Abbott Laboratories v. Canada (Health)

Abbott Laboratories v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2005-09-28
Neutral citation
2005 FC 1332
File numbers
T-1133-02
Decision Content
Date: 20050928
Docket: T-1133-02
Citation: 2005 FC 1332
BETWEEN:
ABBOTT LABORATORIES and
ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
REASONS FOR ORDER[1]
PHELAN J.
A. INTRODUCTION
[1] This is an application by Abbott Laboratories (“Abbott”) for an order prohibiting the Minister of Health from issuing a Notice of Compliance (“NOC”) to Apotex Inc. (“Apotex”) in respect of Apotex’s brand of 250 mg. and 500 mg. clarithromycine tablets known as Apo-Clarithromycine until the expiry of Canadian Patent 2,261,732 (the “'732 patent”). The active medicinal ingredient in these tablets is 6-0-methylerythromycin A Form II (also referred to as Clarithromycine Form II).
[2] This proceeding was commenced under the Patented Medicine (Notice of Compliance) Regulations, SOR/93-133 (the “NOC Regulations”). The issue in this proceeding is whether Abbott has successfully rebutted Apotex’s allegation that the patent is not valid. The issue of infringement is not directly raised in this proceeding, other than that there is no infringement because the patent is invalid.
[3] The nature of the NOC proceedings has been summarized by Layden-Stevenson J. in Fournier Pharma Inc. v. Canada (Minister of Health) 2004 FC 1718:
6. As noted, this proceeding is brought under the Regulations. The history and scheme of the Regulations have been delineated in various decisions of the Federal Court of Appeal and need not be repeated here. See: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.); AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.); Novartis AG et al. v. Abbott Laboratories Ltd. et al (2000), 7 C.P.R. (4th) 264 (F.C.A.). Basically, issues of non-infringement and validity between the patent holder (first person) and the person seeking a NOC from the Minister (second person) originate with a NOA, served on the first person by the second person, setting out the second person’s allegations, including the legal and factual basis in support. The first person may disagree and apply to the court for an order prohibiting the Minister from issuing a NOC to the second person until after expiration of the patent.
8. Section 6 proceedings are not to be likened to actions for determining validity or infringement. They are proceedings in judicial review, to be held expeditiously, whose aim is to determine whether the Minister is free to issue the requested NOC. Their scope is confined to administrative purposes: Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 76 C.P.R. (3d) 1 (F.C.A.). The determination must turn on whether there are allegations by the second person sufficiently substantiated to support a conclusion for administrative purposes (the issuance of a NOC) that an applicant’s patent would not be infringed if the second person’s product is put on the market: Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.).
9. By merely commencing the proceeding, the applicant obtains what is tantamount to an interlocutory injunction without having satisfied any of the criteria a court would require before enjoining issuance of a NOC: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1998), 80 C.P.R. (3d) 368 (S.C.C.); Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 11 C.P.R. (4th) 539 (F.C.A.). The Regulations allow a court to determine summarily, on the basis of the evidence adduced, whether the allegations are justified. Section 6 proceedings are not adjudicative and cannot be treated as res judicata. The patentee is in no way deprived of all the recourses normally available to enable it to enforce its rights. If a full trial of validity or infringement issues is required, this can be obtained in the usual way by commencing an action: Pfizer Canada Inc. v. Apotex Inc. (2001), 11 C.P.R. (4th) 245 (F.C.A.); SmithKline Beecham Pharma Inc. v. Apotex Inc. (2001), 14 C.P.R. (4th) 76 (F.C.T.D.) aff’d (2002), 21 C.P.R. (4th) 129 (F.C.A.); Novartis A.G. v. Apotex Inc. (2002), 22 C.P.R. (4th) 450 (F.C.A.).
B. THE PATENT – NOTICE OF ALLEGATION
[4] The '732 patent is attached as Appendix A to these Reasons. The claims in issue are 1, 2, (3 and 9 are no longer in issue), 13, 15 and 16 to 21.
[5] Apotex alleged that Claims 16 to 21 of the '732 patent are invalid because they claim an admittedly old product (i.e. Form II Clarithromycine). Claims 16 to 21 are set out below:
16. 6-0-methylerythromycin A crystal Form II prepared according to the process of Claim 2.
17. 6-0-methylerythromycin A crystal Form II prepared according to the process of Claim 3.
