Federal Court Decisions

Date: 19971222

Docket: T-2000-97

BETWEEN:

FOURNIER PHARMA INC.,

Plaintiff,

- and -

WARNER LAMBERT CANADA INC. and

WARNER-LAMBERT EXPORT LIMITED,

Defendants.

     REASONS FOR ORDER

TEITELBAUM J.

INTRODUCTION

[1]      This is an application by Fournier Pharma Inc., the plaintiff, for the issuance of an interlocutory injunction against Warner Lambert Canada Inc. (Warner Canada) and Warner-Lambert Export Limited (Warner Export), collectively, the defendants, to cease the marketing of their pharmaceutical product under the mark LIPITOR and to cease the infringement of the plaintiff's rights under the registered trade marks LIPIDIL and LIPIDIL MICRO.

FACTS

[2]      Fournier Industrie et Santé S.A. (hereinafter Fournier Industrie), the parent company of the plaintiff, owns the registered trademarks for LIPIDIL and LIPIDIL MICRO. The plaintiff holds the exclusive licence to use those registered trade-marks in association with the marketing of its pharmaceutical product, a hypolipimiser generically designated as a fenofibrate used to treat certain cardiovascular maladies by reducing the blood cholesterol level. The fenofibrate is sold in Canada under the trade-mark LIPIDIL in 100 mg capsules and LIPIDIL MICRO in 200 mg capsules. The plaintiff has used the mark LIPIDIL since 1991 and has used the mark LIPIDIL MICRO since 1995. There is evidence that the LIPIDIL trade-mark has not been used in Canada since 1996 by the plaintiff. Certain pharmacies who still stock LIPIDIL will sell the product if called for by a doctor's prescription. Plaintiff no longer sells the product LIPIDIL.

[3]      Parke, Davis & Company (hereinafter Parke Davis) registered the trade-mark LIPITOR and sold it to Warner Export. The plaintiff never opposed the registration of LIPITOR. Warner Canada is a licensee of the trade-mark and uses it in association with the marketing of its product in Canada. The defendants' product is also a hypolipimiser known generically as a statin and is used for the same purpose as the plaintiff's product and is aimed at the same category of patients. LIPITOR is sold in 10, 20 and 40 mg tablets. The defendants did not begin to issue pharmaceuticals under the LIPITOR trade-mark until March 1997.

SUBMISSIONS

1. The Plaintiff's Submissions

[4]      The plaintiff submits that there is confusion on the grounds that the marks are similar and they are directed at similar patients for the same use. The plaintiff submits that this confusion gives the impression that LIPITOR was created by the plaintiff or that the plaintiff and defendants have a licensing arrangement. The plaintiff further submits that this confusion would lead one to believe that LIPITOR is a newer version of LIPIDIL or LIPIDIL MICRO. The plaintiff considers that this confusion creates a serious and irreparable harm to itself and for patients who are prescribed the wrong medication. The plaintiff submits that pharmacists may mistakenly substitute one product for the other when filling a prescription. In the absence of an interlocutory injunction, the plaintiff submits that it will continue to suffer serious and irreparable harm which can not be adequately compensated by damages, and that patients will continue to be put in danger. Finally, the plaintiff submits that the balance of convenience is in its favour.

[5]      In support of its submission, Dr. Stephen Huguet, president of the plaintiff corporation, relates a conversation between Nina Menrai, a representative of the plaintiff, and Cathy Thomas, a representative of the defendants, where Ms Thomas allegedly told Ms Menrai a story about an Ottawa pharmacist who filled a LIPITOR prescription as LIPIDIL. Ms Thomas also allegedly stated that Parke-Davis had instructed all of their representatives to ask doctors to fill their prescriptions for Lipitor as "Lipitor-Atorvastatin". The plaintiff also presented an affidavit from Lynn Galbraith, the plaintiff's district manager, who allegedly overheard a conversation involving a representative from Parke Davis, later identified by the defendants as Robert Ramuscak, who discussed the occurrences of prescriptions of LIPITOR being filled as LIPIDIL MICRO by pharmacists.

