Apotex Inc. v. Canada (Health)

Apotex Inc. v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2009-07-15
Neutral citation
2009 FC 721
File numbers
T-2100-07
Decision Content
Federal Court
Cour fédérale
Date: 20090715
Docket: T-2100-07
Citation: 2009 FC 721
Ottawa, Ontario, July 15, 2009
PRESENT: The Honourable Mr. Justice Beaudry
BETWEEN:
APOTEX INC.
Applicant
and
THE MINISTER OF HEALTH and
ASTRAZENECA CANADA INC.
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1] This is an application for judicial review, pursuant to section 18.1 of the Federal Courts Act, R.S.C., 1985, c. F-7, by Apotex Inc. in respect of the refusal of the Respondent, the Minister of Health, to process Apotex’s Supplementary New Drug Submission (SANDS) seeking to change the Product Monograph for its Apo-Omeprazole 20 mg capsules to add an indication for the use of the capsules in combination with antibiotics for the eradication of H. pylori, in accordance with Part C of the Food and Drug Regulations, C.R.C., c. 870. Specifically, the Applicant seeks orders in the nature of declaration and mandamus.
Factual Background
[2] The Applicant, Apotex Inc., is an Ontario drug company who produces and distributes a variety of pharmaceutical products. Most of Apotex’s drug products are termed “generic” in the sense that they are formulations of active medicinal ingredients which have already been brought to market by other manufacturers companies in Canada. Apotex’s products are approved for sale by the Minister as therapeutically equivalent to the original brand formulation of the same active medicinal ingredient.
[3] The Respondent AstraZeneca Canada Inc. received the original Notice of Compliance (NOC) for its 20 mg Omeprazole capsules, known under the brand name LOSEC, on June 13, 1989. Eight patents were listed on the patent register under the Patented Medicines (Notice of Compliance) Regulations (SOR/93-133, as amended SOR/98-166, SOR/99-379, SOR/2006-242 and SOR/2008-211) (PM (NOC) Regulations) in respect of the Canadian reference product LOSEC 20 mg capsules: Canadian Patents Nos. 1,292,693 (the ‘693 patent), 1,302,891 (the ‘891 patent), 2,025,668 (the ‘668 patent), 2,133, 762 (the ‘762 patent), 1,338,377 (the ‘377 patent), 2,180,535 (the ‘535 patent), 2,186,037 (the ‘037 patent) and 2,284,470 (the ‘470 patent).
[4] On January 27, 2004, the Minister issued a NOC to Apotex in respect of submission 054341 for 20 mg Apo-Omeprazole capsules based, in part, upon a bioequivalence comparison to Respondent AstraZeneca’s brand name LOSEC 20 mg capsules. On January 4, 2006, the Minister issued a revised NOC, to reflect that AstraZeneca’s drug LOSEC 20 mg served as the Canadian reference product against which Apotex made the comparisons to demonstrate bioequivalence.
[5] In obtaining this NOC, Apotex was required to address the patents listed by serving a Notice of Allegation (NOA) in respect of each patent, pursuant to the PM (NOC) Regulations. Apotex was exempted by the Court from addressing the ‘037 patent and the ‘470 patent because the PM (NOC) Regulations were not applicable, as confirmed by the Supreme Court of Canada in AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49, [2006] 2 S.C.R. 560.
[6] In respect of the remaining NOAs, Apotex was successful in prohibition proceedings commenced by AstraZeneca in five cases (regarding the ‘668 patent, the ‘762 patent, the ‘693 patent, the ‘891 patent and the ‘377 patent). In respect of the sixth, the ‘535 patent, AstraZeneca did not commence a proceeding in response to the NOA. In respect of the ‘668 and the ‘762 patents, Apotex alleged non-infringement and asserted that it would not use, make or sell its product for the uses claimed by the two patents.
[7] On April 21, 2005, Apotex filed a supplemental submission (SANDS), supplement 098243, with the Minister, seeking approval for a proposed change to its Product Monograph for Apo-Omeprazole 20 mg capsules to add an indication for the use of the capsules in combination with antibiotics for the eradication of H. pylori.
[8] There were eight patents listed on the register in respect of LOSEC 20 mg capsules at the time Apotex filed its SANDS. These were the same patents which were on the register at the time that Apotex obtained its NOC for Apo-Omeprazole 20 mg capsules.
