A-615-01
2002 FCA 290
Genpharm Inc. (Appellant)
v.
The Minister of Health and Procter & Gamble Pharmaceuticals Canada, Inc. and The Procter & Gamble Company (Respondents)
Indexed as: Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health) (C.A.)
Court of Appeal, Linden, Rothstein and Sharlow JJ.A.-- Toronto, June 13; Ottawa, July 8, 2002.
Patents -- Practice -- Patent for new way of using polyphosphonates in treatment of osteoporosis (product packaged in kit for intermittent, cyclical use) -- Genpharm alleging its product would not infringe as not packaged in kit -- Notices of allegation fatally flawed as Genpharm failed to provide facts in its detailed statements addressing use claims in patent, therefore failed to advance any facts to support allegations of non-infringement of use claims -- Evidence establishing Genpharm's product would be used for treatment of osteoporosis if notice of compliance obtained -- Infringement of patent for purposes of Regulations if generic producer sells product and infringement results by patient using product for use protected in patent -- If not direct, then at least indirect infringement of patent.
Practice -- Res Judicata -- Issue estoppel -- Patent for new way of using polyphosphonates in treatment of osteoporosis (product packaged in kit for intermittent, cyclical use) -- Generic producer alleging its product would not infringe as not packaged in kit -- Order, in course of prohibition application proceedings, to produce portions of generic producer's abbreviated new drug submission not estopping original product manufacturer from raising defects in notices of allegation in main proceeding -- Notice of allegation not court document, not subject to being perfected by court order.
In October 2001, McKeown J. granted an order of prohibition preventing the Minister of Health from issuing notices of compliance to Genpharm Inc. for its 200 mg and 400 mg tablets of its product Gen-etidronate, containing the drug etidronate disodium, until after the expiration of Procter & Gamble Co.'s (P&G) patent on the basis that Genpharm's notices of allegation were fatally flawed. McKeown J. did not assess the merits of the application. This was an appeal from that decision. Genpharm submitted that McKeown J. erred in so concluding because the adequacy of the notices of allegation had been previously decided and the matter was res judicata (on a motion under Patented Medicines (Notice of Compliance) Regulations, subsection 6(7), Pelletier J. had ordered that certain portions of Genpharm's abbreviated new drug submission (ANDS) for notices of compliance be produced to P&G), and because, in any event, the notices of allegation were sufficient and not fatally flawed.
Held, the appeal should be dismissed.
The issue estoppel argument was not well founded. It is correct that the disclosure order was not appealed. But since appeals are taken from orders, not from reasons, P&G had no reason to appeal that order. Pelletier J. was not asked to determine whether ordering production would perfect a defective notice of allegation. The order he made cannot be said to have estopped P&G from raising defects in the notices of allegation before McKeown J. or to have precluded McKeown J. from deciding the prohibition application on the basis of defectiveness in the notices of allegation. A notice of allegation is not a court document and is not subject to being perfected by a court order. None of the purposes of subsection 6(7) include curing a defective notice of allegation.
The notices of allegation were fatally flawed. P&G's patent was for a new way of using an existing drug, etidronate or etidronate disodium, in intermittent cycles in the treatment of osteoporosis, since continuous use was not found to be particularly useful. While it tended to inhibit bone loss, continuous use also tended to inhibit bone formation, possibly leading to the development of spontaneous bone fractures. Intermittent use appeared to avoid the negative effect, producing a net increase in bone mass. To facilitate compliance with the intermittent regimen, claims 1 to 16 of P&G's patent provided for a kit containing an appropriate number of tablets of etidronate disodium for a specified number of days and an appropriate number of daily doses of a nutrient supplement or placebo for a specified number of days.
Genpharm argued that since it would not package its etidronate disodium product in a kit in combination with any other active ingredient or nutrient supplement, P&G's patent would not be infringed by its making, constructing, using or selling its product. However, the requirement of Regulations, subparagraph 5(1)(b)(iv) that the generic producer "allege that . . . no claim for the medicine itself and no claim for the use of the medicine would be infringed" necessarily implies that the detailed statement must provide the legal and factual basis for the allegation that none of the patent claims will be infringed. Genpharm's detailed statements only addressed the kit claims (1 to 16). They did not address the use claims (17 to 37). It thus failed to advance any facts in support of its allegations of non-infringement of claims 17 to 37. As a result, the Court could not find that Genpharm's notices of allegation were justified. In the absence of such facts, pursuant to subsection 6(2), McKeown J. was obliged to make an order of prohibition and he did so.
