Toronto, Ontario, January 24, 2006
PRESENT: THE HONOURABLE MR. JUSTICE CAMPBELL
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
and
THE MINISTER OF HEALTH and RATIOPHARM
A DIVISION OF RATIOPHARM INC.
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, you just mix everything up and compress it into a tablet. There are no solvents. There is no water or alcohol or anything else that is used, just a dry blend that is mixed together and pressed into a tablet.
The purpose of a formulation is to ensure that the proper amount of the drug is delivered at the right time and at the proper location while maintaining the stability of the drug prior to ingestion. Most drugs you can't give to humans unless they are appropriately mixed with excipients into a dosage form.
As you can see in paragraph 22 of the excerpt, [Formulation Backgrounder, Abbott's Compendium, Vol. I, Tab 1] we have concluded here that in the second sentence:
Excipients are required because most drugs, including clarithromycin, cannot be pressed into tablets by themselves because of their unfavourable mechanical properties such as poor compressibility, poor flow, and stickiness. Excipients are also used to improve other properties of the drug such as taste, appearance and stability.
If you don't put in, for example, the right amount of a disintegrant, then the tablet won't properly dissolve in the proper area of the body. For example, if it is an immediate-released tablet [sic], you need to have a tablet that dissolves right away in the stomach, whereas if it is an extended release tablet, then you don't want a tablet that dissolves right away; rather, you want to wait until it gets to where it is supposed to go.
The excerpt we provided also talks about the different excipients and what their function is and why each of them are important in what that do [sic]. For example, it talks about a filler, a flow aid, a disintegrant, lubricant. Lubricants, they are important because on the one hand they reduce the problems with machinery to allow the mass to get through the equipment to the tablet press, but they also affect the dissolution and release of the drug once it is ingested.
Some lubricants, such as stearic acid, also serve as an emulsifying agent and a solubilizing agent. It talks about other functionalities that excipients perform, and I think the important thing to recognize here is that any particular excipient can perform more than one function, and that is a complicating factor in all of this. For example, stearic acid in paragraph 24 [Formulation Backgrounder, Abbott's Compendium, Vol. I, Tab 1], the different functions are identified.
Microcrystalline cellulose is a good example of multi-functional excipients. Microcrystalline cellulose is a diluent, a binder, a disintegrant and a lubricant, and the specific role that microcrystalline cellulose plays in a formulation may depend on how much of it you use and where you put it, i.e., whether it is an intra-granular department or the extra-granular department.
(Transcript, pp.5-9)
[38] As described below, Abbott argues that the '614 Patent is innovative because it abridges the non-abridged formulation of clarithromycin in a certain way: the same bioequivalence can be obtained with less excipients put to defined use.
IV. How should the '614 Patent be construed?
[39] The well established principles of claims construction are set out by Justice Binnie in Whirlpool:
¶ 43 The first step in a patent suit is therefore to construe the claims. Claims construction is antecedent to consideration of both validity and infringement issues.
[...]
¶ 49 [...]
(e) [...] a patent is more than just "other writing". The words of the claims are initially proposed by the applicant, but they are thereafter negotiated with the Patent Office, and in the end are accepted by the Commissioner of Patents as a correct statement of a monopoly that can properly be derived from the invention disclosed in the specification. When the patent issues, it is an enactment within the definition of "regulation" in s. 2(1) of the Interpretation Act, R.S.C., 1985, c. I-21, which says:
"regulation" includes an order, regulation, rule, rule of court, form, tariff of costs or fees, letters patent, commission, warrant, proclamation, by-law, resolution or other instrument issued, made or established
(a) in the execution of a power conferred by or under the authority of an Act, or
(b) by or under the authority of the Governor in Council;
A patent must therefore be given such interpretation according to s. 12 of the Interpretation Act "as best ensures the attainment of its objects". Intention is manifested in words, whose meaning should be respected, but words themselves occur in a context that generally provides clues to their interpretation and a safeguard against misinterpretation. [...]
[...]
(g) While "purposive construction" is a label introduced into claims construction by Catnic,supra, the approach itself is quite consistent, in my view, with what was said by Dickson J. the previous year in Consolboard, supra, on the topic of claims construction, at pp. 520-21:
We must look to the whole of the disclosure and the claims to ascertain the nature of the invention and methods of its performance, (Noranda Mines Limited v. Minerals Separation North American Corporation, [1950] S.C.R. 36), being neither benevolent nor harsh, but rather seeking a construction which is reasonable and fair to both patentee and public. There is no occasion for being too astute or technical in the matter of objections to either title or specification for, as Duff C.J.C. said, giving the judgment of the Court in Western Electric Company v. Baldwin International Radio of Canada, [1934] S.C.R. 570, at p. 574, "where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the court, as a rule, will endeavour to give effect to that construction".
[Emphasis added]
[40] The claims of a patent are to be read from the perspective of a person skilled in the art to whom the patent is addressed, and who applies his or her knowledge in the field to which the patent relates (Whirlpool at paras. 48, 52-53).
[41] Therefore, the question arises as to whether any of the four experts retained by both parties does not meet the definition of a "person skilled in the art".
V. Are each of the experts involved in the present Application a "person skilled in the art"?
[42] Both Abbott and Ratiopharm are in agreement as to the credentials of a "person skilled in the art":
22. The person skilled in the art to which the '614 patent is addressed is a person with a Bachelor of Science Degree in Chemistry, pharmacy or chemical engineering, or an equivalent degree, and who has two to five years of experience in the field of formulation, formulation analysis, drug development or a related area (the "Skilled Formulator"). The Skilled Formulator typically gains his or her experience in the employ of a pharmaceutical company.
Miller Affidavit, para 12; RR, Vol. V, Tac C, p. 1289
Amidon Affidavit, para 12, AR, Vol. II, Tab 3, p. 221
Amidon Cross-examination, p. 1398, line 10 to p. 1399, line 2; RR, Vol. VI, Tab D
(Ratiopharm's Memorandum of Fact and Law)
A. Abbott's experts
[43] The credentials of the experts retained by Abbott, Dr. Stephen Byrn and Dr. Gordon Amidon, are as follows:
35. [...]
(a) Dr. Stephen Byrn is a Ph.D. chemist, and chair of the School of
Pharmacy at Purdue University, where he teaches future formulators. Dr. Byrn was a member of the United States Pharmacopoeia (USP) sub- committee on excipients, past chair of the Pharmaceutical Sciences Advisory Committee of the US Food and Drug Administration (FDA) and has been extensively involved in reformulation work. [...]
Reference: Byrn Affidavit, AR, Vol. II, Tab 2, paras. 1-5, pp. 113-115, and Ex. "A", pp. 153-180;
Cross-examination of Stephen Byrn conducted on April 21, 2005 ("Byrn Cross"), pp. 3-4, 7, 14-15, 18, 21-23, 26-27, 33-34 (q. 11, 26, 47, 56, 65, 67, 76, 98-100);
Miller Cross, AR, Vol. III, Tab 6, p. 503 (q. 41-42)
(b) Dr. Amidon is the Charles R. Walgreen Jr. Professor of Pharmacy and Pharmaceutical Sciences in the College of Pharmacy at the University of Michigan, past president of the American Association of Pharmaceutical Scientists, and a Special Government Employee of the FDA. He has published more than 200 research papers in peer reviewed journals, co-
edited 6 books, is the co-inventor of 17 patents, and served on the Editorial Boards of many pharmaceutical journals. Dr. Amidon has also consulted widely for both innovator and generic pharmaceutical companies. [...]
Reference: Amidon Affidavit, AR, Vol. II, Tab 3, paras. 1-8, pp. 218-220;
Miller Cross, AR, Vol. III, Tab 6, p. 503 (q. 41-42)
(Abbott's Memorandum of Fact and Law)
[44] Ratiopharm does not challenge Dr. Amidon's credentials as "a skilled formulator", but does challenge those of Dr. Byrn on the basis that he is an academic:
24. Dr. Byrn is an academic known for his expertise in the field of solid state chemistry of drugs and his text entitled, "Solid State Chemistry of Drugs", which is a general treatise on this broad field. Only three pages from this textbook actually deals with the topic of formulations, one of which merely provides a definition of the term.