[9] Regarding its SANDS, Apotex did no further bioequivalence studies, acquired no further LOSEC 20 mg capsules and made no changes to its original submission which had led to obtaining its NOC in 2004, except that the SANDS now sought the additional indication previously omitted by which the ‘668 and ‘762 patents were attracted.
[10] Because Apotex sought approval for the additional indication, thereby attracting the ‘668 and ‘762 patents, Apotex served a NOA in respect of these two patents, alleging invalidity of the patents in order to be able to make, use and sell its Apo-Omeprazole 20 mg capsules for the patented use. A prohibition application was commenced in court file no. T-985-05 before this Court, which was dismissed by Justice Barnes on June 28, 2007 (AstraZeneca AB v. Apotex Inc., 2007 FC 688, 314 F.T.R. 177).
[11] By letter dated April 28, 2005, the Minister’s officials notified Apotex that its SANDS had been transmitted for review. On July 6, 2005, Apotex was informed by letter that the examination of the supplement was complete and that the NOC would not be issued until the requirements of the PM (NOC) Regulations were met. The supplement was accordingly placed on “patent hold” on that date.
[12] In correspondence with the Office of Patented Medicines and Liaison (OPML) starting in June 2007, Apotex requested immediate issuance of the NOC on the basis of the decision in Court file no. T-985-05. Apotex argued that the remaining patents are not relevant to its SANDS, that they did not use the subject matter of any of the patents in relation to the supplemental submission, and that the patents had been addressed in relation to the NOC issued previously.
[13] The Declaration Re: Patent List (Form V) which Apotex had filed with the supplement indicated its acceptance that the NOC would not issue until the declared expiration date of each patent, so the OPML requested updated Form Vs and corresponding NOAs and proofs of service for each of the eight listed patents. Apotex then filed updated Form V’s with respect to all of the patents, alleging invalidity and/or non-infringement.
[14] By letter in response dated August 15, 2007, the OPML agreed that the ‘668 and ‘762 patents (and the ‘535 patent, not in issue in this application) no longer barred issuance of a NOC. However, Apotex was required to address all of the remaining patents listed on the register in respect of LOSEC 20 mg capsules pursuant to section 5 of the PM (NOC) Regulations (the ‘693, ‘891, ‘377, ‘037 and ‘470 patents). The OPML applied its approach in light of the Supreme Court of Canada’s decision in AstraZeneca, above, followed in Ferring Inc. v. Canada (Minister of Health), 2007 FC 300, [2008] 1 F.C.R. 19 (F.C.), aff’d 2007 FCA 276, 370 N.R. 263. The Minister indicated that the OPML was “not in a position to determine whether an allegation in respect of a particular patent is justified for the purpose of section 5. Rather, such determinations are to be made by the Federal Court.”
[15] By letter dated August 27, 2007, Apotex disputed the OPML’s reasoning, arguing that it was contrary to the decisions of the Supreme Court of Canada in Bristol-Myers Squibb Co. v. Canada (Attorney General), 2005 SCC 26, [2005] 1 S.C.R. 533 (Biolyse) and AstraZeneca, above. Apotex argued that the OPML should compare the subject matter of the patents to that of the generic submission, determine whether they are relevant to one another and, if they are not, exempt the submission from compliance with the PM (NOC) Regulations. Apotex repeated that the patents had bee addressed in its original submission, therefore they did not have to be addressed again in relation to its SANDS.
[16] By letter dated November 26, 2007, the OPML distinguished the decisions in Biolyse and AstraZeneca, maintained the view that the OPML is not in a position to determine whether there has been early-working or infringement of a given patent and repeated that the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, SOR/2006-242 (the October 5, 2006 Amended Regulations) applied. In summary, the OPML considered that Apotex was required to fulfill the requirements of section 5 of the PM (NOC) Regulations in respect of the ‘693, ‘891, ‘377, ‘037 and ‘470 patents.
[17] This application for judicial review was commenced on December 3, 2007. AstraZeneca Canada Inc., as the innovator in respect of the patents at issue, sought to be added as a Respondent and was added, on consent, by order dated April 24, 2008.
