Abbott Laboratories v. Canada (Minister of Health)

Abbott Laboratories v. Canada (Minister of Health)
Court (s) Database
Federal Court Decisions
Date
2006-01-24
Neutral citation
2006 FC 69
File numbers
T-428-04
Decision Content
Date: 20060124
Docket: T-428-04
Citation: 2006 FC 69
Toronto, Ontario, January 24, 2006
PRESENT: THE HONOURABLE MR. JUSTICE CAMPBELL
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and RATIOPHARM
A DIVISION OF RATIOPHARM INC.
Respondents
REASONS FOR ORDERS AND ORDERS
[1] In the present Application under the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 ("the NOC Regulations"), Ratiopharm alleges that Abbott's patent for an "abridged" formulation of the antibacterial composition clarithromycin, being Canadian Letters Patent No. 2,393,614 ("the '614 Patent"), constitutes an attempt to "evergreen", or improperly extend, its expired patent for the older "non-abridged" formulation of clarithromycin which is marketed by Abbott under the name of BIAXIN.
[2] During the course of the oral hearing of the Application, Mr. Bloom, Counsel for Ratiopharm, at the suggestion of his colleague, Mr. Aitken, described the patent in issue as a "pine tree patent due to its distinct evergreen aroma". The serious point advanced by Mr. Bloom is based on the following statement by Justice Binnie for the Supreme Court of Canada:
It is common ground that the bargain between the patentee and the public is in the interest of both sides only if the patent owner acquires real protection in exchange for disclosure, and the public does not for its part surrender a more extended monopoly than the statutory 17 years from the date of the patent grant (now 20 years from the date of the filing of the patent application). A patentee who can "evergreen" a single invention through successive patents by the expedient of obvious or uninventive additions prolongs its monopoly beyond what the public has agreed to pay.
(Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067 at para. 37 [Whirlpool].)
As a result, Ratiopharm alleges that Abbott's abridged formulation is invalid for obviousness; that is, a person skilled in the art of composition formulation would not require an inventive step to arrive at Abbott's evergreen attempt.
[3] In response, Mr. Mason, assisted by Mr. Klee, Counsel for Abbott, vigorously contends that "evergreening" does not exist here; its patented formulation is inventive because it is more streamlined, and, thus, less costly to produce than the formulation for BIAXIN.
[4] In its Notice of Allegation ("NOA"), Ratiopharm also alleges that its formulation for clarithromycin does not infringe the patent for Abbott's abridged formulation. It is agreed that whether the patent for the abridged formulation is infringed depends on the correct construction of Claim 1 of the '614 Patent; that is, if Abbott is correct in its construction of Claim 1, it is agreed that Ratiopharm's formulation does infringe.
[5] Therefore, with respect to the '614 Patent, there are three substantive issues for determination: validity, construction, and infringement. Since a finding on validity depends upon the finding on construction, in the reasons which follow, the issues will be resolved in this order: first construction, then infringement, and lastly validity. There is, however, one preliminary issue which requires attention before the substantive issues can be decided.
I. Is the '614 Patent eligible for inclusion on the patent register?
[6] As a preliminary issue, Ratiopharm essentially argues that Abbott has no jurisdiction to bring the present Application. This issue was raised, at the last hour before the hearing of the present Application, by Ratiopharm's filing of a "Motion to Strike" requesting an order dismissing the Application pursuant to s.6(5)(a) of the NOC Regulations on the basis that the '614 Patent is not eligible for inclusion in the patent register (Court File No. T-428-04: Document 57). The Motion to Strike was argued as a preliminary element of the hearing of the present Application.
[7] The Motion itself states the following grounds upon which it is based:
1. On October 27, 2003, Abbott Laboratories, Limited submitted to the Minister a patent list (Form IV) in respect of the drug BIAXIN in film-coated tablet form in 500 mg strength containing the medicine clarithromycin. The Form IV identified Canadian Patent No. 2,393,614 (the "'614 Patent") and indicated that the patent list was filed on the basis of Supplementary New Drug Submission ("SNDS") 079097. The '614 Patent was added to the patent register on October 28, 2003.
2. By letter dated January 9, 2004, ratiopharm served on Abbott Laboratories, Limited a Notice of Allegation and Detailed Statement ("NOA") pursuant to section 5 of the Patented Medicines (Notice of Compliance) Regulations ("NOC Regulations).
