Date: 20040316
Docket: T-470-02
Citation: 2004 FC 379
BETWEEN:
AB HASSLE, ASTRAZENECA AB and
ASTRAZENECA CANADA INC.
Applicants
- and -
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
BACKGROUND:
[1] Two Canadian patents are involved in this application made pursuant to the Patented Medicines (Notice of Compliance) Regulations, as amended, (the "Regulations"). Both patents claim new uses for a well-known medicinal compound - omeprazole or its pharmaceutically acceptable salts ("omeprazole").
[2] Canadian Patent 2,025,668 (the "668 Patent") has three use claims and is owned by AB Hassle. The field of its invention is the new use of omeprazole as an antimicrobial agent for the treatment of infectious diseases especially infections caused by the bacterium H.pylori which colonizes deeply in the gastric mucosa causing infections to the stomach and the gastric tract. Omeprazole was previously known to have gastric antisecretory activity. The discovery disclosed in the patent the antimicrobial activity of omeprazole or its salts as the active ingredient against gram-negative bacteria, especially H.pylori.
[3] Canadian Patent 2,133,762 (the "762 Patent") has seventy-seven claims and is owned by Astrazeneca AB. The '762 Patent is entitled "Synergistic combination of a substance with gastric acid secretion inhibiting effect and an acid degradable antibiotic". The new use of the combination of a gastric acid inhibitor (such as omeprazole or its salts) and an acid degradable antibiotic (such as penicillin) is in the treatment of gastritis or peptic ulcer diseases caused, in particular, by the bacterium H.pylori. The advantage of the new combination disclosed in the '762 Patent is the effect it has in increasing the effectiveness of the antibiotic (its bioavailability). Acid degradable antibiotics lose their potency in the presence of gastric acid in the stomach. A blocking compound or a gastric acid inhibitor increases plasma levels of the antibiotic thus its therapeutic effectiveness as well as increases the amount of acid degradable antibiotic in the gastric lumen and therefore the amount of the antibiotic which will pass into the small intestine where it will be absorbed in biologically active form.
[4] AstraZeneca Canada Inc. is authorized by the patent owners to market the pharmaceutical preparations disclosed in the '668 and the '762 Patents. For this purpose, AstraZeneca Canada Inc. holds a NOC issued by the federal Minister of Health (the "Minister") for omeprazole tablets and capsules which it markets under the name LOSEC.
[5] This proceeding was initiated by the applicants after Apotex Inc. ("Apotex"), a well-known manufacturer in Canada of generic drugs, served AstraZeneca Canada Inc., on January 28, 2002, with a Notice of Allegation ("NOA") pursuant to the Regulations in which it advised it had filed with the Minister a new drug submission for Apo-Omeprazole tablets for oral administration in strengths of 10mg, 20mg and 40mg. The applicants seek an order prohibiting the Minister from issuing a Notice of Compliance ("NOC") to Apotex until the expiry of the '668 and '762 Patents.
[6] The essence of Apotex' NOA is its allegation of non-infringement. Apotex does not challenge the validity of either patents. Its allegation was as follows:
With respect to Patents ... '668 and ... '762, 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 the said tablets. [emphasis mine]
[7] The legal and factual basis for its allegation on the '668 Patent is as follows:
With respect to Patent ... '668, all claims of this Patent relate to use in the treatment of campylobacter infections. Our product will not be made, constructed, 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. [emphasis mine]
[8] For the '762 Patent, Apotex addressed the legal and factual basis for the allegation of non-infringement according to different claims in that patent which Apotex grouped.
[9] The first group of claims selected by Apotex in the '762 Patent are claims 1 to 34 inclusive and 41 to 57 inclusive. Apotex said the claims in this group:
relate only to compositions which comprise a combination of a histamine H2 blocker or a proton pump inhibitor and antibacterial compound.
Our product will not infringe any of these claims by reason of the fact that our product is not a combination product, but comprises only omeprazole magnesium as its sole active ingredient. [emphasis mine]
[10] The second group of claims in the '762 Patent stated by Apotex are claims 35 to 40 inclusive and 58 to 65 inclusive. Apotex said these claims:
... relate only to use of a histamine-H2 blocker or proton pump inhibitor and antibacterial compound for the treatment of gastritis and peptic ulcer caused by Helicobacter pylori.
Our product will not infringe these claims, because:
i) our product is not a combination product, so that its use would not infringe any of the claims, and
ii) we are not seeking approval for such use, and no such use will be included in our product monograph. Furthermore, our product monograph will make no mention whatsoever of Helicobacter pylori [H.pylori] and will be limited to use for reduction of gastric acid secretion. [emphasis mine]
[11] The third set of claims grouped by Apotex are claims 66 and 67 in the '762 Patent. Apotex asserted these claims:
relate only to use of omeprazole and an antibiotic for the treatment of gastritis and peptic ulcer. [emphasis mine]
Our product will not infringe these claims because:
i) our product is not a combination product (i.e. it contains no antibiotic) so that its use would not infringe the claims, and
ii) we are not seeking approval for such use and no such use will be included in our Product Monograph. [emphasis mine]
[12] Group 4 claims classified by Apotex are all remaining claims not previously dealt with. Apotex said they:
... relate only to use for increasing the bioavailability of an antibacterial compound.
Our product will not infringe because we are not seeking approval for such use and no such use will be included in our Product Monograph. [emphasis mine]
[13] With its NOA letter, Apotex enclosed a copy of its product monograph as included in its new drug submission ("NDS") filed with the Minister.
[14] Apotex' NOA concluded by stating "In view of the dismissal for an Order of Prohibition in Court File T-2016-99 an application in relation to this Notice of Allegation would clearly be frivolous". The case referred to is Justice O'Keefe's decision which will be analysed later.
[15] The applicants commenced this proceeding on March 19, 2002, submitting that the allegations of non-infringement were not justified for a number of reasons.
THE PATENT CLAIMS
(a) The '668 Patent
[16] As mentioned, the '668 Patent has three use claims which are as follows:
(1) Use of [omeprazole or a salt thereof] for the manufacture of a medicament for the treatment of Campylobacter infections [H-pylori].
(2) Use of [omeprazole or one of its salts] for the treatment of Campylobacter infections [H.pylori].
(3) A pharmaceutical preparation for use in the treatment of Campylobacter infections [H.pylori] wherein the active ingredient is [omeprazole or a salt thereof].
(b) The '762 Patent
[17] For the purposes of this proceeding, the relevant claims in the '762 Patent are:
1. A pharmaceutical composition for the treatment of gastritis and peptic ulcer comprising a therapeutically effective amount of a histamine-H2 receptor blocking compound which increases intragastric pH or of a proton pump inhibitor which increases intragastric pH, and a therapeutically effective amount of an acid degradable antibacterial compound.
2. A composition according to claim 1 which comprises a proton pump inhibitor.
3. A composition according to claim 2 where in the proton pump inhibitor is omeprazole or a pharmaceutically acceptable salt thereof.
. . .
11. An oral pharmaceutical composition for the treatment of gastritis and peptic ulcer caused by Helicobacter pylori infections comprising as active ingredients,
(a) a therapeutically effective amount of a histamine-H2 blocker compound with inhibiting effect on the gastric acid secretion which effect increases the intragastric pH; or a therapeutically effective amount of a proton pump inhibitor compound which increases the intragastric pH and
(b) a therapeutically effective amount of an acid degradable antibacterial compound.
12. A composition according to claim 11 which comprises a proton pump inhibitor compound.
13. A composition according to claim 12 wherein the proton pump inhibitor compound is omeprazole or a pharmaceutically acceptable salt thereof.
. . .
41. A synergistic pharmaceutical combination of a therapeutic amount ranging from about 1-200 mg of proton pump inhibiting compound, which increases intragastric pH; and a therapeutic amount ranging from about 250 mg to 10g of an acid degradable antibacterial compound for the treatment of gastritis and peptic ulcer.
. . .
47. A synergistic pharmaceutical combination comprising a therapeutic amount of omeprazole or a pharmaceutically acceptable salt thereof and a therapeutic amount of a weak base antibiotic for the treatment of gastritis and peptic ulcer.
. . .
58. Use of a proton pump inhibiting compound which is an inhibitor of gastric acid secretion and an acid degradable antibacterial compound for the treatment of gastritis and peptic ulcer caused by Helicobacter pylori.
. . .
64. Use according to any one of claims 58 to 63 wherein the proton pump inhibiting compound is omeprazole or a pharmaceutically acceptable salt thereof.
. . .
66. Use of about 1-200 mg omeprazole or a pharmaceutically acceptable salt thereof and about 250 mg to 10 g of a weak base antibiotic for the treatment of gastritis and peptic ulcer.
. . .
68. Use of a histamine-H2 receptor blocking compound or of a proton pump inhibitor for increasing the bioavailability of an acid degradable antibacterial compound.
69. Use according to claim 68 of omeprazole or a pharmaceutically acceptable salt thereof.
. . .
71. Use according to claim 68, 69 or 70 for increasing the bioavailability of a weak base antibiotic. [emphasis mine]
THE ISSUES
[18] Counsel for the applicants raises one issue with respect to the '668 Patent whether, in fact, Apotex' Apo-Omeprazole tablets will be used by patients for the treatment of H.pylori infections resulting in the infringement of the patent and therefore Apotex' NOA not justified.
