Sanofi v the Upjohn Company

[1998] ATMO 45

TRADE MARKS ACT 1995

  DECISION OF A DELEGATE OF THE REGISTRAR OF TRADE MARKS WITH REASONS

Re:      Opposition by The Upjohn Company to an application by Sanofi to partially remove trade mark number 553727(5) - provelle - from the Register of Trade Marks

Trade mark number 553727 is the word provelle.  It stands registered as of 12 April 1991 for goods nominated as pharmaceutical preparations.   The registered owner is The Upjohn Company, a Delaware corporation located at Kalamazoo, Michigan, in the United States of America (hereafter The Upjohn Company).

On 15 April 1996, Sanofi, a French société anonyme located in Paris, France, applied under paragraphs 92(4)(a) and 92(4)(b) of the Trade Marks Act1995 for the partial removal of this trade mark.  The application states that Sanofi is aggrieved and seeks to have the trade mark registration removed in respect of pharmaceutical preparations other than combination hormone replacement therapy packs. 

The legal framework

Section 92 provides for the removal of trade marks from the Register for non-use. So far as it is relevant to this application, it reads as follows:

(1)     A  person aggrieved by the fact that a trade mark is or may be registered may … apply to the Registrar for the trade mark to be removed from the Register.

(2)  The application:

(a)    must be in accordance with the regulations; and

(b)     may be made in respect of any or all of the goods … in respect of which the trade mark may be, or is, registered.

(3) ...

(4)     An application under subsection (1) …("non-use application") may be made on either or both of the following grounds, and on no other grounds:

(a)     that, on the day on which the application for the registration of the trade mark was filed, the applicant for registration had no intention in good faith:

(i)     to use the trade mark in Australia; or

(ii)     to authorise the use of the trade mark in Australia; or

(iii)    to assign the trade mark to a body corporate for use by the body corporate in Australia;

in relation to the goods … to which the non-use application relates and that the registered owner:

(iv)   has not used the trade mark in Australia; or

(v)     has not used the trade mark in good faith in Australia;

in relation to those goods … at any time before the period of one month ending on the day on which the non-use application is filed;

(b)     that the trade mark has remained registered for a continuous period of 3 years ending one month before the day on which the non-use application is filed, and, at no time during that period, the person who was then the registered owner:

(i)      used the trade mark in Australia; or

(ii)    used the trade mark in good faith in Australia;

in relation to the goods and/or services to which the application relates.

The relevant period for the purposes of paragraph 94(b) is the three years from 15 March 1993 to 15 March 1996.  

Regulation 9.1 states;

For the purposes of paragraph 92(2)(a) of the Act (which deals with applications), an application for the removal of a trade mark from the Register:

(a)     must be in an approved form; and

(b)     must be accompanied by a declaration made by, or on behalf of, the applicant:

(i)     stating that an inquiry into the use of the trade mark has been conducted by, or on behalf of, the applicant; and

(ii)   setting out the findings of that inquiry that support the grounds referred to in subsection 92 (4) of the Act in reliance on which the application is made.

In accordance with regulation 9.1 of the Trade Marks Regulations, the application was accompanied by a declaration from David Thomas Wilson.  Mr Wilson is a registered patent attorney.  He says that Sanofi is aware that The Upjohn Company uses the trade mark provelle in respect of combination hormone replacement therapy packs, but is unaware that it uses provelle  in respect of any other goods within the scope of the registration.  On behalf of Sanofi an investigation service was commissioned to enquire whether  The Upjohn Company or any company connected with it is using or has used the trade mark provelle.  Those investigations confirmed use on combination hormone replacement therapy packs but revealed no use of provelle on any other pharmaceuticals, particularly, says Mr Wilson, within the period of three years ending one month before the date of the removal application.

The removal application was duly advertised in the Official Journal of Trade Marks on 16 May 1996 and, on 15 August  1996, in accordance with the provisions of section 96, The Upjohn Company opposed Sanofi's removal application.  The grounds of the opposition broadly stated are:

(a) Sanofi is not a person aggrieved within the meaning of section 92(1) of the Trade Marks Act 1995.