3. In response to the NOA, on February 27, 2004, Abbott Laboratories and Abbott Laboratories, Limited (hereinafter referred to together as "Abbott") commenced application No. T-428-04 (the within proceeding) in the Federal Court pursuant to the NOC Regulations. The Applicants seek an order prohibiting the Minister of Health from issuing to the Respondent ratiopharm a NOC in relation to the medicine clarithromycin (ratio-clarithromycin) until after the expiry of the '614 Patent.
4. Subsections 4(1), 4(3) and 4(4) of the NOC Regulations, provide as follows:
4(1) A person who files or has filed a submission for, or has been issued, a notice of compliance in respect of a drug that contains a medicine may submit to the Minister a patent list certified in accordance with subsection (7) in respect of the drug.
(3) Subject to subsection (4), a person who submits a patent list must do so at the time the person files a submission for a notice of compliance.
4(4) A first person may, after the date of filing of a submission for a notice of compliance and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission, submit a patent list, or an amendment to an existing patent list, that includes the information referred to in subsection (2).
5. In a decision dated May 19, 2005, the Supreme Court of Canada in Bristol-Myers Squibb Co. v. Canada (Attorney General) (2005), 39 C.P.R. (4th) 449 (S.C.C.) (the "Biolyse decision") held that the word "submission" in subsection 4(1) of the NOC Regulations does not include an SNDS. As stated by the Court at paragraph 58:
The Federal Court has consistently held that the word "submission" in s. 4(1) does not include all submissions. It does not include a supplementary NDS. [emphasis in original]
6. On the basis of the Biolyse decision, SNDS 079097 is not a "submission" within the meaning of section 4 of the NOC Regulations.
The '614 Patent is not eligible for inclusion on the patent register
7. As SNDS 079097 is not a "submission" within the meaning of section 4 of the NOC Regulations, it could not properly support the listing of the '614 Patent on the patent register. Accordingly, the '614 Patent is not eligible for inclusion/listing on the patent register.
The application should be dismissed pursuant to Subsection 6(5) of the NOC regulations
8. Subsection 6(5) of the Patented Medicines (Notice of Compliance) Regulations reads as follows:
6(5) In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application
(a) if the court is satisfied that the patents at issue are not eligible for inclusion on the register or are irrelevant to the dosage form, strength and route of administration of the drug for which the second person has filed a submission for a notice of compliance; or
(b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process.
9. As the '614 Patent is not eligible for inclusion/listing on the patent register, the within application is frivolous, vexatious and an abuse of process. Accordingly, the application should be dismissed pursuant to paragraphs, 6(5)(a) and 6(5)(b) of the NOC Regulations.
(Ratiopharm's Motion to Strike)
[8] Ratiopharm's argument in support of the Motion provides the factual details being relied upon, which are not in dispute:
9. The '614 Patent had not issued at the time that Abbott filed NDS 6 HN896510. Accordingly, the '614 Patent was not eligible for listing on the patent register on the basis of NDS 6HN896510 pursuant to subsection 4(3) of the NOC Regulations. As the filing date of the application for the '614 Patent did not precede the date of filing of NDS 6HN896510, the '614 Patent was not eligible for listing on the patent register on the basis of NDS 6HN896510 pursuant to subsection 4(4) of the NOC Regulations.
10. Instead, Abbott used the vehicle of its SNDS 079097 to list the '614 Patent on the patent register pursuant to subsection 4(4) of the NOC Regulations. The July 19, 2002 filing date of the '614 Patent preceded the July 22, 2002 filing date of SNDS 079097, and the Form IV was submitted within 30 days of the September 30, 2003 issue date of the '614 Patent as required by subsection 4(4) of the NOC Regulations. The Form IV clearly indicates that the '614 Patent was being listed on the Patent Register on the basis of supplementary NDS 079097.
(Motion to Strike: Ratiopharm's Written Representations)
[9] On the basis of the factual details, Ratiopharm argues that Abbott has not complied with the strict interpretation required by the NOC Regulations:
17. The strict observation of the timing requirements of section 4 is also reflected in subsection 4(6) which reads as follows:
4(6) A person who submits a patent list must keep the list up to date but may not add a patent to an existing patent list except in accordance with subsection (4)
18. The tactic employed by Abbott to list the '614 Patent on the Patent Register does violence to the timing requirements set out in the NOC Regulations. Subsection 4(3) of the NOC Regulations provides that a person must submit a patent list at the time that the person files a submission for an NOC for that drug. Subsection 4(4) provides an exception where the patent is filed before the submission for the NOC, but issues after the submission for the NOC. In such a case, the patent can be added to the patent register within 30 days of its issuance. In either case, it is clear from the plain language of section 4 of the NOC Regulations that the intention is to limit the patents that are eligible for listing on the patent register to those which were filed before the initial new drug submission by which the patentee first sought regulatory approval to sell the drug in Canada.