[18] According to its Notice of Application, Apotex is not seeking judicial review of the Minister’s refusal to process its SANDS. Rather, Apotex states that it is seeking orders in the nature of declaration and mandamus.
Legislative Framework
[19] The relevant legislative provisions are contained in Appendix A at the end of this document.
[20] In Canada, the sale of pharmaceutical products is subject to both federal and provincial regulatory control. In order to sell and to advertise for the sale of a new drug in Canada, every drug manufacturer must obtain a Notice of Compliance (NOC) for that drug from the Minister pursuant to the provisions of the Food and Drugs Act, R.S., 1985, c. F-27 and the Food and Drug Regulations.
[21] Section C.08.004 of the Food and Drug Regulations directs that a drug manufacturer may obtain a NOC in respect of a new drug only after submitting a New Drug Submission (NDS), filed by an innovative drug manufacturer for a new drug product, or an Abbreviated New Drug Submission (ANDS), filed by a generic company that claims its product is bioequivalent to a drug that has been previously approved (a Canadian reference product). A Canadian reference product is a drug in respect of which a NOC has been granted and is marketed in Canada (section C.08.001.1 of the Food and Drug Regulations).
[22] An ANDS usually contains voluminous clinical trial data and detailed studies and pursuant to section C.08.002 of the Food and Drug Regulations, it must include descriptions of the benefits claimed, the adverse reactions experienced, the chemical composition of the ingredients and the methods of manufacture and purification, all in sufficient detail to enable the Minister to assess the safety and effectiveness of the new drug. The examination process then conducted by the Minister can take several years (Biolyse, above at paras. 13-15).
[23] With an ANDS, a generic company must satisfy the Minister that its generic copy of a Canadian reference product is safe and effective by comparing the two products to show that they are bioequivalent (section C.08.002.1 of the Food and Drug Regulations). The generic drug must be the pharmaceutical equivalent of the Canadian reference product (section C.08.001.01 of the Food and Drug Regulations), meaning that in comparison with the Canadian reference product, the generic drug contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but does not necessarily contain the same non-medicinal ingredients.
[24] The properties, claims, indications, conditions of use, and any other information that may be required for the optimal, safe, and effective use of a drug are described in a document called a Product Monograph. For a generic drug, the conditions of use must fall within the conditions of use of the Canadian reference product (paragraph C.08.002.1 (1)(d), Food and Drug Regulations). Thus, a generic company is required to rely on the information contained in the Product Monograph for the Canadian reference product.
[25] After a NOC has issued, any significant changes to the drug (or to the information regarding the drug contained in the previous submission) are made by filing a supplement to the NDS or ANDS (SNDS or SANDS). The supplement must also receive a NOC before the modified drug may be marketed (section C.08.003 of the Food and Drug Regulations).
[26] The addition of a new use for a generic drug requires such a supplemental submission (subparagraph C.08.003 (2)(h)(iii) of the Food and Drug Regulations). However, when a generic drug company files a supplemental submission seeking approval for a new use, it is not required to include material to re-establish bioequivalence with the Canadian reference product. Rather, the establishment of bioequivalence that was originally required for the approval of the generic’s underlying submission is considered to remain effective.
[27] The PM (NOC) Regulations were enacted by the Governor in Council pursuant to subsection 55.2(4) of the Patent Act, R.S., 1985, c. P-4. For the determination of whether a drug is safe and effective, a submission enters into the drug review process conducted by the Therapeutic Products Directorate (TPD) at Health Canada. In the case of an NDS, if the Minister is satisfied that the submission demonstrates the safety and effectiveness of the drug, a NOC is issued. In the case of an ANDS, a final patent check is performed by the OPML. If the NOC would be issuable but for the operation of the PM (NOC) Regulations, the drug’s sponsor is so notified. The submission is then placed on “patent hold”, with no NOC issued until all the requirements under the PM (NOC) Regulations have been met. On the other hand, if the PM (NOC) Regulations present no bar, the NOC is issued forthwith. In other words, even where a generic drug has been found to be safe and effective, the Minister may not issue a NOC where prohibited by the patent-related concerns set out in the PM (NOC) Regulations.
[28] A generic company seeking a NOC on the basis of a comparison with or reference to another drug for the purpose of demonstrating bioequivalence triggers the application of subsection 5(1) of the PM (NOC) Regulations as enacted in 2006, such that the generic company is required, in its submission, to address patents listed on the patent register in respect of the other drug.