Byrn Affidavit, paras. 2 and 30; AR, Vol. II, Tab 2, pp. 114 and 121 and Exhibit "A" thereto
Byrn Cross-examination, p. 1506, q. 26-27; p. 1527, q. 82-83; pp. 1530-1531, q. 92; RR, Vol. VI, Tab E
25. Dr. Byrn has no practical experience in formulation science. He has never been employed by a pharmaceutical company that developed or marketed pharmaceutical products, has never personally formulated a pharmaceutical preparation and in fact has never used a pharmaceutical tablet press.
Cross-examination of Dr. Byrn, p. 1505, q. 25; pp. 1510-1511, q. 35-38; pp. 1514-1520, q. 48-58 and 61-63; RR, Vol. VI, Tab E
(Ratiopharm's Memorandum of Fact and Law)
[45] I give no weight to this argument. Ratiopharm's own expert, Dr. Miller, under cross-examination had this to say about both Dr. Byrn and Dr. Amidon:
Q [...] in the course of your work, either as a formulator or as a research researcher, have you come across the works of Dr. Stephen Byrn or Dr. Gordon Amidon?
A Yes, I have.
Q Both of them?
A Yes.
Q You'll agree that both are highly respected scientists?
A Yes, they are.
Q Well regarded in this field?
A Yes.
(Cross-Examination of Dr. Miller, Abbott's Record, Vol. III, Tab 6, p.7)
It is obvious from the context of the passage, that the "field" being described, of which Dr. Miller, Dr. Byrn, and Dr. Amidon are a part, is formulation, formulation analysis, and drug development. Indeed, in his evidence under cross-examination, Dr. Amidon stated that "solid state chemistry is part of the [formulation] development process" (Cross-Examination of Dr. Amidon, Ratiopharm's Record, Vol. VI, Tab D, p.1399, line 20), and "[a skilled formulator] could have a B.Sc. in chemistry with two to five years' experience in academe in solid state chemistry" (Cross-Examination of Dr. Amidon, Ratiopharm's Record, Vol. VI, Tab D, p.1399, line 22 - p.1400, line 2).
[46] As a result, I dismiss the credentials concern raised by Ratiopharm, and find that both Dr. Amidon and Dr. Byrn are experts with the credentials of a "skilled formulator".
B. Ratiopharm's experts
[47] The unchallenged credentials as skilled formulators of Ratiopharm's experts, Dr. Robert Miller and Dr. Peter Rue, are as follows:
Dr. Robert Miller
28. Dr. Miller has over 25 years of extensive, hands-on practical experience in formulating an API into a pharmaceutical preparation. He currently provides consulting services to the pharmaceutical industry in the areas of dosage form formulation and manufacturing process design, and was previously responsible for solid dosage product formulation and manufacturing process design at Merck Frosst, Novopharm Limited, and Stanley Pharmaceuticals. Dr. Miller has practical expertise in the development of pharmaceutical formulations and the excipients used in formulating solid dosage forms.
Miller Affidavit, paras. 1, 4-6, and 9, RR, Vol. V, Tab C, pp. 1286-1288
Cross-examination of Dr. Miller, pp. 498-499, q. 12-13; AR, Vol. III, Tab 6
Dr. Peter Rue
29. Dr. Rue has over 20 years of actual practical expertise formulating an API into a pharmaceutical preparation. Dr. Rue has worked for Beecham Pharmaceuticals, Glaxo Group Research, Core Technologies Limited, and Martindale Pharmaceuticals Limited. His entire career has been concerned with devising, developing and testing pharmaceutical preparations.
Rue Affidavit, paras 2-12; RR, Vol. V, Tab B, pp. 1228-1231
Cross-examination of Dr. Rue, p. 398, q. 9 to p. 399, q. 19 and p. 409, q. 70 to p. 420, q. 128; AR, Vol. III, Tab 5
(Ratiopharm's Memorandum of Fact and Law)
[48] Therefore, all experts are capable of offering an opinion on the construction of the '614 Patent. However, as explained below, the weight to be given to each opinion varies.
VI. What is the correct construction of the '614 Patent
A. The content of the '614 Patent
[49] It is agreed that critical features of the '614 Patent, which was added to the Patent Register on October 28, 2002, are as follows:
ANTIBACTERIAL CLARITHROMYCIN COMPOSITIONS AND
PROCESSES FOR MAKING THE SAME
FIELD OF THE INVENTION
This invention is directed to abridged clarithromycin antibacterial compositions and methods for making the same.
BACKGROUND OF THE INVENTION
Clarithromycin is employed in the manufacture of commercially-available antibiotic compositions for human administration. For example, an orally-administered antibacterial composition of clarithromycin in tablet form consists essentially of clarithromycin and a number of excipients which, in toto, control the bioavailability of the antibiotic.
The removal of one or more of these excipients from the composition to provide an abridged antibacterial composition of clarithromycin with substantially similar antibiotic activity of the clarithromycin would provide a more streamlined, less costly avenue toward commercial-availability of the drug. In addition, an abridged antibacterial composition of clarithromycin, if smaller in size or offering other advantages, would be better tolerated by patients. Therefore, there is an existing need in the formulations art for an abridged antibacterial composition of clarithromycin.
SUMMARY OF THE INVENTION
The first embodiment of this invention, therefore, is directed to an abridged antibacterial clarithromycin composition consisting essentially of clarithromycin, water, an intra-granular excipient, and an extra-granular excipient, in which the granular excipient consists essentially of povidone, sodium croscarmellose, and microcrystalline celluose, and the extra-granular excipient consists essentially of sodium croscarmellose, microcrystalline celluose, colloidal silicon dioxide, and impalpable magnesium stearate powder.
A second embodiment of this invention is directed to a process for making an abridged antibacterial clarithromycin composition,
the process comprising the steps of:
(a) granulating a mixture consisting essentially of povidone, clarithromycin, sodium croscarmellose, microcrystalline celluose, and water to provide a wet intra-granular excipient;
(b) drying the wet intra-granular excipient to provide a dry intra-granular excipient; and
(c) mixing the dry intra-granular excipient and an extra-granular excipient, the extra-granular excipient consisting essentially of sodium croscarmellose, microcrystalline celluose, colloidal silicon dioxide, and impalpable magnesium stearate powder.
A third embodiment of this invention is directed to a medicament consisting essentially of an abridged antibacterial clarithromycin composition.
A fourth embodiment of this invention is directed to use of an abridged antibacterial clarithromycin composition in the preparation of a medicament, the medicament being useful for prophylaxis or treatment of bacterial infections in a mammal.
DETAILED DESCRIPTION OF THE INVENTION
The currently commercially-available, non-abridged clarithromycin composition consists essentially of the following components: clarithromycin, colloidal silicon dioxide, D & C yellow dye No. 10, extra-granular sodium croscarmellose, extra-granular microcrystalline celluose (Avicel® PH-102), intra-granular sodium croscarmellose, intra-granular microcrystalline celluose (Avicel® PH-101), magnesium stearate powder, povidone, pre-gelatinized starch, 200 proof alcohol, stearic acid, talc, and water.
This invention is directed to abridged antibacterial clarithromycin compositions, hereinafter referred to as "abridged compositions," which contain any amount of clarithromycin and from which at least one of the aforementioned components have been omitted.
In a preferred first embodiment, the abridged compositions contain the same amount of clarithromycin which is currently available in non-abridged adult and pediatric formulations, such as, for example, 250 mg of clarithromycin or 500 mg of clarithromycin for the adult formulations and aqueous solutions comprising 125 mg per 5 mL or 250 mg per 5 mL of clarithromycin for the pediatric formulations.
In still another preferred first embodiment, the 200 proof alcohol, stearic acid, and talc have been omitted from the abridged compositions.