[6]      There is also further affidavit evidence of instances where pharmacists were confused about the relationship between the products. The affidavit of Paul MacDonald, the plaintiff's sales representative, relates a conversation between Mr. MacDonald and Dr. Leslie Petts where Dr. Petts allegedly asked if LIPIDIL MICRO and LIPITOR were the same product. Dr. Petts also allegedly stated that he saw LIPIDIL MICRO and LIPITOR in an unclear fashion. Mr. MacDonald also stated in his affidavit that he met Dr. Loiskandl who wanted to know about a new product. Mr. MacDonald's affidavit stated that the new product Dr. Loiskandl was referring to was LIPITOR which he believed was created by the plaintiff. The plaintiff also provided an affidavit by Dr. Naresh Kumar who stated that he believed that both LIPIDIL MICRO and LIPITOR were made by the plaintiff and that this similarity could cause confusion which could be dangerous to patients wrongly prescribed.

[7]      Finally, the plaintiff produced two reports by Edward C. Kavalec, pharmacist and Dr. Johnathan M. Daniels, senior scientist at CanTox Inc.that evidence the confusion between similarly named medications and, in particular, the confusion between the plaintiff's and defendants' products.

[8]      Assuming the truth of Dr. Huguet's statement that doctors may be prescribing LIPIDIL MICRO as "LIPIDIL 200" because it is sold in 200 mg capsules, Dr. Daniels states that since the maximum daily dosage for LIPITOR is 40 mg, there could be serious side effects for a patient who was wrongly supplied 200 mg of LIPITOR rather than LIPIDIL MICRO. Dr. Daniels also states that since many patients are prescribed a combination therapy of both a fibrate and a statin, then if a patient accidentally received LIPITOR rather than LIPIDIL MICRO, the patient would be receiving two statins and this could cause serious side-effects.

2. The Defendants' Submissions

[9]      The defendants submit that Dr. Huguet admits that the plaintiff had not been commercializing LIPIDIL prior to August 11, 1997 when this action was commenced. Ms Galbraith also admitted during cross-examination that LIPIDIL is no longer available in Canada, that is, no longer available in the sense that the plaintiff will not supply LIPIDIL.

[10]      The defendants have submitted affidavits from four independent pharmacists which state that they are not confused nor were they aware of any instances of confusion between LIPIDIL MICRO and LIPITOR. The pharmacists state that the computer systems they use keep a history of issued prescriptions and would recognize a change in medication, an inappropriate dosage or a dangerous combination of drugs. Furthermore, the defendants have submitted affidavits from nine doctors with family medical practices or practices specializing in the treatment of patients with cholesterol disorders. These doctors stated that they are not confused by the similarity between the names of the drugs because of their different appearances and dosages as well as the fact that they realize that many medications have similar names.

[11]      In particular, the defendants have produced affidavits from Dr. Petts and Dr. Kumar which deny any statements attributed to them in the plaintiff's affidavits. Both doctors submit that they are not confused due to the similarity of the names of the products. In addition, the defendants also dispute a statement in Mr. MacDonald's affidavit concerning the confusion of Dr. Loiskandl as to the new product manufactured by the plaintiff.

[12]      In his affidavit and on cross-examination, Dr. Kumar stated that he did not read the document nor did he think the affidavit he signed was a legal document and he cannot recollect being asked to swear as to the truth of the information contained therein. However, Dr. Huguet submits that he had spoken to Dr. Kumar concerning the confusion between the products and states that Dr. Kumar believed that there could be confusion and that he would sign an affidavit to that effect. Furthermore, in an affidavit by Marianne Muller, the commissioner who asked Dr. Kumar to sign the affidavit, Ms Muller submits that Dr. Kumar read the affidavit, swore to its contents and signed it. Yet on cross-examination, Ms Muller admitted that she did not tell Dr. Kumar that she worked for a law firm and there was neither a style of cause nor back sheet attached to it. Ms Muller also admitted that she was only a commissioner for Metropolitan Toronto and not in Whitby where the affidavit was commissioned. Furthermore, Ms Muller admitted that she had never before commissioned an affidavit.

[13]      In his affidavit and on cross-examination, Dr. Petts stated that he would not err by prescribing LIPIDIL MICRO for LIPITOR. He also cannot recall making any of the statements contained in Mr. MacDonald's affidavit.

[14]      On cross-examination, Mr. MacDonald admitted that he never spoke with Dr. Loiskandl and did not know whether the "new product" Dr. Loiskandl was referring to was LIPIDIL MICRO or LIPITOR.