18. 6-0-methylerythromycin A crystal Form II prepared according to the process of Claim 9.
19. 6-0-methylerythromycin A crystal Form II prepared according to the process of Claim 13.
20. 6-0-methylerythromycin A crystal Form II prepared according to the process of Claim 15.
21. 6-0-methylerythromycin A crystal Form II prepared according to the process of Claim 1.
[6] Apotex says that a product by process claim cannot be valid if the compound itself is old.
[7] Apotex further alleges that claims 16-21 are invalid because the claims upon which they depend (claims 1, 2, 13 and 15 – set out below) are invalid because each claim is beyond the processes actually invented and disclosed. It is said that the processes were never tested and their utility was not soundly predicted; the processes do not work to make Form II; the processes were obvious and anticipated.
[8] There is a significant issue as to the interpretation of the dependent claims as alternative claims. It is useful to set those claims out as well. The relevant claims are:
1. A method of preparing 6-0-methylerythromycin A crystal Form II comprising:
(a) converting erythromycin A to 6-0-methylerythromycin A;
(b) treating the 6-0-methylerythromycin A prepared in step a with a solvent selected from the group consisting of:
(i) an alkanol of from 1 to 5 carbon atoms, provided said alkanol is not ethanol or isopropanol,
(ii) a hydrocarbon of from 5 to 12 carbon atoms,
(iii) a ketone of from 3 to 12 carbon atoms,
(iv) a carboxylic ester of from 3 to 12 carbon atoms, provided said carboxylic esteris not isopropyl acetate,
(v) an ether of from 4 to 10 carbon atoms,
(vi) benzene,
(vii) benzene substituted with one or more substituents selected from the group consisting of:
alkyl of from one to four carbon atoms,
alkoxy of from one to four carbon atoms,
nitro, and
halogen,
(viii) a polar aprotic solvent,
(ix) a compound having the formula HNR1R2 wherein R1 and R2 are independently selected from hydrogen and alkyl of one to four carbon atoms, provided that R1 and R2 are not both hydrogen,
(x) water and a water miscrible solvent selected from the group consisting of:
a water miscible organic solvent, and
a water miscible alkanol,
(xi) methanol and a second solvent selected from the group consisting of:
a hydrocarbon of from 5 to 12 carbon atoms,
an alkanol of from 2 to 5 carbon atoms,
a ketone of from 3 to 12 carbon atoms,
a carboxylic ester of from 3 to 12 carbon atoms,
an ether of from 4 to 10 carbon atoms,
benzene, and
benzene substituted with one or more substituents selected from the group consisting of:
alkyl of from one to four carbon atoms,
alkoxy of from one to four carbon atoms,
nitro, and
halogen, and
(xii) a hydrocarbon of from 5 to 12 carbon atoms and a second solvent selected from the group consisting of:
a ketone of from 3 to 12 carbon atoms,
a carboxylic ester of from 3 to 12 carbon atoms,
an ether of from 4 to 10 carbon atoms,
benzene,
benzene substituted with one or more substituents selected from the group consisting of:
alkyl of from one to four carbon atoms,
alkoxy of from one to four carbon atoms,
nitro, and
halogen, and
a polar aprotic; and
(c) isolating the 6-0-methylerythromycin A crystal Form II crystals.
2. The process of Claim 1 wherein step (a) comprises
(i) converting erythromycin A into an erythromycin A 9-oxime derivative;
(ii) protecting the 2' and 4'' hydroxy groups of the erythromycin A 9-oxime derivative prepared in step (i);
(iii) reacting the product of step (ii) with a methylating agent; and
(iv) deprotecting and deoximating the product of step (iii) to form 6-0-methylerythromycin A.
13. A method according to Claim 2 wherein the solvent comprises a compound of formula HNR1R2 wherein R1 and R2 are independently selected from hydrogen and alkyl of from one to four carbon atoms, provided that R1 and R2 are not both hydrogen.
15. A method according to Claim 2 wherein the solvent is selected from the group consisting of:
acetone,
heptane,
toluene,
methyl tert-butyl ether,
N, N-dimethylformamide,
ethyl acetate,
xylene,
isopropanol-water,
tetrahydrofuran-water,
ethanol-water,
ethyl ether,
arnyl acetate,
isopropyl acetate-methanol,
diisopropyl ether,
isopropyl butyrate
isopropylamine, and
methanol-ethanol.
