Date: 20020712
Docket: T-1447-00
Neutral citation: 2002 FCT 780
IN THE MATTER OF an application for an Order of Prohibition
pursuant to section 55.2(4) of the Patent Act and section 6 of the
Patented Medicines (Notice of Compliance) Regulations
BETWEEN:
AB HASSLE and ASTRAZENECA CANADA INC.
Applicants
and
RHOXALPHARMA INC. and
THE MINISTER OF HEALTH CANADA
Respondents
GIBSON J.:
INTRODUCTION
[1] On the 4th of August, 2000, the Applicants, AB Hassle ("Hassle") and AstraZeneca Canada Inc. ("AstraZeneca"), (collectively, the "Applicants"), filed an Originating Notice of Application seeking an Order prohibiting the Minister of Health (the "Minister") from issuing a Notice of Compliance pursuant to the Patented Medicines (Notice of Compliance) Regulations[1] (the "Regulations") to the Respondent RhoxalPharma Inc. ("RhoxalPharma") in respect of omeprazole tablets, 20 mg for oral administration, until after the expiration of Canadian Patent No. 2,025,668 (the " '668 patent"). These reasons follow the hearing of the application at Vancouver, British Columbia, on the 26th of June, 2002.
THE PARTIES
[2] Hassle and AstraZeneca are members of the AstraZeneca group of companies. Hassle is the owner of the '668 patent. AstraZeneca is the corporate successor to Astra Pharma Inc. and Zeneca Pharma Inc. Astra Pharma Inc., pursuant to the Regulations, submitted a Patent List to the Minister pertaining to omeprazole, including reference to the '668 patent. Astra Pharma had the consent of Hassle to place the '668 patent on the Patent List.
[3] RhoxalPharma is a "generic drug company", that is to say, a manufacturer and marketer of drugs in Canada which, in the words of Mr. Justice Nadon in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare)[2]:
...market[s] a drug without having to independently establish the safety and effectiveness of the drug.
[4] The Minister is charged with the responsibility of administering the Regulations. No material filed on behalf of the Minister was before me at the hearing of the application and the Minister was not represented.
BACKGROUND
1) The Patent in Suit
[5] The '668 patent contains claims relating to the use of omeprazole in the treatment of infectious diseases due to bacteria of the genus Campylobacter. The claims of the '668 patent read as follows:
1. Use of 5-methoxy-2 [[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]-sulfinyl -1H-benzimidazole or a pharmaceutically acceptable salt thereof for the manufacture of a medicament for the treatment of Campylobacter infections.
2. Use of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl] -sulfinyl]-1H-benzimidazole or a pharmaceutically acceptable salt thereof for the treatment of Campylobacter infections.
3. A pharmaceutical preparation for use in the treatment of Campylobacter infections wherein the active ingredient is 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]-sulfinyl]-1 H-benzimidazole or a pharmaceutically acceptable salt thereof.
[6] The Applicants and ZenecaPharma are in agreement that, for the purposes of the application, the Court should read the chemical nomenclature that appears in the claims, namely, "5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]-sulfinyl]-1 H-benzimidazole, as though it read "omeprazole". The parties further agree that Campylobacter and H. pylori are synonymous scientific names for the types of infection referred to in the claims.
2) RhoxalPharma's Notices of Allegation
[7] The notice of allegation giving rise to this application is the second notice of allegation served by RhoxalPharma on the Applicants in respect of the '668 patent.
[8] RhoxalPharma's first notice of allegation was forwarded to the Applicants on the 29th of February, 2000. It contained the following allegation:
RhoxalPharma's omeprazole will not infringe any of the claims of patent 2,025,668 because RhoxalPharma is not seeking marketing approval for use of omeprazole in the treatment of Campylobacter infections. As evidence, we attach our product monograph for omeprazole. Consequently, infringement will not occur. As seen in the product monograph, RhoxalPharma lists among other indications the commonly known indication of "eradication of H. pylori". It must be noted that H.pylori or Helicobacter pylori is not Campylobacter pylori. Helicobacter pylori is a bacteria capable of residing in the stomach. In contrast, Campylobacter bacteria are not capable of residing in the stomach because of the normal acidity of the stomach. Thus, an indication for "eradication of H. pylori" cannot be argued to be similar to eradication of Campylobacter pylori.[3] [emphasis added]
The product monograph referred to in the foregoing quotation, which was filed with the Minister as in integral part of RhoxalPharma's abbreviated new drug submission in relation to omeprazole, stated as follows under the heading "Indications":
Rhoxal-omeprazole (omeprazole) tablets are indicated in the treatment of conditions where a reduction of gastric acid secretion is required, such as: duodenal ulcer; gastric ulcer; NSAID-associated gastric and duodenal ulcers; reflux esophagitis; symptomatic gastroesophageal reflux disease (GERD), i.e., heartburn and regurgitation; Zollinger-Ellison syndrome (pathological hypersecretory conditions); eradication of H. pylori.[4] [emphasis added]
[9] The Applicants promptly filed an Originating Notice of Application, equivalent to that currently before the Court.[5] In an affidavit supporting the application sworn by Diane E. Taylor, Ph.D., a Professor in the Department of Medical Microbiology and Immunology at the University of Alberta, Dr. Taylor attested:
Having read the ['668] patent, it would be clearly apparent to a person of average skill in the art that the claims, in referencing use of omeprazole to treat Campylobacter infections, encompass C. pylori, or what is now known as H. pylori, infections.[6]
[10] Upon being satisfied that Campylobacter pylori infections and Helicobacter or H. pylori infections are the same, RhoxalPharma withdrew its first notice of allegation and the Applicants' Originating Notice of Application then before this Court was discontinued.
