Solvay Pharma Inc v. Apotex Inc.

Solvay Pharma Inc v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2008-03-06
Neutral citation
2008 FC 308
File numbers
T-427-06
Decision Content
Date: 20080306
Docket: T-427-06
Citation: 2008 FC 308
Ottawa, Ontario, March 6, 2008
PRESENT: The Honourable Justice Johanne Gauthier
BETWEEN:
SOLVAY PHARMA INC. and
ALTANA PHARMA AG
Applicants
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1] This is an application brought under section 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations), by which the applicants Solvay Pharma Inc. and Altana Pharma AG collectively as Altana seek an Order prohibiting the Minister of Health from issuing a Notice of Compliance under the Food and Drug Regulations, C.R.C., c. 870, to the respondent Apotex Inc. for the production and marketing of enteric coated tablets of pantoprazole sodium in 20 mg and 40 mg strengths until after the expiration of Canadian Letters Patent 2,092,694 (the '694 Patent) and 2,089,748 (the '748 Patent). Apotex intends to market its tablets under the trade name “Apo-Pantoprazole”.
[2] Altana Pharma AG, a German company, is the owner of the '694 and '748 Patents. The company was formerly known as Byk Gulden Gmbh. At the hearing, the Court was informed that the company has again changed names and now operates as Nycomed Pharma Gmbh.
[3] Solvay Pharma Inc. is Altana Pharma AG Canadian licensee with respect to the patents in question. Pursuant to the Regulations, the patents are listed against an enteric coated formulation of pantoprazole sodium manufactured and marketed by Solvay under the trade name PANTOLOC. The formulation is available in 20 mg and 40 mg dosage strengths.
[4] Pantoprazole itself is a known compound for which the Canadian Patent (4,758,579) expired on June 19, 2005.[1]
[5] The '748 Patent was filed in Canada on August 23, 1991, and published on March 5, 1992. It generally relates to novel pharmaceutical compositions combining pantoprazole (or one of its salts) as one of the medicinal ingredient, useful for the treatment and prevention of gastrointestinal diseases caused or exacerbated by H. Pylori (Hp) and secreted gastric acid.
[6] The '694 Patent was filed in Canada on September 6, 1991, and published on April 2, 1992. In their respective memoranda, the applicants submit that the patent “discloses pantoprazole, has direct activity against Hp and describes the formulation that is best for this direct action”, whereas Apotex construes the patent to relate to compositions, including those that are simultaneously resistant and not resistant to gastric juice, for combating Hp itself and thereby treating diseases of the stomach and intestine caused by Hp.
[7] In its 88 page Notice of Allegation (NOA) dated January 18, 2006, Apotex made numerous allegations which can generally be regrouped as follows:
i) the patents were improperly listed and/or their claims were irrelevant;
ii) the patents would not be infringed if the NOC applied for was issued to Apotex for its Apo-pantoprazole tablets;
iii) the patents are invalid based on various grounds which included ambiguity, claims too broad, lack of sound prediction, anticipation, obviousness, etc...
[8] This application was filed on March 9, 2006. It is the first application in respect of this drug and these particular patents to be heard on the merits.
[9] After the filing of the evidence (12 affiants for Altana and 9 for Apotex)[2] and the cross examination of most of those affiants, the issues were narrowed down but still required a five-day hearing.
[10] The parties provided useful compendia of the relevant evidence; both advised the Court that all the evidence relevant to the issues still to be determined were included therein. Nevertheless, the Court did review all of the experts’ affidavits as well as the cross-examination transcripts relevant to infringement and the eligibility issues.
[11] For the reasons that follow, the Court found that the application must be dismissed because the applicants have failed to establish that Apotex’ allegations of non-infringement are not justified.
I. Background and Drug Chemistry
[12] By way of background information, the pantoprazole compound[3] at issue in these proceedings and the medicinal use(s) to which it has been put warrant brief comments. [This information, as related in the passages below, is not contested by the parties.]
[13] The term “ulcer” describes an open sore or lesion in the tissue of the body. Gastric ulcers affect the stomach, while duodenal ulcers affect the duodenum, which is part of the small intestine. Such ulcers are both included in the more general description of peptic ulcers, a term often used in the medical literature.