[15]      The defendants' fourth submission disputes the evidence of Edward Kavalec. Mr. Kavalec admitted on cross-examination that he currently specializes in cost-effective information and document retrieval services, that he had not been a practicing full-time pharmacist in 35 years and that he had not worked in a pharmacy since the early 1980s. Mr. Kavalec also admitted that he had never seen or dispensed the medications in issue nor was he aware of pharmacists' use of computer systems nor did he consider the precautions that pharmacists employ in dispensing drugs. Mr. Kavalec admitted that according to the studies attached to his report, more than 60% of the difficult prescriptions received by pharmacists result in the pharmacist contacting the physician for clarification. This was contrary to the statement in his affidavit that pharmacists are reluctant to contact physicians. In addition, Mr. Kavalec stated that only 0.3% of the pharmacists studied needed clarification due to the doctor's handwriting and, contrary to his affidavit, this was not a significant problem.

[16]      Fifth, the defendants submit that the evidence from the pharmacists show that doctors write the words "LIPIDIL MICRO" when prescribing LIPIDIL MICRO and not some variation. The defendants submit that Dr. Huguet admitted on cross-examination that he was relying on anecdotal evidence that he could not confirm when he stated that doctors prescribed LIPIDIL MICRO as "LIPIDIL 200".

[17]      The defendants next submission is based on an affidavit by Allen Van Der Wee, Business Director for the Parke-Davis division of Warner Canada, that disputes the alleged instances of confusion between pharmacists. Mr. Van Der Wee's affidavit states that both Ms Thomas and Mr. Ramuscak were discussing an Ottawa pharmacist who had been presented with a prescription for LIPITOR but had not heard of the drug nor did he have any available to fill a prescription. This incident occurred in March when the defendants were just beginning to send LIPITOR to pharmacists. Mr. Van Der Wee maintains that this was brought to the attention of the defendants' representatives so that they could ensure that pharmacists had LIPITOR on hand to fill prescriptions. In addition, the defendants note that Ms Galbraith admitted on cross-examination that she had not overheard Mr. Ramuscak's whole conversation and did not know why the statements were made. Thus, the defendants submit that this alleged confusion was just a distribution problem and was not a case of actual confusion between the plaintiff's and defendants' products.

[18]      The defendants next submission is based on a lengthy affidavit from Dr. Kazimierz Borkowski, associate medical director at Parke-Davis, that disputes Dr. Daniels claims about the risk to patients from doctors or pharmacists confusing LIPIDIL MICRO with LIPITOR. Dr. Borkowski cites many factors which would stop this from occurring including the use of computer systems in pharmacies to track medications, the noticeably increased cost and increased number of pills taken if a patient was prescribed LIPITOR instead of LIPIDIL MICRO and the products' differing appearance.

[19]      In addition, Dr. Borkowski states that even if a patient was prescribed 200 mg of LIPITOR per day, the risk of serious effects to a patient would be minimal. Dr. Borkowski cites clinical trials where only one subject experienced mild nausea, confusion, euphoria and slight dizziness after receiving 120 mg of LIPITOR. Dr. Borkowski also disputes Dr. Daniels' use of data concerning the effect of taking high levels of ZOCOR, another statin, in determining the effect of taking 200 mgs of LIPITOR. Dr. Borkowski argues that although the medications are both statins, they are different medications and it is speculative to draw such a conclusion. Dr. Borkowski also cites studies on animals that studied the effects of the long-term administration of large doses of LIPITOR that suggest that there is no significant risk if a human patient was administered 200 mg doses for a short period of time. On cross-examination, Dr. Borkowski stated that the increased occurrence or severity of side effects does not necessarily depend on the level of the dose. According to Dr. Borkowski, the only side effect which shows such a relationship is an increase in the incidents of elevations in liver enzymes with an increasing dose, although that can occur at any dose level.

[20]      In response to Dr. Daniels statements concerning the possible negative effects of combining a statin and a fibrate, Dr. Borkowski agrees that this is possible but cites the LIPIDIL MICRO monograph which specifically warns physicians about such combination drug therapy. Additionally, Dr. Borkowski submits that one of the benefits of the LIPITOR product is that a patient may no longer have to consider a combination therapy of a statin and fibrate. This would minimize the risk of an error occurring by a patient taking both products simultaneously. Finally, as Dr. Daniels admitted on cross-examination, these effects would be noticeable to a patient and would be monitored by the patient or the patient's physician.