19. Because the '614 Patent does not have a filing date that precedes the date of filing of Abbott's NDS No. 6HN896510 (the original new drug submission), this is not a new drug submission that could support the listing of the '614 Patent.
20. As supplementary NDS 079097 is not, on the authority of the Biolyse decision, a "submission" within the meaning of section 4 of the NOC Regulations, it could not properly support the listing of the '614 Patent on the patent register.
21. Abbott is improperly attempting to take advantage of the later filed SNDS 079097, a supplementary new drug submission, as the vehicle for the "late" listing of the '614 Patent on the patent register.
(Motion to Strike: Ratiopharm's Written Representations)
[10] Ratiopharm's argument with respect to Justice Binnie's twenty-four word statement in Biolyse is a clear attempt to change the patent registration law that exists under the NOC Regulations. The argument is based on the fundamental premise that the statement is obiter dicta, and, as such, constitutes a considered opinion that must be followed to provide new law on the registration of patents on the patent register under the NOC Regulations.
[11] For the reasons which follow, I find that Ratiopharm's argument fails because the fundamental premise upon which it is based does not exist; the statement is not obiter dicta. This conclusion is the result of an analysis of the legal context in which Justice Binnie's statement was made, with respect to the Federal Court of Appeal's interpretation of s.4 of the NOC Regulations prior to Biolyse being decided, and Justice Binnie's statement read in the full context of his decision.
A. The legal context
1. The existing law on eligibility
[12] The existing law developed by the Federal Court of Appeal with respect to the eligibility of a patent to be placed on the patent register is concisely stated in the following passage from Abbott's written submissions, amended for citation accuracy, in response to the Motion to Strike:
12. The circumstances in which a patent can be included, or "listed", on the Patent Register pursuant to Section 4 of the NOC Regulations - and the specific issue of whether a SNDS is a proper basis for doing so - is the subject of a reasoned and well-established body of law that has consistently held that an SNDS can be a proper basis to list a patent on the Patent Register:
(a) Apotex Inc. v. Canada(Minister of Health) (1999), 87 C.P.R. (3d) 271 (F.C.T.D.)
- Madam Justice McGillis first considered the question, performed a sophisticated, detailed, and purposive construction of the NOC Regulations, in context, and concluded that a SNDS is a "submission" as that word is used in Section 4 (the "Apotex Rule");
(b) Apotex Inc. v. Canada(Minister of Health)(2001), 11 C.P.R. (4th) 538 [(F.C.A.)]
- The Court of Appeal dismissed the appeal from Justice McGillis explicitly affirming that a "submission" in Section 4 includes a SNDS;
(c) Bristol-Myers Squibb Canada Inc. v. Canada(Attorney General)(2001), 10 C.P.R. (4th) 318 (F.C.T.D.)
- After mistakenly failing to add a patent to the Register within the time limits provided, BMS attempted to take advantage of the Apotex Rule to add the patent with a SNDS that made a minor change to the name of its drug (Serzone to Sezone-5HT2). On these facts, Mr. Justice Campbell gave a purposive construction to Section 4 of the NOC Regulations and held that a SNDS could not be used to add patents to the Register in a way that would circumvent the timing requirements in Section 4 itself. The scope of this exception to the Apotex Rule (the "BMS Exception") would be the subject of numerous subsequent cases.
(d) Bristol-Myers Squibb Canada Inc. v. Canada(Attorney General)(2002), 16 C.P.R. (4th) 425 [(F.C.A.)]
- On appeal, the Chief Justice wrote for the Court of Appeal affirming the existence of the BMS Exception created by Justice Campbell on purposive grounds. The Court of Appeal also confirmed that the Apotex Rule remained the law at least as far as some SNDSs (for a new use or indication) were concerned.
(e) Ferring Inc. v. Canada(Attorney General)(2003), 26 C.P.R. (4th) 155 [(F.C.A.)]
- The Federal Court clearly and explicitly re-affirmed the Apotex Rule and held that a SNDS is a submission within the meaning of Section 4; however, the Court of Appeal reversed the decision of the trial judge and applied the BMS Exception because the SNDS in question was filed as part of a "strategy to overcome the time limitations" of Section 4 (here again, a mere change of name) and could not support the listing of a patent for that reason.