[19] With respect to the '762 Patent, the applicants raise two issues. The first issue concerns claims 1 to 34 and 41 to 57 inclusive of that patent which is the first grouping made by Apotex in its NOA. The applicants argue Apotex' NOA is fatally flawed because it misconstrued these claims when it alleged its Apo-Omeprazole tablets would not infringe those claims because its product is not a combination product but comprises only omeprazole magnesium as the sole active ingredient. Applicants say its patent is not limited to one pharmaceutical formulation, that is, to a single tablet formulation containing both active ingredients, i.e. omeprazole and the antibiotic. This is evident, they argue, from a paragraph at page 5 of the '762 patent which is the specification or disclosure of that patent. That paragraph reads:
The combination according to the present invention can be produced in one pharmaceutical formulation comprising both active ingredients or in two separate tablets or capsules, powder, mixture, effervescence tablets or solution. [emphasis mine]
[20] Apotex, the applicants argue, forgot the beneficial effects of the new invention are also produced when a tablet containing only omeprazole magnesium is taken together with a second tablet containing only the antibiotic. They note Apotex already sells the required units of the antibiotic (erythromycin and penicillin). As a result of its selling these components of the combination or failing to address this fact, the claim for non-infringement, even if assumed to be true, is not justified.
[21] The second issue raised by the applicants is that Apotex' Apo-Omeprazole tablets will be used by patients in a manner which infringes the claims in the '762 Patent, i.e., used as a treatment for gastritis and/or peptic ulcer however caused but caused, in particular, by the bacterium H.pylori. As such, the second issue raised by the applicants with respect to the '762 Patent is the same as the sole point they argue in respect of infringement of the '668 Patent.
[22] The focus of this recent Court's jurisprudence on patent infringement by patients is found in the Federal Court of Appeal's decision in Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), 2002 FCA 290 (the Genpharm case), Justice O'Keefe's decision in AB Hassle v. Canada (Minister of National Health & Welfare) (2001), 16 C.P.R. (4th ) 21, in which Apotex had issued the NOA, the Federal Court of Appeal's decision on appeal from Justice O'Keefe cited as AB Hassle v. Canada (Minister of National Health & Welfare), 2002 FCA 421, and Justice Gibson's decision in AB Hassle v. RhoxalPharma Inc., 2002 FCT 780.
THE EVIDENCE
(a) The applicants' evidence
[23] The theory of the applicants' case that a generic omeprazole product such as omeprazole magnesium, not approved by regulatory authorities for the treatment of H.pylori infections, will in fact be used by patients for such treatment given the operations of the pharmaceutical marketplace in Canada was advanced in the affidavits of Adam Pignataro and Stephen Wilton, who were both cross-examined. The applicants also filed the affidavit of Peder Oxhammar of Sweden for the limited purpose of stating that the owners of the '668 and '762 Patents had no knowledge or access to knowledge regarding the existence, contents (including ingredients, reference product, nature of the composition, indications and uses referred to) date of filing or present status of the NDS referred to by Apotex in its NOA dated January 28, 2002, the subject of this proceeding.
[24] Adam Pignataro is licenced to practice pharmacy in Ontario and has continuously done so since 1977 in a retail pharmacy and currently owns one in Mississauga, Ontario. He states he has experience working with other pharmacists and because of his experience, professional training and knowledge of pharmacy, he considers he has expertise in the practice of pharmacy in the Province of Ontario.
[25] It is his opinion generic omeprazole, a prescription drug, will be used by patients for the treatment of H.pylori infections. The building blocks of his opinion are:
(a) There are a significant number of patients who suffer from H.pylori infections. Such patients will attend physicians who would likely prescribe either generically or by brand name an omeprazole product.
(b) The prescription issued by the doctor does not identify the indication for which the drug is being prescribed. The prescription may be written either generically (by chemical name) or by brand name. A significant number of prescriptions are written generically.
(c) Whether prescribed generically or by brand name, Mr. Pignataro states the pharmacist will typically dispense the lowest cost brand which is available and that will be the generic version of an innovator's product if one is available. He concludes: "Accordingly, if a generic brand of omeprazole was available in the marketplace, a pharmacist would typically dispense that brand to a patient presenting a prescription for omeprazole".
(d) He deposes that generally, pharmacists are not aware of the specific indications for which a brand of drug is approved by regulatory authorities and concludes at paragraph 9 of his affidavit:
9. Accordingly, if 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. This will occur even though the particular generic brand may not be formally approved for that indication by regulatory authorities. Pharmacists will assume that generic omeprazole has been approved for the same uses which the corresponding brand name product is approved. Subject to a generic company taking special steps to inform pharmacists, there is no existing mechanism by which pharmacists would be alerted to the generic brand being approved for fewer uses relative to the brand name product.
(e) For the same reasons he expressed in paragraph 9 of his affidavit, he states in the next paragraph that generic omeprazole will be dispensed for use in respect of other indications for which the brand name (LOSEC) product is approved but the generic product is not. He states "some patients who are receiving a combination antibiotic/omeprazole therapy will receive a generic omeprazole product as part of such a therapy even though the generic omeprazole product is not approved for use in such a therapy".
[26] Stephen Wilton is the Executive Director, Business Development, at AstraZeneca Canada Inc. where he has been employed since 1993. He has a Bachelor of Science in Pharmacy and an M.B.A.; he is licenced to practice and has practised pharmacy in the Province of Ontario. He states he is familiar with the marketing and promotion of prescription pharmaceuticals in Canada, including brand name and generic products, is also familiar with the prescription pharmaceutical marketplace in Canada and the role played by health care professionals, particularly pharmacists. He confirms omeprazole products are prescription drugs available only when typically a physician gives a patient a written prescription which is dispensed to the patient by a pharmacist in the form of a particular product (brand). He makes the following points in his affidavit:
(a) While the Minister of Health and the recipient of a NOC will know the precise indications for which a generic product has been approved, physicians, pharmacists and patients generally are not aware of or concerned with the precise indications for which a generic brand has been approved.
(b) A generic company does not normally promote the approved indications for a generic brand to physicians and pharmacists. According to him, patients typically do not have access to the approved indications for a product and physicians and pharmacists are typically concerned only whether the active ingredient is effective in treating the medical condition.
(c) Whether prescribed generically or by brand name, the patient will take the written prescription to a pharmacy where the patient receives any brand of active ingredient available which the pharmacist is permitted to dispense. He states the pharmacist will generally dispense the lowest cost brand available, subject to the patient requesting otherwise. In his view, the product as dispensed to the patient will typically not provide information relating to the approved indications and is of the opinion that should a patient see information pertaining to indications, given the sophisticated medical terminology typically used, the patient is not likely to understand the information.
(d) A drug dispensed by a pharmacist pursuant to a prescription does not typically make reference to any indication on the label prepared by the pharmacist.
[27] Mr. Wilton then refers to the '668 Patent and quotes from Apotex' NOA stating Apotex asserts that all claims of the '668 Patent relate to "use in treatment of Campylobacter infections", that its product "will not be made, constructed, used or sold for the treatment of Campylobacter infections" and that Apotex is "not seeking approval for such use and no such use will be included in [its] Product Monograph". Mr. Wilton deposes that H.pylori is a bacterium "which is now known to cause gastrointestinal disorders, including duodenal ulcers". In addition to what he has already described as the operation of the pharmaceutical marketplace generally, he has the following additional comments in the case of omeprazole and the treatment of H.pylori:
13. Physicians are aware that omeprazole is effective in the treatment of several gastrointestinal disorders including the treatment of duodenal ulcers and H.pylori. Accordingly, physicians will prescribe omeprazole, when appropriate, for patients requiring treatment of H.pylori infections.
14. Accordingly, even assuming that Apotex' NDS does not seek approval for its omeprazole product for the treatment of H.pylori infections, upon approval for any indication, Apotex' omeprazole product will in fact be used for the treatment of H.pylori infections. This is because 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. When prescribing, a 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, as that is a regulatory matter of little concern to the physician.
15. The pharmacist typically does not know the particular reason or indication for which the physician has prescribed a drug. So that 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 has been prescribed omeprazole and hence would likely dispense Apotex' brand, expected to be a lower cost product.
[28] Mr. Wilton then addresses the '762 Patent and refers to Apotex' NOA which asserts claims 1 to 34 and 41 to 57 "relate only to compositions which comprise a combination of histamine-H2 blocker or proton pump inhibitor and an antibacterial compound". He states "Apotex alleges that its product will not infringe as its product is not a combination product but comprises only omeprazole magnesium as the sole active ingredient". To this, Mr. Wilton answers:
17. However, the aforesaid claims are not limited to one pharmaceutical formulation or product (see for example page 5, lines 5-9, and claims 41-51, 56, 57 of the '762 patent) and hence the sole factual basis relied on by Apotex, even if assumed true, does not justify the allegation of non-infringement.
[29] Mr. Wilton also states that claims 35 to 40 and 57 to 77 are not limited to one pharmaceutical formulation or product.
[30] Mr. Wilton then refers to Apotex' assertions of non-infringement with respect to claims 35-40, 58-65 and 66-67, on the basis that it is not seeking approval for particular claimed uses and no such use will be included in its product monograph. He concludes:
20. However, for reasons I have already explained above regarding the '668 patent, a generic omeprazole product will be dispensed for use in respect of other indications for which the generic product is not approved, including the uses described in the claims of the '762 patent.
21. In particular, some patients who are prescribed a combination antibiotic/omeprazole therapy will receive a generic omeprazole product as part of such therapy even though the generic omeprazole product is not approved for use in such a therapy. [emphasis mine]
[31] Mr. Wilton identified in his affidavit certain marketing practices which he says Apotex engages in :
(a) Apotex currently sells penicillin and erythromycin which are antibacterial compounds referred to in the '762 Patent. This fact is confirmed by the 2002 Compendium of Pharmaceuticals and Specialties ("CPS") which he characterizes as "a standard reference available to and consulted regularly by health care professionals in Canada, pharmacists in particular". He states Apotex has control over the amount of information provided in the CPS. He opines, in the case of its antibacterial compounds, Apotex does not provide in the CPS any limits on their indications and concludes "it would be consistent with Apotex' past practice to include its Apo-Omeprazole tablets in the CPS without any limits on indications or uses".