In still yet another preferred first embodiment, the 200 proof alcohol, stearic acid, talc pre-gelatinized starch and D & C yellow dye No. 10 have been omitted from the abridged compositions.
[ ...]
WHAT IS CLAIMED IS:
1. An abridged antibacterial composition consisting essentially of clarithromycin, water, an intra-granular excipient, and an extra-granular excipient, in which the intra-granular excipient consists essentially of povidone, sodium croscarmellose, and microcrystalline celluose, and the extra-granular excipient consists essentially of sodium croscarmellose, microcrystalline celluose, colloidal silicon dioxide, and impalpable magnesium stearate powder.
2. The composition of claim 1 in which the microcrystalline celluose of the intra-granular excipient comprises Avicel® PH-101, the microcrystalline celluose of the extra-granular excipient comprises Avicel® PH-102, and the colloidal silicon dioxide of the extra-granular excipient comprises Cab-O-Sil™ M-5.
3. The composition of claim 1 which is essentially ethanol-free
[...]
(Abbott's Record, Vol. I, Tab 1, pp.4-21)
B. The issue to be determined
[50] It is agreed the outcome of the present Application turns on the correct construction of Claim 1 of the '614 Patent. Ratiopharm's argument on the issue of construction is provided by the following allegation contained in its NOA:
Claim 1 requires an intra-granular excipient consisting essentially of povidone, sodium croscarmellose and microcrystalline cellulose. The term "consisting" is used to specify the constituent elements in the claimed combination to the exclusion of all other elements, and in particular to the exclusion of all elements that are present in the so called "non-abridged" composition described at page 2, lines 17 to 22 of the '614 Patent that are not included in the claimed combination.
[Editorial Note: page 2, lines 17 to 22 of the 614 Patent read as follows:
"The currently commercially-available, non-abridged clarithromycin composition consists essentially of the following components: clarithromycin, colloidal silicon dioxide, D & C yellow dye No. 10, extra-granular sodium croscarmellose, extra-granular microcrystalline celluose (Avicel® PH-102), intra-granular sodium croscarmellose, intra-granular microcrystalline celluose (Avicel® PH-101), magnesium stearate powder, povidone, pre-gelatinized starch, 200 proof alcohol, stearic acid, talc, and water."]
(Abbott's Record, Vol. I, Tab 1, p.24)
As a result, I find that Ratiopharm's construction argument is limited to this allegation. That is, upon developing its construction argument, and making the allegation as quoted pursuant to the NOC Regulations, Abbott has the burden to prove that only the construction argument alleged is not justified.
[51] Therefore, I find that Abbott correctly and concisely states the construction arguments in play in the present Application, and the issue for determination, as follows:
41. ratiopharm's case is that the term "consisting" is used in Claim 1 to specify the constituent elements in the "claimed combination" to the exclusion of all other elements. In other words, it alleges that "consisting essentially of" means "consisting only of" the ingredients specified in Claim 1 and no others.
42. On the other hand, Abbott's experts say that a person skilled in the art would clearly understand that the term abridged antibacterial composition and "consisting essentially of" in Claim 1 denotes a composition from which at least one of the ingredients from the non-abridged composition has been omitted and which contains all of the ingredients listed in Claim 1.
Reference: Amidon Affidavit, AR, Vol. II, Tab 3, para. 33, pp. 229-230;
Byrn Affidavit, AR, Vol. II, Tab 2, para. 36, p. 123
43. The issue therefore is whether a person skilled in the art would understand the term "consisting essentially of" in Claim 1 to mean consisting only of, as Ratiopharm argues, or whether it can include other ingredients contained in the non-abridged composition, as Abbott argues. The answer determines the issue of infringement.
[Emphasis added]
(Abbott's Memorandum of Fact and Law)
C. Abbott's construction of Claim 1 of the '614 Patent
[52] I find that Abbott has a well supported construction argument with respect to Claim 1. In my opinion, according to the interpretative standard set in Whirlpool when Claim 1 is read in the context of the patent as a whole, the inventor's intention is clearly understandable.
[53] Claim 1 of the '614 Patent uses two "terms" which require definition: "an abridged antibacterial composition" and "consisting essentially of". With respect to construing these terms Abbott relies on Minerals Separation North American Corp. v. Noranda Mines, [1947] Ex. C.R. 306 at 359 as authority for the proposition that "the specification [the disclosure and the claims] itself is the dictionary by which the scope and effect of the terms in the claims are to be ascertained, and the words should be read in the light of the inventor's definitions in the specification" (Abbott's Memorandum of Fact and Law, para. 45).
[54] The term "abridged composition" is clearly defined in the second paragraph of the "Detailed Description of the Invention" section of the '614 Patent which reads as follows:
The invention is directed to abridged antibacterial clarithromycin compositions, hereinafter referred to as "abridged compositions," which contain any amount of clarithromycin and from which at least one of the aforementioned components have been omitted.
From the context, the "aforementioned components" referred to in this description are those that constitute the non-abridged formulation.
[55] On the following evidence of Dr. Byrn I find that colour in the non-abridged formulation is irrelevant to formulating an abridged composition within the definition of "abridged composition" contained in the '614 Patent:
Regarding the removal of the color coating, as indicated above, a person skilled in the art would understand that removing the dye in the film coating would not constitute an abridgement of the composition. While D & C Yellow No. 10 is merely the dye in the film coating and acts only as a coloring agent (and could obviously and easily be substituted or omitted), a person skilled in the art would understand that removing or omitting only this ingredient would not constitute an abridged composition as claimed in the claims of the '614 Patent.
(Affidavit of Dr. Byrn, Abbott's Record, Vol. II, Tab 2, para.134)
[56] Given the definition of "abridged composition", I find that clear meaning can be given to the words of Claim 1 as argued by Abbott. That is, taking into consideration all of the ingredients of the non-abridged composition, the abridged composition must include all of the ingredients listed in Claim 1, and, with respect to those that remain to choose from, at least one is not to be included. There are thirteen ingredients in the non-abridged composition when colour is excluded. Thus, after including all nine ingredients listed in Claim 1, those that remain from the non-abridged composition to choose from are: (1) pre-gelatinized starch; (2) 200 proof alcohol (ethanol); (3) stearic acid; and (4) talc.
[57] Abbott points to Claim 3 as support for its interpretation. Claim 3 protects an abridged composition consisting of the ingredients listed in Claim 1, but which is ethanol free. By reading Claims 1 and 3 together, I agree that the interpretation of Claim 3 means that Claim 1 can include ethanol as one of the three out of four ingredients which can be "added" to those stated in Claim 1. That is, I agree that by the existence of Claim 3, the words "consisting essentially of" in Claim 1 cannot be read to mean "consisting only of".
[58] Whirlpool establishes that a purposive construction of Claim 1 must be contextual; that is, the whole of the disclosure of the '614 Patent must be considered. I agree that the following argument advanced by Abbott supports its construction of Claim 1:
51. The disclosure of the '614 Patent sets out four embodiments of the invention claimed that correspond to the claims in the patent. It is the first embodiment - the composition claims - that are relevant to this application.
Reference: Miller Cross, AR, Vol. III, Tab 6, pp. 506 and 509 (q. 58 and 74)
52. Under the heading "Detailed Description", the inventors describe a
number of "preferred embodiments" of the invention, including preferred first embodiments. One such preferred first embodiment is an abridged composition in which 200 proof alcohol, stearic acid, and talc have been omitted from the non-abridged formulation; that is, in which three, not four, components are omitted and which contains ten compounds, not just the nine listed in Claim 1.
Reference: '614 Patent, Ex. "A", Atwell Affidavit, AR, Vol. I, p. 9, line 1
53. Dr. Miller confirmed on cross examination that this preferred first embodiment would be understood by a person skilled in the art to be one way of working the invention claimed in the '614 Patent:
Q: Similarly, on the next page it talks about another preferred first embodiment. Do you see that at the top?
A: Yes.
