Date: 20000908
Docket: T-2016-99
BETWEEN:
AB HASSLE and ASTRA PHARMA INC.
Applicants
- and -
THE MINISTER OF NATIONAL
HEALTH AND WELFARE and APOTEX INC.
Respondents
REASONS FOR ORDER
McKEOWN J.
[1] On November 19, 1999, the Applicants commenced an application under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended ("Regulations"). In the application, the Applicants are seeking to prohibit the Minister from issuing a Notice of Compliance ("NOC") to Apotex in respect of omeprazole capsules, 10, 20 and 40 mg for oral administration, until after the expiration of Canadian Patent No. 2,025,668 (" `668 patent"). On January 19, 2000, the Respondent Apotex brought a motion to dismiss the application, pursuant to paragraph 6(5)(b) of the Regulations, on the grounds that it is frivolous, vexatious and an abuse of process.
[2] This motion was heard in conjunction with Court file T-2026-99. However, as the issues in this case differ from those in T-2026-99, I have chosen to deal with each motion separately.
[3] The Applicant AB Hassle is the owner of the `668 patent, entitled "Use of Omeprazole as an Anti-Microbial Agent". The Applicant Astra Pharma Inc. ("Astra") is a Canadian company which is active in the manufacture, marketing and sale of a variety of pharmaceutical products. Astra is related to AB Hassle, as both companies are members of the Astra group of companies.
[4] There are three claims in the `668 patent:
| 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-methozy-2-[ [ (4-methozy-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-methozy-2-[ [ (4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl]-sulfinyl] - 1H-benzimidazole or a pharmaceutically acceptable salt thereof. |
The third claim is a claim for a pharmaceutical preparation as well as use in treatment.
[5] In the Notice of Allegation, dated October 4, 1999, Apotex states as follows:
| With respect to patent 2025668, we allege that no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by us of capsules for oral administration containing omeprazole in strengths 10 mg, 20 mg, and 40 mg. |
| The legal and factual basis for the aforesaid allegation is as follows: |
| The claims of this patent relate to use in treatment of Campylobacter infections. Our product will not be made, used, or sold for the treatment of Campylobacter infections and, more particularly, we are not seeking approval for such use and no such use will be included in our product monograph. |
In the Notice of Allegation, Apotex made no statements concerning how they will use its product. Apotex also did not disclose how it will market its product.
[6] The issue on this motion is whether in the application under paragraph 6(5)(b) of the Regulations, the Respondent Apotex has shown that the "application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process". In the Notice of Application whereby AB Hassle and Astra Pharma Inc. sought an order prohibiting the Minister from issuing a Notice of Compliance to Apotex, the Applicants state as follows in paragraph 7:
| With respect to the `668 patent Apotex asserts that its product will not be "made, used or sold for the treatment of Campylobacter infections" and that "we are not seeking approval for such use and not such use will be included in out product monograph. As noted above, the Applicants have had no disclosure regarding the contents of Apotex' NDS or the indications for which approval is sought. Further, the basis relied upon by Apotex does not justify the allegation in respect of this patent. Apotex does not assert any facts which explain how the marketing of its product will not result in infringement of the `668 patent, regardless of the use for which the product is indicated or approved. |
[7] The Applicant, Astra, filed three affidavits explaining how there will be infringement. In her affidavit, Ms. Murphy, Vice-President of Medical Affairs, Astra Pharma Inc., indicated, inter alia, as follows:
| (a) The Applicants have no knowledge or access to knowledge regarding the existence, contents or date of filing of a new drug submission ("NDS") relevant to Apotex' proposed omeprazole products. The Applicants also have no knowledge regarding the indications for which Apotex has sought or may seek approval. |
| (b) Omeprazole products can only be made available to members of the public pursuant to a prescription from a physician. Physicians are aware that omeprazole is effective in the treatment of several gastrointestinal disorders including the treatment of duodenal ulcers and H.pylori (formerly known as Campylobacter). Most patients with duodenal ulcers have H.pylori. Accordingly, physicians will prescribe omeprazole, when appropriate, for patients requiring treatment of H.pylori infections. Typically a physician will give to a patient a written prescription with the instruction that the patient take the prescription to a pharmacy in order to obtain the prescribed drug. A pharmacist will dispense to the patient the drug in the form of a particular product (brand). |