(b) After his visit to the Apotex website, he asserts Apotex lists all of its products adjacent to the corresponding brand name product and is of the view, once Apotex gets its approval for Apo-Omeprazole tablets, its product will be listed adjacent to LOSEC and concludes this will give the viewer, whether a pharmacist or a patient, the impression that omeprazole can be used for all therapeutic uses for which LOSEC is used. He also points to Apotex' listing of the "Therapeutic Class" for its products; referring to its antibiotic products, he states Apotex' erythromycin and penicillin products are simply referred to as "Antibiotic" without any detailed information regarding uses or limitations on uses and concludes once Apo-Omeprazole is approved, it will also appear on the website without any limitations as to its use.
(c) He mentions Apotex' website confirms it has sales representatives and that it supplies literature for pharmacists and patients, including literature which discusses medications for use in the treatment of diseases and disorders.
(d) Apotex promotes and markets its products and has strategies for the maximization of sales. Apotex will have internal documents which outline promotional and marketing strategies and directives to be followed by its marketing and sales staff and that, naturally, the applicants have no knowledge of such internal Apotex documents.
(e) He then turns to the chapter in Apotex' draft product monograph entitled "Information for the Patient" and refers to the wording which reads: "Apo-Omeprazole works by reducing the amount of acid made in your stomach. This helps in treating acid-related and bacteria-related stomach problems" (applicants' record, page 104). He concludes "this is a clear suggestion (to a physician, pharmacist or patient) that Apo-Omeprazole tablets may be used to treat bacterial related stomach problems, including H.pylori."
(f) He is of the view the availability of generic products and the information available or not available about them will influence the pharmacist's dispensing decisions. He concludes Apotex is in a position to influence pharmacists and patients to dispense Apo-Omeprazole alone, or in combination with Apotex' erythromycin or penicillin products (or in combination with the antibiotic products of others) for the uses referred to in the claims of the '668 and '762 Patents.
[32] On cross-examination, Mr. Pignataro:
(a) confirmed he is not a medical doctor;
(b) acknowledged he was not an expert on the requirements for interchangeability listing in Ontario (see, answer to question 52, applicants' record, page 158);
(c) acknowledged the Province of Ontario in the Formulary it publishes or by way of a separate communiqué, on occasion, restricted the extent of interchangeability for some medicines and that this information would be available to any conscientious pharmacist, that, as a practising pharmacist, he would try to keep abreast of all pertinent information relating to the medicines which he was dispensing and that his practice would be in compliance with the law (see questions and answers at transcript of cross-examination, applicants' application record, pages 156 and 157);
(d) did not know the Province of Ontario required a second or subsequent brand of a medicine seeking interchangeability status to provide the government with a copy of the product monograph (see transcript of cross-examination, applicants' record, page 60); during argument, counsel for Apotex provided me with a copy of Ontario Regulation 935 made pursuant to the Drug Interchangeability and Dispensing Fee Act, which provides at paragraph 6(1)(a) that it is a condition for each strength or dosage form of a drug product to be designated as interchangeable to submit to the Ontario Minister of Health a copy of the product monograph approved by Health Canada;
(e) confirmed a product monograph would normally be found in a book like the CPS and would list permitted indications. A debate then ensued between counsel for Apotex and Mr. Pignataro as to whether a pharmacist could dispense a product not approved for a particular use during which he acknowledged lack of familiarity with the requirements of the Food and Drug Act (see, applicants' record, pages 160 to 167);
(f) did not know a drug manufacturer who had not obtained approval from the federal Minister of Health for a particular indication for a particular product was not permitted by law to advertise or promote that product for a not-approved purpose but then retracted and acknowledged a drug manufacturer could not do so (applicants' record, page 166, answers to questions 80 and 81) and that he would not expect the product monograph to show a non permitted use but only approved uses (applicants' record, pages 166 and 167);
(g) had no familiarity with how a product got listed in the Ontario Formulary as a drug benefit (applicants' record, page 167);
(h) conceded at applicants' record page 169, he had conducted no study to back up his statement there were a significant number of patients who suffer from H.pylori infections;
(i) confirmed omeprazole is a medicine that may be used to deal with H.pylori infections, that a prescription for omeprazole would not tell him it was being used to treat H.pylori infections and if a doctor wanted to ensure that only LOSEC would be dispensed he could write on a prescription "LOSEC, no substitution" (applicants' record, pages 169 and 170);
(j) acknowledged it was common for drug manufacturers to send out communiqués to pharmacists on their products' approved indications.
[33] On re-examination by counsel for the applicants, Mr. Pignataro gave one example of Apotex promoting a non-approved use for one of its products but then conceded he might have been mistaken about the nature of Apotex' communication (applicants' record, pages 188, 189, 190 to 193); he acknowledged, after Apotex' litigation with the Province of Ontario, the generic version of sertraline had a restriction as to use; he was conscious of that fact and would try to abide by the restriction and if the same thing were to occur with omeprazole, he would try to abide by this restriction as well (applicants' transcript, page 193).
[34] On cross-examination, Mr. Wilton:
(a) confirmed he was not a medical doctor, was a licensed pharmacist in Ontario, was familiar with the Ontario Formulary which all pharmacists in Ontario have a copy of and that the Ontario Formulary gave information on the therapeutic classes of medication, brand names of products (generic or otherwise) and on interchangeability;
(b) acknowledged, on occasion, he had seen instances where there were restrictions as to interchangeability based on use of brand (applicants' record, page 261);
(c) confirmed the subject matter generally of the '762 Patent related to an invention which consists of a combination of a substance that increases the intragastric pH and an acid degradable antibacterial compound and was directed to the combination, whether in a single dosage form or otherwise, in usage together of a substance like omeprazole and an antibacterial. The decision to utilize the combination for the treatment of a patient, he acknowledged, rests with the doctor (applicants' record, page 265);
(d) as to the '668 Patent confirmed, in each of the three claims, the use was for the treatment of Campylobacter infections which meant caused by the H.pylori bacterium;
(e) acknowledged, examining the LOSEC extract from the 2002 CPS, reference was made in several places to a combination use i.e. omeprazole with an antibiotic and that the Federal Government had approved the use of LOSEC for the eradication of H.pylori (applicants' record, pages 268 and 269);
(f) confirmed the 2002 CPS "Information for the Patient" on LOSEC mentioned that the most common uses of LOSEC are for the reduction of gastric acid secretion where required in the case of ulcers including ulcers caused by infections with the bacterium H.pylori, included as an indication eradication of H.pylori and that LOSEC could be prescribed in combination with an antibiotic (applicants' record, page 271 and pages 917 and B142 of the CPS at applicants' record pages 287 and 288);
(g) was not familiar with Apotex' current practices when listing newly approved Apotex products, where amount of information provided by Apotex in the CPS, was similar to the amount of information provided for LOSEC (applicants' record, pages 272 and 273);
(h) acknowledged the CPS contained abbreviated product monographs for products and, if a doctor was interested in learning about a particular product, he or she might go there (applicants' record, page 274);
(i) acknowledged at applicants' record, page 282, it is only the doctor who will know and perhaps the patient, if told, why a particular medicine is being prescribed (applicants' record, page 283).
[35] On re-examination by counsel for the applicants, Mr. Wilton was asked how many examples of restrictions on interchangeability use in Ontario was he aware of. He answered "I'm probably aware of two".
(b) Apotex' evidence
[36] Apotex filed only one affidavit in evidence - that of Dr. Bernard Sherman, its Chairperson and Chief Executive Officer, who founded that company in 1972 and who holds a Ph.D in Systems Engineering obtained in 1967.
[37] He recited the procedural history behind this proceeding : its NDS to the Minister and its NOA to the applicants.
[38] Dr. Sherman explained the legal and factual basis for its allegation of non-infringement of the '668 and '762 Patents by Apotex, making, using or selling its Apo-Omeprazole tablets.
[39] With respect to the '668 Patent, he emphasized the claims were use claims - the use of omeprazole in the treatment of Campylobacter infections and the fact Apotex would not make, use or sell its product for such purpose, would not seek from the Federal Government approval for such use and no such use would be indicated in its product monograph.
[40] As to the '762 Patent, he stressed the claims of that Patent were restricted to combinations of omeprazole with an antibiotic or antibacterial compound and were also further restricted to the use of omeprazole in combination with an antibiotic or antibacterial compound for the treatment of certain diseases or for increasing bioavailability. He reiterated its Apo-Omeprazole tablets are not a combination product and Apotex will not seek approval for such use of its product in combination with an antibiotic or antibacterial compound. He stated Apotex also alleged it would not seek approval for the use of its product for the treatment of any of the diseases claimed in the '762 Patent or for increasing bioavailability, and more particularly, no such use will be included in its product monograph.
[41] He confirmed that as part of its NDS, Apotex was required to submit a proposed product monograph which sets out the proposed uses to which the product may be put once approved by the Minister. He stated once approved the final product monograph is issued by the Minister as part of the NOC documents.
[42] He stated at paragraph 16 of his affidavit the applicants' proceeding was frivolous, vexatious and an abuse of process and he reasoned in the following manner.
[43] With respect to the '668 Patent, he stated this patent does not claim the medicine omeprazole, per se and is limited to claimed uses, i.e. the use of omeprazole in the treatment of Campylobacter infections.