(b)     The Upjohn Co's application to register the trade mark was made with an intention in good faith on the part of the applicant for registration to use the trade mark in relation to pharmaceutical preparations and the trade mark has in fact been so used by The Upjohn Company or a registered user.

(c)     provelle  has been used by The Upjohn Company or an authorised user in respect of the goods for which it is registered within the relevant three years. 

(d)    In the alternative if, as alleged,  there has been use of provelle solely for combination hormone replacement therapy packs, any failure to use the trade mark for pharmaceutical preparations was due to circumstances that were an obstacle to use of the trade mark for that period.

(e)     and again in the alternative, that in the circumstances the Registrar of Trade Marks should refuse to remove the registration from the Register, in the exercise of his discretion.

In support of the opposition, The Upjohn Company filed a declaration by Dr Dennis Feeney of 14 February 1997 with exhibits "A" to "N".

There was no evidence in answer.

The matter of this opposition was set down for a hearing which I conducted in Sydney on 16 July 1998.   The opponent, The Upjohn Co, was represented by Mr Gerard Skelly of the Sydney patent and trade mark attorney firm of Spruson & Ferguson.  The removal applicant, Sanofi, was represented by Mr Andrew Lockhart of Baldwin Shelston Waters, a firm of patent and trade mark attorney, also of Sydney.

Person aggrieved

Section 92(1) of the Trade Marks Act 1995 provides for a person aggrieved by the fact that a trade mark is (or may be) registered, to make application for that trade mark to be removed. Such a person must then apply in an approved form, and accompany the application with a declaration stating that an enquiry into the use of the trade mark has been conducted and setting down the finding of that enquiry (see reg 9.1).  There is no provision, however, for the applicant to file any other evidence to support the  removal application unless the removal application is opposed. 

If the Registrar is satisfied that these requirements have been met, and if there is no opposition, then section 97 obliges the Registrar to remove the mark.

As I found recently in Application by Figgins Holdings Pty Ltd for removal of trade mark number 460449 - b beltrami - registered in the name of Beltrami S.p.A (not yet reported):

… the claim to standing is all that is required under the removal provisions of the Trade Marks Act 1995. In contrast to the Trade Marks Act 1955, the removal applicant is not required to lodge any evidence in support of the removal application. Once there is an opposition to the application for removal, the onus is on the opponent to rebut an allegation that the trade mark has not been used by the registered owner and to that purpose there is provision for the lodgment of evidence. If the opponent challenges the applicant's standing, the applicant has an opportunity to provide evidence to support its claim in evidence in answer. If the removal application is made in accordance with the regulations, and there is no opposition, then as explained in the Draft Trade Marks Office Manual of Practice and Procedure, the trade mark registration will be removed without further enquiry. 

Sanofi does claim to be a person aggrieved.  Mr Wilson says:

Sanofi is a person aggrieved by Registered Trade Mark 553,727 provelle, which has so far prevented registration of its own trade mark, aprovel

As a ground of opposition, however, The Upjohn Company challenges this standing. Sanofi it says, is not aggrieved within the meaning of section 92(1).

The evidence supporting The Upjohn Company’s opposition is the Feeney declaration. Dr. Dennis Feeney is the clinical and regulatory affairs director of Pharmacia & Upjohn Pty Limited. This company is a subsidiary of The Upjohn Company and an authorised user of the provelle trade mark.  Dr. Feeney does not expand on The Upjohn Company’s claim that Sanofi is not aggrieved.  He does, however, refer to an opposition proceeding against trade mark number 598114 which was an application filed by ELF Sanofi. He says that The Upjohn Company:

… opposed application A598114 aprovel in Class 5 in the name of ELF Sanofi S.A..  Terry Williams, the Hearing Officer in the matter, handed down his decision on 14 November 1995 holding that the trade marks provelle and aprovel are deceptively similar and that there is a reasonable likelihood of deception. 

Dr. Feeney's declaration thus puts into evidence the fact that Sanofi applied to register its trade mark, aprovel, and that that application failed at opposition because it was found deceptively similar to provelle — the mark which Sanofi here applies to have removed from the Register.

