people making a video commercial in 2009 when Self Care’s first product, Freezeframe with Inhibox, was launched Ms Amoroso said that “box” or “ox” in the name was a play on “botox” and that she thought that the target market would get the inference.  She says that by “botox” she meant botulinum toxin, not the mark BOTOX, which, she says, is shown by the fact that she did not use capital letters.  I do not accept that evidence.  It strikes me as a convenient reconstruction.  Given the fame of BOTOX, the intention was obviously to leverage off that fame by the reference.  That is the inference that the target market would “get”.

28. As recorded above, the Protox product was initially advertised and promoted under the lead message that it could be used to prolong the effect of Botox.  That was found to be unsuccessful because, on Ms Amoroso’s understanding and assessment, Self Care’s customers do not as a rule use Botox and were accordingly not interested in a product for prolonging its effects.  Therefore, the lead messaging was switched to Protox being an alternative to Botox.

29. Where the term “Botox alternative” is used in a statement, Ms Amoroso’s understanding and intention in relation to the meaning of that term was that the product is something that the customer would use themselves instead of using Botox.  That is, it is a product which does not involve injections of botulinum toxin.

    Inhibox product

30. Since around July 2009, Self Care has promoted, sold or offered for sale, in Australia a skincare product which I will refer to as the Inhibox product.  It is sold in 10 ml units in a hard plastic syringe-like applicator.

31. Until about February 2017, the applicator was packaged in a box containing a clear plastic window through which one can see the syringe-like applicator.  The packaging included the words FREEZEFRAME and WITH INHIBOX appearing separately as well as together.  It also included the phrases “instant Botox® alternative”, “Clinically proven to erase wrinkle appearance in 5 minutes” and “The world’s first Instant and Long Term Botox® Alternative”.

32. Since about September 2016 to date, the applicator has also been packaged in a different box without a window.  The box prominently displays the words FREEZEFRAME and INHIBOX.  It also includes the phrases “instant Botox® alternative”, “clinically proven to erase eye wrinkles & puffiness in 5 minutes” and “The original instant and long-term Botox® alternative”.

33. The current packaging relevantly looks like this:

34. Included in the old and the new packaging is a product information sheet which appears to be the same in each case and the same as the product information sheet for the Protox product.

35. Self Care has sold and offered for sale the Inhibox product in Australia to various retail outlets and pharmacies.  The recommended retail price is about $89.00 including GST.

36. From at least October 2012 to date, the Inhibox product has been promoted and sold from the Freezeframe website.

37. From about October 2012, the Inhibox product together with the statements below have been included on the Freezeframe website at various times, for various periods of time:

    (1)“CLINICALLY PROVEN

    INSTANT BOTOX® ALTERNATIVE

    FREEZES WRINKLES INSTANTLY

    REDUCES WRINKLES LONG TERM”

    (2)“Freezeframe with INHIBOX is the original Instant Botox® Alternative, clinically proven to erase wrinkle appearance under the eyes and on the forehead in just 5 minutes, whilst delivering up to 63.23% reduction invisible [sic] wrinkles in just 28 days”

    (3)“a topical alternative to Botox® injections”

    (4)“The original Instant Botox® Alternative, freezeframe with INHIBOX has been a number 1 seller all over the world”.

38. The original Freezeframe with Inhibox packaging (Exhibit A) includes the phrase “Stop Time – freezeframe”.  Ms Amoroso did not agree that the intention of that phrase was to depict the idea of stopping the passage of time or stopping the ageing process.  She said that FREEZEFRAME as a word was intended to give people the impression of being able to capture a point in time.  That is because it is an instant product and is not a treatment as such; it does not have long-lasting effects.  Ms Amoroso denied that the intention with Freezeframe was to evoke Botox in the sense of “freezing wrinkles”. 

39. Ms Amoroso accepted that the syringe-like applicator for the Inhibox product had the intended implication that it is an alternative to a syringe: “a playful, novelty way of not associating with Botox but associating with an alternative to anti-wrinkle injections in a very playful and non-invasive way”. 

    Night (tube) product

40. From about February 2017 to date, Self Care has sold or offered for sale a skincare product in Australia which I will refer to as the Night (tube) product.  This is to distinguish it from the Night (tub) product which is dealt with next.  The Night (tube) product is sold in a 30 ml tube which is packaged in an elongated box.  The packaging includes the word NIGHT prominently on its own, as well as the word FREEZEFRAME® prominently on its own. 

41. The packaging also includes the phrases “No Needle Topical Micro Injection” and “overnight Collagen and Botox Alternative for advanced line filling and wrinkle relaxing” on the front and side of the box respectively.

42. On the back of the box, the following statements are included:

    (1)“Delivers the results of a collagen injection in 5 sleeps, and a Botox injection in 4 weeks!”

    (2)“Our famous NIGHT cream now includes 2 alternatives to doctor administered injections, with results clinically proven to visually match those of injections – topical line filling equivalent to a collagen injection* and topical wrinkle freezing with visible results rivalling Botox injections…

    *American Society of Plastic Surgeons

    Botox® is a Registered trademark of Allergan Inc.”

    (3)“See results equivalent to ... A Botox Injection in 28 days”.

    (4)“Better than injections? With the visual benefits of both a collagen injection and a Botox injection, our multi action formula works in 3 ways to freeze and fill wrinkles, as well as lift skin for a dramatically younger appearance – without needles or invasive procedures.”

    (5)“Our Topical Botox Alternative now delivers up to 94% wrinkle reduction in just 4 weeks!”

43. The packaging relevantly looks like this:

44. The tube itself has the words NIGHT and FREEZEFRAME® in close proximity and the phrase “Discover the overnight Botox® Alternative which relaxes wrinkles and rejuvenates skin whilst you sleep!”

45. Inside the Night (tube) product packaging is a product information sheet which includes the following statements:

    (1)“Overnight Collagen and Botox Alternative for advanced line filling and wrinkle relaxing.”