[44] Dr. Sherman reiterated Apotex' undertaking and reaffirmed its product monograph for when Apotex obtains NOC approval will not include use for treatment of Campylobacter infections nor will it make any mention whatsoever of Campylobacter infections and will be limited to use for reduction of gastric acid secretions. He states, as a consequence, and by law, Apotex may not and will not counsel doctors nor pharmacists to describe or dispense its Apo-Omeprazole tablets for the treatment of Campylobacter infections. He added the following at paragraph 20 of his affidavit:
20. Notwithstanding the foregoing, the Applicants assert that, because of the possibility that Apotex' Apo-Omeprazole tablets might erroneously be dispensed by a pharmacist to a patient to treat a Campylobacter infection, such event would constitute an act of infringement by Apotex. Contrary to what the Applicants assert, under no circumstances postulated by the Applicants, including the aforesaid circumstances involving an erroneous dispensation of Apotex' Apo-Omeprazole tablets, will Apotex infringe the '668 Patent.
[45] With respect to the '762 Patent and Apotex' allegation, Dr. Sherman characterized the 77 claims of that patent into eight groups.
[46] He stated claims 1 to 10 claim "a combination in the form of a pharmaceutical composition" comprising of an histamine-H2 receptor blocking compound (the "H2 blocking compound") or a proton pump inhibitor plus an antibacterial compound, when used for the treatment of gastritis and peptic ulcer" while claims 11 to 20 are similarly described as a combination in the form of a pharmaceutical composition comprising the same two elements, the H2 blocking compound or proton pump inhibitor plus the antibiotic compound for use in the same treatment but identifying the cause of the gastritis and peptic ulcer to be H.pylori.
[47] Dr. Sherman analysed claims 21 to 34 and 41 to 46 as "a pharmaceutical combination" comprising of either the H2 blocker or proton pump inhibitor plus the antibacterial compound when used in the treatment of gastritis and peptic ulcer while claims 47 to 57 claim a pharmaceutical combination comprising omeprazole or lansoprazole (or a pharmaceutically acceptable salt) as the proton pump inhibitor plus the antibiotic, when used in the treatment of gastritis and peptic ulcer.
[48] Dr. Sherman then tackled claims 35 to 40 and 58 to 65 which he characterized as claiming the use of either the H2 blocker or the proton pump inhibitor plus the antibacterial compound in the treatment of gastritis and peptic ulcer caused by H.pylori while claims 66 and 67 claim the use of omeprazole or a pharmaceutically acceptable salt as the inhibitor plus the antibiotic in the treatment of gastritis and peptic ulcer.
[49] Dr. Sherman then stated claims 68 to 76 claim the use of the H2 blocker or the proton pump inhibitor for increasing the bioavailability of the antibacterial compound while claim 77 claims the use of omeprazole for that purpose.
[50] After making that analysis, Dr. Sherman said this at paragraphs 22 and 23 of his affidavit:
22. All of the above claims of the '762 Patent are limited in scope in at least two ways. First, all of the claims are restricted to combinations, whether in a single composition or otherwise, of omeprazole together with an antibiotic or antibacterial compound. Second, all of the claims are restricted to the use of omeprazole, when used in combination with an antibiotic or an antibacterial compound, for treating certain diseases or for increasing bioavailability. [emphasis mine]
23. Apotex' Apo-Omeprazole is not a combination product and for that reason falls squarely outside the scope of the '762 Patent. More particularly, as is set out in Apotex' Product Monograph:
(a) the composition to be manufactured and sold by Apotex will only contain omeprazole magnesium, and not omeprazole and an antibiotic or antibacterial compound; and
(b) Apotex' Apo-Omeprazole is not indicated nor will it be permitted to be used in combination with an antibiotic or an antibacterial compound.
[51] Dr. Sherman further stated the claims of the '762 Patent will not be infringed by reason of the fact that Apotex is not seeking approval for the specific uses referred to in those claims (whether used alone or in combination with an antibiotic or an antibacterial compound). He reiterated its product monograph is limited to indications for use in the reduction of gastric acid secretions and is not indicated for use for the treatment of gastritis and peptic ulcers however caused or particularly caused by H.pylori nor for increasing the bioavailability of an antibacterial compound. He concludes at paragraph 25 of his affidavit:
25. Based on the foregoing, it is evident that none of the claims of the '762 Patent lay claim to the medicine omeprazole per se or their uses, nor to any antibiotic per se or their uses. Accordingly, any generic manufacturer is free to market and sell in Canada the medicine omeprazole itself and is also free to market and sell an antibiotic or antibacterial compound itself without infringing the '762 Patent. It is only the prospective and speculative interaction of these two products once on the market that gives rise to this frivolous proceeding.
[52] Dr. Sherman, in his affidavit, turns to the affidavit of Dr. Wilton to highlight what he considers the speculative nature of the proceeding before the Court. He specifically refers to paragraph 33 of Mr. Wilton's affidavit. He says Mr. Wilton does nothing more than surmise that Apotex "will be in a position" to induce doctors, pharmacists or patients to infringe the '762 Patent on the basis of purported documents, promotional and other material which he has never seen. He adds Dr. Wilton does not, however, even surmise that Apotex will, in fact, promote its Apo-Omeprazole tablets unlawfully or in any way that would be contrary to the uses for which it will have been approved.
[53] Dr. Sherman deposes the applicants do not state in their evidence that Apotex will promote, encourage or attempt to influence physicians, pharmacists or patients to use its Apo-Omeprazole tablets in combination with any antibacterial compound. Accordingly, Dr. Sherman states the alleged infringement of the '762 Patent is clearly speculative.
[54] He reiterates the undertaking that Apotex will not promote, encourage or attempt to influence physicians, pharmacists or patients to use its tablets in combination with any antibiotic or antibacterial compound.
[55] Dr. Sherman concludes at paragraph 29 that, accordingly, the only basis put forward by the applicants to rebut Apotex' allegations in connection with the claims "namely that Apotex will be « in a position » to infringe the patent or that it will be « in a position » to cause others to do so is entirely without merit".
[56] Dr. Sherman's conclusion is contained in paragraphs 31 to 33 of his affidavit which read:
31. As is evident from all of the foregoing, all of the claims of the '668 and '762 Patents are limited to certain uses and the claims of the '762 Patent are also limited to combinations of omeprazole with an antibiotic or antibacterial compound.
32. As is also evident from the foregoing, Apotex will not seek approval of any of the uses claimed in either the '668 or '762 Patent and no such uses will be included in Apotex' Product Monograph.
33. Furthermore, the Applicants have not adduced any evidence that Apotex will, in fact, promote or encourage doctors, pharmacists or patients to infringe the said patents (and I have indicated herein that Apotex will not, in fact, do so). Accordingly, the within Application is frivolous, vexatious and an abuse of process.
[57] Dr. Sherman was cross-examined on his affidavit. He confirmed his expertise in the Canadian regulatory system dealing with drugs, patented or otherwise, and in the practices of physicians and pharmacists in the context of Canadian regulations.
[58] Dr. Sherman acknowledged (applicants' record, page 200) Apotex' tablets would be therapeutically equivalent to LOSEC on the assumption that it was prescribed for the same purposes. He stated this equivalence is inherent to the compound, that whatever a compound will do is inherent to the compound and is not dependent upon anything other than its unique properties.
[59] He confirmed the product monograph listed as an exhibit to Mr. Wilton's affidavit is the current one in front of the Minister but there could be some changes to it if requested by the Minister (applicants' record, page 204).
[60] Counsel for the applicants drew Dr. Sherman to Apotex' product monograph and, in particular, to the following sentence in the Information to Patients section at page 22 of that document:
Apo-Omeprazole works by reducing the amount of acid made in your stomach. This helps in treating acid-related and bacteria-related stomach problems.
[61] Counsel asked Dr. Sherman whether the reference to "bacteria-related stomach problems" was an indirect reference to H.pylori. The following exchange took place (applicants' record, pages 206):
A. It talks about a consequence here of reducing stomach acid.
Q. What is the bacteria that is being referred to there?
A. I don't know.
Q. While you don't know, you do have knowledge that H. pylori is a bacterium?
A. Yes.
Q. It is the bacterium that does cause the stomach problems that these patents refer to?
A. I don't know.
Q. Am I correct that Apotex copied this section, "Information for the Patient", from the Applicants' product monograph?
A. I am not sure. That may be. In fact, these are ultimately government-issued documents. It is really what the government wants us to say in the product monograph, and it is the same for both firms.
It may be a scientific fact that the reduction of acid has a secondary effect of reducing bacteria. Actually, it says "treating bacteria-related stomach problem." It doesn't say anything about doing anything about eradicating bacteria. It says that it is treating the problem, which is the ulcer.
Q. I am sure counsel will make arguments subsequently. I think you have already answered as to your knowledge on matters of therapeutics and this specific language.
A. If you look at the "Indications" section, the product is being recommended to reduce stomach acid, and that obviously also is to treat ulcers. The cause of the ulcers may well have a bacterial component to it, but that does not change the fact that the indication is for treating excess gastric acid which is the same indication that was there even before your client applied for its patent that is now in issue.
[62] Counsel for the applicants then probed Dr. Sherman on whether Apotex had literature that referred to the treatment of H.pylori using omeprazole and after discussion, two documents entitled "Pharmawise - An Info Letter Provided to Caregivers by your Community Pharmacist" were entered as exhibits to Dr. Sherman's cross-examination.
[63] The most recent Pharmawise is the Volume 5, No. 1 publication; it stated back issues of Pharmawise could be obtained and gave a complete list of every published Pharmawise issue "which you can order through your Apotex sales representative". One of those back issues is Pharmawise, Volume 1, No. 4, published in the winter of 1997 entitled "H.pylori Infection and Peptic Ulcers". The Pharmawise pamphlet states that Pharmawise is authored and published by a named individual and is "made possible through the support of the Pharmacy [a place is provided for the pharmacy who distributed the document] and Apotex Continuing Education (PACE Program), the Apotex Advisory Board and your pharmacist. Reference to articles contained in this info letter are available by contacting the Apotex Professional Affairs Department".