[29] According to subsection 5(2) as enacted in 2006, the same requirements apply where a generic company files a SANDS where that supplement seeks a NOC for a change in formulation, a change in dosage form or a change in use of the medicinal ingredient. Under the 2006 Amending Regulations, subsection 5(2) applies explicitly to a generic company who has filed its SANDS prior to October 5, 2006.
[30] If patents listed in respect of the innovator’s drug are to be addressed under section 5, the generic company proceeds as follows: It either states its acceptance that a NOC will not issue until each patent expires or makes an allegation, of which the most common are that the patent is invalid and that the patent will not be infringed. In practice, the generic company provides this information by filing out a “Form V: Declaration Re: Patent List” (Form V) with the submission. If it makes an allegation, the generic company also provides a notice of allegation (NOA) to the innovator, describing its allegation. A submission requiring a Form V is considered incomplete without one, as section 5 specifies that the generic company must address all relevant patents in the submission. An incomplete submission cannot enter into the drug review process until the generic company completes it by filing the requisite Form V. If the submission is complete, it enters into the drug review process without delay.
[31] A generic company who makes an allegation must then serve a notice of allegation on the innovator under subsection 5(3) of the PM (NOC) Regulations. Within 45 days after service, an innovator may, under section 6, apply to the Federal Court for an order prohibiting the Minister from issuing a NOC until after the expiration of the patent that is the subject of the allegation.
Issue
[32] The issue to be determined in the case at bar is the following: should this application be allowed? If the answer is in the affirmative, what is the appropriate relief?
Analysis
Standard of Review
[33] Questions concerning the interpretation of the PM (NOC) Regulations are questions of law, reviewable upon a standard of correctness (AstraZeneca, above at para. 25; Bayer Healthcare AG v. Sandoz Canada Inc., 2008 FCA 25, 375 N.R. 357 at para. 12).
Applicant’s Submissions
[34] In seeking approval of its SANDS, Apotex took steps to re-address two patents on the patent register which related to the use of Omeprazole 20 mg capsules in combination with antibiotics. The Minister agrees that Apotex has done so satisfactorily pursuant to the PM (NOC) Regulations. There is no dispute that Apotex has satisfactorily addressed the ‘668, ‘762 and ‘535 patents. The only issue at bar is whether the PM (NOC) Regulations require Apotex to re-address the remaining five patents on the patent register.
[35] The Applicant submits that the other patents on the register have no relevance to the change proposed in the SANDS and, as such, are not required to be re-addressed because they have already been addressed in the initial submission. Apotex filed no new bioequivalence studies in its SANDS but instead, it relies upon the old comparisons it had made in obtaining its NOC. Furthermore, Apotex does not seek to make any changes to its Omeprazole 20 mg capsules which could possibly change its product in a manner which would attract these patents.
[36] In obtaining its original NOC, Apotex had addressed the remaining five patents and their SANDS is based upon this NOC. The Apotex SANDS at bar is not a new submission as it is a supplement to a submission which has already been approved and the underlying NOC met the requirements of the PM (NOC) Regulations in addressing all of the remaining patents.
[37] Apotex submits that the PM (NOC) Regulations do not require it to re-address that which it has already addressed provided that there is no change in its SANDS requiring the patents to be re-addressed. There is no proposed change in Apotex’s SANDS which could possibly attract the remaining patents.
[38] The Minister’s position is that he is neither required nor able to turn his mind to that issue but the jurisprudence shows that the Minister’s position is incorrect. Had the Minister completed his obligations under the PM (NOC) Regulations, he would have granted Apotex its NOC. The Minister erred in interpreting Apotex’s position as asking the Minister to determine whether or not any particular allegation is justified because Apotex never asked the Minister to do that. Instead, the Applicant asked the Minister to confirm that, pursuant to the PM (NOC) Regulations, Apotex was not required to re-address the five remaining patents as they had already been addressed in obtaining the initial NOC, which is the role of the Minister under the PM (NOC) Regulations.