(f) GlaxoSmithKline Inc. v. Apotex Inc. (2003), 29 C.P.R. (4th) 350 (F.C.T.D.)
- In relying on the Apotex Rule, Mr. Justice Russell held that a "submission" within the meaning of Section 4 of the NOC Regulations includes a SNDS.
(g) Toba Pharma Inc. v. Canada(Attorney General)(2002), 21 C.P.R. (4th) 232 (F.C.T.D.)
- In relying on and applying the BMS Exception, Mr. Justice Blais upheld that the Minister's decision not to list a patent where the strict timing requirements of section 4 was not complied with (here again, a mere change of name).
(h) Abbott Laboratories v. Canada(Minister of Health)[(2004)], 31 C.P.R. (4th) 321 at para 13 (F.C.A), rev'g 2004 FC 465 (T.D.)
- On appeal, the Chief Justice, writing for the Court of Appeal, reversed the Trial Judge and held that the SNDS in issue was a proper basis to list a patent on the Patent Register. The Court of Appeal considered both the Apotex Rule ("submission" includes SNDS) and the BMS Exception (some SNDSs are not "submissions"). Because SNDS 055754 was for a new indication, the BMS Exception did not apply and the patent was eligible.
(i) AstraZeneca Canada Inc. v. Canada(Minister of Health)(2005), 40 C.P.R. (4th) 353 at para. 50 [(F.C.A.)], rev'g (2004), 36 C.P.R. (4th) 58 [(F.C.T.D.)] ("AstraZeneca")
- In reversing the trial judge, the Court of Appeal quashed a NOC granted to Apotex on the grounds that Apotex should have addressed two patents listed on the basis of SNDSs. The Court of Appeal explicitly re- affirmed the Apotex Rule (by quoting at length from Justice McGillis's analysis). The Court of Appeal held that the BMS Exception did not apply because the submission was not "administrative". It is noteworthy that the SNDSs considered by the Court of Appeal in the AstraZeneca case were for a new use (just like SNDS 055745 in the present case) and for a new formulation (just like SNDS 079097 in the present case). Such submissions do not fall within the BMS Exception.
(j) Hoffmann-La Roche Ltd. v. Canada(Minister of Health)(2005), 40 C.P.R. (4th) 108 at para. 13-17 [(F.C.A.)], aff'g (2004), 38 C.P.R. (4th) 47 [(F.C.T.D.)]
- Hoffman-La Roche was unsuccessful in listing a patent on the Patent Register for Herceptin where the SNDS was administrative, done to reflect an additional drug manufacturing site. Just two months before the Supreme Court would release its decision in Biolyse, the Court of Appeal again explicitly affirmed the Apotex Rule but found its decision in Biolyse, the Court of Appeal again explicitly affirmed the Apotex Rule but found that the BMS Exception applied in that case because of the nature of the SNDS.
2. The issue in Biolyse
[13] Abbott argues that Biolyse has nothing to do with the eligibility of a patent to be placed on the register; the issue to be determined had to do with the correct interpretation of s.5(1.1) of the NOC Regulations. In support of this argument, Abbott supplies the following précis of the substance of the case:
20. At the outset of his decision, Justice Binnie indicated that the facts of Biolyse are important. Biolyse was a case in which an innovator (BMS) had a NOC for a drug containing the medicine paclitaxel. BMS did not invent paclitaxel and had no patent rights to the compound paclitaxel; however, BMS did have patents on the Patent Register related to its paclitaxel product.
Reference: Biolyse at para. 34.
21. Biolyse wanted a NOC for a paclitaxel product. As Justice Binnie noted, Biolyse was not a "copycat generic" seeking to obtain a NOC by comparing itself to BMS's paclitaxel product. Instead, Biolyse did its own clinical studies on sick patients to demonstrate that its paclitaxel was safe and effective. In fact, the Minister had clinical studies on sick patients to demonstrate that its paclitaxel was safe and effective. In fact, the Minister had required Biolyse to do so, and required Biolyse to file a freestanding New Drug Submission ("NDS") instead of an Abbreviated New Drug Submission ("ANDS") by way of comparison to BMS's paclitaxel product.
Reference: Biolyse at para. 31.
22. The Minister reviewed Biolyse's NDS and granted Biolyse a freestanding NOC permitting the sale of Biolyse's paclitaxel in Canada. Even though BMS had no patent rights in paclitaxel itself and Biolyse had not even compared its drug to BMS's paclitaxel product as "copycat generic", BMS nevertheless objected that Biolyse ought to have served a Notice of Allegation under the NOC Regulations.