[64] An examination of the Pharmawise winter 1997 issue dealing with H.pylori infections and peptic ulcers discusses the causes of peptic ulcers and identifies H.pylori as a major cause. It gave a brief history of the treatment of peptic ulcers, which, at first, included drastic surgery or consumption of massive amounts of antacid. It stated all of that changed with the discovery of H2 blockers and proton pump inhibitors of which it named three: lansoprazole (Prevacid), omeprazole (LOSEC), and pantoprazole (Pantoloe). That document also discussed H.pylori eradication and who should receive H.pylori eradication therapy and why.
[65] Dr. Sherman made the point Pharmawise was scientific literature prepared for continuing education purposes by independent experts aimed at health professionals. He stated Apotex is not its author, nor its publisher, nor does it have any control over the contents of Pharmawise. In addition, he said the document, the 1997 winter issue of Pharmawise, did not even refer to Apotex' product; it referred to LOSEC, the applicants' product.
[66] Dr. Sherman, during cross-examination, confirmed several times Apotex did not promote its product to physicians who write prescriptions. Apotex does not distribute its product monograph to physicians. He stated its customer base is the pharmacists but they do not write prescriptions.
[67] He stated members of the public might on rare occasions contact Apotex directly to make a complaint and he was firm in saying the staff of the Professional Affairs Department at Apotex would not provide any medical advice should a member of the public call. He would be referred to his doctor or his pharmacist.
[68] Dr. Sherman acknowledged if Apotex received approval for its Apo-Omeprazole tablets it would make an announcement which would go out to all the pharmacists in Canada stating that these tablets are available. Some information might also go to hospitals.
[69] Dr. Sherman said the focus of Apotex' marketing efforts is directed largely to obtaining market shares from other generic producers and not from patented drug manufacturers.
[70] Dr. Sherman was asked whether he was aware of any law that limited a physician to only prescribe pharmaceutical for formally-approved uses. He answered "No" stating that the laws limit drug companies in terms of their ability to promote but a doctor is really free to do whatever he wants concerning a patient with his/her being limited only by ethical considerations and the restrictions of the provincial laws in the province and College of Medicine guidance. He did not think patent laws prohibited a physician from treating a patient in any particular way.
[71] In response to undertakings given in cross-examination, Apotex confirmed the Pharmawise winter 1997 issue had 1,018 copies distributed to pharmacists in private practice and in hospitals and university settings across Canada.
[72] Apotex also confirmed no documents have been distributed or are intended for distribution to the public that touch on the treatment of H.pylori or Campylobacter nor that relate to peptic ulcers and that there are no internal Apotex documents or memos, or anything of that nature that touch in any way on marketing plans or strategies in respect to Apo-Omeprazole tablets.
ANALYSIS
(a) The previous jurisprudence
[73] Over the last several years, considerable jurisprudence has developed in this Court and in the Federal Court of Appeal, all in the context of NOC proceedings, on the scope and circumstances where indirect infringement by pharmacists or patients may be sufficient to lead to a finding that an allegation of non-infringement by a generic drug manufacturer is not justified with the result that a prohibition order would issue prohibiting the Minister of Health from issuing a NOC to that generic drug manufacturer.
[74] The sequencing of the decisions rendered in these cases and what issues were involved must be appreciated to understand why the courts rendered the decisions they did.
[75] The first case I mention is that of Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), 2001 FCT 1151, decided by Justice McKeown on October 23, 2001. The issue of indirect infringement was raised but was not considered by him. He ruled Genpharm's NOA was fatally flawed because Genpharm had not said its product would not be used in intermittent cyclical treatment for osteoporosis, hence that no claim under the affected patent held by P & G would be infringed if a NOC issued.
[76] The next case was decided on November 16, 2001, by Justice O'Keefe in AB Hassle, supra. In that case, Apotex had sought from the Minister a NOC for Apo-Omeprazole capsules. The '668 Patent was involved and both NOAs were the same.
[77] The applicants, AB Hassle and AstraZeneca Canada Inc., took the position they did not have to show infringement of the '668 Patent by Apotex but are entitled to a prohibition order if they demonstrate, on a balance of probabilities, that there will be infringement by anyone as a result of the issuance of a NOC to Apotex. Justice O'Keefe considered a number of issues including whether the applicants had demonstrated on the evidence that Apotex would induce or procure infringement of the '668 Patent if a NOC was issued.
[78] The applicants' theory of the case was similar to the theory advanced before me (see paragraph 70 of Justice O'Keefe's reasons for order). In that case, the applicants filed three affidavits, one sworn by Ms. Murphy who is an officer of AstraZeneca Canada. The second affidavit was sworn by Dr. Pinto who is a physician and the third affidavit was sworn by Ms. Samuel who is a pharmacist. Justice O'Keefe concluded the applicants had failed to establish on the evidence that infringement by pharmacists, doctors, patients or other third parties will necessarily take place if a NOC is issued to Apotex and therefore had failed to demonstrate that the allegation of non-infringement by Apotex is not justified.
[79] On July 8, 2002, the Federal Court of Appeal rendered its decision on appeal by Genpharm from Justice McKeown's decision. Notwithstanding the fact Justice McKeown had not decided the issue of indirect infringement, Justice Rothstein considered that point and ruled in favour of P & G Canada, the patent holder.
[80] A few days later, Justice Gibson, on July 12, 2002, decided the case of AB Hassle, supra. The applicants sought an order prohibiting the Minister from issuing a NOC to RhoxalPharma in respect of omeprazole tablets for oral administration until the expiry of the '668 Patent. The applicants' deponents were the same as those before Justice O'Keefe but none of those affiants were cross-examined. RhoxalPharma led in evidence the affidavit of Len Arsenault, its Director of Regulatory Affairs. He was cross-examined on his affidavit. Justice Gibson, on the facts before him, reached a different conclusion than had Justice O'Keefe. He was satisfied, at paragraph 43 of his reasons, the connection had been made out between RhoxalPharma and users of the drug for which RhoxalPharma was seeking the NOC. He ruled in favour of the applicants and issued the prohibition order sought.
[81] In a postscript to his reasons for order, Justice Gibson considered the Federal Court of Appeal's decision in Genpharm, supra, just released and which had been provided to him by counsel for the applicants. He did not reopen the case to hear submissions arising out of the Genpharm decision because he was reasonably satisfied that, whatever those submissions might be, they would not modify the results of his analysis.
[82] On November 1, 2002, the Federal Court of Appeal rendered its decision in AB Hassle, supra, on appeal from Justice O'Keefe's November 16, 2001 decision. The Federal Court of Appeal dismissed the appeal.
[83] After I had taken this case under reserve, counsel for the applicants forwarded to me a copy of Justice Layden-Stevenson's decision of December 22, 2003. The applicants in that case were the same as those in the case before me. The respondent was Genpharm Inc. The patents involved included the '668 and '762 Patents in respect of which Genpharm made a NOA claiming non-infringement. There were also two other patents in that case where Genpharm claimed invalidity.
[84] In her decision, cited 2003 FC 1443, Justice Layden-Stevenson, with respect to the '668 Patent, found that if a NOC issued and Genpharm were to sell its omeprazole tablets, patients would infringe Astra's new use patent. With respect to the '762 Patent, she concluded Genpharm had failed to address some of the claims in that patent and had not provided the facts, in its detailed statement, that addressed the claims where omeprazole is taken with antibiotic, but not in a single dosage form. She concluded in doing so, Genpharm had not advanced facts to support its allegation of non-infringement of those particular claims and as a result, its NOA cannot be justified. She also held if she was wrong in regard to this point, her findings of fact on the evidence in relation to the '668 Patent would apply to the claims of the '762 Patent in relation to H.pylori and Genpharm's allegation would not be justified in any event because of the patent infringement which would take place.
[85] Also, after the case was under reserve, counsel for Apotex forwarded me two recent decisions by my colleagues, Justices Russell and Snider, which I have not taken into account.
[86] In terms of Justice Layden-Stevenson's decision in Genpharm, supra, I did not rely on that decision in support of my analysis but simply read it to determine the factual findings she had arrived at.
(b) Discussions and conclusions
(i) Issue No. 1 - Is Apotex' NOA defective?
[87] In support of its allegation of non-infringement of claims 1 to 34 and 41 to 57 of the '762 Patent, Apotex stated as a fact its Apo-Omeprazole tablets were not a combination product because it comprises only omeprazole as the sole active ingredient.
[88] The applicants argue this assertion is premised on an incorrect construction of the patent, namely, the claims are limited to a single product (tablet) containing the two active ingredients : the omeprazole and the antibiotic, which is not the case because the combination can be produced in separate tablets each containing one of the two necessary active ingredients. I disagree with the applicants' argument.
[89] There can be no doubt the novelty or discovery disclosed in the '762 Patent is produced by combining, i.e. joining together or uniting or mixing omeprazole and an antibiotic in order to make more potent the antibiotic in order to eradicate H.pylori.
[90] In stating Apo-Omeprazole is not a combination product, Apotex stated as a fact its tablet would not unite or mix together omeprazole and an antibiotic, a statement which covers the single one tablet and the separate dosage forms or two tablets. If true, that statement of fact justifies its allegation.
[91] The purpose of the detailed statement required in the Regulations is to put the patentee on notice of the grounds advanced by the generic manufacturer for its allegation of non-infringement (see Justice Stone's reasons in AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (FCA) at paragraphs 16 to 19; and SmithKline Beecham Inc. v. Apotex Inc. (2000), 10 C.P.R. (4th) 338 (F.C.A.).