    (2)“Our famous NIGHT cream has been reinvented to include not 1, but 2 alternatives to doctor administered injections, with results clinically proven to visually match those of injections – topical line filling equivalent to a collagen injection and topical wrinkle freezing with visible results rivalling Botox injections ... American Society of Plastic Surgeons Botox® is a Registered trademark of Allergan Inc.”

    (3)“See results equivalent to... A Botox Injection in 28 days”.

    (4)“Better than injections? With the visual benefits of both a collagen injection and a Botox injection, our multi action formula works in 3 ways to freeze and fill wrinkles, as well as lift skin for a dramatically younger appearance – without invasive procedures”

    (5)“Our Topical Botox Alternative now delivers up to 94% wrinkle reduction in just 4 weeks!”

    (6)“Delivers the results of a collagen injection in 5 sleeps, and a Botox injection in 4 weeks!”

1. Since about February 2017 to date, Self Care sold or offered the Night (tube) product for sale at pharmacy retail outlets and on the Freezeframe website.  The recommended retail price of the Night (tube) product is around $79.00, including GST.

2. From about February 2017, the Night (tube) product together with the statements below have been included on the Freezeframe website at various times, for various periods of time:

   (1)On the website banner:

   (a)“The same visible results of a COLLAGEN INJECTION 15 NIGHTS And a BOTOX® INJECTION 4 WEEKS”

   (b)“Collagen Injection 15 DAYS 

   Botox Injection 28 DAYS

   Mini Face Lift 84 DAYS

   2 x TOPICAL MICRO INJECTORS”

   (2)On the website:

   (a)“Imagine ... the same visible results of a collagen injection in just 15 sleeps*, and a Botox® injection in 4 weeks*! ...

   *American society of plastic surgeons confirms results ...

   *Results may vary. Botox® is a registered trade mark of Allergan Inc. freezeframe NIGHT has no association with any anti-wrinkle injection brand”

   (b)“New freezeframe NIGHT contains 2 Topical Micro Injection technologies, both clinically proven to visually match those of injections – topical line filling equivalent to a collagen injection and topical wrinkle freezing with visible results rivaling Botox Injections”

   (c)“What’s better than a topical alternative to wrinkle fillers? One formula that includes both an alternative to fillers and alternative to Botox Injections!”

   (d)“The same visible results of a COLLAGEN INJECTION 15 NIGHTS And a BOTOX® INJECTION 4 WEEKS

   Reduces wrinkle appearance by as much as 94% in 28 days!”

3. Advertisements for the Night (tube) product featured in print advertising in 2017 which included the following statements:

   (1)“Imagine... the same visible results of a collagen injection in just 15 sleeps*, and a Botox® injection in 4 weeks*! …

   *American Society of Plastic Surgeons – collagen injections deliver a 15% wrinkle reduction

   *Botox is a Registered trademark of Allergan Inc.

   *NIGHT actives can reduce the appearance of wrinkles by up to 96% as compared to 84% in one Botox study. Data on file. Refers only to the visible effects on skin surface”

   (2)“2 x TOPICAL MICRO INJECTORS Collagen Injection 15 DAYS Botox Injection 28 DAYS Mini Facelift 84 DAYS”

   (3)“New freezeframe NIGHT contains 2 Topical Micro Injection technologies, both clinically proven to visually match those of injections – topical line filling equivalent to a collagen injection and topical wrinkle freezing with visible results rivaling Botox Injections. But it’s the dramatic face lifting effects that have astounded customers and experts alike, with skin structure brought back to baby’s skin in less than 3 months.”

   (4)“What’s better than a topical alternative to wrinkle fillers? One formula that includes both an alternative to fillers and alternative to Botox Injections!”

4. In respect of the Night (tube) product, Ms Amoroso denied that her intention was to convey that the product would do as well as Botox; her intention was to convey that the product achieves a very high level of wrinkle smoothing which is comparable to Botox.

   Night (tub) product

5. In or around 2009, Self Care developed a skincare product which I will refer to as the Night (tub) product.  From about October 2012 to about March 2017, Self Care sold or offered for sale the Night (tub) product in a 30 ml glass jar/tub packaged in a cube-shaped box.

6. Inside the Night (tub) product packaging was a product information sheet.

7. Self Care sold the Night (tub) product in Australia to certain retail outlets and pharmacies.  The recommended retail price was around $79.00, including GST.

8. Self Care promoted, sold or offered for sale the Night (tub) product in Australia on the Freezeframe website where the following statements were made at various times and for various periods of time:

   (1)“Overnight Botox® ALTERNATIVE!”

   (2)“LONG TERM BOTOX® ALTERNATIVE” 

   (3)“This luxurious cream is clinically proven to relax facial expressions and reduce the appearance of wrinkles by up to 63.23% in just 28 days, providing a long term alternative to Botox® injections”.

   Boost Product

9. From about March 2017 to date, Self Care has sold or offered for sale a skincare product in Australia which I will refer to as the Boost product.  The product is sold in a 12 ml tube with a combined pump/rollerball applicator which is packaged in an elongated box.

10. The Boost product packaging prominently displays the words FREEZEFRAME and BOOST SERUM and contains the statement “Botox® alternative peptides provide targeted results on even the deepest wrinkles.”

11. The packaging relevantly looks like this:

12. The product information inside the Boost product packaging contains the statement “Botox® alternative peptides also add to the anti aging cocktail for dramatic, targeted results on even the deepest wrinkles”.

13. Self Care has promoted, sold or offered for sale the Boost product in Australia on the Freezeframe website and sold it in Australia to the retail outlet Priceline.  The recommended retail price is around $59.00, including GST.

14. From March 2017, the Boost product was included on the Freezeframe website with the following statement at various times, for various periods of time: “Botox® alternative peptides also add to the anti aging cocktail for dramatic, targeted results on even the deepest wrinkles”.

15. Since at least October 2012, the Boost Product was included on the Freezeframe website with the following statement at various times, for various periods of time: “LONG TERM BOTOX® ALTERNATIVE”.