Although it was not absolutely necessary to do so, for the purposes of the appeal, the Court decided to deal with the merits. The evidence satisfied the Court 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 obtained the notices of compliance that it was seeking. Genpharm also argued that the Regulations contemplate infringement by the generic producer, not by patients who will be the ones who will use Genpharm's product. However, that is not what paragraph 5(1)(b)(iv) says. The phrase "would be infringed" is not qualified. 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 the patent for the purposes of the Regulations. Furthermore, paragraph 55.2(4)(e) of the Patent Act 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. 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 interpretation is further supported by the definition of "claim for the use of the medicine" in section 2 of the Regulations. Use claims referred to in subparagraph 5(1)(b)(iv) contemplate use, not just by the generic producer, but by patients as well, and that infringement will result by patients using a medicine sold by a generic producer, even if there is no inducement or procurement by the generic producer. In the case of use claims, 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. Here, the evidence was 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 P&G's patent.
Accordingly, Genpharm's allegations of non-infringement were not justified and, on the merits, a prohibition order should be issued.
statutes and regulations judicially
considered
Patent Act, R.S.C., 1985, c. P-4, s. 55.2(4) (as enacted by S.C. 1993, c. 2, s. 4; 2001, c. 10, s. 2).
| Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2 "claim for the use of the medicine", 5(1)(b)(iv) (as am. by SOR/99-379, s. 2), (3)(a) (as am. idem), 6(2),(7) (as enacted by SOR/98-166, s. 5). |
cases judicially considered
applied:
Bayer AG v. Canada (Minister of National Health and Welfare) (1995), 60 C.P.R. (3d) 129; 179 N.R. 122 (F.C.A.); AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272; 256 N.R. 172 (F.C.A.); Merck Frosst Canada Inc. v. Canada (Minister of Health) (2001), 12 C.P.R. (4th) 447; 274 N.R. 297 (F.C.A.); Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) (1995), 61 C.P.R. (3d) 538; 96 F.T.R. 189 (F.C.T.D.).
considered:
Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), [2000] F.C.J. No. 511 (T.D.) (QL).
referred to:
Blueberry River Indian Band v. Canada (Department of Indian Affairs and Northern Development), [2001] 4 F.C. 451; (2001), 201 D.L.R. (4th) 35; [2001] 3 C.N.L.R. 72; 6 C.P.C. (5th) 1; 274 N.R. 304 (C.A.); Gronnerud (Litigation Guardians of ) v. Gronnerud Estate (2002), 211 D.L.R. (4th) 673; 287 N.R. 1 (S.C.C.); AB Hassle v. Canada (Minister of National Health and Welfare) (2001), 16 C.P.R. (4th) 21 (F.C.T.D.); Dableh v. Ontario Hydro, [1996] 3 F.C. 751; (1996), 68 C.P.R. (3d) 129; 199 N.R. 57 (C.A.).
APPEAL from a Trial Division order (Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), (2001), 15 C.P.R. (4th) 496) prohibiting the Minister of Health from issuing notices of compliance to the appellant for its product Gen-etidronate until after the expiration of Procter & Gamble's patent. Appeal dismissed.
appearances:
Roger T. Hughes,Q.C. and Kamleh J. Nicola for appellant.
No one appearing for respondent the Minister of Health.
Ronald E. Dimock and Sheila R. Block for respondent Procter & Gamble.
solicitors of record:
Sim, Hughes, Ashton & McKay LLP, Toronto, for appellant.
Deputy Attorney General of Canada for respondent the Minister of Health.
Dimock Stratton Clarizio LLP, Toronto, for respondent Procter & Gamble.
The following are the reasons for judgment rendered in English by
Rothstein J.A.:
INTRODUCTION
[1]This is an appeal of the order of McKeown J. dated October 23, 2001, (now reported at (2001), 15 C.P.R. (4th) 496) allowing the prohibition application of Procter & Gamble Pharmaceuticals Canada, Inc. and The Procter & Gamble Company (P&G) under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended by SOR/98-166 and SOR/99-379. The order of prohibition prevented the Minister of Health from issuing notices of compliance to Genpharm Inc. (Genpharm) for its 200 mg and 400 mg tablets of its product Gen-etidronate, which contains the drug etidronate disodium, until after the expiration of P&G's patent 1338376 (the 376 patent).