Q: Again, that's talking about another preferred first embodiment, meaning the composition?
A: Yes.
Q: And a person skilled in the art would understand this to be another preferred first embodiment of this invention?
A: Yes.
Q: "This invention" meaning the invention claimed in the 614 Patent, correct?
A: Yes.
Reference: Miller Cross, AR, Vol. III, Tab 6, p. 511 (q. 87-90)
54. Thus, a person skilled in the art reading this patent would understand that one of the preferred embodiments of the invention is the removal of 200 proof alcohol, stearic acid, and talc. The remaining components in an abridged composition would be those listed in Claim 1 plus starch.
55. According to Ratiopharm's proposed construction, the composition covered by Claim 1 cannot contain starch because it is not specifically listed in Claim 1. Ratiopharm's construction is therefore inconsistent with one of the preferred embodiments of the invention.
(Abbott's Memorandum of Fact and Law)
[59] Further support for Abbott's construction is found in Dr. Amidon's evidence which supports Abbott's argument that a person skilled in the art would read Claims 1 and 3 in the same way as its apparent clear meaning:
The invention claimed in the '614 Patent is an abridged clarithromycin composition. The term abridged as understood by a person skilled in the art as of October 28th, 2002 would be generally understood to mean a composition which has been reduced in some way. A person skilled in the art as of the relevant date would understand the term "abridged composition," as used in the claims of the '614 Patent and the disclosure, as a composition in which at least one of the following excipients have been omitted from the non-abridged composition:
Water, povidone, intra-granular sodium croscarmellose, extra-granular sodium, croscarmellose, intra-granular microcrystalline cellulose, extra-granular microcrystalline cellulose, magnesium stearate, extra-granular colloidal silicon dioxide, pregelatinized starch, stearic acid, ethanol, or talc.
A person skilled in the art would understand the term "consisting essentially of" as used in claim 1, and the other claims of the '614 Patent, as of the relevant date, to mean that the composition contains all of the ingredients listed in the claim but it could include additional ingredients as well. A person skilled in the art, at the relevant date, would understand claim 1 to cover clarithromycin tablets which contain all of the designated ingredients [mentioned in claim 1] and which do not contain at least one of the ingredients from the list [of excipients of the non-abridged composition not included in claim 1].
A person skilled in the art, as of the relevant date, would understand the term "essentially ethanol free" as used in claim 3 of the '614 Patent to mean that there is at most an insignificant amount of ethanol in the abridged composition described in claim 1.
[Clarification and emphasis added]
(Affidavit of Dr. Amidon, Abbott's Record, Vol. II, Tab 3, paras. 32-34)
Dr. Byrn's evidence exactly parallels that of Dr. Amidon on this critical point (Affidavit of Dr. Byrn, Abbott's Record, Vol. II, Tab 2, paras. 33 - 36).
[60] In an attempt to reduce the weight to be given to Dr. Amidon's evidence, Ratiopharm raises an issue relating to what Dr. Amidon meant by his statement that the abridged formulation contains all of the ingredients listed in Claim 1 "but it could include additional ingredients as well". There are two contexts in which this phrase can be understood.
[61] First, the phrase must be read in the context of the passage in which it was used. By reading the phrase this way, I have no difficulty finding that Dr. Amidon was referring to three of the four ingredients remaining from the non-abridged composition. However, Ratiopharm refers to the phrase to open an argument that Dr. Amidon meant much more. Ratiopharm places reliance on the evidence of Dr. Miller who said the following in his affidavit:
I must say that I completely disagree with Dr. Stephen Byrn (at paragraph 35 of the Bryn [sic] Affidavit) and Dr. Gordon Amidon (at paragraph 33 of the Amidon Affidavit), wherein they express the view that the term "consisting essentially of" means that the composition contains all of the ingredients listed in the claim 1 but that it could include additional ingredients apparently without restriction. The additional ingredients could potentially add to the complexity, cost and size of the tablet. Not only would this interpretation fly in the face of the goals of the patent, it would allow for the "abridged composition" to potentially cover or even surpass the number of excipients in the Patent Disclosed Non-Abridged Formulation.
[Emphasis added]
(Affidavit of Dr. Miller, Ratiopharm's Record, Vol. V, Tab C, para. 59)
I find that Dr. Miller's interpretation of what Dr. Amidon said is taken out of context, and I give his evidence no weight.
[62] Second, the phrase must be read in the context of what Dr. Amidon said about the nature of the "additional ingredients". Ratiopharm interprets Dr. Amidon's evidence to make the following argument:
56. Having regard to the purpose of the alleged invention claimed in the '614 patent of removing excipients to provide a more streamlined and less costly formulation of clarithromycin, claim 1 of the patent must be read as being a more streamlined formulation of the Non-abridged Composition. In other words, these claims should not be read to include a composition that is more complex than the Non-abridged Composition.
57. Dr. Amidon opines that the Skilled Formulator would construe claim 1 of the '614 patent to be a composition that includes all the ingredients listed in the claim plus other additional ingredients. Dr. Amidon expresses the view that these additional ingredients could include any excipient material that was approved for human use by the Food and Drug Administration ("FDA") in amounts less or equal to those amounts approved by the FDA in its inactive ingredient list provided that at least one of the ingredients in the Non-abridged Composition was omitted. These amounts are within the usual range approved for use in humans. Dr. Amidon recognized that, in view of the way in which he expressed his opinion, claim 1 would in theory permit a number of additional ingredients to be added (up to 13) to those specifically listed in claim 1 and, "by wild extrapolation", in large quantity.
Amidon Affidavit, para 33; AR, Vol. II, Tab 3, pp. 229-230
Amidon Cross-examination, p. 1432, line 15 to p. 1442, line 10; RR, Vol. VI, Tab D
58. The construction of claim 1 advanced by Dr. Amidon would lead to a complex formulation and clearly not a more streamlined formulation of the Non-abridged Composition, and would therefore be contrary to the purpose of the alleged invention in the '614 patent. This construction must for that reason be rejected.
(Ratiopharm's Memorandum of Fact and Law)
[63] Under cross-examination by Mr. Bloom, Dr. Amidon agreed that there will most certainly be more ingredients in the abridged composition than those stated in Claim 1 of the '614 Patent, but made important qualifications with respect to their nature:
Q. Then, Dr. Amidon, would you tell me all of the possible additional ingredients that you're referring to in the first sentence of paragraph 33 and in what quantities?
A. Well, of course, I can print out the inactive ingredient list from the FDA and the GRAS list from the FDA, but I don't think you want me to do that.
Q. Just go from your recollection.
A. It could include any material. I mean, at the broadest it could include any excipient material that was approved for human use in amounts less than or equal to those amounts in the FDA's inactive ingredient list, which the FDA has published a compilation of the lists of inactive ingredients. The FDA says they're inactive, but that just means pharmacologically inactive or at least in the usual dose range. They're not inactive from the point of view of the formulation and performance and formulation process.
Q. But they potentially react within a formulation but they're regarded by the FDA as inactive?
A. The title of the publication that I'm referring to which would be the inactive ingredient list, and how - - how I interpret them, the term inactive ingredient. I'm not going to speculate what the FDA really means by that title.
[...]
Q. Are you intending to refer to more than one ingredient?
A. Yes, there could be a few ingredients. I think of additional ingredients as being less than the listed ingredients and smaller amounts, so that there might be things like waxes or dusting agents or plasticizers or something, some surfactant. If they used some polymers that are lattices, aqueous type systems, to avoid ethanol and there could be some other minor ingredients.
If they use a coloring agent, they might get a formulation of a color from FMC and it might contain three or four things. But I would start out to say that it would probably be similar or less than the number of listed ingredients.
Q. So as I look at the commercially available nonabridged clarithromycin composition I see 13 excipients. So you're saying there could be in addition - - 13 additional ingredients within the meaning of that term in paragraph 33?