    SELF CARE’S IMPUGNED STATEMENTS AND ITS UNDERTAKINGS

16. On 18 February 2019, after the filing of Allergan’s further amended statement of claim, and with reference to that pleading, Self Care made a number of undertakings to the Court.  The undertakings were expressly made without admission, in order to narrow the issues in dispute.

17. The undertakings were that Self Care will not make certain of the statements of which Allergan has complained.  Self Care nevertheless stated that it intends to, and considers that it is entitled to, continue to make a number of statements, including various statements to the effect that the Self Care products are “Botox alternatives”.

18. As indicated, Allergan complains of statements by the respondents in four ways, namely as trade mark infringements, as affiliation representations, as efficacy representations and as contraventions of the TG Act.

19. The tables below, in respect of each product, reflect the statements that Allergan complains of, the ground for the complaint in each case (trade mark infringement, affiliation representation, efficacy representation and TG Act), and whether Self Care has undertaken not to make the statements anymore. These tables are prepared from Schs A, B and C to Allergan’s closing submissions.

20. Protox product:

No.	Statement	TM inf. Y/N	Aff. rep Y/N	Eff. rep Y/N	TG Act Y/N	U/taking Y/N
1	Use of the words “PROTOX” and “FREEZEFRAME PROTOX”	Y	Y	N	N	N
2	“Clinically proven to prolong the effect of Botox®”	Y	Y	Y	N	Y
3	“PROTOX prolongs the skin smoothing effect of Botox® injections”	Y	Y	Y	N	Y
4	“At Last! A serum that can prolong the look of Botox®”	Y	Y	Y	N	Y
5	“The most powerful BOTOX® alternative ever discovered”	Y	Y	Y	N	Y
6	“The accidental Botox Alternative”	Y	Y	Y	N	Y
7	“…Freezeframe Protox ($69, 1800 662 686), can make Botox last longer, and reduce wrinkles even if you haven’t had injections”	Y	Y	Y	N	Y
8	“IMAGINE A SERUM THAT MAKES BOTOX LAST LONGER”	Y	Y	Y	N	Y
No.	Statement	TM inf. Y/N	Aff. rep Y/N	Eff. rep Y/N	TG Act Y/N	U/taking Y/N
9	“MAKE BOTOX LAST Imagine a serum that makes Botox® last longer”	Y	Y	Y	N	Y
10	“Better without Botox Freezeframe Protox is clinically proven to make Botox look better and last up to three times longer, …”	Y	Y	Y	N	Y
11	“Introducing freezeframe PROTOX, the anti-aging serum so powerful, it not only gives you dramatic skin smoothing without the use of Botox, it can actually make the visual effect of Botox injections last up to 3 times longer!”	N	N	Y	N	N
12	“…which could produce a Botox-like visual effect when applied topically to the skin”	N	N	Y	N	N
13	“freezeframe PROTOX’s peptide complex was proven to make the visual skin smoothing effect achieved from Botox injections last up to 3 times longer than they would on their own!”	N	N	Y	N	N
14	“…it actually made the visual effect, that lovely smooth skin look achieved with Botox, look even more dramatic than injections alone”	N	N	Y	N	N
15	“In fact, skin looked better 6 months after injections than at 2 months, when Botox injections are still at their peak.  Botox injections alone would have worn off by then”	N	N	Y	N	N
16	“Look better without Botox, or make Botox look better for longer – the power is now in your hands!”	N	N	Y	N	N
17	“the ultimate proof: freezeframe PROTOX is so powerful, it can even make Botox look better”	N	N	Y	N	N
18	“freezeframe PROTOX intensified the skin smoothing look achieved by Botox, and had prolonged it even after 6 months”	N	N	Y	N	N
19	“Introducing freezeframe Protox, the anti-aging serum so powerful, it not only gives you a dramatic skin smoothing without the use of Botox, it can actually make the visual effects of Botox last up to three times longer. See smoother, fresher, younger-looking skin in as little as two-to-four weeks.  Call 1800 662 686 or visit freeze-frame.com  *Botox is a registered trademark of Allergan, Inc.”	N	N	Y	N	N

1. It should be noted that the Protox product statements in the table above that are shaded and numbered 7-10 and 19 appeared in the Body+Soul supplement mini-features referred to at [67] above. That is recorded in the parties’ statement of agreed facts. In Sch A to its closing submissions, Allergan gave various references to the court book as evidence of the statements having been made by Self Care. Some of the references are to pages of the Freezeframe website but the shaded impugned statements do not appear there. The other references are to the Body+Soul mini-features.

2. Ms Amoroso’s evidence, which was not challenged, was that the content of the mini-features in which the statements appeared were controlled by the publishers of Body + Soul and that Self Care had no control over the content.  On that basis, I am not able to find that Self Care made the statements, or adopted them or that the statements are otherwise attributable to Self Care.  For that reason, those statements are left out of account in what follows.

3. Inhibox product:

No.	Statement	TM inf. Y/N	Aff. rep Y/N	Eff. rep Y/N	TG Act Y/N	U/taking Y/N
1	“Instant BOTOX® alternative”	Y	Y	Y	Y	N
2	“The World’s first Instant and Long Term Botox® Alternative”	Y	Y	Y	Y	Y re “Long term Botox alternative” only
3	“The original instant and long term Botox® alternative”	Y	Y	Y	Y	Y re “Long term Botox alternative” only
4	“Clinically Proven, Instant Botox® Alternative”	Y	Y	Y	Y plus “freezes wrinkles instantly”	N
5	“Freezeframe with INHIBOX is the original Instant Botox® Alternative”	Y	Y	Y	Y	N
6	“…a topical alternative to Botox® injections…”	Y	Y	Y	Y	N
7	“The original Instant Botox® Alternative”	Y	Y	Y	Y plus “has been a number 1 seller all over the world”	N