| (c) As part of the regulatory approval process and pursuant to the Food and Drug Regulations, an NOC issues with respect to, inter alia, the indications applied for and approved for the particular pharmaceutical product. While the Minister and the recipient of the NOC will know the precise indications for which the generic product has been approved, physicians, pharmacists and patients generally are not aware or concerned of the precise indications for which a generic brand has been approved. Only the fact of availability and the price of generic brands is normally promoted to physicians and pharmacists. Patients typically do not have access to the approved indications for a product. Physicians, pharmacists and patients are typically concerned only with whether the active ingredient is effective in treating the medical condition. The CPS, a widely used reference book, does not provide indications for Apotex' products. |
| (d) Even assuming Apotex' NDS does not seek approval for its omeprazole product for the treatment of H.pylori infections, upon approval of any indication, Apotex' omeprazole product will in fact be used for the treatment of H.pylori infections since there are a significant number of individuals in Canada who suffer from H.pylori infections. Such individuals will seek the assistance of a physician who will likely prescribe omeprazole. The physician may prescribe generically ("omeprazole") or by brand name ("LOSEC"). The physician will not know or be concerned with whether a particular brand of omeprazole is formally approved for the treatment of H.pylori infections. |
| (e) Whether prescribed generically or by brand name the patient will take the prescription to a pharmacy where the patient may receive any brand of omeprazole available which the pharmacist is permitted to dispense. The pharmacist will generally dispense the lowest cost brand available, subject to the patient requesting otherwise. According to Ontario provincial law, the pharmacist shall dispense a lower cost generic product in certain circumstances. The product dispensed to the patient will typically not provide information relating to the approved indications. |
| (f) The pharmacist typically does not know the particular reason or indication for which the physician has prescribed a drug so even if a pharmacist was aware that Apotex' omeprazole product was not formally approved for use in the treatment of H.pylori infections, the pharmacist typically would not know why a particular patient had been prescribed omeprazole and hence would likely dispense Apotex' brand, expected to be a lower cost product. |
| (g) The label of a prescription requiring drug such as omeprazole does not need to mention indications. |
| (h) In the present circumstances, in the event Apotex obtains approval for its omeprazole product, regardless of whether it is approved for the treatment of Campylobacter infections or not, it likely will in fact be used for such treatment. |
[8] The Applicants could have brought a motion to obtain information with respect to the existence, contents or date of filing of the NDS. They did not do so. As a result, the only evidence in the record with respect to the Notice of Allegation itself is the evidence submitted by the Applicant, Astra. For purposes of the present motion, therefore, I must assume that this evidence is true. Thus, it would appear that if Apotex gets approval for its product, there will be patients taking the Apotex product for use that is included in the patent. Both the doctor and pharmacist who provided affidavits for Astra state that if the Apotex product is approved, patients will be taking the product for the uses set out in the patent.
[9] I will now set out the relevant sections of the Regulations. With respect to the Notice of Allegation, paragraph 5(1)(b)(iv) of the Regulations reads as follows:
| 5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug, |
| ... |
| (b) allege that |
| ... |
| (iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed. |
The definition of "claim for the medicine itself" in section 2:
| includes a claim in the patent for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents; (revendication pour le médicament en soi) |
[10] On March 12, 1998, the Regulations were amended to provide by subsection 5(4), that the relevant time for looking at the indications with respect to the Notice of Allegation is what was said at the time the Notice of Allegation was made. As stated above, Dr. Sherman refused to disclose this information.