[39] This Court and the Federal Court of Appeal have held that a generic company who has already served a NOA in respect of a ANDS is not required to re-address those patents previously addressed when filing a SANDS. In a situation involving strikingly similar circumstances, a generic company who had already served a NOA in respect of a ANDS was not required to re-address those patents when filing a SANDS where the Minister determined that no new patent issues could prevent the issuance of an NOC. The Courts further held that the Minister has the authority and the responsibility to make that determination (see Patented Medicines (Notice of Compliance) Regulations (Re) (1998), 152 F.T.R. 262, 81 A.C.W.S. (3d) 874 (F.C.T.D.), aff’d. (1999), 249 N.R. 110, 92 A.C.W.S. (3d) 1064 (F.C.A.) at paras. 13-16 and 28-29 (Re Patented Medicines)). In recent jurisprudence, this Court and the Federal Court of Appeal have confirmed the Minister’s authority to determine whether particular patents do not need to be addressed by generic companies (Ferring, above at paras. 63-65).
Respondent Minister’s Submissions
[40] The Respondent Minister of Health submits that Apotex has overlooked subsection 5(2) of the PM (NOC) Regulations, as enacted in October 2006, which explicitly invokes the application of the PM (NOC) Regulations in relation to a SANDS. In addition, Apotex’s claim that it did not use the subject matter of the patents in relation to the supplement amounts to an allegation of infringement. Under the PM (NOC) Regulations, the innovator of the drug copied by Apotex is entitled either to make that determination itself or have it determined by the Court and not by the Minister.
[41] Apotex first argues that it has previously addressed the patents in its original submission which contained the bioequivalence studies; therefore, they should not have to do so again. However, this entirely disregards the provisions of subsection 5(2) of the PM (NOC) Regulations, enacted October 5, 2006, which provides that a SANDS like Apotex’s triggers the application of the PM (NOC) Regulations in the same way as the ANDS itself does.
[42] Apotex’s supplement is one of the types explicitly referred to in the provision, as it is a submission seeking a NOC for a change in use. Moreover, the 2006 Amending Regulations at section 7(2) make subsection 5(2) of the PM (NOC Regulations even more plainly applicable to Apotex’s SANDS.
[43] The Minister argues that the decision in Re Patented Medicines, above, is of no assistance to Apotex because it was based on earlier versions of the PM (NOC) Regulations which did not include the current subsection 5(2). Accordingly, Apotex’s argument does not apply here and pursuant to subsection 5(2) of the PM (NOC) Regulations, the fact that Apotex has previously addressed the patents at issue, in the context of its original submission, does not exempt it from doing so in respect of its supplement.
[44] In its second argument, Apotex states that the Minister must determine that the new use is not the subject of the patents at issue, and accordingly, he must process the submission without regard to the PM (NOC) Regulations. Apotex says that the Minister must compare the subject matter of the patents at issue to the subject matter of its SANDS in order to determine that one is not relevant to the other and to exempt the submission from compliance with the PM (NOC) Regulations. To support this argument, Apotex cites the decisions in AstraZeneca, Ferring and Re Patented Medicines. However, the Respondent Minister submits that those cases involved different facts and different reasoning which do not apply to the facts in the case at bar or to the current legislative context. Furthermore, the responsibility for the determination that Apotex ascribes to the Minister is actually within the mandate given not to the Minister by the Governor in Council but to the Court.
[45] In deciding AstraZeneca and Ferring, the Courts developed and applied the notion of a “patent-specific analysis” to conclude that a generic company is not always required to address every patent listed against a drug it seeks to copy. However, these cases required the analysis of issues of timing and not of issues of subject matter. In AstraZeneca, different versions of the innovator’s drug were available on the market at different times and the Supreme Court held that the generic company was not required to address patents that had been listed in respect of the version of the innovator drug that was available only after the generic company had conducted its comparative tests. In Ferring, the Minister applied the timing test described in AstraZeneca and in three of the four instances comprised in the Ferring case, did not require the generic companies to address such patents and issued NOCs to them.
[46] In Novopharm v. Sanofi-Aventis, Court file no. T-2220-06, one of the cases contained in the Ferring decision (see Ferring, above at paras. 111 and 117), the generic company had argued, as Apotex does here, that the Minister should have applied not only a timing test, but also a test involving a comparison of the subject matter of the patents to the subject matter of the submission. The Minister refused to do so and this Court upheld that decision. Even in AstraZeneca, the Supreme Court recognized that if the timing test had not exempted the generic company, the patents would at least have to be addressed. However, in AstraZeneca and in Ferring, the Court did not, as stated by Apotex, extend the Minister’s responsibilities to include any test involving a subject matter comparison between the innovator’s patent and the generic’s submission.