[9] Apotex therefore raises the issues of novelty, sound prediction and inutility.
[10] Abbott contends that the claims within Claims 1 and 15 are alternate claims for purposes of section 27(5) of the Patent Act and therefore Apotex must successfully invalidate all of the claims in Claims 1 and 15. Abbott also says that Apotex’s experiments are inadmissible; that the allegations against Claims 13 and 15 are not justified; that the allegations of lack of novelty are also not justified.
[11] Crystals are solid materials in which molecules (like Clarithromycine) are arranged in a specific geometric pattern extending in those dimensions. Where multiple crystal forms exist, the phenomenon is known as “polymorphism”.
[12] Clarithromycine is a chemical compound whose molecules crystallize into at least two shapes; polymorphs. Clarithromycine is used as an antibiotic, particularly in the treatment of infections in the upper respiratory tract of both children and adults.
[13] Form I and Form II Clarithromycine are the names given respectively to two polymorphs of Clarithromycine. Each displays a specific result when subjected to x-ray powder diffraction, differential scanning calorimetry or infrared spectrum analysis.
[14] Form II is the polymorphic form of the Clarithromycine included in Biaxin tablets since 1993 and sold by Abbott.
[15] The earliest claim date of the '732 patent is July 29, 1996. Claims 1 to 15 of the '732 patent claim processes to make Form II, and claims 16 to 21 of the patent claim Form II when made by those processes. (In the patent, Clarithromycine is called 6-0-methylerythromycin A.) Since Claims 1 to 15 are process claims, they are not eligible claims under the NOC Regulations and cannot be the basis for a prohibition order.
[16] It is not disputed that the “person skilled in the art” of the '732 patent would have a B.Sc. in chemistry or chemical engineering and two to five years’ experience in pharmaceutical process development. All the experts’ qualifications far exceeded this “person skill” in the art.
C. SUFFICIENCY OF PLEADINGS AND EVIDENTIARY BURDEN
[17] Much has been made about the sufficiency of the pleadings, and the burden and sufficiency of proof as well as the presumption of validity. Abbott has challenged the Notice of Allegation (“NOA”) and based its application to this Court on the grounds that:
· The NOA does not comply with the NOC Regulations because it is insufficiently detailed.
· Claims 16 to 21 of the '732 are not dependent on invalid claims.
· None of claims 1, 2 (3 and 9 are no longer in issue), 13 and 15 is invalid for being broader than the invention made or disclosed, being anticipated or obvious, being claims for an old method, lacking utility or being claims for an old product.
[18] Apotex says that Abbott’s Notice of Application does not challenge the allegation that claims 16 to 21 claim an old product and that a product by process claim is not valid if the product is old. Apotex also complains that Abbott’s Notice of Application does not raise Abbott’s argument regarding s.27(5) of the Patent Act.
[19] A review of the pleadings and the evidence discloses that all of the issues raised by each party were sufficiently raised to “put the issues in play”, even if that were the correct legal standard as argued by Abbott. No party was unduly surprised or prejudiced by the manner in which any issue came before the Court. The parties had available all the pre-hearing procedural steps to deal with any deficiencies in the record. The parties were not shy to use these procedures where they thought necessary.
[20] The NOA, particularly paragraph 16, raises the issue of “old product” – lack of novelty, invalid breadth of claim, anticipation/obviousness, inutility in respect of Claim 1. Paragraph 17 deals with Claim 2; paragraph 20 deals with Claim 13, paragraph 21 with Claim 15. Furthermore, paragraph 21, which covers Claims 16-21, raises all those same issues because these claims are dependent on the earlier claims (and their alleged deficiencies) including in subparagraph (iii), the issue of old product.
[21] The test for adequacy of pleadings was recently reviewed in Pfizer Canada Inc. v. Novopharm Ltd. 2005 FCA 270:
14. The purpose for Novopharm providing the detailed statement of the legal and factual basis for the non-infringement allegations was to notify the patentee (Pfizer) of the reasons why its patent would not be infringed or was invalid (see AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.) at paragraph 16). At paragraph 17 of that decision Stone J.A. stated:
… the detailed statement must be such as to make the patentee fully aware of the grounds for claiming that the issuance of an NOC would not lead to infringement of a listed patent for, otherwise, the patentee would be unable to decide whether or not to initiate a section 6 proceeding.