[11] The burden of proof and standard is very high on a motion to dismiss pursuant to paragraph 6(5)(b) of the Regulations. In considering such a motion, any doubt must be left for resolution by the trial judge. A proceeding should not be summarily dismissed unless it is without doubt or obvious that the application is so clearly futile that there is not the slightest chance of succeeding. The Federal Court of Appeal in Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1995), 58 C.P.R. (3d) 209 (F.C.A.), on a motion to strike an originating notice of motion pursuant to old Rule 419, confirmed that the Court may dismiss judicial review proceedings only in exceptional cases. At page 217:
| For these reasons we are satisfied that the trial judge properly declined to make an order striking out, under Rule 419 or by means of the gap rule, as if this were an action. This is not to say that there is no jurisdiction in this court either inherent or through Rule 5, by analogy to other rules, to dismiss in a summary manner a notice of motion which is so clearly improper so as to be bereft of any possibility of success ... Such cases must be very exceptional and cannot include cases such as the present where there is simply a debatable issue as to the adequacy of the allegations in the notice of motion. |
[12] In deciding whether to dismiss a proceeding pursuant to paragraph 6(5)(b) of the Regulations, I should take into account some of the following considerations. First, the issue on the motion is not the determination of the merits of the proceeding, but rather a determination of whether a proceeding is frivolous, vexatious or an abuse of process. I should avoid converting a motion under paragraph 6(5)(b) into a motion for judgment or for the determination of a question of law where all the facts are not in agreement before me. In considering motions pursuant to paragraph 6(5)(b), courts have repeatedly refused to decide issues of law or facts where the law is not well established, indicating the determination of such contentious issues are matters properly for the trial judge hearing the matter on the merits. For example, in Pfizer Canada Inc. v. Apotex Inc.(2000), 1 C.P.R. (4th) 358 (F.C.T.D.), Lemieux J. stated at pages 369 to 370:
| In the context of issues relating to statutory interpretation, Reed J. in Amway of Canada Ltd. v. Canada, [1986] 2 F.C. 312 (T.D.) at 326, was of the view that where there exists a contentious legal issue of statutory interpretation to be resolved, that issue, not being clear and obvious, should be left for argument at trial and should not be disposed by a motions judge in a preliminary proceeding. |
| ... |
| In my view all of these issues of statutory interpretation raise genuine questions which are required to be determined on the merits and not on a motion to strike. |
[13] Second, I also must consider whether Apotex is in effect receiving a "sneak preview" of the details of the Applicant's case on the merits. It is particularly prejudicial to the Applicants when Apotex has not yet filed its evidence on the merits. Finally, I must be convinced that the Applicants' case cannot succeed. It is essentially the same test as on a motion to strike out a statement of claim.
[14] I must also take into account that on a paragraph 6(5)(b) motion, the disposition of the motion is in the discretion of the Court.
[15] Unlike Court file T-2026-99, where the patent is a composition patent and not a process patent, in this case, the question of use and the pharmaceutical composition is at issue. The law is not clear as here as it is on the issue of composition patents.
[16] The disputed issues of fact and law in this proceeding include: 1) if Apotex had an NDS pending at the relevant date, what are the indications for which Apotex is seeking approval; 2) whether, in law, Apotex' allegation is justified on the factual and legal basis alleged by Apotex; 3) whether Apotex itself will directly infringe the `668 patent; 4) whether Apotex will induce or procure infringement of the `668 patent; and, 5) whether there will be infringement generally of the `668 patent.
[17] One issue in this case is whether the allegation of non-infringement with respect to the `668 patent is justified on the detailed basis asserted by Apotex. Apotex asserts that its product "will not be made, used or sold for the treatment of Campylobacter infections". The only particulars or details given for this statement are that Apotex is "not seeking approval for such use and no such use will be included in our product monograph".
[18] Consequently, 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 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.
[19] In looking at whether Apotex will directly infringe the `668 patent, claim 3 is a claim for the medicine itself, as well as its use in treatment. Apotex is proposing to make and sell the subject matter of claim 3 (preparations wherein the active ingredient is omeprazole), but not for the use outlined in the claim. In order to determine whether Apotex will infringe this claim, it will be necessary for the Court to construe the claim and to make factual determinations regarding the activities of Apotex. In particular, the Court will have to determine how the words "for use" modify the phrase "pharmaceutical preparation" and will have to consider the intentions of Apotex in seeking approval for the pharmaceutical preparation.
[20] A second issue is whether Apotex will induce or procure infringement of the `668 patent. A party who induces or procures another to infringe a patent is itself responsible for infringement of the patent. Whether there is an inducement or procurement will depend on the particular fact situation, the evidence, inferences that may be drawn from facts found by the trier of fact, and on the credibility of the evidence. [See Windsurfing International Inc. v. Triatlantic Corp. (1985), 8 C.P.R. (3d) 241 (F.C.A.) at 263-268.] In The Copeland-Chatterson Company v. Hatton (1906), 10 Ex. C.R. 224 at pages 246 to 247, the Court stated:
| Under the grant made by Canadian letters patent the patentee and his legal representatives and assigns acquire during the prescribed term the exclusive right privilege and liberty of making, constructing and using and vending to others to be used, in Canada, the invention covered by the patent. And it does not appear to me to be going too far to hold that any invasion or violation of that right is an infringement of the patent. But is not that the right which one invades who knowingly and for his own ends induces or procures another to violate or infringe it? And if so, may not the act of the procurer or inducer be with propriety termed an infringement of the patent? In short does not one who knowingly and for his own ends and benefit and to the damage of the patentee induces or procures another to infringe a patent himself infringe the patent? It seems to me on principle that it comes to that. |
[21] There is an issue in the case before me as to whether Apotex' relevant product monograph refers to the treatment of Campylobacter pylori or H.pylori or if there are there any other references in the Apotex New Drug Submission to the use of omeprazole for the treatment of Campylobacter pylori or H.pylori. [See Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), [2000] F.C.J. No. 510, T-1970-99 (April 17, 2000) (T.D.).] The evidence before me is that Apotex' CPS listings do not limit the indications for which its drugs may be used. Moreover, Apotex will promote price and availability of its omeprazole products.