[47] AstraZeneca’s timing test has been superseded by the 2006 Amending Regulations. Prior to the decision, under the legislative provisions at issue in AstraZeneca, a generic company was required to address all patents listed by an innovator against the Canadian reference product, including any listed between the time the generic filed its ANDS and the issuance of the NOC. The application of AstraZeneca’s timing test in cases to which the 2006 Amending Regulations apply is thus neither necessary nor appropriate.
[48] The Respondent Minister specifies that the comparison of the subject matter of the patent to that of Apotex’s submission is to be made by the Court and not by the Minister. The comparison may first be made by the innovator who may decide that its patent will not be infringed and choose not to initiate an application under section 6 of the PM (NOC) Regulations upon receipt of Apotex’s allegations. If it does choose to do so, the Court will determine whether Apotex’s allegation that the innovator’s patent will not be infringed is justified. In other words, the question that Apotex says should be determined in its favour by the Minister is the kind of question that the Governor in Council has directed to be determined in the Court proceeding resulting from the right granted to an innovator in section 6 of the PM (NOC) Regulations.
[49] The Respondent Minister notes that in Apotex Inc. v. Canada (Attorney General), [1994] 1 F.C. 742, (C.A.) aff’d [1994] 3 S.C.R. 1100, the Applicant sought an Order requiring the Minister of Health to issue a NOC for one of its drugs. The Court reviewed some 50 years of jurisprudence and ruled that, as affirmed by the Supreme Court, that “several principal requirements must be satisfied before mandamus will issue”, and articulated those requirements. The law has been clearly established for many years that the Court will not issue an order of mandamus unless the Applicant first shows that it satisfies certain specific requirements as conditions precedent. The most fundamental of these requirements may be summarized as such: the Applicant must show that it has a clear right to the performance of a public legal duty owed to the Applicant at the time of the hearing.
[50] Here, Apotex seeks orders requiring the Minister to process its submission immediately, and an order requiring the Minister to “prioritize” the review of its supplement “on the basis of a filing date of April 21, 2005”. However, Apotex has presented neither evidence nor argument to show that it has satisfied the conditions precedent established by the jurisprudence.
Respondent’s AstraZeneca’s Submissions
[51] It is trite law that the words of an Act and Regulations are to be read in their entire context and in their grammatical and ordinary sense harmoniously with the scheme of the Act, the object of the Act and the intention of Parliament (AstraZeneca, above at para. 26). The duty of the courts is to give effect to the intention of the legislature as expressed in the words of the statute. This follows from the constitutional doctrine of the supremacy of the legislature when acting within its legislative powers. The fact that the words would give an unreasonable result when interpreted, however, is certainly ground for the courts to scrutinize a statute carefully to make abundantly certain that those words are not susceptible of another interpretation (Barton No-till Disk Inc. v. Dutch Industries Ltd., 2003 FCA 121, [2003] 4 F.C. 67 at para. 41).
[52] Apotex submits that the Minister has misconstrued the PM (NOC) Regulations but fails to put forth any arguments relating to the applicable provisions. The Respondent AstraZeneca respectfully submits that the Minister was correct to apply subsection 5(2) of the currently enacted PM (NOC) Regulations, specifically by virtue of subsection 7(2) of the 2006 Amending Regulations.
[53] Because Apotex’s SANDS was filed on April 21, 2005, subsection 5(2) of the PM (NOC) Regulations, as currently enacted, is applicable because this subsection is triggered when the supplement seeks approval for a “change in use” of the medicinal ingredient pursuant to section C.08.003(2)(h)(iii) of the Food and Drug Regulations, as in the case of Apotex’s supplement, which seeks approval for a new use of Apo-Omeprazole for the eradication of H. pylori.
[54] According to the plain and ordinary terms of subsection 5(2), which states that Apotex shall make the requisite statement or allegation with respect to each patent on the register as of October 5, 2006 in respect of AstraZeneca’s LOSEC 20 mg capsules in its SANDS, the Minister’s decision was correct.