[2]McKeown J. found that Genpharm's notices of allegation were fatally flawed and granted the order of prohibition on that basis alone. He did not consider it necessary to go on and assess the merits of the application.
ISSUES
[3]In this Court, Genpharm makes two submissions regarding the adequacy of its notices of allegation. It argues that McKeown J. erred in concluding that the notices of allegation were fatally flawed because:
1. the adequacy of the notices of allegation had been previously decided and the matter was res judicata; and
2. in any event, the notices of allegation were sufficient and not fatally flawed.
[4]Genpharm then submits that, on the merits of the prohibition application, its notices of allegation alleging non-infringement of the 376 patent were justified and that the order of prohibition should not have been granted.
| Res Judicata |
[5]I turn first to the res judicata argument. The species of res judicata being argued by Genpharm is issue estoppel. In the course of the prohibition application proceedings, on a motion by P&G under subsection 6(7) [as enacted by SOR/98-166, s. 5] of the Regulations, Pelletier J. (as he then was) [Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), [2000] F.C.J. No. 511 (T.D.) (QL)] ordered that certain portions of Genpharm's abbreviated new drug submission (ANDS) for notices of compliance for its 200 mg and 400 mg Gen-etidronate tablets be produced to P&G. Subsection 6(7) provides in relevant part:
6. (1) . . .
(7) On the motion of a first person [P&G], the court may, at any time during a proceeding,
(a) order a second person [Genpharm] to produce any portion of the submission for a notice of compliance filed by the second person . . . .
[6]Genpharm says that whatever defect there may have been in its notices of allegation, Pelletier J. found that making a disclosure order under subsection 6(7) would remedy the defect and it was not open to McKeown J. to re-decide that issue and find that the notices of allegation were still defective. In his reasons of April 17, 2000, Pelletier J. stated at paragraph 8:
In my view, the Notice of Allegation served by Genpharm does not adequately address the claims in the patent and would not enable P&G to address the issue of infringement adequately. This disclosure required to remedy the defect is disclosure of the following portions of the Master Volume . . . .
Genpharm says that the order of Pelletier J. was not appealed and his decision that the defect in the notices of allegation is res judicata, or more precisely, is subject to the doctrine of issue estoppel.
[7]It is correct that the order of Pelletier J. was not appealed. However, that order only required disclosure of portions of Genpharm's ANDS. What Genpharm is really arguing is that there was no appeal taken from Pelletier J.'s reasons, because it is the reasons, and not the order, which suggest that the disclosure he was ordering would remedy any defect in the notices of allegation. It is trite law that appeals are taken from orders not from reasons. Here, the order was for disclosure, which is what P&G sought and was granted. P&G had no reason to appeal that order.
[8]I do not say that it is not permissible to have regard to reasons to determine what an order actually decided. See Blueberry River Indian Band v. Canada (Department of Indian Affairs and Northern Development), [2001] 4 F.C. 451 (C.A.), at paragraph 38. But the reasons of Pelletier J. in this case merely confirm that the issue of curing a defective notice of allegation was not raised before him. The only issue decided by Pelletier J. was whether to order production of portions of Genpharm's ANDS to P&G on an application by P&G for its own benefit. He was not asked to determine whether ordering production would perfect a defective notice of allegation. The order he made cannot be said to have estopped P&G from raising defects in the notices of allegation before McKeown J. or to have precluded McKeown J. from deciding the prohibition application on the basis of defectiveness in the notices of allegation.
[9]In any event, a notice of allegation is not a court document and it is not subject to being perfected by court order. In Bayer AG v. Canada (Minister of National Health and Welfare) (1995), 60 C.P.R. (3d) 129 (F.C.A.), at page 134, Strayer J.A. stated:
This clearly means that the Court has no jurisdiction to make orders concerning the filing of notices of allegation or requiring them to be perfected in some way.
In AB Hassle v. Canada (Minister of National Health and Welfare) (2001), 7 C.P.R. (4th) 272 (F.C.A.), Stone J.A. stated, at paragraph 23:
The intent appears to be that the entire factual basis be set forth in the statement rather than be revealed piecemeal when some need happens to arise in a section 6 proceeding.
In Merck Frosst Canada Inc. v. Canada (Minister of Health) (2001), 12 C.P.R. (4th) 447 (F.C.A.), Stone J.A. stated, at paragraph 19:
. . . the authorities in this Court are to the clear effect that a second person must not, in a s. 6 proceeding, rely on facts that exceed those laid out in the detailed statement.