[11] On the 19th of June, 2000, RhoxalPharma served a second notice of allegation on the Applicants. It is that notice of allegation that gives rise to the application to which these reasons relate. It alleges that RhoxalPharma's omeprazole tablets would not infringe the '668 patent because:
The '668 patent is directed to and claims the use of omeprazole in the treatment of Campylobacter infections. Our tablets will not be made, used or sold for the treatment of Campylobacter (Helicobacter) pylori infections. More particularly, we are no longer seeking approval for this use and no such use will be included in our product monograph.[7] [emphasis added]
[12] In a revised product monograph made available to the Applicants in support of the second notice of allegation, under the heading "Indications", the paragraph from the first product monograph quoted earlier in these reasons is repeated except that the closing words "eradication of H. pylori" are deleted. In the course of this application, a further modified product monograph, the third product monograph, was prepared to respond to a further concern of the Applicants. At the date of institution of these proceedings, and for sometime thereafter, neither the second product monograph nor the third product monograph was before the Minister in support of RhoxalPharma's abbreviated new drug submission. At the hearing of the application, the Court was informally advised that the third product monograph was finally before the Minister.
THE EVIDENCE
1) On behalf of the Applicants
[13] The Applicants filed three (3) affidavits, the first of Philippa Murphy, the Vice-President of Medical Affairs at AstraZeneca, the second of Adam Pignataro, a pharmacist, and the third of Christopher Pinto, a physician.
[14] Ms. Murphy attested at paragraph 16 of her affidavit:
Given the current knowledge pertaining to the use of omeprazole, the language in Exhibit H [the second draft product monograph] relating to use of Rhoxal-omeprazole in combination with amoxicillin, clarithromycin or metronidazole and the language " . . . in treating . . . bacteria-related stomach problems" can only be a reference to treating H. pylori. This would be readily understood by physicians and pharmacists familiar with the treatment of H. pylori infections.[8]
The words "bacteria-related" where they appear in the foregoing quotation were deleted to produce the third product monograph.
[15] Mr. Pignataro attested in part as follows:
I have been asked to provide my expert opinion as to whether a generic omeprazole product, not approved by the regulatory authorities for the treatment of H. pylori infections, will in fact be used by patients for such treatment, given the existing circumstances under which patients are prescribed and receive pharmaceutical products such as omeprazole.
Based on my knowledge, experience and training, it is my opinion that a generic omeprazole product will under the aforesaid circumstances, in fact be used by patients for the treatment of H. pylori infections, given that such treatment is an approved indication for the LOSEC brand of omeprazole [AstraZeneca's brand of omeprazole]. An explanation for this follows.
Omeprazole is a highly prescribed drug in Canada. There are a significant number of patients who suffer from H. pylori infections. Such patients will attend physicians who will likely prescribe either generically or by brand name an omeprazole product. The patient will take the written prescription to a pharmacy. The pharmacist typically does not know the specific indications for which a drug has been prescribed. Whether a drug has been prescribed generically or by brand name, in the absence of the physician designating "no substitution" (which occurs less than about 10% of the time), the pharmacist will usually dispense the lowest cost brand which typically is a generic brand. In the event a generic brand of omeprazole was available in the marketplace, a pharmacist would typically dispense that brand to a patient presenting with a prescription in respect of omeprazole. Generally, pharmacists are not aware of the specific indications for which a specific brand of a drug is approved. As a result, in the event that a generic omeprazole product is available in the marketplace, that product will in fact be dispensed to patients who will use it for the treatment of H. pylori infections, even though the particular brand may not be formally approved for that indication by the regulatory authorities.[9]
[16] Dr. Pinto's evidence is to essentially the same effect as that of Mr. Pignataro. Briefly, he attests:
Physicians generally assume that all generic brands of an active ingredient are approved for the same indications that the innovator's brand is approved. Consequently, should a generic omeprazole product be available in the marketplace, physicians would generally assume it is approved for the treatment of H. pylori.[10]
[17] None of the Applicants' affiants was cross-examined.