1. Night products (tube and tub):

No.	Statement	TM inf. Y/N	Aff. rep Y/N	Eff. rep Y/N	TG Act Y/N	U/taking Y/N
1	“Discover the overnight BOTOX® Alternative which relaxes wrinkles and rejuvenates skin while you sleep!”	Y	Y	Y	Y	N
2	“Overnight Collagen and Botox Alternative for advanced line filling and wrinkle relaxing”	Y	Y	Y	Y	N
3	“Delivers the results of a collagen injection in 5 sleeps, and a Botox injection in 4 weeks”	Y	Y	Y	N	Y
4	“Our Topical Botox Alternative now delivers up to 94% wrinkle reduction in just 4 weeks”	Y	Y	Y	Y	N
5	“Overnight Botox® alternative” “Long term BOTOX® Alternative”	Y	Y	Y	N	Y (tub) N (tube)
6	“Botox Injection in 4 weeks Botox Injection in 28 days BOTOX® INJECTION 4 WEEKS Botox Injection 28 DAYS”	Y	Y	N	N	Y

1. Boost product:

No.	Statement	TM inf. Y/N	Aff. rep Y/N	Eff. rep Y/N	TG Act Y/N	U/taking Y/N
1	“…Botox® alternative peptides provide targeted results on even the deepest wrinkles”	Y	Y	Y	Y	N
2	“Botox® alternative peptides also add to the anti aging cocktail for dramatic, targeted results on even the deepest wrinkles”	Y	Y	Y	Y	N
3	“Long term BOTOX® alternative”	Y	Y	Y	Y	N
4	“Wrinkle relaxing eye-roller for a long term BOTOX® alternative”	Y	Y	Y	Y	N

THE REPUTATION OF BOTOX

1. The reputation of the BOTOX word mark is relevant to a number of the claims that fall to be decided.  It is thus convenient to consider the reputation of BOTOX as a separate issue.  That is undertaken in this section.

2. Ms Dawn Judith De Cruz, the Associate Director, Legal & Compliance – Australia & New Zealand of Allergan Australia gave evidence.  Ms De Cruz testified that in Australia there is coverage of the Botox product by journalists and that Allergan’s overseas marketing material is reproduced or mentioned by third parties in publications circulating in Australia.  She annexed to her affidavit internet Google search results for the word BOTOX and publications that were linked to the search results.  The search was conducted on 20 November 2017.

3. Most of the search results, even in their summary forms as appearing on Google’s search engine results page, refer to Botox as being an “anti-wrinkle injection”.  Also, the knowledge panel (right-hand panel) identifies Botox as botulinum toxin.

4. The media articles identified by Ms De Cruz discuss Botox injections, including their cost and the pain associated with their administration.

5. As recorded above, Ms De Cruz explained that for the purposes of selling, marketing and promoting Botox, Allergan makes a distinction in its business model between the use of Botox for the purpose of medicinal therapeutic indications and its use for cosmetic indications. 

6. Ms De Cruz explained that Allergan engaged the company Edelman Australia to provide public relations and media communications related services to Allergan.  Edelman regularly monitors Australian media coverage for and on behalf of Allergan in relation to the mark BOTOX.  Edelman provided a media audit report on the media coverage of Botox in Australia for the period June 2016 to July 2017.  The report shows that there were 1,054 mentions of Botox in the media surveyed in that period, which covered both positive and negative sentiment for Botox. 

7. Edelman concluded that most often BOTOX is used as a category term rather than as a brand which, Edelman said, would be used for familiarity with their audience over “anti-wrinkle treatment” or “anti wrinkle injections”.  However, given that Edelman’s methodology for reaching that conclusion was not revealed, and it obviously involved some level of judgement and hence opinion, I am not able to give much weight to that conclusion.

8. In the “anti-wrinkle” category of this survey, Edelman found that in every month in the survey BOTOX had overwhelmingly more mentions than any of the other 13 brands surveyed.

9. Ms De Cruz exhibited to her affidavit more than 200 articles from the media that mentioned Botox in the period 2003 to 2017.  I reviewed the articles.  Almost all of the articles refer to Botox being administered by way of injection and many of them refer to Botox being a toxin.  Frequently Botox was referred to in the context of cosmetic surgeries.  None of the articles suggests that Botox can be topically applied.

10. Ms De Cruz also exhibited reports of surveys conducted for Allergan by AC Nielsen in relation to brand awareness.  Twice in 2004 and then once in each of the following years through to and including 2008, AC Nielsen conducted surveys of more than 400 female respondents over the age of 25 in Australian capital cities.  Each survey showed that more than 80%, and in later years more than 90%, of respondents were aware of Botox and more than 20% were aware of botulinum toxin therapy.  I do not think that the relatively low awareness of botulinum toxin therapy is indicative of a low awareness that Botox is an injectable product that is only administered by healthcare professionals.  All it indicates is that most of the respondents who were aware of Botox were not aware that Botox is constituted by botulinum toxin.

11. Ms De Cruz testified that the survey reports also show that the mark BOTOX had the highest brand awareness for “wrinkle removal procedures” in Australian women aged 25-54.  That can be accepted, it being significant that it is “procedures” rather than treatments for which Botox is known.

12. Ms De Cruz also cited mainstream media and television programs that frequently referred to Botox.  One of those, as I have already mentioned, is the film Sex and the City.  That film was released in Australia in June 2008 and box office sales for the period June to September 2008 grossed more than US$25 million.  I take that to indicate that a large number of people watched the film.

13. An episode of the television series Sex and the City, in season five, included a scene mentioning Botox.  Season five apparently premiered to nearly eight million viewers, as reported in August 2017, although the evidence does not show when season five aired in Australia.

14. I have reviewed the scenes in the movie and in the episode in season five that mentioned Botox.  There is nothing in those scenes to suggest that Botox is topically applied, and in one scene “having Botox” is associated with pain implying widespread knowledge that Botox is an injectable.

15. Ms De Cruz also referred to several other popular television programs that mentioned Botox.  One of those is an episode called “Skin Deep” on Catalyst, a television program that aired on ABC in September 2012 to approximately 800,000 viewers in Australia.  The program discussed, amongst other things, the use of Botox as an injectable that is required to be administered by a healthcare professional.  The program also made a distinction between Botox and its active ingredient botulinum toxin, however referred throughout to “botox” as short hand for anti-wrinkle injections.  Other programs include Real Housewives of Sydney and The Bachelorette.  The submission is that Botox occupies a place in Australian popular culture.  That can be accepted.