[14] Pantoprazole is a member of a benzimidazole class of compounds. It is a potent gastric acid inhibitor or “anti-secretory agent”, which came into wide use as a medicine in the treatment of gastric and duodenal ulcers in the early 1990s, initially in the German market. The medical literature describes pantoprazole as a proton-pump inhibitor (PPI), with reference to its mechanism of action; the drug interferes with the secretion of gastric acid from the parietal cells of the stomach, where gastric acid is produced, to the stomach itself. It accomplishes this by inhibiting the enzyme which acts as the “pump”, H+, K+-ATPase. Other PPIs which function similarly include the benzimidazoles, omeprazole and lansoprazole, both of which have been the subject of NOC proceedings before this Court. See for example Abbott Laboratories Ltd. v. Canada (Minister of Health), 2006 FC 1411, [2006] F.C.J. No. 1766 (QL); AstraZeneca AB v. Apotex Inc., 2007 FC 268, [2007] F.C.J. No. 933 (QL); AB Hassle v. Genpharm Inc. 2003 FC 1443, [2003] F.C.J. No. 1910 (QL). The first PPI on the market was omeprazole. This benzimidazole class which includes omeprazole was discovered around 1979 and that particular compound came to the market in the late 80’s.
[15] Up until the mid-1980s, prevailing medical wisdom held that the stomach was an essentially sterile environment, owing to its acidity. Excess acid and factors such as diet or smoking were thought to be the causes of gastric and duodenal ulcers. Accordingly, such ulcers were treated with acid inhibitors, namely histamine-2 receptor antagonists, which interfere with the formation of acid in the gastric parietal cells, and later with the more potent PPIs.
[16] This conventional wisdom was first put into doubt by Drs. Warren and Marshall (the latter of whom provided expert testimony on behalf of the applicants in these proceedings) in the June 4, 1983 issue of The Lancet, wherein they posited a link between diseases of the gastrointestinal tract with the presence of bacteria. In 1984, the positive results of a follow-up study were published in the same journal.
[17] The bacteria observed by Warren and Marshall was then known as Campylobacter Pylori but was later renamed Helicobacter Pylori (Hp). Over the next decade, additional research by Marshall and Warren and others in the field provided stronger evidence of a link between gastrointestinal ulcers and the presence of Hp, such that by the early to mid-1990’s a pathogenic association between the two was generally recognized by gastroenterologists and medical doctors. In 2005, Warren and Marshall shared a Nobel Prize in recognition of their discovery of Hp and its pathogenic relation to gastritis and gastrointestinal ulcers.
[18] In his affidavit evidence introduced by Altana, Dr. Joerg Senn-Bilfinger, a senior Altana researcher named as a co-inventor on the European patent corresponding to the '694 Patent at issue in these proceedings, relates that by 1989 it was understood how Hp managed to thrive in the acidic environment of the stomach. The bacterium contains an enzyme which catalyzes the transformation of urea in stomach acid into ammonia; ammonia so formed provides the bacterium with a neutral microenvironment, sheltering “the bug” from the surrounding gastric acid. This much is not disputed by Apotex’ witness Dr. Howden[4] (who otherwise disagrees with Senn-Bilfinger over sound prediction).
[19] With the discovery of Hp and the mounting evidence of its relation to gastrointestinal ulcers, beginning in the mid-1980s researchers in the field turned their attention to the development of treatment regimes which would directly combat Hp infection, alongside PPI or Histamine-2 inhibiting acid suppressant regimens.[5] This meant a new focus on antimicrobial agents and various combinations thereof. The numerous prior art documents at issue in these proceedings speak to the intensity of research activity in the field at the relevant time, providing some context for the '694 and '758 Patents.
[20] Today, it appears to be generally accepted that the best method of treating an asymptomatic Hp infection or an Hp positive gastric or duodenal ulcer is to eradicate Hp by means of a combination therapy, be it so-called bismuth triple therapy[6], bismuth quadruple therapy (i.e., bismuth and antibiotics) or a PPI triple therapy (i.e., a PPI plus two antibiotics)[7].
[21] Not all gastric and duodenal ulcers are caused or exacerbated by Hp infections. The parties agree however that the majority of such ulcers not associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) are Hp associated. There is some conflicting evidence as to the exact percentage in question. Solvay claims that 70-90% of gastric ulcers and 90 % of duodenal ulcers not associated with NSAIDs are associated with Hp, while Apotex puts the numbers at 50% and 60% respectively. Obviously, the exact numbers are not decisive of anything at issue here. There is also some evidence that the number of Hp associated ulcers is diminishing in developed countries such as Canada. On the other hand, there may be an increase of NSAID-associated ulcers, given the increased use of such NSAIDs by an aging population. There is also some evidence of an increase of peptic ulcers not associated with Hp or NSAIDs. Again, this is merely part of the context and is not determinative of any of the issues here.