Sanofi has not responded to the challenge to its standing. It filed no evidence to answer the grounds of opposition or the Feeney declaration, and has done nothing to rebut the allegation that it has no standing as an aggrieved  person. However, the opponent's own evidence testifies to that standing, and that evidence needs to be taken into account.

Mr Lockhart argues that because the Trade Marks Act 1995 has moved the onus in removal actions from the removal applicant to the opponent, it is for the opponent to establish that the removal applicant is a not a person aggrieved. He says that there is nothing in the evidence to upset Sanofi’s claim that it is aggrieved, and accordingly, the statement in the removal application must stand. Mr Skelly argues that section 92 requires the person applying for a removal to be aggrieved and, as was the case under the Trade Marks Act 1955,  the applicant's standing is still a threshold issue. 

As mentioned per the beltrami case (supra) in unopposed actions the Registrar will generally be satisfied with an appropriately worded statement.  However, standing is a threshold test, and if a statement is unsatisfactory, or is brought into question by an opponent's evidence or otherwise, the onus to redress the matter lies with the removal applicant. Here, although the opponent raised the question of standing as a ground of opposition in its own evidence it shows that its trade mark, provelle, has been the downfall of Sanofi's attempt to register aprovel.

Standing as an aggrieved person has been found by Justice McLelland in Ritz Hotel Ltd v Charles of the Ritz Ltd (1988) 12 IPR 417 at 454, to embrace:

… any person having a real interest in having the register rectified or the trade mark removed in respect of any goods, as the case may be, in the manner claimed and this would include any person who would be, or in respect of whom there is a reasonable possibility of his being appreciably disadvantaged in a  legal or practical sense by the register remaining unrectified, or by the trade mark remaining unremoved in respect of any goods.

In view of the successful opposition mounted by The Upjohn Company on the basis of this trade mark registration, and the consequent refusal suffered by Sanofi, it is apparent that, both in legal and practical terms, Sanofi has been appreciably disadvantaged by the registration of The Upjohn Company's trade mark  provelle.

Mr Skelly referred me to the Kraft General Foods Inc v Gains Pet Foods Corp (1995) 31 IPR 439. In that case, Kraft claimed standing on the basis of a pending trade mark application whose registration prospects was blocked by the trade marks then under attack for non-use. Kraft's intention to use the trade marks, subject of its pending applications, was brought into question and Kraft declined to satisfy the Court on that point. Here, the facts are rather different. Standing has been raised as a ground, but The Upjohn Company's notice of opposition gives no hint as to why Sanofi's claim to standing should fail. It has certainly never raised a question of Sanofi's intention to use its trade mark aprovel. The Upjohn Company’s evidence, however, shows that as of November 1995, the parties were in dispute and an outcome of the dispute was that Sanofi's trade mark application failed.

I agree with Mr Skelly that standing is still a threshold issue under the Trade Marks Act1995.  If it is not brought into question, then an appropriate statement in an application will be enough to satisfy the requirements of the Registrar.  If it is brought into question, then the removal applicant must be prepared to refute the challenge by using its right to file and serve evidence.  In the present case, the applicant failed to do this, but it has been saved by the opponent's own evidence which brought into view the successful opposition against Sanofi's aprovel trade mark. It is on the basis of that fact that I find that Sanofi has a real interest in the removal of this trade mark, and therefore has standing as aggrieved.  

The removal application 

The Upjohn Company then contests the removal application on the grounds that the application was not in compliance with the requirements of regulation 9.1.  This regulation, says Mr Skelly, requires the applicant to set out the results of enquiry in respect of both the 92(4)(a) and the 92(4)(b) grounds. The Wilson declaration, he says, shows that enquiries were directed to the 92(4)(b) ground.  But neither the design for nor the results of the investigation relate to The Upjohn Company’s intention at the date of application (12 April 1991)  to use the mark in respect of pharmaceuticals.    