16. As one would expect, Allergan regularly publishes press releases to the media, although the evidence does not reveal the extent to which the press releases are picked up by the media and reported on.  Allergan also has websites, both internationally and in Australia, where Botox is promoted.  The Australian website for Allergan reflects that the active ingredient in Botox is botulinum toxin and that Botox is available only by prescription.

17. Ms De Cruz also gave evidence as to Allergan’s global revenue from sales of the Botox product.  That rose from a little under US$1 billion in 2006 to US$2.7 billion in 2016.  As at 30 September 2017, Allergan’s revenue for sales of the Botox product for the calendar year 2017 was US$2.3 billion.

18. With regard to the sales of Botox in Australia for cosmetic uses, the evidence is that annual sales in 2016 were about 44% higher than they were in 2009.  The annual sales for cosmetic uses have, since 2014, increased year on year by more than 9%.  By October 2017, the growth rate for the calendar year 2017 was already reflected at 10.7%. 

19. With regard to the sale of Botox for cosmetic uses in Australia, Ms De Cruz referred to a confidential exhibit showing such sales to be worth very substantial amounts each year for the period 2003 to 2017.  The strong growth and high net value of sales are indicative of a strong brand awareness.

1. Mr Williams explained that in Australia cosmetic manufacturers tend to use the results of studies on ingredients when formulating their products.  The extrapolation is justified where the concentration of the active ingredient in the product is at the same level (or greater) as in the test and if there is nothing in the product which will impair the result that is shown for the active ingredient it is accepted.  Although that is not the approach with respect to therapeutics, presumably because of critical safety issues in relation to therapeutic substances which is what justifies their strong regulation, it is the case with respect to cosmetics because of the prohibitive cost relative to the size of the Australian market to conduct studies on each product itself.

2. Dr Haley accepted that the concentrations of the active ingredients in each of the Self Care products, save for the Boost product prior to a correction in its formulation in August 2018, was the same as in the respective studies relied on by Self Care.  He also did not identify any component in any of the products that would impair the performance of the peptides in the product formulations.

3. In the result, I accept that the results of each of Studies 3, 4, 6-10 and 13, to which this extrapolation issue applies, can be extrapolated to the respective products.

   Prolonging the effect of Botox specifically

4. Studies 6 and 7 investigated the use of peptides to prolong the visible effects of Botox.  Each is a report of the same trial the objective of which was to evaluate the anti-wrinkle effect of the Active E peptide after a botulinum toxin type A treatment by injection.  A panel of 22 females (51 years on average) received 50 µl (i.e., 0.05 ml) of the toxin in the periorbital (crow’s feet) and frontal region.  After the injection, the participants applied either the test formulation with 10% Active E or a placebo formulation (control treatment) twice a day for six months.

5. Skin silicone replicas were obtained before the injection and at different times during the treatments.  The skin relief was evaluated by confocal profilometry, quantifying the reduction of the average surface roughness against the baseline.  Macroscopic photographs were also taken at baseline and after two, four and six months.

6. In the frontal region, the active topical treatment apparently highly intensified the anti-wrinkle effect of the botulinum toxin type A injection at all times, prolonging its benefit on the skin even after six months.  The frontal region skin roughness graph shows that by the six-month period the regions under the control treatment had increased skin roughness from the baseline measurement by 13%.  In comparison, the regions under the active treatment had remained at a decrease of 23%.  In that way the active can be said to have prolonged the effect (reduction in skin roughness) of the Botox injection past the point when it would be expected that no effect would be present.  In the periorbital region, the active treatment potentiated the smoothing effect on wrinkles induced by the injection, improving the results over six months.

7. In his written evidence, Dr Haley said that the clinical test tries to compare the performance of a therapeutic product injected once with a cosmetic product applied topically twice a day for six months which is not a valid comparison.  That, of course, misunderstood the study. Dr Haley accepted this in cross-examination.  Dr Haley also accepted that the experiment was apt to produce results that allow a comparison between the anti-wrinkle effects of the two different treatments, the only difference between them being the presence of Active E in the test group.  He also accepted that the results at six months show that the effect of the botulinum toxin type A injection when administered alone had worn off.  In contrast, the results for the combination of the botulinum toxin type A injection and the test product showed strong ongoing efficacy at six months.  The results of the study thus apparently demonstrate that Active E prolongs the visible effects of Botox.

   Conclusions on reasonable grounds

8. In the result, I find that the representations as to a Self Care product being an alternative to Botox (i.e., the first category of statements identified at [494]-[504] above) are justified as having been made on reasonable grounds. Self Care offered a lot of evidence in support of the proposition that its relevant products produce a noticeable and significant reduction in the appearance of wrinkles. Allergan failed to discharge the onus on it to prove that Self Care did not have reasonable grounds for making the representations. Since, in my evaluation, the achievement of a reduction in the appearance of wrinkles is a similar effect to the use of Botox, the representations were not misleading. That is to say, as concluded above, the ordinary and reasonable consumer would not understand Botox to have a readily quantifiable effect on the appearance of wrinkles, and no evidence has been adduced to actually quantify that effect. Thus, the noticeable and not insignificant effect of Self Care’s products in reducing the appearance of wrinkles is sufficiently similar to the effect of Botox in reducing the appearance of wrinkles that the representation that one is an alternative for the other is not misleading.

9. In the second category of representations (identified at [505]-[507] above), the statement that Protox “could produce a Botox-like visual effect” is also not misleading for the same reasons. The evidence establishes reasonable grounds for the representation that Protox can produce a noticeable and significant visual effect in the appearance of the reduction of wrinkles similar to that produced by Botox (although not quantifiably so).