Reference: Biolyse at para. 32 and 34.
23. The basis for BMS's position in this respect was a literal reading of Section 5 of the NOC Regulations which would have required Biolyse to give such a Notice of Allegation. However, the Supreme Court of Canada held that a purposive construction of the NOC Regulations compelled the opposite conclusion. The Supreme Court of Canada held that Biolyse did not have to give a Notice of Allegation to BMS.
Reference: Biolyse at para. 69.
(Motion to Strike: Abbott's Written Representations)
3. The sentences in Biolyse relied upon by Ratiopharm
[14] It is agreed that Ratiopharm's basic argument is that, by the two sentences used by Justice Binnie, the law as stated by the Court of Appeal will be reversed to provide that an SNDS can never result in a patent registration. In order to accomplish this result, Ratiopharm grounds its Motion to Strike on two sentences culled from paragraph 58 of Justice Binnie's decision in Biolyse, which itself is only one paragraph in a five paragraph passage of the decision as follows:
D. The Scheme of the NOC Regulations
¶ 57 The word "submission" is used in various places in the NOC Regulations. In particular, the text of s. 4(1) provides the template on which s. 5(1.1) is modelled. The relevant words in s. 4(1) are:
4. (1) A person who files or has filed a submission for, or has been issued, a notice of compliance in respect of a drug that contains a medicine ...
¶ 58 Section 4(2) permits a person who makes the "submission" to file at the same time a list of patents "that contains a claim for the medicine itself or a claim for the use of the medicine". (There is a procedure to add after-acquired patents but otherwise the deadline is enforced.) The patent list becomes the minefield that the generic "copy-cat" manufacturer must navigate to obtain a NOC. The Federal Court has consistently held that the word "submission" in s. 4(1) does not include all submissions. It does not include a supplementary NDS. (Bristol-Myers Squibb Canada Inc. v. Canada(Attorney General) (2001), 10 C.P.R. (4th) 318 (F.C.T.D.), at paras. 13, 19 and 21, affirmed (2002), 16 C.P.R. (4th) 425, 2002 FCA 32; Ferring Inc. v. Canada(Attorney General) (2003), 26 C.P.R. (4th) 155, 2003 FCA 274, at para. 18; Toba Pharma Inc. v. Canada (Attorney General) (2002), 21 C.P.R. (4th) 232, 2002 FCTD 927, at para. 34; AstraZeneca Canada Inc. v. Canada (Minister of Health) (2004), 36 C.P.R. (4th) 58, 2004 FC 736, at paras. 39-40).
¶ 59 Applying a purposive interpretation, the Federal Court in these cases held that to read "submission" in s. 4(1) to include all NDSs would allow innovator companies to sidestep the time limits applicable to patent lists by the simple expedient of submitting a supplementary New Drug Submission (SNDS) making corporate or technical changes to their filing (Bristol-Myers, at para. 19). Such a result would not be consistent with the scheme of the NOC Regulations as a whole. In my view, this purposive approach is correct.
¶ 60 The parallel words in s. 5(1.1) are:
5. (1.1) ... where a person files or has filed a submission for a notice of compliance in respect of a drug that contains a medicine ...
¶ 61 The text of s. 5(1.1) closely tracks the language of s. 4(1). It is a reciprocal provision in the sense that s. 4(1) sets up the patent list that the person subject to s. 5(1.1) must circumnavigate. Section 5(1.1) should therefore receive a similarly purposive interpretation. The word "submission" should also be construed so as to fulfill the purposes laid out in s. 55.2(4) of the Patent Act.
4. The purpose of the sentences
[15] Ratiopharm argues that Justice Binnie, in the two sentence statement, expressed obiter dicta which, since it appears in a decision by the Supreme Court of Canada, constitutes considered opinion which is binding with respect to the present Application. To be considered obiter dicta, a statement in a judgment must meet a certain test.
[16] In Celliers du Monde Inc. v. Dumont Vins & Spiritueux Inc., [1992] 2 F.C. 634 (F.C.A.) at paragraph 12, Justice Decary provides a concise meaning of the basic legal terms obiter dictum (the singular of dicta) and ratio decidendi. The latin "obiter" means "by the way, incidentally", and "dictum" means "what is said". Thus, obiter dictum is "an opinion given by a judge which is not required to support the decision he [or she] is making" and which is to be contrasted to the "ratio decidendi". The "ratio decidendi" means "the reason (or reasons) for deciding", thus "the essential reason for a judgment, the basis of the decision, is the ratio decidendi; a proposition which is not essential to the decision in the case, on the other hand, is an obiter dictum" (source : A. Mayrand, Dictionnaire de maximes et locutions latines utilisées en droit, Cowansville, Yvon Blais, 1985, at pp. 193 and 239).