[22] A final issue is whether the `668 patent will be infringed generally. The intention of the Regulations is to prohibit the Minister from issuing an NOC where infringement will result following issuance of an NOC, regardless of the identity of the infringer. If the issuance of an NOC will result in infringement, whether by a generic, a pharmacist, a doctor or a consumer, an order of prohibition will issue. In Lishman v. Erom Roche Inc. (1996), 68 C.P.R. (3d) 72 (F.C.T.D.), Rothstein J. held at page 77 that "[w]hile infringement is nowhere defined in the Patent Act, R.S.C. 1985, c. P-4, any act which interferes with the full enjoyment of the monopoly granted is said to be an infringement."
[23] In Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) (1995), 61 C.P.R. (3d) 190 (F.C.T.D.), the patent at issue contained six claims, including claims for the medicine itself, as well as a claim for the use of the medicine. In that case, Apotex alleged that it would not make, construct or use or sell the medicine in question. The sole basis for the allegation was that Apotex had an inventory of bulk lisinopril acquired before the issuance of the patent. Apotex proposed to simply sell product from this inventory to pharmacies. Before Richard J., Apotex argued that it was the prescribing physician and patient, not Apotex, who would determine what use would be made of the product. As the product could be used to treat a number of different illnesses other than those claimed in the patent, the use of the tablets could not be said to infringe the patent at issue in that proceeding.
[24] Richard J. dealt with this "for use" issue 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 not indirectly. |
This decision was overturned on appeal, but not in respect of these particular comments.
[25] In the present case, there is evidence that patients will use Apotex's proposed omeprazole product for the treatment of H.pylori infections.
[26] In short, unlike in Court file T-2026-99, there are, in my view, a number of contentious issues of fact and law that are better left for the judge hearing this case on its merits.
[27] For the foregoing reasons, I am dismissing Apotex' motion pursuant to paragraph 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations.
[28] The motion is dismissed. In the circumstances, the motion to grant Apotex an extension of time to file its evidence within 30 days of disposition of this motion is dismissed. Costs to the applicants AB Hassle and Astra Pharma Inc.
"W. P. McKeown"
J.F.C.C.
Toronto, Ontario
September 8, 2000
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
| COURT NO: T-2016-99 |
| STYLE OF CAUSE: AB HASSLE and ASTRA PHARMA INC. |
Applicants
| - and - |
| THE MINISTER OF NATIONAL HEALTH AND WELFARE and APOTEX INC. |
Respondents
| DATE OF HEARING: THURSDAY, MAY 11, 2000 |
| PLACE OF HEARING: OTTAWA, ONTARIO |
| REASONS FOR ORDER BY: McKEOWN J. |
DATED: FRIDAY, SEPTEMBER 8, 2000
| APPEARANCES BY: Mr. Gunars A. Gaikis and |
| Mr. J. Sheldon Hamilton |
| For the Applicants |
| Mr. Andrew Brodkin and |
| Ms. Julie Perrin |
For the Respondent Apotex Inc.
| SOLICITORS OF RECORD: Smart and Biggar |
| Barristers & Solicitors |
| Box 111, 1500-438 University Avenue |
| Toronto, Ontario |
| M5G 2K8 |
| For the Applicants |
| Goodman, Phillips & Vineberg |
| Barristers & Solicitors |
| 2400-250 Yonge Street |
| Toronto, Ontario |
| M5B 2M6 |
| For the Respondent Apotex Inc. |
Morris Rosenberg
Deputy Attorney General of Canada
| For the Respondent The Minister of National Health and Welfare |
FEDERAL COURT OF CANADA
Date: 20000908
Docket: T-2016-99
BETWEEN:
| AB HASSLE and ASTRA PHARMA INC. |
Applicants
| - and - |
| THE MINISTER OF NATIONAL HEALTH AND WELFARE and APOTEX INC. |
Respondents
| REASONS FOR ORDER |