10. However, also in the second category is the statement that the Night (tube) product “delivers the results of a Botox injection in 4 weeks” which, as I have said, constitutes a representation that the product will deliver the same results as Botox in four weeks.  The time period of Study 2 which tested the Active in the Night (tube) product corresponds to the time period of four weeks referred to in the statement.  That study does not, however, provide reasonable grounds for the representation that the product produces the same results as Botox.  There is no head-to-head study to compare the results of the two products, and although Study 2 quantifies the reduction in wrinkles over four weeks of use of a formulation containing Active A, there is no study which in a comparable way quantifies the efficacy of Botox over four weeks.  Self Care has not sought to justify the comparative representation and it is not justified by the evidence.  The statement is therefore misleading within the meaning of s 29(1)(g) of the ACL.

11. The third category of statements (identified at [508] above) is those that represent that the product in question prolongs or improves the look of Botox. The studies provide an adequate foundation, and thus reasonable grounds, for the statements with regard to prolonging and improving the look of Botox. Once again, the representations are with regard to appearance. Thus the fact that the underlying physiological effect of Botox is not prolonged by Protox is not to the point. The studies show, albeit in an unexplained way, that the appearance in the reduction of wrinkles that is achieved by Botox is prolonged and enhanced by the use of Protox.

    LOSS AND DAMAGE

12. As identified (at [42] above), Allergan is required in this part of the case to establish at least one instance of loss or damage under each head of damage that it claims. The quantification of those losses is separated out for later determination.

13. In view of the fact that none of Allergan’s claims, whether as to trade mark infringement, misleading and deceptive conduct under the ACL (with one exception) and passing off has succeeded, the question of loss and damage falls away.  The usual practice of a trial court is to decide all the issues, even those that strictly speaking do not arise because of prior findings, to guard against the possibility of the prior findings being held to be wrong and so as to enable a court on appeal to then dispose of all the issues and not to have to refer the matter back to the trial court.  That practice is, however, not a rigid requirement.  Where there is good reason not to take that course, it is appropriate not to do so but the reasons for not doing so should be explained.  See, for example, Chief Commissioner of State Revenue v Adams Bidco Pty Ltd [2019] NSWCA 34 at [3] per Leeming JA (White JA and Emmett AJA agreeing).

14. In my view there is good reason not to separately identify whether an instance of loss or damage has been proved under each head of damage.  First, that exercise would involve addressing it in respect of each trade mark infringement that is asserted by Allergan, each asserted basis for passing off, and in respect of each affiliation representation and each efficacy representation.  That is a demanding exercise in circumstances where none of it or at least parts of it may prove to be entirely unnecessary. 

15. Second, Allergan has indicated, on the assumption of success on liability, that it is likely to seek an account of profits in relation to its asserted trade mark infringements.  Moreover, in the event that it was found that no instance of loss or damage had been proved, it would almost certainly seek an account of profits.  The result is that even if I was to now conclude that no instance of loss or damage was proved on each of the separate bases on which the claims are put, and that was upheld on appeal, if my findings on liability were overturned there would still have to be a further hearing.  Therefore, not dealing now with loss and damage will not in any foreseeable circumstances avoid the need for a remittal and a further hearing in the event that my findings on liability are found to be wrong.

16. Third, in the event that there is an appeal on some limited basis and the parties considered that it would be conducive to the whole case being disposed of by the court on appeal in the event that the appeal is otherwise successful, they could ask me to decide some limited question of loss and damage at this stage.  If persuaded, I could then decide that question in time for it also to be dealt with in the appeal.

17. In the circumstances, I have decided not to make any further decision with respect to loss and damage at this stage.

18. The exception is the misleading statement with regard to the results of Night (tube) after four weeks being the same as Botox.  The ACL claim in relation to that statement succeeds.  I accept the submission that it can be inferred that someone somewhere is likely to have not used Botox, or to have delayed using Botox, because of that statement.  I am accordingly satisfied that this claim can properly proceed to the quantification of damages, if Allergan elects to follow that course.

    LIABILITY OF MS AMOROSO

19. Allergan pleads that since 24 November 2008, Ms Amoroso has been the sole director and secretary of Self Care IP and the person responsible for the day-to-day decision-making and management of Self Care IP.  Further, Ms Amoroso directed and procured the business dealings and affairs of Self Care IP.  That was all admitted by Self Care and Ms Amoroso.

20. Allergan also pleads that since 14 July 2008, Ms Amoroso has been the sole director and secretary of Self Care Corp and the person responsible for the day-to-day decision-making and management of Self Care Corp.  Further, Ms Amoroso directed and procured the business dealings and affairs of Self Care Corp.  Save that Ms Amoroso was the sole director and secretary as pleaded, the other matters in respect of Self Care Corp were not admitted on the basis that they are unclear.

21. On the strength of the allegations pleaded in the two preceding paragraphs, Allergan pleads three separate bases for the personal liability of Ms Amoroso, namely:

    (1)Ms Amoroso infringed the BOTOX marks by having authorised the infringing acts of each of Self Care IP and Self Care Corp within the meaning of s 20(1)(b) of the TM Act;

    (2)Ms Amoroso directed, procured or entered into a common design with Self Care IP and Self Care Corp in their acts of infringement of the BOTOX marks pursuant to s 120(1) and/or s 120(2) of the TM Act; and

    (3)Ms Amoroso:

    (a)is a person who aided, abetted, counselled or procured the conduct of Self Care IP and Self Care Corp in their contravention of ss 18, 29(1)(a), 29(1)(g) and 29(1)(h) of the ACL, within the meaning of s 75B of the Competition and Consumer Act 2010 (Cth);

    (b)directed or procured or entered into a common design with Self Care IP and Self Care Corp in engaging in the tort of passing off; and

    (c)is a joint tortfeasor with Self Care IP and Self Care Corp in engaging in the tort of passing off.

22. Needless to say, the matters pleaded by Allergan in the preceding paragraph were all denied by Self Care and Ms Amoroso.

23. Before going any further, it can be observed that the pleaded basis for Ms Amoroso’s personal liability for any contravention of the ACL by the Self Care companies is unsustainable. That is because it is pleaded to rest on s 75B of the Competition and Consumer Act 2010 (Cth), but that provision does not apply to Pt XI Div 2 of the Act and hence to the ACL. It may be that the pleader had in mind s 236 of the ACL read with para (a) of the definition of “involved” in s 2, i.e., a person who “has aided, abetted, counselled or procured the contravention”. Allergan does not plead or rely on the wording in para (c) of the definition, i.e., a person who “has been in any way, directly or indirectly, knowingly concerned in, or party to, the contravention”.