2) On behalf of RhoxalPharma
[18] RhoxalPharma filed only one affidavit, that of Mr. Len Arsenault, Director, Regulatory Affairs, of RhoxalPharma. He attested at paragraph 6 of his affidavit:
Roxal is seeking marketing approval from Health Canada in relation to off-patent or non-patented uses of omeprazole. Rhoxal is neither seeking marketing approval from Health Canada in relation to the use of omeprazole for the eradication of H. pylori infections nor will it promote such use. ...[11] [emphasis in original]
[19] By reference to the paragraph from the affidavit of Philippa Murphy that is quoted above, Mr. Arsenault continues:
... the applicants ... are attempting to demonstrate that Rhoxal is surreptitiously promoting, elsewhere in its product monograph, the use of omeprazole for the eradication of H. pylori. This is incorrect for the following reasons:
...
b) The reference at page 2 of the product monograph to the use of omeprazole in combination with amoxicillin, clarithromycin or metronidazole, which are antibiotics, is made strictly for safety purposes. Indeed, Rhoxal clearly states that the monographs for those agents must be consulted and followed if they are used in conjunction with omeprazole.
... [12]
[20] Mr. Arsenault was cross-examined on his affidavit. Regarding his reference to the use of omeprazole in combination with three (3) listed antibiotics, the following exchange took place:
Now, you say in your Affidavit, ..., that there's a reference to certain antibiotics; you list three of them.
Yes.
And you say that that reference is made strictly for safety purposes, can you explain that to me, please?
There is a note at the top of Page 2, [of the product monograph in both its second and third iterations] which I will read to you: "When used in combination with Amoxicillin, Clarithromycin or Metronidazole, product monographs for those agents must be consulted and followed".
Yes, I see that, ... and doesn't that note contemplate the use of Rhoxalpharma's Omeprazole in combination with one or more of those three antibiotics?
Well, clearly from the indications, that is not the intention of the use of this product.
No, but it says 'when used in combination with, doesn't that clearly contemplate the use of your product in combination with one or more of those three antibiotics?
It is a statement that simply reflects that if it were to be used in combination with those products, that the product monograph specifically for those ingredients should be consulted.
Okay, Isn't it correct that Omeprazole, in combination with one or more of those three antibiotics, is used for the treatment of H. pylori?
I believe that that's correct.
And there's no other use for such a regimen is there, that you're aware of, other than H. pylori treatment?
Each one of those ingredients could be indicated for any bacterial infection on their own.
Yes, but you're just speculating, you're not aware of any recognized, medically recognized, use for the specific combination of Omeprazole with one or more of those three antibiotics, are you?
I think the witness answered that, ...[13]
THE ISSUES
[21] The issues on this application identified on behalf of the Applicants are the following:
1) whether the notice of allegation constitutes an abuse of process of this Court and therefore is not an allegation as contemplated by the Regulations;
2) whether RhoxalPharma has complied with subparagraph 5(3)(c)(i) of the Regulations which requires a relevant submission to be pending before the Minister at the date the notice of allegation is served;
3) whether RhoxalPharma's allegation of non-infringement is justified, including
a) whether the allegation is justified on the factual basis detailed in the notice of allegation;
b) whether there will be infringement of the '668 patent;
c) whether RhoxalPharma itself will directly infringe the '668 patent;
d) whether RhoxalPharma will induce or procure infringement of the '668 patent; and
4) whether RhoxalPharma's assertion that the '668 patent was improperly listed on the Patent Register is an allegation under the Regulations.
I am satisfied that sub issues 3) a) and b) are subsumed within issues 3) c) and d). The fourth issue regarding improper listing was essentially not pursued before the Court.[14]
ANALYSIS
1) Abuse of Process
[22] In Bayer Inc. v. Canada (Minister of National Health and Welfare)[15], Mr. Justice Lutfy, as he then was, wrote at paragraph [9]:
The bringing of more than one notice of allegation before the Court, provided it is separate and distinct from the others, cannot be seen to be an abuse of process.
For this proposition, Mr. Justice Lutfy cited Apotex Inc. v. Canada (Minister of National Health and Welfare)[16], where Mr. Justice Marceau wrote at page 10:
I agree with the views expressed in the numerous Trial Division decisions referred to by the motions judge to the effect that successive allegations are possible and each one must be treated independently provided it is separate and distinct from the others and its bringing before the Court cannot be seen as an abuse of process.