[17] Thus, for a statement to be "obiter dicta", as that is the term used in the arguments in the present Application, the statement must express an "opinion" or a "proposition". In my opinion, the sentences expressed by Justice Binnie cannot be considered to meet this criterion; they are purely descriptive.
[18] Mr. Reddon, Counsel for Abbott, argues that, reading the sentences in the context of the decision as a whole, Justice Binnie's purpose was not to alter or reverse the Federal Court of Appeal's decisions with respect to the eligibility of a patent for registration, but to use the Court of Appeal's purposive interpretation of the term "submission" in s.4 of the NOC Regulations to bolster his finding that a similar interpretative approach should be used with respect to the term "submission" in s.5(1.1). I agree with this argument; a cursory review of the decision supports this conclusion.
[19] In Biolyse, at paragraph 36, Justice Binnie states that the legal issue for determination is the correct interpretation of the word "submission" in s.5(1.1), and in reaching a conclusion, he applies the following five factual factors as sections in the decision at paragraphs 39 - 64:
A. The Grammatical and Ordinary Sense of the Words;
B. The General Context;
C. The Regulation-Making Power of the Patent Act;
D. The Scheme of the NOC Regulations; and
E. The Mischief Sought to be Cured by s.5(1.1).
[Emphasis added]
[20] The fourth factor is the full passage from which the two sentences relied upon by Ratiopharm is taken. In the Motion to Strike, Ratiopharm states that, in the sentences relied upon, Justice Binnie "held" that the word "submission" in s.4(1) of the NOC Regulations does not include an SNDS (para. 5), and reiterates this point in the argument supplied with the Motion by saying that Justice Binnie "found" that a patent cannot be listed on the patent register pursuant to an SNDS (para. 11). Therefore, Ratiopharm argues that Justice Binnie expressed an "opinion" in the two sentences in question; I find that this argument is unfounded.
[21] The sentences relied upon by Ratiopharm in paragraph 58 of Biolyse are a statement of fact, the fact being the content of the decisions of the Court of Appeal which are cited, and which Justice Binnie uses to reach a conclusion on the interpretation issue before him. Therefore, I find that Ratiopharm's argument that the sentences constitute an "opinion" is contrary to the contextual meaning of the sentences.
[22] Indeed, in "Section D: The Scheme of the NOC Regulations", Justice Binnie did express an important opinion, but not the one fostered by Ratiopharm; Justice Binnie found that the interpretive approach used by the Court of Appeal in the interpretation of s.4 was correct. Thus, it seems that, by inference, Justice Binnie has acknowledged that, by using the correct approach, the Court of Appeal found the correct interpretation of the word "submission" in s.4; it can include an SNDS.
5. Features requiring clarification
[23] There are two features of the sentences relied upon by Ratiopharm which are given great weight in the "opinion" argument fostered. I find these features are incidental, and of no consequence, when each is clarified by a fair contextual reading.
[24] First, Ratiopharm argues that in paragraph 58 of Biolyse, the sentence "it does not include a supplementary NDS" should be read literally. Whether this is the proper approach depends on whether the context in which the words are used supports a literal interpretation; that is, the sentence before the words, the cases cited after, and the paragraph which follows, must all be considered.
[25] The sentence before the words reads: "The Federal Court has consistently held that the word "submission" in s.4(1) does not include all submissions". This sentence gives the reader notice that there are cases which express this certain line of reasoning. In the cases cited after the much relied on words "it does not include a supplementary NDS", the line of reasoning is stated; some SNDSs are not a "submission" as that word is used in s.4. That is, a "submission" in s.4, as Justice Binnie says in paragraph 59, does not include SNDSs which make only "corporate" or "technical" changes. Therefore, the sentence under consideration is ambiguous when read literally because it appears to be in conflict with the cases which it describes. However, in my opinion, the ambiguity is resolved when the sentence is read in context; by doing so it can be understood as saying: "It does not include a supplementary NDS [in certain circumstances]".