15. Similarly, in SmithKline Beecham Pharma Inc. v. Apotex Inc., Noël J.A. stated the following at paragraph 24:
The detailed statement … is intended to place the patentee in the position of deciding whether to oppose the issuance of a notice of compliance by instituting a section 6 proceeding or to stand aside.
16. The Applications Judge erred in his formulation of the legal test to determine whether Novopharm’s NOA was deficient when he required Novopharm to ‘put into play’ all aspects of the non-infringement issue. Whether Novopharm’s NOA was adequate depends on whether it provided Pfizer with a sufficient understanding of the case it had to meet (supra at paragraph 4). The legal test of adequacy does not require Novopharm to anticipate all possible grounds of infringement, including Pfizer’s speculative theory that the dihydrate could be used in the process of manufacturing Novopharm’s bulk monohydrate. As noted by Evans J.A. in AstraZeneca AB v. Apotex Inc. 2005 FCA 183, [2005] F.C.J. No. 842 (QL) at paragraph 11:
A second person [the generic] should not be required to anticipate every theory of possible infringement, however speculative, in the detailed statement supporting its allegations.
[22] The adequacy of the NOA is determined by whether it provided Abbott with a sufficient understanding of the case it had to meet. The NOA clearly meets that standard.
[23] In addition to the allegation of insufficiency of pleadings, the parties have raised the question of on whom the burden of proof rests. This is a relevant issue because of the arguments pertaining to the various experts’ testimony.
[24] Abbott’s position is that because of the presumption of patent validity, where the NOA challenges the patent’s validity, the evidentiary burden on Apotex is to put the allegations of invalidity in play by filing evidence in support of each allegation of invalidity.
[25] Unlike the issue of adequacy of pleadings where the matter of putting “the issues in play” is not the legal test, in respect of burden of proof, the matter of putting “the issues in play” does become relevant.
[26] The evidentiary burden was also discussed in Pfizer Canada Inc. v. Novopharm Ltd., supra, at paragraphs 19 and 20:
19. In Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1995), 64 C.P.R. (3d) 450 (F.C.A.), Hugessen J.A. addressed the evidentiary burden placed on a generic under the Regulations. He adopted the reasons of the trial judge who described this burden as follows:
… the grounds that the patentee has for challenging the generic’s notice of allegation should be advanced in the originating notice of motion filed pursuant to s. 6(1) of the Regulations. … The generic may then be informed as to what vexes the patentee and why a prohibition order barring entry should be issued. Initially, i.e., before the Minister, the generic has raised the issue of non-infringement. At this stage, before the court, the generic now has the opportunity to file evidence supporting its detailed statement. In essence, this is the evidential burden on a respondent.
(see Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1995), 60 C.P.R. (3d) 328 at 339-40 (F.C.T.D.), per Wetston J.)
20. In my view, this statement remains good law. Where, as here, the NOA is found to be adequate, the legal burden remains squarely on Pfizer to prove, on a balance of probabilities, that the allegations in the NOA are unjustified. Novopharm has no evidential burden to support the allegations in its NOA and detailed statement (see AB Hassle v. Canada (Minister of National Health and Welfare) (2002), 22 C.P.R. (4th) 1 at paragraph 35). Therefore, Novopharm need only file evidence supporting its detailed statement to counter evidence, if any, submitted by Pfizer in the course of the prohibition proceedings.
[27] Gibson J. in SmithKline Beecham Pharma Inc. v. Apotex Inc. (2001), 14 C.P.R. (4th) 76 (F.C.T.D.) limited the burden of proof to requiring the Applicant to disprove the allegations in the NOA.
14. Against the foregoing, I conclude that while an “evidential burden” lies on Apotex to put each of the issues raised in its Notice of Allegation “in play”, if it is successful in doing so, the “persuasive burden” or “legal burden” then lies with SmithKline. Assuming Apotex to be successful in putting the issue of validity of the '637 Patent “in play”, SmithKline is entitled to rely on the presumption of validity of the patent created by subsection 43(2) of the Act.
15. Against the foregoing, I conclude that while an “evidential burden” lies on Apotex to put each of the issues raised in its Notice of Allegation “in play”, if it is successful in doing so, the “persuasive burden” or “legal burden” then lies with SmithKline. Assuming Apotex to be successful in putting the issue of validity of the '637 Patent “in play”, SmithKline is entitled to rely on the presumption of validity of the patent created by subsection 43(2) of the Act.