[23] Counsel for the Applicants urged that the second notice of allegation, that now before the Court, is not separate and distinct from the first notice of allegation which was withdrawn when it became apparent to RhoxalPharma that Campylobacter infections and H. pylori infections are one and the same. Counsel urged that RhoxalPharma, in effect, withdrew its first allegation when it recognized that the resulting proceeding was progressing unfavourably and, through the second notice of allegation, sought to litigate essentially the same allegation of non-infringement, thereby obtaining a procedural advantage. Counsel urged that for the Court to allow RhoxalPharma to pursue this stratagem would be to allow it to abuse the process of this Court and to abuse the regulatory scheme established under the authority of Parliament that has, among its objectives, an objective of ensuring that proceedings under the Regulations move forward expeditiously.
[24] Counsel for RhoxalPharma urged that the issues and the evidence arising out of the two consecutive notices of allegation are clearly separate and distinct.
[25] With some hesitation, I prefer the position of counsel for RhoxalPharma. There is nothing before the Court that would lead me to conclude that the misapprehension that was fundamental to RhoxalPharma's first notice of allegation was anything other than inadvertent. I am not satisfied that any procedural advantage was sought or gained by RhoxalPharma from the service and subsequent withdrawal of its first notice of allegation and its replacement by the second notice of allegation. It was only by proceeding in this way that RhoxalPharma was able to ensure that the more substantive issues arising on both notices of allegation could effectively be litigated. While RhoxalPharma's inadvertence is not to be condoned, I am not satisfied that its first false start, remedied by the second notice of allegation, amounts either to an abuse of the process of this Court or an abuse of the regulatory scheme.
[26] I conclude that the Applicants cannot succeed on this ground.
2) A Relevant Pending Abbreviated New Drug Submission
[27] It was not in dispute before me that RhoxalPharma had an abbreviated new drug submission for its omeprazole tablets before the Minister at both the time when the first notice of allegation was issued and the time when the second notice of allegation was issued. It was further not in dispute before me that the new drug submission, through the related product monograph in its first iteration, referenced the use of RhoxalPharma's omeprazole for the treatment of H. pylori infections. Certainly the amended product monograph from which direct and indirect references to use of RhoxalPharma's omeprazole for the treatment of H. pylori infections have been deleted was not before the Minister when the second notice of allegation was served on the Applicants.
[28] Counsel for RhoxalPharma urged that the matching of RhoxalPharma's new drug submission and its product monograph is the responsibility of the Minister and is not relevant to the proceeding before this Court. In essence, counsel urged that RhoxalPharma's new drug submission was at all times sufficiently relevant for the purpose of this proceeding. Counsel relied on the following passages from Merck & Co. v. Canada (Minister of Health)[17]:
...At the relevant time, the Minister has a NDS for Apo-lovastatin on file that satisfied all requirements under the F & D Regulations. It does not matter whether the NDS was a "new" or "re-filed" NDS, or the same NDS which was filed with the Minister in 1993. The NDS review process is separate and distinct from the prohibition proceedings provided for under s. 6 of the NOC Regulations. It is the NOA, not the NDS, that underpins the prohibition proceedings. The NDS does not form part of the record in prohibition proceedings under s. 6, and does not play a substantive role in determining the outcome of such proceedings: ...
Similarly, the content of a NDS, at any given point in time, however it has been amended, is not material to the substantive effect of an allegation, and any ongoing prohibition proceedings. The NDS approval process and the prohibition proceedings in relation to an allegation are separate and distinct. While an allegation must be attached to a NDS, the validity of an allegation with respect to a claim for the medicine itself or a claim for the use of a medicine only needs to be linked to the proposed method of manufacture of the medicine specified in the NDS prior to the issuance of a NOC: ... [citations and some text omitted]
[29] Counsel for the Applicants urged that the foregoing authority has been overtaken by amendments to the Regulations[18] which now more closely link prohibition proceedings before this Court and new drug submission approval processes before the Minister. He notes that where a person such as RhoxalPharma has filed a new drug submission alleging that no claim for a medicine itself and no claim for the use of the medicine would be infringed if a Notice of Compliance were issued, and such is certainly the case here, that person is required to serve on persons such as the plaintiffs here a notice of allegation "relating" to the submission filed either at the time of filing of the submission or thereafter. Where, as here, a prohibition proceeding follows, pursuant to subsection 6(7) of the Regulations, the persons instituting the proceeding may move the Court for an Order that the person who served the notice of allegation produce: any portion of the new drug submission that is relevant to the disposition of the issues in the prohibition proceedings; and any change made to the portion produced during the course of the prohibition proceedings. Further, the Court may order the Minister to verify that any portion produced corresponds fully to the information in the new drug submission itself.