[22] There is no evidence before the Court as to the comparative size of the group of ulcers associated with the use of NSAIDs versus ulcers associated with Hp infection or other diseases. There is little evidence before the Court on the relative frequency of prescriptions for triple therapy which include pantoprazole for ulcers associated with Hp infection versus those for pantoprazole alone, either for the treatment of NSAID associated ulcers or for other gastrointestinal diseases where a reduction of gastric secretion is indicated, such as GERD, reflux esophagitis (see other indications listed in the Pantoloc product monograph).
[23] The Court notes however that Apotex’ expert Mr. Brown indicated during his cross-examination that at least in Manitoba[8], where all prescriptions are included in a central database (the Drug Program Information Network), his impression was that the vast majority of prescriptions written for Pantoloc or pantoprazole sodium were for the drug alone and not as an element of a triple therapy regime, meaning that the drug was prescribed most often for indications such as GERD and reflux esophagitis, which do not require Hp eradication. (see Mr. Brown’s comments at questions 55-67, and 182-187 of the cross-examination transcript). This appears to be in line with the evidence referred to in Abbott Laboratories Ltd. v. Canada (Minister of Health) (2006) 55 C.P.R (4th) 48, where Justice von Finckenstein was dealing with an application relating to lansoprazole, another PPI used in triple therapy for the treatment of ulcers and other gastrointestinal disorders. In that case, Abbott had produced evidence in respect of the actual use of its lansoprazole product (Prevacid) which indicated that the compound was sold for various uses in the following percentages: (a) GERD 52%, (b) Dyspepsia/Heartburn 29%, (c) Peptic Ulcer 4% (presumably Abbott included here gastric and duodenal ulcers not associated with NSAIDs), (d) NSAID-induced ulcer 3%, (e) others 12 %. Again, this information is not determinative of any of the issues here, but it certainly puts them in proper context.
II. Construction of the Relevant Claims
[24] Before considering the allegations with respect to eligibility, infringement or invalidity, the Court is required to construe the patent at issue from the perspective of a person skilled in the art when it first became public. The principles applicable to such construction are clear. They were enunciated by the Supreme Court of Canada in Whirlpool v. Camco Inc. 2000 SCC 67, [2000] 2 S.C.R. 1067 and Free World Trust v. Électro Santé Inc. 2000 SCC 66, [2000] 2 S.C.R. 1024. Those principles are also discussed in Pfizer Canada Inc. v. Canada (Minister of Health) (2005) 46 C.P.R. (4th) 244 at paras. 29 to 48, and more recently in Eli Lilly Canada v. Apotex Inc., 2008 FC 142, [2008] F.C.J. No. 171 (QL), at paras. 25 -33.
[25] There was a broad consensus between the parties’ respective experts that the nominal person skilled in the art whose perspective the Court should adopt for purposes of construction would be either a gastroenterologist or infectious diseases specialist, or a general practitioner knowledgeable about ulcers, Hp, and gastrointestinal disorders (see paragraph 8 of Altana’s Memorandum and paragraph 14 of Apotex’). Drs. Fennerty and Marshall also remarked that some of the information in the patents, particularly in the ‘694 patent, would be addressed to drug formulators; this was also the position of Drs. Hopfenberg and McGinity, themselves formulators.
A. The '748 Patent
[26] The '748 Patent was published on March 5, 1992. Several of the parties’ experts commented on the construction of claims 15 and 16, particularly Drs. Graham and Thompson for Apotex, and Drs. Marshall, Wolman and Fennerty for Altana. These claims read as follows:
15. Use of the pharmaceutical composition defined in any one of claims 1-14 for the regulation of a gastrointestinal disorder.
16. Use of the pharmaceutical composition defined in any one of claims 1-14 for treating duodenal or gastric ulcer relapse.
[27] Having considered this evidence and reviewed the patent as a whole, the Court must decide, as a matter of law, on its correct construction. The pharmaceutical compositions[9] described in claims 1-14 all include two essential elements: pantoprazole or a pharmaceutically acceptable sort thereof and a Helicobacter-inhibiting antimicrobial agent (HIAMA).