16. The “persuasive burden” or “legal burden” that lies with SmithKline in the circumstances described in the preceding paragraph is, however, impacted by the nature of the proceeding here before the Court. In Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.), Mr. Justice Hugesson, for the Court, wrote at pages 319-20:
As I understand the scheme of the regulations, it is the party moving under s. 6, in this case Merck, which, as the initiator of the proceedings, has the carriage of the litigation and bears the initial burden of proof. That burden, as it seems to me, is a difficult one since it must be to disprove some or all of the allegations in the notice of allegation which, if left unchallenged, would allow the Minister to issue a notice of compliance.
.....
In this connection, it may be noticed that, while s. 7(2)(b) [of the Regulations] seems to envisage the court making a declaration of invalidity or non-infringement, it is clear to me that such declaration could not be given in the course of the s. 6 proceedings themselves. Those proceedings, after all, are instituted by the patentee and seek a prohibition against the Minister; since they take the form of a summary application for judicial review, it is impossible to conceive of them giving rise to a counterclaim by the respondent seeking such a declaration. Patent invalidity, like patent infringement, cannot be litigated in this kind of proceeding.
Thus, the burden on SmithKline is only to disprove the allegations in the notice of allegation, not to justify declarations of validity and infringement or conversely to negative claims for declarations of invalidity and non-infringement.
[Justice Gibson’s judgment was affirmed on appeal at (2003), 21 C.P.R. (4th) 129.]
[28] Given the summary nature of NOC proceedings and the focus on disproving the allegations in the NOA, the statutory presumption of validity is not sufficient defence, in and of itself, to shift the burden of proof to Apotex. The burden of disproving the allegations in the NOA rests on Abbott and does not shift to Apotex because of the presumption of validity.
[29] Therefore, the issue for this Court is whether Abbott has disproven the allegations made by Apotex. If Abbott has disproved each of the allegations, a prohibitive order would issue.
D. EXPERTS
[30] As with most NOC proceedings, the parties produce numerous eminently qualified expert witnesses. The principal witnesses were:
For Abbott:
Dr. Stephen Bryn, a Ph.D. chemist, and a highly respected scientist and author in the very field of science in issue. He consults widely in the pharmaceutical industry on the very questions at issue in this case. Dr. Byrn, says Abbott, “wrote the book” on Solid State Chemistry of Drugs. He is widely published on the very matters of the crystal forms of drugs which is the issue in this case.
Dr. Allan Myerson, the Provost of the Illinois Institute of Technology. He is a Ph.D. chemical engineer. He also consults to the pharmaceutical industry but on the more concrete issues of designing processes to crystallize drugs. Dr. Myerson is also widely published on the process of crystallization in industry and his leading textbook is in fact called The Handbook of Industrial Crystallization.
Dr. Jerry Atwood, Chairman of the Department of Chemistry at the University of Missouri-Columbia. He is a highly accomplished Ph.D. chemist with broad expertise in solid-state chemistry.
For Apotex
Dr. Robert McClelland, a professor of chemistry at the University of Toronto holding both a B.Sc. (Honours Chemistry) and Ph.D. in Chemistry from that university. His expertise was in the area of mechanistic organic chemistry, and in the area of biological and medicinal chemistry. He has been an accepted expert in many proceedings before this Court.
Dr. Robert Brown, a professor at Queen’s University, who holds B.Sc. Honours in Chemistry, a M.Sc. Physical Organic Chemistry and Ph.D. with expertise in mechanistic organic chemistry.
Dr. Michael Cima, a professor at M.I.T., holds a Ph.D. in chemical engineering with expertise in material science including the field of polymorphism.
Dr. James B. Hendrickson, who is a professor at Brandeis University, also has a Ph.D. with expertise in organic chemistry.
[31] The one witness not produced by either party is a person with a B.Sc. in chemistry or chemical engineering and two to five years experience in pharmaceutical process development – the “person skilled in the art”. There was a paucity of evidence about this mythical person. Like the “reasonable man” in tort law, this person’s knowledge, understanding and actions are described to the Court through the prism of the battery of experts.
[32] The parties engaged in a considerable amount of attack on the respective witnesses, colloquially, “slagging” their reputations and their findings. Aside from the rhetoric, these arguments were of little benefit to the parties or the Court.