[30] Counsel urged that the amendments to the Regulations clearly reflect that a link has now been made mandatory between prohibition proceedings and new drug submission processes before the Minister. Counsel further urged that the mandatory link renders the contents of RhoxalPharma's new drug submission relevant and material to the substantive effects of its allegation in any resultant prohibition proceedings. Counsel thus urged that it is now open to this Court, and indeed incumbent on it, to ensure that RhoxalPharma's new drug submission on which this prohibition proceeding is based fully corresponds to the notice of allegation before the Court.
[31] Once again, I favour the position advocated by counsel for RhoxalPharma. If those who framed the relevant amendments to the Regulations on which the Applicants rely had intended to place an obligation on this Court to satisfy itself of the concordance between an underlying new drug submission and a relevant notice of allegation, they could have done so much more clearly and directly. It is worthy of note that the amended Regulations place no onus on a second person such as RhoxalPharma to file its new drug submission with this Court and that the authority of the Court to order production of relevant portions of a new drug submission is discretionary, not mandatory where a first person such as the Applicants here seeks such production. I regard the interpretation of the amendments to the Regulations that counsel for the Applicants urges on the Court as imaginative, but unduly strained.
[32] I am satisfied that the evidence before me establishes that RhoxalPharma intended, at all relevant times, to modify its product monograph that was before the Minister as part of its new drug submission. As earlier indicated in these reasons, at the hearing of the application, I was informally advised that the revised product monograph is now in fact before the Minister. While it would have been much preferable that such advice be put before the Court by affidavit, I have no reason to doubt the goodwill of RhoxalPharma in expressing its intent to so modify its new drug submission before the Minister nor reason to doubt counsel's assurance that that intent has now been fulfilled.
[33] I conclude that the Applicants cannot succeed on this ground.
3) Infringement of the '668 Patent, either directly or through inducement or procurement
[34] In AB Hassle v. Canada (Minister of National Health and Welfare)[19], Mr. Justice McKeown, in reasons for an order on a preliminary motion to dismiss an application involving a notice of allegation in respect of the same patent as is here at issue, on the grounds that the application was frivolous, vexatious or an abuse of process, wrote at paragraph [18]:
...Apotex submits that its product will not be, inter alia, used for the treatment of Campylobacter, on the basis that Apotex is not seeking approval for such use and no such use will be included with [indicated for ?] its product. In my view, the approval referred to by Apotex has no bearing in fact or law on the allegation of non-infringement. For example, the Regulations do not say that there is no infringement in respect of "use", if the generic does not seek "approval" for such use. Furthermore, the evidence is that Apotex' omeprazole product will be used by patients for the treatment of H. pylori, regardless of its approved indications. In my view, the Regulations must contemplate the use of medicine by patients. Thus, the legal and factual basis relied on by Apotex may not, in fact, justify the allegation of non-infringement. [emphasis added]
[35] Counsel for the Applicants urged, by reference to the foregoing quotation, that the factual basis alleged by RhoxalPharma in its notice of allegation simply does not justify the conclusion of non-infringement and on that basis alone, the Applicants should succeed.
[36] In my opinion, this argument is best dealt with in the context of an analysis on infringement, either directly or through inducement or procurement. I am satisfied that my infringement analysis will be determinative of this issue.
[37] On the totality of the evidence before the Court, I am satisfied that, if a Notice of Compliance were to issue to RhoxalPharma in accordance with its modified abbreviated new drug submission, RhoxalPharma would not directly infringe the '668 patent. In his reasons in AB Hassle v. Canada (Minister of National Health and Welfare[20], Mr. Justice O'Keefe, in reasons arising from the substantive hearing of the application with which Mr. Justice McKeown was dealing on a preliminary motion in his reasons quoted immediately above, wrote at paragraphs [32] to [36]:
The '668 patent only reserves exclusive rights to omeprazole that are somehow related to the treatment of Campylobacter infections. The '668 patent does not contain any claims for the compound omeprazole itself, and the '668 patent does not contain any claims for pharmaceutical preparations or use of omeprazole apart from its use in the treatment Campylobacter infections.
Claim 1 claims the exclusive right to use omeprazole for the manufacture of a medicine for the treatment of Campylobacter infections. In this case, Apotex is seeking approval to use omeprazole to manufacture a medicine. However, the manufacture by Apotex only falls within the exclusive domain of the patent holder if the medicine is being manufactured for the treatment of Campylobacter infections. Apotex alleges in the NOA, which this Court is to presume to be true, that it is not manufacturing the medicine for the treatment of Campylobacter infections. The applicants have not specifically argued that claim 1 was directly infringed by Apotex and, in my view, has [sic] not succeeded in entering evidence to successfully establish an infringement of claim 1.
The applicants have conceded that as a corporation, it is impossible for Apotex to use omeprazole to treat a Campylobacter infection. Apotex does not and will not directly infringe claim 2.