A. Well - -
Q. I'm just trying to understand the magnitude of it.
A. I'm trying to be careful and answer the question. At what level, you know? What level do you want to test for things in a formulation? I mean, if you want to test to .1 percent or .001 percent, do you want to include other components from clarithromycin, from the manufacturer of clarithromycin at the .1 percent impurity level? I mean, there's lots [sic] of minor contaminants.
But let's ignore those that are minor contaminants, but then you take a coloring agent. That will often come in a formulation. You might just decide to put a latex color on it, which would be a formulation and that could contain three, four, five things, some of them like water would evaporate, but contain a plasticizer or two or three.
Yeah. I mean, there could be up 13 [sic]. I would say that would be less likely. I'm thinking when it's saying other minor, other ingredients, it would be some of the things that are part of the manufacturing process approved for use in humans but they're in lesser amounts than any of the listed ingredients.
(Cross-Examination of Dr. Amidon, Ratiopharm's Record, Vol. VI, Tab D, p.1432, line 15 to p.1433, line 13; p.1437, lines 11 to 25)
[64] Thus, Dr. Amidon is referring to what might be considered to be ingredients incidental to the abridged composition; that is, contrary to Ratiopharm's argument, they are of no consequence to the formulation claimed in the '614 Patent. Therefore, I find that Ratiopharm's argument does not give a fair reading to Dr. Amidon's evidence considered in context.
[65] As a result, I dismiss Ratiopharm's "additional ingredients" argument.
D. Ratiopharm's construction of Claim 1 of the '614 Patent
[66] In my opinion, Ratiopharm's construction argument is weak.
[67] First, the argument that the invention claimed in Claim 1 of the '614 Patent is limited to the ingredients listed in Claim 1 is literal, not contextual; I agree with Abbott that it does not take into consideration the definition provided for the term "abridged composition":
49. The meaning of abridged composition is clear. To have an abridged composition, one must omit at least one of the components of the non-abridged composition. Ratiopharm's proposed construction requires the Court to rewrite the definition of abridged composition from "omit at least one of the components" to "omit four components".
50. Ratiopharm's proposed construction is inconsistent with the definition of abridged composition in the patent.
(Abbott's Memorandum of Fact and Law)
[68] Second, Ratiopharm's support for a literal interpretation of the words "consisting essentially of" comes from American patent jurisprudence and practice. Based on this support, Ratiopharm presents the following argument:
55. The phrase "consisting essentially of" has been construed by U.S. courts to limit the scope of a patent claim to the specified materials or steps and those that do not materially affect the basic and novel characteristics of the alleged invention.
In re Herz, 537 F. 2d 549 at 551-552 (CCPC, 1976).
U.S., United States Patent and Trademark Office, Manual of Patent Examining Procedure, (Eagen, MN: West, 2004) at para. 2111.03.
(Ratiopharm's Memorandum of Fact and Law)
While Ratiopharm concedes that the American authorities are not binding in Canada, it argues that they are persuasive. When this argument was presented in the course of the oral hearing of the present Application, Mr. Mason had this to say:
[...] In construing the claim, the courts consider not only the literal meaning of its terms but also the prior art and the prosecution history of the patent.
That is how courts in the United Statesconstrue claims. It is called "literal construction." They look at the words of the claim and construe them literally with reference to extrinsic evidence.
In Canada, a court is prohibited from looking at extrinsic evidence. It is not allowed. It is in Whirlpool, and I can take you to the reference, if you like, my Lord. Justice Binnie says you are not allowed to look at extrinsic evidence to construe a Canadian patent.
(Transcript, p.503)
As a result, I find Ratiopharm's American jurisprudence and practice support for a literal interpretation is irrelevant to the claim construction issue in the present Application. Indeed, I find that Ratiopharm's literal interpretation argument has no support in Canadian law.
[69] Ratiopharm's expert evidence is also weak.
[70] For example, Dr. Rue made the following statement:
The term "consisting essentially of" in claim 1 of the '614 Patent appears as part of the phrase "abridged antibacterial composition consisting essentially of". The first part of that phrase, i.e., the term "abridged antibacterial composition", is not defined in the claim. In my opinion, the Skilled Formulator would therefore conclude that the term is used to distinguish an abridged antibacterial composition from a non-abridged antibacterial composition.
[Emphasis added]
(Affidavit of Dr. Rue, Ratiopharm's Record, Vol. V, Tab B, para. 102)
While it is true that the definition of "abridged composition" is not included in Claim 1, it is included in the "Detailed Description of the Invention". Therefore, I give no weight to this opinion expressed by Dr. Rue.
[71] Dr. Rue's opinion is that the phrase "consisting essentially of" in Claim 1 is used to distinguish an abridged composition from a non-abridged composition, however, on cross-examination, he essentially agreed with Abbott's construction of the '614 Patent. In cross-examination, Dr. Rue confirmed his opinion that a person skilled in the art would construe Claim 1 as comprising an exhaustive list of the ingredients of the abridged composition, but also agreed that "from a strictly sort of patent point of view", a reading of the second paragraph of the "Detailed Description of the Invention" conforms with Abbott's construction of Claim 1; that is, if one ingredient is removed from the non-abridged composition, the result would fall within the reading of Claim 1 (Abbott's Compendium, Vol. I, Tab. 23, p.479).
[72] When asked to explain the apparent conflict in his expert opinion, Dr. Rue said this:
[...] Yes, the inconsistency is entirely my fault.
I understood Mr. Mason to be saying, let us assume that this patent is valid and Claim 1 is valid and, therefore, if you take one out of there, does it meet Claim 1, to which my answer would be and was yes.
However, that is only on the assumption that Claim 1 is a valid claim which I simply cannot understand.
My interpretation of the patent is that in order for it to be inventive, it has to be an exhaustive list and, furthermore, it has to be in some way surprising that that exhaustive list works. In neither case do I agree.
(Abbott's Compendium, Vol. I, Tab 23, p. 482)
[73] As a result, I give no weight to Dr. Rue's construction opinion because his construction presupposes that the '614 Patent is invalid, contrary to Whirlpool which requires that claims construction is antecedent to consideration of both validity and infringement issues.
[74] In support of Ratiopharm's construction allegation contained in the NOA, in his affidavit Dr. Miller gives the expert opinion that the term "consisting essentially of" in Claim 1 leads to the conclusion that Claim 1 defines an exclusive list of ingredients in the abridged composition. However, I have two reasons for giving his opinion no weight.
[75] The following paragraphs from Dr. Miller's affidavit disclose his rationale for coming to the conclusion he has expressed:
To understand claim 1 of the '614 Patent, a Skilled Formulator would need to construe the meaning of the phrase "abridged antibacterial composition consisting essentially of". To understand claim 18 of the '614 Patent, the Skilled Formulator would have to construe the meaning of the terms "abridged antibacterial composition" and "consisting essentially of".
The term "abridged antibacterial composition" is not a term of art that would have been known to the Skilled Formulator as of October 2002. Although the Skilled Formulator would have been well familiar with the term "consisting of" in the context of a pharmaceutical formulation, the formulator would not likely have been familiar with the term "consisting essentially of". In the context of a pharmaceutical formulation, the formulator would have known that "consisting of" was a term used to define an exhaustive list of the ingredients of the formulation. The formulator would not have contemplated the possibility of there being ingredients in the formulation in addition to those specified.
In my opinion, to construe the terms "abridged antibacterial composition" and "consisting essentially of", the Skilled Formulator would have considered the terms in the context of the '614 Patent as a whole, the purpose of the alleged invention described therein and possibly the ordinary meaning of the words which make up these terms.
Upon reading the '614 Patent, the Skilled Formulator would have been led to understand that the purpose of the patent was to arrive at a reformulation of the Patent Disclosed Non-Abridged Composition which would have fewer ingredients and would be less costly to manufacture through a more streamlined process. The Skilled Formulator would be well aware that omitting excipients in reformulating a tablet formulation could potentially reduce both the number of steps required during the tablet manufacture process and the cost of manufacturing the tablets.
