[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.)).

[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.

[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.

[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)

[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.

DMC comment: The Court expressly rejected American jurisprudence and practice as support for a literal interpretation of the phrase “consisting essentially of” as having no support in Canadian 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.

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