The applicants submit that Apotex will directly infringe claim 3, which claims a pharmaceutical preparation of omeprazole for use in the treatment of Campylobacter infections. The applicants submit that claim 3 is a claim for the medicine itself pursuant to the NOC Regulations. The Court notes that claim 3 is limited by the wording "for use in the treatment of Campylobacter infections" such that pharmaceutical preparations of omeprazole that are not for use in the treatment of Campylobacter infections would not infringe the '668 patent. This is a significant limitation and departure from an unencumbered claim for the medicine.
For the applicants to successfully show that Apotex infringes claim 3, it is necessary for the applicants to demonstrate on the evidence that Apotex proposes to make and sell such a pharmaceutical preparation for use in the treatment of Campylobacter infections. In my view, the applicants have not shown on the evidence that Apotex intends to make, use or sell the pharmaceutical preparation for use in the treatment of Campylobacter infections. [emphasis added]
[38] After citing from SmithKline Beecham Inc. v. Apotex Inc.[21], Mr. Justice O'Keefe concluded that Apotex would not directly infringe the '668 patent if a Notice of Compliance issued to it. I adopt Mr. Justice O'Keefe's reasoning and reach the same conclusion on the facts of this matter.
[39] The issue of whether RhoxalPharma would induce or procure the infringement of the '668 patent by others, specifically, medical doctors, pharmacists and omeprazole users, I find to be substantially more problematic. In relation to inducement or procurement, I find RhoxalPharma's intent, as referred to in the foregoing quotation from Mr. Justice O'Keefe's reasons, to be irrelevant.
[40] Mr. Justice O'Keefe went on in his reasons in AB Hassle v. Canada (Minister of National Health and Welfare) supra, to examine at some length the issue of infringement through inducement and procurement. At paragraph [51] of his reasons, he wrote:
...However, infringement by anyone is not relevant under the NOC Regulations unless it can be demonstrated that there is a connection to the second person [here RhoxalPharma] such that the second person is involved in the infringement either directly or indirectly such as through inducement or procurement. [emphasis added]
[41] Counsel for the Applicants urged that Mr. Justice O'Keefe in effect formulated a new "connection test" for determination of infringement by inducement or procurement and that his reference to "infringement either directly or indirectly" was derived from a passage in the reasons of Mr. Justice Richard, as he then was, in Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) [22] where he wrote at page 203:
However, as noted above, Apotex acknowledged that the uses for which it sought governmental approval included congestive heart failure. I conclude on the basis of the material before me that the lisinopril tablets are intended by Apotex and capable of being used for the treatment of congestive heart failure. It makes no difference that a physician and a pharmacist are involved as intermediaries in the prescribing and sale of the medicine to the ultimate consumer. Section 55.2(4)(e) of the Patent Act specifically contemplates regulations governing the issue of a notice in circumstances where the issue of such notice might result directly or indirectly in the infringement of a patent (emphasis mine). In these circumstances, the claim for use in the '351 patent would be infringed, if not directly, then certainly indirectly. [emphasis added]
[42] Mr. Justice O'Keefe, on the facts before him, and those facts were somewhat similar to the facts before me, concluded that there would be no infringement through inducement or procurement. He satisfied himself that his conclusion was entirely consistent with the conclusion of Mr. Justice Richard in ZenecaPharma, supra. He wrote at paragraphs [65] and [66]:
The actions and knowledge of the second person in Zeneca, supra were the route through which the potential infringements by third parties (patients) were relevant to the NOC Regulations proceeding. This connection was made clear when Richard J. (as he then was) wrote "I conclude on the basis of the material before me that the lisinopril tablets are intended by Apotex and capable of being used for the treatment of congestive heart failure." Although Richard J. (as he then was) did not ultimately label the patent infringing action by the second person ... as direct infringement or indirect infringement, or inducement or procurement, the necessary connection between the second person and the resulting infringement was clearly made.
Returning to the case at hand, Apotex alleges that they are not seeking approval for a use of omeprazole that is protected by a patent. The NOA is not contradicted by the evidence. The connection between the second person and the resulting infringement that might result from the issuance of an NOC has not been made out. Furthermore, it is my view that my decision and that of Richard J. (as he then was) are not at odds. [emphasis added]
[43] On the facts before me, I reach a different conclusion. I am satisfied that, if indeed a "connection" between a second person, in this case RhoxalPharma, and resulting infringement is required, that "connection" in this matter, has been made out.
[44] The "actions"of RhoxalPharma, including the manufacturing, marketing, and selling of omeprazole, combined with its "knowledge" of the practices of physicians, pharmacists and patients, is sufficient to constitute inducement or procurement of infringement, notwithstanding that the evidence before me clearly does not establish that RhoxalPharma's omeprazole tablets are "intended" by RhoxalPharma for the treatment of H. pylori infections.