[10]Because a defective notice of allegation cannot be cured by court order, an order under subsection 6(7) cannot be said to have that effect. An order under subsection 6(7) is for the benefit of the patentee--to enable it to decide whether to continue with a prohibition application or assist it in attacking the generic producer's allegation of non-infringement. It may have other uses. However, none of these purposes include curing a defective notice of allegation.
[11]I conclude that the issue estoppel argument is not well founded.
| Were the Notices of Allegation Fatally Flawed? |
| The P&G Patent |
[12]P&G's 376 patent is a patent for a new way of using an existing drug. The existing drug is a polyphosphonate, specifically, etidronate or etidronate disodium. The new way of using it is in intermittent cycles in the treatment of osteoporosis.
[13]According to the background of the invention in the patent, in a healthy adult, bone is lost and replaced in such a manner that bone resorption and bone formation is in balance. In osteoporotics, bone is lost at a rate faster than it is being replaced.
[14]The use of polyphosphonates to inhibit bone loss was well known. However, its continuous use in a chronic condition such as osteoporosis was not found to be particularly useful. This is because, while its use tended to inhibit bone loss, it also inhibited bone formation. Further, long-term chronic inhibition of bone loss and bone formation was thought to lead to the development of spontaneous bone fractures.
[15]The invention of the 376 patent is a new way of using polyphosphonates in the treatment of osteoporosis. If certain polyphosphonates are given, in a limited amount, according to a specific regimen of intermittent, rather than chronic dosing, bone loss can be inhibited and bone mass can be increased. The intermittent use of the polyphosphonate appears to uncouple bone loss and bone formation by selectively inhibiting the loss or resorption phase without adversely affecting the formation phase and thus, producing a net increase in bone mass.
[16]This new way of using a polyphosphonate in the treatment of osteoporosis is described in claims 17 to 37 of the patent. Claim 17, which is the most general use claim, provides:
17. Use of a bone resorption inhibiting polyphosphonate for the treatment or prevention of osteoporosis in humans or lower animals afflicted with or at risk to osteoporosis, wherein the polyphosphonate is used in two or more cycles including use for about 1 day to 90 days followed by a rest period from about 50 days to 120 days.
[17]In addition, to facilitate compliance with the intermittent regimen, claims 1 to 16 of the 376 patent provide for a kit which contains an appropriate number of tablets of etidronate disodium for a specified number of days and an appropriate number of daily doses of a nutrient supplement or placebo for a specified number of days.
| Genpharm's Notices of Allegation |
[18]Genpharm's notices of allegation characterize the invention in the 376 patent as a pharmaceutical regimen consisting of a kit containing etidronate or etidronate disodium and a nutrient supplement. Genpharm says it will not package its etidronate disodium product in a kit in combination with any other active ingredient or nutrient supplement. Therefore, Genpharm says the 376 patent would not be infringed by its making, constructing, using or selling its etidronate disodium product. Its detailed statement of fact and law in its notices of allegation states:
Canadian Patent No. 1338376 (the 376 patent) is directed to a pharmaceutical regimen used in the treatment of osteoporosis. The regimen consists of a kit containing etidronate or its pharmaceutical accepted salts (i.e. etidronate disodium) and a nutrient supplement (i.e. calcium bicarbonate). Genpharm's product will not be packaged as a kit in combination with any other active ingredient or nutrient supplement. Genpharm is seeking approval for a product containing etidronate disodium as the only active ingredient. Therefore, the medicine [sic] would not be infringed by the making, constructing, using or selling by Genpharm of the drug for which the submission for Notice of Compliance is filed.
| Analysis of Whether the Notices of Allegation are Fatally Flawed |
[19]As McKeown J. found, Genpharm is trying to subsume the use claims in the 376 patent into the kit claims in order to say that Genpharm will not be infringing the patent because its product will not be packaged in a kit. However, this is a mis-characterization of the claims in the patent. The use claims describe a new way of using a polyphosphonate in the treatment of osteoporosis--the intermittent, cyclical use of a polyphosphonate, i.e. etidronate disodium, in the treatment of osteoporosis. The kit claims describe a way to facilitate compliance with the intermittent, cyclical therapy.
[20]Subparagraph 5(1)(b)(iv) [as am. by SOR/99-379, s. 2] and paragraph 5(3)(a) [as am. idem] of the Patented Medicines (Notice of Compliance) Regulations provide:
5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug,
. . .
(b) allege that
. . .
(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.