Mr Wilson’s declaration reads as follows:

4      On 14^th  March, 1996 my firm commissioned Trade Mark Investigation Services to make enquiries for the purposes of ascertaining whether The Upjohn Company or any company connected with it is using or has used the trade mark provelle on pharmaceutical preparations other than combination hormone replacement therapy packs.  Those investigations confirm the use of provelle-14 and provelle-28 on combination hormone replacement therapy packs, but revealed no use of the trade mark provelle on any other goods, in particular within the period of three years ending one month before the date of this application.

5      The investigations which have been made on behalf of Sanofi have also revealed no evidence that, on the day on which the application for registration of this trade mark was filed, the applicant for registration had an intention in good faith:

(i) to use the mark in Australia; or

(ii) to authorise the use of the trade mark in Australia; or

(iii) to assign the trade mark to a body corporate for use by the body corporate in Australian;

in relation to pharmaceutical preparations other than combination hormone replacement therapy packs, and those investigations indicate that neither The Upjohn Company nor any other party

(iv) has used the trade mark in Australia in relation to pharmaceutical preparations, other than combination hormone replacement therapy packs, at any time before the period of one month ending on the day on which the non-use application is filed.

In my opinion, Mr Wilson’s declaration fulfils the requirements of regulation 9.1.  In his paragraph 4, Mr Wilson gives evidence that an enquiry into the use of the trade mark has been conduced on behalf of the applicant.  In his paragraph 5, he sets out the findings of that enquiry that support both the 92(4)(a) and 92(4)(b) grounds. 

Having found that the applicant, Sanofi, is a person aggrieved, and that its application to remove this trade mark, provelle, is in order, I turn to what are essentially four grounds of opposition

The paragraph 92(4)(a) ground

Mr Skelly here tendered two separate arguments.

First he referred me to the provision of section 234 of the Act. This section lays down that if a trade mark was registered in Part A immediately before 1 January 1996, it is taken to be valid in all respects after a period of 7 years from the date of registration, unless it is shown that the original application was obtained by fraud; was made contrary to the provisions of section 28 of the Trade Marks Act 1955; or that, at the beginning of the current proceedings, the trade mark did not distinguish the goods or services. 

On 14 December 1992, 553727 was registered in Part A. Immediately before 1 January 1996 it stood as a registered trade mark. Its priority date, however, is 12 April 1991, and the date of the removal application is 15 April 1996. When the removal application was filed, therefore, the registration of 553727 was less than 7 years old.  Mr Skelly mentioned that by the date of hearing, 16 July 1998, 7 years had elapsed, but this, I believe, is not material. In line with the specific wording of paragraph 234(2)(e), the 7 years must be taken to run from the priority date to the date on which  the removal application was filed.  Accordingly I hold that the provisions of section 234 do not  protect 553727 against the current removal application.

Second, and in the alternative to relief being available under section 234, Mr Skelly pointed to the evidence of the statement of use and to the evidence of the Feeney declaration.

The statement of use filed on 553727 is in accordance with regulation 10 of the Trade Marks Act 1955. It is dated 4 April 1991. It states that The Upjohn Company does not itself intend to use the trade mark in Australia, but it is intended that Upjohn Pty Limited shall use the trade mark in Australia in relation to all the goods for which registration is sought. On registration of this trade mark, in accordance with the provisions of section 45(1)(b) of the Trade Marks Act 1955, Upjohn Pty Limited was registered as a user.  Verification of The Upjohn Company’s intention that Upjohn Pty Limited was to use provelle  is provided by the Feeney declaration.  Here, under exhibit “A”  are two separate approvals from the Therapeutic Goods Administration (TGA) for Upjohn Pty Limited to use first, provelle-14, and second, provelle-28, in respect of conjugated oestrogen tablets.  The grant in respect of provelle-14 is dated 27 September 1993.  The grant in respect of provelle-28 is dated 13 April 1994.  Dr Feeney further describes continuing trials into the effects of and uses of conjugated oestrogens in cardiovascular diseases, and he says (clause 12) that while the provelle preparations have not been approved by the TGA for the treatment of cardiovascular disorders, he believes it possible that this approval will be forth-coming and to that purpose, research is continuing.