In my opinion, the Skilled Formulator, upon considering the '614 Patent as a whole and the purpose of the patent, would conclude that the term "abridged antibacterial composition" referred to in claim 1 of the patent was the Patent Disclosed Non-Abridged Formulation which had been reformulated to omit one or more of the ingredients specifically listed in that formulation. Reading claim 1, the Skilled Formulator would see that the D & C yellow dye No. 10, pregelatinized starch, 100 proof alcohol, stearic acid and talc had been omitted from the Patent Disclosed Non-Abridged Composition to form the abridged anti-bacterial composition claimed in claim 1.
I now turn to the meaning of the term "consisting essentially of". In my opinion, having regard to the object of the '614 Patent to abridge the Patent Disclosed Non-Abridged Composition, and the environment in which the Skilled Formulator operated, the Skilled Formulator would most likely have concluded that "consisting essentially of" in claim 1 identified the ingredients in the claim as being exhaustive. The Skilled Formulator would not likely have contemplated the possibility of providing a list of ingredients for a reformulation of a pharmaceutical preparation that did not list all of the ingredients intentionally added to the reformulated preparation.
(Affidavit of Dr. Miller, Ratiopharm's Record, Vol. V, Tab C, paras. 52-57)
[76] First, in my opinion, in the passages quoted, Dr. Miller's search for a meaning for the term "consisting essentially of" is no better than that of a person not skilled in the art. Dr. Miller first establishes that the term "consisting essentially of" was not known to persons skilled in the art at the time the '614 Patent was added to the Patent Register, but, nevertheless, in paragraph 57 attempts to make an argument on meaning from the perspective of a skilled formulator. In the paragraph there is no rationale provided for the expert opinion reached; it appears that it is only the best that Dr. Miller can do, as a reader of English, to interpret the complex language of the '614 Patent. As a result, I consider his conclusion that the terms "consisting of" and "consisting essentially of" "would most likely have" the same meaning to a skilled formulator is just speculation.
[77] My second reason for giving no weight to Dr. Miller's opinion emanating from paragraphs 56 and 57 of his affidavit is it does not admit to the interpretation advanced by Abbot, which I have found to be clear. That is, the last sentence in Dr. Miller's paragraph 56 is not accurate when the meaning of "abridged composition" is taken into consideration as I have expressed above in paragraph 54 of these reasons. Therefore, I find that Dr. Miller's failure to deal with this interpretation fundamentally undermines his opinion.
[78] Ratiopharm's expert evidence is also weakened by the fact that Dr. Rue and Dr. Miller venture into alternate opinion giving, albeit conflicting, on a construction which is outside of Ratiopharm's construction allegation in the NOA. Dr. Rue says this:
In my opinion, a Skilled Formulator would construe the term "consisting essentially of" as used in the '614 Patent only to include ingredients purposefully added to the composition covered by the claim in sufficient quantities as to have a material impact on the purpose of the invention. [...]
(Affidavit of Dr. Rue, Ratiopharm's Record, Vol. V, Tab B, para. 98)
And Dr. Miller says this:
I do, however, admit that there is another possible, but less likely, construction that the Skilled Formulator could give to the term "consisting essentially of". The Skilled Formulator could have regard to the ordinary meaning of the word "essential". From the Oxford English Dictionary, the Skilled Formulator would have determined the meaning of the adverb "essentially" in the context of the term "consisting essentially of" as being "an essential attribute or constituent" or "in respect of the essential points, materially, substantially". In other words, the term "consisting essentially of" could be construed as meaning "consisting of the material or essential ingredients". This meaning would exclude the inclusion of any other material or essential ingredient but permit the inclusion of ingredients other than those specifically listed but only those which were not material or essential to the composition. A trace solvent or an impurity might be such an immaterial or inessential ingredient. I should add that, in my opinion, the interpretation of "consisting essentially of" that I have described in this paragraph is the one that the Skilled Formulator would unlikely adopt because it would go against one of the purposes of the patent of reducing the number of ingredients in the Patent Disclosed Non-Abridged Composition and would be contrary to the formulator's intuition which would have been guided by his practical experience in formulating pharmaceutical preparations.
(Affidavit of Dr. Miller, Ratiopharm's Record, Vol. V, Tab C, para. 58)
[79] This opinion giving has been taken up by Ratiopharm in its written argument by adding a construction to that stated in the NOA:
59. ratiopharm contends that the phrase "abridged antibacterial composition consisting essentially of ..." in claim 1 of the '614 patent must be read in the context of the '614 patent as a whole, consistent with the purpose of the alleged invention. It is evident from the Non-abridged Composition that each of pre-gelatinized starch and D & C yellow dye No. 10 are essential ingredients for the composition. The removal of, e.g. pre-gelatinized starch, from the Non-abridged Composition would render the composition abridged. These ingredients therefore materially affect the basic and novel characteristics of the composition. Claim 1 of the '614 patent must be construed to exclude these ingredients from the claimed invention. This can be achieved in a way consistent with the purpose of the '614 patent if the phrase "abridged antibacterial composition consisting essentially of ..." is construed as either (1) consisting of only the ingredients specifically listed in the claim, or (2) only those ingredients specifically listed and other ingredients which are not purposefully or intentionally added.
(Ratiopharm's Memorandum of Fact and Law)
[80] I find that Ratiopharm's construction argument in the present Application is limited to the construction allegation made in the NOA (see Hoffmann-La Roche Ltd. v. Apotex Inc., [1997] F.C.J. No. 370 (F.C.T.D.) and Eli Lilly and Co. et al. v. Novopharm Ltd. et al. (1995), 60 C.P.R. (3d) 163). As both Dr. Rue's and Dr. Miller's alternate opinions and Ratiopharm's argument based thereon are not alleged in the NOA, I find they are irrelevant.
[81] For clarification, there is one inconsequential point in Abbott's construction argument with which I disagree. Abbott argues that Dr. Rue's opinion that "consisting essentially of" means "consisting only of" should be discounted because, in a patent of his own, he does not give the phrase "consisting essentially of" the meaning "consisting only of". I accept Ratiopharm's argument that the words in Dr. Rue's patent are being used for a different purpose than the words in the '614 Patent, and, therefore, there is no conflict.
C. Conclusion
[82] I find that Abbott's construction of Claim 1 of the '614 Patent is correct.
VII. Is the '614 Patent infringed by Ratiopharm's formulation?
[83] As stated above, it is agreed that if Abbott's construction of Claim 1 is found to be correct, Ratiopharm's product infringes the '614 Patent. Therefore, given my finding that Abbott's construction is correct, I find that Ratiopharm's formulation infringes the '614 Patent.
VIII. Is the '614 Patent invalid for obviousness?
[84] The test for obviousness is well understood:
The test for obviousness is not to ask what competent inventors did or would have done to solve the problem. Inventors are by definition inventive. The classical touchstone for obviousness is the technician skilled in the art but having no scintilla of inventiveness or imagination; a paragon of deduction and dexterity, wholly devoid of intuition; a triumph of the left hemisphere over the right. The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent. It is a very difficult test to satisfy.
(Beloit Canada Ltd. et al. v. Valmet Oy (1986), 8 C.P.R. (3d) 289 (F.C.A.) at 294.)
[85] As decided in Section II above, Ratiopharm bears the burden of proving, on a balance of probabilities, that a person skilled in the art would have come directly and without difficulty to the invention claimed in the '614 Patent.
[86] The outline of Ratiopharm's obviousness allegation in the NOA reads as follows:
The alleged invention claimed in each claim of the 614 Patent was obvious as at the claim date having regard to the prior art references referred to in Schedule "A" hereto and the common general knowledge in the art. The references listed in Schedule "A" were all first published prior to the claim date of the 614 Patent.