. . .
(3) Where a person makes an allegation pursuant to paragraph (1)(b) . . ., the person shall
(a) provide a detailed statement of the legal and factual basis for the allegation; . . .
[21]Genpharm's notices of allegation do contain an allegation that the 376 patent "would not be infringed by its making, constructing, using or selling by Genpharm of the drug for which the submission for the notice of compliance is filed". These words track the words of subparagraph 5(1)(b)(iv). Further, its notices of allegation do contain what purport to be detailed statements of the legal and factual basis for its allegations. On their face, they would appear to comply with the Regulations.
[22]However, the notices of allegation and the detailed statement of legal and factual basis for the allegation must provide all the facts the generic producer intends to rely upon in subsequent prohibition proceedings. It cannot rely on facts that exceed those laid out in its detailed statement. See Merck Frosst Canada Inc. v. Canada (Minister of Health) (2001), 12 C.P.R. (4th) 447 (C.A.), at paragraph 19, per Stone J.A.
[23]The requirement of subparagraph 5(1)(b)(iv) that the generic producer "allege that . . . no claim for the medicine itself and no claim for the use of the medicine would be infringed" necessarily implies that the detailed statement must provide the legal and factual basis for the allegation that none of the patent claims will be infringed.
[24]I do not say that it is necessary for the generic producer to address each and every dependent patent claim if the basic claim or claims that describe the invention are addressed in the detailed statement. However, it is not open to the generic producer to ignore patent claims that describe the basic invention. If it does so, it will not be providing facts demonstrating that "no claim for the use of the medicine would be infringed", and its notice of allegation will be defective and not in compliance with section 5.
[25]Genpharm's detailed statements do not demonstrate that no claim for the use of a polyphosphonate, i.e. etidronate disodium, in an intermittent, cyclical regimen for the treatment of osteoporosis, which is the new use for etidronate disodium invented by P&G, would be infringed by Genpharm making, constructing, using or selling its etidronate disodium product. The detailed statements only address the kit claims, i.e. claims 1 to 16. They do not address the use claims, i.e. claims 17 to 37. They do not say that Genpharm's product cannot be used in an intermittent, cyclical therapy for the treatment of osteoporosis. Therefore, the detailed statements in the notices of allegation ignore the use claims in the 376 patent.
[26]Subsection 6(2) of the Regulations provides:
6. (1) . . .
(2) The court shall make an [prohibition] order pursuant to subsection (1) in respect of a patent that is the subject of one or more allegations if it finds that none of those allegations is justified.
In this case, Genpharm alleged that the 376 patent would not be infringed by its making, constructing, using or selling its etidronate disodium product. However, Genpharm has not provided facts in its detailed statements that address the use claims in the 376 patent. In failing to do so, it has not advanced any facts to support its allegations of non-infringement of claims 17 to 37. As a result, the Court cannot find that Genpharm's notices of allegation are justified. In the absence of such facts, pursuant to subsection 6(2), McKeown J. was obliged to make an order of prohibition and he did so.
| The Merits |
| Introduction |
[27]Because an order of prohibition had to be made for the reasons stated above, it is not absolutely necessary, for purposes of the appeal, to deal with the merits. However, 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. I do not need to decide whether a second notice of allegation would have any useful purpose in this case. It is sufficient to say that the Court is in a position to preclude unnecessary litigation by dealing with the merits on this appeal. The merits were addressed by the parties in their affidavits and cross-examinations and in argument before this Court. This Court is in a position to deal with the merits and I proceed to do so now.
[28]As the Motions Judge disposed of the matter solely on the basis of procedure, there are no reasons on the merits. In these circumstances, it is necessary for this Court to conduct a de novo assessment. See Gronnerud (Litigation Guardians of) v. Gronnerud Estate (2002), 211 D.L.R. (4th) 673 (S.C.C.), at paragraph 33, per Major J.
| The Evidence |
[29]Etidronate disodium had been used for treating two relatively rare diseases, Paget's disease and hypercalcemia of malignancy. P&G's product for these diseases is called Didronel.
[30]The invention in P&G's 376 patent includes the use of etidronate disodium in intermittent cycles for the treatment of osteoporosis. P&G calls this product Didrocal.
[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.
[32]Genpharm does not deny these facts, but has explanations for them. However, I find the explanations unpersuasive. Genpharm says that the blister packaging of 14 tablets has no significance. However, the 14-tablet package is only relevant to the intermittent regimen for the treatment of osteoporosis and not for the treatment of Paget's disease and hypercalcemia of malignancy.