[28] HIAMA is a term defined in the patent disclosure as a natural, synthetic, or semi-synthetic compound or mixture thereof which is effective in eradicating Hp organisms. There is no dispute that when this term is used in the claim it may include a combination of more than one antimicrobial agent.
[29] The only other essential element in claim 15 is that such compositions be used for the regulation of a gastrointestinal disorder.
[30] Although the word “gastrointestinal disorder” is not particularly qualified or restricted in claim 15, the Court agrees with the applicants' experts that it would be understood by a person skilled in the art to refer to those disorders caused or exacerbated by Hp[10] and the secretion of gastric acid. At the hearing, Apotex agreed that, for the purpose of this proceeding, that is the construction that should be adopted by the Court.
[31] The word “regulation” in claim 15 is not a term of art; it thus had no special meaning for a person skilled in the art at the relevant time. According to the Canadian Oxford Dictionary, the verb “regulate” in this context would normally be taken to denote the “keeping of a biological function regular” or “the maintenance of health.” It is evident that to various degrees, most of the experts struggled with the term. The difficulty here arises from the fact that this word is juxtaposed with the phrase “gastrointestinal disorder” and is not used at all in the disclosure, which refers rather to the “treatment” or “prevention” of gastrointestinal disorders.
[32] Despite this, all experts were required to approach the term’s construction with a mind willing to understand. The Court agrees with the statement of Justice Roger Hughes in Pfizer Canada Inc. et al v. Minister of Health et al., 2005 FC 1725, (2006), 46 C.P.R. (4th) 244, at para. 53, that ambiguity is a conclusion of last resort.
[33] Having examined the evidence of each of the experts (see, for example, the evidence collected under Tabs 2 and 3 of Apotex' Compendium and the evidence on patent construction in the Applicant's Compendium at Tabs 23, 24, and 25) the Court concludes that in context, “regulation” means the treatment of gastrointestinal disorder through the combined action of pantoprazole acting as an anti-secretory PPI[11], and a HIAMA defined by its ability to eradicate[12] Hp.
[34] With respect to claim 16, it refers to the same compositions described in claims 1 to 14, and thus contains the first two essential elements of claim 15. Its third essential element lies in the use of those compositions for the treatment of gastric or duodenal ulcer relapse.
[35] The experts are in agreement that “treatment” in that claim necessarily involves the eradication of Hp. Considering that the compositions in question are said to lower the relapse rate observed by treatment with pantoprazole alone, the Court is satisfied that here, “treatment” of relapse in fact means or refers to the “prevention” of relapse, given that the actual treatment of the gastrointestinal disorder itself (which includes gastric and duodenal ulcers), be it a first time occurrence or the result of relapse, is already covered in claim 15.
[36] As is the case with respect to claim 15 (paragraph 30 above), the Court prefers Altana’s evidence and finds that duodenal and gastric ulcer relapse in claim 16 would also be read as limited to those ulcers caused or exacerbated by Hp, as it was affirmed by Drs. Fennerty and Marshall (see tab 20 of the applicant’s compendium).
B. The '694 Patent
[37] The relevant claims are claims 3, 6 and 13, which read as follows:
3. Drug formulation containing 5-difluoromethoxy-2-[3,4-dimethoxy-2-pyridyl)methylsulphinyl]-1H-benzimidazole or a pharmaceutically tolerated salt thereof simultaneously in a form which is resistant to gastric juice and in a form which is not resistant to gastric juice.
6. A Helicobacter bacteria treatment oral composition comprising 5-difluoromethoxy-2-[3,4-dimethoxy-2-yridyl)methylsulphinyl]-1H-benzimidazole or a pharmaceutically tolerated salt thereof, together with a pharmaceutically acceptable carrier.
13. A Helicobacter pylori treatment oral composition comprising 5-difluoromethoxy-2-[3,4-dimethoxy-2-yridyl)methylsulphinyl]-1H-benzimidazole sodium, together with a pharmaceutically acceptable carrier.
[38] It is not disputed that claim 3 has the following three essential elements:
(1) a formulation containing pantoprazole; (2) the formulation being designated to be partially not resistant to gastric juice; (3) the formulation also being partially resistant to gastric juice.
[39] All experts agree that there is no limitation on claim 3 to a specific use of those compositions.
[40] With respect to claims 6 and 13, it is not disputed that the essential elements of the claims are:
(1) a formulation of pantoprazole;
(2) for use as an antimicrobial;
(3) to treat Hp infections and diseases arising therefrom.