[45] In Valmet Oy v. Beloit Canada Ltd.[23], Mr. Justice Pratte, for the Court, wrote at page 15:
In order to induce or procure another person to infringe a patent, one must do something that leads that other person to infringe the patent. If one does nothing, there cannot be any inducement ... .
Whether the words of Mr. Justice Pratte imply the requirement of a "connection" between a second person, here RhoxalPharma, and an ultimate infringer, here a consumer of omeprazole tablets, is not, I think, a question I need answer. I read the words of Mr. Justice Pratte as indicating that it is sufficient to create an inducement or procurement of infringement if RhoxalPharma does something, or indeed anything, that leads another person to infringe.
[46] The evidence before me is very clear. RhoxalPharma seeks permission from the Minister to do something: to manufacture, market and sell omeprazole tablets.
[47] The evidence is equally clear that those actions will lead to infringement of at least claim 3 of the '668 patent. I accept the evidence before me that it is well-known among doctors who prescribe omeprazole, and pharmacists who fill prescriptions, that omeprazole is useful in the treatment of H. pylori infections. Doctors and pharmacists often do not rely on the "indications" reflected in a product monograph, but rather on their general knowledge. Omeprazole is a highly prescribed drug in Canada. None of this was disputed by RhoxalPharma in its evidence or through cross-examination of any of the Applicants' affiants.
[48] The mere fact that RhoxalPharma's product monograph will not include an indication of use in the treatment of H. pylori infections is not relevant. For those who do refer to RhoxalPharma's product monograph, it will there be apparent that RhoxalPharma anticipates the possibility, and indeed perhaps the likelihood, of the use of omeprazole in combination with certain antibiotics. RhoxalPharma's affiant acknowledged on cross-examination that he believes it to be correct that omeprazole, in combination with one or more of the named antibiotics is used for the treatment of H. pylori infections. In the result, I conclude that RhoxalPharma has "knowledge" of probable, if not inevitable, infringement.
[49] I conclude on the basis of the foregoing that, if a Notice of Compliance is issued by the Minister to RhoxalPharma in respect of omeprazole tablets, RhoxalPharma will do something that it knows, regardless of its intent, will lead doctors to prescribe RhoxalPharma's omeprazole tablets, pharmacists to fill prescriptions that are either generic or specifically for RhoxalPharma's omeprazole tablets, and patients to utilize RhoxalPharma's omeprazole tablets in a manner that will infringe the '668 patent, that is to say, to treat H. pylori infections. Put another way, I am satisfied that failure to prohibit the issuance of a Notice of Compliance by the Minister to RhoxalPharma in connection with omeprazole tablets will lead inevitably to RhoxalPharma inducing or procuring infringement of the '668 patent.
4) A Postcript
[50] Under cover of a letter dated the 10th of July, 2002, counsel for the applicants drew to the attention of the Court a decision of the Federal Court of Appeal dated the 8th of July, 2002 in Genpharm Inc. v. The Minister of Health and Procter & Gamble Pharmaceuticals Canada, Inc. and the Procter & Gamble Company[24]. This was after these reasons had been drafted but before they were signed and issued. In Genpharm Inc., Mr. Justice Rothstein, for the Court, considered the issue of infringement by inducement or procurement. He wrote at paragraphs [47] to [49]:
If the words of the definition ["claims for the use of the medicine" in section 2 of the Regulations] are read into paragraph 5(1)(b)(iv) [of the Regulations], i.e. "no claim for the use of the medicine for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof", it is apparent that the use contemplated includes use by patients. That is, medicine used for diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof, must contemplate use of the medicine by a patient. The point is that use claims referred to in subparagraph 5(1)(b)(vi) [sic] contemplate use, not just by the generic producer, but by patients as well, and that infringement will result by patients using a medicine sold by a generic producer, even if there is no inducement or procurement by the generic producer.
The scheme of the Regulations seems obvious. If a generic producer sells a product and infringement by anyone using the product results, that is the infringement the Regulations are intended to preclude. There is no suggestion that the generic producer must have induced or procured patients or others to infringe the patent.
For this reason, I am satisfied that in the case of use claims, it is not necessary for a patentee to demonstrate that a generic producer's actions will induce or procure patent infringement by patients or others. Provided that the generic producer cannot establish that no claim for the use of the medicine would be infringed by patients or others by its selling of its product, it will not satisfy the justification test in subsection 6(2) of the Regulations and a prohibition order must be made.
[51] For ease of reference, subsection 6(2) of the Regulations reads as follows:
6. (2) The court shall make an order pursuant to subsection (1) in respect of a patent that is the subject of one or more allegations if it finds that none of those allegations is justified.