[21]      The last argument provided by the defendants is contained in the affidavit from John Krayacich, Category Manager for LIPITOR for Warner Canada. He cites the process leading to the application and registration of the trade-mark as well as its advertising and promotion. Mr. Krayacich cites the great number of press releases to various medical journals, newspapers, television and radio stations. There have also been conferences, sales meetings and letters to pharmacists, drug stores and physicians in order to promote the LIPITOR product. In total, Warner Canada has spent almost $10,000,000 in promotion costs. As of the end of September, there have been over $18 million in sales which represent over 118,000 prescriptions.

[22]      Mr. Krayacich also submits that LIPIDIL can no longer be sold in Canada as of August 12, 1997. His affidavit also states that Cathy Thomas never stated that Warner Canada had requested that their medical representatives inform doctors to write a combination of the name LIPITOR and the words "atorvastatin" on their prescriptions in order to avoid prescription errors.

[23]      Mr. Krayacich's affidavit concludes with a discussion of the effect that an interlocutory injunction would have on the defendants' reputation, sales and sunk investment costs. The affidavit also discusses the time involved for searching and clearance of a new trade-mark, new packaging and approval by the various medical bodies.

DISCUSSION

The Motion For An Interlocutory Injunction

[24]      An interlocutory injunction is to be exercised with great care and only if the facts warrant such an order. The Associate Chief Justice had the following general remarks concerning the granting of an interlocutory injunction due to allegedly confusing trade-marks in 1036029 Ontario Ltd. v. Crown Life Insurance Co. et al. (1995), 64 C.P.R. (3d) 342 (F.C.T.D.) at pages 344-345:

The grant of an interlocutory injunction is a discretionary remedy which is extraordinary in nature. The Court is asked to render an order which not only pronounces on the merits of several complex issues, but which also restrains a party from carrying on a legitimate business enterprise without the benefit of assessing the evidence or the credibility of witnesses at trial. In this regard, I am mindful of the statement made by Thurlow C.J. in Cutter Ltd. v. Baxter Travenol Laboratories of Canada Ltd. (1980), 47 C.P.R. (2d) 53 at 56:

It is always necessary to bear in mind that the damages that can be caused to a defendant in being restrained, for a period that may run into several years, from doing what, if he succeeds, he was, but for the injunction, entitled to do in the meantime, may have consequences that are as serious for him as any that his infringement, if he does not succeed, may have for the patentee.

Accordingly, the remedy is reserved for those exceptional cases where the merits are clear and the risk of harm to the grieving party is great and imminent.

[25]      In all cases where an interlocutory injunction is requested, reference must be made to the three part-test contained in the decision in American Cyanamid Co. v. Ethicon Ltd., [1975] A.C. 396 (H.L.) [hereinafter American Cyanamid]. This test has been widely accepted in Canada (see e.g., RJR-MacDonald Inc. v. Canada (Attorney General), [1994] 1 S.C.R. 311; Turbo Resources Ltd. v. Petro Canada Inc. (1989), 24 C.P.R. (3d) 1 (F.C.A.) [hereinafter Turbo Resources]). In American Cyanamid, the court held that the initial threshold which must be passed is whether there is a "serious question to be tried" (at page 407).

[26]      Thus, the first question to consider is whether the evidence "fails to disclose that the plaintiff has any real prospect of succeeding in his claim for a permanent injunction at the trial..." (American Cyanamid at 408). It is not necessary to settle contradictions in the opposing affidavits or decide other questions which require expansive argument by the parties.

[27]      On this threshold question, the plaintiff submits that there is a likelihood of confusion because of the similarity in the sound and look of the two trade-marks as well as the fact that they are both hypolipimisers directed at the same category of patients. I should first note that these drugs are only available by prescription and therefore, as Pinard J. noted in Novopharm Ltd. v. Nu-Pharm Inc. (1990), 31 C.P.R. (3d) 99 (F.C.T.D.) at page 101:

[the] likelihood of confusion, in the prescriptive drug field, is not easy to establish. The nature of the trade is such that great skill and care is exercised in prescribing and dispensing the drug products. [...] Pharmacists are careful professionals who are accustomed to making fine distinction in names. They can distinguish similarly named chemicals from one another, so I would expect them to be able to distinguish two trade names or two trade marks.