[92] Furthermore, a person in a NOC proceeding cannot add new facts to the NOA delivered but that person can provide evidence to support facts already alleged in the NOA (see Justice Stone's in AB Hassle, supra at paragraph 25).
[93] The applicants were fully aware Apotex put both formulations in play (see its Notice of Application at paragraph 15) and led evidence to meet the point to which Dr. Sherman responded.
[94] Should I be wrong on this issue, I will resolve the proceeding on its merits for the same reason as did Justice Rothstein in Genpharm, supra, as it is clear from the '762 Patent use is an essential feature in all claims.
(ii) Issue No. 2 - Would either the '688 or '762 Patents be infringed by patient use?
[95] The answer to this question involves a consideration of the Federal Court of Appeal's decisions in Procter & Gamble Pharmaceuticals Canada, supra, dated July 8, 2002, and in AB Hassle, supra, dated November 1, 2002.
[96] Justice Rothstein wrote for the Court in Genpharm. That Court included Justices Linden and Sharlow.
[97] Justice Rothstein upheld Justice McKeown's finding Genpharm's NOA was fatally flawed and he dismissed the appeal on this basis. Notwithstanding the fact Justice McKeown had made no finding on the merits, Justice Rothstein considered it appropriate to address the merits of the case, on a de novo basis, because a prohibition order based on a procedural defect might leave open the possibility that Genpharm may serve another notice of allegation that is not procedurally defective, another prohibition application may be commenced by P & G and the matter decided on the merits in that proceeding. Such would not serve any useful purpose in this case and to preclude unnecessary litigation, Justice Rothstein dealt with the matter on its merits since those merits had been addressed by the parties in their affidavits and cross-examinations and in argument before the Court.
[98] The Genpharm, supra, case was an old-use, new-use situation. Etidronate disodium had been used for the treatment of two relatively rare diseases and P & G's product for these diseases is called Didronel. The invention in P & G's '376 Patent included the use of etidronate disodium in intermittent cycles for the treatment of osteoporosis. P & G calls this product Didrocal.
[99] Paragraph 31 of Justice Rothstein's reasons sets out the evidence in support of AB Hassle's submission its patent would be infringed by Genpharm selling Gem-Etidronate:
¶ 31 P & G submits that its patent claims in the '376 patent for the use, in intermittent cycles, of a polyphosphonate, i.e. etidronate disodium, for the treatment of osteoporosis would be infringed by Genpharm selling Gen-etidronate, its etidronate disodium product. P & G relies on the following evidence in support of this submission.
1. Genpharm uses blister packed strips of 14 Gen-etidronate tablets containing etidronate disodium, consistent with the intermittent, cyclical regimen for the treatment of osteoporosis described in the '376 patent. This is the same packaging used by P & G for its Didrocal product.
2. Genpharm proposes to sell its Gen-etidronate product both in 200 mg and 400 mg tablets, although P & G's Didronel, the equivalent in the market for Paget's disease and hypercalcemia of malignancy, is only available in a 200 mg size. The 400 mg size is the same as P & G's Didrocal product for the treatment of osteoporosis. If Genpharm only wished to make its product available for Paget's disease and hypercalcemia of malignancy, it should only be proposing to sell its product in the 200 mg size.
3. In its product monograph for its Didronel product, P & G warns against use of its Didronel or Didrocal products for osteoporosis without following the intermittent, cyclical therapy. By contrast, in its product monograph for its Gen-etidronate, Genpharm does not include any precaution against using the product for the treatment of osteoporosis.
4. Genpharm has included studies in its product monograph that compare the bioavailability of its product to the bioavailability of the etidronate disodium from Didrocal, P & G's osteoporosis product, rather than from Didronel, P & G's Paget's disease and hypercalcemia of malignancy product.
5. Genpharm has named Didrocal as the Canadian reference product. A notice of compliance for the Genpharm product will state the name of the Canadian reference product and will constitute a declaration of equivalence of Genpharm's Gen-etidronate product with Didrocal. As such, Genpharm's product, allegedly for the treatment of Paget's disease and hypercalcemia of malignancy, will be considered equivalent to Didrocal, the product used for the treatment of osteoporosis.
6. The market for the use of etidronate disodium for Paget's disease and hypercalcemia of malignancy is small and declining. The market for the use of etidronate disodium for the treatment of osteoporosis is much larger.
[100] At paragraph 37 of his reasons, Justice Rothstein referred to the cross-examination of Genpharm's deponents. He wrote:
¶ 37 In cross-examination, Genpharm's deponents:
1. would not confirm that the Genpharm product would not be interchangeable with P & G's Didrocal in the marketplace;
2. confirmed that Genpharm's intention was to market its product for those indications listed in its ANDS, that one such indication was the treatment of osteoporosis and that the 400 mg tablets for 14 days was the dosing regimen for osteoporosis;
3. indicated that if anyone suggested that its product was being used for the treatment of osteoporosis, steps would not be taken to prevent such use; and
4. agreed that the Canadian market for the use of etidronate disodium for Paget's disease and hypercalcemia of malignancy was small and declining and that it was for use in the treatment of osteoporosis that made etidronate disodium a significant product.
[101] Justice Rothstein, at paragraphs 38 and 39, referred to other evidence. Those paragraphs read:
¶ 38 Dr. Alan Tennenhouse, Director, McGill University Bone Centre, and Director of the Division of Bone Metabolism of the Montreal General Hospital, deposed, at paragraph 64 of his affidavit, that Genpharm's product would be used for the treatment of osteoporosis:
Regardless of whether Genepharm's 400 mg tablet is indicated for the treatment of Paget's disease of the bone or hypercalcemia malignancy, the product could, and in some cases would, be used for the treatment and prevention of osteoporosis, in accordance with the cyclic regimen, discussed above.
¶ 39 Peter A. Cook, a licensed pharmacist in British Columbia, deposed that if generic etidronate disodium 400 mg tablets were not designated as non-interchangeable with Didrocal by the British Columbia College of Pharmacists, he would give patients the choice of being dispensed Didrocal or loose etidronate disodium tablets:
If generic etidronate disodium 400 mg tablets were not designated as non-interchangeable with DIDROCAL by the British Columbia College of Pharmacists, then, provided that the prescription did not specify that DIDROCAL should not be substituted, I would present any patient who attends with a prescription to be filled for DIDROCAL with the choice of being dispensed DIDROCAL or being dispensed loose etidronate disodium tablets, and possibly calcium supplements as well. If requested, I would blister pack the tablets being dispensed, although I would not offer this service in the ordinary course.
[102] After considering all of the evidence, Justice Rothstein concluded at paragraph 40:
¶ 40 The evidence cited above satisfies me that Genpharm's actions and intentions would lead inevitably to the use of its etidronate disodium product, Gen-etidronate, for the treatment of osteoporosis if it obtains the notices of compliance that it seeks. [emphasis mine]
[103] Justice Rothstein then considered Genpharm's submissions that, even if the evidence shows that its Gen-etidronate product will be used for the treatment of osteoporosis, that itself does not constitute infringement under the Regulations because the Regulations contemplate infringement by the generic producer and not infringement by patients who will be the ones who will use Genpharm's product. Genpharm stated the only way that it can be found to infringe the '376 Patent is if it determined that Genpharm induced or procured infringement by patients relying upon Justice O'Keefe's decision in AB Hassle, supra.
[104] Justice Rothstein rejected that submission pointing out the patent claims at issue in the appeal were use claims. He then referred to paragraph 55.2(4)(e) of the Patent Act which speaks of direct or indirect infringement of a patent on the issuance, inter alia, of a NOC. He also referred to subparagraph 5(1)(b)(iv) of the Regulations which led him to the following conclusions at paragraphs 44 and 45 of his reasons:
¶ 44 In the case of a use patent, if the generic producer sells its product and infringement results by patients using the product for a use protected in a patent, there will be infringement of that patent for purposes of the Regulations. The connection between the generic producer and infringement by the patient is in the generic producer selling its product.
¶ 45 Paragraph 55.2(4)(e) of the Patent Act, R.S.C., 1985, c. P-4 as amended [as enacted by S.C. 1993, c. 2, s. 4; 2001, c. 10, s. 2], which authorizes the Governor in Council to make the Patented Medicines (Notice of Compliance) Regulations, provides that a regulation may be promulgated dealing with circumstances in which the issuance of a notice of compliance might result directly or indirectly in the infringement of a patent. Paragraph 55.2(4)(e) provides:
55.2 (1) ...
(4) The Governor in Council may make such regulations as the Governor in Council considers necessary for preventing the infringement of a patent by any person who makes, [page421] constructs, uses or sells a patented invention in accordance with subsection (1), including, without limiting the generality of the foregoing, regulations
...
(e) generally governing the issue of a notice, certificate, permit or other document referred to in paragraph (a) in circumstances where the issue of that notice, certificate, permit or other document might result directly or indirectly in the infringement of a patent.
Where infringement is by a patient in the case of a use patent, the issuance of the notice of compliance can be said to result in the infringement of the patent, if not directly, then at least indirectly. This is the conclusion reached by Richard J. (as he then was) in Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) (1995), 61 C.P.R. (3d) 190 (F.C.T.D.), at page 203. I think that conclusion was correct and I reach the same result in this case.
[105] In conclusion, Justice Rothstein wrote the following at paragraphs 48, 49 and 50 in his reasons:
¶ 48 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.
¶ 49 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.
¶ 50 In this case, if a patient used the Genpharm product for osteoporosis, the use claims of P & G's '376 patent would be infringed. It would be Genpharm's selling of its product that would result in the infringement. Here, the evidence is overwhelming that it is not only probable, but inevitable, that Genpharm's Gen-etidronate product would, if notices of compliance issue, be used for the treatment of osteoporosis in the cyclical regimen that constitutes the invention under the '376 patent.