6. (2) Le tribunal rend une ordonnance en vertu du paragraphe (1) à l'égard du brevet visé par une ou plusieurs allégations si elle conclut qu'aucune des allégations n'est fondée.
[52] We are dealing here with use claims. Thus, notwithstanding that I have not had the advantage of submissions from counsel on either side, I read the foregoing passage as binding authority directing me, on the facts of this matter, towards a conclusion to the same effect as that which I have reached on the basis on an "inducement or procurement" analysis, albeit somewhat more directly.
[53] Given that there is some urgency to release my decision and reasons in this matter at an early date, I have chosen not to modify the analysis reflected in these reasons. In that way, I find it unnecessary to consult counsel regarding reopening to hear submissions arising out of the Genpharm decision. I am reasonably satisfied that, whatever those submissions might be, they would not modify the result of my analysis, notwithstanding that they might very well impact the form of the analysis.
CONCLUSION
[54] Based upon the foregoing, an Order will issue, pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, prohibiting the Minister of Health from issuing a Notice of Compliance pursuant to those Regulations to the Respondent RhoxalPharma Inc. in respect of omeprazole tablets, 20 mg for oral administration, until after the expiration of Canadian Patent No. 2, 025, 668.
COSTS
[55] An Order for costs of this application will go in favour of the Applicants, against RhoxalPharma, such costs, if not agreed upon, to be taxed on the ordinary scale. There will be no Order as to costs, in favour of or against, the Minister.
__________________________________
J. F.C.C.
Ottawa, Ontario
July 12, 2002
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF SOLICITORS AND SOLICITORS ON THE RECORD
COURT FILE NO.: T-1447-00
STYLE OF CAUSE: AB HASSLE ET AL. v. RHOXALPHARMA INC. ET AL.
PLACE OF HEARING: VANCOUVER, B.C.
DATE OF HEARING: JUNE 26, 2002
REASONS FOR ORDER OF THE HONOURABLE MR. JUSTICE GIBSON
DATED: JULY 12, 2002
APPEARANCES:
MR. GUNARS A. GAIKIS
MS. YOON KANGFOR APPLICANT
MS. MARIE LAFLEUR
MR. ALAIN LECLERCFOR RESPONDENT (RHOXAL)
SOLICITORS OF RECORD:
SMART & BIGGAR
TORONTO, ONTARIOFOR APPLICANT
FASKEN, MARTINEAU, DUMOULIN LLP
MONTREAL, QUEBECFOR RESPONDENT (RHOXAL
[1] SOR/93-133, as amended.
[2] (1997), 74 C.P.R. (3d) 307 (F.C.T.D.) at 314.
[3] Applicants' Application Record, Vol. 1,tab 2 C, page 41.
[4] Applicants' Application Record, Vol. 1, tab 2 C, page 43.
[5] Notice of Application dated April 14, 2000 in Court File No. T-691-00. Applicants' Application Record, Vol. 1, tab 2 D, pages 45 to 53.
[6] Applicants' Application Record, Vol. 1 tab 2 E, page 60, para 27.
[7] Applicants' Application Record, Vol. 1, tab 2 G, page 67.
[8] Applicants' Application Record, Vol. 1, tab 2, pages 16 and 17.
[9] Applicants' Application Record, Vol. 1, tab 3, pages 102 and 103.
[10] Applicants' Application Record, Vol. 1, tab 4, page 122.
[11] Applicants' Application Record, Vol. 1, tab 5, page 140.
[12] Applicants' Application Record, Vol. 1, tab 5, page 141.
[13] Applicants' Application Record, Vol. 1, tab 6, pages 231 to 233.
[14] See: the Applications' Application Record, tab 10, paragraph 61, page 343 and RhoxalPharma's Application Record, page 10, paragraph 27 D.
[15] (1998), 82 C.P.R. (3d) 359 (F.C.T.D.).
[16] (1997), 76 C.P.R. (3d) 1 (F.C.A.).
[17] (1998), 79 C.P.R. (3d) 57 at paragraphs [42] and [43], pp. 72 and 73 (F.C.T.D.); affirmed, (1999), 3 C.P.R. (4th) 77 (F.C.A.).
[18] SOR/98-166 and SOR/99-379.
[19] (2000), 9 C.P.R. (4th) 79 (F.C.T.D.).
[20] (2001), 16 C.P.R. (4th) 21 (F.C.T.D.). Notice of Appeal filed December 14, 2001 (Court File No. A-716-01).
[21] (1999), 1 C.P.R. (4th) 99 (F.C.T.D.)
[22] (1995), 61 C.P.R. (3d) 190 (F.C.T.D.).
[23] (1988), 20 C.P.R. (3d) 1 (F.C.A.).
[24] [2002] FCA 290, July 8, 2002, Court file: A-615-01.