The parties are also agreed that these use claims (Shell Oil type claims) cover all formulations of pantoprazole, even those entirely resistant to gastric acid. It is not disputed that that the word “comprising” means “including,” Thus, such formulations could include other medicinal ingredients. In fact, the disclosure, at the first paragraph of page 5, provides for the use of pantoprazole with other antimicrobials (non-essential elements).
Eligibility for listing on the patent register
[41] As a preliminary matter, it should be noted that the Regulations applicable here are the “old” ones, as they stood prior to the modifications which came into force on October 5, 2006. It should also be noted that this case does not raise any issue of timing with respect to eligibility.
[42] Apotex states that as recently illustrated in Abbot Laboratories v. Canada 2006 FC 1588, at paras. 116-134, affirmed 2006 FCA 187, paras. 32-45, Pfizer Canada Inc. v. Apotex Inc., (2005) 43 C.P.R. (4th) 81 at para. 169-178, Astra Zeneca A.B. v. Apotex Inc. (2007) 60 C.P.R. (4th) 199 at para. 106, patent claims that are either ineligible or irrelevant to a second person's submission cannot provide the basis for a prohibition order. Thus, the issue can and should be considered by the judge hearing the application filed pursuant to subsection 6(1) whether or not the second person has filed a motion pursuant to subsection 6(5) of the Regulations.
[43] In its Notice of Allegation (NOA), which was filed before the Supreme Court of Canada issued its decision in AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49, [2006] S.C.J. No. 49 (QL), Apotex included most of the arguments it now raises in respect of the eligibility or relevance of the '748 and '694 patents, namely:
a. with respect to the '748 patent
(i) the patent contains no claim for the medicine contained in Pantoloc or Apo-pantoprazole, as the patent covers only combinations of pantoprazole and HIAMA;
(ii) no NOC has been issued for the use of pantoprazole sodium in a 20mg dosage strength for the combination therapy covered by the '748 patent;
(iii) claims 15-16 are not relevant to Apotex's Abbreviated New Drug Submission (ANDS), as Apotex only seeks bio-equivalence with the 40 mg tablet of Pantaloc used for monotherapy. It is thus not working the patented invention disclosed in the '748 patent (non-application of subsection 5(1) of the Regulations.)
b. with respect to the '694 patent
(i) the patented invention is for new oral drug forms (partly non-resistant to gastric juice), whereas no NOC was issued for such forms to Altana[13]. Apotex does not compare its product to a product on the market that embodies this patented invention. It is not early working the invention, as required for the application of subsection 5(1) of the Regulations.
(ii) claims 3, 6 and 13 are irrelevant to Apotex's ANDS as no NOC was issued for a formulation covered by claim 3 and/or for Pantaloc as an anti-microbial. This is particularly true with respect to the 20 mg dosage strength of Pantoloc, against which Altana now says the '694 patent was listed in 2003 (pursuant to submission no. 087266).
[44] In its application, Altana took the position that the Court has no jurisdiction to deal with such issues because they are not relevant to the grounds enumerated at subsection 5(1)(b) of the Regulations which, in its view, are the only grounds that can be addressed in the NOA. Also, the legislator has provided at subsection 6(5) for a specific remedy to deal with such issues because, among other things, of the different burden of proof that applies to them. Altana notes that, as the applicant, it has the burden of establishing that the allegations in the NOA are not justified, whereas it is Apotex that has the burden of establishing that these patents should not have been listed; this is why these arguments must be raised by way of a distinct motion which will also allow for the filing of evidence by Altana in response of Apotex’ evidence.
[45] At the hearing, Altana was asked to respond more specifically to the substance of Apotex' arguments.
[46] With respect to Apotex’ argument that it is not early working either patented invention and that therefore, subsection 5(1) of the Regulations would not apply at all to the proposed Apo-pantoprazole, Altana submits that this argument does not accord with the Supreme Court of Canada decision in AstraZeneca as construed in Ferring Inc. v. Minister of Health 2007 FC 300, (2007) 55 C.P.R. (4th) 271 at page 299, affirmed 2007 FCA 264, 2007 F.C.J. No. 1138 (F.C.A.) (QL). According to Altana, in Ferring the Federal Court of Appeal confirmed that a second person must address all patents listed before the filing date of its ANDS (in this case, September 9, 2005). There is no dispute that here the '748 and '694 patents had been listed against NOCs issued for Pantoloc prior to that date.