[55] The Supreme Court of Canada has accepted that the general purpose of the PM (NOC) Regulations is to protect the rights of patentees by preventing generic companies from marketing their products until the expiry of all relevant patents. The Supreme Court has stated that: “It seems clear that the NOC Regulations were introduced to help generic drug companies and at the same time curb potential patent abuse by them.” (Biolyse, above at paras. 45-47).
[56] If a generic company is not required to address a patent, the innovator will not have the opportunity to determine in Court whether the generic company will infringe their patent when they market their product. The requirement to make an allegation under section 5 is therefore critical to the protection of the innovator’s patent rights. When a generic company relying on an innovator’s drug files a SANDS related to a change in formulation, a change in dosage form or a change in use, because these are substantive submissions that have the potential to bear on patent infringement, this triggers a reasonable presumption that the generic company has early-worked the invention and therefore must address the patents on the patent register.
[57] The Respondent AstraZeneca submits that the PM (NOC) Regulations cannot bear the interpretation urged by Apotex because by reading the text of subsection 5(2) in its context, mindful of the scheme and object of the PM (NOC) Regulations and the intention of Parliament, the grammatical and ordinary sense of the words does not lead to the absurd result suggested by Apotex. The interpretation of subsection 5(2) urged by Apotex would require a fundamental re-writing of the provision. Parliament wanted section 5 of the PM (NOC) Regulations to mirror the structure of section 4; therefore, it had compared the language of the two provisions. Yet, Parliament specifically chose not to include the language of subsection 4(3) in subsection 5(2) of the PM (NOC) Regulations.
[58] Requiring a generic company to address, in its SANDS, patents that may have been addressed in its initial submissions was contemplated by Parliament in drafting the 2006 Amending Regulations. These amendments include a provision (section 4.1) which allows innovators to carry forward patent lists submitted in relation to a NDS by resubmitting them in relation to a supplement to that NDS. In contrast to the language of section 5 of the PM (NOC) Regulations prior to October 5, 2006, subsections 5(1) and 5(2) now expressly provide that the comparison to the innovator drug may occur “directly or indirectly”. In addition, the previous language that the comparison or reference be “for the purpose of establishing bioequivalence” was removed. Following this amendment, a change in use of the medicinal ingredient is now included as a triggering circumstance in subsection 5(2), notwithstanding that further bioequivalence studies are not required for such supplements.
[59] Apotex’s arguments that the supplement is based upon the original NOC and is not a new submission, that without the underlying submission the SANDS could not be applied for or approved, and that no bioequivalence studies were filed in the supplement, improperly disregard the entire scheme of the PM (NOC) Regulations. The PM (NOC) Regulations expressly treat a supplement for a new use as a separate and distinct trigger of a generic company’s obligations.
[60] The filing of a SANDS for a change in formulation, a change in dosage form or a change in use of the medicinal ingredient creates a reasonable presumption that the submission may bear on patent infringement. Therefore, it would not be absurd to require a patent to be addressed in relation to such a supplement even if the patent was addressed in relation to the original submission. Furthermore, paragraph 6(5)(b) provides for a summary dismissal of a proceeding “on the ground that it is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process in respect of one or more patents”. Thus, the generic company has recourse if it believes that an application has no merit. An innovator would not have the opportunity to make submissions if such a determination would be made by the Minister alone pursuant to subsection 5(2).
[61] The Respondent AstraZeneca submits that the only authority relied upon by Apotex, Re Patented Medicines, does not apply to the present circumstances because that decision was based on the PM (NOC) Regulations as originally enacted in 1993, which did not include subsection 5(2).
[62] Furthermore, AstraZeneca agrees with the Minister that a consideration of whether Apotex has early-worked or infringed the patents at issue falls outside the scope of what is required of the Minister under the PM (NOC) Regulations and is a consideration for the innovator, who can then refer the matter to the Court pursuant to section 6 of the PM (NOC) Regulations. If the Minister was required to review every SANDS filed by a generic company to consider whether it is relevant to the subject matter of each patent, this would have been mentioned in the legislative scheme.