24. In any event, Allergan does not make any submissions with regard to Ms Amoroso having been knowingly concerned in the contraventions or having aided or abetted the companies in them.  The submissions are put on a narrower basis.

25. It is submitted on behalf of Allergan that Ms Amoroso was so closely involved with the development, the branding, the signing-off and the way in which the products went to market, and that she exercised ultimate decision-making control over the companies, that she is jointly liable with the companies for their infringing conduct.  It is submitted that Ms Amoroso had a close personal involvement in the infringing acts of the company to the extent that she went beyond simply acting in her capacity as director, and made the conduct her own.

26. Allergan thus relies on a test of “close personal involvement” in the infringing conduct by the director of the company as expressed by Davies J in Insight Radiology Pty Ltd v Insight Clinical Imaging Pty Ltd [2016] FCA 1406; 122 IPR 232 at [153]. That phraseology was in turn drawn from that of Besanko J in Keller v LED Technologies Pty Ltd [2010] FCAFC 55; 185 FCR 449 at [291].

27. Also in Keller, Emmett J (at [83] and [84]) said that to be liable as a joint tortfeasor with the company the director must have done something more than acting as a director and been involved in invading the applicant’s rights. Jessup J said (at [404]) that the director must be effectively standing apart from the company and directing or procuring it as a separate entity and that there must be a sense in which the director is using the company as the instrument of his or her wrong, and (at [405]) that the director must have made the tort his or her own.

28. More recently, the Full Court has spoken with one voice in JR Consulting & Drafting Pty Ltd v Cummings [2016] FCAFC 20; 329 ALR 625 per Bennett, Greenwood and Besanko JJ after considering a number of authorities including Keller. The Court stated (at [347]) that unless the director is standing apart from the company there will not be concurrence in the act but merely a coincidence of roles in which the only true actor is the company itself, and that “the director must be shown to have directed or procured the tort and the conduct must, clearly enough, go beyond causing the company to take a commercial or business course of action or directing the company’s decision-making where both steps are the good faith and reasonable expression of the discharge of the duties and obligations of the director, as a director” (emphasis in the original): at [350].

29. Ms Amoroso’s role in relation to the impugned conduct of the companies can relevantly be summarised as follows.

30. Ms Amoroso is the sole director and secretary of both the Self Care companies.  She has been the sole director of the companies since 2008.  The shares of both companies are held on trust by Juventas Group Pty Ltd, a company in respect of which Ms Amoroso has been the sole director, secretary and shareholder since 15 May 2007, as trustee for the Artemis Trust.  The Artemis Trust is a family trust which exists for the benefit of various of Ms Amoroso’s family members, including herself.

31. Ms Amoroso incorporated Self Care IP.  In her role as director of that company she decided whether ownership of a trade mark used by Self Care Corp would be owned by Self Care IP.

32. Ms Amoroso has been the CEO of Self Care Corp since mid-2013.  That company employs around 17 to 19 people at any given time.  As part of her role as CEO of Self Care Corp and director of both companies, Ms Amoroso is ultimately responsible for the operations of Self Care.  Despite not being involved in every decision and wishing to empower her staff, Ms Amoroso still has ultimate control over what goes out to consumers and the public.  That includes ultimate control over the creative direction of any advertising campaign, but not necessarily how it is implemented on a day-to-day basis.

33. Ms Amoroso reviewed and had final sign-off on Self Care’s brand guidelines.  All new packaging and advertising is printed and placed on her desk with a sign-off sheet.  That enables her to immediately rectify any inconsistency or inadequacy with the packaging or advertising, including the way that the relevant trade marks appear.

34. At the time that the Inhibox product was developed, Ms Amoroso was aware from her own observation that there were a number of products in the market promoting themselves as “Botox alternatives”.  Her idea was to develop a similar product that also had an instant effect.  Ms Amoroso was part of the team that ultimately selected the statements made by Self Care about this product in respect of which Allergan complains.  It was Ms Amoroso who decided to refer to botox as Botox (i.e., with a capital ‘B’) and to acknowledge Allergan as the trade mark owner on the packaging and marketing of the product.

35. Ms Amoroso came up with the brand PROTOX.  She made the decision that Self Care IP would own the trade mark.  She decided to first register PROTOX on its own rather than FREEZEFRAME PROTOX.  A decision was made by the marketing team at Self Care, including Ms Amoroso, to switch the messaging from Protox prolonging Botox to Protox being an alternative to Botox.  Ms Amoroso was part of the team that selected the promotional statements that would be made by Self Care in respect of the Protox, Night (tube) and Boost products about which Allergan complains.

36. Only about six people were working in the business at the time that the Night (tub) statements were selected.  All those people, including Ms Amoroso, were involved in selecting the relevant statements.  Each member of the team reviewed summaries of the clinical studies supporting the product to ensure that the statements were accurate.

37. Ms Amoroso’s evidence in chief put her firmly at the centre of the companies, in ultimate control of their decision-making and in charge of their creative direction.  She did not seek to shy away from any of that.  However, none of it puts her in a position such as to have gone beyond her role as a director or CEO.  In everything she was clearly acting in the interests of the companies and not directly in her own interests; the activities of Self Care of which Allergan complains are squarely activities within the ordinary course of Self Care’s business.  There was no indication that anything Ms Amoroso did for the companies was also conduct done on her own behalf.

1. Allergan relies on Ms Amoroso’s previous involvement with Cat Media, and the knowledge and experience she gained there, to submit that the conduct that it complains of with regard to Self Care shows bad faith or consciousness of wrongfulness by Ms Amoroso.  I understand Allergan to submit that on that basis she went beyond or outside her role with the companies and made the conduct her own conduct.  However, I do not consider that that is established.  That perhaps flows inevitably from my findings that, save in one relatively minor respect, the causes of action must fail.  Depending on what basis, in the hypothetical alternative now under consideration, it might be found that one or more of the other causes of action succeeded, it might be found that the assertions of bad faith or consciousness of wrongfulness are upheld.  But on my factual findings, they must be rejected.