[28]      However, the plaintiff has brought forward a number of statements that suggest that confusion between LIPIDIL MICRO and LIPITOR is possible. These studies and statements have been vehemently attacked by the defendants. In fact, the defendants have produced affidavits by Dr. Kumar and Dr. Petts who maintain that the statements attributed to them in the plaintiff's materials are false or were made without their knowledge and understanding. Furthermore, the defendants have submitted affidavits that seriously question the scientific basis upon which the plaintiff's affidavits are grounded.

[29]      Still, it is not the job of the court to decide the outcome of this dispute. I do not find that the defendants have sufficiently rebutted the plaintiff's evidence such that this case has no hope of succeeding at trial. The evidence from the studies contained in the plaintiff's affidavits is sufficiently persuasive to find that, notwithstanding the skill of pharmacists and doctors, the plaintiff has shown that the question of whether there is confusion between LIPIDIL MICRO and LIPITOR is an issue to be tried notwithstanding the fact that the evidence, at this point in the proceedings, is weak..

[30]      Moving to the second part of the American Cyanamid test, the plaintiff must convince the court that it will suffer irreparable harm if the relief is not granted. In the Turbo Resources decision, the Federal Court of Appeal stated this part of the test in the following manner (at pages 463-4):

(a) Where a plaintiff's recoverable damages resulting in the continuance of the defendant's activities pending trial would be an adequate remedy that the defendant would be financially able to pay, an interlocutory injunction should not normally be granted;

(b) where such damages would not provide the plaintiff an adequate remedy but damages (recoverable under the plaintiff's undertaking ) would provide the defendant with such a remedy for the restriction on his activities, there would be no ground for refusing an interlocutory injunction;

[31]      It is clear that the evidence as to irreparable harm must be clear and not speculative (Syntex Inc. v. Novopharm Ltd. (1991), 36 C.P.R. (3d) 129 (F.C.A.)). It is also clear that the irreparable harm must be to the plaintiff itself and so harm to patients is a consideration under the "irreparable harm" heading only with regard to the indirect effect on the plaintiff (Eli Lilly and Co. v. Novopharm Ltd. (1996), 69 C.P.R (3d) 455 (F.C.A.); Merck Frosst Canada Inc. et al. v. Minister of Health et al. (1997), 74 C.P.R. (3d) 460 (F.C.T.D.)).

[32]      The plaintiff's affidavits contain a great deal of argument and evidence on the merits of the case, but provide scant evidence to support a finding of irreparable harm. Only the affidavit of Dr. Huguet addresses this issue. Dr. Huguet's affidavit cites the plaintiff's claims as to confusion and cites the alleged instances of confusion in the affidavits of Ms Galbraith and Mr. MacDonald as well as the memo by Cathy Thomas. Then, Dr. Huguet's affidavit states the following at paragraph 37:

La demanderesse subira donc un préjudice sérieux et irréparable en raison de la confusion créée par la commercialisation par les défenderesses d'un hypolipémiant sous la marque "LIPITOR", à moins qu'une injonction interlocutoire soit émise en vue de leur interdire pendant l'instance de commercialiser leur produit sous la marque "LIPITOR".

That is the only statement as to irreparable harm contained in the affidavit. A virtually identical statement is contained in the plaintiff's "Declaration" dated September 8, 1997.

[33]      Clearly, the plaintiff has not shown proof of irreparable harm to itself or to any other party and has engaged in mere speculation. I have no difficulty in finding that the plaintiff has failed on the second part of American Cyanamid test and is not entitled to an interlocutory injunction. Given this finding, I will not consider in detail the balance of convenience stage of the test. I would simply state that I am satisfied that the balance of convenience favours the defendants. The plaintiff waited five months before making it known to the defendants it had a concern about the use of the trade-mark LIPITOR. When it was advertised that Parke-Davis had applied to register the trade-mark LIPITOR, the plaintiff failed to file a notice of objection. Furthermore, plaintiff does not contest the validity of the registration of the trade-mark LIPITOR.

CONCLUSION

[34]      Thus, I would deny the plaintiff's motion for an interlocutory injunction because the plaintiff has not shown irreparable harm if the defendants continue to use the trade-mark LIPITOR in association with their pharmaceutical product.

                                 "Max M. Teitelbaum"

                                                              J.F.C.C.

OTTAWA, ONTARIO

December 22, 1997