[106] In AB Hassle, supra, the Federal Court of Appeal's panel was composed of Justices Linden, Sexton and Evans with Justice Sexton writing the Court's reasons for judgment. As mentioned, that case involved an appeal from Justice O'Keefe's reasons. Justice Sexton also had an opportunity to consider the Federal Court of Appeal's decision in Genpharm, supra. The appeal was dismissed.
[107] Justice Sexton characterized the only patent in issue, the '668 Patent, as containing three use claims and reserved exclusive rights to omeprazole that are somehow related to the treatment of Campylobacter infections; it does not contain any claims for the compound omeprazole itself. He wrote the following at paragraphs 10 and 11 of his reasons:
¶ 10 In conjunction with and as part of its New Drug Submission, each manufacturer must submit a proposed product monograph which sets out the proposed uses to which the product may be put once approved by the Minister. Once approved, a final product monograph is issued by the Minister as part of the NOC documents. Although the product monograph is not before this Court, Apotex has undertaken that the product monograph for which Apotex will obtain approval will not include any use for the treatment of Campylobacter infections. Rather, the product monograph will make no mention of Campylobacter infections, and will be limited to use for the reduction of gastric acid secretions.
¶ 11 Nowhere in the Appellants' evidence is it shown that Apotex intended to sell its drug for the use prohibited by the '668 Patent, specifically for the treatment of Campylobacter infections. In fact, to the contrary, Apotex stressed in its NOA that its product would not be made, used or sold for the treatment of Campylobacter infections.
[108] He held at the core of Justice O'Keefe's judgment is the finding there was no evidence Apotex intends to make, use or sell its drug for the specific use patented by the applicants in their three use patent claims.
[109] Justice Sexton set out the nub of the applicants' case before Justice O'Keefe in the following words:
¶ 19 Specifically, O'Keefe J. found that the Appellants had alleged and were obliged to prove the following theory: a pharmacist typically does not know the particular reason or indication for which a physician has prescribed a drug. Therefore, even if a pharmacist was aware that Apotex' generic omeprazole product was not approved for use in the treatment of Campylobacter infections, the pharmacist would likely dispense the generic product because of its lower cost and because the pharmacist was unaware of the medical problem for which the product was being prescribed.
¶ 20 To prove this theory, the Appellants filed three affidavits, each of which offered their opinion on the following two points: (1) a physician would likely prescribe the medicine omeprazole by its generic name for the treatment of Campylobacter infections; and, (2) a pharmacist would likely dispense to the patient the lowest cost generic product, which would result in an infringement of the '668 patent.
[110] Justice Sexton went on to analyse the findings of fact made by Justice O'Keefe and after that review concluded the applicants had not met their burden of proof in that they have not proved, on a balance of probabilities, that any future infringements will occur. The evidence, in his opinion, failed to prove the applicants' theory on a balance of probabilities and at paragraphs 37 to 43, identified the weaknesses in the applicants' case:
¶ 37 There are many weaknesses in the Appellants' affidavit evidence that contribute to this inability to meet the burden. First, the Appellants did not present sufficient evidence to qualify the affiants as expert witnesses in the subject matter on which they purported to opine. Consequently, the affiants' evidence cannot speak beyond their individual viewpoint. No groundwork was laid to establish that Dr. Pinto could speak to the practices of other physicians. For the same reason, Ms. Samuel, while a qualified pharmacist, cannot speak to the practices and knowledge of other pharmacists and physicians because she provided no basis for her statement. Finally, Ms. Murphy is neither a physician nor a pharmacist, and establishes no other base of knowledge which would establish her qualifications to speak authoritatively on the practices in those professions.
¶ 38 Second, aside from their general lack of qualifications, the three affiants offer no evidence as to how they arrived at their opinions to support their generalized statements. For instance, Dr. Pinto qualified his statements by limiting them to his own experience: "It has been my experience that generic products are dispensed when they are available". When speaking about pharmacists not honouring prescriptions, he stated: "I just think that is the practice" (my emphasis).
¶ 39 Third, even if the affiants' evidence concerning the practices of others was admissible, they made admissions in their cross-examinations that undermine the authoritativeness of their generalizations and diminish the weight that should be attributed to the evidence. In particular, Ms. Murphy agreed that the Minister would only provide approval for those indications sought by the drug manufacturer for approval. Dr. Pinto made a similar admission.
¶ 40 Thus, O'Keefe J. gave little weight to, and, ultimately, refused to accept, the affidavit evidence as support for the Appellant's theory. Without an evidential foundation, their theory collapses.
¶ 41 In fact, there is a further weakness in the evidence of the affiants: at the time of swearing her affidavit, Ms. Murphy was a senior officer of Astra Pharma Inc., one of the Appellants to this action and, as a result her "opinion" evidence could be viewed as biassed or self-serving statements of an interested party.
¶ 42 Certain aspects further weakened Dr. Pinto's evidence, such as: (1) his acknowledgment that a patient trusts that the physician has made himself or herself aware of what ailments the prescribed medication can treat; (2) his inability to provide any examples of incidents where pharmacists conducted themselves illegally in dispensing generic drugs for which "no substitution" was indicated; and, (3) his lack of experience in circumstances where a generic drug product is approved for only limited uses - he has only had experience with drugs that have been approved as interchangeable for all uses. Consequently, Dr. Pinto cannot speak authoritatively on the subject of new and limited uses of an existing compound. As a result, his theory constitutes mere speculation of what might happen in circumstances beyond his level of experience.
¶ 43 The evidence of Linda Samuel is further weakened by the fact that, during her cross-examination, it became clear she was ignorant of many aspects of the regulatory regime governing the approval and dispensation of drug products in Canada: she could not provide the name of the legislation that governs the interchangeability of drug products in Ontario and was unaware of the interchangeability requirements; she did not know which branch of government approves a pharmaceutical product as safe and effective; she did not know that a drug manufacturer had to set out the specific uses for which it sought approval for its drug product; and, she was unaware that once the federal government is satisfied that a product is safe and effective, it issues an NOC and a Product Monograph to the submitting drug manufacturer.
[111] Justice Sexton completed his analysis at paragraphs 45 and 46 in these words:
¶ 45 The Supreme Court of Canada stated in R. v. Abbey, [1982] 2 S.C.R. 24, that a party tendering expert evidence has "the obligation of establishing, through properly admissible evidence, the factual basis on which such opinions are based. Before any weight can be given to an expert's opinion, the facts upon which the opinion is based must be found to exist". Thus, even if the affiants in this case can be considered "experts", nowhere do they provide evidence to support their generalized statements about the practice of physicians and pharmacists. No independent studies or properly conducted surveys were tendered.
¶ 46 In order to allow this appeal, therefore, it must be found that the trial judge, O'Keefe J., made a palpable and overriding error with respect to these facts and factual inferences. No such error was made. The Appellants cannot build a case upon such a shaky foundation.
[112] Justice Sexton then engaged in a discussion of the findings of the Federal Court of Appeal in the Genpharm case, supra, stating the thrust of the applicants' argument was that infringement by patients alone, with no further evidence beyond the mere fact that the generic sold the product initially, is sufficient to support the grant of an order of prohibition under the Regulations. He distinguished the Genpharm case, supra, on the facts stating the following at paragraph 54:
¶ 54 First of all, Genpharm can be distinguished on its facts. The Court said:
The evidence cited above satisfies me that Genpharm's actions and intentions would lead inevitably to the use of its etidronate disodium product, Gen-etidronate, for the treatment of osteoporosis if it obtains the notices of compliance that it seeks.
There was no such evidence adduced in the present case, and it would, I suggest, be essential in order to reach the same result.
[113] He then turned to Genpharm's product monograph and wrote the following at paragraph 55:
¶ 55 In addition, when reaching its conclusion as to Genpharm's intention, the court in Genpharm had the benefit of examining Genpharm's product monograph. Upon attaining government approval, a drug manufacturer receives a NOC together with a product monograph. The product monograph, among other things, sets out what the indications are for the drug product - the uses for which the government has approved a product. Therefore, a product monograph limits indications, and is available on the Compendium of Pharmaceutical Specialities (CPS). The CPS is a reference book which lists the dosages, ingredients and directions for certain drugs, and is widely used by pharmacists and physicians. Again, it should be reiterated that Apotex' product monograph was not available in these proceedings. Apotex had sought to file evidence but was late in doing so, and their application for an extension of time was opposed by the Appellants and was refused by McKeown J. However, during the present appeal hearing, Apotex' representatives stated that it had produced its product monograph to the Appellants in the course of a cross-examination. The Appellants did not place this document before the Court, and, as a result, the Court was without the benefit of the document, a document which played a key role in the Genpharm decision by providing the Court with an indication of the intentions of the generic company and the likelihood of infringement.
[114] He then considered certain passages of Justice Rothstein's written reasons, namely those contained at paragraphs 47 through 50 of his decision in Genpharm, supra.
[115] Justice Sexton stated the following about Justice Rothstein's decision:
It should be emphasized, however, that the Court made these statements after having concluded that the evidence in Genpharm overwhelmingly demonstrated that the actions and intentions of Genpharm would inevitably lead to an infringement. Because no such conclusion can be reached in the case before us, the Genpharm case can be distinguished on that basis. I do not view Genpharm as being authority for the proposition that mere sale by a generic, without more, of a medicine subject to a use patent is sufficient to constitute infringement for the purpose of subparagraph 5(1)(b)(iv). [emphasis mine]
and concluded his reasons at paragraphs 57, 58 and 59:
¶ 57 Thus Apotex cannot be prevented from obtaining a NOC solely on the basis that it will sell omeprazole. If it were otherwise, then serious policy issues would arise. If there was any likelihood that a patient would consume a generic product for a patented use, then the generic product would not be approved. This would prevent new uses from being approved for existing drugs because there is always the possibility that someone somewhere will use the drug for the prohibited, patented purpose. This would result in a real injustice: since a generic company cannot possibly control how everyone in the world uses its product, the prevention of the generic from marketing the product would further fortify and artificially extend the monopoly held by the patent holders. The patent holder would, therefore, effectively control not just the new uses for the old compound, but the compound itself, even though the compound itself is not protected by the patent in the first place. The patent holders, as a result, would obtain a benefit they were not meant to have. In the end, society would be deprived of the benefit of new methods of using existing pharmaceutical medicines at a lower cost.