[33] I reject the suggestion that these experts, on both sides, were not qualified and were not honest in the opinions they held. The fact that some worked for a company related to one of the parties or that others have been regular expert witnesses for a particular party was not persuasive in terms of undermining their credibility.
[34] What is important in assessing the evidence is to look at what was said and what was done and to give the evidence the appropriate weight in the full context of the record. There is no evidence that any witness deliberately tried to mislead nor that those who conducted tests did so for the purpose of having the tests fail.
[35] On many key points there was not much direct conflict, discrepancies between witnesses were generally based on addressing slightly different questions. The evidence was often carefully nuanced, in part due to equally nuanced questions.
[36] Dr. McClelland was singled out for particular attack on his opinions and the integrity of his evidence. I have found his evidence, both in affidavit form and under cross-examination, to be clear, cogent and rational. I see no basis for suggesting that he was anything but forthright.
E. SECTION 27(5) PATENT ACT
[37] Abbott defends the patent’s validity, particularly in respect of Claims 1, 15 and 16-21 by arguing that, where a claim is made in the alternative, so long as one alternative is patentable, the claim is valid. Put another way, Abbott contends that even if one or more alternatives in the claim includes unpatentable matter, that fact does not affect the overall validity of that claim in the patent.
[38] In effect, Abbott says that Apotex would have to be able to allege that every alternative in the '732 patent is not patentable in order to succeed in this case. Abbott says it would be unfair for it to lose patent protection just because one small part of a claim was bad.
[39] Section 27(5) does not speak directly to this point. The provision reads:
27. (5) For greater certainty, where a claim defines the subject-matter of an invention in the alternative, each alternative is a separate claim for the purposes of sections 2, 28.1 to 28.3 and 78.3.
27. (5) Il est entendu que, pour l'application des articles 2, 28.1 à 28.3 et 78.3, si une revendication définit, par variantes, l'objet de l'invention, chacune d'elles constitue une revendication distincte.
[40] The starting point of this analysis is the patent itself and the construction of that patent. The '732 patent teaches how to obtain Form II by mixing amenes and solvents rather than by means of heating. The first 15 claims are “method” or “process” claims while claims 16-21 are compound claims.
[41] Claim 1 is the broadest claim, Claim 13 relates to the amenes group and Claim 15 refers to the use of 17 solvents.
[42] The principles of patent construction were reviewed by Justice Binnie in Free World Trust v. Électro-Santé Inc., [2000] 2 S.C.R. 1024 and Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067. The principles were summarized by Harrington J. in Biovail Pharmaceuticals v. Canada, [2005] F.C.J. No. 7 as follows:
1. A patent is construed as a bargain between the inventor and the public. In consideration of disclosing the invention, the inventor is given a temporary monopoly to exploit it.
2. It is a statutory requirement that the patent contain a specification and end with a claim or claims “defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed”. The specification must be sufficiently full, clear, concise and exact “as to enable any person skilled in the art or science to which it pertains, or to which it is most closely connected, to make, construct, compound or use it”. (Patent Act, R.S.C. 1985, c. P-4, as amended, s. 27)
3. The patent is notionally addressed to a person skilled in the art or science of the subject-matter and is to be read as such a person would have read it when it first became public. (More will be said about this skilled reader.)
4. The claims are to be read in an informed and purposive way to permit fairness and predictability and to define the limits of the monopoly “[I]ngenuity of the patent lies not in the identification of the desired result but in teaching one particular means to achieve it. The claims cannot be stretched to allow the patentee to monopolize anything that achieves the desired result” (Free World Trust, paras. 31, 32).
5. The claim portion of the patent specification takes precedence over the disclosure portion in the sense that the disclosure is read to understand what was meant by a word in the claims “but not to enlarge or contract the scope of the claim as written and thus understood” (Whirlpool, para. 52).
6. It is only such novel features that the inventor claims to be essential that constitute the “pith and marrow” of the claim. “The key to purposive construction is therefore the identification by the Court with the assistance of the skilled reader, of the particular words or phrases in the claims that describe what the inventor considered to be the “essential” elements of his invention” (Whirlpool, para. 45).
7. Some elements of the claimed invention are essential and others are not, based either on common knowledge when the patent was published or according to the intent of the inventor, expressed or inferred from the claims. This lies at the heart of Biovail’s position that Novopharm’s allegation that it will not infringe the '320 patent is not justified. Put another way, was it obvious at the time the patent was published that the substitution of a variant would make a difference?