[26] During the course of the oral hearing of preliminary issue, Mr. Reddon provided a detailed analysis of the arguments presented to the Supreme Court in Biolyse as substantiation for another reasonable explanation for the use of the terms NDS and SNDS in Justice Bastarache's and Justice Binnie's reasons: the case was presented as if there is no difference between an NDS and an SNDS.
[27] In any event, I find that the use of the terms has no impact on the conclusion of the present analysis: apart from deciding that s.4 and s.5(1.1) of the NOC Regulations must be given a purposive interpretation, in paragraph 58 of his reasons, Justice Binnie did not express an opinion as advanced by Ratiopharm.
[28] Second, Ratiopharm argues that important meaning should be given to the inclusion of Toba Pharm Inc. v. Canada in the list of cases cited. As mentioned above, in Toba, Justice Blais applied the "BMS Exception", but just before doing so in the decision, makes the following statement at paragraph 28:
In addition, an SNDS cannot be considered an appropriate opportunity to file a patent list.
Ratiopharm argues that by simply citing Toba in paragraph 58 of Biolyse, Justice Binnie is somehow agreeing with the literal words of the statement; that is, since Toba is in the list of cases cited, it must be viewed as support for the literal non-contextual meaning placed on the words "It does not include a supplementary NDS" which precede the case list. I do not accept this conclusion as it is based on reading Justice Blais's statement in paragraph 28 out of context.
[29] The context in which paragraph 28 of Toba must be read includes paragraphs 27 to 33 as follows:
¶ 27 A patent list was filed in respect of the drug Sevoflurane (SEVORANE or SEVORANE AF). The patent list for EVOTANE would therefore have been eligible for inclusion on the register only if it had been filed within 30 days after the grant of the EVOTANE patent. This, however, was not done and accordingly the timing requirements of s. 4 of the Regulations were not met.
¶ 28 In addition, an SNDS cannot be considered an appropriate opportunity to file a patent list. The purpose here was solely to indicate a change in the manufacturer's name and product name. The filing of a patent list on the basis of a NOC for a change in the manufacturer's name and product name in accordance with the policy on Changes in Manufacturer's Name and/or Product Name (referred to in the letter dated December 18, 2001) is contrary to the scheme of s. 4, which provides only for the addition of a patent to be made within the time requirements reflected in s-ss. 4(3), 4(4) and 4(6) of the Regulations.
¶ 29 Therefore it was well within the Minister's discretion, granted to it by s-s. 3(1) of the Regulations, to refuse this means of presenting a patent list.
The applicable jurisprudence
¶ 30 The applicant has attempted to fit the specific circumstances of this case into certain broad legal concepts and interpret such concepts so as to support its position. The Court does not find this helpful, particularly in comparison to the relevant and specific case law put forward by the respondent.
¶ 31 I find the case of Bristol-Myers Squibb Canada Inc. v. Canada(Attorney General), supra, to be very instructive. In that case, Campbell J. concluded that a patent list filed with the SNDS for a change in brand name did not meet the requirements of s. 4 of the Regulations. The facts in Bristol-Myers, supra, are described as follows [from the C.P.R. headnote]:
The applicant applied for a notice of compliance for a series of tablets of differing strength containing the medicine nefazadone hydrochloride, to be sold under the brand name Serzone . . . Through inadvertence, it omitted from that list a further patent, the '436 patent. After the time limit had run out, the applicant made three attempts to have the '436 patent added to the register, each unsuccessful.
The applicant then sought registration of the '436 patent through the use of s. C.08.003 of the Food and Drug Regulations, C.R.C. 1978, c. 870. The applicant filed a supplemental new drug submission relating to a change in the name of its product from Serzone to Serzone-5HT2. It certified that only the product name differed as between the two submissions. Along with the second submission, the patentee filed a patent list including the '436 patent. The Minister issued a further notice of compliance and added the '436 patent to the patent register on the basis of s. 4(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. On further consideration, the Minister advised the patentee that the '436 patent was improperly included in the patent register in view of the express wording of s. 4(6) of the Regulations, which had been added in the amendment of 1998. The Minister fixed a date when the '436 patent would be removed from the register.
¶ 32 It is true that Bristol-Myers, supra, involved the filing of a patent list with an SNDS for change in brand name whereas the present matter involves the filing of a patent list with an SNDS for change in the manufacturer's name and product name; however, I find that the material facts on which this Court's reasoning was based in Bristol- Myers, supra, are essentially the same. Specifically, it is the issue of circumventing the time constraints imposed by s. 4 of the Regulations which is identical. On this issue, Campbell J. held:
[19] It is evident from the record that the underlying concern held by the Minister in reversing the decision to register the '436 Patent is forward looking. That is, to allow the use of Food and Drug Regulation C.08.003 by BMS in the present case would allow innovative companies to circumvent the timing requirements of NOC Regulation 4 by changing brand names in order to put patents on the Patent Register that were not there before, for which the time lines had not been complied with originally.