The references listed in Schedule "A" disclose that since a time well prior to the claim date:
a) development of a tablet formulation for the large scale manufacture of compressed tablets was routine;
b) the process of wet granulation was well known;
c) the excipients claimed in the patent for the so-called abridged composition were all well known and in common use and the amount to each excipient required was well known or could be determined by routine procedures;
d) the location of the excipients in relation to the structure of the tablet depend on the function of that excipient;
e) the concept of an "abridged composition" containing reduced numbers of excipients to maximize acceptability of the tablet to the patient and ensure simplicity and commonality of the manufacturing process was well known to the skilled formulator
[Emphasis added]
(Abbott's Record, Vol. I, Tab 1, p. 29)
[87] In support of its allegations, Ratiopharm makes the following argument:
75. There is no inventiveness in following an obvious and well-charted route using known techniques and processes involving known compositions, unless the inventor encounters difficulties that could not have been reasonably expected by a person versed in the art or overcome by the application of ordinary skill.
Apotex Inc. v. Wellcome Foundation Ltd. (1998), 79 C.P.R. (3d) 193 (F.C.T.D.) at 269; affd (2000), 10 C.P.R. (4th) 65 (F.C.A.).
Pfizer Canada Inc. v. Apotex Inc. (2002), 22 C.P.R. (4 th) 466 (F.C.T.D.) at 489.
76. The '614 patent does not disclose that the Abridged Composition contains any new uses or surprising results or properties that are clearly superior to the Non-abridged Composition, a known composition commercially available other than the alleged streamlined and less costly commercial availability of the drug clarithromycin. Instead, the alleged invention includes a composition containing known ingredients compiled in a known manner. The '614 patent does not show that the resulting Abridged Composition has produced a result beyond what a Skilled Formulator would have expected from the teachings of the prior art.
Struthers Scientific International Corp. v. Commissioner of Patents (1973), 30 C.P.R. (2d) 70 (Comm.) at 75-76.
77. The '614 Patent shows no unexpected beneficial result from taking the obvious step of removing ingredients from the Non-abridged Composition in order to achieve the Abridged Composition.
78. As of the Claim Date, it would have been evident to the Skilled Formulator that, to abridge the Non-abridged Composition, the formulator would merely have to remove or omit one of the ingredients from the Non-abridged Composition.
Amidon Cross-examination, p. 1377, line 12 to p. 1378, line 18; RR, Vol. VI, Tab D
79. The issue is whether, as of the Claim Date, the alleged invention claimed in the '614 patent as construed by Abbott would have been obvious to the Skilled Formulator.
[Emphasis added]
(Ratiopharm's Memorandum of Fact and Law)
[88] With respect to the issue stated in paragraph 79, Ratiopharm goes on to cite three pieces of evidence in support of its argument that there is nothing inventive in removing an ingredient from the abridged composition:
80. As at the Claim Date, the prior art available to the Skilled Formulator included the 500 mg adult tablet formulation of clarithromycin. That tablet formulation omitted pre-gelatinized starch from the Non-abridged Composition. It is therefore self evident that it would have been obvious to the Skilled Formulator, as of the Claim Date, that the Non-abridged Composition could be abridged by removing pre-gelatinized starch from the Non-abridged Composition.
Compendium of Pharmaceuticals and Specialties (2000), Exhibit A-11 to North Affidavit; RR, Vol. II, Tab 11, p. 488
Canwell Enviro-Industries Ltd. v. Baker Petrolite Corp. (2002), 17 C.P.R. (4th) 478 (F.C.A.) at 496-500.
Rue Affidavit, paras. 56 to 58 and 123; RR, Vol. V, Tab B, pp. 1246-1247 and 1264
Miller Affidavit, paras. 45 and 75; RR, Vol. V, Tab C, p. 1300 and 1309
81. Furthermore, it would also have been obvious as of the Claim Date that the Non-abridged composition could be abridged by omitting the D & C yellow dye No. 10. On cross-examination Dr. Amidon stated:
Q. And you agree with me, don't you, that the person skilled in the art in September 2002, were to go to page two line 17 of the patent, review the list of ingredients that follow that line in the patent, and remove D & C yellow dye number 10, that a person would have abridged the commercially available nonabridged clarithromycin composition?
A. I think a person skilled in the art would view a dye that you put on a tablet or incorporate in a tablet being in such a small amount or not including a dye as being a small change. I would look at the patent to decide on whether that would be included or not. And there is - in the patent there's no listing of - in the patent on page two beginning at line 17, yes - well, there is a dye, so that might technically be an abridged formulation.
Q. Yes, it would, wouldn't it, technically?
A. Technically, yes.
...
Q. Dr. Amidon, would you agree with me that as of September 2002, a person skilled in the art would exercise no inventive ingenuity in removing a dye, the dye which is D & C yellow dye number 10, from the commercially available nonabridged clarithromycin composition referred to on line 17 of page two in order to abridge the composition?
A. I think that removing the dye would be considered to be a minor change. It would technically considered [sic] to be an abridged formula.
Q. There is no inventive ingenuity in removing the dye, is there?
A. It's unlikely, no.
Amidon Cross-examination, p. 1391, lines 4-21 and p. 1395, line 18 to p. 1396, line 4; RR, Vol. VI, Tab D
82. Furthermore, the excipients used in the Abridged-Composition were commonly used as excipients in wet granulation formulations of pharmaceutical preparations as of the Claim Date. As a result a Skilled Formulator, in light of the state of the art and the common general knowledge, as of the Claim Date, would have come directly and without difficulty to the solution contended by Abbott to fall within claim 1 of the '614 patent through merely following routine industry practices and using industry standard testing procedures by mechanical process and without the exercise of any inventive skill.
Rue Affidavit, paras 119-134; RR, Vol. V, Tab B, pp. 1264-1269
Miller Affidavit, paras 69-79; RR, Vol. V, Tab C, pp. 1307-1312
(Ratiopharm's Memorandum of Fat and Law)
[89] In my opinion, for three reasons, Ratiopharm fails to meet the standard of proof of a balance of probabilities with respect to its obviousness argument.
[90] First, I find that the evidence quoted in paragraphs 80 to 82 does nothing to contribute to the argument that the formulation claimed in Claim 1 would be obvious to a skilled formulator. There is no evidence to prove that, because it was known that starch and colour can be omitted, or that the excipients of the abridged composition were in use in wet granulation formulations, skilled formulators would know from the prior art which location to put what excipients in an abridged formulation to attain bioequivalence to the non-abridged formulation of BIAXIN.
[91] Second, I accept Mr. Mason's argument made during the course of the oral hearing that it was improper for Mr. Bloom to put the '614 Patent to Dr. Amidon. Mr. Mason argued that the '614 Patent provides information that is not available in the CPS [Compendium of Pharmaceuticals and Specialties (2000)] being the location of certain of the excipients, and, thus, Dr. Amidon should have been asked to consider how obvious it would have been to remove an excipient from those listed in the CPS, not the '614 Patent. Mr. Mason stressed the point that the invention in the '614 Patent is not merely the removal of D & C Yellow Dye No. 10 or starch, but is the placement of the excipients in their specific locations, followed by the removal of at least one of them.
[92] I accept Mr. Mason's argument, and therefore, give no weight to Ratiopharm's argument based on the cross-examination of Dr. Amidon.
[93] And third, in answer to Ratiopharm's broad obviousness allegations, Abbott makes a precise and well supported case that the abridged composition is inventive.
[94] Abbott's key argument reads as follows:
101. The '614 Patent is an improvement patent and is inventive because it discloses, for the first time, which specific excipients, in which locations, are required to make the non-abridged composition and discloses which excipients can be removed and retained, to make an abridged composition. As Dr. Amidon emphasized, an abridged clarithromycin composition would be particularly challenging since clarithromycin is a class IV compound, is practically insoluble, has a low permeability, an unpalatable taste, and is a large complex molecule with numerous functional groups which would pose degradation issues. This is far greater than the "scintilla of inventiveness" necessary to support the validity of a patent.