[33]Genpharm agrees that, in Canada, P&G's Didronel product for Paget's disease or hypercalcemia of malignancy is marketed in 200 mg tablets. However, counsel submits that Genpharm's proposed 400 mg tablets are for use in the U.S. If that is the case, there is no apparent reason for Genpharm to seek a Canadian notice of compliance for its 400 mg tablets. Further, during cross-examination on affidavits, counsel for Genpharm objected to questions asking Genpharm's deponent about marketing its product in the U.S. It is not now open to Genpharm to rely on the marketing in the U.S. argument to justify seeking a notice of compliance for a 400 mg tablet when such evidence was refused on examination.
[34]Genpharm says that it has no precaution against the use of its Gen-etidronate product for osteoporosis in its product monograph because it considered it prudent to make no mention at all of osteoporosis. This is hardly convincing. When the primary issue in the prohibition proceedings is whether its product will be used in the intermittent, cyclical regimen for the treatment of osteoporosis, it seems obvious that, if Genpharm intended that its product not be used for the treatment of osteoporosis, it would have no reason not to include a warning against such use in its product monograph.
[35]Genpharm says the Minister required it to compare its product to the highest Canadian reference product dosage, i.e. Didrocal. There seems to be only one credible reason for this and that is that Genpharm wished to keep open to itself the option of having its product used in the treatment of osteoporosis.
[36]Genpharm does not provide any other explanation as to why it named Didrocal, P&G's osteoporosis product, as its Canadian reference product, rather than Didronel, P&G's product for Paget's disease and hypercalcemia of malignancy. It would seem that the only reason is to ensure that the Genpharm product will be considered to be equivalent to Didrocal and, therefore, available for use in the treatment of osteoporosis.
[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.
[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.
[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.
| Inducement and Procurement |
[41]Genpharm then submits 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. Genpharm argues that the infringement contemplated under the Regulations is infringement by the generic producer, not infringement by patients who will be the ones who will use Genpharm's product. Therefore, says Genpharm, the only way that it can be found to infringe the 376 patent is if it is determined that Genpharm induced or procured infringement by patients. (See AB Hassle v. Canada (Minister of National Health and Welfare) (2001), 16 C.P.R. (4th) 21 (F.C.T.D.), under appeal in Court file A-716-01.) Genpharm says the test for inducement or procurement, as set out in Dableh v. Ontario Hydro, [1996] 3 F.C. 751 (C.A.), at pages 780-782, is a difficult one to meet and that the evidence does not satisfy the test in this case.
[42]The patent claims at issue in the appeal are use claims. Therefore, the words that are relevant in subparagraph 5(1)(b)(iv) are "no claim for the use of the medicine would be infringed by the . . . selling by that person [the generic producer] of [its] drug".
[43]The phrase "would be infringed" is not qualified. In other words, subparagraph 5(1)(b)(iv) does not say, as Genpharm argues, that the act of infringement must be the act of the generic producer. Indeed, by expressly referring to sales by the generic producer ("the selling by that person"), the Governor in Council turned his mind to when it is relevant to associate actions with the generic producer under the Regulations. By not using that same phrase "by that person" in respect of the act of infringement within the same subparagraph, the Governor in Council cannot be said to have intended that infringement must necessarily be limited to acts of the generic producer itself. For Genpharm to suggest that the act of infringement must be by the generic producer reads words into the Regulations which the Court must not do.
[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, 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.
[46]I think this interpretation is further supported by the definition of "claim for the use of the medicine" in section 2 of the Regulations:
2. . . .
"claim for the use of the medicine" means a claim for the use of the medicine for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof.
[47]If the words of the definition are read into subparagraph 5(1)(b)(iv), i.e. "[no] claim for the use of the medicine for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof", it is apparent that the use contemplated includes use by patients. That is, medicine used for diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof, must contemplate use of the medicine by a patient. The point is that use claims referred to in subparagraph 5(1)(b)(vi) contemplate use, not just by the generic producer, but by patients as well, and that infringement will result by patients using a medicine sold by a generic producer, even if there is no inducement or procurement by the generic producer.
[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.
[51]Accordingly, Genpharm's allegations of non-infringement are not justified and, on the merits, a prohibition order should be issued.
CONCLUSION
[52]The appeal should be dismissed with costs.
Linden J.A.: I agree.
Sharlow J.A.: I agree.