. . . . .
[21] I agree with the Minister's argument that to allow innovative companies to potentially add patents to the Patent Register by filing a patent list using BMS's Food and Drug Regulation C.08.003 strategy, is contrary to the specific intention of Parliament as expressed in NOC Regulation 4(6). Thus, I find that Food and Drug Regulation C.08.003 cannot be used to achieve the result pursued by BMS.
¶ 33 The applicant is of the opinion that the case of Bristol-Myers, supra, can be distinguished for several reasons, namely due to the highly specific fact situation. I find that the essence of the decision is applicable in the case at bar. Both Bristol-Myers Squibb and the applicant were attempting to avail themselves of a circuitous route with the intention of avoiding the timing requirements of the Regulations. This is not permissible.
[30] On this basis, I find that Justice Blais's statement, read in context, can be easily understood as meaning "an SNDS cannot [in certain circumstances] be considered an appropriate opportunity to file a patent list".
B. Conclusion
[31] In summary, the question to be answered is:
Is the '614 Patent eligible for inclusion on the patent register? My answer is "yes".
[32] At the request of Counsel, an order on the Motion to Strike, separate from the order on the present Application, is provided below.
II. Who has the burden of proof in an NOC Application?
[33] The Notice of Compliance ("NOC") procedure is well understood. The legislative scheme and the detailed procedures relevant to these proceedings have been explained in many cases (see for example Hoffman LaRoche v. Canada (1996), 67 C.P.R. (3d) 484 (F.C.T.D.), aff'd (1996), 70 C.P.R. (3d) 206 (F.C.A.)).
[34] According to the NOC Regulations, as the basis of the present Application, Ratiopharm served Abbott with an NOA placing in issue three considerations: the construction of the '614 Patent, whether it is infringed by Ratiopharm's formulation and whether the '614 Patent is valid.
[35] It is agreed that Abbott has the burden to prove construction and infringement on a balance of probabilities. With respect to the burden of proof on the issue of validity, given that the '614 Patent is presumed to be valid as provided in s.43(2) of the Patent Act, R.S.C. 1985, c. P-4, and given the precedents that have previously decided this question, I find that Ratiopharm has the burden to prove, on a balance of probabilities, that the '614 Patent is invalid (see AB Hassle v. Apotex Inc., [2003] F.C.J. No. 994 at paras. 23-27, 96; aff'd [2004] F.C.J. No. 1856, leave to appeal to S.C.C. refused; Procter & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health) (2004), 37 C.P.R. (4th) 289 (F.C.A.) at paras. 15-16; Abbott Laboratories v. Canada (Minister of Health) (2004), 36 C.P.R. (4th) 437 at paras. 101, 122 (F.C.T.D.); aff'd [2005] F.C.J. No. 1147 (F.C.A.)).
III. Background information about formulation
[36] As an aid to understanding the arguments with respect to claims construction, it is important to understand the basics of composition formulation.
[37] During the course of the oral hearing, Mr. Mason provided the following primer on formulation to which I have added some clarification:
A 'formulation' is simply a mixture of a drug, in this case clarithromycin, and other components [Source: Abbott's Compendium, Vol. I, Tab 1, para. 14].
Clarithromycin is the active medicinal ingredient in Biaxin. The other components are called excipients. Excipients are inert ingredients and are mixed with the drug in some fashion and manufactured into a drug product, which can be a tablet; it can be a capsule. There are a few in which the drug can be formulated, either by granulation or direct compression. Granulation, it can be dry or wet granulation.
In granulation, in some cases granules when you make them are mixed with other ingredients or excipients, what are called extra granular excipients. So you have intra-granular excipients, which is the wet mass that is produced, and the extra-granular excipient, which is a dry powdered blend which is put on the outside of the granule, which is called extra-granular. Then you take the entire mixture and compress them into tablets, if that is the route you are going to go.
The evidence is that a formulation becomes more complex when you have intra-granular and extra-granular excipients. These are sometimes referred to as locations or compartments, and there are reasons why it is sometimes necessary in a formulation to split the excipients into different locations and have some extra-granular and some intra-granular.
By contrast, direct compression, you don't have granules. Direct compression, yo