8. To overclaim is to lose everything. If the inventor underclaims, the court will not broaden the monopoly in the interests of the “spirit” thereof. This often, as in this case, results in layers of claims, each limitation serving as a potential safety net so that if the broadest claims fail, the monopoly may be saved in part by the more modest claims.
9. Yet a patent is not an ordinary writing. It meets the definition of a “regulation” in the Interpretation Act, and must be read to assure the attainment of its objects. “Claims construction is a matter of law for the judge, and he was quite entitled to adopt a construction of the claims that differed from that put forward by the parties.” (Whirlpool, para. 52)
[43] The person skilled in the art has been described by Binnie J. in Free World Trust v. Électro-Santé Inc. (2000), 9 C.P.R. (4th) 168, at paragraph 44, as follows:
The courts have traditionally protected a patentee from the effects of excessive literalism. The patent is not addressed to an ordinary member of the public, but to a worker skilled in the art described by Dr. Fox as:
A hypothetical person possessing the ordinary skill and knowledge of the particular art to which the invention relates, and a mind willing to understand a specification that is addressed to him. This hypothetical person has sometimes been equated with the “reasonable man” used as a standard in negligence cases. He is assumed to be a man who is going to try to achieve success and not one who is looking for difficulties or seeking failure. [Fox, H.G. The Canadian Patent Law and Practice relating to Letters Patent for Inventions 4th ed Toronto: Carswell 169 at 184]
[44] Abbott must establish that there are alternative claims in the relevant claim. This issue was examined in Abbott Laboratories et al v. The Minister of Health and Ratiopharm 2005 FC 1095 dealing with this same patent but focused primarily on non-infringement although issues of validity were also addressed. The evidentiary base of that case and this instance case are somewhat different, as were some of the legal arguments.
[45] Without reference to any other evidence, I would have immediately adopted the reasoning of Justice von Finckenstein, principally, that claim 15 uses the exact words “selected from the group consisting of”, as well as the word “and” instead of “or” before enumerating the last solvent. That would indicate that the use of all of the named solvents would produce Form II.
[46] However, Dr. Cima, an expert for Apotex, admitted under cross-examination that in respect of Claim 1, the solvents were claimed as alternatives to each other and that a person skilled in the art in February of 1998 (the claim date is July 29, 1996) would have understood it to be claimed as alternatives. (Application Record, Vol. IV (Transcripts), p. 847, Q. 289 and 290)
[47] Claim 1 and Claim 15 are structured similarly opening with “… a solvent selected from the group consisting of …” and with “and” as the penultimate word of the claim.
[48] Dr. Cima’s answer is the only evidence relied upon by Abbott. Having reviewed his evidence on this point, it is unclear whether Dr. Cima understood the purport of the question. His answer flies in the face of the wording of the patent. There is insufficient evidence, given the multitude of experts who said nothing about the issue, to say that on the balance of probabilities, there were alternate claims and the patent would be understood as such. I am not satisfied that there are alternative claims.
[49] Even if Dr. Cima’s answer is to the effect urged by Abbott that there are alternate claims in Claim 1 and 15, s. 27(5) cannot be interpreted in the manner argued by Abbott.
[50] The specific wording of s. 27(5) limits its application to three sections of the Patent Act, evidencing a legislative intention to circumscribe the operation of the section. S. 27(5) did not say something to the effect of “For all purposes…”.
[51] The sections of the Patent Act to which s. 27(5) refers are (a) section 2 – the definition provision; (b) section 28.1 – the claim date provision; (c) section 28.2 – the non-prior disclosure provision; (d) section 28.3 – the non-obvious provision; and (e) section 78.3 – transitional provision related to s. 43. Therefore, the application of s. 27(5) is very limited within the operation of the Patent Act itself.
[52] S. 27(5) is part of the provisions under the heading “Application for Patents”. The section requires that if there are alternative claims, each alternative meet the test for patentability – novelty, utility and inventiveness. Failure to establish that each alternative meets the test for patentability would result in the alternative being invalid as well as the whole of the claim.
[53] S. 27(5) does not direct that alternatives in a claim constitute a separate claim for purposes of either s. 27 and 58. It is particularly significant that s. 58 is not included by reference in s. 27(5) because s. 58 allows a court to sever an invalid claim from a patent and allow the remainder of the patent to survive.