Taken as a whole, I find that

• the evidence of the statement of use

• the registration of Upjohn Pty Limited as a user,

• the success in Upjohn Pty Limited’s two application for TGA approvals, and

• the evidence of continuing trials aimed at extending the use of provelle to conjugated oestrogens for use in the treatment of cardiovascular disorders,

satisfy me that The Upjohn Company filed its application to register provelle with the intention to use the mark on pharmaceutical products.

I therefore find for The Upjohn Company on the first ground of opposition. 

The paragraph 92(4)(b) ground ¾ use and circumstances

Sub-section 100(1) at paragraph (c) of the Trade Marks Act 1995, briefly stated, specifies that in an opposed section 92(4)(b) removal application, it is for the opponent to rebut the allegation that the trade mark was not in use in the relevant three years (here 15 March 1993 to 15 March 1996). Subsection 100(3) then lays down, in paragraph (a), that the opponent succeeds if it shows it used the trade mark in good faith in relation to the goods nominated in the removal application in the relevant three years; or (paragraph (c)) if it shows that the trade mark was not used on those goods, in that period of time, because of circumstances that were an obstacle to the use of the trade mark.

The goods that Sanofi has applied to have removed from trade mark number 553727 are:  pharmaceutical preparations other than combination hormone therapy packs.

The Upjohn Company’s evidence does not show any use on pharmaceuticals in general. It only shows that it has used provelle on combination hormone therapy packs.  Further, as Mr Lockhart pointed out, there is no evidence that The Upjohn Company has TGA approval to use provelle on any pharmaceuticals other than combination hormone therapy packs -  nor that it has any application pending approval for an extension of this specific range of pharmaceuticals. 

The Upjohn Company has failed to refute the allegation that it has not used the trade mark in the relevant period on the goods for which removal is sought.

Mr Skelly argues, however, that The Upjohn Company’s evidence demonstrates  circumstances which bring it within the protection of paragraph 100(3)(c).  He refers me to Dr. Feeney’s description of continuing research into application of conjugated oestrogens.  He says:

The TGA product information on the Provelle Preparation states that the Provelle Preparation is for ‘oral administration of conjugated oestrogens to post-menopausal women which may increase serum high density lipoproteins (HDL) cholesterol and decrease low density lipoprotein (LDL) cholesterol level.  The improvement in lipoprofile may be a factor contributing to the beneficial effect of conjugated oestrogens on the risk of coronary heart disease in post-menopausal women.  (paragraph 7)

and:

The effects of hormone replacement therapy on the cardiovascular system … have been proven in clinical studies … long term studies are currently in progress to assess the direct effects of oestrogens on morbidity in terms of the incidents of myocardial [infarction].  In due course, these studies are expected to confirm the clinical impression of the beneficial effects of oestrogen on the cardiovascular system. (paragraph 11)

and:

… in the future the Provelle Preparation could be recommended for use in reducing coronary disease in post-menopausal women.  Further research is continuing. (paragraph 12) 

and:

… use of the Provelle Preparation may not be restricted to its present TGA approved purposes and it is foreseeable that other favourable effects of hormone replacement therapy may be realised in the future as a result of continuing research in the area. (paragraph 13)

Mr Skelly points out that any new pharmaceutical preparation must undergo a long and careful development regime before it reaches the market.  It must also qualify for  TGA approval - a special circumstance which does not apply to the general class of goods or services. It is, he says, commonplace for pharmaceutical companies to seek and achieve registration for goods under the broad heading of pharmaceutical preparations. This is a standard approach because, when new pharmaceutical preparations are introduced, secondary and tertiary indications are not yet likely to have become apparent.  It is therefore not reasonable, he says, for companies to confine themselves to the goods which align strictly with the primary indication. Conjugated oestrogens were initially developed as hormone replacement therapy but it is now apparent that there are secondary as well as possible tertiary indications.  This means that the product Dr Feeney refers to as the “Provelle Preparation” may be useful in treating a wider range of medical conditions.