[47] Secondly, Altana argues that the application of the early working requirement discussed in AstraZeneca and Ferring applies only to claims for the medicine itself. It would be inconsistent to apply them to use claims, given that pursuant to section C.08.002.1 of the Food and Drug Regulations, a generic filing an ANDS need only show bioequivalence of its drug to the reference product, and is not required to practice the use claimed as part of its submission.
[48] Finally, Altana argues that in serving its NOA, Apotex has acquiesced to the Minister's decision requiring it to address the '748 and '694 patents pursuant to subsection 5 (1) of the Regulations. Thus, Apotex should have raised its objections via an application for judicial review of the Minister's decision, as indeed it did in Court file T-2100-07.
[49] Insofar as the eligibility of the '748 patent is concerned, Altana submits that there is an appropriate link between the NOC issued for its 40 mg tablets on March 10, 2000 (pursuant to submission no. 55738) and that, as noted by the Minister of Health in his letter dated July 30, 2007, the '748 patent is eligible for listing as the combination covered by said patent is expressly set out in the approved indications for Pantaloc, and the patent allows for the separate administration of the other active ingredients (the HIAMAs).
[50] Furthermore, the '694 patent was properly listed in respect of the NOC issued on October 15, 2003 (pursuant to submission no. 087266), for the use of PANTALOC 20 mg tablets in the prevention of ulcers induced by NSAID in patients with a need for continuous NSAID therapy and having an increased risk of developing gastrointestinal damage, because a person at "increased risk" would be understood to include a reference to Hp infection.
[51] Once the patents are properly listed, it is Altana’s position that Apotex is required to address them for all dosage strengths (40 and 20 mg), as dosage strength is irrelevant to the Regulations unless there is some restriction in that respect to be found in the claims of the patents themselves, which is not the case here.
[52] In response to the jurisdictional issue raised by Altana, Apotex replied that even accepting that it has the burden of proof with respect to eligibility and relevance, Altana had full notice of its position and had an opportunity to file all of its evidence, as was done by first persons in those cases mentioned above at paragraph 33, where the Court actually dealt with those issues without the generics having made a motion under section 6(5)(a).
Jurisdiction to consider eligibility in the absence of a motion under 6(5)(a)
[53] The Court will start its analysis by noting that Apotex’ NOA was filed long before the Supreme Court of Canada decision in AstraZeneca and the Federal Court of Appeal decisions in Ferring and Wyeth Canada v. Ratiopharm Inc., 20076 FCA 264, [2007] F.C.J. No. 1062 (QL). As indicated in paragraph 63 of Ferring (trial decision), at that time there was no mechanism in place to determine whether or not a generic manufacturer was required to address any particular listed patent. Thus, the Court does not accept Altana's argument that Apotex had acquiesced to anything by filing its NOA. There is no evidence before me as to whether the Minister would have agreed to the use of the new mechanism put in place sometime after November 2006, because by then, the present application had already been filed.
[54] That said, having reviewed the three cases cited by Apotex (see paragraph 41 above), the Court is not satisfied that either this Court or the Federal Court of Appeal have in point of fact indicated that the eligibility of a patent for listing or early working issues (the application of paragraph 5(1)) may be decided as a matter of law on the sole basis of an application made pursuant to subsection 6(1) of the Regulations, in the absence of a motion under subsection 6(5). The relevant passage in Astrazeneca was clearly in obiter, while that in the Pfizer case was arguably so, considering that it was not incorporated into Justice Mosley’s actual conclusions in that case, at paragraph 179.
[55] Certainly, the Federal Court of Appeal, when reviewing Justice Elizabeth Heneghan's decision in Abbott Laboratories, above, at paragraphs 44-45, appears to have carefully refrained from dealing with the issue of eligibility, opting to confirm the application judge's decision on the basis that she was correct in finding that there was no relevant claim for a medicine or use of a medicine before her, i.e., no relevant claim against which to assess the validity of the allegation per subparagraph 5(1)(b)(4) of the Regulations (see paragraphs 66 and 67, below).