[54] The conflicting interpretations result in Abbott arguing that so long as one alternative in a claim is valid, the whole claim is saved and Apotex saying that if one alternative is proven not to be patentable, the whole claim fails.
[55] Abbott makes this argument on the effect of s. 27(5) without reliance on any direct authority in support. One would have thought that if s. 27(5) had the scope argued by Abbott, it would have been the subject of at least some learned writing if not actual decisions of this Court.
[56] Given that alternative claims can result in a vast number of claims and the general adverse consequences of overclaiming, I interpret the application of s. 27(5) more narrowly than Apotex. It applies only to the named provisions and is principally an administrative provision for purposes of a patent application.
[57] Therefore, even if the claim (1 or 15) is in the alternative, if Apotex establishes that an alternative is not patentable, the whole claim fails – at least for purposes of an NOC.
F. NOVELTY
[58] Apotex has alleged that Form II is an old product for which Abbott cannot have a valid patent on the basis of a product by process claim. Hoffman-La Roche & Co. Ltd. v. Commissioner of Patents (1955), 23 C.P.R. 1 (S.C.C.) is still good law in Canada; the principle of novelty is still contained in s. 2 of the Patent Act. I do not understand Canwell Enviro-Industries Ltd. v. Baker Petrolite Corp. et al (2002), 17 C.P.R. (4th) 478 to have eliminated the requirement for novelty. That decision is more relevant to issues of disclosure.
[59] In addition, Apotex alleges that Form II has been disclosed prior to the claim date. For this, it relies most particularly on an article by I.I. Salem entitled “Clarithromycine found in analytical profiles of drug substances and excipients” Vol. 24 published by Academic Press Inc. San Diego – 1996.
[60] Apotex also relies upon the prior sale and use of the tablets BIAXIN.
Old Product
[61] As Dr. Bryn attested, prior to the priority date, Clarithromycine was known without a numerical reference. It was known to have a melting point of 225°C. What is now called Form I does not have a melting point, it simply changes its molecular shape at something beyond 135°C and has now been labelled Form II. This process of obtaining Clarithromycine through heating was well-known before the priority date.
[62] Dr. Cima confirmed that the '732 patent clearly admitted that the practice at the time of the priority date was to make Form II (which the '732 patent states to have been in the marketed product at the time of the priority date of the '732 patent) by thermal conversion at a temperature greater than 80°C.
[63] The evidence of Drs. Hendrickson, Brown and Myerson is all to the same effect - that Form II was a known product well before the priority date. In essence, Clarithromycine upon heating moves from Form I, to Form II at 135°C and the substance melts at 225°C. What Abbott has done is give a name or numerical designation to each of these forms.
[64] The fact that Form II is “old product” was highlighted by five European Patent Applications dating back as far as 1981 up to 1988 in which solvents were used to obtain Form II.
[65] A similar description of the process was contained in the 1984 Journal of Antibiotics. To the same effect were articles published in the Journal of Antibiotics in 1990, 1991 and 1993. The 1980 European Patent Application and the 1984 Journal of Antibiotics both describe what is Example II in the '732 patent.
[66] Abbott’s Dr. Myerson confirmed in cross-examination that the 1980 European Patent Application describes the same crystallization of Form II using water and solvents as are described in the '732 patent.
[67] This aspect of Apotex’s evidence establishes the allegation in the NOA that Form II was old product. Abbott has no satisfactory answer to this allegation other than to say that what was produced, either through heating or the use of solvents, was not called Form II.
Prior Disclosure/Anticipation
[68] Apotex alleged that the invention described in the '732 patent had been anticipated by the Salem article. While the exact date of publication is not certain, it is certain that the priority date of the patent was July 29, 1996.
[69] To be able to establish anticipation, Apotex must establish that the Salem article was available to the public in Canada or elsewhere prior to the priority date. The evidence must satisfy the requirements of subsection 28.2(1)(a) and (b) set out below:
28.2 (1) The subject-matter defined by a claim in an application for a patent in Canada (the "pending application") must not have been disclosed
(a) more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject-matter became available to the public in Canada or elsewhere;
(b) before the claim date by a person not mentioned in paragraph (a) in such a manner that the subject-matter became available to the public in Canada or elsewhere;
28.2 (1) L'objet que