AB Hassle v. Apotex Inc.

AB Hassle v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2004-03-16
Neutral citation
2004 FC 379
File numbers
T-470-02
Notes
Digest
Decision Content
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
REASONS FOR ORDER
LEMIEUX J.:
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 pe