[56] The Court was initially attracted to the view that the filing of a motion under subsection 6(5) of the Regulations was more in the nature of a procedural vehicle for the quick dismissal of applications rather than a matter of substance and jurisdiction, if the application for prohibition was filed in response to a NOA that expressly included the second person’s arguments on eligibility, such that the first person would have a full opportunity to know the case to meet and to file evidence in response. (In that respect, the Court notes that except for the letter of the Minister dated July 30, 2007, there is no indication that Altana sought and was refused the opportunity to file reply evidence pertaining to the patents’ eligibility for listing, as nothing of the sort was discussed in Prothonotary Tabib's decision of June 15, 2007, or in Justice Pierre Blais’ Order of August 28, 2007, 2007 FC 857). Moreover, costs could normally be used to discourage second persons from raising listing in the application itself, given that the filing of a subsection 6(5) motion early in the process is the only way to avoid useless prohibition proceedings, as was noted by the Federal Court of Appeal in Wyeth at paragraph 39.
[57] However, on a closer review of the wording of subsection 5(1), it appears that the legislator, although clearly aware that the propriety of a patent’s listing could become contentious (he included subsection 6(5)), did not leave any room for the addition of allegations other than those listed there[14]. Indeed it would change the nature of an application under subsection 6(1) if the first person had to deal with issues that are left to the whim of the author of the NOA. The sequence normally applicable to the filing of evidence is already difficult. It would become almost impossible to manage if new issues involving a different burden of proof could be added.
[58] In fact, the reasoning of the Federal Court of Appeal in Apotex v. Canada (Minister of Health), (2000) 3 C.P.R. (4th) (F.C.A.) 1, where it was held that a generic manufacturer cannot by means of a judicial review obtain an order forcing the Minister to remove an improperly listed patent, was to the effect that the Regulations provide a comprehensive scheme, albeit an imperfect one, which includes a specific process to deal with improperly listed patents, that is, the filing of a motion pursuant to subsection 6(5). In addition, with the inclusion paragraph 6(10)(b), the legislator provided for potential awards of costs having regard to the improper listing of a patent, to say nothing of the possibility of seeking damages pursuant to section 8 of the Regulations.
[59] Recently, the Federal Court of Appeal reiterated in Wyeth, at paragraph 34, that a generic drug manufacturer may initially be required to address every patent listed, even those that are improperly listed, and that the possibility to contest an improper listing by way of a paragraph 6(5)(a) motion does not arise until a prohibition application has been commenced.
[60] At paragraph 36, the Court in Wyeth also stated:
A motion under paragraph 6(5)(a) is not analogous to a motion for summary judgment or a motion to strike proceedings, and cannot be governed by the principle from David Bull Laboratories (Canada) Inc. v. Pharmacia Inc., [1995] 1 F.C. 588 (F.C.A.) that an application normally will not be struck out on a motion before the hearing. The purpose of a paragraph 6(5)(a) motion is to remove from consideration in a prohibition application any patent or patents that should not have been listed. That purpose can be achieved only if the motion is made and dealt with prior to the hearing on the merits of the application.
Indeed, a motion under paragraph 6(5)(a) cannot be assimilated to a motion for summary judgment or a motion to strike because it doesn't broach the questions normally at issue in the application itself. This is why it should normally be dealt with prior to the hearing on the merits of the application, although as indicated by Prothonotary Tabib in her order in file T-738-06 dated October 24, 2007, this cannot always be achieved or accommodated.
[61] With respect to the early working arguments and the application of paragraph 5(1)(b), the Court cannot accept Apotex' proposition that AstraZeneca stands for a wider proposition than the one submitted by Altana. Apotex referred the Court to paragraph 57 of Ferring (trial decision), which cites para.39 of AstraZeneca. However, the arguments raised by Novopharm before Justice Roger Hughes and the Federal Court of Appeal in Ferring were essentially the same as those raised here (see para. 111 of the trial decision), with the difference that they arose in part because the innovator had listed its patent for new uses after the filing of the ANDS but in respect of NOCs issued prior to that filing. Even if Novopharm argued that it was clearly not making use of the patented invention (the new use was not even listed when they filed their ANDS) and no NOC had been issued to the innovator for that use, Justice Hughes was nevertheless clear that it was still required of them to file an NOA, as they were subject to paragraph 5(1)(b). To come to that conclusion, he again specifically quoted, at para. 112, the passage from Astrazeneca relied upon by Apotex here.[15] The Federal Court of Appeal affirmed this decision on this point. On the basis of these decisions, the Court finds that Apotex had no choice but to file its NOA and to address the issues specifically listed at subsection 5(1) of the Regulations.
[62] The difficulty here is that the cumulative conditions (especially the last one) for the application of paragraph 5(1)(b) set out in Ferring, at para. 59, call for a review of the relationship between the patent list and the NOC pursuant to which the comparator drug has been marketed in Canada.