[63] Apotex’s interpretation of the PM (NOC) Regulations reads in a relevance requirement into subsection 5(2), linking the subject matter of the listed patents and the generic company’s drug submission. However, this Court has affirmed, following the patent-specific analysis articulated by the Supreme Court in AstraZeneca under the pre-amended PM (NOC) Regulations, that a generic company would always be required to address patents listed in respect of the innovator drug before the filing of the ANDS. This analysis considers the previously listed patents purely from a timing perspective (see Ferring, above; Abbott Laboratories Limited v. Canada (Attorney General), 2008 FCA 186, 380 N.R. 40; Pharmascience Inc. v. Canada (Minister of Health), 2008 FC 922, [2008] F.C.J. No. 1135 (QL)). Similar early working arguments (including that the claims are irrelevant to Apotex’s ANDS) have been rejected by the Court on a subsequent occasion (Solvay Pharma Inc. v. Apotex Inc., 2008 FC 308, (2007), 323 F.T.R. 1 at para. 61).
[64] Under the current PM (NOC) Regulations, the requirement to address patents is now explicitly premised on timing and subsection 5(4) now limits the patents that are required to be addressed by a generic company to those listed as of the date it filed its regulatory submission or supplement, as the case may be. The further timing requirement that the generic company must have filed its submission before making an allegation will decrease the risk of a generic company avoiding a patent that would be infringed.
[65] The fact that a generic company was not required to address a patent in relation to its original submission in view of timing issues does not mean that its original product would not infringe such a patent. Indeed, regarding the ‘470 and ‘037 patents, the Supreme Court stated that there was no evidence before it either way as to infringement by Apotex (AstraZeneca, above at para. 42). Since it is premised on timing alone, section 5 of the PM (NOC) Regulations is both over and under inclusive. It is therefore not absurd that certain patents that may not ultimately be infringed are required to be addressed as this is inherent in the scheme. In the case at bar, despite Apotex’s assertions, it is not plain that there will be no infringement.
[66] Apotex’s argument that the Minister has the authority to determine whether particular patents do not need to be addressed is misguided. The issue raised by this application is not the Minister’s authority but rather the scope of the Minister’s duty in making this determination. Apotex would impose a duty upon the Minister to consider the subject matter of the listed patents and to make a comparison to Apotex’s drug submission. However, it is well established that in determining whether patents must be addressed, the Minister is acting in a purely administrative capacity. The evaluation urged by Apotex would go beyond a purely administrative role (Ferring, above at paras. 77-78).
[67] AstraZeneca submits that there is no absurdity in interpreting subsection 5(2) according to its ordinary meaning and requiring Apotex to address all of the remaining patents at issue. If, despite this, the Court is of the view that the Minister was required to determine whether the submission at issue relates to the subject matter of the patents, AstraZeneca submits that insofar as the Minister did not consider this factor and insofar as the necessary evidence is not before this Court to make such determination, the matter should be remitted back to the Minister to make such determination.
Analysis
[68] Pursuant to the PM (NOC) Regulations as they read prior to October 5, 2006, a generic drug company seeking a NOC on the basis of a comparison with or reference to an innovator’s drug for the purpose of demonstrating bioequivalence triggers the application of subsection 5(1) such that the generic company must, in the submission, address each patent on the patent register in respect of the innovator’s drug. Under the 2006 Amending Regulations, subsection 5(2) applies to a generic company who has filed a supplemental submission prior to October 5, 2006.
[69] According to subsection 5(2) of the current PM (NOC) Regulations, a generic company who files a SANDS seeking a NOC for a change in formulation, a change in dosage form or a change in use of the medicinal ingredient and the supplemental submission directly or indirectly compares the drug with, or makes reference to, another drug in respect of which patents are listed on the patent register must, in the SANDS, address each patent listed on the patent register in respect of the other drug. In all cases, when addressing the patents listed in respect of the innovator’s drug under section 5, the second person (the generic company) must either state its acceptance that a NOC will not issue until each patent expires or make an allegation. As noted by AstraZeneca in their submissions, the requirement that the comparison or reference with the innovator’s drug be for the purpose of establishing bioequivalence as been removed in the current PM (NOC) Regulations.
[70] Subsection 5(1) applies to generic company who file “a submission for a notice of compliance”. Subsection 5(2) applies to a “supplement to a submission referred to in subsection 5(1)”, whenever a generic company files a SANDS to a submission for a change in formulation, a change in dosage form or a change in use of the me