Mr Lockhart points out that the evidence does not establish either a long development lead time, or delays in TGA approval for the use of provelle. There is, he says, no evidence of any obstacle preventing use of the trade mark provelle on an extended range of pharmaceuticals. TGA delays are not an issue because no further TGA approval had been applied for.  The registration rights, moreover, have now existed for over five years and, he says,  The Upjohn Company has not produced evidence of any circumstances which impede use of provelle on all pharmaceuticals other than preparations for hormone replacement therapy.

Generally speaking, Mr Skelly’s submissions clearly have substance.  Pharmaceutical products stand apart from the mass of goods.  Research and development must meet more rigorous standards. There is the need for TGA approval and it appeared to be  common ground, that TGA approval is not always immediate. Furthermore, as Mr Skelly explained, the full potential use of any new pharmaceutical preparations, is unlikely to be realised when it is initially allowed into the market.  Under these circumstances it seems to me quite reasonable that pharmaceutical companies should frame their statement of goods in a way that is likely to accommodate what Mr Skelly refers to as secondary and tertiary indications.  That is not to say, however, that a claim as broad as pharmaceutical preparations is justified in every case. On the contrary: this description comprehends the majority of all goods in class 5, and unless a company intents to apply its trade mark to a significant proportion of that class that mark may well stand vulnerable to an attack for non-use. Moreover, should use remains confined to a narrow and specific range, the difficulty of defending a wide monopoly will increase as the term of that monopoly extends.

In the present case, provelle has not been registered for a particularly long time.  Indeed the statutory five years specified under section 93 had barely passed when Sanofi filed its removal application (filing date, 12 April 1991 - removal application date, 15 April 1996).  Moreover, I am satisfied that in the course of this time, both The Upjohn Company and the scientific community generally have been actively engaged in researching other favourable effects of oestrogen replacement therapy.  I am also satisfied, on the evidence, that these particular pharmaceutical preparations have potential for wider use than that specified in the TGA approval for provelle -14 and provelle -28.  All told, I consider that the opponent, The Upjohn Company, has established that because research and trials are still ongoing - a circumstance which affected pharmaceutical companies generally as well as The Upjohn Company in particular - there were obstacles to use of provelle on secondary and tertiary indicators, in the relevant three years.

Nevertheless, while the evidence indicates a reasonable expectation that use of the pharmaceutical preparation will extend beyond hormone replacement therapy packs, it does not indicate that provelle will be used in respect of the broad range of pharmaceutical preparations comprehended by the application.  Accordingly, although I am not prepared to find that the removal sought is warranted, I find that The Upjohn Company has been only partially successful in rebutting the allegation of non-use.

The subsection 101(3)(c) ground - discretion

Under the terms of subsection 101(3) the Registrar has a discretion not to remove a trade mark.  This discretion hinges on the Registrar being satisfied that even though the removal grounds are made out, it is reasonable to leave the trade mark on the Register.

This discretion to refuse a removal application is generally regarded, as per Evershed J in J. Lyons & Co. Ld’s Application, [1959] RPC 120 at 130, as a power which may be applied when “exceptional circumstances … would make it just to refuse the application”. Mr Skelly has suggested that there is a public interest in leaving the application intact because to do otherwise would be contrary to public interest. He has not convinced me of this, and indeed there seems to be a strong counter argument that the public will be best served by a Register that confines registrations to accord with the realities of use.

I am not satisfied that the trade mark number 553727 should not be partially removed, and find no reason to exercise the discretion provided by subsection 101(3).

Decision

I am satisfied that trade mark number 553727 should be partially removed.  However, in consideration of circumstances which The Upjohn Company has shown concerning on-going research and development into further clinical use of the pharmaceutical preparations it refers to as “Provelle Preparations,” I have decided that the trade mark registration should be removed for all goods other than: preparations for use in combination hormone replacement therapy, and preparations for the treatment of cardiovascular disorders. 

According, I direct that the statement of goods on trade mark number 553727 is to be amended to read :

Pharmaceutical preparations for use in combination hormone replacement therapy; pharmaceutical preparations for treatment of cardiovascular disorders.

Costs

In the circumstances of partial success for both parties, I make no award of costs.

Helen R. Hardie
Deputy Registrar

22 September 1998