¶ 58 Nor can Apotex be held liable in patent infringement proceedings under the Patent Act if, contrary to the evidence presented in the NOC proceeding, third party infringements do occur after the issue of a NOC, unless Apotex has implicated itself in the infringements by, for example, inducing or encouraging them. Genpharm has no application to a generic's liability under the Patent Act for any patent infringement by a third party that occurs after a NOC has been issued.
¶ 59 The Appellants have not proved that, if a NOC were issued to Apotex and it were to sell omeprazole, patients or other third parties would infringe the Appellants' use patent. If a first person cannot prove in prohibition proceedings that future infringements will occur if a NOC is issued, it cannot obtain a prohibition by relying on subparagraph 5(1)(b)(iv), however the required nexus between the generic and the infringement is defined.
[116] As stated by Justice Sexton in AB Hassle, supra, where use claims are involved, a generic drug manufacturer such as Apotex cannot be prevented from obtaining a NOC solely on the basis it will sell a generic version of a drug whose use patent has not expired. There must be evidence of something more. However, Justice Rothstein, again in the context of use claims, held the issuance of a NOC to a generic drug manufacturer will be prohibited where it has been demonstrated, on the balance of probabilities, infringement will occur by patients consuming a patented drug. The theory behind indirect infringement of a patent by a patient necessarily involves a consideration of how the prescription drug market operates in Canada.
[117] The operation of the regulated prescription drug marketplace focusses on the behaviour of doctors, pharmacists and drug manufacturers and on the laws regulating federal approvals authorizing the marketing of drugs and provincial laws relating to Formulary requirements.
[118] At the level of the physician, the operation of the prescription drug marketplace involves consideration of how doctors prescribe a drug to patients, for which illnesses, how they might choose to prescribe one of two competing drugs, what knowledge they have of approved indications and the extent to which they may be involved in prescribing non-approved drugs.
[119] At the level of the pharmacist, similar questions arise : what knowledge does the pharmacist have of why a drug is prescribed and for what purpose, what factors influence the pharmacist to fill a prescription where two or more competing drugs are available, what knowledge does the pharmacist have of approved indications and how that knowledge might affect his behaviour.
[120] The operation of the prescription drug marketplace in Canada is a matter of evidence and drawing reasonable conclusions from that evidence.
[121] After reviewing the case law on the issue of indirect patient infringement which might justify prohibiting the Minister from issuing a NOC to a generic drug manufacturer, it became apparent to me that the evidence led in each of the cases I reviewed varied substantially from case to case and this explains why the courts came to different conclusions even where the same patents but different parties were involved.
[122] The review of the cases easily demonstrates the vast difference in the evidence before Justice Rothstein in Genpharm, supra, and the evidence before Justice O'Keefe in the AB Hassle, supra, case considered by Justice Sexton and in the recent case decided by Justice Layden-Stevenson.
[123] My review of the evidence in this case leads me to conclude the applicants have led insufficient evidence to show, on a balance of probabilities, either the '668 or '762 patents will be infringed should Apotex receive from the Minister a NOC for its Apo-Omeprazole tablets. Indeed, the evidence led before me by the applicants is similar in nature to the evidence led before Justice O'Keefe, which Justice Sexton endorsed. That evidence, properly assessed, would deny Apotex its NOC by merely selling its Apo-Omeprazole tablets. The law requires something more by Apotex. That evidence of something more is lacking.
[124] The same pharmacist was involved in both cases. Mr. Pignataro described how pharmacists behave when dispensing drugs.
[125] Although persons speaking for AstraZeneca Canada were different in the two cases, they led in their respective affidavits similar evidence how the prescription drug marketplace operates in Canada.
[126] In the case before me, the applicants led no evidence from a doctor.
[127] I conclude for the same reasons expressed by Justices O'Keefe and Sexton the applicants' evidence, in the case before me, suffers from the same weaknesses identified by both of those judges. I also come to the conclusion the evidence before me is weaker than the evidence before Justice O'Keefe in his decision relating to the '668 Patent. In the case at hand, the applicants did not lead any evidence from a doctor and, as a result, I have no evidence on what factors drive Canadian doctors' prescribing behaviour. This gap in the evidence is significant because, as I understand the applicants' theory, the operation of the prescription drug market and findings of indirect patient infringement through use is dependent on how doctors prescribe drugs.
[128] The infirmities in Mr. Pignataro's evidence are apparent. He made no independant studies or surveys. He is not a doctor and his experience as a pharmacist is limited to Ontario. I find the statement in his affidavit that "he has experience working with other pharmacists", insufficient to qualify him to provide expert opinion on how pharmacists dispense in Ontario. He provided no resumé. I limit my acceptance of his evidence to how he himself behaves but I conclude that even there, his evidence is of insufficient strength to support or make out the applicants' case of indirect patient infringement through use should Apo-Omeprazole come on the marketplace.
[129] The answers he gave on cross-examination damaged his direct evidence. He showed a lack of familiarity with federal and provincial drug laws. He conceded the existence of interchangeability restrictions for non-approved uses in some situations and confirmed he would obey them should they be in place for Apo-Omeprazole.
[130] Mr. Wilton's evidence was insufficient, in my view, to make the applicants' case. The thrust of his evidence was to show Apotex' "intentions and actions" to repeat the phraseology used by Justice Rothstein in Genpharm, supra.
[131] The strongest point he made were to the words in the Information to Patients portion of Apotex' draft product monograph "this helps in treating . . . bacteria-related stomach problems" as a direct reference to the use of Apo-Omeprazole for the treatment of infections caused by H.pylori.
[132] I do not think the evidence shows Mr. Wilton could reasonably come to that conclusion. Nowhere in Apotex' draft product monograph does Apotex say its Apo-Omeprazole tablets are useful in the eradication of H.pylori and the quoted sentence does not say that (in contrast to what LOSEC's product monograph says as being useful in eradicating its H.pylori particularly in combination with antibiotics (applicants' record, pages 285 and 286)).
[133] Also, this sentence quoted by Mr. Wilton must be read in context. Mr. Wilton ignores the previous sentence where Apotex says its Apo-Omeprazole works by "reducing the amount of acid made in your stomach". This is a clear reference to the old known use for omeprazole - reduction of gastric acids in the stomach. Dr. Sherman made these points on cross-examination.
[134] Mr. Wilton is not a doctor and his statements (particularly paragraphs 13 and 14 of his affidavit) on how doctors will prescribe omeprazole for patients requiring treatment of H.pylori can be given no weight.
[135] I find some of Mr. Wilton's conclusions in his affidavit to be speculative or unsubstantiated by the evidence. For example, that is the case for the inference drawn about Apotex' possible listing of its Apo-Omeprazole tablets adjacent to LOSEC on Apotex' website creating "the impression" in the minds of pharmacists and patients that its product can be used for all therapeutic uses for which LOSEC is used. Mr. Wilton admitted on cross-examination that approved indications appear in the CPS which is widely consulted by pharmacists.
[136] Another example is the statement Mr. Wilton makes that the availability of generic products and the information available are not available about them will influence a pharmacist dispensing decisions. He admitted on cross-examination he was not aware of Apotex' current practices about the extent of the information supplied by Apotex for the CPS about its new products.
[137] In cross-examination, Mr. Wilton acknowledged interchangeability restrictions had been imposed on a couple of occasions by Ontario.
[138] I do not think the applicants' case was advanced in Dr. Sherman's cross-examination. I have in mind the Pharmawise bulletin and specifically the one connecting H.pylori and omeprazole. That bulletin is dated, does not refer to Apotex and to Apo-Omeprazole but to LOSEC and AstraZeneca. In any event, Dr. Sherman undertook to take the publication out of circulation.
[139] In addition, in response to an undertaking given by Apotex on cross-examination, Apotex confirmed there are no documents that have been distributed or are intended for distribution to the public that touch on the treatment of H.pylori or Campylobacter or that relate to peptic ulcers. Also, Apotex confirmed there was no internal Apotex documents, memos or anything of that nature that touch in any way on the marketing plans or strategies with respect to Apo-Omeprazole tablets.
[140] Weighing and appreciating all of this evidence leads me to conclude the applicants' evidence is not sufficiently strong to show Apotex' NOA is not justified.
[141] For all of these reasons, the applicants' application for a prohibition order is dismissed with costs.
" François Lemieux "
J U D G E
OTTAWA, ONTARIO
MARCH 16, 2004
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-470-02
STYLE OF CAUSE: AB HASSLE, ASTRAZENECA AB and ASTRAZENECA CANADA INC. V.
APOTEX INC. and THE MINISTER OF
HEALTH
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: DECEMBER 2 and 3, 2003
REASONS FOR ORDER BY THE HONOURABLE JUSTICE LEMIEUX
APPEARANCES:
Gunars Gaikis FOR APPLICANTS
Harry Radomski FOR RESPONDENT
Andrew Brodkin
SOLICITORS OF RECORD:
GUNAR GAIKIS FOR APPLICANTS
TORONTO, ONTARIO
GOODMANS FOR RESPONDENT
TORONTO, ONTARIO