2. In the circumstances, I do not find any basis upon which Ms Amoroso would be personally liable on the non-ACL causes of action against the Self Care companies.

3. With regard to the ACL claims, I have already identified Allergan’s pleading difficulty.  It also makes no submissions in support of any finding of accessorial liability based on the relevant (or any) wording of the ACL or with reference to any authority.  On the factual findings I have made above, it would face some difficulty in establishing that Ms Amoroso knew that the impugned statements made representations that were misleading or deceptive, or false.  In the circumstances, I also do not find any basis upon which Ms Amoroso would be personally liable on the ACL causes of action against the Self Care companies.

   THERAPEUTIC GOODS ACT CLAIM

4. In this claim, Allergan seeks injunctions against Self Care and Ms Amoroso restraining them from making the statements that are identified in the “TG Act” column in the tables at [111]-[116] above. The asserted basis for the injunctions is that the making of the statements constitute contraventions of the offence provisions in s 42DL(2) or (3) read with s 42DL(10) and the civil penalty provisions in s 42DLB(1) and (7) of the TG Act.

5. The claim is pleaded on the basis that the impugned statements are claims of a therapeutic use, as that term is defined in the TG Act, namely that the physiological processes in a person who has used the relevant product may be inhibited, influenced, intensified, modified or extended by means of the same mode of action as the Botox product.

6. Relevantly, the definition of “therapeutic goods” in the TG Act includes goods “that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be for therapeutic use”: s 3. The definition of “therapeutic use” includes use in or in connection with “influencing, inhibiting or modifying a physiological process in persons”: s 3.

7. Thus, for a good to be a therapeutic good under the TG Act it need not actually have a therapeutic use or effect; it need only be represented to have that effect. Following the evidence of the expert witnesses in this case, and in particular with reference to the Kraeling article, it is uncontroversial that Self Care’s products have no therapeutic use or effect. Allergan accordingly rests its case on Self Care representing, by the impugned statements in context, that the products have a therapeutic use or effect. In particular, it is pleaded that the statements represent that the products have a therapeutic use or effect “by means of the same mode of action as the Botox product”.

8. In the context of the ACL claims I have found that the statements that are relied on in relation to the TG Act claims do not make any representation with regard to the mode of action of the products and that they do not represent that Self Care’s products have the same mechanism as Botox. I have found that the statements will be understood as saying something about the effect that the products will have with regard to the reduction in the appearance of wrinkles, but not about the mechanism to achieve that effect. See [494]-[509] above.

9. In that regard, it is to be noted that Allergan does not identify Night statement 3 as being one of the statements in respect of which it seeks an injunction.  That is presumably because Self Care has given an undertaking not to make that statement.  It will be recalled that that is the statement that the product “delivers the results of a Botox injection in four weeks”.  In respect of that statement, the case might more readily be made that it makes the representation that the product will have the same mode of action as the Botox product, but I have concluded that that statement also speaks only to observable results and not mode of action.  In any event, in view of no injunction being sought in relation to that statement that question need not be considered further.

10. In the circumstances, the TG Act claims fall at the first hurdle. Allergan has simply failed to prove that the statements make the representations that are pleaded and which are in turn said to constitute contraventions of the TG Act. The claims should therefore be dismissed.

11. It should, however, be noted that there are also other possible obstacles to the TG Act claims succeeding even if I am wrong in my conclusion that the statements do not make the pleaded representations with regard to the therapeutic effect of Self Care’s products. The most significant other obstacle is whether Allergan has standing to seek injunctive relief in reliance on contraventions of the TG Act.

    CONCLUSION

12. In the result, for the reasons set out above, I have found as follows in the NSD15/2017 proceeding:

13. Allergan’s claims of trade mark infringement under s 120 of the TM Act against Self Care for its word mark PROTOX, the use of various phrases including the word BOTOX and the use of the word BOTOX itself are not established and should be dismissed.

14. Allergan’s claims that Self Care made representations which were contrary to the ACL of affiliation or that Self Care engaged in passing off are not established and should be dismissed.

15. Allergan’s claims that Self Care made efficacy representations contrary to the ACL are established for only one of the 35 statements complained of, and the rest should be dismissed.  The successful claim is with regard to the statement that the Night (tube) product produces the results of Botox in four weeks.

16. Allergan’s claims that Self Care infringed the TG Act are not established and should be dismissed.

17. Self Care’s cross-claim for removal (including cessation of protection) from the register of the word mark BOTOX in class 3 of the 655 mark for non-use is successful and an appropriate order should be made.  Its claim for cancellation of the BOTOX 426 defensive mark in respect of all the class 3 goods is not established and should be dismissed.

18. In the NSD1802/2017 proceeding I have found as follows:

19. Allergan Inc’s appeal against the decision of the delegate of the Registrar of Trade Marks to allow Self Care IP’s application for the registration of the mark FREEZEFRAME PROTOX in class 3 should be dismissed.

20. I will require the parties to bring in short minutes of order to dispose of the proceedings in accordance with my reasons, including with regard to costs.  Mindful also that much of the evidence is the subject of suppression orders, and conscious that despite my efforts to avoid including suppressed information in my reasons, I may have included such information inadvertently, I will also restrict these reasons to the external lawyers of the parties and give them the opportunity to bring to my attention any redactions that should be made.  Only after that will the reasons be published to the parties themselves and made public.

21. The Court will retain the physical exhibits pending the possibility of an appeal.

I certify that the preceding six hundred and twenty-seven (627) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Stewart.

Associate:

Dated:       22 October 2020

SCHEDULE OF PARTIES

NSD 15 of 2017
Cross-Claimants
Second Cross-Claimant:	SELF CARE CORPORATION PTY LTD (ACN 132 213 113)
Cross-Respondents
Second Cross-Respondent	ALLERGAN AUSTRALIA PTY LTD (ACN 000 612 831)