Reference: Amidon Affidavit, AR, Vol. II, Tab 3, para. 59, p. 237
(Abbott's Memorandum of Fact and Law)
[95] Dr. Amidon also provides evidence that just because two excipients have similar functions does not mean that one can be taken out (Affidavit of Dr. Amidon, Abbott's Record, Vol. II, Tab 3, para. 62). In addition, Dr. Byrn also confirms that abridging the composition for the '614 Patent is made more complex because of the use of the two locations for the excipients, intra-granular and extra-granular (Affidavit of Dr. Byrn, Abbott's Record, Vol. II, Tab 2, para. 95). Indeed, Dr. Rue admitted that some of the prior art only teaches one location, the extra-granular excipient. As such, if a person skilled in the art was formulating in accordance with the prior art, he or she would not necessarily arrive at the '614 Patent (Cross-Examination of Dr. Rue, Abbott's Record, Vol. III, Tab 5. pp.434-438).
[96] Solid support for Abbott's response on the issue of obviousness comes from Ratiopharm's expert witnesses on the need for testing to arrive at the invention.
[97] Dr. Miller agrees that a process of careful evaluation of the non-abridged formulation would need to be conducted. This evidence is conveniently stated as follows:
106. In his affidavit, Dr. Miller 'described' how a person skilled in the art would 'deduce' the abridged composition claimed in the '614 Patent:
The formulator would likely have first reviewed the list of ingredients in the formulation as it appeared in The Compendium of Pharmaceuticals and Specialties 2000. Based upon common general knowledge in the art, the formulator would have then begun to select excipient candidates to be omitted from the Abbott 250 mg Formulation.
Reference: Miller Affidavit, para. 76, p. 25
107. Once the formulator decides which excipients to remove, the person would have developed prototype Formulations and would have conducted the routine stability and dissolution tests on the prototype formulations with the objective of achieving a more efficient formulation having the objectives specified to the formulator.
Reference: Miller Affidavit, para. 76, p. 25
(Abbott's Memorandum of Fact and Law)
[98] Abbott also accurately quotes the evidence in making the following arguments:
109. The starting point for the person skilled in the art would be the CPS which lists some of the ingredients contained in Abbott's commercial formulation. While Ratiopharm's experts suggest in their affidavits that the commercial formulation contains many redundant components (suggesting that the task of identifying and removing excipients obvious), Dr. Miller conceded on cross-examination that a skilled formulator looking at the CPS would still start from the proposition that the ingredients are in the formulation for a reason and that one would not know, in advance of experimentation, how many excipients could be removed, in what amounts, and in which combinations. This admission alone is sufficient to dispose of Ratiopharm's allegation of obviousness.
Reference: Miller Cross, AR, Vol. III, Tab 6, pp. 570 and 600 (q. 370-2 and q. 469)
[...]
113. Dr. Miller admitted on cross examination that a person skilled in the art would not know in advance of selecting candidates for removal and doing experiments, how many, if any, excipients could be removed, in what amount, and in which combinations. Because of this, a "package of experiments" is necessary in order to arrive at an abridged composition.
Reference: Miller Cross, AR, Vol. III, Tab 6, p. 562 (q. 339-40), p. 570-2 (q. 370-2 and q. 374-6) and p. 600 (q. 469)
[...]
119. The "package of experiments" would then need to be repeated, one by one, then two by two, then three by three, and so on, as each selected excipient is sequentially removed from the formulation, and then all of the experiments would have to be run again. The permutations and combinations of excipients to be removed are vast and the experiments to be conducted would run into the hundreds.
Reference: Miller Cross, AR, Vol. III, Tab 6, pp. 597-598 (q. 455-62)
(Abbott's Memorandum of Fact and Law)
[99] However, I agree with Abbott's argument that testing is not allowed based on a consistent line of authority of this Court:
98. The test for obviousness has recently been summarized by Madam Justice Snider who observed that the solution to the problem posed must be "plain as day" or "crystal clear". The Court must determine whether a person skilled in the art would be led, based on the state of the art, to the claimed invention without conducting further experiments, serious thought or research.
Reference: (Procter & Gamble Pharmaceuticals Canada Inc. v. Canada (2004), 32 C.P.R. (4th) 224 (F.C.T.D.) at 36)
99. The Court of Appeal endorsed the test for obviousness as articulated by Justice Snider, and expressly stated that the jurisprudence since Beloit had not made the test any less difficult to meet.
Reference: (Procter & Gamble Pharmaceuticals Canada Inc. v.
Canada(Minister of Health) (2004), 37 C.P.R. (4th) 289 (C.A.) at paras. 43-47)
100. Justice Layden-Stevenson recently rejected an allegation of obviousness which rested on the very same premise as that put forward by Ratiopharm in this case:
Thus, although one would normally imagine that this mythical person's laboratory is filled with mythical test tubes and Petri dishes and that his or her daily life is spent in experimentation, for the purposes of this legal exercise, no research of any kind can be contemplated. So, although it may have been logical to an actual skilled person at the time, based on the state of the art, to conduct certain testing, that is not open to the mythical skilled technician. The mythical researcher cannot have an inquiring or thinking mind which ultimately would lead him or her to the answer but rather he or she is expected to instantly and spontaneously exclaim, without more, "I already know the answer and it is obvious".
Reference: (AB Hassle v. Genpharm Inc., [2003] F.C.J. No. 1910
(T.D.) at para. 112-113; affd [2004] F.C.J. No. 2079
(C.A.))
(Abbott's Memorandum of Fact and Law)
[100] Given the evidence that testing would be required to arrive at the invention, to advance its obviousness allegation, Ratiopharm cites Janssen-Ortho Inc. v. Novopharm Limited (2004), 35 C.P.R. (4th) 353 (F.C.) at 374 as the authority for the proposition that "routine testing" is permitted:
[T]he test for obviousness does not exclude routine testing to determine characteristics of known compounds, not undertaken for the purpose of "searching for something novel", but rather for the purpose of verifying the actual attributes of already known compounds, where the results indicate no new uses or surprising results, or properties that are clearly superior to the already known parent compound. Concerning the issue of determining whether there has been an inventive step or "undue experimentation" in the obviousness inquiry, see the reasoning of Justice Dawson of this Court in Pfizer Canada Inc. v. Apotex Inc. (2002), 22 C.P.R. (4th) 466 (F.C.T.D.) at paras. 103-114.
Ratiopharm argues that coming up with the abridged formulation would be "routine".
[101] I do not accept Ratiopharm's "routine testing" argument based on the Janseen-Ortho decision for two reasons: first, I cannot find that the statement quoted is sufficiently fully reasoned to overturn the solid line of authority against testing; and second, the kind of testing that would be required in the present case would not be "routine"; I am satisfied it would be intensively investigative.
[102] As a result, I dismiss Ratiopharm's obviousness argument.
IX. Are Ratiopharm's allegations justified?
[103] For the reasons provided, the answer to this question is "no".
ORDER
On the Motion to Strike
For the reasons provided in Section I of these reasons, the Motion to Strike is dismissed.
Costs on the Motion to Strike are awarded to Abbott, on terms to be determined on further argument.
"Douglas R. Campbell"
Judge
ORDER
On the Application
For the reasons provided in Sections II to IX of these reasons, the Minister of National Health and Welfare is prohibited from issuing a Notice of Compliance to the Respondent, Ratiopharm, a Division of Ratiopharm Inc., until after the expiration of Canadian Letters Patent No. 2,393,614.
Costs on the Application are awarded to Abbott, on terms to be determined on further argument.
"Douglas R. Campbell"
Judge
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-428-04
STYLE OF CAUSE: ABBOTT LABORATORIES and ABBOTT
LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and RATIOPHARM
A DIVISION OF RATIOPHARM INC.
Respondents
PLACE OF HEARING: TORONTO, ONTARIO
DATES OF HEARING: DECEMBER 13-14, 2005
APPEARANCES:
| Andy Reddon Steven Mason
|
|
| David W. Aitken
|
SOLICITORS OF RECORD:
| McCarthy Tétrault LLP Toronto, Ontario |
|
| Osler, Hoskin and Harcourt LLP Toronto, Ontario |
|