[63] Had the matter arisen after the Minister instituted the patent list review initiated after AstraZeneca and the Wyeth decisions, the latter might have decided that the '694 patent could not be listed at all, or that the '748 patent could only be listed against the March 10, 2000 NOC (submission no. 055738) applicable to the 40 mg tablet only.
[64] But this is not what happened and there is no mechanism in the Regulations that enables the Court to decide such issues outside of judicial review proceedings.
[65] Altana argues that these issues are akin to eligibility issues, and must be decided as part of the subsection 6(5) motion. I agree.
[66] Thus, in light of the above, the Court concludes that it has no jurisdiction to consider eligibility issues (section 4) or the early working issues. However, as mentioned above, pursuant to subparagraph 5(1)(b)(iv), the Court must consider whether the claims that are still at issue in respect of infringement are claims for the medicine itself or for the use of the medicine because as mentioned, these are the only relevant claims that need to be addressed in the NOA and which can justify a prohibition order if Apotex’ allegations of non-infringement are not justified.
[67] In this particular case, Apotex did not allege in its NOA that claims 15 and 16[16] were irrelevant and need not be addressed because they were not claims for the medicine itself or the use of the medicine in Pantoloc, the only comparative drug used as reference for the purpose of demonstrating bioequivalence. In the absence of such allegations, the Court cannot consider this argument. With respect to the ‘694 Patent, Apotex’s allegations in respect of irrelevant claims at pages 53 and 54 of its NOA deal only with claim 3[17], presumably because it is quite obvious that claims 6 and 13 are Shell Oil type claims intended to cover a particular use of pantoprazole.
[68] Having considered claim 3, the Court finds that indeed it is not a claim for pantoprazole or pantoprazole sodium or its use. However, this finding is not determinative in this case, because as it is explained hereinafter (at paragraphs 204-222) , even if the Court were to accept that claim 3 is a relevant claim for the purpose of subparagraph 5(1)(b)(iv), Altana has not established that the allegations of non-infringement in Apotex’ NOA in respect of this claim are not justified.
Eligibility issues
[69] Normally I would not say more in respect of eligibility issues, but here Apotex has three recent decisions in which those issues were decided by the application judges, without the second persons having filed motions under subsection 6(5) of the Regulations. It is trite law that jurisdiction is a matter of law reviewable on the standard of correctness. It would therefore be appropriate to add some comments on the merits of the issue, in the event that I am wrong in finding that the Court has no jurisdiction to review them.
[70] The relevant NOCs and the patents listed against them are as follow:
40 mg Tablets
Submission No.
and Date
NOC Issue Date
Reason for Supplement
Used to list
748 patent
Used to list
694 patent
055738
April 9, 1998
March 10, 2000
New Indication: In combination with appropriate antibiotics, eradication of H.pylori infection associated with an active duodenal ulcer
Yes
Yes
057926
August 31, 1998
March 10, 2000
New Indication: Maintenance treatment of patients with reflux esophagitis
No
No
066552
April 20, 2000
March 2, 2001
New Indication: Treatment of symptomatic gastro-esophageal reflux disease (GERD) such as acid regurgitation and heartburn
Yes
Yes
20 mg Tablets
057926
August 31, 1998
March 10, 2000
New Indication: Maintenance treatment of patients with reflux esophagitis
Yes
Yes
087266
Sept 22, 2003
October 15, 2003
New Indication: Prevention of gastrointestinal lesions induced by non-steroidal anti-inflammatory drugs in patients with a need for continuous NSAID therapy
Yes
Yes
[71] As noted, for their listing to be valid, first there must be a relationship between the patented invention described in the '748 and '694 patents and the various NOCs or the particular NOC against which they were listed (AstraZeneca, para. 39; Wyeth Canada v. Ratiopharm Inc., [2007] F.C.J. No. 462 (at para. 22), affirmed [2007] F.C.J. No. 1062 (at para. 29).
a) The Patented Inventions
[72] To define the patented invention the Court must, as indicated by the Supreme Court of Canada in Bristol-Myers Squibb Co. v. Canada (Attorney General), [2005] 1 S.C.R. 533 (Biolyse) at para. 52, look at the whole of the patent, not only the claims (Wyeth (trial decision), at paragraph 21).
[73] Having considered the disclosure of the '748 patent as well as all of its claims, the Court is satisfied that the patented invention is a novel pharmaceutical composition combining pantoprazole or